Access to Medicine
Index 2022

Access to Medicine Index 2022

ACKNOWLE DG E M E NTS
The Access to Medicine Foundation would like to thank thefollowing people and organisations for their valuable contributions to this report.
FU N D E RS

UK Foreign, Commonwealth, and Development Office
The Dutch Ministry of Foreign Affairs
Bill & Melinda Gates Foundation
Leona M. and Harry B. Helmsley Charitable Trust
AXA Investment Managers
Wellcome Trust

E XPE RT R E VI E W

R E VI E WE RS

R ES E ARCH TE AM

E D ITO R IAL TE AM

CO M M IT TE E

François Bompart

James W. Hazel

Eleanor Bley Griffiths

Hans Hogerzeil (Chair)

Cathyryne Manner

Emma Shiffman

Jana Jacobs

Emily Bleimund

Jennifer Dent

Alexa Ruiz

Tessa Wiles

Githinji Gitahi

Mariana Roldão Santos

Moy Bracken

Michela Gregory

Niranjan Konduri

Kasper BlomOTH E R CO NTR I B UTO RS

Fumie Griego

Nine Steensma

Sjors van Gijzel

The Access to Medicine

Martha Gyansa-Lutterodt

Sébastien Morin

Elisabetta Cesari

Foundation would like to

Dennis Ross-Degnan

Esteban Burrone

Marina Plazas Domènech

thank the different stake-

Alan Staple

Joseph Saba

Diane Dinar-Farjon

holders working to improve

Fatima Suleman

Veronika J. Wirtz

access to medicine who

Klara Tisocki

Prashant Yadav

contributed their views dur-

Prashant Yadav

ing the development of thisAccess to Medicine Index.

ACCESS TO M E D I CI N E FO U N DATI O N

The Access to Medicine Foundation is an independent nonprofit organisation that seeks to transform the healthcare
ecosystem by motivating and mobilising companies to expand
access to their essential healthcare products in low- andmiddle-income countries.
Naritaweg 227-A
1043 CB, Amsterdam
The Netherlands
For any queries about the 2022 report, please contact
James Hazel
Research Programme Manager
jhazel@accesstomedicinefoundation.org+31 (0) 20 215 3535
www.accesstomedicineindex.org

2

Access to Medicine Index 2022

FO REWO RD

Beyond COVID-19:
learning the lessons
on equitable access

The COVID-19 pandemic has shown us the power of science,as unprecedented R&D efforts have brought life-saving vaccines and therapies to market in record time. But it has also
underscored the divide between rich and poor countries,
exposing alarming gaps that still leave hundreds of millions ofpeople without adequate access to medicine.
The past three years have demonstrated that the need forequitable access to medicine has never been more importantor more urgent. Pharmaceutical industry leaders and policymakers must now learn the lessons of the worst healthcare
crisis in a century to tackle the chronic lack of affordable
healthcare beyond the pandemic.
Our 8th Access to Medicine Index finds that, while R&D

forward since such licences – which allow generic manufac-

efforts against COVID-19 have clearly paid off, sadly there has

turers to supply patented products in many LMICs – are one

been little progress in addressing R&D gaps for other emerg-of the most effective ways to get medicines to under-served

ing infectious diseases and future pandemic threats. This is acommunities.

major missed opportunity, given the great strides in vaccine
technology that could help people worldwide.

However, while multinational companies have implemented
more access plans and strategies in LMICs, the quality and

My team has been monitoring the pharmaceutical indus-

geographic spread of this work still varies widely. Accesstry’s role in global health for nearly two decades. By bench-

strategies are less likely to cover low-income countries andmarking leading players – based on actual performance,plans for non-communicable diseases lag well behind those

not just promises – the Access to Medicine Index provides afor infectious diseases.

unique insight into how individual companies are performing.

Unfortunately, COVID-19 has only widened the inequities

It also acts as a roadmap to the tried-and-tested measuresin global health, having taken the greatest toll on vulnerable

that companies can deploy to remove access barriers. The

populations in low-resource settings. Our latest Index there-

aim is simple: to ensure that people in low- and middle-in-fore comes at a pivotal time in determining if pharmaceuticalcome countries (LMICs) get the choice of affordable medi-companies are now ready to put sustainable access front

cines they deserve, from vaccines against emerging infections

and centre in their strategies. The conclusion must be that –to treatments for diabetes and cancer.

despite some progress – there is still a way to go.

By taking the appropriate steps, pharmaceutical companies
will not only help some of the world’s poorest people facing
the highest burden of disease. They also stand to improve thesustainability of their businesses by opening up new markets
for their products.
Overall, our latest insights show there has been progress ina few key areas, although the picture is patchy.
Encouragingly, non-exclusive voluntary licensing (NEVL) is3

now being used beyond products targeting HIV, hepatitis andJayasree K. Iyer

tuberculosis, with the inclusion of both COVID-19 therapeu-

Chief Executive Officer

tics and a treatment for leukaemia. This is an important step

Access to Medicine Foundation

Access to Medicine Index 2022

Table of Contents
5127

B EST PR ACTI CES

128▶ Best practices in Governance of Access

131▶ Best practices in Research & Development137▶ Best practices in Product Delivery

147

CO M PANY RE PO RT CARDS148

AbbVie Inc

152

Astellas Pharma Inc

156

AstraZeneca plc

160

Bayer AG17	First voluntary licence for a cancer treatment is a

164

Boehringer Ingelheim

promising sign for future expansion of access to168

Bristol Myers Squibb

innovative medicines

172

Daiichi Sankyo Co, Ltd

176

Eisai Co, Ltdto more products, but with limited breadth and180

Eli Lilly & Co

depth

184

Gilead Sciences

9

EXECUTIVE SU M MARY
2022 I N D EX

10	Companies approach access to medicine more
systematically, yet show stagnation in some key areas
13
15

How the companies compare in 2022
KE Y FI N D I NGS

15	Some companies engaging in R&D for emerging
infectious diseases, but pipeline mainly empty

19	More access plans and strategies to expand access

188

GSK plc

21

SPECIAL RE PO RTS

192

Johnson & Johnson

21▶ COVI D -19 & PAN D E M I C PR E PAR E D N ESS

196

Merck & Co, Inc (MSD)	Assessing pharma companies' response to COVID-19

200

Merck KGaA (Merck)and the threat of future pandemics

204

Novartis AG▶ WO M E N ’ S S E XUAL & R E PRO D U C TIVE H E ALTH

208

Novo Nordisk A/S212

Pfizer Inc

reproductive health access barriers for women and216

Roche Holding AG

girls?

220

Sanofi▶ PRO G R ESS ANALYS I S

224Takeda Pharmaceutical Co, Ltd33

	Are pharma companies addressing sexual and47	Is the industry making progress on improving accessto medicine?

APPE N D ICES

229

I

Key parameters for evaluation

56

TECH N I CAL ARE AS

234

II

Indicators and scoring guidelines

57▶ G OVE R NAN CE O F ACCESS

246

III

Identifying best practices

58

How the companies perform

247	IV 	The Good Practice Standards framework for

59

Governance strategy & responsible business 		
practices4228

capacity building
249

V

Guide to Report Cards

251

VI

Definitions

62▶ R ES E ARCH & D E VE LO PM E NT

254

VII

Figures

63

How the companies perform

256

VIII References

64

Pipeline analysis

70

Access planning77▶ PRO D U C T D E LIVE RY

78

How the companies perform

79

Portfolio analysis

81

Registration

88

Access strategies

99

Licensing

105

Product donations

109

Inclusive business models

117

Supply, quality & manufacturing

Access to Medicine Index 2022 ▶ Executive Summary

Executive Summary

I NTRO D U C TI O NGlobally each year, millions of people suffer illness or lose their lives because thevaccines, medicines and diagnostic tests that they need are either unavailable orunaffordable – and this lack of access to medicine is acute in low- and middle-income countries (LMICs). While the COVID-19 pandemic laid this inequity bare, italso saw the pharmaceutical industry develop and bring new vaccines and treatments to market at unprecedented speed. As the world emerges from the worstof this crisis, pharmaceutical companies are now at an important juncture, where
lessons learned from the pandemic can prove pivotal in finding solutions to bridge
long-standing gaps in access to medicine in LMICs.
Every two years, the Access to Medicine Index evaluates and compares 20 of theworld’s leading research-based pharmaceutical companies according to their efforts
to improve access to medicine in LMICs.* These 20 companies account for morethan half of global pharmaceutical revenue, with pipelines, portfolios, resources,and global reach that give them the unique capacity to develop and market theinnovative health products that people in LMICs need. The Index ranks companies
on their performance on priority access-to-medicine topics, while identifying bestpractices and examples, and highlights areas where progress has been made andareas where critical action is required. The methodology is updated every two
years in line with developments in access to medicine and global health following awide-ranging multi-stakeholder dialogue.
The 2022 Access to Medicine Index report marks the eighth edition of the Accessto Medicine Index, which was first published in 2008. A total of 31 metrics cover
the core role for pharmaceutical companies on access to medicine in strategy, compliance, R&D, pricing and product delivery, making up the framework within which
company performances are analysed over two years (1 June 2020 to 31 May 2022).
Data analysed relates to 83 diseases, conditions and pathogens that disproportionately impact people living in the 108 LMICs in scope of the Index where better
access to medicine is most urgently needed.
This report outlines the key findings and overall ranking analysis of the 2022 Accessto Medicine Index before presenting a detailed analysis of company performancesand rankings in each of three Technical Areas assessed by the Index: Governance ofAccess, Research & Development, and Product Delivery. The report concludes with
20 detailed, tailored company report cards. These explain each company’s rank in
the Index by providing a contextualised analysis of the company’s access-to-medicine performance, its relevant product portfolio and R&D pipeline, and company-specific opportunities to improve access to medicine.

5* Indexes have been published in 2008,2010, 2012, 2014, 2016, 2018 and 2021.
The publication date of the previous Index
was postponed from November 2020
to January 2021 due to the impact of
the COVID-19 pandemic. However, theperiod of analysis was not extended andremained the same. Each Index analyses
two years’ worth of data.

Access to Medicine Index 2022 ▶ Executive Summary
H OW D I D TH E I N D USTRY PE R FO R M?

The 2022 Access to Medicine Index finds that more companies stepped up theiraccess efforts – including some companies that were previously less likely to takeaction.
Overall, there has been an industry-wide improvement in R&D access planning;for 77% of projects nearing the end of the R&D pipeline, companies now have aplan in place to promote access after product launch, compared with 40% in theprevious Index. The Index also finds examples of companies that are strengthening
delivery of their products, with standout companies reporting strong equitable
access strategies across different country income groups. For the first time, all
20 companies in scope report an access-to-medicine strategy, with 19 integrating
this into their overall corporate strategy. Additionally, three more companies haveengaged in voluntary licensing agreements, which means 50% of the companies inscope are allowing generic manufacturing of specific on-patent products in certain
countries. This can increase regional availability, supply and affordability of new andinnovative medicines that would otherwise not reach many people living in LMICs.
However, much of this progress is disproportionate, with low-income countries still widely overlooked. Only 15% of access plans include at least one of the
27 low-income countries in scope; conversely, 85% include at least one of the 26
upper-middle income countries. Upper-middle income countries are thus six times
more likely to be included in companies’ access plans for a late-stage R&D project.
Furthermore, companies' R&D access plans, and their access strategies for products in their portfolios, are often limited in depth and breadth, sometimes only containing one or a few of the most basic elements. When this is the case, such plans
and strategies are less likely to secure long-term, sustainable access to a product.
While sustainably expanding access to healthcare products across LMICs – particularly low-income countries – is a complex challenge, some companies havereported ambitious commitments to improving access in these countries. If suchcommitments are successfully translated into action going forward, and current
access efforts are scaled across portfolios and across countries, more people withthe greatest need stand to benefit.
2022 KE Y FI N D I N GS

• R&D pipeline for emerging infectious diseases mainly empty: Successive editions of the Index show that prior to the COVID-19 pandemic, companies werelargely not engaging in R&D for emerging infectious diseases (EIDs). Apart froman increase in R&D for coronaviral diseases, this picture has not changed. Only
five of the 20 companies in scope – Bayer, Johnson & Johnson, Merck, MSD and
Takeda – are active in this area, and they target a small number of the EIDs identified as those with the potential to trigger the next pandemic or epidemic.
• Breakthrough voluntary licence for a cancer treatment is a promising sign: Morecompanies are newly engaging in voluntary licences and technology transfers. Six
companies entered into new licensing agreements covering at least one LMIC inscope, with AstraZeneca, Eli Lilly and Novartis doing so for the first time. A significant milestone is Novartis signing a voluntary licence for a leukaemia drug with
the Medicines Patent Pool, the first such agreement covering a non-communicable disease.
• More access plans and strategies, but limited breadth and depth: Six companies – Astellas, Boehringer Ingelheim, Johnson & Johnson, Merck, Novartis andTakeda – now have access plans in place for 100% of late-stage R&D projects, andthe proportion of projects covered by such plans has increased overall among the
20 companies in scope. In addition, more products in companies’ portfolios are
now covered by access strategies. However, many company R&D access plans,
and many strategies for existing products, consistently overlook the poorest
countries and are not yet comprehensive enough to ensure access on the scalerequired.

6

Access to Medicine Index 2022 ▶ Executive Summary

ATMI22_overallRanking_cond

2022 ACCESS TO M E D I CI N E I N D E X – OVE R ALL R AN KI N G
1 GSK plc

4,06

2 Johnson & Johnson

4,03

3 AstraZeneca plc

3,93

4 Novartis AG

3,87

5 Merck KGaA (Merck)

3,72

6 Pfizer Inc

3,62

7 Takeda Pharmaceutical Co, Ltd

3,51

8 Sanofi

3,47

9 Bayer AG

3,36

10 Roche Holding AG

3,23

11 Novo Nordisk A/S

2,97

12 Eisai Co, Ltd

2,95

13 Boehringer Ingelheim

2,93

14 Gilead Sciences

2,84

15 Bristol Myers Squibb

2,60

16 Astellas Pharma Inc

2,46

17 Daiichi Sankyo Co, Ltd

2,20

18 Merck & Co, Inc (MSD)

2,15

19 AbbVie Inc

1,84

20 Eli Lilly & Co

1,79
0

1

2

● Governance of Access3

4● Research & Development

5● Product Delivery

2022 R AN KI NG ANALYSIS
Although GSK retains the number one spot, it is by

LE AD E RS PE R TECH N I C AL AR E A

a very narrow margin ahead of Johnson & Johnson,
which has moved up from third in 2021. AstraZeneca▶ Governance of Accesshas newly joined the top three, having risen from

Pfizer leads with AstraZeneca, GSK, Johnson & Johnson, Novo Nordisk,

the seventh spot in the previous Index. These three

Sanofi and Takeda following closely behind. These companies scorecompanies are also in the top three for the Producthighly in all areas related to governance and strategy, as well as in most

Delivery Technical Area, with AstraZeneca taking theareas of responsible business practices.

lead by excelling in its approach to patent transparency and technology transfers.

▶ Research & Development

GSK leads the 2022 Index ranking by engaging

GSK leads with the largest pipeline comprised of projects that target

in R&D to develop treatments for diseases that dis-well-established treatment priorities. Johnson & Johnson and Novartis

proportionally affect people living in LMICs and byfollow closely behind, scoring well across all assessment criteria includ-

applying tailored access strategies across producting R&D access planning and R&D capacity building.

categories. For some products, these access strategies include voluntary licences.

AstraZeneca leads, with improved performance across several areas

improving its performance in R&D – with the broad

including tailored access strategies across different country income

geographic reach of its R&D access plans high-classifications in all product categories, as well as supply and manufac-

lighted as a best practice in the 2022 Index. Merckturing capacity building. GSK, Johnson & Johnson and Novartis follow

joins GSK, Johnson & Johnson, AstraZeneca andclosely behind, GSK and Novartis with new licensing agreements in

Novartis in the top five. It excels in R&D accessplace and Johnson & Johnson leading in its approach to access strate-planning, with access plans in place for all late-stage

gies for supranationally procured products.

R&D projects, in addition to performing strongly in
its approach to patent transparency.

7▶ Product Delivery

For the first time, Bayer has joined the top ten,Access to Medicine Index 2022 ▶ Executive Summary

FI N D I NGS PE R TECH N ICAL ARE A▶ Governance of Access• For the first time, all 20 companies report a defined access-to-medicine strategy,
with 19 companies integrating this into their overall corporate strategy; only 11
companies had integrated strategies in the 2021 Index.
• Over half of the companies have a governance system that includes direct boardlevel responsibility for access-to-medicine activities and access-related incentives
for the CEO, senior management and in-country/regional managers to encouragethem to perform towards achieving access goals.
• The number of companies decoupling sales’ agents rewards from sales targets
has steadily increased over time, with all but two companies now taking this step.
Compensation is increasingly tied to qualitative performance indicators, such astechnical knowledge or compliance adherence▶ Research & Development• The 20 companies have 1,060 R&D projects in the pipeline for the 83 diseases,
conditions and pathogens in scope. Most of these R&D projects (64%) target
non-communicable diseases.
• Over 70% of the internationally identified R&D priorities for LMICs remain unaddressed by the companies in scope. This includes maternal health conditions suchas hypertensive disorders during pregnancy, and infectious diseases such as bunyaviral diseases.
• 15 companies participate in R&D capacity building, with the Index identifying
52 R&D capacity building initiatives. These initiatives range from building clinical trial capacity to empowering R&D researchers in LMICs to facilitate drug
development.
• The Index shows 77% of late-stage R&D projects are accompanied by an accessplan (compared to 40% in 2021), but the quality and geographic scope of accessplans vary widely.
• Six companies now have access plans in place for 100% of their late-stage R&D
projects – the first time any company has reported this to the Index.
▶ Product Delivery• Products are more likely to be filed in upper-middle income countries such as
Brazil, Mexico and Thailand, rather than in low-income countries. The countries
with no filings for registration include the Pacific Islands, Djibouti, Guinea-Bissau
and Lesotho.
• Access strategies with the biggest potential impact in terms of equitable accessare those that aim to make products affordable for all patients across the income
pyramid. Of the products assessed by the Index, 83% are covered by an accessstrategy in at least one of the LMICs in scope, compared with 58% in the previous
Index.
• Despite the progress, the Index finds that the access gap is widening for low-income countries, for which 65% of products analysed do not have an access strategy (compared to 19% of products in upper-middle income countries).
• The Index identified 13 companies that take a comprehensive approach to ensuring uninterrupted supply of their products while paving the way for continuous
supply of products outside of their portfolios. These companies have processes
in place for mitigation of supply risks like demand surges and active pharmaceutical ingredient (API) shortages. At the same time, they show evidence of building
capacity of local suppliers and manufacturers in LMICs.

8

Access to Medicine Index 2022
The 2022 Access to Medicine Index provides a finely detailed
picture of how 20 of the world’s largest pharmaceutical companies take action to address access to medicine. This firstsection of the report provides the core analyses of how thecompanies in scope performed. It includes:
I N D E X R AN KI N G & ANALYS I S• Companies approach access to medicine more systematically, yet show stagnation in some key areas• How the companies compare in 2022
KE Y FI N D I N GS

• Some companies engaging in R&D for emerging infectious
diseases, but pipeline mainly empty• First voluntary licence for a cancer treatment is a promising
sign for future expansion of access to innovative medicines• More access plans and strategies to expand access to moreproducts, but with limited breadth and depth
S PECIAL R E PO RTS• Assessing pharma companies' response to COVID-19 andthe threat of future pandemics• Are pharma companies addressing sexual and reproductive
health access barriers for women and girls?
• Is the industry making progress on improving access to
medicine?

9

Access to Medicine Index 2022 ▶ Industry Trends

I N DUSTRY TRE N DS

Companies approach access to medicine more
systematically, yet show stagnation in somekey areas
In assessing how the pharmaceutical industry is performing as a whole, the 2022

IN BRIEF

Access to Medicine Index can identify some signs of progress, with more companies▶ For the first time, all 20 companies

taking an increasingly systematic approach to access to medicine. This includes

have an access-to-medicine strat-

addressing access as part of corporate strategy, and implementing systematic

egy. 19 have integrated this into

approaches to ensure that products are already covered by ‘access plans’ while they

their overall corporate strategy.

are still in the R&D phase. The 20 companies in scope are also using a variety of▶ Companies are increasingly put-

access strategies to improve access to the products in their portfolios in low- andting access plans in place before

middle-income countries (LMICs), including voluntary licensing, equitable pricing

launching new products, but analy-

strategies, and manufacturing capacity building, with an increase in the use of thesesis shows plans have limited depth

strategies.

and breadth.

However, progress is not uniform across the companies, particularly when it▶ During the period of analysis, com-comes to product delivery, i.e., ensuring healthcare products are accessible, afforda-

panies pursued 68 R&D projects

ble and available to people living in LMICs. There have also been limited changes infocused on coronaviral diseases.

the makeup of the R&D pipeline, leaving significant gaps. For example, there is little

Non-communicable diseases oth-

R&D activity to address the majority of emerging infectious diseases, and new anderwise continue to dominate theimproved treatments are still urgently needed for conditions including mycetoma,

pipeline.

river blindness, and postpartum haemorrhage. Areas of stagnation are holding the▶ Companies have access strategies

industry back from making wholesale progress on ensuring equitable access toin place for a greater proportion

medicine for people living in LMICs.

of products, but are less likely tohave strategies to expand access

Improvements in governance of access
For the first time, all 20 companies have a defined access-to-medicine strategy, up

countries.

from 17 in the previous three Indexes. This is a number that has risen significantly▶ Encouragingly, the use of voluntary

over time since the 2010 Index, when the figure was eight. Further, all but one oflicensing has grown, which could

the companies have now also integrated their access-to-medicine strategies into

increase the supply and affordabil-

their overall corporate strategy. An increase in good practice can be seen in mostity of more products.

areas of Governance of Access, in particular a move towards engaging in more
responsible sales and promotional practices, e.g., decoupling sales agents’ financial
rewards from sales targets.
Pre-launch, companies increasingly plan for access to new productsCompanies have progressed in introducing frameworks for access planning andintegrating this approach into their R&D process. Fifteen companies now have astructured policy in place to create an access plan for each late-stage R&D project in the pipeline, compared to eight companies in 2021. Notably, this year bothBoehringer Ingelheim and Bayer have introduced comprehensive new policies toplan for access during the R&D stage. In a sign that this systematic approach canlead to results, 77% of late-stage R&D projects are now accompanied by an accessplan (compared to 40% in 2021), and six companies now have access plans forall of their late-stage R&D projects, up from zero in the 2021 Index. However, thequality of these access plans varies greatly. The industry has less-robust plans for
non-communicable diseases (NCDs) compared to communicable diseases, andmany companies’ plans are limited in scope and scale.

10

to their products in the poorest

Access to Medicine Index 2022 ▶ Industry Trends

Little change in R&D pipeline, gaps remain
The total number of projects in development has remained relatively consistent
with the last Index (1,060 in 2022 and 1,073 in 2021). Companies continue to focus
on developing products targeting NCDs; almost half of all R&D projects analysed by
the Index target a type of cancer.
For projects targeting communicable diseases, companies continue to invest
R&D resources in malaria, HIV/AIDS and tuberculosis, as well as coronaviruses suchas COVID-19. Seventeen of the companies engaged in R&D for coronaviruses during
the period of analysis. For emerging infectious diseases such as Nipah and Marburg,
none of the companies have projects in the pipeline, and the number of projects
targeting neglected tropical diseases has also dropped. However, both the quantityand quality of companies’ R&D capacity building initiatives in LMICs have increased
since the previous Index.
Tentative signs of improvement in product delivery
Companies are using access strategies to expand access to more of their products.
This refers to, for example, the use of equitable pricing strategies, patient assistance programmes, or voluntary licences. Of the products assessed by the Index,
83% are covered by an access strategy in at least one country in scope, up from
58% in the previous Index. However, the increase in the proportion of products
covered by an access strategy is disproportionately observed in middle-income
countries, compared to low-income countries. There is also variation in the qualityof companies’ access strategies.
One tentative sign of progress is the increased use of voluntary licensing, which
can be used by pharmaceutical companies to enable generic medicine manufacturers in LMICs to produce generic versions of their on-patent drugs, thereby increasing accessibility and affordability. Half of all companies in scope now engage in atleast one voluntary licence, and there are now more licences among the companies
overall – with COVID-19 products accounting for most of that increase. In addition,
for the first time, the use of voluntary licensing has expanded to cover a compoundtargeting an NCD.
The 2022 Index also finds that companies are engaging in more manufacturing capacity building initiatives, most notably technology transfers related to thelicences for COVID-19 vaccines and therapeutics, although these are taking place in
only a handful of the countries in scope.

11

Access to Medicine Index 2022 ▶ Industry Trends

2022 ACCESS TO MEDICINE INDEX – OVERALL RANKING
1= 1

GSK plc

4,06

2 ▲ 3

Johnson & Johnson

4,03

3 ▲ 7

AstraZeneca plc

3,93

4 ▼ 2

Novartis AG

3,87

5 ▲ 8

Merck KGaA (Merck)

3,72

6 ▼ 4

Pfizer Inc

3,62

7 ▼ 6

Takeda Pharmaceutical Co, Ltd

3,51

8 ▼ 5

Sanofi3,47

9 ▲ 13 Bayer AG

3,36

10 ▼ 9

Roche Holding AG

3,23

11 ▼ 10 Novo Nordisk A/S

2,97

12 ▼ 11 Eisai Co, Ltd

2,95

13 ▼ 12 Boehringer Ingelheim

2,93= 14 Gilead Sciences

2,84

15 ▲ 19 Bristol Myers Squibb

2,60

16 ▼ 14 Astellas Pharma Inc

2,46

17 ▼ 16 Daiichi Sankyo Co, Ltd

2,20

18 ▼ 15 Merck & Co, Inc (MSD)

2,15

19 ▼ 17 AbbVie Inc

1,84

14

20 ▼ 18 Eli Lilly & Co

1,79
0

rank 2022

rank 2021*

1● Governance of Access2

3● Research & Development

45● Product Delivery

GSK in top spot, Johnson &AstraZeneca leaps up to

Bayer and Merck** climb

A group of top-ten

Johnson close second

join the top three

the Index ranking

companies has emerged

GSK ranks in first place, aAstraZeneca is one of theBayer has newly joined the

The group of companies

position it has held since thebiggest movers in the 2022

top ten, rising from 13th toincluded in the top ten

first Index was published in

Index ranking. The company

9th. Merck has joined theremains relatively consistent2008. However, Johnson &has moved up to 3rd place,

top five, moving up from 8th

with the previous Index, withJohnson comes in very closecompared to 7th place in theplace in the previous Index.

these companies leading

second, rising from 3rd place.

previous Index.

on addressing access to
medicine.

12*In the 2021 Index, dense ranking wasused. In the 2022 Index, standard competitive ranking is used. Therefore, a directcomparison with the previous ranks of
AbbVie, Astellas, Bristol Myers Squibb,
Daiichi Sankyo, Eli Lilly and Merck & Co,
Inc (MSD) is not possible.

**Merck KGaA (Darmstadt, Germany)

Access to Medicine Index 2022 ▶ Industry Trends

R AN KI NG ANALYSISHow the companies compare in 2022
The Access to Medicine Index assesses how 20 of the world’s leading pharmaceutical companies perform on ensuring access to medicine for people living in LMICs.
The ranking is based on their scores in each Technical Area, with Product Delivery
weighted most highly, followed by R&D and Governance of Access.
Four companies stand out as leaders
In the 2022 Index, GSK retains the number one spot, followed closely by Johnson &Johnson. AstraZeneca has risen to third, with Novartis in fourth. These four companies are the clear leaders among the companies assessed by the Index.
GSK (1st) tops both the overall ranking and the R&D sub-ranking. The company
develops treatments and vaccines for diseases that disproportionally affect people in LMICs. It is also in the top three of the other two Technical Areas, and its
access-to-medicine strategy is central to its approach to ensuring that medicinesreach those that need them most. Johnson & Johnson (2nd) demonstrates strong
performance in all three Technical Areas and performs well across all assessment
criteria including access strategies, R&D access planning and capacity building.
AstraZeneca (3rd) has newly joined the top three, ranking as the number one
company in the Product Delivery Technical Area by excelling in its approach topatent transparency and technology transfers. The company also performs highly
in Governance of Access. Novartis (4th) performs well in R&D access planning andequitable access strategies and was the first company to agree a non-exclusive voluntary licence covering a product for a non-communicable disease.

FIGURE 1 Ranking per Technical Area

ATMI22_GA_Subranking

ATMI22_RD_Subranking

G OVE R NAN CE O F ACCESSPRO D U C T D E LIVE RY

1Pfizer

4.57

1

GSK

3.78

1

AstraZeneca

4.29

2

AstraZeneca

4.43

2

Johnson & Johnson

3.73

2

GSK

4.11

2

GSK

4.43

3

Novartis

3.70

3Johnson & Johnson

4.09

2

Johnson & Johnson

4.43

4

Merck KGaA (Merck)

3.40

4

Novartis

4.08

2

Novo Nordisk

4.43

5

Pfizer

3.15

5

Merck KGaA (Merck)

3.78

2

Sanofi

4.43

6AstraZeneca

3.03

6

Pfizer3.61

2

Takeda4.43

7

Takeda2.98

7

Takeda3.55

8

Astellas

4.29

8

Roche

2.88

8

Sanofi

3.53

8

Bayer

4.29

8

Sanofi

2.88

9

Bayer

10 Eisai

4.14

10 Bayer

2.65

10 Novo Nordisk

10 Merck KGaA (Merck)

4.14

11 Merck & Co, Inc (MSD)

2.38

11 Roche3.22

12 Boehringer Ingelheim

4.00

12 Boehringer Ingelheim

2.23

12 Gilead

3.18

12 Roche

4.00

13 Astellas

2.05

13 Eisai

3.13

14 BMS

3.86

14 Eisai

2.03

14 Boehringer Ingelheim

3.02

3.49
3.39

15 AbbVie

3.43

15 Gilead

1.93

15 BMS

15 Daiichi Sankyo

3.43

16 Eli Lilly

1.90

16 Astellas

15 Gilead

3.43

17 BMS

1.80

17 Daiichi Sankyo

2.17

15 Novartis

3.43

18 Daiichi Sankyo

1.63

18 AbbVie

1.98

19 Eli Lilly

3.29

19 Novo Nordisk

1.48

19 Merck & Co, Inc (MSD)

20 Merck & Co, Inc (MSD)

3.14

20 AbbVie

0

13

ATMI22_PD_Subranking

R ES E ARCH & D E VE LO PM E NT

1

2

3

4

5

1.75

20 Eli Lilly

0.78

0

2.69
2.18

1

2

3

4

5

1.31

0

1

2

3

4

5

Access to Medicine Index 2022 ▶ Industry Trends

Below the four leaders at the top of the Index ranking, the companies fall into threedifferent categories.
A high-performing group stands out by taking the lead in specific areas andconsistently performing above average across the three Technical Areas, while
companies in the middle-performing group still score relatively well but miss out ona higher ranking due to below average performance in one or more areas such as
R&D or Product Delivery. The lowest-ranked group comprises five companies thatparticularly fall behind in Product Delivery and perform below average in R&D.
The high-performing companies
The companies ranked 5th to 10th are high performers on access to medicine, competing closely in the overall ranking. Merck (5th) excels in R&D access planning,with access plans in place for all late-stage R&D projects and performs strongly its
approach to patent transparency. Pfizer (6th) leads in Governance of Access for its
approach to incentivising responsible promotional practices. Takeda (7th) is a topperforming company in R&D access planning and equitable access strategies for
products that are administered by healthcare practitioners. Sanofi (8th) performs
well in engaging in supranational procurement mechanisms to supply products in
LMICs; it also engages in R&D for neglected diseases that disproportionally affectpeople in poorer countries. Bayer (9th) has joined the top ten, improving its performance in R&D access planning and demonstrating best practice with the broad
geographic reach of its plans. Roche (10th) engages in high-quality health systems
strengthening initiatives and has improved in its approach to R&D access planning.
The middle-performing companies
Novo Nordisk (11th) has strong policies governing access and builds capacity byengaging in health systems strengthening. Eisai (12th) has an average performanceoverall across the three Technical Areas, with a particularly strong performance inlong-term product donations. Boehringer Ingelheim (13th) has an average performance in the Technical Areas, but has introduced a comprehensive new framework
for R&D access planning, and performs well in expanding access via inclusive business models. Gilead (14th) is a leading company in non-exclusive voluntary licensing,but its performance in R&D and Governance of Access is below average. Bristol
Myers Squibb (15th) has greatly improved its ranking this year, strengthening its
performance in Product Delivery through engaging in health systems strengthening
and access strategies. In R&D it is carrying out several clinical trials in countries inscope and commits to registering successful R&D candidates in those countries.
The low-performing companies
The bottom of the ranking is rounded out by five companies whose performanceis below average for much of the criteria assessed by the Index. Astellas (16th) has
strengthened its access planning processes during R&D and has comparatively
strong policies in place for Governance of Access, but falls behind its peers inapplying equitable access strategies to its products in LMICs. Daiichi Sankyo (17th)
performs relatively well in intellectual property (IP) sharing, but lags in all Technical
Areas. MSD (18th) has improved in R&D with the introduction of a new access planning policy. Yet is has a comparatively poor performance in the other two Technical
Areas, Governance of Access and Product Delivery, and is among the least transparent companies in scope. AbbVie (19th) scores poorly across all Technical Areas but
particularly lags in R&D, in both product development and R&D access planning. Eli
Lilly (20th) performs poorly, ranking in the bottom five in all three Technical Areas.
The company chooses not to disclose information across a range of issues, nor to
make relevant information available in the public domain.

14

Access to Medicine Index 2022 ▶ Key Findings

KE Y FI N D I NG 1: R&D PRIO RITI ES

Some companies engaging in R&D for
emerging infectious diseases, but pipeline
mainly empty▶ Only 5 of the 20 companies analysed by the Index are currently engaging in R&D
for emerging infectious diseases other than COVID-19.
▶ Approvals of Johnson & Johnson’s Ebola vaccine and Bayer’s vector control product for mosquito-borne diseases are significant, but more companies need toinvest in preventing future outbreaks.
The COVID-19 pandemic has underlined the urgent need forDefining R&D priorities for emerging infectious diseases

pharmaceutical companies to address other emerging infec-

The number of pathogens that pose a potential global health risk istious diseases (EIDs) via R&D. It is not a question of whether
EIDs pose a significant global health risk – it’s a case of being
prepared for when the next crisis hits. Yet, the 2022 Indexvast, globally. The World Health Organization (WHO) lists priority diseases and pathogens based on their epidemic potential and/or whether
there are no or insufficient countermeasures. This list aims to ensure
R&D efforts against EIDs are focused and productive.

shows that only five companies of the companies in scope
are targeting EIDs other than COVID-19, and for the majority

Global warming means that more places are reaching suitableof EIDs identified as a priority, there are no projects in thetemperatures for transmission of climate-sensitive diseases.

pipelines of the world’s largest R&D-based pharmaceutical

The devastation left in the wake of unprecedented naturalcompanies.

disasters also provides the perfect environment for infectious
diseases to thrive. As more people migrate, moving to cities

The rising global threat of emerging infectious diseases

and across borders, these diseases will not remain confined

Many people living in low- and middle-income countries

to specific countries. The COVID-19 pandemic proved beyond(LMICs) already face the threats posed by EIDs. Recent out-

doubt that pathogens can and will travel indiscriminately.

breaks of Ebola, Marburg virus and Lassa Fever illustrate theurgent need for vaccines and treatments. Without access toSome companies show the way, but more to be done

products that target infectious diseases, many of the world’s

In spite of the COVID-19 pandemic, the 2022 Index shows little

most vulnerable people will continue to suffer.

change in companies’ R&D efforts against emerging infectious

In addition, there are several factors that are alreadydiseases. Companies still have very few R&D projects target-

increasing the risks these diseases pose globally, including

ing the EIDs considered to be the highest priorities for R&D;

climate change, urbanisation, globalisation and migration.

excluding projects targeting coronaviruses, the total number
of EID projects is 12, compared to 13 and 15 in the previous two
Indexes. Such an empty pipeline for so many dangerous dis-

FIGURE 2 Just five of the 20 companies engage in R&D for emerging

the companies in scope that engage in R&D efforts for EIDs

Of these, 1 is a clinical trial for a new and innovative product,and 1 (the two-shot Ebola vaccine) has reached the endof the pipeline, achieving market approval. Johnson &Johnson's other projects involve testing existing products on
additional patient populations such as children and pregnant
women, to expand their potential usage.

other than COVID-19. However, these companies target a small
number of priority pathogens, which means most diseases andpathogens capable of triggering the next pandemic or epidemic
are going unaddressed. While there are companies outside theJohnson & Johnson
Two R&D projects fromBayer, both of them
vector-control products
targeting Zika, dengue
and Chikungunya, havereached the end of thepipeline during this period- one gaining market
approval and one entering
its technical lifecycle.

15eases puts the world at risk of future epidemics and pandemics.
Bayer, Johnson & Johnson, Merck, MSD and Takeda are

infectious diseases other than COVID-19

scope of the Index that are engaged in R&D projects targeting

7

Bayer

some of these diseases, the 20 companies assessed by the2Index are some of the world’s largest and most well-resourced

Merck 1pharmaceutical companies, and greater investment from more

MSD 1of these companies could move the dial on tackling EIDs.

Takeda 1
0

MSD has a Chikungunya
vaccine in Phase II

2

4

6

8

No. of R&D projects

Takeda has a Zika
vaccine in Phase I

Successes in R&D
Despite this stark picture, the few companies that are currently
engaging in R&D for other EIDs have had some significant

Access to Medicine Index 2022 ▶ Key Findings

successes. For example, Zabdeno® & Mvabea®, Johnson &funds invested huge sums of money into private companies’

Johnson’s two-shot Ebola vaccine regimen, was approved by

R&D and into contracts to buy COVID-19 vaccines and treat-

the European Medicines Agency (EMA) in 2020. In April 2021,

ments. However, the number of COVID-19 products launched

WHO granted prequalification status to the regimen.* Thisduring the pandemic, and the speed with which they were

could accelerate registration in countries with high diseaselaunched, does indicate that companies have the capabilities

burdens, where an outbreak is likely to occur.

to rapidly respond to urgent R&D needs and dedicate exper-

Bayer’s Fludora® Co-Max is a vector control product usedtise and resources to finding solutions. Even without the same

to control adult mosquitos (Aedes spp. and Culex spp.). Withlevel of financial incentives seen during COVID-19, companies

its dual mode of action, it has the potential to prevent mos-can now choose to invest – potentially with a public or private

quito-borne diseases such as Zika and Chikungunya. The

co-investor – in R&D for other EIDs that pose a grave danger

product has now received WHO prequalification, and Bayer

both to people living in LMICs, and also to people worldwide.

also provided evidence that it plans to register the product in several countries in scope of the Index. In addition,

What next?

after the period of analysis for the 2022 Index had ended,

The rapid development and authorisation of medicines and

MSD announced that is working with the International AIDS

vaccines for COVID-19 indicates that the pharmaceutical

Vaccine Initiative (IAVI) toward a formal agreement to pro-industry is willing and able to respond quickly to public healthduce and donate investigational vaccine doses for IAVI’s vac-

emergencies. Through the 2022 IFPMA Berlin Declaration,cine development programme targeting the Sudan ebolavirus.

pharmaceutical companies pledged to draw on lessons
learned from the COVID-19 pandemic to ensure equitable

What can be learned from R&D efforts against COVID-19?

access to vaccines and medicines in future pandemics. This

Successive editions of the Index show that prior to theincludes manufacturing, sustainable supply and accelerating

COVID-19 pandemic, pharmaceutical companies were largely

R&D to develop new health products. To fulfil this commit-

not engaging in R&D for EIDs. This included coronaviruses,

ment, companies can make use of insights on how to acceler-a group of viruses that had already been identified as hav-ate R&D in order to create medicines, vaccines, diagnostics,

ing pandemic potential, but for which there were no R&D

and platform technologies to prevent future outbreaks of dis-projects in the 2018 Index. Yet, by the end of May 2020, theeases that have been identified as posing a global health risk.

number of R&D projects targeting the virus had already sky-Companies that are serious about targeting EIDs must notrocketed to 63, as shown in the 2021 Index.

only invest resources into R&D pre-emptively, but they needThis R&D effort led to results. During the period of analysis

to engage in access planning in tandem with developing prod-

for the 2022 Index, between the 20 companies in scope, four

ucts. This will ensure that essential vaccines and products will

preventative vaccines and ten medicines for COVID 19 werereach those who need them – preventing unnecessary loss ofregistered and approved.1 The circumstances surrounding

life as well as curbing the spread of disease.

COVID-19 were unique, in that governments and international

FIGURE 3 R&D pipeline empty for most emerging infectious diseases
This figure shows the number of R&D projects* and companies targeting emerging infectious diseases

R&D

identified by WHO and Policy Cures Research as posing pandemic or serious epidemic risk.

16

1 This includes projects that were granted
emergency use authorisation or conditional marketing authorisation because of
the urgent nature of the COVID-19 pandemic. Some have since received full regulatory approval.

Active

2018

2021

2022

2018

2021

2022

companies

Disease flagged as an epidemic/pandemic risk
Arenal haemorrhagic fevers (incl. Lassa fever)

0

0

0

0

0

0

Chikungunya

3

4

5

3

4

3

Crimean-Congo haemorrhagic fever (CCHF)

0

0

0

0

0

0

Ebola virus disease (EVD)

7

5

4

5

4

1

Emergent non-polio enteroviruses (incl. EV71, D68)

1

1

0

1

1

0

Takeda’s enterovirus 71 vaccine
project has been discontinued. No
projects in the companies’ pipelines
now target these enteroviruses.
A project that was previously being
tested against multiple diseases inscope, including Marburg, has moved
further down the pipeline and now
specifically targets Ebola. No projects
in the companies’ pipelines now
target Marburg.

projects

Marburg viral disease (MVD)

1

1

0

1

1

0

Middle East respiratory syndrome coronavirus (MERS-CoV)

0

0

0

0

0

0

Nipah

0

0

0

0

0

0

Bunyaviral diseases (other than CCHF, RVF and SFTS)

0

0

0

0

0

0

Filoviral diseases (other than EVD and MVD)

0

0

0

0

0

0

Henipaviral diseases (other than Nipah)

0

0

0

0

0

0

COVID-19 and other coronaviral diseases (other than SARS and MERS-CoV)

0

63

68

0

17

17

Rift Valley fever (RVF)

0

0

0

0

0

0

Severe acute respiratory syndrome (SARS)

0

0

0

0

0

0

Severe fever with thrombocytopenia syndrome (SFTS)

0

0

0

0

0

0

Zika virus disease

3

4

7

3

4

4

Disease X**

0

0

0

0

0

0

* As four projects target Zika, dengue
and/or Chikungunya, these have been
included in several categories in the table.

** ‘Disease X’, added to this list in 2018,
represents the knowledge that a serious
epidemic or pandemic could be caused bya pathogen currently unknown to cause
human disease. COVID-19 can be seen as
a first example of Disease X.

Access to Medicine Index 2022 ▶ Key Findings

KE Y FI N D I NG 2: LICE NSI NGFirst voluntary licence for a cancer treatment
is a promising sign for future expansion ofaccess to innovative medicines▶ Milestone development as Novartis signs a voluntary licence for a leukaemia drugwith the Medicines Patent Pool, the first such agreement covering a non-communicable disease.
▶ More companies newly engaging in voluntary licences and technology transfers,
especially for COVID-19 products – but in a small number of countries.
To address chronic inequity in access to new and innovative

What is a non-exclusive voluntary licence?

medicines, rapid action is needed by pharmaceutical compa-

A voluntary authorisation given by the patent holder to a generic man-nies to expand access to their on-patent products in low- andmiddle-income countries (LMICs). Enabling a product to be
manufactured by multiple manufacturers is important, andone key way to do this is to engage in voluntary licensing,ufacturer, allowing it to develop and manufacture generic versions ofpatented medicines. When a licence is ‘non-exclusive’, this means thatthe patent holder can issue licences to multiple manufacturers, often indifferent countries. The Medicines Patent Pool (MPP) is a key organisation that can facilitate this.

which can improve availability and affordability in different regions of the world. Non-exclusive voluntary licences

announced plans for a NEVL covering nilotinib (Tasigna®), a(NEVLs) have been used very successfully for HIV and hepa-

medicine indicated for chronic myeloid leukaemia. This drug

titis, and recently more companies have agreed to NEVLs forhad been on the MPP’s Priority List, and an agreement with

their COVID-19 medicines and vaccines. One company has

the MPP was ultimately signed in October 2022.

now expanded the use of NEVLs to include a non-communi-This is the first time that the use of NEVLs has expanded

cable disease (NCD) for the first time, with a voluntary licencebeyond products or compounds targeting communicablefor a cancer product.

diseases – specifically HIV, hepatitis, tuberculosis and COVID-

As part of these licensing efforts, pharma companies can

19 – and is a particularly hopeful sign as the burden of NCDs,

carry out technology transfers. This is a crucial additionalsuch as cancer and diabetes, is rising globally. In 2030, aroundstep companies can take to ensure the uptake and success of

three-quarters of deaths from cancer are expected to occur

NEVLs, and can include, e.g., transferring knowledge on pro-in LMICs, yet essential on-patent oncology medicines arecesses such as active pharmaceutical ingredient (API) produc-often unavailable or unaffordable in these countries.

tion, equipment use and raw material handling. Technology

The potential impact of the NEVL will be limited by thetransfers can be used to sustainably scale up access in LMICs

fact that it does come less than a year before the expiry ofand ensure that local manufacturers are adequately equipped

the main patent for nilotinib (Tasigna®). In addition, Novartis

to efficiently produce high-quality medicines in the long term.

had previously chosen not to file for patents in several of thecountries included in the NEVL. However, if generic medicine

First voluntary licence for a cancer medicine

manufacturers do take up the opportunity offered by Novartis

Significantly, during the period of analysis, Novartis

via the MPP, this agreement could accelerate the expansion

FIGURE 4 Use of voluntary licences has increased, primarily due to new

FIGURE 5 More companies now engage in voluntary licensing

agreements for COVID-19 and cancer compounds
No. of compounds

4
14

2016

17

1
1

6

7

7

15

15

13

2018

1

5

2021

2022

10

● Targets cancer● Targets TB● Targets Hepatitis C virus● Targets HIV/AIDS● Targets COVID-19

7

7

7

2016

2018

2021

2022

Half of the companies inscope now have at least
one voluntary licence, with
AstraZeneca, Eli Lilly andNovartis joining the groupof companies engaging involuntary licences.

Access to Medicine Index 2022 ▶ Key Findingsof availability and affordability of this cancer drug – which

products, with India included in the greatest number (three).

is classed as an “essential medicine” by the World Health

If a country is covered, that means generic versions of theOrganization – to patients living in LMICs. It also sets a prece-originator product can be introduced in that country; it does

dent for other companies to sign NEVLs for medicines target-

not, however, mean that generic medicine manufacturers

ing NCDs. Novartis has committed to reinvesting all royalties

have taken up the licence, or that the product is actually beingfrom this agreement into the Access to Oncology Medicines

made available to people living in that country.

(ATOM) Coalition, a new global initiative launched in 2022 toWhile companies’ engagement in NEVLs and their com-sustainably expand access to quality-assured essential cancer

mitments not to file or enforce patents in particular countries

medicines in low- and lower-middle income countries.

can lead to positive outcomes for access, the gold standard
is to back up this approach with technology transfers. Yet,The rise of NEVLs, driven by COVID-19

although many countries are covered by NEVLs for COVID-19

Companies including AstraZeneca, Eli Lilly, GSK, MSD,

products, actual technology transfers – with specific generic

Novartis and Pfizer entered into new licensing agreements

medicine manufacturers – have been carried out in just aduring the period of analysis, with ten of the companies in

handful of countries, as seen in the map below.

scope now engaging in at least one voluntary licence – upfrom seven in the previous Index. The number of licensed

What next?

compounds has risen from 22 to 27.

Companies have demonstrated growing willingness to engage

Much of this trend is driven by companies engaging inin voluntary licensing. However, the momentum must con-voluntary licensing for COVID-19 products. Out of the eighttinue - with more NEVLs for more products, from more com-companies in scope with COVID-19 products in their portfo-

panies, covering a wider range of diseases and countries, ear-lios, four companies now have at least one NEVL (and one

lier in products’ lifecycles, and with access-oriented clauses.

further company has a private voluntary licence, not analysed

This will be especially important in the context of novel thera-here). MSD agreed to a NEVL with the MPP before the launchpies and NCD medicines. Companies can also expand the geo-of its oral antiviral molnupiravir (Lagevrio®), as did Pfizer forgraphic scope of existing NEVLs, especially to include morenirmatrelvir/ritonavir (Paxlovid®). Gilead signed a royalty-free

upper-middle income countries, which are often excluded

voluntary licensing agreement and carried out a technology

from these agreements.

transfer for the manufacture of its injectable antiviral remde-Companies should take advantage of existing resources tosivir (Veklury®) in India, Egypt and Pakistan. Eli Lilly signed a

guide their licensing decisions, such as the MPP’s list of med-royalty-free NEVL with Cipla, Sun Pharma, and Lupin covering

icines that should be prioritised for NEVLs, which included

its COVID-19 treatment baricitinib in India. In addition, for its

Novartis’s nilotinib at the time of signing.* Companies with

COVID-19 vaccine (ChAdOx1-S [recombinant]) (Vaxzevria),

other products on the priority list can take similar actions,AstraZeneca has engaged in a sequence of exclusive voluntarysuch as Boehringer Ingelheim with empagliflozin (Jardiance®)

licences (rather than NEVLs) in different parts of the world.

and AstraZeneca, with its lung cancer treatment osimertinib(Tagrisso®). Companies can also supplement current andQuality and scope of voluntary licensing agreements

future NEVLs with technology transfers and other capacity

At least 80% of the countries in scope of the Index arebuilding efforts.

covered by at least one of the four NEVLs for COVID-19

FIGURE 6 Technology transfers for COVID-19 products are concentrated in just a few of the 108
countries in scope of the Index● 0 tech transfers● 1 tech transfer● 2 tech transfers● 3 tech transfers● Countries not in scope

18*Medicines Patent Pool. Prioritisationof medicines for in-licensing by the
Medicines Patent Pool. MPP; 2022.
Accessed 01/11/22: https://medicinespatentpool.org/what-we-do/
prioritising-medicines-for-licensing

Access to Medicine Index 2022 ▶ Key Findings

KE Y FI N D I NG 3: ACCESS PL AN N I NG & STR ATEG I ES

More access plans and strategies to expand
access to more products, but with limited
breadth and depth▶ While companies are taking steps to improve access to their products in low- andmiddle-income countries, their plans and strategies consistently overlook thepoorest countries.
▶ For some products, companies are moving to consider availability, affordability
and sustainable supply, signalling possibility for change.
Out of the 20 companies assessed by the Index, six now haveaccess plans in place for 100% of late-stage R&D projects.
This is the first time any single company has hit that milestone, and is an encouraging sign that companies will maketheir new products more available to the people who needthem in low- and middle-income countries (LMICs).
For products already on the market, the data also demonstrates progress; 83% of the products assessed by the Index

Access plans are ways for companies to ensure they take account ofpublic health needs while new products are still in development, so thatpeople in LMICs can gain access to products more rapidly and affordably following their market entry. Companies should have plans in place
for products in the pipeline from at least Phase II of R&D.
Access strategies are ways that companies can ensure equitable
access to the products in their portfolios. Companies are expected toapply access strategies to key products across LMICs, maximising theavailability of these products to those with less income.

are covered by an access strategy in at least one of the LMICs
in scope, compared with 58% in the previous Index.
Yet, analysis of companies’ access plans and strategies

during the R&D stage, the number of countries included inplans is low. On average, an access plan includes only six ofshows that they are often limited in depth and breadth,the 108 countries in scope of the Index. Only 15% of accesssometimes only containing the most basic elements. As ever,plans include at least one of the 27 low-income countries;

low-income countries are paid the least attention. A few

conversely, 85% include at least one of the 26 upper-middle

examples from a handful of companies show, however, that

income countries. Upper-middle income countries are six

this situation is not inevitable, and that it is possible to expand

times more likely to be included in companies’ access plans

access to essential healthcare products so that people world-

for an R&D project.

wide get the treatments they need.

Currently, 52% of the access plans assessed by the Index
consist solely of plans to register products in at least one

Steps forward in R&D access planning, but low-income

LMIC, once approved. Companies mostly commit to filing forcountries left out

registration in the countries where clinical trials have been

Astellas, Boehringer Ingelheim, Johnson & Johnson, Merck,

conducted – predominantly in upper-middle income countries

Novartis and Takeda have now provided evidence that theysuch as South Africa, China, Mexico, Colombia and Brazil.

have developed project-specific access plans for all their late-

Registering a product is a vital step, but it should not be thestage R&D projects in scope of the Index.1

only element of an access plan.

Yet, despite an industry-wide expansion of access planning

FIGURE 7 Six companies now plan for access for all late-stage projects

However, some companies have access plans that are more

FIGURE 8 More R&D projects now covered by access plans

20 companies

Late-stage R&D projects

20

60%

14

23%
77%

6
2021

19

2022

R&D projects
with access plans

40%
Astellas, Boehringer Ingelheim, Johnson& Johnson, Merck, Novartis and Takeda
have access plans for 100% of their latestage R&D projects.

1 Projects from Phase II and onwards(late-stage) were selected for analysis
based on their priority disease designation

or if they were identified as having a public health benefit in LMICs.

2021

2022

Access to Medicine Index 2022 ▶ Key Findings

FIGURE 9 Products covered by an access strategy in at least one

What next?

upper-middle, lower-middle, and low-income country

More companies can now ensure all their late-stage R&D pro-More of the products in scope are now covered by access strategies.

jects have comprehensive access plans in place that contain a

However, this improvement disproportionately favours upper-middle andvariety of measures to increase access, and cover more coun-lower-middle income countries.

tries – including low-income countries.

UMICs

49%

LMICs

20%

Companies can also expand the quality and quantity of

LICs

58%

29%

80%

79%

66%

people and treatments. To sustainably expand access in
low-income countries, companies need business plans that71%

account for such challenges and facilitate access across all

51%

42%

34%
21%

2021

their access strategies to cover a wider range of countries,

2022

2021

2022

2021

2022

● Covered by an access strategy● Not covered by an access strategy

LMICs. Some companies are already seeking ways to develop
such plans; Sanofi, for example, launched a new Global Health
Unit in 2021, though which it commits to expanding accessto 30 of its products in 40 of the world’s poorest countries,
while Pfizer has made a commitment to creating sustainedand equitable access to all of its patented products in 45 lower-income countries through its 2022 Accord for a HealthierWorld. These are signs that the companies are taking thecomprehensive, and include low-income countries. For exam-challenge of expanding access in low-income countries seri-ple, Novartis includes five low-income countries in clinicalously, but their success will depend on their implementation.

trials for cipargamin (KAE609), for the treatment of severe
malaria; in line with its post-trial access policy, the company
commits to registering the medicine in those countries
once approved. Takeda’s access plan for its dengue vaccine

FIGURE 10 Two thirds of products scope of this analysis* are not

QDENGA® (TAK-003) considers burden of disease in its planscovered by any access strategies in low-income countries

for where to file for registration, as well as innovative equitable pricing models and methods to ensure sustainable cold
chain supply.
Companies’ efforts to ensure existing products reach●P roduct not covered by an accessstrategy in any low-income
country

Products in scope
AbbVie●●●●●●

Astellas●●●●●AstraZeneca●●●●●●●●●●

Bayer●●●●●●

Bristol Myers Squibb●●●●●

Boehringer Ingelheim●●●●●●●

Daiichi Sankyo●●●●●●

Eisai

●●●●

Eli Lilly●●●●●●●●●

Gilead●●●●●●

less likely to provide a high yielding market. Even though there

GSK●●●●●●●●

is no ‘one-size-fits-all-products’ approach, companies can uti-

Johnson & Johnson●●●●●●●●●●

lise a wide range of tools and approaches to directly address

MSD●●●●●●●●●●

access and affordability in LMICs. Companies can implement

Merck●●●●●●●

equitable pricing strategies, or can work with other stakehold-Novo Nordisk●●●●●

Novartis●●●●●●●●●

Pfizer●●●●●●●●●●

Roche●●●●●●●●●

Sanofi●●●●●●●●●●

Takeda●●●●●●●

patients still overlook low-income countries
Although the number of products in scope covered by accessstrategies has increased overall, companies are still far lesslikely to include low-income countries in their strategies,
despite the urgent need for greater access to medicine inthese countries.
Expanding access in low-income countries can present complex challenges for companies, for example if the country lacks
regulatory capacity, has weak healthcare infrastructure, or isers, e.g. by using non-exclusive voluntary licensing agreements(NEVLs) to facilitate an increase in generic supply in LMICs, orby engaging with supranational procurement organisations.
Some companies are already taking steps to implement
access strategies in low-income countries (see figure, right).
Yet, when companies were asked to provide an example of astrategy used to expand access in a low-income country foreach of up to 10 products from their portfolios, the positive
examples outlined above were the exception, not the rule. Twothirds of all products analysed by the Index were still not covered by any access strategies in a low-income country.

20●P roduct covered by an accessstrategy in at least one low-income country*Companies were requested to submit
up to 10 products each for this analysis,
including healthcare practitioner-administered and self-administered products.

Takeda has filed its non-Hodgkin's
lymphoma treatment brentuximab
vedotin (Adcetris®) for registration in
Rwanda. Once approved, it will provide
access through a patient assistanceprogramme, using an intra-country
pricing strategy that assesses individual
patients’ ability to pay.

Good examples of accessstrategies
Gilead has a NEVL covering its hepatitis C productsofobuvir/ledipasvir (Harvoni) and sets a flat pricefor the product across all
low-income countries.

Johnson & Johnson
reports an access strategy
for its schizophrenia
medication paliperidone palmitate (Invega
Sustenna®) that includes
an equitable pricing
strategy complemented
by non-pricing and healthsystems strengthening
initiatives.

Novartis has introduced its
heart failure drug sacubitril/valsartan (Entresto®)in Ethiopia through anemerging market brand,which addresses affordability issues through differentiated pricing.

Access to Medicine Index 2022 ▶ Special Report

SPECIAL RE PO RT: COVI D -19 & PAN D E M I C
PRE PARE D N ESS

Assessing pharmacompanies’ response
to COVID-19 andthe threat of future
pandemics

The COVID-19 pandemic has had enormous consequences
globally, not least in low- and middle-income countries(LMICs). It has shown the pharmaceutical industry’s capacity
to quickly bring products to market, but has also highlighted
the inequitable distribution of new vaccines and therapeutics.
The Index analyses data about 'coronaviral diseases,' acategory that covers all coronaviruses including COVID-19,
Middle East respiratory syndrome coronavirus (MERS-CoV)and severe acute respiratory syndrome (SARS). However, during the period of analysis for the 2022 Index, the overwhelming majority of products developed for coronaviral diseases
targeted COVID-19.
This Special Report looks at how companies responded in
the initial phase of the COVID-19 pandemic by rapidly engaging in research and development (R&D) to develop products
targeting COVID-19. It also analyses how companies performin terms of registration and applying equitable access strategies for COVID-19 vaccines. Additionally, the report outlines
how some companies engaged in voluntary licensing agreements and technology transfers to enable generic supply of
COVID-19 vaccines and therapeutics. Finally, the Index looks
forward towards how companies are preparing for future epidemics and pandemics.

21

Access to Medicine Index 2022 ▶ Special Report
CO N T E X T

Where we are now: the impact of the COVID-19 pandemic in
LMICs
The COVID-19 pandemic has had a devastating effect in LMICs. It placed a hugeburden on weak health systems and disrupted other important public health services, such as routine childhood immunisation campaigns. For example, in 2020, an
additional 3.7 million children did not receive their DTP (diphtheria, pertussis, andtetanus) vaccine.1 Further, the World Health Organization (WHO) estimates that the
COVID-19 pandemic resulted in an additional 14 million cases of malaria and 69,000
deaths from malaria in 2020.2 Alongside the direct effects on people's health, lockdowns and COVID-19 prevention measures have prevented individuals from conducting their usual social and economic activities, thereby increasing poverty andinequality.
In LMICs, lack of access to COVID-19 vaccines and treatments has exacerbatedthe effects of the pandemic. According to one study, an estimated 600,000 deaths
in LMICs could have been prevented in the period up to December 2021 if WHO
vaccination targets of 40% had been achieved.3
The inequitable distribution of vaccines has been observed in previous pandemics, such as during the H1N1 pandemic in 2009. This resulted from the greater purchasing power of high-income countries in comparison to LMICs, and also due tothe lack of global vaccine production capacity.4 Despite efforts from global healthorganisations, a similar situation has been observed during the COVID-19 pandemic.
What is the role of pharmaceutical companies in ensuring equitable access to
COVID-19 products?
Several factors have contributed to the inequitable supply of COVID-19 vaccines
globally, including a lack of capacity to immediately scale up production, poor supply chain infrastructure and weak health systems.
Furthermore, early large-scale buying of most available stock by high-bidding
high-income countries left little for international procurement for LMICs. Donation
programmes, while important, were not sufficient to bridge the gap in access andensure sustainable global supply. When public investments are made in R&D, asthey have been during the COVID-19 pandemic, conditions for future investments
could include obligations to reserve part of the early production capacity for people
in LMICs to help increase access and limit health inequities.
Pharmaceutical companies have a public health responsibility to ensure people have equitable access to COVID-19 products by taking steps both during drug
development and after products are launched on the market. Examples of important steps for the future include investing in innovative R&D projects to target
diseases with epidemic or pandemic potential. Planning ahead for access during the
R&D stage, or ‘access planning,’ is also necessary to ensure products can be maderapidly and universally available.
On the supply side, companies can engage in technology transfers and voluntary
licensing with local manufacturers to scale up production in LMICs. Additionally,
they must ensure that these products are affordable in LMICs. These steps areneeded not only to ensure equitable access to COVID-19 products, but also toensure all countries have the necessary knowledge, infrastructures, strategies andtools prepared for inevitable future pandemics.

22

Access to Medicine Index 2022 ▶ Special Report
R ESE A RCH & D E V ELO PM EN T

R&D for COVID-19 accelerated in response to urgent need
During the period of analysis,* four preventative vaccines and ten medicines wereregistered or received regulatory approval.** Several of these products received
US Food and Drug Administration (FDA) Emergency Use Authorisation (EUA) or
European Medicines Agency (EMA) conditional marketing authorisation, which aremechanisms designed to facilitate availability during a public health emergency.
Such provisional authorisations enabled products targeting COVID-19 to be accelerated through the pipeline, indicating that companies can rapidly respond to urgent
R&D needs and dedicate resources and investments towards finding solutions.
In addition to new innovations, some companies in scope of the Index invested
resources into researching whether they could repurpose products that werealready approved for other diseases and conducted trials to test products fromtheir portfolios against COVID-19. For example, Roche's tocilizumab (Actemra®/
RoActemra®) and Eli Lilly’s baricitinib (Olumiant®), both of which were originallyindicated for rheumatoid arthritis, received FDA EUA for the treatment of COVID19 in hospitalised patients.
Of the 20 companies in scope, 17 were engaged in projects targeting COVID-19
during the period of analysis. During this two-year period, the companies collectively had 68 R&D projects in the pipeline targeting coronaviral diseases, including
vaccines, medicines, diagnostics and platform technologies. This represents thesecond highest number of R&D projects in development for any disease in scope,
after cancer. The number of projects in development surpasses those of otherdiseases including malaria (55 projects), HIV/AIDS (46 projects) and tuberculosis(34 projects). Unsurprisingly, the number of projects correlates with investment in
R&D; in 2020, USD 3.87 billion was quickly made available for COVID-19 R&D.5

FIGURE 11 Multiple R&D projects targeting COVID-19 have alreadyresulted in approved** and/or registered products
Of the 68 R&D projects devoted to COVID-19 or unspecified coronaviraldiseases during the period of analysis, 42 were medicines and 17 were
vaccines.
Platform technologies

0 Discovery
2

Phase I

2

Phase II

5

4

3

2

2

Market approval

2

Registered1

3
17

Discovery

6
68
projects

13

pre-clinical8

Phase I42

Medicines

2

Phase II

5

Phase III

3

Market approval

7

Registered

0 Other0*Period of analysis for the 2022 Index: 1
June 2020 to 31 May 2022.

23

Preventative
vaccines

Phase III

5

6

Diagnostics

pre-clinical

4

3

Other
0

**This number includes vaccines thatreceived emergency use authorisation orconditional marketing approval during theperiod of analysis

1
2

4

6

8 10 12 14

Access to Medicine Index 2022 ▶ Special Report
PRO D U C T D ELI V ERY

Companies launched key vaccines and therapeutics targeting
COVID-19
Pharmaceutical companies have been key stakeholders in the fight against COVID19, having quickly developed vaccines, treatments and diagnostics for the virus andbrought them to market. Due to the rapid progression from development to product launch during the two-year period of analysis, several projects/products are not
only included in the Index’s scope of analysis as R&D projects, but are also alreadyassessed as products in the companies’ portfolios. To be included in the Index portfolio, a product must have received regulatory approval (or EUA), the first necessary
step to ensure a product is available.
The Index found that eight of the 20 companies in scope had COVID-19 products in their portfolios, with a combined total of 17 products – including vaccines,
therapeutics, diagnostics and platform technologies. Three COVID-19 vaccines areincluded in the portfolio: AstraZeneca's COVID-19 vaccine ChAdOx1-S [recombinant] (Vaxzevria), Pfizers BioNtech's COVID-19 mRNA vaccine (nucleoside-modified) (Comirnaty®) and Johnson & Johnson's COVID-19 vaccine (Ad26.COV2-S[recombinant]). Of these three, Johnson & Johnson's was filed most widely for registration in countries in scope of the Index (41), followed by Pfizer’s COVID-19 vaccine (37) and AstraZeneca's COVID-19 vaccine (14). Furthermore, for both Johnson& Johnson and Pfizer, their COVID-19 vaccines were the most widely registered ofany the products selected from their portfolio for analysis.
This suggests that, despite weak regulatory capacity in many LMICs, pharmaceutical companies were still able to successfully file their COVID-19 vaccines forregistration, although much of this was facilitated through EUA in response to theurgency of the pandemic. Going forward, however, companies can explore otherfacilitated registration pathways to overcome regulatory barriers in order to fileother products in their portfolios for registration in LMICs with weak regulatory
capacity.
What access strategies were used to ensure COVID-19 vaccines andtherapeutics reach LMICs?
Pharmaceutical companies should use access strategies to expand access to key
products in their portfolios so that they reach people across LMICs, including thoseat the base of the income pyramid. Such strategies can include equitable pricing,voluntary licensing, product donations and technology transfer. When setting pricing strategies, companies are expected to aim for affordability, and to integrate apayer’s ability to pay for the product in their pricing approach. The Index identified
three key mechanisms that companies have used to increase access in LMICs for
COVID-19 products: non-exclusive voluntary licensing (NEVL), technology transfers,
and supranational procurement agreements.

FIGURE 12 How many companies have COVID-FIGURE 13 What types of COVID-19 products

19 products?

are in companies' portfolios?
Company has
no COVID-19
products

1220companies

8

1
Vaccines

Company has atleast 1 COVID-19
product

AstraZeneca, Eli Lilly, Gilead, GSK,Johnson & Johnson, MSD, Pfizer
and Roche.

24

Platform technologies

Diagnostics

3

5

17
COVID-19
products

8

Medicines

Access to Medicine Index 2022 ▶ Special Report
PRO D U C T D ELI V ERY

Companies engage in voluntary licensing to enable genericmanufacturing, but with limitations
Pharmaceutical companies can engage in voluntary licensing by transferring intellectual property (IP) rights to a licensee, enabling them to produce generic versionsof their product under certain terms and conditions. Voluntary licensing agreements can expand availability and affordability by facilitating generic supply, and areparticularly valuable for expanding access in countries where the originator company does not intend to market the drug that it has patented.
For companies that hold patents for COVID-19 products, one approach has been
to engage in direct licensing agreements to build global manufacturing networks.
Another approach has been to agree to voluntary licences through an intermediarysuch as Medicines Patent Pool (MPP). When a licence is between a company andmultiple sub-licensees (generic manufacturers), it is deemed to be a NEVL.
Of the eight companies with COVID-19 products in their portfolios, five
(AstraZeneca, Eli Lilly, Gilead, MSD and Pfizer) have engaged in licensing agreements to facilitate access to COVID-19 products.
Voluntary licences for COVID-19 products• AstraZeneca pursued a sequence of exclusive voluntary licences with Serum
Institute of India, among others, for its COVID-19 vaccine (Vaxzevria). Details ofthese licences remain private.
• Eli Lilly signed royalty-free voluntary licensing agreements for baricitinib, an oral
COVID-19 therapeutic, with three Indian pharmaceutical companies: Cipla, Sun
Pharmaceuticals and Lupin.
• Gilead signed a royalty-free voluntary licensing agreement for its injectable antiviral medication remdesivir (Veklury®) with technology transfer included.
• MSD’s product molnupiravir (Lagevrio®) was the first oral antiviral to be includedin WHO treatment guidelines for COVID-19. MSD signed a NEVL with the MPP
when the drug was still in development, before it reached regulatory approval.
• Pfizer signed a NEVL with MPP for nirmatrelvir, one of the compounds in its
COVID-19 antiviral nirmatrelvir/ritonavir (Paxlovid®). The company will notreceive royalties from sales of nirmatrelvir while COVID-19 is considered a publichealth emergency of international concern by WHO. After that period, sales to
low-income countries will remain royalty free.
Three of the licences analysed (for molnupiravir, nirmatrelvir and remdesivir)
include a large number of countries in scope. However, a consistent finding isthat upper-middle income countries, such as Colombia, Ecuador and Peru are notincluded in voluntary licences. This means sizeable low-income populations in thesecountries will only have access to the more expensive branded version of the drug,
without the option of a more affordable generic version.
Furthermore, inclusion of a country in the geographic scope of a licence does
not guarantee that generic medicine manufacturers will choose to make use of thelicence to manufacture the product and market it in that country. Additional follow-up is required to monitor the uptake and impact of these licences.

25

Access to Medicine Index 2022 ▶ Special Report

FIGURE 14 Which LMICs are covered by NEVLs for COVID-19 products?
This map highlights the number of NEVLs per country in scope of the Index
for the four COVID-19 licensing agreements analysed (baricitinib, molnupiravir, nirmatrelvir and remdesivir), showing the countries in which generic
medicine manufacturers are able to produce and market the companies’
COVID-19 products. Three of these agreements cover at least 80% of thecountries in scope of the Index.*

Only India is covered by
all four NEVLs shown in
the figure.
● 0 NEVLs● 1 NEVLs● 2 NEVLs● 3 NEVLs● 4 NEVLs● Countries not in scope

Almost all African countries included in
the Index are covered by three of thefour NEVLs, with the exception of theCentral African Republic and Somalia,
which are covered by two.

Key developments in transferring technology for COVID-19 productsTechnology transfers – i.e., the transfer of manufacturing processes and expertisefrom the pharmaceutical company to local manufacturers – are a valuable tool in
expanding access. The approach boosts the capacity of generic medicine manufacturers to efficiently and effectively manufacture quality-assured medicines andvaccines.
Four companies have transferred technology for COVID-19 products during theperiod of analysis: AstraZeneca, Gilead, Johnson & Johnson and Pfizer. For example, Gilead transferred technology as part of its NEVL agreement for remdesivir,

FIGURE 15 Technology transfers for COVID-19 are focused in India,
Brazil and South Africa
Ten technology transfers were conducted for medicines (1) and vaccines (9)to treat COVID-19. Technology transfers are concentrated in India, Brazil andSouth Africa.

During the surge of
COVID-19 cases in India in
April 2021, Gilead provided
support to its voluntary
licensees in India to accelerate production of remdesevir by scaling up theirbatch sizes, adding new
manufacturing facilities
and/or onboarding local
contract manufacturers
across the country.

● 0 tech transfers● 1 tech transfer● 2 tech transfers● 3 tech transfers● Countries not in scope

26*Companies submitted information
regarding the NEVLs and/or non-assert declarations to the Index for analysis. AstraZeneca’s sequence of exclusive voluntary licences was not shown in
the graph, as details remain private. Eli

Lilly’s licence (baricitinib) is only reported
for India.

Access to Medicine Index 2022 ▶ Special Report

while AstraZeneca transferred technology to manufacturers in LMICs in combination with its private licensing agreements across a selection of LMICs. AstraZeneca
reports technology transfers with more than 20 partners across more than 15 countries, including countries in Asia and Latin America.
The Index finds that technology transfers for COVID-19 vaccines and therapeutics are concentrated in a select few countries, particularly in India, South Africa andBrazil. Within these countries, the third-party manufacturers that receive the knowhow to produce these products often have a high level of capacity for manufacturing vaccines and medicines already (e.g., Bio-Manguinhos/Fiocruz, Serum Instituteof India and Dr. Reddy’s Laboratories).
These technology transfers can help improve the supply of COVID-19 products.
They can also help ensure resilience in supply chains in LMICs for future production,
including production of other healthcare products. Therefore, companies can domore to ensure that more LMICs with an industrial base have access to these technologies – for example in Senegal, which is already producing COVID-19 vaccines via
its Pasteur Institute, or in Algeria, which received a technology transfer to facilitate
the production of the Russian COVID-19 Sputnik V vaccine.6

27

Access to Medicine Index 2022 ▶ Special Report
PRO D U C T D ELI V ERY

Some – but not enough – company action to ensure
procurement and supply of COVID-19 vaccines in LMICs
When participating in pooled procurement, companies supply their products
through organisations (supranational procurers), which in turn distribute theminternationally to LMICs. Previously, these supranational agreements have beensuccessfully used to improve access to antiretroviral medicines for HIV and products for other diseases of public health concern, such as tuberculosis.
During the pandemic, COVID-19 vaccines have been supplied in LMICs throughsupranational agreements. The Index analysed the sale of the three COVID-19 vaccines in scope through the COVID-19 Vaccines Global Access (COVAX) programme,a global initiative co-led by WHO, Gavi, the Vaccine Alliance (GAVI) and the Coalition
for Epidemic Preparedness Innovations (CEPI), which aimed to accelerate thedevelopment and distribution of COVID-19 vaccines.
Despite COVAX's aim to facilitate an equitable global vaccine supply, a disparity
in access to vaccines between high-income countries and LMICs persists. Moreover,this pandemic has also shown that the world cannot rely on such procurement programmes alone. Because of this, bilateral agreements are an additional step thatcompanies should take to facilitate access.
AstraZeneca and Johnson & Johnson engaged in technology transfers andlicensing agreements to increase supply of their vaccines with local partners.
Although Pfizer transferred technology to bolster manufacturing capacity of its
vaccine in some countries in scope, the Index did not find evidence that it had
engaged in licensing agreements to enable generic supply of its COVID-19 vaccine.
AstraZeneca performs best in the field of technology transfer and licensing, withtechnology transfers of its vaccine across more than 15 countries, perhaps reflecting the sources of funding for the vaccine; it is reported that 97% of the funding for
R&D behind AstraZeneca's vaccine came from public and charitable funds.7
In the event of a future pandemic, governments must work with companies toensure that the terms of supranational procurement agreements are transparent
and consider equitable pricing and global access. This could help to reduce disparities and ensure that people globally get the vaccines and treatments they need.
However, companies should especially engage in technological transfers and knowledge sharing, as a step in fighting against a pandemic.

28

Access to Medicine Index 2022 ▶ Special Report

TABLE 1: Supranational procurement for vaccines in LMICs
Company

VaccineSupranational procurement for LMICs*

Price via COVAX

AstraZeneca

COVID-19 vaccine• One agreement via COVAX facility: COVAX

Cost-based price: 4 USD per dose. Information

Advance Market Commitment (AMC)**is available on UNICEF website. Price applies(Vaxzevria)• Four regional sub-licensing agreements, including with the Serum Institute of India
Johnson &COVID-19 vaccine

Johnson• Three agreements via COVAX facility: COVAX
Advance Market Commitment; Procurementin 91 countries funded by the COVAX AdvanceMarket Commitment.
Not-for-profit price: USD 7.50 per dose.
Information is available on UNICEF website.

agreement; COVAX Humanitarian Buffer***• Procurement agreement with the African
Vaccine Acquisition Trust (AVAT)
Pfizer

COVID-19 vaccine• One agreement via COVAX facility

Not-for-profit price; price is not disclosed.

(Comirnaty®)

TABLE 2: Examples of national procurement for vaccines in LMICs
Each of the three companies provided an example to the Index about anaccess strategy being used to expand access to their vaccine in one of the
108 LMICs in scope, outside of the COVAX programme and any othersupranational agreements.
Company

VaccineSpecific country example

AstraZeneca

COVID-19 Vaccine

Brazil(Vaxzevria)• Licence and technology transfer to a local manufacturer, the Oswalda Cruz Foundation (Fiocruz).
• Brazil is also covered by a COVAX supply agreement, and received 9,122,400 doses of
AstraZeneca’s COVID-19 vaccine via COVAX in 2021.

Johnson &COVID-19 vaccine

JohnsonSouth Africa• Vaccines were provided via two advance procurement agreements at a not-for-profit price.
• Technology transfer agreement with local manufacturer Aspen Pharmacare Limited.
• Drug substance supply agreement with Aspen SA Operations (Pty) Ltd.†• Collaboration with local government to make vaccine doses immediately available to healthcare
workers via the Sisonke study in South Africa.
• Health systems strengthening initiative, including cold chain strengthening initiatives.
• While disaggregated bilateral data about patient reach in South Africa has not been made available, the company reports it has shipped approximately 270 million doses to the African continent.

Pfizer

COVID-19 vaccine

Rwanda(Comirnaty®)• Supply agreement at not-for-profit price.
• Health systems strengthening initiative focused on country delivery readiness.
• Covered by COVAX supply agreement.
• 7.4 million doses supplied in support of both COVAX and the Rwandan government's vaccination
programme.

29*The data in this table is not comprehensive, but is based on publicly-available information and data provided by thecompanies to the Access to Medicine
Index.
**The AMC is one strand of COVAX, that
finances the supply of COVID-19 vaccines

to LMICS. The AMC is funded by voluntary
contributions from richer countries andprivate donors.
***The Humanitarian Buffer is a novel
additional initiative established within the
COVAX Facility to act as a measure of ‘last
resort’ to ensure access to COVID-19 vac-cines for high-risk and vulnerable populations in humanitarian settings.
†The agreement enables Aspen SA
Operations (Pty) Ltd, using COVID-19 vaccine drug substance supplied by Johnson& Johnson, to produce Aspen-branded
finished vaccine and make doses availa-

ble to the public sector in Africa, including
all 55 Member States of the African Union
and key multilateral entities supporting
Africa’s COVID-19 vaccination drive, inclusive of the African Vaccine Acquisition
Trust (AVAT), and the COVAX Facility.

Access to Medicine Index 2022 ▶ Special Report
R ESE A RCH & D E V ELO PM EN T

R&D for pandemic preparedness has not increased, despite
COVID-19
In July 2022, the International Federation of Pharmaceutical Manufacturers &Associations (IFPMA) released the Berlin Declaration, in which the pharmaceuticalindustry pledged to draw on lessons learned from the COVID-19 pandemic to ensure
equitable access to vaccines and medicines in future pandemics.8 This includes provisions for manufacturing, sustainable supply and accelerating R&D to develop new
health products. Collaboration between actors and their awareness of responsibilities
is a key component to prepare for the next pandemic. Although it is too soon to measure the impact such a declaration may have on access, the Index has analysed the pipelines of companies in scope to see what products they are developing to target otherdiseases with the potential to cause a pandemic.
Investment in R&D is important for the development of products which target diseases with epidemic potential. To encourage innovation, the WHO has compiled a listof priority emerging infectious diseases (EIDs) that pose the greatest public health risk
due to their epidemic potential and/or lack of measures to counter them. The Index
analyses R&D projects for 17 EIDs, based on the priorities identified by WHO and Policy
Cures Research.
Among these is ‘Disease X’, a term which WHO adopted to refer to a pathogen thatis currently unknown to cause human disease but could cause a serious international
epidemic in the future. In 2020, the emergence of the SARS-CoV-2 virus (COVID-19)
was deemed to be the first example of Disease X, since the inception of the term in
2018. The ‘Disease X’ designation seeks to incentivise cross-cutting R&D that can beeasily adapted for emerging strains of infectious diseases, for example, platform technologies or diagnostics. The development of such underlying technologies could facilitate a rapid response to counteract an outbreak should one arise. The Index found thatnone of the companies in scope have R&D projects in development to target Disease
X. This suggests that despite the rapid R&D response to COVID-19 (68 projects forcoronaviral diseases), companies in scope are not investing in R&D for projects that
could limit the spread of future unknown infectious diseases.
When no product is currently available on the market to sufficiently treat, diagnose or
prevent a priority disease, this is defined as a 'product gap.' These products may be medicines, vaccines, diagnostics, medical devices or vector control products. Every company,
regardless of size or therapeutic focus, can play a role in addressing these gaps.

R&D

FIGURE 16 While significant products have reached the market for

projects

30

Zika is the only disease for which a
positive trend can be seen, excluding
COVID-19. R&D projects devoted
to this infectious disease haveincreased over the years. In 2020, theWHO prequalified Bayer's Fludora®
Co-Max. This vector control product,a space spray for indoor and outdoor,
can not only prevent the spread of
Zika, but also that of dengue andchikungunya by targeting Aedes
mosquitos.

2022

2018

2021

2022

Even though the number of Ebola projects
in the pipeline has decreased over the lastyears, improvements have been made. In
July 2020, the Johnson & Johnson preventative two-shot vaccine regimen Zabdeno & Mvabea received EMA marketing
authorisation for the prevention of Ebola(Zaire ebolavirus) species.

Disease flagged as an epidemic/pandemic risk

2021

majority of priority EIDs

companies

2018

some EIDs, the companies in scope have nothing in the pipeline for the

ActiveArenal haemorrhagic fevers (incl. Lassa fever)

0

0

0

0

0

0

Chikungunya

3

4

5

3

4

3

Crimean-Congo haemorrhagic fever (CCHF)

0

0

0

0

0

0

Ebola virus disease (EVD)

7

5

4

5

4

1

Emergent non-polio enteroviruses (incl. EV71, D68)

1

1

0

1

1

0

Marburg viral disease (MVD)

1

1

0

1

1

0

Middle East respiratory syndrome coronavirus (MERS-CoV)

0

0

0

0

0

0

Nipah

0

0

0

0

0

0

Bunyaviral diseases (other than CCHF, RVF and SFTS)

0

0

0

0

0

0

Filoviral diseases (other than EVD and MVD)

0

0

0

0

0

0

Henipaviral diseases (other than Nipah)

0

0

0

0

0

0

COVID-19 and other coronaviral diseases (other than SARS and MERS-CoV)

0

63

68

0

17

17

Rift Valley fever (RVF)

0

0

0

0

0

0

Severe acute respiratory syndrome (SARS)

0

0

0

0

0

0

Severe fever with thrombocytopenia syndrome (SFTS)

0

0

0

0

0

0

Zika virus disease

3

4

7

3

4

4

Disease X*

0

0

0

0

0

0

*‘Disease X’, added to this list in 2018, represents the knowledge that a serious epidemic or pandemic could be caused bya pathogen currently unknown to cause
human disease. COVID-19 can be seen as
a first example of Disease X.

Access to Medicine Index 2022 ▶ Special Report

Out of the 20 companies in scope, only five – Bayer, Johnson & Johnson, Merck,
MSD and Takeda – engage in R&D efforts for EIDs other than COVID-19. There are
currently no projects in development for 13 of the 17 priority EIDs analysed by theIndex, meaning that many product gaps remain unaddressed. For example, for Lassa
fever, G-FINDER and WHO recommend a preventative vaccine to be developed
which can protect for at least three years in healthy adults and children, against all
four strains.9 Unfortunately, no such vaccine exists and no companies in scope of
the Index target this EID.
This disparity indicates that, although companies responded quickly to develop
COVID-19 products, the world remains ill-equipped to prevent future epidemics
caused by other priority diseases. For companies in scope, the number of projects
targeting some EIDs has remained relatively stable since the last Index.
Despite R&D gaps for most priority EIDs going unaddressed, companies havemade some important advancements in addressing two diseases with epidemic
potential during the period of analysis. Both products are accompanied by a robust
plan to overcome barriers to access in LMICs.
What access issues should companies consider when developing products toprevent future epidemics and pandemics?
When developing products to combat infectious diseases, companies should consider factors that may hinder the supply, storage and administration of vaccines ortherapeutics in LMICs. As observed with the COVID-19 vaccines, there are manyfactors which can impede vaccination campaigns. This includes complicated multidose regimens, ultra-cold chain storage requirements and routes of administrationthat require skilled health workers. To overcome such obstacles, a product should
ideally be easily administrable and heat stable. For example, despite having a lower
efficacy than mRNA vaccines, the single-dose Johnson & Johnson COVID-19 vaccine offered advantages in terms of ease of use and storage in LMICs.4 The Index
identified one sublingual vaccine in development for COVID-19 during the periodof analysis, i.e., a vaccine that could be dissolved under the tongue; this route ofadministration offers many advantages to people living in LMICs with weak healthsystems, as it does not need to be administered by health professionals.
To address these challenges and the development of health products, WHO lists
target product profiles (TPPs) and product profile characteristics (PPCs) in its R&D
Roadmaps. These outline the desired 'profile' or characteristics of a target productthat is aimed at a particular EID, including potential new vaccines for MERS-CoVand Zika virus disease.10
How can industry contribute to pandemic preparedness?
The COVID-19 pandemic has shown that companies have the capacity to rapidly
shift R&D focus to quickly develop new products when required. While urgent
investments to develop COVID-19 vaccines and therapeutics were necessary, companies should now use this opportunity to work with global health stakeholders andshift focus to develop products for other infectious diseases with the potential tocause outbreaks.
Furthermore, companies need to put the lessons learned in the COVID-19 pandemic into practice and consider barriers to access during R&D and beyond. This
includes developing heat-stable formulations, easily administrable products andplanning for access in the early stages of development. Pricing, procurement andsupply must also be considered to ensure equitable access. With infectious diseases with pandemic potential, the issue of equitable access is even more pertinent
because “no one is safe until everyone is safe”.

31

Access to Medicine Index 2022 ▶ Special Report

Conclusions
The rapid development and authorisation of medicines and vaccines for COVID-19
indicates that the pharmaceutical industry is willing and able to respond quickly
to public health emergencies. However, the disparity in vaccination rates between
high-income countries and low-income countries highlights the inequitable supplyof COVID-19 vaccines in LMICs. Although there are multiple obstacles to the supplyof vaccines in LMICs, some companies work to improve access by engaging in equitable access strategies for their products.
The industry can also build on its successful approaches to equitable accessduring the COVID-19 pandemic and expand these approaches to other products
and countries. This includes engaging in more non-exclusive voluntary licensing andtechnology transfers.
Although the COVID-19 pandemic is still ongoing, companies must address gapsthat exist for the prevention and treatment of other potential EIDs by engaging
in more R&D. Even when no public investment in R&D is involved, pharmaceuticalcompanies should plan early on to ensure any innovations are easily accessible in
LMICs.

R E FE R E N CES
1	United Nations International Children’s
Emergency Fund (UNICEF). COVID-19
pandemic leads to major backsliding
on childhood vaccinations, new WHO,
UNICEF data shows. Published July
15, 2021. Accessed August 4, 2022.
https://www.unicef.org/press-releases/covid-19-pandemic-leadsmajor-backsliding-childhood-vaccinations-new-who-unicef-data
2.	World Health Organization. World
Malaria Report 2021.; 2021. Accessed
October 11, 2022. https://www.who.
int/teams/global-malaria-programme/
reports/world-malaria-report-2021
3.	Watson OJ, Barnsley G, Toor J, Hogan
AB, Winskill P, Ghani AC. Global
impact of the first year of COVID-19
vaccination: a mathematical modellingstudy. Lancet Infect Dis. 2022;0(0).
doi:10.1016/S1473-3099(22)00320-6/
ATTACHMENT/CF5CA979-59F2496B-81AB-FB356D7881BD/MMC1.
PDF

32

4.	Wouters OJ, Shadlen KC, SalcherKonrad M, et al. Challenges in ensuring global access to COVID-19 vaccines: production, affordability, allocation, and deployment. Lancet.
2021;397(10278):1023. doi:10.1016/
S0140-6736(21)00306-8
5.	Chapman N, Doubell A, Tuttle A,
et al. G-FINDER - Landscape ofEmerging Infectious Disease Researchand Development: From Pandemic
Response to Pandemic Resilience.;2022
6.	Loembé MM, Nkengasong JN. COVID19 vaccine access in Africa: Global
distribution, vaccine platforms,
and challenges ahead. Immunity.
2021;54(7):1362. doi:10.1016/J.
IMMUNI.2021.06.017

7.	Cross S, Rho Y, Reddy H, et al.
Who funded the research behind
the Oxford–AstraZeneca COVID19 vaccine? BMJ Glob Health.
2021;6(12):e007321. doi:10.1136/
bmjgh-2021-007321
8.	International Federation of
Pharmaceutical Manufacturers& Associations (IFPMA). Berlin
Declaration BiopharmaceuticalIndustry Vision For Equitable Access
In Pandemics.; 2022. Accessed July22, 2022. https://www.ifpma.org/
resource-centre/berlin-declaration-biopharmaceutical-industry-vision-for-equitable-access-in-pandemics/

9.	Chapman N, Doubell A, Tuttle A,
et al. G-FINDER | Landscape ofEmerging Infectious Disease Researchand Development: Preventing the
Next Pandemic.; 2020. Accessed
July 5, 2022. https://s3-ap-southeast-2.amazonaws.com/policy-cures-website-assets/app/
uploads/2020/09/16021708/EID20_
Report_Web_1_FINAL.pdf
10.	World Health Organization (WHO).
Research and Development (R&D)
Roadmaps. Accessed October 27,
2022. https://www.who.int/teams/
blueprint/r-d-roadmaps

Access to Medicine Index 2022 ▶ Special Report

SPECIAL RE PO RT: WO M E N 'S H E ALTH AN D SRH R

Are pharma companies
addressing sexual andreproductive healthaccess barriers for
women and girls?

Sexual and Reproductive Health and Rights (SRHR) are
human rights for all people. However, the ability to exercise
these rights is not accessible for all. SRHR range from having
access to safe, effective and affordable forms of contraception, access to skilled healthcare providers and services tosupport safe pregnancies and births, to access to treatments
and products for various sexual and reproductive diseases
and health needs. SRHR are a key component to achieving
the Sustainable Development Goals (SDGs) set by the United
Nations General Assembly and Universal Health Coverage set
by the World Health Organization (WHO). To achieve theseby 2030, action needs to focus on ensuring women and girls,
no matter where they live, have access to medicines, products
and services for sexual and reproductive health.
Although addressing SRHR requires global efforts fromvarious stakeholders, pharmaceutical companies have a keyrole to play.
This Special Report in the 2022 Access to Medicine Index
highlights critical areas where companies can do more toaddress access issues for SRHR-related diseases and healthneeds impacting women and girls. The diseases and healthneeds covered were selected based on existing definitions of
SRHR, with a focus on those that disproportionately impact
women and girls in low-and middle-income countries (LMICs).
It examines the extent to which companies are conducting
research on new products and formulations for SRHR-related
health needs, as well as strategies companies are applying
in LMICs to make products accessible through mechanisms
such as registration and pricing strategies. The report also
analyses company capacity building efforts and engagement
in inclusive business models that reach women and girls living
in LMICs.

33

Access to Medicine Index 2022 ▶ Special Report
CO N T E X T

SRHR and women’s health is a critical priority for expanding
access to medicine
In the past half century, progress has been made to improve women and girls’

Defining the scope of this Special

access to SRHR (Sexual and Reproductive Health and Rights) products, services andReport on SRHR of women andinformation, but stark inequalities persist both within and between countries thatgirls

prevent women from realising their full rights to health.1 Particularly in low- andUnder its broadest definition, Sexual

middle-income countries (LMICs), women’s health services, specifically SRHR ser-and Reproductive Health and Rights

vices, are often not provided at a level of quality that meets minimum medical andinclude the rights to the prevention

human rights standards.2 The COVID-19 pandemic and related mitigation efforts

and treatment of sexually trans-

have also disrupted access and utilisation of sexual and reproductive health services

mitted infections (STIs), including

such as contraceptive services, testing for sexually transmitted infections (STIs) andHIV/AIDS, and other genitourinary

safe abortion services.3

diseases; affordable and acceptable

In many LMICs, women’s ability to attain SRHR services may be impacted by sev-

methods of contraception; effec-

eral barriers, such as a lack of trained staff, limited access to epidemiological data,

tive services for healthy pregnancy

or inability to source or fund supply of medicines and contraceptives. These barri-and birth; prevention and manage-ers exist alongside gaps in research and development (R&D) for some SRHR-related

ment of reproductive cancers; safe

diseases and health needs, for example new products or adaptations that would beabortion and post-abortion care;suitable for women living in LMICs.4

safe and hygienic management ofHowever, global shifts are in motion, with the United Nations identifying univer-

menstruation; and management

sal access to SRHR as a global health priority and its inclusion in the 2030 agenda

of sub-fertility, infertility and otherfor Sustainable Development.5

fertility issues. It also extends to

SRHR should be afforded to everyone regardless of gender. However, the Accessconcepts of care and services related

to Medicine Foundation is focusing on women’s health in this report given theto sexuality and sexual and/or gen-

impact of gender inequality on the sexual and reproductive health of women and

der identity, sexual dysfunction, andgirls and the need for increased focus and improvements within the space.7

gender-based and intimate partner
violence.4,6

SRHR-related diseases and health needs

Approved products

R&D projects intarget SRHR-related diseases and healthin scope of the Index

in portfolio

pipeline

needs

Hypertensive disorders of pregnancy

30

Of the 83 diseases and health needs in scope ofMaternal abortion and miscarriage

10

the Index, 19 (23%) are related to SRHR. Of theMaternal sepsis

32

total 1,060 projects in the pipeline, 171 (16%)

Obstructed labour00address SRHR-related diseases and health needs

Maternal haemorrhage

32

and of the 740 products in the portfolio, 176

Contraceptive methods

171(24%) are related to SRHR diseases and healthEndometriosis

6*3

needs.

STIs

Chlamydia

1*

2*

Gonorrhoea

2*3*

HTLV-1

0

1

HSV-2

0

0

TABLE 3 Products and R&D projects that34

*One or more of these projects/products may be indicated for multiple disease
areas (e.g., a treatment for both endometriosis and cancer, or a diagnostic for bothchlamydia and gonorrhoea) and therefore
may be included more than once in theSyphilis

10

Hepatitis B

17*

22

HIV/AIDS

62*

30

M. genitalium

02*

Uterine cancer

013*

Ovarian cancer

17*

36*

Breast cancer

47*

62*

Cervical cancer (including HPV-related)

10*

20*

All diseases/health needs

176

171

table. The total overall number of products/projects is given in ‘All diseases/
health needs’.

Access to Medicine Index 2022 ▶ Special Report
R ESE A RCH & D E V ELO PM EN T

R&D projects and priorities for SRHR – what are companies
doing to fill the gaps?
Cancers (i.e., breast, ovarian, cervical and uterine) are a well-addressed category
within the SRHR-related diseases and health needs in scope of the Index, with 105(60%) projects in the SRHR pipeline targeting one of these cancer types. However,of the four cancer types, breast and ovarian cancer account for the highest numberof projects. This finding mirrors the makeup of the pipeline for all diseases in scope,where companies invest resources into developing products for non-communicablediseases (NCDs), where significant commercial potential is more likely in comparison to other diseases and health needs like contraceptives or maternal healthconditions.
R&D for some SRHR-related diseases and health needs in scope of the Index
is particularly under-resourced. For example, five diseases and conditions are notaddressed at all by any R&D project. Conditions related to maternal health areespecially underrepresented, with just four projects split between maternal haemorrhage and maternal sepsis.

FIGURE 17 Almost all SRHR-related pipeline projects are directed
towards cancer types, HIV/AIDS and hepatitis B
All SRHR-related projects, split per phase of development.
Breast cancer

28

Ovarian cancer

21

HIV/AIDS

5

Hepatitis B

99

Cervical cancer (including HPV-related)

8

Uterine cancer

5

Endometriosis

4

5

20

7
5

11

3

8

5 2

8
6 2 2

4

3

2

Gonorrhoea
Chlamydia
M. genitalium

2

Maternal haemorrhage (incl. postpartum haemorrhage)
Maternal sepsis
Contraceptive methods
HTLV-1HSV-2
Hypertensive disorders of pregnancy
Maternal abortion and miscarriage
Obstructed labour
Syphilis

0

10

20

30

● Discovery/pre-clinical ● Phase I ● Phase II● Phase III ● Registered/market approval ● Other*

Opportunities for R&D efforts to address specific therapeutic gaps in SRHR
An R&D 'product gap' exists when there is an urgent need but low commercial
incentive to engage in R&D for products to sufficiently treat, diagnose or prevent a
disease or condition. Examples of product gaps for SRHR include human papillomavirus (HPV) diagnostics and medicines for postpartum haemorrhage.
A Policy Cures Research report on R&D for SRHR identified several product gaps
specific to LMICs for SRHR conditions and health needs through an in-depth consultation with an expert advisory group.4 Eleven SRHR diseases or health needs inscope have R&D product gaps; HPV-related cervical cancer, hypertensive disordersof pregnancy (pre-eclampsia), maternal haemorrhage (postpartum haemorrhage),
STIs (particularly hepatitis B, herpes simplex virus type 2 (HSV-2), chlamydia, gonorrhoea, syphilis, human T-cell lymphotropic virus type 1 (HTLV-1) and HIV/AIDS),

35*’Other’ is defined as projects which follow a different development cycle thanR&D projects which target the treatmentof a disease, such as a technical lifecyclefor devices.

40

50

60

70

Access to Medicine Index 2022 ▶ Special Reportand contraceptives. The Index defines R&D projects in the pipeline that address
product gaps as 'priority projects.’
Of the 171 SRHR-related projects in the R&D pipeline, 56 are projects in development that address product gaps for a priority disease (see Appendix I). The remaining R&D projects address other SRHR diseases in scope such as ovarian cancer.
To ensure the necessary therapeutics can be developed and ultimately reachmore women and girls, more companies need to invest in R&D for SRHR-relateddiseases and health needs. Currently, only eight of the 20 companies included in the
Index are conducting R&D for gaps in any of these therapeutic areas. These companies are AbbVie, Daiichi Sankyo, Gilead, GSK, Johnson & Johnson, MSD, Roche andSanofi.

FIGURE 18 Almost all SRHR priority projects in the pipeline are
directed towards HIV/AIDS and hepatitis B, while many other diseases
remain unaddressed
There are 56 priority projects in the pipeline targeting at least one R&D gap
covering six different SRHR-related priority diseases or health needs. There
are no projects that address HSV-2, pre-eclampsia and syphillis, although
they are diseases or health needs with R&D product gaps.
Projects addressing
an R&D priority gap
HIV/AIDS

29
56
171
projects
115
Other
SRHR-related
projects in scope

56
priority
projects
addressing
a gap
115

19

Only five of the 56 priority
projects are in Phase III of
R&D, and all target HIV/
AIDS.

Hepatitis B
Gonorrhoea*: 3
Chlamydia*: 2
HPV-related cervical cancer: 2
HTLV-1: 1
Postpartum haemorrhage: 1

Missing R&D for products targeting STIs and HPV-related cervical cancer
Research is currently underway to address certain gaps (e.g., a preventative chlamydia vaccine), however, many gaps are unaddressed – such as therapeutic vaccines and medicines for HPV-related cervical cancer. Although HIV/AIDS and hepatitis B comprise 30% of all SRHR projects in the pipeline, there are no projects indevelopment to address two of the identified product gaps – namely, microbicidesfor HIV and diagnostics for hepatitis B. There are also no R&D projects currently indevelopment targeting product gaps for HSV-2 (commonly referred to as genital
herpes), due to the termination of a project to develop a preventative vaccine forthe virus.
Addressing specific R&D gaps for maternal health could reduce mortality in
LMICs
Maternal mortality rates are disproportionately high in low-income countries, withan average of 462 deaths per 100,000 live births, compared with an average of
11 deaths per 100,000 in high-income countries.8 Several factors influence this,including distance to hospitals, inadequate healthcare services and a lack of accessto existing medicines.
While addressing health system barriers is an important step in addressing highmaternal mortality, R&D investment is also a key element that can help in this regard.
One key gap in R&D for maternal health is for diagnostics for pre-eclampsia. Noneof the companies in scope have priority projects addressing this gap. An accurate
diagnostic suitable for use in LMICs could lead to earlier detection and appropriate

36*There is one diagnostic project in thepipeline targeting both chlamydia andgonorrhoea.

Access to Medicine Index 2022 ▶ Special Reportmanagement of the condition, including timely referral, reducing rates of mortality.
Another notable R&D product gap is for products to treat postpartum haemorrhage, the leading cause of maternal deaths. Currently, treatment for this condition
requires intravenous or intramuscular administration of oxytocin by a skilled healthcare worker.4 A new formulation is needed that is both heat stable and can be easily and quickly administered as an alternative. Currently, among the companies inscope, there are no projects in development to address this need. However, throughMerck for Mothers, MSD collaborated with Ferring Pharmaceuticals and WHO to
support the advancement of Ferring’s proprietary and investigational heat-stablecarbetocin, for the prevention of postpartum haemorrhage. It's well-suited to use
in LMICs as it can be stored and transported at much higher temperatures thanoxytocin, and it was added to the 21st WHO Model List of Essential Medicines. It
addresses part of the gap with its heat stability, but still needs to be administeredintramuscularly. While a step in the right direction, companies can take further
steps to address gaps in ease of administration.

Spotlight on clinical research during pregnancy
Pregnant and lactating women have been historically excluded from clinical trials
for non-obstetric conditions, with safety concerns, ethical and legal considerations cited as reasons for their exclusion.9 As a result, the body of evidence tosupport clinical decision-making for medicines used during pregnancy is lacking,despite many women still needing and using medically necessary medicines
throughout the course of their pregnancy.10 The underrepresentation of pregnant women in clinical trials means that the mechanism by which physiologicalchanges in pregnancy alter the absorption and metabolism of medicines ispoorly understood.11
In 2021, the Word Health Organization (WHO), alongside the International
Maternal Paediatric Adolescent AIDS Clinical Trials Network (IMPAACT) and theInternational AIDS Society, issued a call to action to accelerate the study of new
medicines for HIV in pregnant and breastfeeding women.12 The report makes
several recommendations for how the pharmaceutical industry can play its partto close the knowledge gap created by the exclusion of pregnant women fromclinical research.

37

Access to Medicine Index 2022 ▶ Special Report
PRO D U C T D ELI V ERY

Registration of many products in LMICs is lacking, but
positive exceptions for essential HIV/AIDS medicines andcontraceptives
The Index looks at how companies are utilising mechanisms such as registration andpricing strategies to improve access to their products in LMICs.
Despite standout examples, many SRHR-related products are not widely filed forregistration in LMICs
Filing for registration with a national regulatory authority is the first step required togain 'approval' before a product is launched on the market. Despite a high disease burden and unmet healthcare needs for SRHR-related products in LMICs, some products
may never receive regulatory approval in countries in scope. When a product is notregistered in a country, it limits choice and potentially leaves women and girls without
essential and life-saving SRHR products.
Of the 190 products analysed in the Index in terms of registration data, 39 werefor SRHR-related diseases and health needs.* In general, older products like Bayer’s
levonorgestrel-releasing intrauterine system (Mirena®), which received its first global
regulatory approval in 1990, are most widely registered in LMICs. The levonorgestrel-releasing intrauterine system is a form of long-term contraception, and is themost filed product within the SRHR-related scope of the Index, with a total of 64
filings in LMICs.
Although more recently-launched products are less widely registered acrossLMICs, some examples of good practice are seen. For example, trastuzumab/hyaluronidase-oysk (Herceptin HylectaTM) from Roche, approved by the US FDA in 2019,has been filed for registration in 58 countries within the scope of the Index.
Data analysed by the Index on which products have been registered, and where,suggests that – of the countries in scope – companies are most likely to register
their products in middle-income countries. Only 18 (46%) out of the 39 products
have been filed for registration in any low-income countries. For example, Uganda
has 11 products filed, while Mozambique has 5 and both Ethiopia and Rwanda have 4.
Although several barriers may make registration in some countries more challenging,companies should now ensure more SRHR products are filed consistently across
low-income countries, with a particular focus on the countries with a high burden of
the disease targeted by their particular product.**

FIGURE 19 Number of registration filings in
LMICs for SRHR-related products defined as

BREASTCANCER“essential” by the World Health Organization
Among the products in scope of this analysis,eight are on the WHO Model List of Essential
Medicines (EML), which is a list of the medicines

CERVICALCANCER

1 5

HEPATITIS B

DTaP, hep B, polio, Hib conjugate
vaccine (Vaxelis®), MSD***

0

HIV/AIDS

dolutegravir (Tivicay PD),
GSK

6

micafungin (Mycamine®),Astellas6

these products. This figure shows the number offor registration, broken down by whether the

CONTRACEPTIVESIUD levonorgestrel-releasing,(Mirena®), Bayerfiling is in a low-, lower-middle or upper-middle
income country.

38*A maximum of ten recently-launched
products were included in the Index foranalysis of product registration. As somenewer products are not indicated for
SRHR-related diseases and health needs,
information is not available for all 176 products in scope of this special report. For Eli

5

CINtec PLUS Cytology,
Roche

companies have marketing rights for seven of
the 108 LMICs in which these products are filed

0

VENTANA HER2 Dual ISH,
Roche

considered to be most effective and safe to meetthe most important needs in a health system. The

trastuzumab (Ontruzant®),
MSD***

Lilly and MSD the exact registration statusof their latest products within LMICs could
not be reported as no data was provided/
verified or available in the public domain
during the period of analysis.
**High disease burden countries are thosethat are among the ten countries with

Roche’s CINtec® PLUS cytology,
for cervical cancer screening,and VENTANA HER2 Dual ISH,a diagnostic used to identify
breast cancer patients eligible for
HER2-targeted personalised therapies, are not widely registered inlow- and middle-income countries.

6
8

9

11
15

9

20

30

10

0

10

Of the eight SRHR products
in scope that are listed on
the 2021 WHO EML, Bayer’s
levonorgestrel-releasing
IUD is the most widely
registered product. It also
has the most registrations in
low-income countries.
32

40

22

50

60

70

● Filings in low-income countries● Filings in lower-middle income countries● Filings in upper-middle income countries

the highest disability-adjusted life year
(DALY) value, for any particular disease.
One DALY equals one lost year of healthy
life, allowing for an estimation of thetotal number of years lost due to specificcauses (e.g., diseases and injuries).

***No data about filings for Ontruzant®
and Vaxelis® was sumbitted by MSD,
and no evidence was found in the publicdomain. DTaP: Diphtheria, tetanus pertussis (acellular, component); hep B: hepatitis B; polio: poliomyelitis; Hib: Haemophilus
type b.

Access to Medicine Index 2022 ▶ Special Report

Recent steps forward on registering HIV/AIDS products where the need isgreatest, but mixed picture overall
Some companies have performed well on registering their HIV/AIDS products incountries with a high burden of the disease, but some key products are not registered in the countries where the need is greatest. The ten countries with the highest burden of HIV/AIDS (among adults) are Lesotho, Eswatini, Mozambique, South
Africa, Botswana, Equatorial Guinea, Namibia, Zimbabwe, Zambia, and the Central
African Republic.
Both emtricitabine/tenofovir alafenamide (Descovy®) from Gilead and dolutegravir (Tivicay PD) from GSK (via its majority-owned business specialising in HIV
products, ViiV Healthcare), have recently been filed for registration in seven highdisease burden countries. Specifically, dolutegravir has been filed for registration inthese countries within two years of being approved by the US FDA.
However, for the remaining HIV/AIDS products in scope, five have all been filedin less than three of the ten countries with the highest burden of disease, while theremaining eight products have not been filed in any of these ten countries.

39

Access to Medicine Index 2022 ▶ Special Report
PRO D U C T D ELI V ERY

What are companies doing to ensure their SRHR products areavailable and affordable?
Access strategies are ways in which companies can make sure their products reach

GO O D PR AC T I CE

the people who need them. Companies should put strategies in place for their

GSK’s supranational procurement

products to increase availability, affordability and supply in LMICs, ensuring thesestrategy for its HPV vaccine

strategies are tailored for both the product and the country.

GSK’s HPV bivalent vaccine is supplied through supranational agree-

Products in scope of this analysis

ment via Gavi. GSK applies tiered

This Special Report analyses access strategies for 44 products indicated for SRHR-

pricing for this product, based

related diseases and health needs, looking at the products that have been sampled

on World Bank income classifica-

from companies’ portfolios according to the Index methodology. All the companies

tions (whether a country is high-,

in scope have at least one product included in this analysis, with the exception of

upper-middle, lower-middle or

Boehringer Ingelheim, Merck and Novo Nordisk. Of these products, 17 are analysed

low-income), with countries eligible

as supranationally-procured products. The other 27 are analysed in terms of com-for Gavi’s programme eligible for thepanies’ strategies to ensure access to the product to individual countries.

lowest price for the vaccine.

What is pooled procurement and which companies participate?

ing the same terms of the agreement

Supranational procurement agreements are pooled procurement mechanisms

to countries that have transitioned

whereby large volumes of health products are purchased by an organisation forout of the Gavi programme (e.g.,

supply in multiple countries. This is an important mechanism to ensure a sufficientif they have moved into a different

supply of affordable SRHR-related products are available in LMICs, especially the

income classification) and therefore

poorest countries.

don't receive the lowest cost for vac-

GSK has also committed to apply-

Eight of the companies in scope – AbbVie, Bayer, Bristol Myers Squibb, Pfizer,

cines. GSK also applies an equitable

GSK, MSD, Roche and Johnson & Johnson – engage in international agreements

pricing strategy in South Africa, a

for the procurement of SRHR products. Between them, they work with organi-country not eligible for Gavi support,

sations including Gavi, the Vaccine Alliance (Gavi); the Global Fund to Fight AIDS,

by offering its HPV bivalent vaccine

Tuberculosis and Malaria (the Global Fund); UNITAID; Clinton Health Accessto the Ministry of Health via a tender

Initiative (CHAI); and the Pan American Health Organization (PAHO).

process. Since South Africa’s HPV
immunisation programme began in

Supranational procurement of HPV vaccines to prevent cervical cancer

2014, GSK has won all tenders based

In 2020, an estimated 90% of global deaths from cervical cancer occurred inon the cost of vaccines.

LMICs,13 where access to preventative products such as the HPV vaccine arelimited. In an effort to reduce the number of women dying from this preventable disease, 41 countries in scope have introduced national HPV immunisation
programmes. Two companies in scope (GSK and MSD) supply HPV vaccines tocountries in scope of the Index through Gavi's pooled procurement mechanism.
Programmes such as Gavi’s play an important part in reducing deaths from cervicalcancer.
It is important that companies consider the access needs of people living incountries that do not qualify for Gavi support. For example, due to the high cost of
the vaccine, non-eligible countries may face challenges in budgeting for vaccination
programmes. In recognition of this, both GSK and MSD have agreed, with conditions
and for a limited timeframe, to continue to support countries that have transitioned
from Gavi by providing HPV bivalent vaccine (Cervarix®) and HPV quadrivalentvaccine (Gardasil®), respectively, at the same price they were accessed when supported by Gavi.

40

Access to Medicine Index 2022 ▶ Special Report

Access to contraceptives through supranational procurement and pricing
strategies
In 2019, it was estimated that of the 1.1 billion women of reproductive age that havea need for family planning, 270 million still had an unmet need for contraception.14
Access to contraception is important to prevent unwanted pregnancy and pregnancy-related health risks for women living in LMICs. Pregnancy-related health risks
disproportionately impact women in LMICs, where an estimated 94% of maternal
deaths occurred in 2017.15
Global access to contraception is increasing, with the United Nations Population
Fund (UNFPA), the world’s largest supranational procurer of contraceptives, reporting that an additional 60 million women and girls were using modern contraceptives in 2020 compared to 2012 via its supranational agreements and public-private
partnerships.

GO O D PR AC T I CE

GO O D PR AC T I CE

Bayer’s participation in supranational procurement for

Pfizer’s participation in supranational procurement for

Jadelle®

Sayana Press®

Bayer is the biggest supplier of contraceptives to UNFPA,

Pfizer supplies subcutaneous depo medroxyprogesterone

accounting for 11% of UNFPA procurement in 2021.16 Bayeracetate (Sayana Press®), a LARC providing at least 13

supplies its levonorgestrel-releasing implant (Jadelle®), aweeks of contraception, through Family Planning 2030

long-acting reversible contraceptive (LARC) that provides(FP2030). Subcutaneous depo medroxyprogesterone ace-

contraception for up to five years. Within the last ten

tate has several characteristics that make it well suited foryears the annual volume of the levonorgestrel-releasing

low-income countries, particularly its potential for self-ad-

implant has quadrupled and in total more than 49 million

ministration, its length of contraceptive cover, compact

implants have been provided to the world’s poorest coun-and discreet size, and shelf life at room temperature.

tries. This is important as LARCs, including implants, canbe a safe and cost-effective alternative to short-acting
contraceptives.

Although supranational procurement agreements are important means of providing
access in the world's poorest countries, these agreements are often limited to asmall group of products for women's health conditions – particularly contraceptives, HIV/AIDS medicines and diagnostics and HPV vaccinations.
NCDs, such as breast and uterine cancer, have so far not been included in supranational procurement agreements. Therefore, to ensure access in LMICs, companies should particularly pursue access strategies – outside of supranational agreements – to ensure their NCD products reach these countries.

41

Access to Medicine Index 2022 ▶ Special Report

Examining access strategies and equitable pricing for SRHR-related products

GO O D PR AC T I CE

It is important that companies tailor access strategies to overcome barriers to

Novartis’s access strategies for its

access that are specific to the country. This means considering challenges pre-maternal haemorrhage productsented by weak health and regulatory systems in LMICs. A good access strategy has

For its product methylergonovine

equitable pricing that considers the ability to pay of different buyers (both publicmaleate, for maternal haemorrhage,and private) in all contexts (between upper-middle, lower-middle and low-income

Novartis can demonstrate examples

countries, and also between countries) and additional non-pricing initiatives toof good access strategies in at least

maximise the reach of low-income patients.

one upper-middle income country(Colombia), a lower-middle income

Lack of access strategies for oncology products, especially in low-income

country (India) and a low-income

countries

country (Togo).

Although the quality of access strategies varies across products and countries,

Although the strategies imple-

the Index found that in low-income countries, companies consistently do not havemented in Colombia and India areaccess strategies in place for some SRHR products. Weak health systems, lack ofmore comprehensive, Novartis does

regulatory capacity and inadequate funding pose challenges to reaching patients inreport some efforts to improve

low-income countries.

affordability in Togo.

This gap in access is particularly pronounced for oncology products, especially

In Colombia, the product isbreast cancer. The Index analysed access strategies for 14 breast cancer prod-

included in the national Healthucts, of these 11 (78%) did not have an access strategy in any low-income country

Benefit Plan and is offered toin scope. Products for HIV/AIDS and hepatitis B are more likely to be covered bypatients at no cost. Novartis’s priceaccess strategies in low-income countries. Of the combined total of six products

is based on budget impact and prices

for these indications that are included in this analysis, five products had an accessin external reference countries. In

strategy in at least one low-income country.

India, in addition to pricing strategies, Novartis manufactures locallyCompanies could consider non-exclusive voluntary licensing for key breastand has eliminated promotional

cancer products

investments to decrease cost to the

Despite the complexities in accessing markets in low-income countries, companies

patient.

can think beyond traditional routes to provide access to these patients. One mecha-

Togo's national health author-

nism to achieve this is non-exclusive voluntary licensing, where, under certain terms

ity is responsible for setting theand conditions, the company agrees to allow sub-licensees to manufacture and sell

price of methylergonovine maleate

generic versions of their products in LMICs. Currently, the only non-exclusive volun-(Methergine®), and patients pay outtary licences addressing the SRHR diseases in scope of this report are for HIV.

of pocket in the private channel.

The Medicines Patent Pool (MPP) is an intermediary that facilitates licensing

Novartis reports that during priceagreements between pharmaceutical companies and generic manufacturers, and it

negotiations with the government,

has identified three products to treat breast cancer. Where gaps in access for these

local affordability was considered.

products exist, voluntary licensing through MPP would lead to substantial publichealth impact. The products identified include ribociclib (Kisqali®) from Novartis,
abemaciclib (Verzenio®) from Eli Lilly and palbociclib (Ibrance®) from Pfizer.

42

Methylergonovine is also includedin the list of essential medicines.

Access to Medicine Index 2022 ▶ Special Report
PRO D U C T D ELI V ERY

What are companies doing to ensure the uptake of SRHR
products and care in LMIC health systems?
In addition to developing and researching new products, capacity building isanother way companies can help improve access to medicine and address issues in
the availability and accessibility of SRHR products. Health systems, supply chains,and manufacturing capacity within LMICs should be equipped for delivering SRHR
treatments to women and girls. Companies can also build R&D capacity in LMICs todevelop medicines and vaccines for SRHR-related products.
What kinds of capacity building initiatives are companies involved in for SRHR?

FIGURE 20 Engagement in capacity building

Supply chain

for SRHR varies across fields

5

While companies are engaged in multiple healthsystems strengthening initiatives for SRHR, fewer
examples are seen for supply, manufacturing or

19

R&D capacity building initiatives.

39
capacitybuilding
initiatives

5

10

Manufacturing

R&D

Health systems
strengthening

Health systems strengthening to address uptake of SRHR products
Of the capacity building efforts assessed in the Index, health systems strengthening
initiatives are the most common way that companies address SRHR-related diseases and health needs, with 11 companies involved in a combined total of 19 initiatives. Through initiatives like MSD for Mothers, Takeda and World Vision’s Healthy
Village programme, or Roche’s involvement with NJIA, companies are addressing
health system gaps, such as lack of trained healthcare workers and lack of diseaseawareness.
MSD for Mothers began in 2011 and has the largest country reach out of all the
SRHR-related capacity building initiatives seen in the Index, targeting 31 LMICs
in scope of the Index. It is a USD 650 million global initiative that contributes thecompany's scientific and business expertise and financial resources to address preventable maternal deaths through supporting quality maternity care and access tomodern contraception. MSD has worked with more than 150 collaborators and hasreached over 18.2 million women globally through its programmes that aim to support safe, high-quality and respectful maternal care.
Notably, 11 of the 19 health systems strengthening initiatives for SRHR are active
in a single country. Especially when outcome measurements show impact like
reduced maternal mortality or improved patient awareness, companies can now act
to scale up their health systems strengthening efforts to reach more women andgirls in countries with high disease burden or unmet health needs.
Companies can help address supply chain barriers through capacity building
Fewer examples are seen of companies engaging in supply chain capacity building,despite supply being a major barrier to accessing SRHR products. Although several
supply barriers require efforts from governments and other local stakeholders,some companies are performing well in capacity building, by supporting efforts
from local and international actors.
Supply chain issues like a lack of trained staff and weak information systems
pose a threat to the continuous supply of contraceptives in LMICs. Several agencies

43

GSK funds two SRHR-related research projects
led by African scientists through its NCD Open
Lab; one on cardiovascular disease in pregnancy in Tanzanian women and the other on
pathophysiology of pre-eclampsia in Ugandan
women.

Access to Medicine Index 2022 ▶ Special Report

like UNFPA are actively working in LMICs and low-income countries to support sup-GO O D PR AC T I CE

ply of contraceptives in addition to other SRHR products. However, such agencies

In the Philippines, Novartis has anrely on partnerships with pharmaceutical companies, who supply the necessary

inclusive business model for its

products and greatly impact product availability, affordability, and uninterrupted

breast cancer treatment

supply. Four companies engaged in supply chain capacity building specifically

In 2021, Novartis launched an inclu-

targeting SRHR-related diseases and health needs, three of which report work-

sive business model to help low-in-ing directly with the UNFPA. For example, Bayer is one of the three suppliers ofcome women in the Philippines

implants and oral contraceptives for the Reproductive Health Supplies Coalition’s

access and afford ribociclib(RHSC), Global Family Planning Visibility and Analytics Network (GFP-VAN) and(Kryxana®/Kisqali®) for breast cancer

participated in shaping the platform. As of April 2022, the RHSC reported that its

treatment. Through research, theefforts to mitigate stockouts averted 2 million pregnancies across 48 countries andcompany found that patients in theprovided 373,000 additional CYPs* across 37 countries.

Philippines began treatment but wereunable to sustain treatment due toReaching women and girls through inclusive business models

the cost. The company subsequently

Inclusive business models are scalable, commercially viable models that provide

launched a model where patients pay

goods, services and livelihood opportunities to low-income populations. Theseless for a longer duration of treat-models are particularly relevant for women and girls, as they are disproportionately

ment, thus incentivising adherence.

impacted by poverty and face additional barriers to access. Several constraints pre-Further, to enable implementation

vent companies from including women and girls as consumers, employees or pro-of a progressive discounting scheme

ducers in their value chain, such as gender-based expectations, limited literacy, andacross different pharmacy partners,

lack of rights and agency. Nonetheless, if pharmaceutical companies want to ensure

Novartis partnered with a technol-that the entire income pyramid is able to benefit from accessing their medicines,

ogy provider to extend eligibility of

they must engage in inclusive business models that target these groups.

patients to the scheme and assist

Nine of the twenty companies in scope of the Index show evidence of their

them in areas such as enrolment,

engagement in inclusive business models that address SRHR-related diseases andeligibility tracking and medicine com-

health needs (AstraZeneca, Bayer, Boehringer Ingelheim, Gilead, Johnson & Johnson,

pliance reminders. In parallel, Novartis

MSD, Novartis, Pfizer and Roche), despite 19 companies having products in theiris also working with governments

portfolio that cover SRHR diseases or health needs. Although half of the SRHR inclu-

to encourage inclusion of ribociclib

sive business models evaluated target maternal health, women’s health needs extend

in the national formulary to support

beyond those related to reproduction. Across all disease areas, companies cangovernment reimbursement for theaddress women and girls’ unmet access needs using inclusive business models.

product for those that require it.

FIGURE 21 Inclusive business models cover
multiple SRHR-related disease areas andhealth needs
Half of the SRHR-related inclusive businessmodels analysed by the Index are targeted toward
addressing maternal health needs.

Maternal

7

Cancer**

3

STIs

3

HIV/AIDS

2

Contraceptives

1

Other

1

0

2

4

6

8

10

12

14

16

One of the business models covered by thisanalysis includes women as employees in thecompany’s value chain, but does not cover a
specific disease area.

44*The United States Agency forInternational Development (USAID)
defines Couple-Years of Protection (CYP)
as the estimated protection provided byfamily planning methods during a oneyear period, based upon the volume of allcontraceptives sold or distributed free ofcharge to clients during that period. This
includes permanent methods, such as
sterilisation, and the lactational amenorrhea method.

**Cervical and breast cancer

Access to Medicine Index 2022 ▶ Special Report
N E X T S T EPS

What can companies do to ensure women and girls in LMICs
have access to the SRHR-related products they need?
R&D investment and clinical trials
Of the SRHR-related diseases and health needs included in this report, cancers,
hepatitis B and HIV/AIDS draw the bulk of the R&D focus. The remaining half of thediseases and health needs make up less than 10% of the SRHR pipeline, with some
not addressed at all. More R&D investment in these areas is needed, especially tofill product gaps for diseases and health needs that currently remain unaddressed,
for example, pre-eclampsia and postpartum haemorrhage. Furthermore, there isan underrepsentation of pregnant women in clinical trials and, where appropriate,
companies can make additional efforts to include them in clinical research in linewith WHO recommendations.
Supporting access through supranational procurement
Companies’ efforts to make their products affordable in LMICs are unbalanced, withareas for improvement, especially in access to SRHR-related non-communicablediseases. Pooled procurement via supranational agreements is focused on HIV
medicines and diagnostics, HPV vaccines, and contraceptives. When countries are
not eligible, or no longer eligible (due to their income classification changing) tobenefit from supranational procurement, companies should develop access strategies for these countries to ensure that women and girls can access medicines at asimilar price.
Access strategies for more products, in more countries
For key products in their portfolios, and particularly for non-communicable diseases like ovarian cancer, endometriosis and uterine cancer, for which there is no
supranational procurement mechanism, companies must implement country-specific access strategies to ensure equitable access. Access strategies are generally
missing in low-income countries, especially for breast cancer, while treatments
for HIV/AIDS and hepatitis B are mostly covered by equitable pricing strategies
across all income tiers. Companies can take steps to develop access strategies forthese products and ensure that they reach women and girls living in low-income
countries.
Investment in capacity building and tailoring inclusive business models
Companies have an additional role to play beyond researching and supplying products. Barriers such as lack of awareness, supply chain barriers, and lack of trained
health workers also need to be addressed. Higher levels of company engagement inhealth systems strengthening are needed and efforts can be made to scale up these
initiatives to more countries where there are women and girls with unmet accessneeds. Companies can engage with partners, such as the UNFPA, to build supply
chain capacity for SRHR products in specific areas including demand forecastingand improving infrastructure for storage and delivery of medicines.
In addition, several companies have SRHR products in their portfolio, like contraceptives, products indicated for HIV/AIDS, and cancer therapies, that are only accessible through regular business practices that may not be inclusive, meaning thatthey are not tailored to address the specific needs of women and girls.

45

Access to Medicine Index 2022 ▶ Special Report

R E FE R E N CES
1.	United Nations Population Fund.
Unfinished Business: The Pursuit ofRights and Choices for All.; 2019.
2.	Mariani G, Kasznia-Brown J, Paez D,
et al. Improving women’s health in
low-income and middle-income countries. Part I: challenges and priorities.
Published online 2017. doi:10.1097/
MNM.0000000000000751
3.	Vanbenschoten H, Kuganantham
H, Larsson EC, et al. Impact of the
COVID-19 pandemic on access to andutilisation of services for sexual andreproductive health: a scoping review.
BMJ Glob Health. 2022;7:9594.
doi:10.1136/bmjgh-2022-009594
4.	Chapman N, Doubell A, GoldsteinM, et al. G-FINDER | Sexual andReproductive Health Research andDevelopment: Understanding theSpectrum.; 2020. Accessed July 5,2022. https://www.policycuresresearch.org/g-finder/
5.	United Nations General Assembly.
Transforming Our World : The 2030
Agenda for Sustainable Development.;
2015.

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6.	Starrs AM, Ezeh AC, Barker G, etal. Accelerate progress—sexualand reproductive health and rights
for all: report of the Guttmacher–
Lancet Commission. The Lancet.
2018;391(10140):2642-2692.
doi:10.1016/S0140-6736(18)30293-9
7.	The United Nations Entity for Gender
Equality and the Empowerment of
Women. Promoting Gender Equality
in Sexual, Reproductive, Maternal,
Newborn, Child and Adolescent
Health: Programming Guide.; 2019.
8.	World Health Organization. Maternalmortality. Published 2019. Accessed
October 15, 2022. https://www.who.
int/news-room/fact-sheets/detail/maternal-mortality
9.	Smith DD, Pippen JL, Adesomo AA,
Rood KM, Landon MB, Costantine
MM. Exclusion of Pregnant Womenfrom Clinical Trials during theCoronavirus Disease 2019 Pandemic:
A Review of International Registries.
Am J Perinatol. 2020;37(8):792.
doi:10.1055/S-0040-1712103

10.	van der Graaf R, van der Zande ISE,
den Ruijter HM, et al. Fair inclusionof pregnant women in clinical trials: An integrated scientific and ethical approach. Trials. 2018;19(1):19. doi:10.1186/S13063-017-2402-9/
TABLES/1
11.	Avram MJ. Pharmacokinetic studies in pregnancy. Semin Perinatol.
2020;44(3):151227. doi:10.1016/J.
SEMPERI.2020.151227
12.	Word Health Organization (WHO),
International Maternal Paediatric
Adolescent AIDS Clinical Trials
Network (IMPAACT), International
AIDS Society. Research for Informed:
Accelerating the study of New Drugs
for HIV in Pregnant and breastfeeding
Women.; 2021. Accessed October 10,
2022. https://www.impaactnetwork.
org/sites/default/files/inline-files/
PW_Call_to_Action_final.pdf
13.	Sung H, Ferlay J, Siegel RL, et al.
Global Cancer Statistics 2020:
GLOBOCAN Estimates of Incidence
and Mortality Worldwide for 36
Cancers in 185 Countries. CA Cancer J
Clin. 2021;71(3):209-249. doi:10.3322/
caac.21660

14.	Kantorová V, Wheldon MC, Ueffing
P, Dasgupta ANZ. Estimating progress towards meeting women’s contraceptive needs in 185 countries: A
Bayesian hierarchical modelling study.
PLoS Med. 2020;17(2):e1003026.
doi:10.1371/journal.pmed.1003026
15.	UNFPA, UNICEF, Organization
WH, Group WB, Division the UNP.
Trends in Maternal Mortality: 2000
to 2017 | UNFPA - United Nations
Population Fund. WHO, UNICEF,
UNFPA,World Bank Group and theUnited Nations Population Division.
Published online 2019:104. Accessed
November 4, 2022. https://www.
unfpa.org/featured-publication/
trends-maternal-mortality-2000-201716.	United Nations Population
Fund. UNFPA Procurement
Statistics 2021.; 2021. Accessed
November 4, 2022. https:https://www.unfpa.org/resources/
unfpa-procurement-statistics-2021

Access to Medicine Index 2022 ▶ Special Report

SPECIAL RE PORT: PROG RESS ANALYSISIs the industry making
progress on improving
access to medicine?

The 2022 Index report marks the eighth edition of the Accessto Medicine Index, which was first published in 2008. For
over a decade, the Index has provided insights into how 20of the world’s largest pharmaceutical companies perform
on access to medicine in low- and middle-income countries(LMICs). The methodology for the 2022 Index has a high levelof continuity with the previous Index, allowing for a detailed
longitudinal analysis of where progress has been made – andwhere it has not.
This Special Report explores the extent to which theindustry is making progress on improving access to medicine,and progress towards the UN Sustainable Development Goal
3 (SDG3) for 2030, despite the challenge of the COVID-19
pandemic.
The analysis presented here compares data from the 2022
Access to Medicine Index with data from the 2021 Index, andwhere possible, previous editions of the Index. Although themethodology was updated with a new robust framework
after the publication of the 2018 Index, comparisons havebeen drawn where viable and meaningful.

47

Access to Medicine Index 2022 ▶ Special Report
GOV ER N A N CE O F ACCESS

Progress seen at board level as companies increasingly
integrate strategies to address access to medicine
This section looks at where there has been a shift from indirect to direct top-levelaccountability for access to medicine and whether the companies are increasingly embedding an access-to-medicine mindset in their business operations.
Additionally, this section considers changes in how companies ensure compliancewith codes of conduct and incentivise good ethical conduct by sales agents.
Governance structures and incentives
Since 2018, the number of companies with either a board

FIGURE 22 Progress in number of companies with direct board-level

member or a board-level committee responsible and account-responsibility for access to medicine

able for access to medicine activities has increased from 11 in2018, to 12 in 2021, and 16 in 2022, with Eisai, Bristol Myers

9

8

4
16

Squibb, Merck and Sanofi now also providing evidence of directboard-level accountability for access-to-medicine activities.
In 2019, the Foundation published an independent ten-

11

12With directboard-level
responsibility

year analysis titled, “Are pharmaceutical companies making
progress when it comes to global health?”, which identified
a shift from indirect board-level responsibility for access to

2018

2021

2022

medicine towards assigning direct responsibility to a named
board member. As the data from the 2021 and 2022 Indexes
shows, there has been noticeable progress.
In 2021, 13 companies provided evidence of access-related

FIGURE 23 Small increase in the number of companies with accessincentives for senior executives, including the CEO, andincentives for senior management

regional or in-country management. In 2022, one morecompany, Gilead, provided evidence of incentives for senior
management, indicating only a slight improvement in thecompanies’ top-level incentivisation of access-related targets

7

13

6
14

and goals.

2021

Access incentives forsenior executives,
including the CEO,and in-country or
regional managers

2022

The 2022 Index finds that three companies have newly

FIGURE 24 Clear signs of progress as all 20 companies now have an

implemented an access-to-medicine strategy, meaning all 20

access-to-medicine strategy

companies now have an access-to-medicine strategy in place
to expand access to their products for people living in LMICs.

12

11

5

These companies are AbbVie, Astellas and Daiichi Sankyo.

15

3

3

3

17

17

17

2016

2018

2021

20

Companies
with no clear
access strategy

Previously, these companies had only general commitments
to improve access to medicine rather than a clear, intergrated
access-to-medicine strategy.

8

2010

9

2012

2014

2022

Nineteen of the 20 companies have integrated their

FIGURE 25 Significant increase in number of companies that haveaccess-to-medicine strategy into their overall corporate

integrated their access-to-medicine strategies into their overall

strategy, with Gilead having a business rationale for its

corporate strategy
1
919

access-to-medicine strategy that is focused on partnerships
to enhance access. This is in stark contrast to the 2021 Index,
where just 11 companies had integrated strategies.

Access-to-medicine
strategy integrated
into overall corporate
strategy

11

48
2021

2022

Access to Medicine Index 2022 ▶ Special Report

While all pharmaceutical companies included in the analysis

FIGURE 26 More companies are increasing transparency about their

have set targets and goals related to their access-to-medicine

access-to-medicine activities

initiatives, companies vary considerably in terms of the quantity and quality of outcome reporting.

10

5For example, several companies report outcomes using

15

centralised, easy-to-digest dashboards detailing how andwhen short-, medium- and long-term results were achieved

Centralised,
comprehensive andhigh quality reportingof outcomes10

for all activities. Other companies do not have such transparent practices; for example, they may share this information
via multiple documents or external websites, or only reporton certain products or therapeutic areas, making it difficult to

2021

2022

gain a complete picture of the company’s activities and holdthem accountable.
Ethical marketing and complianceWith respect to risk management of unethical marketing

FIGURE 27 Companies are making progress on decoupling agents’and other practices, the 2022 Index has determined thatrewards from sales targets

companies are making strides. AbbVie, Bristol Myers Squibb,
Boehringer Ingelheim, Daiichi Sankyo, Gilead and Sanofi newly

118

demonstrate that sales agents' incentives are not based solely
on sales volume.
The number of companies decoupling sales agents’rewards from sales targets has steadily increased over time.

2
18

12

Companies
decoupling bonuses
from sales targets

9Compensation for sales representatives is becoming increasingly tied to qualitative performance indicators, such as technical knowledge or compliance adherence.

2018

2021

2022

The Foundation’s ten-year progress report, published in 2019,

FIGURE 28 Some signs of progress in applying specific compliancefound that all 20 companies had auditing controls in place

controls

since the 2016 Index. In the 2022 Index, this remains the case.
In 2018, the Index began analysing whether companies had
additional controls in place to ensure compliance with eachsystem for compliance and processes to ensure third-party
compliance.

9

Live monitoring systemcountry’s regulatory and anti-corruption laws. This included
fraud-specific risk assessments, a continuous monitoring

20
20
20

Auditing
11

15
16

Third-party compliance systems
6

Fraud-specific risk assessment
0Country risk-based assessment

12

15

12
● 2018● 202120
20

17● 2022

In 2021, country risk-based assessment
was added to the control framework.

Of the five controls measured by the Index in 2021, only eight

FIGURE 29 Progress in implementing a comprehensive set ofcompanies demonstrated evidence of applying all of them. In

compliance controls to prevent corrupt and non-compliant activity

2022, five additional companies have implemented all controls, meaning there are 13 companies that have a strong –127i.e., comprehensive – internal control framework for ensuring
13

compliance. The five additional companies are Bayer, Bristol
Myers Squibb, Eisai, Merck and Pfizer.

2021

49

Implements acomprehensive
set of compliance
controls

82022

Access to Medicine Index 2022 ▶ Special Report
R ESE A RCH & D E V ELO PM EN T

Companies make progress in access planning but littlechange in makeup of R&D pipelines

Breakdown of the pipeline
The total number of projects targeting specific disease classi-

FIGURE 30 HIV/AIDS and COVID-19 draw more R&D attention, number

fications has remained relatively stable since the 2021 Index,

of projects targeting NTDs decreases

with a slight decrease in the number of R&D projects in thepipeline targeting diseases in scope; 1,060 projects in 2022

89

Neglected tropical diseases

69

compared with 1,073 projects in 2021. A total of 62 products
received regulatory approval,* 479 new projects were added
to the pipeline and 466 projects were removed during the

68
55

Malaria

period of analysis.** Notably, there has been a decrease in
the number of projects targeting neglected tropical diseases

55
32

HIV/AIDS(NTDs). Despite 20 new NTD projects being added to thepipeline, the total number of NTD projects fell from 89 in

46
34

Tuberculosis

the previous Index to 69 in the 2022 Index. The decreasein the number of active projects is mostly a result of some34
34

Diabetes

discovery-phase projects being discontinued and some projects leaving the pipeline after successfully reaching product

63

Coronaviral diseases (incl. COVID-19)

Maternal & neonatal health conditions

approval and launch.

31
11
10
● 2021● 2022

Among R&D projects to address priority diseases, a small
number of diseases dominate the pipeline
and Chagas disease decreases

global health organisations (see Appendix VI) – a figure consistent with the findings of the previous Index.
However, although there are 64 priority diseases, over halfof these projects (202) focus on four priority diseases: coronaviral diseases, HIV/AIDS, malaria, and tuberculosis. Manydiseases with urgent requirements for R&D are not being
addressed by research-based pharmaceutical companies.
This figure remains consistent with the 2021 pipeline, where
199 projects targeted these four diseases. This is a long-term
trend that was also identified by the Foundation’s 10-year progress report in 2019, which found that, in general, companies’
R&D activities are concentrated on a few diseases.

FIGURE 32 Limited change in companies’ focus on R&D for priority
diseases
699

374

2021

50

693

367

Projects targetingan R&D priority gap

2022*This includes products that received
emergency use authorisation or conditional marketing approval during theperiod of analysis (1 June 2020 - 31 May2022).

**Period of analysis 1 June 2022 - 31 May
2022

Neglected tropical disease>10 projects
5-10 projects
1-4 projects
0 projects

2022

FIGURE 31 R&D activity for NTDs such as leishmaniasis, onchocerciasis

ease identified as a priority R&D treatment gap, as defined by2021

Of the 1,060 projects in the pipeline, one third target a dis-Buruli ulcer

00Chagas disease27

21

Dengue and chikungunya

12

11

Dracunculiasis

00Echinococcosis

00Food-borne trematodiases

10

Human African trypanosomiasis

7

7

Leishmaniasis

28

15

Leprosy2

1

Lymphatic filiariasis

51

Mycetoma11

Onchocerciasis

11

4

Rabies3

3

Scabies and other ectoparasites

00Schistosomiasis

18

16
0

Snakebite envenoming

0

Soil-transmitted helminthiasis

43

Taeniasis/cysticercosis

00Trachoma

0

0

Yaws

0

0

Access to Medicine Index 2022 ▶ Special ReportCompanies begin to look ahead but with a narrow lensWhile the ten-year progress report published by the

FIGURE 33 More late-stage R&D projects have access plans comparedFoundation in 2019 found that the proportion of late-

to previous years

stage R&D projects with access plans had remained largely
unchanged over the previous decade, in 2022 the number of238

late-stage projects with access plans has increased markedly.

77

In the 2021 Index, 40% of late-stage projects analysed had

257

plans for access in place during the R&D stage. This year, 77%of late-stage projects have access plans in place.

156
Late-stage R&D projects
with access plans

This improvement corroborates a Key Finding from the2021 Index, which identified an industry shift towards systematic access planning during late-stage R&D so that new
products quickly reach the people who need them in LMICs.
The significant increase between the 2021 and 2022 Indexes
may indicate that companies’ commitments to systematically
implementing access planning during R&D are now leading totangible results.
However, an in-depth analysis of the quality and breadthof these plans concludes that the majority of these plans
focus on a select number of countries in scope, thus leaving
these important product developments out of reach for most.
Furthermore, most of these plans focus solely on registering
the product in at least one country in scope of the Index withfew provisions for affordability to ensure the product will beaccessible for all.

51

2021

2022

Access to Medicine Index 2022 ▶ Special Report
PRO D U C T D ELI V ERY

Progress in access strategies and voluntary licensing, but
overall picture mixed
Each product should have an access strategy to ensure it is widely available andaffordable in LMICs. Equitable pricing and non-exclusive voluntary licensing (NEVL)
are two important mechanisms that companies can use as part of an access strategy to increase access to a product. Furthermore, patent transparency is an important tool to ensure generic manufacturers can quickly enter the market once theoriginal patents on a health product expire.
This section shows how companies have developed their access strategies sincethe 2021 Index. It also looks at how companies have progressed in NEVL and patenttransparency over past Indexes.
More products now covered by access strategies
Since the previous Index, there has been a significant increase

FIGURE 34 Percentage of products covered by access strategies inin the number of products in scope that are now covered byupper-middle, lower-middle, and low-income countries

an access strategy. Access strategies can include, for example,
pricing strategies, non-pricing initiatives (e.g., patient assistance programmes, non-exclusive voluntary licensing, donations) or a combination of pricing strategies with non-pricing

Healthcare practitioner-administered products
UMIC

53%

initiatives.

practitioner (HCP)-administered products. However, as in

LMIC

58%

78%

It is important that companies put access strategies inplace for both self-administered products and healthcare

22%

27%

LIC

87%

73%

47%

42%
29%

the 2021 Index, HCP-administered products continue to be
13%

covered by fewer access strategies compared to self-administered products in upper-middle income and lower-middle
income countries. Access strategies are also far less likely to
be used to expand access to products in low-income coun-

71%

2021

2022

2021

2022

2021

2022

● Covered by an access strategy● Not covered by an access strategy

tries, compared to upper-middle income countries and lower-middle income countries.

Self-administered products
UMIC

49%

19%

LMIC

57%

81%
51%

30%

LIC

74%

62%

70%
43%

38%
26%

2021

Compared with the 2021 Index, data analysed in the 2022

2022

2021

2022

2021

2022

● Covered by an access strategy● Not covered by an access strategy

Index shows an increase in the number of companies engaging in supranational agreements.
AstraZeneca now supplies products via supranational
agreements, and in countries not eligible for international
procurement processes. The company, along with Pfizer, also
has access strategies that include the same terms as supranational agreements. As the figure shows, this has slightly

FIGURE 35 Small increase in number of products included in accessstrategies outside of supranational agreements
20%

8%
51%

42%

increased the proportion of the products in scope that arecovered by these access strategies. Data analysed in the 2022
Index shows progress in the percentage of products covered

38%

41%

2021

2022

by an access strategy in countries outside supranational
agreements. A smaller percentage of products are not covered by access strategies in non-eligible countries.

52● Not covered by any access strategy outside ofsupranational agreements● Covered by at least one access strategy that is
equitable, but differs from terms included insupranational agreements● Covered by at least one access strategy with the sameterms included in supranational agreements

Access to Medicine Index 2022 ▶ Special Report

Increase in voluntary licensing is mainly related to COVID19 products
Engaging in NEVLs is one way that research-based pharma-

FIGURE 36 Five products have been newly covered by voluntary

ceutical companies can ensure that key healthcare products,

licences in the last two years*

or the compounds vital to making those products, reach more
people who need them – particularly those living in LMICs.

No. of compounds

When companies offer NEVLs, this can facilitate the entranceof generic manufacturers to market, making medicines more
affordable and accessible.
AstraZeneca, Eli Lilly and Novartis have entered into new

4
14

1
1

6

7

7

15

15

13

licensing agreements since the previous Index. There are now
27 licenced compounds, which include three new NEVLs for
COVID-19 treatments and one private voluntary licence fora COVID-19 vaccine (in addition to the COVID-19 productalready covered by a licence in the 2021 Index). Althoughmore companies are getting involved in licensing agreements,
the transparency, quality and breadth of these licences vary.

2016

2018

1

5

2021

2022

● Targets cancer● Targets TB● Targets Hepatitis C virus● Targets HIV/AIDS● Targets COVID-19

Number of companies disclosing patent status for some of
their products remains highWhen companies publicly disclose patent status data about

FIGURE 37 Number of companies sharing patent status data for sometheir products – i.e., sharing information about where patents

products in their portfolios

are filed – this transparency can bring significant benefits interms of access to medicine. In particular, it provides greatercertainty to generic medicine manufacturers and international drug procurers when planning the manufacture and/or supply of generic products, thereby facilitating increased
supply and affordability.
Of the 20 companies, 19 publicly disclose information on

The first company to take thisstep was Merck, followed in2016 by AstraZeneca, Gilead
and Novo Nordisk.

Boehringer Ingelheim
does not publicly disclose
the patent status of its
products on its website or
Pat-INFORMED.

20 companies

20

20

19

16

3
17

the status of patents related to at least some of the prod-

1

1

19

19

2021

2022

cuts in their portfolio, the same number as the 2021 Index.
Most of the data is shared through the online database
Pat-INFORMED – an intitiative coordinated between theInternational Federation of Pharmaceutical Manufacturers& Associations (IFPMA) and the World Intellectual Property
Organization (WIPO) – while a few companies self-publish
patent information online.

2010

2012

1

4

2014

2016

2018

● Disclose patent status● Did not disclose patent status

19 companies disclose
patent information throughthe Pat-INFORMED online
database, or on their company
website. AstraZeneca, Merck
and Sanofi lead in patenttransparency, by currently
sharing the expiry dates ofpatents on their websites.

* During the period of analysis for thisIndex: 1 June 2020 - 31 May 2022.

53

Access to Medicine Index 2022 ▶ Special Report
PRO D U C T D ELI V ERY

Progress in capacity building in R&D and manufacturing, but
stagnation in health systems strengthening
Capacity building initiatives focused on health systems strengthening, manufacturing, supply chain and R&D represent additional ways in which pharmaceuticalcompanies can improve access to medicine and address issues in health productavailability and accessibility (e.g., appropriate prescription, efficient administration).
Overall improvement in proportion of initiatives meeting
all Good Practice Standards
For almost all fields of capacity building, improvement has

FIGURE 38 More supply, manufacturing and R&D capacity building

been seen in the percentage of initiatives included that meet

initiatives meet all Good Practice Standards, but improvements in

all Good Practice Standards (GPS; see Appendix IV); over-health systems strengthening initiatives have stagnatedall, 21 additional initiatives meet all GPS compared with the% Initiatives meeting all GPS

previous Index. The most significant improvement was seen
in R&D capacity building, with an increase of 34 percentage

76%

69%

points. Supply and manufacturing had smaller increases of56%

18 and 26 percentage points, respectively. For R&D capacity

43%

building, 11 more initiatives were included compared with

79%

73%71%

58%
50%

45%

43%

the previous Index. In both supply chain and manufacturing

22%

capacity building, 13 new initiatives were included for analysis.

D

re
n

gt

he

● 2018● 2021● 2022

R&

ng
ni

pl
st

an

sy
st
em

s

M

systems strengthening initiatives were improving in terms of

uf
ac
t

relatively stable. In the 2021 Index, analysis showed that health

Su
p

ur

in

g

tiatives focused on health systems strengthening has stayedy

However, the number of high-quality capacity building ini-

quality and quantity. In the 2022 Index, while seven new initia-

He
al

th

tives have been included for analysis, only two more initiatives
meet all GPS, thereby reducing the overall percentage ofhealth systems strengthening initiatives that meet all GPS.

FIGURE 39 Varied progress in measuring outcomes across capacity

Progress in outcome measurement focused on R&D

building fields

capacity building% of initiatives measuring outcomes

Measuring and sharing outcomes can provide valuable
insights that can improve ongoing projects and inform future

79%
75%

activities. Because of this, measuring capacity building out-

92%

84%
73%

comes is one of the GPS for manufacturing, supply and R&D
capacity building, and publicly disclosing outcomes is a GPS

43%

for health systems strengthening. Outcome measurements
across capacity building can include changes in patient health● 2021● 2022

D
R&

pl
y
Su
p

rin
uf
ac
tu
an

Since the last Index, companies have especially done more
to measure outcomes of R&D capacity building. ImprovementMpatient reach or decreased stockouts in pharmacies.

goutcomes, quantity of donated equipment, evidence ofin outcome measurement was also seen in supply chain
capacity building initiatives, but no improvement was seen

FIGURE 40 Stagnation in public disclosure of outcomes for healthin measuring outcomes of manufacturing capacity building

systems strengthening

initiatives.
The Index measures whether companies both measure andpublicly disclose outcomes of health systems strengthening% of initiatives publicly reporting outcomes

76%

80%

initiatives. In the 2022 Index, only a marginal improvementin public disclosure of outcomes was seen across health systems strengthening initiatives.

2021

54

2022

Access to Medicine Index 2022 ▶ Special ReportFive-fold increase in scaled-up inclusive business models
since 2021 Index
Since 2014, when inclusive business models were first

FIGURE 41 Use of inclusive business models continues to expand, withassessed in the Index, ten more companies are engaged

an emphasis on scaling up models

in inclusive business models, with 16 companies currently

32

engaged in 51 inclusive business models. This change reflects
companies’ efforts to address unmet health needs of vulnerable groups who may face additional barriers to access. The
number of inclusive business models that have scaled up has

19

increased five-fold since 2021, whereas the number of piloted

15

inclusive business models has stayed relatively consistent.
Scale-up can involve expanding to new countries, increasing
the number of patients served, or expanding the diseases
covered.

55

2

4

2014

7
0
2016

5

6

2018

2021

1

2022

● Pilot● Scaled-up

Technical Areas

The 2022 Index's analytical framework consists of three
Technical Areas: Governance of Access, Research andDevelopment and Product Delivery.
The following chapters lay out the data collected about the
20 companies in scope – and analyse this information to drawout conclusions.
Each of the following Technical Areas feature:• An overview of how the Index assesses company
performance.
• A ranking of the 20 pharmaceutical companies detailingwhat separates the best and worst performers.
• Detailed figure-led analyses identifying industry and company strengths, weaknesses, trends and opportunities.

56

GOVERNANCE OF ACCESSCO NTE X T

I N S I G HTSAs pharmaceutical companies search for new opportunities to increase patient• All 20 companies assessed havereach in low- and middle-income countries (LMICs), they must ensure that theirestablished an access-to-medicine

products are accessible to people at the base of the income pyramid. Improving

strategy with measurable objectives.

access to medicine sustainably requires that companies create clear access strat-• Most companies have incentives thategies that focus on the long term and incorporate these into their business strat-

are not fully linked to sales, with someegies, while simultaneously engaging their workforce to adopt an access-to-medi-companies reporting not using sales

cine mindset. Moreover, companies need to conduct business ethically and enforce

and marketing representatives at all

stringent compliance processes across their operations while additionally demon-

for some products related to diseases

strating transparency in reporting their access outcomes.
This technical area looks at how companies plan, integrate, implement and man-in scope.
• Many companies still do not provide

age objectives related to improving access to medicine in LMICs, as well as theirevidence of a comprehensive set of

approach to limiting unethical behaviour that, in contrast, would hinder access.

compliance controls for preventing
non-compliant activities that may

PE R FO R MAN CE I N D I C ATO RS

create barriers to access in countries

In this Technical Area, the company’s performance is assessed against the following

in scope.

indicators:• Board-level responsibility of an access-to-medicine strategy and incentivisationof senior management and in-country management toward achievement ofaccess-to-medicine goals• Integration of an access-to-medicine strategy within the overall corporate strategy and across all therapeutic areas in which the company is involved• Public disclosure and measurement of access-to-medicine activities, including
commitments, goals, targets, objectives and outcomes• Ethical business conduct• Intellectual property (IP) strategy conducive to facilitating access to medicine incountries in scope of the Index
WHAT D O ES B EST PR AC TI CE LO O K LI KE?

The top-performing companies have an access-to-medicine strategy that extends
across all therapeutic areas they are involved in. They have access-related incentives in place for senior managers, including the CEO, and are actively engaged inmeasuring the progress and outcomes of their access-to medicine-initiatives in
LMICs. The best-performing companies also engage in ethical business practices
by decoupling financial rewards among sales agents from sales volume targets, andimplementing robust frameworks for compliance to mitigate the risk of non-compliance across business operations in LMICs, including third-party collaborators.

FI N D O UT M O R E

Sub-ranking

PAG E

58

How do companies prioritise
access to medicine?

59

This section features a detailed
figure-led analysis identifying industry
strengths, weaknesses, trends andopportunities as of the time ofwriting. For a fine-grained view ofindividual company activity in thisTechnical Area, see the Report Cards,
page 147.

57

Access to Medicine Index 2022 ▶ Governance of Access

HOW TH E CO M PAN I ES PE RFO RM

Top-performing companies
demonstrate strong
responsible business practices
ATMI22_GA_Subranking_large
FIGURE 42 Governance of Access Ranking
1

Pfizer4,57

2

AstraZeneca

4,43

2

GSK

4,43

2

Johnson & Johnson

4,43

2

Novo Nordisk

4,43

2

Sanofi4,432

Takeda4,438Astellas

4,29

8

Bayer

4,29

10 Eisai

4,14

10 Merck KGaA (Merck)

4,14

12 Boehringer Ingelheim

4.00

12 Roche

4.00

14 BMS

3,86

15 AbbVie

3,43

15 Daiichi Sankyo

3,43

15 Gilead

3,43

15 Novartis

3,43

19 Eli Lilly

3,29

Pfizer has risen to the top spot, up four
positions since the previous Index. The
company scores highly across all areas
assessed within Governance of Access.

3,14

20 Merck & Co, Inc (MSD)
0

1

2

3

4

5

The top spot is held by Pfizer, with the company scoring highly across all areas
assessed within Governance of Access. Pfizer provides evidence of well-establishedstructures of governance and management, with responsibility assigned and incentives
offered at the highest level. It takes an optimal approach to ensuring ethical businesspractices – e.g., in addition to adopting a balanced scorecard approach, sales targets
for sales agents are not set at the individual level, and it has a policy to limit transfersof values to healthcare professionals in LMICs. It also has stringent compliance processes across its operations, including with third parties.
The lower-performing companies do not provide evidence of direct board-level
responsibility for their access activities, nor do they provide evidence of incentives toachieve access-related goals. Furthermore, they demonstrate only some of the compliance controls analysed by the Index and provide little information related to responsible promotional practices. Novartis is an exception here as a company with a strong
compliance programme but a low score in this Index, due to a breach settlement.
58

Access to Medicine Index 2022 ▶ Governance of Access

GOVE RNANCE STR ATEGY AN D RESPO NSI B LE BUSI N ESS PR ACTI CES

How do companies prioritise
access to medicine?

Patients in LMICs shoulder the bulk of the global disease burden, yet essential healthcare products are often entirely unaffordable or unavailable to them.
Achieving greater access for these patients requires companies to give LMICs an
important place in their business operations.
Implementing clear, long-term strategies
All 20 companies that were assessed have established an access-to-medicine strategy with measurable objectives. Most companies demonstrate best practice byembedding their access-to-medicine strategy within their overall corporate strategy, indicating that access to medicine in LMICs is relevant for long-term growth.
Of the 19 companies with integrated strategies, 14 apply access thinking across all
therapeutic areas in which they are involved. Gilead provides evidence of a businessrationale for its access-to-medicine strategies rather than a fully integrated strategy covering all therapeutic areas.

FIGURE 43 Do companies have strong access-to-medicine strategies
in place?
17

Access-to-medicine strategy

20
11Strategy is integrated into corporate strategy

19
11Strategy covers all therapeutic areas

14● 2021

Gilead has a business rationale
for its strategy rather than a fully
integrated strategy● 2022

Prioritising access to medicine at the top level
Companies that demonstrate best practice in prioritising access to medicine have

FIGURE 44 Is access to medicine a priority ata board member or a board-level committee that is directly responsible for accessthe highest level?

initiatives to ensure that access-related objectives are given attention, remain on
track and are achieved. In the 2021 Index, 12 companies provided evidence of directboard-level responsibility for their access initiatives. During the period of analysis*,the number of companies with a board-level committee increased to 16 companies.
Astellas, Daiichi Sankyo, Eli Lilly and MSD** provide evidence of indirect board-level4
20companies

responsibility, with executive-level committees and executive team members often
responsible for access strategies.

59*Period of analysis for the 2022 Index: 1
June 2020 to 31 May 2022**Merck & Co., Inc., Rahway, NJ USA

16
Have indirectboard-level
responsibility

More than half ofcompanies prioritise
access to medicine
at the top level withdirect board-level
responsibility

Access to Medicine Index 2022 ▶ Governance of Access

Incentivising action
Access is more likely to be an important goal of an organisation when senior

FIGURE 45 Are access-related goals

management, and especially the CEO, have key performance indicators specifi-

incentivised among senior management?

cally linked to access-to-medicine objectives. Ideally, access incentives include a
non-financial component and are oriented toward long-term goals, as evidenced
by AstraZeneca, Bayer, Daiichi Sankyo, Novartis, Sanofi and Takeda. Companies in

620
companies

scope with no evidence of access incentives for either senior executives, including
the CEO or in-country/regional managers include AbbVie, Bristol Myers Squibb, Eli

14

Lilly, MSD and Merck.
Promoting ethical sales practices

More than half ofthe companies
in scope haveaccess-related
incentives for senior
management,
including the CEO

Although incentives can encourage employees to work towards achieving
access-related goals, bonuses and rewards for sales representatives are commonly
linked to sales volume. This can negatively affect access to medicine by increasing

6
20
companies

the risk of mis-selling or over-selling products. Companies are, however, moving
away from such sales incentive structures and taking steps to decouple sales incen-

14

tives from sales targets, thereby removing the incentive to oversell. This is often
done by including qualitative metrics in agents’ variable compensation scheme
through distinction in practice related to antimicrobial resistance; market uptake

More than half ofthe companies
in scope haveaccess-related
incentives forin-country managers

for priority products; or safeguards to ensure ethical practices.
In the period of analysis, 18 companies have incentives that are not fully linked
to sales volume. However, Pfizer and Sanofi are the only companies demonstrating

FIGURE 46 Are companies promoting ethicalsales practices?

evidence that sales targets are not set at the individual level, with Sanofi reporting
2

that such targets are set at the national level in countries in scope of the Index; thefurther incentives are from the individual level, the better, as it can reduce the moti-

20
companies

vation to engage in unethical practices to achieve targets. Furthermore, some companies report not using sales and marketing representatives at all for some products related to diseases in scope of the Index. For example, Johnson & Johnson
does not deploy sales representatives for all products in scope of its Global Public
Health organisation, such as HIV medicines.

18

Most companies
have incentives thatare not wholly linked
to sales.

Incentives are fully
or mostly driven bysales volume

Publicly disclosing outcomes of access-to-medicine activities
Monitoring and evaluation of access-to-medicine activities are crucial to track anddemonstrate progress toward objectives, and the public disclosure of this progress

FIGURE 47 How are companies reporting

facilitates accountability and transparency. All companies publicly disclose commit-

progress on their access-to-medicine

ments, targets and objectives related to their access-to-medicine initiatives, but

activities?

they differ in the quality of outcome reporting. Several companies, such as Takeda
and Novo Nordisk, report outcomes of all access-related activities directly on theirwebsite in a centralised manner (e.g., a company report or outcomes dashboard)as opposed to reporting on only a subset of access-related activities on an external
platform. For example, Takeda reports its outcomes within its Access to Medicines
progress report, and Novo Nordisk reports outcomes within its Year in Review
report. Additionally, outcome reporting occurs regularly (e.g., at least annually)among top-performing companies.

60

5
20
companies
15

Centralised,
comprehensive andregular reporting ofoutcomes

Access to Medicine Index 2022 ▶ Governance of Access

Mitigating non-compliance and corrupt behaviour
Within the health sector, the pharmaceutical industry is argued to be one of the

FIGURE 48 How do companies monitor

sub-sectors particularly vulnerable to corruption due to the highly complex andcompliance?

multifaceted structure of the sector itself (e.g., multiple actors, high-value products

the Index. Other companies include Astellas, AstraZeneca, GSK, Eli Lilly, Johnson

Companies

Fraud-specific risk assessment

Third-party compliance systems

Country risk-based assessment

Auditing

Live-monitoring systemand contracts). This may create multiple points of potential vulnerability related& Johnson, Novo Nordisk, Novartis, Sanofi and Takeda. Bristol Myers Squibb, Eisai,

Abbvie

●

●

●

●

●

Gilead and Merck newly demonstrate evidence of country risk-based assessments,

Astellas

●

●

●

●

●

while Eli Lilly reports that it conducts country risk-based assessments annually

AstraZeneca

●

●

●

●

●

in every country/region where there is an Ethics & Compliance Officer present.

Bayer

●

●

●

●

●

Bristol Myers Squibb

●

●

●

●

●

Boehringer Ingelheim

●

●

●

●

●

Daiichi Sankyo

●

●

●

●

●

Eisai

●

●

●

●

●

Eli Lilly

●

●

●

●

●

Gilead

●

●

●

●

●

GSK

●

●

●

●

●

Johnson & Johnson

●

●

●

●

●

MSD

●

●

●

●

●

Merck

●

●

●

●

●

Novo Nordisk

●

●

●

●

●

Novartis

●

●

●

●

●

Pfizer

●

●

●

●

●

Roche

●

●

●

●

●

There is evidence that, during the period of analysis, Novartis has agreed to

Sanofi

●

●

●

●

●

pay to settle charges that a former subsidiary violated the books and records andTakeda

●

●

●

●

●

internal accounting controls provisions of the Foreign Corrupt Practices Act (FCPA)

Total

15

20

17

20

15

to bribery and other corrupt activities.1 Therefore, the Index looks for a strong
internal framework for ensuring compliance (i.e., processes and structures aimed
at minimising the risk of occurrence of non-compliant activities and/or behaviour among the company’s employees and the third parties with which it formallyengages). All companies have auditing and third-party compliance mechanisms
in place. Compared with the 2021 Index, five additional companies - Bayer, Bristol
Myers Squibb, Eisai, Merck and Pfizer - provide evidence of all controls assessed by

AbbVie, Bristol Myers Squibb and Merck disclose evidence of fraud-specific risk
assessments. Bayer, Bristol Myers Squibb, Merck and Pfizer newly provide evidenceof a live-monitoring system.
Have any cases been recently settled that relate to breaches of law orcompliance issues?
Cases of breaches are often not exposed publicly in countries in scope of the Index,
or they may not be identified by regulatory or law enforcement entities due toweaker capacity to impose measures against unethical marketing or corruption.
Still, breaches do occur and may become public knowledge. Therefore, the Index
analyses whether companies have been found to be the subject of negative rulings
or settled cases regarding breaches of internationally recognised codes of conduct,laws and regulations related to unethical marketing practices, corrupt practices,anti-competitive practices, or misconduct in clinical trials in countries within scopeof the Index.

between 2011 and 2014 in Vietnam, which is in scope of the Index.
Conclusions
The 2022 Index is seeing evidence that companies are making progress when it
comes to adopting good governance structures and enforcing rigorous standards of
behaviour across their operations. This is reflected in the increase in the number ofcompanies with top-level accountability for their access-to-medicine activities andthose incentivising senior management to deliver on access-to-medicine goals andenforcing ethical marketing practices.
Yet, in other areas related to responsible business practices, progress is still lagging. Many companies still do not provide evidence of a comprehensive set of compliance controls for preventing non-compliant activities that may create barriers toaccess in countries in scope of the Index. Furthermore, while all companies perform
well in their public reporting of commitments, measurable targets, and objectives
for access-related activities, there is room for improvement when it comes to the
public disclosure of outcomes related to these activities. This is especially important for transparency and accountability purposes.
R E FE R E N CE S

61

1	Gurun, N., Gürkaynak, G., & Yildiz, C.
(2019, February 6). An Overview ofCorruption Risks in the Pharmaceutical
Sector | IFLR1000. IFLR1000.

Thirteen companies inscope demonstrate bestpractice by applying allcompliance controls
looked for by the Index

RESEARCH AND DEVELOPMENTH OW R& D C AN H E LP E XPAN D ACCESS TO M E D I CI N E

I N S I G HTSThe Research and Development (R&D) technical area focuses on the products that

1 Slight decrease in the number of R&D

companies are developing to target diseases in scope of the Index. The Index tracks

projects in the pipeline targeting dis-

R&D activity for all diseases in scope, with a particular focus on those which lackeases in scope. 1,060 projects in 2022

treatment options and disproportionately affect people in low- and middle-income
countries (LMICs). These so called 'priority diseases’ require R&D investment tocompared to 1,073 projects in 2021.
2 62 products received regulatory

develop viable treatments. Such product development is referred to as 'priority

approval and 479 new projects were

R&D' by the Index. Companies have the expertise and resources to develop prod-

added to the pipeline during theucts with the potential to overcome these treatment gaps.

period of analysis.*

Inequitable access to healthcare products is a universal issue, therefore companies should begin developing individual access plans for each product in thepipeline to ensure that they will be available to those that need them, regardless

3 Over one third of projects in the pipeline target treatment gaps identified
as priority R&D.

of where they live. The quality and geographic scope of these R&D access plans

4 All companies improve in planning forare evaluated to assess whether companies are laying the groundwork to makeaccess for late-stage R&D projects.

their products available and accessible to people living in LMICs. Outside of their

However, these plans tend to focus

own pipelines, companies can contribute to capacity building by working with local

on a core group of upper-middle

stakeholders during the R&D process. This empowers local researchers to address

income countries, with only 15% of

relevant R&D needs and identifies key access obstacles that may be faced once theplans including a low-income country.

products are registered.
The importance of developing new products and initiating plans for accessduring the R&D stage is increasingly recognised by global health stakeholders.
Consequently, in terms of scoring and ranking the companies, this technical area ismore heavily weighted than in the previous Index.
PE R FO R MAN CE I N D I C ATO RS

The companies’ performance in the R&D technical area is assessed against the following criteria:• Product development: The composition of a company’s pipeline, including thenumber and type of projects in development targeting diseases in scope of theIndex.
• R&D investment disclosure: Transparency of R&D investment data is necessary
to highlight gaps in funding for neglected diseases.
• Planning for access: Planning ahead to ensure new products can be swiftly
made available and accessible in countries in scope. Such plans are referred to as‘access plans.’• R&D capacity building: The quality of initiatives that build local R&D capacity isassessed against the Good Practice Standards framework (see Appendix IV).
WHAT D O ES B EST PR AC TI CE LO O K LI KE?

FI N D O UT M O R E

The best-performing companies have projects in development that address urgent

Company ranking in R&D

PAG E

63

R&D treatment gaps for priority diseases as identified by global health organisa-

Products in the R&D pipeline

64

tions. Top companies systematically plan for access during R&D and have policies

Assessing companies’ accessto implement project-specific access plans no later than Phase II of clinical trials.

plans for pipeline projects

70

Leading companies put these policies into practice and provide evidence of comprehensive plans for every late-stage project in development, i.e., from Phase II
onwards. Comprehensive plans consider ways to make the product available in the
countries in scope of the Index and ensure it can be supplied continuously at anThis section takes an in-depth look at
the quality and quantity of companies'
access plans during the R&D stage

affordable price. The best plans have a broad geographic scope in order to reachthe greatest number of patients.
62*This includes products that received
emergency use authorisation or conditional marketing approval during theperiod of analysis (1 June 2020 - 31 May2022).

Access to Medicine Index 2022 ▶ Research & Development

HOW TH E CO M PAN I ES PE RFO RM

Marked improvement acrossthe board in R&D

ATMI22_RD_Subranking_large
FIGURE 49 Research & Development Ranking
1

GSK

3,78

2

Johnson & Johnson

3,73

3

Novartis

3,70

4

Merck KGaA (Merck)

3,40

5

Pfizer3,15

6

AstraZeneca

3,03

7

Takeda

2,98

8

Roche

2,88

8

Sanofi2,88

10 Bayer

2,65

11 Merck & Co, Inc (MSD)

2,38

12 Boehringer Ingelheim

2,23

13 Astellas

2,05

14 Eisai

2,03

15 Gilead

1,93

16 Eli Lilly

1,90

17 BMS

1,80

18 Daiichi Sankyo

1,63

19 Novo Nordisk

1,48

GSK, Johnson & Johnson and Novartis
retain their positions from the 2021
Index. GSK stands out across all 20
companies as having the largest R&D
pipeline targeting diseases in scope of
the Index.

0,78

20 AbbVie
0

1

2

3

4

5

The top spot is retained by GSK, followed closely by Johnson & Johnson andNovartis. Out of all 20 companies, GSK has the largest pipeline targeting diseases
in scope of the Index. It also has the largest number of projects in development thattarget priority diseases such as malaria, tuberculosis and HIV/AIDS.
The top-performing companies score highly across all assessment criteria,
including access planning and capacity building. Johnson & Johnson, Novartis, andMerck provide evidence of access planning during the R&D stage for all late-stage
projects in this analysis.
Bayer has made progress from its previous ranking in the R&D technical area
by introducing a comprehensive policy that systematically plans for access.
Furthermore, the company includes the highest number of countries in its accessplans on average.

63

Access to Medicine Index 2022 ▶ Research & Development

PI PE LI N E ANALYSIS

Products in the pipeline: arecompanies addressing R&Dpriorities?

New health products, including medicines, vaccines and diagnostics, can help those
suffering from previously untreatable conditions or enhance health outcomes byimproving on existing treatments. However, the development of health products is
a lengthy and expensive process. Because they need to conform to high standardsof safety and efficacy, most candidates in development targeting unmet healthcare
needs never reach the market. As a result, developments for diseases with high burdens in LMICs are often overlooked in favour of products for markets that are more
profitable.
To tackle this problem, the global health community has urged that the needs ofpeople living in LMICs should be proactively included in companies’ R&D activity.
The industry plays a pivotal role in responding to this call. For example, GSK and
Novartis have reinforced commitments to invest in R&D for neglected tropical diseases (NTDs).1
How R&D priorities are identified and defined in this analysis
The World Health Organization (WHO) and Policy Cures Research, an independent
R&D-focused policy group, have published lists of the most urgently needed products to incentivise their development. Thirty-nine of the diseases, conditions andpathogens in scope of the 2022 Index are included on these lists, and are considered ‘priority diseases’ – i.e., particular R&D priorities for global health. The Accessto Medicine Index assesses R&D activity for these projects separately from otherdiseases in scope to highlight companies' efforts in addressing unmet healthcare
needs for diseases despite there being little financial incentive to do so. The Index
also monitors R&D activity for diseases in scope that fall outside the ‘priority disease’ categorisation, because these diseases have a high prevalence in LMICs.
When no product is currently available on the market to sufficiently treat, diagnose or prevent a priority disease, or therapeutic efficacy is lacking; this is defined
as a 'product gap.' These products may be medicines, vaccines, diagnostics, medical
devices or vector control products. Every company, regardless of size or therapeutic focus, can play a role in addressing these gaps. This analysis looks at whichof these gaps are being addressed by the 20 companies assessed. Any project in
the pipeline that targets a product gap for a priority disease is considered 'priority
R&D' by the Index. There are 243 product gaps within scope of the Index. As thesepriority lists focus primarily on neglected and communicable diseases, the Accessto Medicine Index methodology also analyses products for non-communicable diseases (NCDs) that have a clear public health value in LMICs.

64

Access to Medicine Index 2022 ▶ Research & Development

TA_RD2-PipelinePerPhase
FIGURE 50 About a third of projects address a
Projects that target an established priority gap

specific priority R&D gap
R&D projects usually start in the discovery phase1060
projects

of development and progress through thepipeline until they are approved for market use.

Discovery/pre-clinical

367

166

Phase I 45
Phase II 44

693

Phase III 43

Note that the 2022 Index does not monitor

Applied for/received market approval

pre-clinical R&D activity for non-priority diseases.

36

Other*

33
100

0

200

300

Projects

Other projects that target diseases in scope of the Index
Phase I

282

Phase II

207

Phase III

142

Applied for/received market approval 53
Other*

9
0

100

200

300

Projects

FIGURE: 51 What does each company pipeline look like?
TA_RD2-PipelineAllCompanies

All companies are developing products that target an established R&D priority gap.
GSK
64

Merck**33

Eisai

GSK focuses on established treatment gaps forpriority diseases such as malaria, tuberculosis andneglected tropical diseases.

22

Pfizer21

Gilead101

AstraZeneca's pipeline focuses mainly on
non-communicable diseases such as cancer,
asthma and cardiovascular diseases. Although
new products for these diseases are not regarded
as priority R&D, innovative products may offer atherapeutic advantage to existing ones. Furthermore, more effective formulations and dosage
forms are needed to enhance access to existing
medicines. All such R&D projects require accessplans to accelerate access in LMICs.

26
31
36

17

31

Roche

17

Daiichi Sankyo

16

19

16

21

SanofiMSD***

13

Takeda

11

Bayer

10

AbbVie6Astellas6

AstraZeneca

4

Eli Lilly

3

Boehringer Ingelheim

2

Novo Nordisk

1

37

35

23

Novartis

BMS

26

81

Johnson & Johnson

70

34
10
19
36
17
42
33
17

1

0

52

20

40

60

80

100

● Projects that target an established priority gap● Other projects

120

Projects

FIGURE: 52 More than half of projects are for non-communicable diseases
This chart shows which diseases are the focus of the 1,060 R&D projects.†

TA_RD2-DiseaseCategories
Non-communicable diseases

Oncology projects dominate the pipeline, withalmost half of the projects in development (485)targeting one of the cancer types in scope of theIndex (see Appendix I).

675

Communicable diseases

313

Neglected tropical diseases

69

Maternal and neonatal health conditions 10
065*Other includes projects that are market
approved, subject to first global registration, have a technical lifecycle and projects
that follow a different development cycle(e.g., diagnostics).

200

400

**Merck KGaA (Darmstadt, Germany)***Merck & Co, Inc (Rahway, NJ, USA)†The total is the sum of all projects
counted. Some projects fall into several
disease categories.

600

800

Projects

The number of projects targeting neglected
tropical diseases (NTDs) has fallen by almost 25%
since the 2021 Index (69 projects versus 89).
The decrease in the number of active projects
from 2021 to 2022 is mostly a result of discovery-phase projects being discontinued, as well assome products being approved and leaving thepipeline. However, it is essential that companies
renew the R&D pipeline with products targeted at
NTDs. There are many diseases for which new or
improved treatments are urgently needed, suchas mycetoma or river blindness.

Access to Medicine Index 2022 ▶ Research & Development

FIGURE 53 By disease, how does the priority R&D pipeline break down?
Although all the diseases in this figure have been identified as priority diseases by global
health stakeholders, the number of projects in development to address the priority gaps
varies according to disease type. There are many projects in development targeting

TA_RD2-PriorityPipelineByDiseasecoronaviral diseases, malaria and HIV/AIDS, while other neglected diseases are left behind.
Disease category
Communicablediseases

60

70

Projects

Disease name
Arenaviral haemorrhagic fevers (Lassa fever)
Bunyaviral diseases (other than CCHF, RVF or SFTS)
Chlamydia
CholeraCoronaviral diseases*
Crimean-Congo haemorrhagic fever (CCHF)● Discovery/pre-clinical phase
Cryptosporidiosis● Clinical phases
Ebola virus disease (EVD) 3● Applied for/received
Emergent non-polio enteroviruses (including EV71, D68)
market approvalEnteroaggregative E. coli (EAEC) infections● Other (e.g. diagnostics)
Enterotoxigenic E. coli (ETEC) infections
Filoviral diseases (other than EVD or MVD)
Giardiasis (lambliasis)
Gonorrhoea
4 2
Henipaviral diseases (other than NiV infection)
Hepatitis B
8Hepatitis C
Herpes simplex virus type 2 (HSV-2) infection
HIV/AIDS
5
HPV-related cervical cancer
Human T-cell lymphotropic virus type 1 (HTLV-1) infection
Influenza
5 2
Leptospirosis
Malaria (P. falciparum)
Malaria (P. vivax)
Marburg virus disease (MVD)
Meningitis (N. meningitidis)
6
Meningitis (C. neoformans)
Nipah virus (NiV) infection
Non-typhoidal S. enterica (NTS) infection
4
Pneumococcal disease (S. pneumoniae) 3 2
Respiratory syncytial virus (RSV) disease 2 2
Rheumatic fever (S. pyogenes)
Rift Valley fever (RVF)
Rotaviral gastroenteritis
Severe fever with thrombocytopenia syndrome (SFTS)
Sexually transmitted infections** 2
Shigellosis
Syphilis
Tuberculosis
Typhoid and paratyphoid fever (S. Typhi, S. Paratyphi A) 3
Zika virus disease 2 2 2Other prioritised antibacterial-resistant infections
13
Disease X***
Ascariasis
Neglected tropicaldiseasesBuruli ulcer
Chagas disease17
Chikungunya 3
Dengue4 3 2
Hookworm diseases
Human African trypanosomiasis 3 2
Leishmaniasis
10
4
Leprosy
Lymphatic filariasis
MycetomaRiver blindness (onchocerciasis)
3
Scabies
Schistosomiasis
9 2 2 3
Snakebite envenoming
Strongyloidiasis 2
Taeniasis/cysticercosis
Trachoma
Trichuriasis
Maternal and neonatal
Contraceptive methods
health conditions
Neonatal sepsis (group B streptococcus)
Postpartum haemorrhage
Pre-eclampsia

066*Including Middle East respiratory syndrome coronavirus (MERS-CoV), Severe
acute respiratory syndrome (SARS) andother highly pathogenic coronaviral diseases. There were only developments for
COVID-19.

**Other than chlamydia, gonorrhoea,
syphilis or HSV-2 or HTLV-1 infections.
***Disease X is defined by WHO as a pathogen currently unknown to cause humandisease that could cause a serious international epidemic. Priority R&D for this dis-

10

28

19

14

7

14

32

24

6 2

35

8

34

8

8

7 2

16

3

4

2

20

ease is restricted to platform technologies
that enable cross-cutting R&D preparedness that is also relevant for an unknown
Disease X. Not included in the remaining gaps.

30

40

50

60

70

Projects● Discovery/pre-c● Clinical phases● Applied for/rec
market approva● Other (e.g. diagno products in development to address

0
0
0
0
0
0
0
0
0

3
0
20
0
0
39
0
0

2
0

0
0
1

38

3
1
0
8

broken down by the category of product (e.g.,whether it is a vaccine or medicine). The ‘productgaps’ indicated in the table show which products
are urgently needed by people living in low- andDisease category
Communicablediseases

middle-income countries, as identified by WHO
and Policy Cures Research (see Appendix I). R&D
gaps include maternal health conditions, such as
pre-eclampsia and several sexually transmitted
infections (STIs), as well as emerging infectious
diseases such as Crimean Congo haemorrhagic
fever. The zeroes represent gaps for which no
R&D activity could be identified. Of the gaps, 173of the 243 are unaddressed.
>10 projects
5-10 projects
1-4 projects
0 projects
No priority

Disease name
Arenaviral haemorrhagic fevers (Lassa fever)
Bunyaviral diseases (other than CCHF, RVF or SFTS)
Chlamydia
CholeraCoronaviral diseases*
Crimean-Congo haemorrhagic fever (CCHF)
Cryptosporidiosis
Ebola virus disease (EVD)
Emergent non-polio enteroviruses (including EV71, D68)
Enteroaggregative E. coli (EAEC) infections
Enterotoxigenic E. coli (ETEC) infections
Filoviral diseases (other than EVD or MVD)
Giardiasis (lambliasis)
Gonorrhoea
Henipaviral diseases (other than NiV infection)
Hepatitis B
Hepatitis C
Herpes simplex virus type 2 (HSV-2) infection
HIV/AIDS
HPV-related cervical cancer
Human T-cell lymphotropic virus type 1 (HTLV-1) infection
Influenza
Leptospirosis
Malaria (P. falciparum)
Malaria (P. vivax)
Marburg virus disease (MVD)
Meningitis (N. meningitidis)
Meningitis (C. neoformans)
Nipah virus (NiV) infection
Non-typhoidal S. enterica (NTS) infection
Pneumococcal disease (S. pneumoniae)
Respiratory syncytial virus (RSV) disease
Rheumatic fever (S. pyogenes)
Rift Valley fever (RVF)
Rotaviral gastroenteritis
Severe fever with thrombocytopenia syndrome (SFTS)
Sexually transmitted infections**
Shigellosis
Syphilis
Tuberculosis
Typhoid and paratyphoid fever (S. Typhi, S. Paratyphi A)
Zika virus disease
Other prioritised antibacterial-resistant infections†
Disease X***

Neglected tropicaldiseases

Maternal andneonatal healthconditions

67*Including Middle East respiratory syndrome coronavirus (MERS-CoV), Severe
acute respiratory syndrome (SARS). There
were only developments for COVID-19.

**Other than chlamydia, gonorrhoea,
syphilis or HSV-2 or HTLV-1 infections.
***Disease X is defined by WHO as a pathogen currently unknown to cause humandisease that could cause a serious interna-

Medicines

diseases and conditions in scope of the Index,

0
0

32
0
0
0
0

0
4
6
3
1
0
0
0
0
0
0
0
1
1
0
0
33 1
3
0
2 2
19 14

Ascariasis 0
Buruli ulcer 0
Chagas disease 19
Chikungunya 3
Dengue 7
Hookworm diseases 0
Human African trypanosomiasis 6
Leishmaniasis 14
Leprosy 1
Lymphatic filariasis 1
Mycetoma 1
River blindness (onchocerciasis) 4
Scabies
Schistosomiasis 9
Snakebite envenoming 0
Strongyloidiasis 0
Taeniasis/cysticercosis 0
Trachoma
Trichuriasis 0Contraceptive methods 0
Neonatal sepsis (group B streptococcus)
Postpartum haemorrhage 2
Pre-eclampsia 0
tional epidemic. Priority R&D for this disease is restricted to platform technologies
that enable cross-cutting R&D preparedness that is also relevant for an unknown

0
0
2
1
0
8

0
0
1
1
0
0
0
0

0
0
0

0

0
2
0
1

0
0
0
0
0
0

0
1
1
0
0

0

0
0
0

0

0

0
0

0

5
5
0

0
0
0

0

0

0

0

0
0
0
0
0
0
0
0

0
2
0
0
0
0
0
1

0

1
0
0

0
0
0
0

0
0
0

0
0

0
0
0
2

0
0
1
0
3
0
0
0
0
0
0
0
0
2
0
0
1
0
1
1
0

Vector control products

Vaccines (therapeutic)

0
0
1
0
0
42 17
0
0
0
2
0 4
0
0
1
1
0 0

companies are pursuing for each of the priority

Microbicides

Vaccines (preventive)

This table shows how many R&D projects the

Diagnostics

treatment gaps

0
0
0
0
0
0
0
2
0
1
0
0

0

2

1
2
2
1

0
0
0

0

0
0

0

0

Gaps remaining

FIGURE 54 For many diseases, there are

Devices (for reproductive health only)

Access to Medicine Index 2022 ▶ Research & Development

4
5
1
4
2
5
3
4
4
1
1
5
1
1
5
1
2
4
1
4
3
0
1
1
1
5
1
2
5
3
1
0
0
5
1
5
3
2
4
2
3
2
0
1
3
2
2
2
2
3
3
3
2
1
3
2
3
3
2
3
2
1
4
0
1
3

Disease X. Not included in the remaining gaps.
† The WHO priority pathogen list does notdefine specific products needed.

Access to Medicine Index 2022 ▶ Research & Development

Exiting the pipeline: recently approved products
During the period of analysis,* 62 R&D projects successfully reached the end of
the pipeline. Companies were then able to launch these new products by filing forregistration with a national regulatory authority – the first steps towards making a
product available. When a product meets the standards of safety and efficacy set
by the regulators, it is deemed 'approved' and can be marketed. Below are examples
of products that received regulatory approval with an internationally recognised
authority during the period of analysis, as well as details of the specific steps thatcompanies are taking to make these products available and accessible in LMICs.

VACCI N E R EG I M EN FO R EBO L A

PA ED I AT R I C FO R M U L AT I O N FO R CH AGA S D ISE A SE

Company: Johnson & Johnson

Company: Bayer

Description: In 2020, Zabdeno® & Mvabea®,** a two-

Description: In 2020, nifurtimox (Lampit®) became theshot vaccine regimen to prevent Ebola virus disease

first US Food and Drug Administration (FDA)-approved(Zaire ebolavirus strain), was approved by the European

treatment for Chagas disease in children. Nifurtimox

Medicines Agency (EMA). In April 2021, WHO granted pre-has been available for several decades, but Bayer has

qualification status to the regimen.2 This is an importantdeveloped a new paediatric formulation that disperses instep that could accelerate registration in countries withwater to assist in administration for children.

high disease burdens, where an outbreak is likely to occur.
O R A L T R E AT M EN T FO R SLEEPI N G SI CKN ESS

68

PA ED I AT R I C FO R M U L AT I O N FO R M A L A R I A

Company: Sanofi

Company: GSK

Description: Developed by Sanofi in partnership with

Description: In 2022, tafenoquine (Kozenis®) received

Drugs for Neglected Diseases initiative (DNDi), fexinidazole

regulatory approval for the prevention of relapse of

was approved during the period of analysis as the first

Plasmodium vivax malaria in paediatric populations.

all-oral treatment for both stages of sleeping sickness

Developed in partnership with Medicines for Malaria(human African trypanosomiasis). Sanofi's plan for access

Venture (MMV), the approval includes a novel 50 mg tablet

includes registration in countries within scope of the Index,

that can be dispersed in water. This makes administra-

submitting the product for WHO prequalification, and ation much easier for children, who are disproportionately

donation programme in partnership with WHO to ensure

affected by the disease.

availability in endemic countries.

*Period of analysis: 1 June 2020 - 31 May
2022.

**Ebola vaccine Ad26.ZEBOV-GP(Zabdeno®) and Ebola vaccine (MVA-BNFilo) (Mvabea®)

Access to Medicine Index 2022 ▶ Research & Development

Spotlight on R&D for diabetes
Diabetes is a growing problem worldwide with approximately 75% of the 537 million adults with diabetes living in LMICs.3 Yet, access to diabetes products such as
insulins and glucometers is often limited in LMICs. For glucose-lowering medicines(including insulin) only half of people in LMICs reported having their treatment
needs met.4 In LMICs, there are many barriers to accessing products currently available on the market – for example, insulins require continuous cold storage and bothinsulin and delivery devices such as pens often present affordability challenges.
R&D can therefore play an essential role in overcoming these barriers to access forpeople with diabetes in LMICS. The Access to Medicine Index has identified several
promising projects in development with the potential to address the needs of people with diabetes living in LMICs.

Sanofi's biosimilar insulin aspart was approved during the

Novo Nordisk received a positive opinion from the EMA toperiod of analysis. A biosimilar drug is a drug that is highly

update the storage conditions of two of its human insulin

similar to a biological drug (such as insulin) that is alreadyproducts, insulin human (rDNA) (Actrapid®) and isophaneon the market. Quality-assured biosimilar insulins canhuman insulin (rDNA) (Insulatard®). The more flexible

stimulate price competition and hold a great deal of as-yet

storage conditions allow the insulins to be stored outside

unrealised potential, especially with several patents on

a refrigerator for up to four weeks before opening (if kept

long-acting insulins recently expiring.

below 30C°) in countries outside the European Union. Thishas the potential to facilitate insulin distribution and stor-

Novo Nordisk is developing DuraTouch, a low-cost dura-

age in countries in scope of the Index, for example, during

ble pen device for the administration of insulin. Accesshumanitarian crises and in areas where access to refrig-

to an affordable pen device has the potential to improveeration is limited. In August 2022, Novo Nordisk received

adherence to insulin regimens, as it is a preferred modethe first country approval for the new storage conditionsof administration to traditional insulin vials (which requirein Lebanon, the company plans to pursue national submis-

syringes to inject the insulin). The company plans to makesions in more than 50 low- and middle-income countries.

this product available in several countries in scope of theIndex.

Further analysis of the actions that pharmaceutical companies are taking to ensure
access to insulin in LMICs and opportunities for expanding access to diabetes carecan be found in the Access to Medicine Foundation’s October 2022 report.5
Conclusions
The Index finds that projects targeting NCDs continue to dominate the pipeline,with almost half of all pipeline projects targeting a type of cancer in scope. The
total number of projects in development has remained relatively consistent withthe last Index (1,073 in 2021, compared to 1,060 in 2022). There has, however, beena significant drop in the number of projects in development to treat neglected tropical diseases.
367 projects in development target an R&D product gap for a priority disease.
These projects primarily focus on coronaviral diseases, HIV/AIDS, malaria andtuberculosis. The number of projects targeting these diseases has remained relatively consistent since the last Index (374 priority projects in 2021). Despite priority
diseases comprising one third of the pipeline, several product gaps remain unaddressed. Consequently, there continues to be little to no R&D activity developing
products for several debilitating diseases that disproportionally affect people in
LMICs.

69

Access to Medicine Index 2022 ▶ Research & Development

ACCESS PL AN N I NG

Assessing the quality andquantity of companies’ accessplans during the R&D stage

Why should companies begin planning for access during the R&D stage?
Planning for access is important during the research and development (R&D) phaseto facilitate timely access to medicines. It is crucial that pharmaceutical companies
begin planning during the development phase to overcome potential barriers toaccess, particularly in low- and middle income countries (LMICs) where, for example, poor supply chain infrastructure or weak regulatory capacity can be obstacles
to access. Due to large variations in healthcare systems between countries, thiscomplex task requires country-by-country assessments. This is why companies
need to start early on during R&D to ensure that access is accelerated once thenew product is registered.
Companies are expected to start establishing access plans for projects that arein Phase II of clinical development and onwards, referred to as 'late-stage candidates'. Pharmaceutical companies need to plan ahead to ensure new products are
rapidly accessible and affordable once they become available.
Industry puts policies into practice
The previous Index found a shift within the pharmaceutical industry towards systematic access planning during R&D. In 2021, the Index identified eight companies
leading in implementing frameworks for access planning. This year 15 companies
now have systematic frameworks to plan for access in LMICs for all R&D projects.

FIGURE 55 Number of companies with processes to systematicallyaddress access to medicine for all new products
The number of companies that now have systematic frameworks in place toplan for access in LMICs for all R&D projects has increased in successive
TA_RD2-RD_SystematicAccessPlanning
editions of the Index.
20 companies

19

12

5
15

8
1
2018

70

2021

2022

The companies that do not yet
have a systematic process inplace for all R&D projects are
AbbVie, Eli Lilly, Eisai, Daiichi
Sankyo, and Novo Nordisk. While
Eisai does have a systematic
process in place, the company
only applies this to a subset of
products in the pipeline.

Access to Medicine Index 2022 ▶ Research & Development

The number of companies that now plan for access during R&D for every single

FIGURE 56 Six companies now plan for accesslate-stage project in scope has risen from zero in the previous 2021 Index to six.

for all late-stage projects

Johnson & Johnson, Merck, Novartis, and Takeda – four of the eight companies

In the 2021 Index, no companies had access plansthat were highlighted as shifting to more systematic access planning for their R&D

in place for all late-stage R&D projects, so thisTA_RD2-AccessPlans2021v2022

projects in the previous Index – have now reported access planning for 100% of all

represents a significant improvement.

their late-stage R&D projects. Additionally, Astellas and Boehringer Ingelheim also

20 companies

have access plans for all their late-stage R&D projects. This marks the first time20

any of the companies have reached this milestone and represents a significant

14

improvement.
6

FIGURE 57 19 of the 20 companies demonstrate evidence of accessplanning

2021

This figure shows the percentage of late-stage R&D candidates for which
TA_RD2-AccessPlansByCompany
each company has access plans.
Astellas100

Boehringer Ingelheim

100

Johnson & Johnson

100

Merck

100

Novartis

100
100

Takeda96

AstraZeneca

90

Roche

89

GSK

85

Pﬁzer

4
10
11
15

Sanoﬁ

81

19

Bayer

80

20

78

Novo Nordisk

22

Eli Lilly

76

24

Daiichi Sankyo

75

25

73

BMS

57

24

Gilead
Eisai

27

43

MSD

76

14

86
100

AbbVie● Late-stage R&D projects with access plans (%)● Late-stage R&D projects without access plans (%)

TA_RD2-ProportionAccessPlans
FIGURE 58 One in four projects have noaccess plans in any countries in scope of the
Index
This figure shows the proportion of late-stage
projects in the pipeline supported by an accessplan for at least one country in scope.

77
334
projects
257

Late-stage projects
with access plans77%

Late-stage projects
without plans 23%

More than three-quarters of late-stage R&D projects (77%) are accompanied by anaccess plan in at least one country in scope of the Index. This finding is a significant
improvement compared to the previous Index, where 40% of late-stage projects
were covered by an access plan. Although there is progress in access planning,many products and many countries in scope are not covered by any access plan at
all.

71

2022

Companies planning
for access for 100%of their late-stage
projects.

Access to Medicine Index 2022 ▶ Research & Development

Access plans focus on a small number of LMICs, with the poorest countries
missing out
Despite an industry-wide improvement in planning for access during the R&D
stage, the number of countries included in plans is low. On average, an access plan
includes only six of the 108 countries in scope of the Index, and only 38 out of 257
projects (15%) are covered by an access plan that includes at least one low-income
country. This gap in access is amplified further for non-communicable diseases(NCDs) where only 5.5% of plans include a low-income country. Donor funding
is typically directed towards prioritised communicable diseases, yet the growing
burden of NCDs in LMICs means that resources need to be directed towards these
diseases during the R&D stage to ensure equitable access. Notably, Bayer's accessplans include an average of 26 countries in scope, with 63% of these plans including
a low-income country. These access plans target both communicable and NCDs in
scope of the Index.
The countries included in access plans often mirror those where clinical trials
are being conducted. Predominantly, they are upper-middle income countries or
emerging markets such as India, South Africa, China, Mexico, Colombia and Brazil.
Carrying out clinical research can be a gateway to providing access to investigative
and, in due course, approved medicines for people living in these countries. In general, if the medicine is successful in clinical trials, companies commit to filing for
regulatory approval in the countries where the trials have taken place.
To expand the range of countries in which clinical trials take place, Roche has
initiated a framework for clinical trials in East Africa. The company is building local
research and clinical trial capacity in Uganda and Kenya and is thereby ensuring theinclusion of patients in Africa in clinical trials, focusing initially on oncology.

FIGURE 59 Which countries are included in access plans?
Companies are more likely to plan for access in emerging markets such as
Brazil, India, China, Mexico and South Africa. Consequently, the availability of
newly-launched products may be limited to these countries. Fewer plans for
product launch consider lower-middle income countries and low-income
TA_RD2-CountriesWithAccessPlans
countries.

● 1–3 R&D projects with accessplans● 4–10 R&D projects withaccess plans● 11–50 R&D projects withaccess plans● 50+ R&D projects withaccess plans● Countries not in scope

FIGURE 60 Geographic reach of R&D access plans

TA_RD2-RD_AccessPlanCoverage
More than half of access plans include fewer than five countries in scope of
the Index.
1–4 countries

134

5–9 countries

65

10+ countries

31

No countries reported by company

27
0

50

100

150

Number of R&D projects with access plans

72

Access to Medicine Index 2022 ▶ Research & Development

What are the components of a good access plan for R&D

5

Plans to make product donations

projects?

Companies can donate products to increase availability in

The Index analyses access plans that are project specific andcountries within scope of the Index.

tailored to the needs of countries in scope. There is no one-

6

Supply and demand planningsize-fits-all approach to access planning, but a comprehensive

Companies can plan by forecasting the anticipated quanti-

plan considers availability, affordability and sustainable supply

ties of a product required in countries within scope of theof the product.

Index. This can help to guarantee supply chains and pre-The Index has identified several components that are conducive to access. These are:1

vent drug shortages.
7

Plans to register the product in many of the countries inlicensing agreements

scope

If a company does not intend to register a product in coun-

To make a product available, companies must file for regis-

tries within scope of the Index, it can engage in non-exclu-

tration with the national regulatory agency of the country

sive voluntary licensing. These agreements allow selected

where they intend to market the product. Once the prod-

manufacturers to produce generic versions of the drug

uct receives regulatory approval, it can be marketed in thatand supply them in countries where the product may oth-country. To ensure that the largest unmet medical needs
are addressed for each project, companies must consider

2

3

erwise be unavailable.
8

Plans to apply equitable pricing strategies

burden of disease when deciding where to launch the

To ensure accessibility, companies must ensure that prod-

product on the market.

ucts are affordable. Each project should be accompanied

Plans to apply for WHO prequalification

by an equitable pricing strategy that considers ability toPrequalification means WHO has deemed the product to

pay in different countries. As best practice companies

meet acceptable standards of quality, safety and efficacy.

should include intra-country differential pricing with spe-

This process can accelerate the registration process incial prices for the public sector and/or health insurance;

LMICs where national regulatory capacity may be lacking.

this is especially relevant for upper-middle income coun-

Post-trial access guarantees for clinical trial participantsOnce clinical trials have ended, companies can provide

4

Commitments to engage in non-exclusive voluntary

tries with large private markets.
9

Commitments to future patent waivers

continued access to the investigational products that have

Companies can waive intellectual property rights for prod-demonstrated significant benefits.

ucts in LMICs. This enables generic manufacturers to pro-Plans to engage in technology transfers or local manu-

duce the product without the risk of infringing patents.

facturing arrangements
Companies can transfer knowledge on a medicine and its

A comprehensive plan includes several of these ‘access com-

established manufacturing processes to local manufactur-ponents’ to expedite access to the product while it is still in theers. This ensures that the product is available in sufficient

R&D stage. Furthermore, the access plan should have a broadquantities to meet demand locally.

FIGURE 61 At the R&D stage, a good accessplan includes multiple access components
Access plans must address availability, affordabil-geographic scope to maximise the number of patients reached.
TA_RD2-AccessComponents

4
5Technology transfer
Product donations

ity and sustainable supply. Various combinations

Availability
Registration preparation
2 WHO prequalification
3 Post-trial access1of access components can be incorporated tofulfil these requirements.

7

Non-exclusive
voluntary licensing

Affordability

Sustainable supply
6

8 Equitable pricing

Supply anddemand planning

strategy

973

Patent waivers

Access to Medicine Index 2022 ▶ Research & Development

Many plans include very few ‘access components’ and are far from

Partnering with access-oriented

comprehensive

organisations to improve access

Although there has been progress in the proportion of late-stage R&D projects withplanning

access plans, the quality of access plans for projects in the pipeline varies widely. To

R&D projects developed in collabo-

be comprehensive, an access plan must consider several factors to ensure a medi-

ration with access-oriented organi-cine is available and affordable.

sations such as Wellcome Trust, theOf the 257 plans analysed, 134 (52%) only contain plans for registration inBill and Melinda Gates Foundation

countries in scope but have no other components to ensure equitable access.

and DNDi have more comprehensive

Regulatory approval is necessary for a drug to be launched in a particular country

access plans than those which aren't.

but is not sufficient to guarantee patients’ access to medicine, unless companies

The Index found that these pro-take further steps to make the product available and affordable.

jects consider on average 4.1 access

Only 56 plans (22%) contained project-specific strategies that address affordabil-components (compared with 1.9

ity. Furthermore, only 22 plans (8%) consider the burden of disease when deciding

components for other projects). This

what countries in scope of the Index to launch the product in. There is discrepancy

means these access plans are morein the quality of access plans for priority diseases compared to those for NCDs.

likely to consider a variety of factors

Inclusion of R&D gaps for NCDs on priority lists could stimulate R&D activity andto enable access (e.g., availability,

access planning to address these gaps.

affordability and supply). Almost 30%

Supply and demand planning

Non-exclusive voluntary licensing

Equitable pricing strategy

Patent waivers

receive public funding.

Product donations

are in partnership with partners thatreach for many when they are brought to market.

Technology transfer

ented organisations and almost halfand supply in countries in scope of the Index, these products may remain out of

Post-trial access

oped in partnership with access-ori-

populations that need them the most. Without tailored plans to ensure affordability

WHO prequalificationof priority R&D projects are devel-

there is a lack of evidence to suggest that these plans will result in access to theRegistration preparation

Although companies have made headway in planning for access during R&D,

AbbVie

●

●

●

●

●

●

●

●

●

Astellas

●

●

●

●

●

●

●

●

●

AstraZeneca

●

●

●

●

●

●

●

●

●

Bayer

●

●

●

●

●

●

●

●

●

Bristol Myers Squibb

●

●

●

●

●

●

●

●

●

Boehringer Ingelheim

●

●

●

●

●

●

●

●

●

Daiichi Sankyo

●

●

●

●

●

●

●

●

●

Eisai

●

●

●

●

●

●

●

●

●

Eli Lilly

●

●

●

●

●

●

●

●

●

Gilead

●

●

●

●

●

●

●

●

●

GSK

●

●

●

●

●

●

●

●

●

Johnson & Johnson

●

●

●

●

●

●

●

●

●

MSD

●

●

●

●

●

●

●

●

●

Merck

●

●

●

●

●

●

●

●

●

Novo Nordisk

●

●

●

●

●

●

●

●

●

Novartis

●

●

●

●

●

●

●

●

●

Pfizer

●

●

●

●

●

●

●

●

●

Roche

●

●

●

●

●

●

●

●

●

Sanofi

●

●

●

●

●

●

●

●

●

Takeda

●

●

●

●

●

●

●

●

●

FIGURE 62 Which access components do companies use?
In this chart, a green dot indicates that the company has used the accesscomponent at least once in any of its access plans. On the other hand, a grey
dot indicates that there was no evidence for this.

74

Access to Medicine Index 2022 ▶ Research & Development

Access plans for key R&D projects
Below are some examples of important access plans identified by the Index. These
access plans demonstrate how companies are planning to ensure access to theirproducts in LMICs and are tailoring their access plans to the needs of different
patient populations.

GSK , M A L A R I A VACCI N E

M ERCK , SCH IS TOSO M I A SIS T R E AT M EN T

In 2021, GSK's malaria vaccine RTS,S/AS01 (Mosquirix™)

In partnership with the Pediatric Praziquantel Consortium,

was recommended by WHO for large-scale implementation

Merck is developing arpraziquantel, a potential new treat-

and rollout to children living in regions with moderate toment option for children under six years old suffering fromhigh transmission. The recommendation was based on aschistosomiasis.7 Merck’s access plan considers availa-

pilot programme that was supported by GSK and carried

bility, affordability and supply. Merck intends to apply forout in three countries in scope of the Index: Ghana, Kenya

WHO prequalification to accelerate regulatory approval in

and Malawi. As part of its plans for access GSK has donatedcountries within scope of the Index, and has also entered

the first ten million doses for use in the pilots and publicly

into a contract manufacturing agreement with Universal

committed to a not-for-profit price. It has also submitted a

Corporation Ltd., Nairobi, Kenya for the large-scale pro-dossier for prequalification to WHO. In parallel, it is building

duction and future provision of the treatment in endemic

capacity for large-scale sustainable manufacturing of thecountries in Africa.

vaccine and has entered into a technology transfer agreement with Indian manufacturer Bharat BioTech Vaccines.

BAY ER , V EC TO R CO N T RO L PRO D U C T FO R M OSQ U I TO BO R N E D ISE A SESTA KEDA , D EN GU E VACCI N EBayer’s Fludora® Co-Max is a vector control product used

During the period of analysis,* Takeda began regulatory

to control adult mosquitos (Aedes spp. and Culex spp.).

submissions for its dengue vaccine QDENGA® (TAK-003).

With its dual mode of action (providing benefits in manag-

In August 2022 (after the period of analysis concluded),ing pyrethroid- and organophosphate-resistant mosquitoes

the vaccine received first regulatory approval in Indonesia

and in slowing down the development of resistance) it has

and subsequently was recommended for approval in thethe potential to prevent mosquito-borne diseases such as

EU and dengue-endemic countries by the Committee

Zika and dengue. The product received WHO prequalifica-

for Medicinal Products for Human Use (CHMP) of EMA.6

tion during the period of analysis to facilitate faster regis-

Takeda’s access plan for its dengue vaccine focuses primar-

tration in countries where it is required. Bayer also provides

ily on countries with the highest unmet medical need. The

evidence that it plans to register the product in several

company's access plan includes innovative equitable pricing

countries in scope of the Index.

models and plans for sustainable supply.
BAY ER , CH RO N I C KI D N E Y D ISE A SE A SSO CI AT ED W I T H
T Y PE 2 D I A B E T ES

In 2021, the FDA approved finerenone (Kerendia®) for thetreatment of patients with chronic kidney disease (CKD)
associated with type 2 diabetes. Bayer has a comprehensive access plan with a clear objective to address patient
access by considering affordability for patients. Multiple
measures are being taken by the company to accelerateaccess, including a comprehensive strategy to gain regulatory approval in a wide range of countries. The plan covers
29 countries in scope of the Index, including low-income
countries.

*Period of analysis: 1 June 2020 - 31 May
2022

75

Access to Medicine Index 2022 ▶ Research & Development

PFIZER , G RO U P B S T R EPTO CO CCUS VACCI N E

N OVA RT IS , I V FO R M U L AT I O N FO R SE V ER E M A L A R I A

Pfizer is developing a group B streptococcus vaccine

In partnership with PAMAfrica Consortium funded bycandidate (PF-06760805) with funding from the Bill and

EDCTP and Wellcome Trust, Novartis is developing cipar-

Melinda Gates Foundation (BMGF). The support fromgamin (KAE609), an IV formulation for the treatment of

BMGF will enable faster and more equitable deployment

severe malaria. Although the project is only in Phase II ofof the vaccines, particularly in LMICs with high burden ofclinical trials, Novartis provides evidence of a comprehen-disease, at a sustainable price. Plans for sustainable supply

sive plan for access. Clinical trials are ongoing or planned inand WHO prequalification are in development should the

12 countries in scope of the Index. Should this candidate bevaccine be successful in clinical trials.

successful in trials, Novartis commits to register the drugs
in those countries in line with its post-trial access to medicines policy.

Conclusions
The 2022 Index has identified clear evidence that companies’ policies for systematic access planning are actually being implemented, with more companies now
establishing access plans for more of their projects in the R&D pipeline. Six companies now have access plans in place for all the late-stage candidates included in thisanalysis.
For leading companies, the focus must now shift to improving the quality andexpanding the geographic reach of plans. The Index finds that companies’ accessplans only include an average of six of the 108 countries in scope, with certain
countries included more often than others. Most plans focus solely on registration,
but companies can do more to ensure that their plans consider affordability andsustainable supply. Establishing an access plan is a promising first step, but thequality of that plan is key to determining whether it results in widespread access in
LMICs.
In particular, companies must do more to ensure a wider and more diverse rangeof countries are included in access plans, specifically low-income countries whoare currently not included in more than 85% of plans. It is vital that this is plannedout during the R&D stage to ensure that innovative products are widely and rapidly
available to those that need them most.

R E FE R E N CE S
1	Grover N, Rigby J. GSK, Novartis
pledge funds for diseases that mostly
affect the poor. Published 2022.
Accessed July 5, 2022. https://www.reuters.com/business/healthcare-pharmaceuticals/gsk-novartispledge-funds-diseases-that-mostly-affect-poor-2022-06-23/
2.	Johnson & Johnson. Johnson &Johnson Ebola Vaccine Regimen
Demonstrated Robust and Durable
Immune Response in Adults andChildren in Data Published in The
Lancet Infectious Diseases. Published2021. Accessed August 24, 2022.
https://www.jnj.com/johnson-johnson-ebola-vaccine-regimen-demonstrated-robust-and-durable-immuneresponse-in-adults-and-children-indata-published-in-the-lancet-infectious-diseases

76

3.	International Diabetes Federation. IDF
Diabetes Atlas 10th Edition.; 2021.
4.	Flood D, Seiglie JA, Dunn M, et al. The
state of diabetes treatment coveragein 55 low-income and middle-income
countries: a cross-sectional study ofnationally representative, individual-level data in 680 102 adults. Lancet
Healthy Longev. 2021;2(6):e340-e351.
doi:10.1016/S2666-7568(21)00089-1
5. 	Martinez C, Romero C, Sánchez
Villalobos N. What are pharma companies doing to expand access to insulin - and how can efforts be scaled
up? Access to Medicine Foundation.
Published October 2022. Accessed
November 1, 2022. https://accesstomedicinefoundation.org/news/drugmakers-that-dominate-the-worlds-insulin-market-must-scale-up-access-efforts-globally

6.	Takeda. New Dengue Vaccine
Approved in Indonesia for Use
Regardless of Prior Dengue Exposure.
Published 2022. Accessed September
7, 2022. https://www.takeda.com/
newsroom/newsreleases/2022/takedas-qdenga-dengue-tetravalent-vaccine-live-attenuated-approved-in-indonesia-for-use-regardless-of-prior-dengue-exposure/
7.	Merck. Merck Announces Positive
Phase III Results for Arpraziquantel asPart of its Schistosomiasis Elimination
Program. Published 2021. Accessed
August 24, 2022. https://www.merckgroup.com/en/news/phase-three-results-for-arpraziquantel-16-11-2021.
html

PRODUCT DELIVERY

CO NTE X T

I N S I G HTS

The choices pharmaceutical companies make in delivering their products are a

1 Overall industry-wide improvement

critical factor in ensuring people in need receive access to essential medicines andin access planning and an increase intreatments. The Product Delivery Technical Area assesses a wide range of elements

products covered by an access strat-

that contribute towards equitable access after a product has been developed. Thisegy, but low-income countries remain

includes, among others, registration, licensing, equitable pricing, donations, intellec-

overlooked.
2 Of the 20 companies, 15 have scaled

tual property sharing and health systems strengthening.

up 32 inclusive business models
PE R FO R MAN CE I N D I C ATO RS(IBMs) to reach more countries andCompanies’ performance in this Technical Area is assessed against the following

more patients at the base of theindicators:

income pyramid. Some companies are• Disclosing patent statuses and public commitment not to enforce patents

also piloting IBMs offering products• Sharing intellectual property (IP) with third parties• Using non-assert declarations and/or licensing agreements to enable generic
medicine manufacturing and supply• Registering products in countries within scope, highlighting those that face a highburden of disease• Deploying access strategies for three types of products: supranationally pro-for non-communicable diseases.
3 Despite an improvement in the number of technology transfers, the geographic scope of capacity building initiatives for manufacturing continues
to focus on India, China and Brazil.

cured, healthcare professional-administered and self-administered• Engaging in manufacturing and supply chain capacity building initiatives• Ensuring continuous product supply in low- and middle-income countries (LMICs)• Engaging in health systems strengthening initiatives• Piloting and scaling up inclusive business models that reach populations at thebase of the income pyramid• Reporting of substandard and falsified medicines in a timely manner• Donating products in response to expressed need
• Engaging in structured donation programmes aimed at the elimination, eradication, or control of diseases in scope
WHAT D O ES B EST PR AC TI CE LO O K LI KE?

Best-performing companies register their products in a wide range of LMICs in

FI N D O UT M O R E

scope of the Index – in particular those facing the highest burden of disease.

Sub-ranking

78

Portfolio

79

Having equitable access strategies in place is crucial to securing affordability and

PAG E

supply for patients. Top-performing companies achieve this by entering suprana-

Registration81

tional procurement agreements, and/or by implementing pricing models that are

Access Strategies

88

based on all relevant payers' ability to pay. Best-performing companies also apply

Licensing99

additional non-pricing initiatives to maximise the availability of their products to the

Product Donations

105

most vulnerable patients through, for example, patient assistance programmes andInclusive Business Models

109

non-exclusive voluntary licensing agreements.

Supply, Quality and Manufacturing

117

Companies that partner with local manufacturers on projects with clear andmeasurable goals and objectives, to ensure the sustainability of their efforts in
LMICs, stand out across health systems strengthening, manufacturing and supply
chain capacity building indicators. Additionally, these companies make efforts toscale-up inclusive business models that address the access needs of underserved
populations and work in partnerships to pilot new models where needs are unmet.

77

The various sections within the Product Delivery Technical Area include
detailed, figure-led analyses identifying industry strengths, weaknesses,
trends, and opportunities at the timeof writing. For a granular view of eachcompany’s activities in this area, seecompany Report Cards.

Access to Medicine Index 2022 ▶ Product Delivery

HOW TH E CO M PAN I ES PE RFO RM

Stand-out performers demonstrate wideranging approaches towards equitable access
ATMI22_PD_Subranking_large
FIGURE 63 Product Delivery Ranking
1AstraZeneca

4,29

2

GSK

4,11

3

Johnson & Johnson

4,09

4

Novartis

4,08

5

Merck KGaA (Merck)

3,78

6

Pfizer3,61

7

Takeda3,55

8

Sanofi

3,53

9

Bayer

3,49

10 Novo Nordisk

3,39

11 Roche

3,22

12 Gilead

3,18

13 Eisai3,13

14 Boehringer Ingelheim

3,02

15 BMS

2,69

16 Astellas

2,18

17 Daiichi Sankyo

2,17

18 AbbVie

1,98

19 Merck & Co, Inc (MSD)

1,75

AstraZeneca takes the top spot in Product
Delivery, leading in its approach to patenttransparency and sharing of intellectual
property assets. It has made progress bylicensing and transferring technology for
its COVID-19 vaccine. GSK and Johnson &Johnson complete the top three, performing
well across all assessment criteria, including
equitable access strategies. Notably, in
2022, Novartis became the first company toagree to a non-exclusive voluntary licence
for a medicine to treat a non-communicabledisease.

1,31

20 Eli Lilly
0

1

2

3

4

5

What separates the best and worst performers?
The top ten companies rank closely in terms of scoring, with various companies inthe top ten excelling in different areas, such as intellectual property (IP) management and access approaches for specific products. The best-performing companies
demonstrate strong examples of patent transparency, sharing of IP assets andengage in voluntary licensing in tandem with technology transfers. Almost half ofthese companies also apply equitable access strategies broadly and participate inhigh-quality capacity initiatives across all fields.
Medium-performing companies tend to have a more varied performance acrossassessment criteria by, for example, having a less diverse range of equitable accessstrategies or capacity building initiatives. Companies may perform strongly in someareas but below average in other areas, such as registration, IP management, supply
chain and manufacturing capacity building.
The lowest ranked companies employ a minor number – if any – equitable accessstrategies that cover few products and countries. They perform poorly when it
comes to registering their products in low-income countries and countries witha high disease burden. These companies engage in few or no manufacturing andsupply chain capacity building initiatives, with some evidence of health systems
78

strengthening initiatives.

Access to Medicine Index 2022 ▶ Product Delivery

PO RTFO LI O ANALYSIS

What products do companies
have in their portfolios?

The Portfolio Analysis section provides an overview of the products covered in
the Product Delivery Technical Area of the 2022 Index, by summarising the product types and disease categories included – and not included – in the companies’
portfolios, and providing the broader context to the analysis that follows. Collating
information on all 20 companies’ portfolios also reveals what types of products aremost common, and where the gaps are.
The products have been selected for analysis in the 2022 Index based on several inclusion criteria, such as whether they are included on the World HealthOrganization (WHO) Model List of Essential medicines (EML) or the WHO Essential
Diagnostic List (EDL), or – in the case of off-patent products – whether their availability can significantly shape the market (see Appendix I).
Product types and disease coverage
FIGURE 64 What types of products are in the companies’ portfolios?

FIGURE 65 What categories of diseases are covered by the products in

Most of the products in scope of this analysis are medicines, followed by

the companies’ portfolios?

diagnostics and vaccines.

Most of the products are for non-communicable diseases.

Contraceptives methods
and devices: 17

Multiple diseases
categories**: 24

Other*: 33
Vaccines
Diagnostics

Maternal and neonatal
health conditions: 32

60
86

Neglected tropical diseases: 35

740
products

Medicines
544

229
Communicable diseases

740
products

There are few products in the companies’ portfolios for maternal and neonatal health conditions. Further analysis is available elsewherein the Index in the Special Report on women’s
sexual and reproductive health.

*Other includes vector control products
and platform technologies.

79**This refers to products that target diseases in more than one of these categories – for example, Intron® A (MSD) is indicated for chronic hepatitis B and C (communicable diseases) and some cancers(non-communicable diseases).

468

NoncommunicablediseasesAccess to Medicine Index 2022 ▶ Product Delivery

TABLE 4 What diseases are not covered byproducts in companies’ portfolios?
This table shows the diseases and medical

Disease category

Disease, condition or pathogen

Non-communicable diseases

Bipolar affective disorder

Communicable diseases

Arenaviral haemorrhagic fevers (Lassa fever)
Bunyaviral diseases

conditions that are not targeted by any of the

Disease X

products in scope of the 2022 Index – collectively

Emergent non-polio enteroviruses

across the 20 companies. The Index also finds

Henipaviral diseases

that this overall picture is unlikely to change in the

Leptospirosis

near future, as only three of these diseases andconditions have active developments in thecollective R&D pipeline: river blindness(onchocerciasis), mycetoma and rheumatic fever.

Rheumatic fever
Maternal and neonatal

Birth asphyxia and birth trauma

health conditions

Obstructed labour

Neglected tropical diseases

Buruli ulcer
Dracunculiasis
Mycetoma, chromoblastomycosis and other deep mycoses
River blindness (onchocerciasis)
Scabies and other ectoparasites
Snakebite envenoming
Trachoma
Yaws

Cancer products are well-represented in company portfolios – but for somecancers more than others
Among the 468 products for non-communicable diseases, 183 are indicated forcancer. Breast cancer is one of the most prevelant cancer types globally, and istargeted by many products in the companies’ portfolios. On the other hand, there
are no products for gallbladder cancer, and only one for head and neck, uterine andoesophageal cancer, respectively. Osteosarcoma, a type of bone cancer, has been
newly added to the list of cancers in scope of the Access to Medicine Index for
2022, and is targeted by three products included in this analysis.

FIGURE 66 How many products are in60

companies’ portfolios for each cancer type?
Cancer products in the portfolio mainly target
lymphoma), breast cancer and lung cancer. Out of30

the 183 cancer products, 142 are medicines, 35

20

are diagnostics, four are vaccines and two are

10 14

platform technologies – e.g. delivery technologies

ne
n,
Br
ai

45

41
35

3

10

17

15
0

1

6

7

1

16

11

8

0

3

rv Bla
ou d
s de
sy r
st
em
Br
ea
Ce st
Co rviclo al
G re
He allb cta
a la lKa d a dde
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si ne
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r
Le co
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on
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ly Lu
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es
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om
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s*

0

and devices.

80

47

40

blood cancer (leukaemia and non-Hodgkin*This category refers to products indicated to treat more than one cancer type.

59

50

Access to Medicine Index 2022 ▶ Product Delivery

PRO DUCT D E LIVE RY - REG ISTR ATION

How do companies perform
on registering their products
in LMICs?

When a product is ready to be launched, the first step the company can taketowards making it available in any given country is filing it for registration with thatcountry’s regulatory authorities. Once the product is registered, it can then be marketed and sold.* Registering products in a wide range of countries, including lowand middle-income countries (LMICs), is vital for ensuring access to those products
globally.
Regulation of medical products aims to ensure that only high-quality, safe andeffective medicines, vaccines and diagnostics are allowed onto the market.1 If a
product gains approval from a national regulatory body recognised as a ‘stringent
regulatory authority’ (SRA) by the World Health Organization (WHO), such as theEuropean Medicines Agency (EMA), this can help streamline and speed up regulatory processes in other countries, including LMICs.2
However, even after SRA approval, local regulatory processes must be completed. In countries with limited regulatory capacity, there can be lengthy regulatory
processes, compromising patients’ timely access to much-needed safe, effective

FIGURE 67 Products analysed with regards toand quality-assured medical products.3 Among other steps, companies can mitigate

registrationthese challenges by engaging in a Collaborative Registration Procedure or applying

There are 190 products in scope of this analysis.

for WHO prequalification, as explored in the following pages.

Of these products, 28 received their first market
approval from the European Medical Agency

Which products are in scope of this analysis?

(EMA), US Food and Drug Administration (FDA),The Index assesses a sample of the 20 companies’ most recently-marketed prod-

Health Canada, the Japanese Pharmaceuticals

ucts to gain insight into the companies' registration practices in the 108 LMICs

and Medical Devices Agency (PMDA), or anotherin scope. Companies each submitted up to a maximum of ten recently-launched

Stringent Regulatory Authority (SRA) during the

products to the Index for analysis, resulting in a total of 190 products. The Index

period of analysis (1 June 202o to 31 May 2022).

looks at the number of LMICs in which the companies have registered these 190
products, as well as aggregating the data to show which countries are most likely toreceive submissions for registration – and which are most likely to be overlooked.

Beforethis cycle

Duringthis cycle

28
190
products

In particular, this analysis assesses the extent of companies' efforts to register theirproducts in the countries with the highest burden of disease.
For newer products – i.e., those that received their first global regulatory

162

approval in the last five years – the gold standard for a company is to file in as many
LMICs as possible, and in at least half of the ten countries with the highest burden

19

of disease (measured according to the global burden of the disease targeted byeach specific product). This is particularly important for products that are innovative or superior to those already on the market.
With each company submitting up to ten products, some of the products in

6
3

81

*As part of the registration process, theresponsibility to file a product for registration rests with companies. For the purpose of this analysis, products are counted
as having been registered in a coun-try if the company has filed it for registration, even if the approval status is not
yet known.

tic

s

s

os

ne

in

Va
cc
i

D
ia
gn

with a high burden of disease.

edic

istration in more than 45 LMICs in scope, and in seven or more of the ten countries

M

For these older products, the Index looks for companies to have filed them for reg-esscope actually received their first global regulatory approval at least five years ago.

Access to Medicine Index 2022 ▶ Product Delivery

In which countries do pharma companies file their products for registration?
Among the 108 countries in scope, there are particular countries – mainly
upper-middle income countries – where products are far more likely to beregistered.
While products for non-communicable diseases (NCDs) such as diabetes andcancer are at least filed in some low-income countries, more so than products forcommunicable diseases, there are low-income countries in which no products havebeen filed at all. For example, the Access to Medicine Foundation’s October 2022
report on access to insulin in LMICs found that no insulin products in scope of thatanalysis have been filed in 24 countries – the majority of which are low-income
countries.4

FIGURE 68 The ten countries in scope where the most products havebeen filed for registration
The countries in which the highest number of the 190 products are filed aremainly upper-middle income countries, with Brazil topping the list. There arethree lower-middle income countries in the top ten, but no low-income
countries.
Brazil123

Mexico113

Thailand111

Colombia

105

China

88

South Africa

78

Peru

77

Philippines

77

Egypt

74

India

73

0

10 20 30 40 50 60 70 80 90 100 110 120 130 140 150 160 170 180 190● Upper-middle income countries● Lower-middle income countries

FIGURE 69 Which countries do companies register their products in? *This map highlights the number of the 190 products in scope that have been
filed for registration in each of the 108 LMICs included in the analysis.

Number of filings forregistration per country● 0 filings● 1-10 filings● 11-30 filings● 31-50 filings● >50 filings● Countries not in scope

Based on data analysed by the Index, countries
in which none of the products have been filed
for registration include the Pacific Islands andcountries in several regions of Africa, e.g., Djibouti(East Africa), Lesotho (Southern Africa), Guinea-Bissau (West Africa), Sao Tome and Principe
and Equatorial Guinea (Central Africa); and one inSoutheast Asia, Timor-Leste.

82* For a subset of companies, the exact
registration status of their latest products
within LMICs could not be reported as nodata was provided/verified by the company or available in the public domain dur-Among the 27 low-income countries,
Uganda has received most filings forregistration, namely 33, followed by
Ethiopia (22), Rwanda (20) and the
Syrian Arab Republic (20).

ing the period of analysis. Registration filings are based on companies’ data submission, there are non-submitting companies such as Eli Lilly and MSD.

Access to Medicine Index 2022 ▶ Product Delivery

Companies rarely file in countries with highest disease burdens
Most products (78%) are registered in less than half of the countries with a highburden of disease, according to the product's main indication (see box, below).
Bayer has the highest number of products that meet the milestone of being filed in
at least half of these countries.

What does ‘burden of disease’ mean?
The burden of disease has been measured with the rate of disability-adjusted
life years (DALYs), a universal metric that allows comparison between different
populations and health conditions across time. One DALY equals one lost year ofhealthy life, allowing for an estimation of the total number of years lost due tospecific causes (such as diseases and injuries).
What is a product’s ‘indication’?
The disease or condition that a product is targeted towards treating. Some products have more than one indication – e.g., when indicated for multiple different
types of cancers. Of the 190 products assessed in this analysis there was data
available for the global burden of disease for 179 products, 21 of which havemultiple indications. For these 21 products, their main indication was selectedby determining for which disease they serve as a first-line treatment in order tomeasure the global burden of diseases targeted by each specific product.

FIGURE 70 There is considerable variation in how widely each company
registers its products in LMICs
Out of the 190 products in scope, this figure analyses the 179 products forwhich global burden of disease data was available (certain products, such as
COVID-19 and contraceptive products, were not assessed in terms of burdenof disease). It shows how many have been filed for registration in at least fiveof the ten countries with the highest burden of disease (measured according
to the global burden of the disease targeted by each specific product).**AbbVie3

Astellas1

AstraZeneca

1

4
4
5

Bayer

3

Bristol Myers Squibb

3

3

2

4

5

Boehringer Ingelheim

9Daiichi Sankyo

1

Eisai

1

Eli Lilly

1

Gilead

1

GSK

1

9
2

4
8
5

3
7

Johnson & Johnson

2

7

MSD

2

6

Merck

1

3

3

6

Novo Nordisk

9

Novartis2

5

Pfizer1

Takeda4
5

Sanofi

3

6

4
9

0

2

4

1
3

5

Roche

1

6

8

1

10

● Registered in 5-10 countries● Registered in 1-4 countries● Registered in none of the countries

83** All companies were assessed based ondata submitted to the Index in the current and previous periods of analysis, aswell as information the companies havemade publicly available, or that are acces-

sible through other sources. Eli Lilly and
MSD declined to submit data to the 2022
Access to Medicine Index.

Two products indicated for HIV/AIDS have been filed in seven of the
top ten highest burden countries. Emtricitabine/tenofovir alafenamide(Descovy®) from Gilead, approved in 2016 by the US FDA, has been
filed for registration in Botswana, the Central African Republic andMozambique. Dolutegravir (Tivicay PD) from GSK, approved in 2020
by the US FDA, has been filed for in Namibia, Malawi, Zimbabwe (withhigh burdens among the paediatric population).
The product most filed in highest burden disease countries according
to its indication is Elecsys® Chagas, from Roche, approved in 2020 by
the US FDA. This diagnostic, used to identify and screen individuals
infected with Trypanozoma cruzi, is included in the WHO Essential
12 Diagnostic List, and has been filed in eight of the top ten high burden
disease countries, including Brazil, Colombia and Ecuador.5 The product has not been filed for registration in Bolivia or Paraguay.

Access to Medicine Index 2022 ▶ Product Delivery

How do companies perform on registering products rapidly, and which
products do they prioritise?
Rapidly filing new products for registration in LMICs is important to allow and accelerate access to these products. Yet, in LMICs, the registration of newly-launched
products typically occurs less frequently and usually later than in higher-income
countries where markets are considered to have higher commercial value. Only twocompanies, AstraZeneca and Novartis, filed all their newer products for registration
in at least one LMIC in scope of the Index within 12 months of first global approval.
In addition, there are some companies that do not provide any evidence of having
rapidly filed any of the products in scope within an LMIC.***FIGURE 71 How rapidly do companies file their products forregistration in LMICs after approval?
Within 12 months after first global approval, only two companies had filed alltheir products in scope (a maximum of ten products per company) for
registration in at least one of the 108 countries in scope.
AbbVie7

Astellas2

3

AstraZeneca

10

Bayer

7

Bristol Myers Squibb

3

4

6

Boehringer Ingelheim

9Daiichi Sankyo

2

8

Eisai

4

3

Eli Lilly

10

Gilead

8

2

GSK

9

Johnson & Johnson

9

MSD

1
1
10

Merck

6

Novo Nordisk

6

4
4

Novartis

10

Pfizer

8

Roche

2

6

4

SanofiTakeda

1

8
0

1

2

3

4

5

6
6

7

8

2
9

4
10

● Products filed within 12 months in at least one country in scope● Products with no evidence of being filed within 12 months in at least one
country in scope

84*** All companies were assessed basedon data submitted to the Index in the current and previous periods of analysis, aswell as information the companies havemade publicly available, or that are acces-

sible through other sources. Eli Lilly and
MSD declined to submit data to the 2022
Access to Medicine Index.

Access to Medicine Index 2022 ▶ Product Delivery

Older products and those for NCDs are more widely filed
Among the products in scope of this analysis – i.e., a maximum of ten of each company’s most recently launched products – the products that are registered in thehighest number of the countries in scope are generally those that were launchedlongest ago. The ten on-patent products that have been most widely filed in LMICs
had their first global launch at least seven years ago, with the exception of Johnson& Johnson’s COVID-19 vaccine.
Companies had more time to file those products for registration widely compared to newer products, but it is also vital that new products are widely filed assoon as possible so that patients worldwide can benefit from new treatments.

FIGURE 72 The top ten most widely filed on-patent products are mainly
older products targeting non-communicable diseases
These products mostly target non-communicable diseases such as diabetes
mellitus, cardiovascular diseases and various cancers.
analogue insulin (Levemir®)(Levemir®)®
(Xarelto®)
rivaroxaban (Xarelto)®
(Mirena®)levonorgestrel IUS (Mirena
)

Bayer
Bayer

64

®
(Nexavar®)sorafenib (Nexavar)®
(Victoza®)liraglutide (Victoza
)

Bayer

54

®
analogue insulin (Tresiba(Tresiba®))
sacubitril/valsartan (Entresto™)

COVID-19 vaccine
Johnson & Johnson COVID-19
vaccineenzalutamide (Xtandi™)®
(Jardiance®)empagliflozin (Jardiance)

Novo Nordisk

71
68

49

Novo Nordisk

49

Novo Nordisk

48

Novartis

41

Johnson & Johnson

40

Astellas

37

0

20

40

60

80

Boehringer Ingelheim

How some companies are overcoming registration challenges, and whatmechanisms are available
The regulatory approval of medical products in countries with limited regulatory
resources can be lengthy, which often compromises patients’ timely access tomuch-needed safe, effective and quality-assured medicines.6 To ensure access to
those products, companies must overcome registration challenges, such as lack ofmature regulatory systems, unclear local regulatory requirements or lack of capacity for processing registration dossiers due to resource-limited health authorities.
Below, several potential solutions for companies to overcome those challenges arehighlighted, as well as mechanisms available to them.
Collaborative Registration Procedure
Facilitated regulatory pathways are designed to increase the speed and efficiency ofregistration in resource-limited settings. The Collaborative Registration Procedure(CRP), for example, helps pharmaceutical companies and other stakeholders ensure
faster access to quality-assured, safe and effective medical products to patients inneed.6The CRP is developed based on reliance and recognition approaches to accelerate national registrations by providing National Regulatory Authorities (NRAs)
with detailed product assessments and inspection reports generated by SRAs, or by
WHO through its prequalification procedure. Through collaboration between NRAs,
SRAs, the WHO prequalification programme (WHO PQ) and pharmaceutical companies, the CRP facilitates and accelerates the registration of medical products thathave received WHO PQ or have been approved by SRAs.
By participating in the CRP, pharmaceutical companies need only submit one
product dossier across countries that also participate, avoiding the duplicationof both good manufacturing practice inspections and product testing prior to85

Novo Nordisk has filed its older
analogue insulins relatively widely.
For example, insulin detemir[rDNA origin] (Levemir®), globally
approved by the EMA in 2004, hasbeen filed in 71 of the 108 LMICs
in scope.

Out of the ten products fromBayer analysed by the Index, three
have been filed for registration inat least half of the 108 countries
in scope. For example, rivaroxaban(Xarelto®), indicated for stroke
and ischaemic heart disease, hasbeen filed in 68 countries in scope.
It was first approved in 2008, byHealth Canada.

Access to Medicine Index 2022 ▶ Product Delivery

registration.6 The CRP process allows for more efficient post-approval changes,
reduces the amount of human and financial resources required, and can shorten
the timeline for a product becoming available to populations in need. Furthermore,
the process enhances and facilitates collaboration, interactions, and informationexchanges between companies, countries and WHO.
WHO prequalification programme
WHO PQ was initiated in 2001 to improve access to safe, effective and affordable
quality-assured medicines used by millions of people in LMICs by assessing a rangeof essential products initially focused on HIV, tuberculosis and malaria, for procurement by UN agencies and the Global Fund to Fight AIDS, Tuberculosis and Malaria(the Global Fund).7 This programme also aims to support regulatory capacity in
LMICs by providing professional development and training for regulators and developing a mechanism to generate assessments of medical products which can significantly reduce the registration time for those products in countries.
WHO PQ assesses medical product dossiers, conducts good manufacturing practice inspections and organises quality control testing of products.7 By submitting all
their relevant products for WHO PQ, companies can help facilitate UN procurement
and promote rapid regulatory uptake by all LMICs. WHO research also shows thatparticipating in prequalification can provide companies with benefits over time,
including increased sales or market access and reduced manufacturing costs.8
Examples of companies using facilitated tools and mechanisms
Twelve of the 20 companies in scope of the Index now participate in WHO PQ. The
entire portfolio of the companies (including products older than the 190 products
analysed for registration), includes 35 WHO prequalified products, covering communicable diseases such as HIV/AIDS, hepatitis B and C and coronaviral diseases;
NCDs, such as cancer; neglected tropical diseases such as lymphatic filariasis; aswell as contraceptives.
Some companies are already making use of the CRP to accelerate the registration of their products in countries, including Johnson & Johnson and ViiV
Healthcare (majority owned by GSK), which are actively collaborating with WHO in
the African Region (AFRO Region), and have had many products approved throughthis process. Pfizer and Roche have also made use of CRP in the AFRO region forsome of their products.3
Other facilitated pathways available to companies include regional/joint assessments, such as the Joint Assessment Procedure of the Association of Southeast
Asian Nations (ASEAN), which currently considers a wide disease scope. GSK also
participates in this procedure.9
More companies should collaborate closely with NRAs, SRAs and other stakeholders such as WHO, to participate in these facilitated mechanisms, make use of
relevant tools, and support strengthening regulatory authorities, with the goal tobe able to timely register much-needed medical products in as many relevant countries as possible.

86

Access to Medicine Index 2022 ▶ Product Delivery

Facilitated regulatory
pathways

FIGURE 73 More than half of the companies are participating in facilitated pathways to register

CRP for SRA-approved/
assessed products

AFRO Regional
Joint Assessments

ASEAN Joint
Assessment

their products.

Gilead

●

GSK

●

●

●

●

Johnson & Johnson

●

●

●

MSD

●

Companies can participate in Collaborative Registration Procedures (CRP) with WHO prequalified
products or products assessed and/or approved by an SRA. Companies can also participate in regional/
CRP for WHO
PQ products

joint assessments such as various AFRO Region Joint Assessments and the ASEAN Region Joint
Assessment. These facilitated regulatory pathways help to increase access to healthcare products incountries that are often underserved.
AbbVie●AstellasAstraZeneca
Bayer

●

Bristol Myers Squibb
Boehringer●

Ingelheim
Daiichi Sankyo
Eisai

●

Eli Lilly

Conclusions
Filing for registration is only the first step in a complex regulatory process that willallow for a product to be available on the market in a particular country. Rapidly
filing for registration can play a critical role in shortening the amount of time taken
to have products reach the hands of patients. More companies need to file theirproducts more widely for registration in LMICs – particularly in low-income countries and in those with a high disease burden. These countries are commonly leftout, which means that people living here do not have access to any newly launched

Merck
Novo Nordisk
Novartis●

Pfizer

●

●

●

Roche

●

●

●

Sanofi●Takedaand potentially life-saving healthcare products. While these countries often present
complex regulatory barriers that make it difficult for companies to register products, there are unique solutions that can help overcome these challenges.
Some companies are already making use of facilitated procedures and tools,
including the CRP, to accelerate the registration of their products in LMICs.
Companies can also submit all their relevant products for WHO prequalification tofacilitate UN procurement and promote rapid regulatory uptake.
Regulation of quality-assured medicines is a shared effort between regulators,
manufacturers, procurers, health providers, donors and institutions such as WHO.7
Companies must contribute to these endeavors to increase access to medicines,
protecting people from health emergencies and providing them with better healthand well-being.

R E FE R E N CES
1. World Health Organization (WHO).
Health products policy and standards. Published 2022. Accessed July25, 2022. https://www.who.int/teams/
health-product-policy-and-standards/
assistive-and-medical-technology/
medical-devices/regulations
2. WHO. List of Stringent Regulatory
Authorities. Published 2022.
Accessed November 1, 2022. https://www.who.int/initiatives/who-listed-authority-reg-authorities/
SRAs
3. WHO. Accelerated Registration of
FPPs Approved by SRAs. Published2022. Accessed July 25, 2022. https://87

extranet.who.int/pqweb/medicines/
faster-registration-fpps-approved-sras
4. Martínez C, Romero C, Sánchez
Villalobos N. Published October 6,2022. Accessed November 9, 2022.
https://accesstomedicinefoundation.
org/news/drugmakers-that-dominatethe-worlds-insulin-market-must-scaleup-access-efforts-globally
5. WHO. The Selection and Use of
Essential in Vitro Diagnostics: Reportof the Third Meeting of the WHOStrategic Advisory Group of Experts on
in Vitro Diagnostics; 2020. Accessed
November 1, 2022. https://www.
icao.int/EURNAT/EUR%20and%20

NAT%20Documents/COVID%2019%20
Updates-%20CAPSCA%20EUR/02%20
February%202021%20COVID19%20
Updates/COVID19%20-%20202102-01%20Updates/WHO%20
Essential%20diagnostics%20list%20(EDL).pdf
6. Vaz A, Roldão Santos M, Gwaza L, et al.
WHO collaborative registration procedure using stringent regulatory authorities’ medicine evaluation: reliance inaction? Expert Rev Clin Pharmacol.
2022;15(1):11-17. doi:10.1080/17512433.
2022.2037419
7. World Health Organization. Medicines
Prequalification. Published 2022.

Accessed November 9, 2022. https://extranet.who.int/pqweb/medicines
8. WHO. Manufacturers. Published 2022.
Accessed November 9, 2022. https://extranet.who.int/pqweb/medicines/
information/manufacturers
9. National Pharmaceutical Regulatory
Agency (NPRA). ASEAN Joint
Assessment Procedure. Published2020. Accessed November 9, 2022.
https://npra.gov.my/index.php/
en/directive-general/1527125-asean-joint-assessment-procedure-for-pharmaceutical-products-public-announcement.html

Access to Medicine Index 2022 ▶ Product Delivery

ACCESS STR ATEG I ES

How do companies ensure
worldwide access to theirproducts?

In general, companies can use three main access strategies to increase access to
medicine:• Equitable pricing strategies: Setting prices within the ability of specific payers topay, with reference to a range of socioeconomic and demographic factors in the
country. Equitable pricing strategies should be supported by additional non-pricing initiatives such as patient assistance programmes, non-exclusive voluntary
licensing and health systems strengthening, in order to improve availability andaffordability of the healthcare products.
• Responsible intellectual property (IP) management: Licensing agreements under
pro-access terms and/or pledges not to enforce patents to facilitate generic entry.
• Product donations: Identifying populations with no capacity to pay for the
new product and donating products as appropriate in collaboration with local
partners.
Products assessed by the Index
To see how companies tailor their access strategies to reach a larger proportion of
the income pyramid globally, and how they overcome product-specific access barriers when dealing with different products, the Index analyses three different categories of products: supranationally procured, healthcare practitioner-administered,and self-administered.
For each of these three product categories, the Index analysed a sample of a
maximum of five products per company, resulting in a total of 188 health products.
Overall, this sample consists of a group of products that are considered essential for a well-functioning healthcare system, and for which large companies holda controlling position regarding access – determined either through patents ortheir dominance of the market. Of these 188 products, 102 are listed on the World
Health Organization Model List of Essential Medicines (EML).

FIGURE 74 Breakdown of products analysed in this section
Across all three areas, there are a total of 160 medicines, 1739

vaccines, 6 contraceptive products, 3 diagnostics* and two
vector control products.

90

188
products
59

88*All three diagnostics products are from
Roche and are included in the analysis ofsupranationally-procured products.

Supranationally procured products
Products linked to international pooled procurement,
advance market commitments, market-shaping facilities
and significant public funding and donor support. These
products include vaccines and products indicated for thetreatment of HIV, tuberculosis, malaria, neglected tropicaldiseases (NTDs) and maternal and neonatal healthconditions.
Healthcare practitioner (HCP)-administered products
Nationally procured products that often require either
hospital administration of the product or the attentionof a skilled healthcare professional during administration, such as IV-administered cancer treatments andantibiotics.
Self-administered products
Nationally procured products that can be administered by
the individual patient and are not necessarily prioritised
by governments or by the global health community (typically, treatments for other non-communicable diseases,
such as diabetes, stroke, hypertension and heart disease).

Access to Medicine Index 2022 ▶ Product Delivery
ACCE SS S T R AT EG I E SSupranationally-procured products
Supranational procurement agreements between the public and private sectors tosecure vaccines and treatments for high-burden infectious diseases, including HIV/
AIDS, tuberculosis (TB) and malaria, as well as products for reproductive health,have been demonstrably successful in expanding equitable access and ensuring
availability of affordable, quality-assured products that meet countries’ needs.
These agreements enable the procurement of products at a large volume for multiple low- and middle-income countries (LMICs) and help mitigate supply chain
weaknesses and other logistical barriers to securing sufficient supply, in addition to
improving affordability for lower-income countries and reducing commercial risks
for companies.
The 2022 Index analyses up to five supranationally-procured products per company, i.e., products for which international pooled procurement, advance market
commitments, market-shaping facilities and significant public funding and donor
support exist. Organisations engaged in supranational procurement include Gavi,
the Vaccine Alliance (Gavi), the Global Fund to Fight AIDS, Tuberculosis and Malaria(the Global Fund), the Pan American Health Organization (PAHO) and the United
Nations Population Fund (UNFPA).

FIGURE 75 Overview of supranationallyprocured products in scope
The majority of the 39 products in scope of thisanalysis target communicable diseases,
particularly the infectious diseases HIV/AIDS (10),Multiple
Maternal andneonatal conditions
Neglected
tropical diseases

7
3

1
39
products

Communicable diseases28

TB (5) and malaria (4).

Non-communicable diseases: 0

Two vaccine products, GSK’s human papillomavirus bivalent vaccine (Cervarix®) and MSD’s humanpapillomavirus quadrivalent vaccine (Gardasil®), areprocured and supplied via an agreement with Gavi forthe prevention of HPV-related cancer.

Do companies extend the terms of supranational agreements to non-eligible
countries?
With selection criteria based on income level, gross national income (GNI) per capita, or World Bank classification, not all LMICs are eligible for all – or any – supranational procurement programmes. Yet, in many countries that are not eligible,
including many upper-middle income countries, there is still a high need for a more
affordable and reliable supply of these key healthcare products.
For this reason, the Index also assesses whether these companies offer thesame terms of access for their products to countries which are not covered bythese agreements, or which are not otherwise eligible. To provide an insight into
this, companies have been requested to provide one example, per product, of theirapproach in a non-eligible country.
Companies show best practice when they extend their strategies for these products not only to countries graduating from supranational procurement agreements(e.g., if they have recently moved into a higher World Bank country income classification), but also to those countries and populations that have never met the criteria
for inclusion. Companies can either apply the same terms of the agreements or
implement strategies with different yet equitable terms, based on the relevant payers’ ability to pay.

89

Access to Medicine Index 2022 ▶ Product Delivery

FIGURE 76 How many companies have products under supranational
agreements, and do they offer the same terms of access to countries
outside these agreements?
Thirteen of the 20 companies supply products via supranational agreements.
This figure looks at how many companies offer equitable pricing strategies
to at least one country outside of supranational agreements, and – of those– whether they offer the same terms of access to both eligible andnon-eligible countries.

7

20
companies

Companies withproducts undersupranational
agreements

7

13Companies withno products undersupranational agreements

13companies

Companies applying
equitable pricing
strategies for countries
outside agreements

8

12

1

12
companies

Company offering thesame terms of accessto both eligible andnon-eligible countries*

8

4Company not applying
equitable pricing strategies
for countries outside agreements

companies offering different termsof access to non-eligible countries,
yet offering equitable strategies

Roche does not show evidence ofextending its supranational agreement“Global Access Programme” to non-eligible countries.

FIGURE 77 How do companies facilitate
access to products in countries outside ofsupranational agreements?

AbbVie2AstraZeneca

1

Bayer

3

In total, 36 of the supranationally-procured

Bristol Myers Squibb

1

products in scope are covered by an access

Boehringer Ingelheim

1

Gilead1

GSK

1strategy in at least one non-eligible country.

1

4

Johnson & Johnson

4

MSD

1

Novartis1

Pfizer

1

2
3
4

Roche
Sanofi

3
4

0

1

2

3

1

4

● Product with equitable pricing strategy where company offers the same terms in a
non-eligible country● Products with equitable pricing strategy in a non eligible-country (not same terms)● Products without equitable pricing strategy in a non-eligible country

Eight companies extend the same terms of supranational agreements to at least
one non-eligible country. These agreements cover a total of 16 products. Basedon this sample of products, the companies with the greatest number of products
supplied to non-eligible countries under the same terms as through supranational
agreements are Johnson & Johnson, Sanofi and Bayer.
Among the companies that extend the same terms of the supranational agreements to non-eligible countries, AstraZeneca, GSK, Johnson & Johnson, MSD and
Pfizer have each expanded patient reach for all products in scope of this analysis,compared to the previous Index.
GSK and Pfizer both apply equitable pricing strategies to four out of their fiveproducts analysed. GSK, for example, applies pricing models based on the Human
Development Index (HDI) that incorporate socioeconomic and demographic factors
to reflect people’s individual ability to pay. Additional non-supranational accessstrategies are discussed in greater detail below.
Among companies applying equitable access strategies, seven are implementing
additional non-pricing initiatives to reach more patients in the non-eligible countries

90*For at least one product5

Access to Medicine Index 2022 ▶ Product Delivery

assessed, such as non-assert declarations, technology transfers and non-exclusive
voluntary licensing. Bayer, Boehringer Ingelheim and Gilead demonstrate expanded
patient reach for all their products in scope of this analysis, while GSK does so forthree out of its four products assessed.*

FIGURE 78 Countries covered by supranational procurementagreements
The map shows eligible countries covered by supranational agreements
signed between companies in scope and international procurers Gavi, Global
Fund Partnership, PAHO, UNFPA, and/or Family Planning 2030 (FP2030).
Agreements signed with these procurers cover 30 of the 39 products inscope. For some products, multiple organisations are involved in
procurement.

● 0 products● 12–25 products● 26–36 products● 37- 46 products● Countries not in scope

GO O D PR AC T I CE

GO O D PR AC T I CE

For its human rotavirus vaccine, GSK applies the same

For an antifungal medicine, Gilead uses different terms

terms used in its Gavi supranational agreement in a nonin non-eligible countries than in its supranational

Gavi-eligible country (Angola)

agreements, but employs equitable access strategies

GSK supplies its human rotavirus rix4414 strain (live, atten-

Gilead supplies its antifungal medicine amphotericin buated) (Rotarix®), for the prevention of rotavirus infection

liposome (AmBisome®), which is used to treat both visceralthat causes diarrhoeal diseases, supranationally via Gavi.

leishmaniasis and cryptococcal meningitis, through multiple

The example submitted to the Index relates to Angola, asupranational procurers. Outside of these agreements, itcountry outside the supranational agreement, for which

supplies the medicine at a not-for-profit price in a number

GSK applies the same terms of the agreement. It providesof LMICs, specifically the same group of countries that areevidence of increased patient reach. Through the GSK pricecovered by the company’s voluntary licence for its HIV/freeze commitment, GSK continues to supply Angola at

AIDS product. For countries that do not qualify for theGavi prices for 10 years from the date of their graduation

not-for-profit price, such as Mexico, the company employs

from Gavi support.

tiered pricing, based on a payer’s ability to pay and disease
burden. 4,108 patients were reached in Mexico during theperiod of the analysis.

The scope of supranational procurement has so far been limited to a small numberof disease areas, because there is no large-scale donor funding available to procurecommodities or to support government procurement more widely – particularly
for products that target non-communicable diseases.1 In in the absence of supranational procurement options, companies can instead focus on expanding access totheir products by using country-specific access strategies, including equitable pricing strategies and non-pricing initiatives, as explored in the following section.

91* Increase in patient reach might be notpossible to assess for products that are
newly in scope of the Index, or if data wassubmitted relating to a different country
than in previous Indexes.

Access to Medicine Index 2022 ▶ Product Delivery
ACCE SS S T R AT EG I E SCountry-specific access strategies for healthcare practitioneradministered and self-administered products
Globally, on average, out-of-pocket spending on medicines accounts for the largest
household expenditure: up to 44% in low-income countries, 40% in lower-middle
income countries, and 34% in upper-middle income countries, respectively.2 The
consequence of this spending is that 100 million people are pushed into extreme
poverty each year.3
Affordability is one of the main barriers to access to medicine. Companies canincrease equitable access to their products across the income pyramid by improving
the affordability of their products and tailoring country-specific strategies that consider relevant payers' ability to pay, as well as features of local health systems.
For each product in scope (up to five healthcare practitioner (HCP)-administeredand up to five self-adminstered product per company), the Index assessed examples of the access strategies applied in three countries: one classified as upper-middle income, one lower-middle income, and one low-income, as per the World Bank
income group classification.
What does best performance look like, in terms of access strategies?
The best-performing companies demonstrate how their pricing strategies* takethe payers' ability to pay into account across different segments of the population(e.g., by considering socioeconomic and demographic factors)** and how non-pricing initiatives (i.e., patient assistance programmes, donations, voluntary licensing)complement those pricing strategies to maximise the numbers of patients reachedacross the income pyramid.

FIGURE 79 Products covered by countryspecific access strategies
Products analysed in this section include 59
HCP-administered products and 90 self-administered products. This figure shows which types of
diseases they treat.

Multiple: 2Maternal andneonatal conditions: 2
Neglected
tropical diseases: 1
Communicablediseases

21
149
products

Non-communicablediseases123

92* Equitable pricing strategies play a significant part in increasing access to medicine. To maximise the availability of key
products to those with less income, companies can apply access strategies tothese products across LMICs. However,when setting pricing strategies, companies do not always integrate into theirpricing approach a payer's ability to pay
for a product.

** The characteristics of a population suchas age, sex, income level, education level,
employment, etc.

Access to Medicine Index 2022 ▶ Product Delivery

ACCESS STR ATEG I ES

What strategies do companies
use to expand access to theirproducts, and where?

In looking at the access strategies used by companies to expand access to theirproducts, three main types of strategies can be identified:• Pricing strategy as the main access strategy;• Non-pricing initiative as the main access strategy;• Combined access strategy including both a pricing strategy and a non-pricing
initiative.
Most products included in the analysis are covered by an access strategy with atleast one pricing or a non-pricing initiative in at least one upper-middle income
country (UMIC) and at least one lower-middle income country (LMIC) among the
108 countries in scope. However, low-income countries are left behind, with mostproducts not covered by any access strategy.
In terms of quality of access and pricing strategies, Novartis, Johnson & Johnson,
and GSK are leaders in implementing access strategies that take the payer's ability
to pay into account.

FIGURE 80 Where do companies provide
access to their products and what types ofstrategies are applied?

19%
34%

27%
5%

Between upper-middle income, lower-middle
income and low-income countries, there isvariation in the number and type of access

42%

25%

65%
5%

43%
15%

strategies used by companies to expand access totheir products.

13%
UMIC

Among the examples analysedby the Index, Novartis has 11
such strategies, the most outof any of the companies inscope, while GSK, Sanofi and
Pfizer follow with 10 each.

LMIC

LIC

6%

● Products not covered by an access strategy or forwhich coverage is unknown● Products covered by a non-pricing initiative as themain access strategy● Products covered by a pricing strategy as the main
access strategy● Products covered by a combined access strategy

Johnson & Johnson, Gilead, AstraZeneca
and Novartis lead in applying combined
access strategies that consider affordability
across their products. Among the examples
analysed by the Index, Johnson & Johnson
reports 18 such strategies, Gilead 14, and­Novartis and AstraZeneca 12 each.

93

Access to Medicine Index 2022 ▶ Product Delivery

ACCESS STR ATEG I ES

How many products arecovered by access strategies,
and where?
Upper-middle income countries

FIGURE 81 How many products are being

Companies

Combinedstrategy

Pricing
Strategy

Non-pricing
initiatives

No accessstrategy orcoverage is
unknown

AbbVie

●

●

●

●●●

Astellas●●●AstraZeneca

●●●●●

●●●●●

three examples of a country-specific access

Bayer

●●

●●●

strategy covering that product – one in an

Bristol Myers Squibb

●●

●●●

upper-middle income country, one in a low-

Boehringer Ingelheim

●●●●●

●●

Daiichi Sankyo

●

●●●

Eisai

●●

●●

covered by an access strategy?
For each company, a maximum of 10 products (upto five HCP-administered and up to fiveself-administered products) were selected foranalysis. Each company was asked to provide

er-middle income country, and one in a
low-income country. The figure shows thenumber of products covered by each accessstrategy type across all three World Bank country
income classifications.

●●
●

●

Eli Lilly●●●●●●●●●●

Gilead

●●●●

GSK

●●●●●

●●●

Johnson & Johnson●●●●●●●●

●●

Merck

●●●●●

●

Novo Nordisk

●●

●●●

Novartis

●●●●●

●●●●

Pfizer

●●●●

●●●●●

Roche

●●●●●

Sanofi*●●●●●●●●●

Takeda

●●

●●●●

●●

MSD

●

●●●●●●●●●
●

●

●●●

●

Lower-middle income countries

Companies

Combinedstrategy

Pricing
Strategy

AbbVie●Astellas●●AstraZeneca●●●●●●

●●●●

Bayer

●●●

●●

Bristol Myers Squibb●●●●

Boehringer Ingelheim

●●●

●●●●

Non-pricing
initiatives

●●●●●
●●●
●
●

Daiichi Sankyo
Eisai●●●●●●●●●●Eli Lilly●●●●●●●●●

Gilead

●●●●●

GSK

●●●

●●●●

Johnson & Johnson●●●●●●●●

●●

●
●

MSD

●●●●●●●●●

Merck

94

*Sanofi has one product in scope which is
excluded from analysis in the upper-middle income country category.

No accessstrategy orcoverage is
unknown●●●●

Novo Nordisk●●●●

Novartis●●●●●●●●●

Pfizer

●●●●●

●●●

Roche

●●●●●●

Sanofi●●Takeda

●●●●●

●

●●

●
●●
●●●
●●●●●●●●●●

Access to Medicine Index 2022 ▶ Product Delivery

Low-income countries

Companies

Combinedstrategy

AbbVieAstellas●●AstraZeneca

●

Bayer

●●

Pricing
Strategy

Non-pricing
initiatives

No accessstrategy orcoverage is
unknown

●

●

●●●●
●●●

●●●

●●●●●●●●●●

Bristol Myers Squibb●

Boehringer Ingelheim●●●●●●●

Daiichi Sankyo●●●●●●

Eisai

●●●●

Eli Lilly●●●●●●●●●

Gilead

●●●●●

GSK

●

●●●

●●●●

Johnson & Johnson

●●

●●●

●●●●●

●

MSD

●●●●●●●●●●

Merck
Novo Nordisk●●●●●●●●●●●●

Novartis

●●●●●

●

●●●

Pfizer

●

●●●●

●●●●●

Roche

95

●●●●

●●●●●●●●●

Sanofi●Takeda

●●●

●●●●

●●●●●
●

●●●

Access to Medicine Index 2022 ▶ Product Delivery

Examples of companies’ access strategies across countries with different
income levels
AstraZeneca

PfizerIn Egypt, a lower-middle income country, AstraZeneca’s

Pfizer applies tailored pricing strategies for both the public

medicine osimertinib (Tagrisso®), used to treat lung cancer,

and private market in Mexico for its lung cancer medicine

is distributed through both the public and private sectors.

lorlatinib (Lorbrena). In the public sector, lorlatinib’s price

Osimertinib (Tagrisso®) is reimbursed in the public sector

has been determined based on a formal government HTA

and the eligible patients (70% of patients) can access it(Health Technology Assessment). In the private channel,

without co-payment. The product is covered by private

the price is set by internal and external reference pricing,insurance funds and the number of patients who pay

competitor-based pricing, and private patient affordability

out-of-pocket is limited. AstraZeneca also implemented aconsidering demographic variables such as monthly income

patient access programme, for patient support, with educa-by household.

tion materials and funding for testing.
GSK
Pfizer

GSK considers the ability to pay of the payers in both the

In Malawi, a low-income country, Pfizer uses a patientpublic and private sectors to set the price of its asthma andassistance programme (PAP) to provide access to apixaban

COPD medicine, fluticasone propionate/salmeterol xina-(Eliquis®), a product for stroke prevention. While the prod-foate (Seretide®). The examples provided are Thailand (anuct is not yet registered in Malawi, Pfizer uses the PAP toupper-middle income country), Pakistan (a lower-middle

offer the product free of charge to eligible patients.

income country) and Uganda (a low-income country). In
Thailand, although the product is reimbursed in the public
sector, the company launched a second brand product(Evolfo) at a reduced price to meet the ability to pay of
public hospitals with budget constraints.

More products now covered by access strategies
Since the 2021 Index, 15 companies have demonstrated an increase in the number of
products covered by at least one access strategy in an upper-middle income country,
and at least one access strategy in a lower-middle income country.
Bristol Myers Squibb demonstrates the largest improvement in both upper-middle and lower-middle income countries. For each of its five products in scope, it now
reports access strategies in both upper-middle and lower-middle income countries,
a significant change from the 2021 Index which could not identify any access strategies among the company's products included for assessment. In showing the biggest
increase, Bristol Myers Squibb is followed by Johnson & Johnson and AstraZeneca. In
lower-middle income countries, Johnson & Johnson's access strategies cover six additional products, while AstraZeneca now has strategies for all its 10 products assessed,
compared to four out of nine products assessed in 2021.
However, although there is an improvement in the number of products covered by atleast one access strategy compared to the 2021 Index, especially in lower-middle income
countries, the strategies can now become more robust and comprehensive in order forcompanies’ products to be made available and affordable to more people.
Many products in low-income countries still not covered by access strategies, but
progress seen since 2021 Index
Most of the products in scope (97 of 149) are not covered by any access strategy in any
low-income country. However, of the 52 access strategies in low-income countries analysed by the Index, 37 of these do consider payers’ ability to pay, which is good practice.
While Novartis was the only company with an access strategy for all of its products
in scope in low-income countries, the 2022 Index results suggest that more companies
are expanding access to their products in the poorest countries. Compared to the 2021
Index, 13 companies demonstrate an increase in the number of products covered by anaccess strategy in at least one low-income country, with Johnson & Johnson, Gilead andSanofi leading in this regard. For example, Johnson & Johnson has strategies for five ofits 10 products assessed, compared to one of 10 in 2021.
96

Access to Medicine Index 2022 ▶ Product Delivery

ACCESS STR ATEG I ES

Do companies track how many
people they reach with theiraccess strategies?

The Index looked for evidence of patient reach resulting from the access strategies
employed by the companies in scope.
In general, companies do provide evidence of patient reach of products coveredby access strategies. They do so at a similar level for the examples provided ofaccess strategies used in upper-middle and lower-middle income countries, and at aslightly lower level in the examples they provided for low-income countries.

FIGURE 82 Among products covered byaccess strategies, for what percentage arecompanies tracking patient reach?*

16%

17%

84%

83%

For the HCP and self-administered products

27%
73%

covered by at least one access strategy,● Percentage of products covered by an accessstrategy, but with no tracking of patient reach● Percentage of products covered by an accessstrategy, with tracking of patient reachcompanies report evidence of patient reachacross countries in different income classifications (upper-middle, lower-middle, andlow-income) for the majority of their products.

UMIC

LMIC

LIC

Examples of tracking of patient reach
Bayer

Novartis

In the two years prior to the inclusion of Bayer’s can-For its cardiovascular product sacubitril/valsartan

cer product regorafenib (Stivarga®) on China’s National(Entresto™), Novartis has seen increased patient reach in

Reimbursement Drug List (NDRL), patient reach for

Mexico after it was included for reimbursement and fullregorafenib was less than 2,700 patients. After obtaining

access in the public channel. Patient reach was 11,069 inreimbursement, patient counts rose to 16,000 in 2019,2019, 18,628 in 2020, and 41,265 in 2021.

25,000 in 2020, and 36,000 in 2021. The price reduction and broad reimbursement enabled by the NRDL has
improved access to regorafenib.

97* This chart assesses only the products forwhich access strategies were reported.
As only 35% of products in scope are covered by an access strategy in any of the
low-income countries in scope, it should
be borne in mind that this bar in the figure

therefore refers to only a small number ofaccess strategies.

Access to Medicine Index 2022 ▶ Product Delivery

Conclusions
For supranationally-procured products, including many medicines and vaccines
targeting communicable diseases, companies are strongly recommended to extend
pricing arrangements using the same terms to countries not eligible for such procurements. These are mostly in lower-middle and upper-middle income countries
where patients still face barriers to access due to high prices, yet are less likely tobenefit from supranational procurement.
For products that are not subject to supranational procurement, companies now
have access strategies for more products. However, the quality of the strategies
varies across products and income groups. In addition, data suggests that accessstrategies are not consistently applied for the same product across countries withdifferent income levels, and lack of access to products remain an evident issue in
low-income countries.

R E FE R E N CES
1	NCD Alliance. Invest to Protect
NCD financing as the foundation for
healthy societies and economies.
Published 2022. Accessed August 26,
2022. https://ncdalliance.org/sites/
default/files/resource_files/NCD%20
Financing_ENG.pdf

98

2.	World Health Organization. Global
Expenditure on Health: Public
Spending on the Rise?; 2021.
Accessed October 12, 2022. https://www.who.int/publications/i/
item/9789240041219

3.	World Health Organization. WorldBank and WHO: Half the world lacks
access to essential health services,
100 million still pushed into extreme
poverty because of health expenses.
Published December 13, 2017.
Accessed October 17, 2022. https://www.who.int/news/item/13-12-2017world-bank-and-who-half-the-worldlacks-access-to-essential-health-services-100-million-still-pushed-into-extreme-poverty-because-of-health-expenses

Access to Medicine Index 2022 ▶ Product Delivery

LICE NSI NG

How are companies using
voluntary licensing as partof their strategies to expand
access?

Pharmaceutical companies can improve access to their patented medicines by
granting voluntary licences, so that generic medicine manufacturers in low- andMedicines Patent Pool

middle-income countries (LMICs) are able to develop generic versions of the prod-

The MPP is a UN-backed interna-

uct. This can be an effective way of improving the availability and affordability oftional organisation that aims to

key products, especially those that are new and innovative, and that might not oth-facilitate the process of voluntary

erwise be accessible to people living in LMICs.

licensing by negotiating licence terms

In particular, companies can engage in non-exclusive voluntary licences (NEVLs),

with patent holders and sub-licensing

which means the licence is open to multiple manufacturers, often in different coun-to generic manufacturers on publictries and regions. The Medicines Patent Pool (MPP) plays a central role in facilitat-

health-oriented terms and conditions.

ing the agreement of NEVLs. Similarly, companies can opt not to enforce or file for

The MPP covers treatment options

patents, or engage in non-assert declarations in LMICs. These Intellectual Property

for HIV, hepatitis C and tuberculosis,(IP) strategies can promote access by fostering competition in the market andand it has expanded its mandate toincreasing the manufacturing base.

work on priority medicines for otherdisease areas including cancer, car-

What is the gold standard for a non-exclusive voluntary licence?

diovascular diseases, diabetes and

To be most effective, NEVLs should have access considerations at their centre, and

COVID-19.2

should be designed to reach a wide range of patients with a need for the licensed

Licensing through the MPP offers

product. Good-quality NEVLs involve coordination and sustained commitment fromadvantages from a global health per-industry, governments, NGOs and organisations such as the MPP.

spective because the process is more

However, detailed information about NEVLs is sometimes not publicly available,transparent than when licences are

and access clauses are often not transparent. Some NEVLs are also limited in geo-

issued privately. Licences throughgraphical scope – by being restricted to Least Developed Countries only, for exam-

MPP also tend to apply to a larger

ple – which can restrict their impact on expanding access and benefitting global

number of territories – meaning

health.

fewer limitations on where thegeneric drugs can be produced andWhat is a non-assert declaration?

sold – and include several otherA non-assert declaration is where a rights holder commits not to enforce certain

access-friendly terms.3

patents in a defined group of countries. This allows a generic version of a patent-protected product to be produced and commercialised in those countries.1

99

Access to Medicine Index 2022 ▶ Product Delivery

LICE NSI NG

More compounds are coveredby licences in 2022

The 2022 Index has identified 27 voluntary licences and three non-assert declarations among the companies in scope.* These are 26 NEVLs and one sequence of

FIGURE 83 27 compounds are covered by

exclusive voluntary licences, from AstraZeneca. Out of the 20 companies, ten canlicensing agreements by the companies in

be identified as engaging in licensing agreements: AbbVie, AstraZeneca, Bristol

scope

Myers Squibb, Eli Lilly, Gilead, GSK, Johnson & Johnson, MSD, Novartis and Pfizer.

Licensing agreements for compounds to treat

The three non-assert declarations identified by the Index include lopinavir/
ritonavir (Aluvia®/Kaletra®) adult and paediatric licences from AbbVie, as well as
non-assert declarations for Darunavir (Prezista®, Prezcobix®/Rezolsta®, Symtuza®)
from Johnson & Johnson.
The 26 NEVLs cover an average of 80 of the 108 countries in scope (a meanof 80; a median of 91). AbbVie’s adult lopinavir/ritonavir, indicated for HIV, is thebroadest, covering all countries in scope except Ukraine. The reason for this wide
scope is that the company gave up its global patent rights in 2020 for lopinavir/ritonavir so that it could be tested as a potential treatment for COVID-19.
Ultimately, no benefits were observed with lopinavir/ritonavir treatment for COVID19. However, AbbVie’s non-assert declarations and NEVL now have the potential tohelp expand access to a key HIV medication in LMICs.
This section explores NEVLs that cover cancer and HIV. NEVLs for COVID-19
products are covered in the Index’s COVID-19 Special Report.
Access to cancer medicines
Cancer is a leading cause of death worldwide.4 Data from the Global Cancer
Observatory shows that in 2020, just over three million new cases of cancer werereported in LMICs, with nearly two million deaths reported. The World HealthOrganization (WHO) estimates that by 2030, approximately three quarters of allcancer deaths will occur in LMICs.
In addition to the existing burden of communicable diseases in LMICs, the rise in
non-communicable diseases (NCDs), such as cancer, has led to a ‘double burden of
disease’ in these countries.5 In resource-poor settings, affordable access to cancer
medicines can be a major challenge. International collaboration is required to beable to make cancer medicines available, and to guarantee that patients will receive
accurate and timely treatment.6,7
ATOM coalition
The Access to Oncology Medicines (ATOM) Coalition is an innovative collaborativemodel aiming to increase access to quality-assured essential cancer medicines in
low-income and lower-middle income countries in a sustainable manner.
This unprecedented partnership was formed to ensure that specific needs ofeach country with respect to its cancer burden will be addressed. Countries will
receive the support they need to receive essential medicines and diagnostics
where they are lacking, as well as training on their use, so that availability becomes

100*Companies submitted information
regarding the patent status of their products, NEVLs and/or non-assert declarations to the Index for analysis. Information
available in the public domain was mainly
found on the MPP website.2 For a sub-set of companies, details regarding scopeor access clauses of NEVLs could not bereported as no data was provided/verified
by the company or available in the publicdomain during the period of analysis. Not
all NEVLs were publicly available.

HIV are most common.
Cancer

1

Coronaviral diseases

2

Viral hepatitis C

2

3
4

HIV

14 1

0

4

8

12

16

Compounds● Not MPP licences● MPP licences

Access to Medicine Index 2022 ▶ Product Delivery

sustainable in the long term. The intent is to not only ensure access to cancer medicines but also follow-up and quality care. Existing organisations will be brought
together to create synergy and exchange best practices between partners.8
AstraZeneca, Bristol Myers Squibb, Eli Lilly, Gilead, MSD, Novartis, Roche and Sanofi
have all committed to collaborating with the ATOM Coalition.9
MPP is part of this global partnership as an observer, responsible for negotiating
voluntary licences for priority medicines. Licensing for cancer medicines is important to expanding affordable access to these essential medicines in LMICs.10 Good
quality licensing agreements for oncology products will enable generic versions to
be available in LMICs pending regulatory approval.4
Coalition to Accelerate Access to Long-Acting PrEP
HIV pre-exposure prophylaxis (PrEP) is the use of prescription medication as ameans of preventing HIV infection. Oral PrEP was approved in 2012 and was shown
to be safe and effective in HIV prevention. The Coalition to Accelerate Access toLong-Acting PrEP advocates for an accelerated, equitable, sustainable and collaborative approach to make longer-acting PrEP options equitably and quickly accessible. The coalition is convened by Unitaid, WHO, Joint United Nations Programme
on HIV/AIDS (UNAIDS), the Global Fund to Fight AIDS, Tuberculosis and Malaria(the Global Fund) and US President's Emergency Plan for AIDS Relief (PEPFAR),
with global advocacy for HIV prevention (AVAC) as the Secretariat, and works withleading donors and agencies to develop strategies to identify and overcome accesschallenges for new PrEP options, such as long-acting injectable options.14

GO O D PR AC T I CE

GO O D PR AC T I CE

Novartis, first NEVL for a cancer compound

ViiV Healthcare, HIV licensing agreement for CAB-LA

Novartis has entered into a non-exclusive voluntary licens-

PrEP

ing (NEVL) agreement with the MPP for its on-patent

Cabotegravir (CAB) long-acting (LA) (Apretude) fromblood cancer medicine nilotinib (Tasigna®), allowing for

ViiV Healthcare, the global HIV company majority-owned

production by generic medicine manufacturers.* This is aby GSK, is an extended-release formulation of CAB andsignificant milestone, as it is the first cancer compound to

in 2021 became the first long-acting injectable option

be added to the patent pool, as well as the first-ever drug

approved for HIV PrEP. This extended dosing regimen isfor an NCD to be added.11 It also sets a precedent for otherconvenient and overcomes potential administration chal-companies to engage in NEVLs for products covering can-lenges in LMICs, as one injection every two months cancer and other NCDs.

be more convenient than oral medication that needs to be

Nilotinib is used for chronic myeloid leukaemia in bothtaken daily.

children and adults. Due to its cardiovascular side effects,

In July 2022, ViiV Healthcare announced a voluntary

patients need to be carefully assessed before it is adminis-

licensing agreement with MPP for CAB-LA PrEP, which will

tered and must be periodically monitored.11, 12 The primary

allow selected generic manufacturers to develop, manu-

patent for nilotinib expires in 2023, with secondary patents

facture and supply generic versions of the product in 87

expiring later.13 The MPP will sub-license nilotinib so thatcountries in scope of the Index.15, 16, 17 While this voluntarya generic version can be manufactured and supplied in thelicence has not been assessed or included in the scope of

licenced territory, subject to local regulatory authorisation.

the 2022 Index, as it was announced after the period of

All royalties that would have been received by Novartis will

analysis had ended, it is highlighted here as a notable devel-

be reinvested back into the ATOM coalition.

opment that will be especially significant for women of
reproductive age in sub-Saharan Africa who are disproportionately affected by HIV; the disease is the leading causeof death in women and girls between the ages of 15 and 49
in this region.18,19

101*Novartis announced that it would enter
into the NEVL in May 2022, during theperiod of analysis of the Index (1 June
2020 – 31 May 2022). While the agreement was officially signed in October
2022, after the period of analysis had

ended, the NEVL meets the inclusion criteria to be in scope of the 2022 Index.

Access to Medicine Index 2022 ▶ Product Delivery

LICE NSI NG

Greater transparency neededfrom companies on patentstatus and policies

Several criteria are assessed when analysing licensing and patent policies fromcompanies. Apart from engaging in NEVLs, companies can publicly and clearly share
information regarding patent status, patent information, and where patents will be
filed or enforced.20, 21 This can give greater certainty to international drug procurers
and generic medicine manufacturers when planning to manufacture and/or supply
generic products.
Nineteen of the 20 companies publicly share data about their products' patentstatus. Seventeen of them do so via the Pat-INFORMED platform, a publicly available resource where patent holders can voluntarily provide information about thepatent status of their product. Companies can, however, go further, or share information via other platforms or websites in order to make patent information moreaccessible in the public domain. The gold standard is that each company publicly
discloses the patent status for all its products in its portfolio that are in scope of
the Index. This information is transparent and updated; it includes the jurisdiction,
publication number, publication date, filing date, grant date, grant number, and expiration date of each patent. As expiry dates cannot be shared in Pat-INFORMED, or if
the platform is not used by the company, information about expiry dates should beshared publicly elsewhere, e.g., on the company’s website.
Companies can also support the expansion of access to medicine by making apublic commitment not to enforce or file patents, or to abandon existing patents, ina wide range of LMICs – and being transparent about this policy. A majority of thecompanies (17) publicly commit not to enforce or file patents in LMICs. However,
only five make the commitment not to enforce patents for all their products in a
broad range of countries in scope of the Index.

FIGURE 84 For less than 40% of theon-patent products in companies’ portfolios,
information about patent expiry dates ispublicly available
Among the companies in scope, an overall figure

128

323
on-patent
products 195

of 740 products are included for analysis in the
Index. Of these, 323 are on-patent and 292
off-patent. For the remaining 125, information
about patent status is not available, or is
non-applicable (e.g., for biological products). Evenamong products known to be on-patent, expiry
dates are not easily found in the public domain.

102

Expiry datepublicly available

Expiry date
not available

Access to Medicine Index 2022 ▶ Product Delivery

FIGURE 85 How do companies perform in patent policies?
This table shows companies’ performance on patent disclosure (via either
Pat-INFORMED or the company's website), and what public commitments it
has made not to force or file patents in LMICs. AstraZeneca, Merck andSanofi are more transparent in this area compared to their peers, while
Boehringer Ingelheim does not publicly disclose patent information about its
on-patent products.

Companies

On its company website, AstraZeneca discloses the expiry
date for the patents of all products in its Index portfolio. The
information is transparent andlinks each marketed product,
including brand name and INN,
with the expiry date in the US,
China, EU and Japan.

Patent disclosure on

Public commitmentcompany's website /not to enforce or file

Pat-INFORMED

patents

AbbVie●●Astellas●●AstraZeneca

●

●

Bayer

●

●

Bristol Myers Squibb●●

Boehringer Ingelheim●●

Daiichi Sankyo

●

●

Eisai

●

●

Eli Lilly●●

Gilead

●

●

GSK

●

●

Johnson & Johnson

●

●

MSD

●

●

Merck

●

●

Novo Nordisk●●

Novartis●●

Pfizer

●

●

Roche

●

●

Sanofi●●Takeda●●Merck commits not to file orenforce patents in countries ina total of 90 countries in scopeof the Index.

● No disclosure● No disclosure●D iscloses for a subset of products with●F
 or all products in all Least Developed Countries

less transparency*● Discloses for a subset of products with

(LDCs) and/or low-income countries (LICs)● For all products in all LDCs and LICs, plus in aa good standard of transparency●D iscloses for all products with a goodsubset of lower-middle income countries●F or all products in all LDCs, LICs, and subset ofstandard of transparency

lower-middle and upper-middle income countries

Conclusions
While the majority of the licensing agreements analysed in the 2022 Index covera wide range of countries in scope, many of these agreements exclude upper middle-income countries. Further, companies do not always make information on their
non-exclusive voluntary licences (NEVLs) publicly available. Transparency in licensing agreements and patent policies is essential, as it helps facilitate procurement
agencies’ decision-making regarding product supply, and enables generic medicine
manufacturers to identify designated LMICs in which they can develop and supply
generic versions of medicines.
Companies now need to engage in more NEVLs to cover more products – particularly for non-communicable diseases – across a wider range of countries. In
addition, when entering future NEVLs, companies also need to consider technology
transfers and access-oriented clauses in order to help accelerate the subsequent
product delivery, uptake and sustainable supply in LMICs.

103*The standard of transparency is compared to the standard set out by the US
FDA's Orange Book where patent data
includes at least the patent number, jurisdiction and expiry date.

Access to Medicine Index 2022 ▶ Product Delivery

R E FE R E N CES
1	International Federation of
Pharmaceutical Manufacturers &Associations (IFPMA). Voluntary
licenses and non-assert declarations.
Published July 28, 2010. Accessed
August 31, 2022. https://www.ifpma.
org/resource-centre/voluntary-licenses-and-non-assert-declarations/
2.	Medicines Patent Pool. Licences.
Published 2022. Accessed July 20,
2022. https://medicinespatentpool.
org/progress-achievements/licences
3.	Shadlen KC. Accelerating
pooled licensing of medicines to enhance global production and equitable access. The
Lancet. 2022;400(10352):632-634.
doi:10.1016/S0140-6736(22)01013-3
4.	Oomen, Karin P Q; Karuranga, Suvi;
Iyer, Jayasree K. Improving Accessto Cancer Care: A First Analysis of
Pharmaceutical Company Actions in
Low- and Middle-Income Countries;
2017. Accessed August 31, 2022.
https://accesstomedicinefoundation.
org/publications/improving-accessto-cancer-care-a-first-analysis-ofpharmaceutical-company-actions-inlow-and-middle-income-countries
5.	Pramesh CS, Badwe RA, Bhoo-Pathy
N, et al. Priorities for cancer researchin low- and middle-income countries: a global perspective. Nat Med.
2022;28(4):649-657. doi:10.1038/
s41591-022-01738-x

104

6.	Robertson J, Barr R, Shulman LN,
Forte GB, Magrini N. Essential medicines for cancer: WHO recommendations and national priorities. Bull
World Health Organ. 2016;94(10):735742. doi:10.2471/BLT.15.163998
7.	Union for International Cancer Control(UICC). UICC - who we work with.
Published July 26, 2022. Accessed
August 31, 2022. https://www.
uicc.org/who-we-work/networks/
access-oncology-medicines-atom-coalition#3
8.	UICC. Improving access to and useof essential life-saving cancer medicines in LLMICs. Published May 30,
2022. Accessed August 31, 2022.
https://www.uicc.org/news/improving-access-and-use-essential-life-saving-cancer-medicines-llmics
9.	UICC. ATOM Coalition Partners.
Published July 26, 2022. Accessed
August 31, 2022. https://www.
uicc.org/who-we-work/networks/
access-oncology-medicines-atom-coalition#partners
10.	Medicines Patent Pool. MPP
joins ATOM, a new global coalition to increase access to andthe use of essential cancer medicines in low and lower middle-income countries. Published May 20,
2022. Accessed August 31, 2022.
https://medicinespatentpool.org/
news-publications-post/mpp-joinsatom-a-new-global-coalition-to-increase-access-to-and-the-use-of-essential-cancer-medicines-in-low-andlower-middle-income-countries

11.	Novartis. Boosting access to cancer care where it’s needed most.
Published May 24, 2022. Accessed
August 31, 2022. https://www.novartis.com/stories/boosting-access-cancer-care-where-its-needed-most
12.	Novartis. INDICATIONS forTASIGNA® (nilotinib) Capsules.
Published 2022. Accessed August
31, 2022. https://www.hcp.novartis.com/products/tasigna/
ph-cml/#important-safety-info
13.	Burrone. Bulletin of the World
Health Organization. Bull World
Health Organization. 2019;97:575577. doi:http://dx.doi.org/10.2471/
BLT.18.229179
14.	Global Advocacy for HIV Prevention.
Coalition to Accelerate Access toLong-Acting PrEP. Published July
2022. Accessed November 9, 2022.
https://www.avac.org/resource/coalition-accelerate-access-long-acting-prep
15.	Medicines Patent Pool. MPP, ViiV
Healthcare CAB-LA for PrEP.
Published May 27, 2022. Accessed
October 13, 2022. https://medicinespatentpool.org/news-publications-post/medicines-patent-pool-viiv-healthcare-enter-negotiations-over-voluntary-licensing-of-cabotegravir-long-acting-for-hiv-pre-exposure-prophylaxis

16.	Medicines Patent Pool. ViiV Healthcare
and MPP sign NEVL. Published
July 28, 2022. Accessed October
13, 2022. https://medicinespatentpool.org/news-publications-post/viiv-healthcare-and-the-medicines-patent-pool-sign-new-voluntary-licensing-agreement-to-expandaccess-to-innovative-long-acting-hivprevention-medicine
17.	Medicines Patent Pool. Cabotegravir
long-acting (LA) for HIV pre-exposure
prophylaxis (PrEP). Published July
2022. Accessed October 13, 2022.
https://medicinespatentpool.org/
licence-post/cabotegravir-long-acting-la-for-hiv-pre-exposure-prophylaxis-prep
18.	ViiV Healthcare. ViiV Healthcare
cabotegravir LA for PrEP. PublishedMarch 2022. Accessed October 13,
2022. https://viivhealthcare.com/
hiv-news-and-media/news/company-statements/viiv-healthcare-statement-on-voluntary-license/#1
19.	Institute for Health Metrics and
Evaluation. GBD Compare. Published2022. Accessed October 13, 2022.
https://vizhub.healthdata.org/
gbd-compare/20.	Medicines Patent Pool (MPP).
MedsPal. Published online 2022.
Accessed November 10, 2022. https://www.medspal.org/?page=1
21.	WIPO. Pat-INFORMED. Published
online 2022. Accessed November
10, 2022. https://www.wipo.int/
patinformed/

Access to Medicine Index 2022 ▶ Product Delivery

PRO DUCT DO NATIONS

Are companies donating
medicines responsibly basedon expressed need?

Long-term donation programmes are implemented by pharmaceutical companies

Ad hoc donations

as a clear, defined long-term strategy to control, eliminate or eradicate a disease,

A gift of products for which there is

ad hoc donations are a short-term gift of medical products made in response to an

no clear, defined long-term strategy

expressed need. Ad hoc donations can be made based on the explicit request of ato control, eliminate or eradicate acountry but can also be made during emergency situations, such as conflicts anddisease. This may include a company

natural disasters. Pharmaceutical companies can provide ad hoc donations in sev-

donating a range of medicines basederal ways. For example, they can preposition key medicines in distribution partners’

on the explicit needs of a country.

warehouses for later donation or respond directly to requests for medicines madeDonations made during emergency

by stakeholders, such as governments and humanitarian aid organisations.

situations, such as conflicts and natu-

Ad hoc donations can be valuable in filling gaps in health systems and providing
access to life-saving products in times of crisis. In Tigray Ethiopia, ad hoc donations
have been made to supplement the weakened health infrastructure caused by the
recent conflict.1 For example, in August 2021 the Novo Nordisk Foundation supported humanitarian aid efforts in Ethiopia by donating 92,000 human insulin vials
through a request from the Danish Red Cross. In the recent war in Ukraine, pharmaceutical companies have donated over 22 million doses of essential medicines as ofMarch 2022.2 Examples are seen of companies making efforts to ensure donations
reach the country despite the supply chain disruption caused by the ongoing war.
At the same time, when medicine donations are poorly executed, they can cause
harm to recipient countries through, for example, high disposal costs for expired
products. Research has shown that up to 70% of donated medicines and medical
products are not used as they are not functional, appropriate or staff lack training
in administering/using the products.3 Despite several companies having donation
policies in place, recent crises like the COVID-19 pandemic have shown that ad
hoc donation efforts can present opportunities for malpractice, such as offloading
unwanted or nearly expired medicines. According to the Africa Centres for Disease
Control and Prevention, during the pandemic, 2.8 million doses of vaccines had
expired on the continent of Africa as of early 2022, most of these being donatedproducts.4 Although this is only a small percentage of the total vaccines received,
the number is likely to be underestimated due to lack of information about doses
supplied to low- and middle-income countries (LMICs) through donations.
When making ad hoc donations it is important that companies take steps toensure that these donations are held to the quality standards of the updated 2010
World Health Organization (WHO) Guidelines for Medical Donations.5 While ensuring proper distribution of such donations can be met with several logistical barriers– given the varied stakeholders involved in the supply chain – these barriers emphasise the importance of company involvement in the full process of medical donations, from needs assessments to last-mile distribution. This includes collaboratingwith recipients to ensure that medicines reach the final user – the patient.

105

ral disasters, are also included here.

Access to Medicine Index 2022 ▶ Product Delivery

FIGURE 86 Main stakeholders in medical donation supply chain
This streamlined diagram shows the stakeholders involved in the supply of medical donations. Several
other stakeholders can be involved before a donation reaches a beneficiary, such as customs controls
and local third-party logistics providers in recipient countries. Furthermore, these stakeholders are
based in multiple countries and have varying regulatory requirements, further complicating the supply
chain. This complexity can make tracing donations to the end user difficult, especially during emergency
situations when administrative systems can become disrupted and at a higher risk for corruption.
Donors(e.g., pharmaceuticalcompanies)

Intermediaries(e.g., internationalNGOs, World HealthOrganization)

Recipients(e.g., local NGOs,
Ministries of Health)Beneficiaries(e.g., individuals,
communities)

What makes a good donation policy?
The Index measures whether pharmaceutical companies have policies in place todeploy ad hoc donations in response to expressed need. These donation policies
should be set up in such a way that the provided products benefit the recipient to
the maximum extent possible, meaning that unsolicited medicine donations are
discouraged. Donations should be made in accordance with the government policies and administrative arrangements of the recipient country. Further, donatedproducts should be listed on the national list of essential medicines, or on the WHO
Model List of Essential Medicines (EML). A plan should be made for effective coordination and collaboration between the donor and recipient, and this plan shouldbe agreed upon by both parties. Provisions should be made to uphold the quality of
medicine donations, and these quality standards should at minimum be the sameas what is expected in the donor country. Companies are also expected to takeresponsibility for donations reaching their intended user and when working withpartners.
What ad hoc donation policies do companies have in place?
All 20 companies analysed in the 2022 Index have a donation policy for ad hoc
requests for medicine donations. Nine companies publicly specify their alignment
with WHO Guidelines for Medicine Donations, including compliance with country
requirements and requirements for securing and storing medicines in the recipient
country. An additional four companies shared their alignment with WHO Guidelines
with the Access to Medicine Foundation but do not have a publicly available statement. For the remaining seven companies, there is no evidence to suggest that the
donations made align with WHO Guidelines.

106Access to Medicine Index 2022 ▶ Product Delivery

Examples of companies that publicly disclose their commitments to upholding
the quality of their product donations
GSK

AbbVieSanofiAs a global healthcare company,

AbbVie supports targeted product

The Sanofi Espoir Foundation, in

GSK recognises a responsibility to

donations that build and advancecharge of coordinating and validating

make product donations in the form

health system capacity, access andall medicine and vaccine donations forof ongoing humanitarian assistanceinfrastructure.

humanitarian purposes from Sanofi’s

and/or as emergency support when

We are committed to ensuringorganisations worldwide, has estab-that our donations to charitable, phil-lished a set of guidelines modelled on

We are committed to ensuring

anthropic partners are responsibly

those used in WHO, setting stringent

that our donation programmes aremanaged, meet important healthcare

criteria to evaluate each donation

managed in a responsible way, areneeds, and sustain the healthcare

request submitted to the Group’s

needs-based and should not disrupt

system capabilities in recipient

subsidiaries. These criteria include

or undermine healthcare provision incountries.

an on-the-ground needs assessment,

natural disasters hit.

recipient countries.

AbbVie adheres to a strict Global

the evaluation of the medical skills

GSK donations are, therefore,

Product Donations Policy, whichof the applicant organisation, themade in accordance with an estab-aligns with WHO Guidelines foradequacy of the drugs with the dis-lished framework of legal obligations

Medicine Donations. AbbVie is anease profile in the recipient country,

and internal processes, and in line

active member of the Partnership foran expiry date of at least 12 months

with WHO Guidelines on ProductQuality Medical Donations (PQMD).

upon arrival in the country, the pres-Donations.

ence of notices and labels written
in an understandable language, andthe availability of storage in a secure
location with an access limited to

TABLE 5 Examples of company donations during the Ukraine crisis

authorized people.

This table does not include financial donations or medical equipment donations. The information presented in this table is not an exhaustive list of all donations made by pharmaceuticalcompanies and is instead based on company data submissions to the 2022 Index.
Company
AstraZeneca

Partner(s)Product(s)Date of first donation

Direct Relief Ukraine

budesonide* (Pulmicort®);14 March 2022

dapagliflozin** (Forxiga®);budesonide/formoterol*(Symbicort®);ticagrelor (Brilinta®);fulvestrant (Faslodex®);olaparib (Lynparza®);goserelin** (Zoladex®)
Bayer

Ukrainian Ministry of Healthmoxifloxacin* (Avelox®) IV and tablets; ciprofloxacin*

Boehringer

Direct Relief

ipratropium bromide* (Atrovent® HFA) inhalation aerosol;
Q1 2022
telmisartan* (Micardis®) oral tablets three dosages;
telmisartan/hydrochlorothiazide* (Micardis Plus®) oral tablets three doses;
tiotropium* (Spiriva® Respimat®) inhaler two doses;
tiotropium* (Spiriva®) inhalation powder capsules

Polish Ministry of Healthtiotropium /olodaterol (Yanimo®)

Q1 2022

Americaresolmesartan (Benicar®)

Before 31 May 2022

Portuguese PharmaceuticalIndustry Association (Apifarma)

metoprolol** 100 mg film-coated tablets;
metoprolol** 200 mg prolonged-release tablets

Before 31 May 2022

Belgian Pharmaceutical Industry
Association (Pharma.be)diclofenac sodium (Motifene®)

Before 31 May 2022

GSK

Ukrainian Ministry of Healthamoxicillin clavulanate* (Augmentin®);ceftazidime*(Fortum®);
cefuroxime* (ZinacefTM/Zinnat®);salbutamol*;paracetamol*(Panadol)

8 March 2022

Novo Nordisk

Ukrainian Ministry of Healthinsulin human (rDna)*(Actrapid® HM);
insulin human (rDna)* (Actrapid® FLEXPEN);
insulin aspart (l-arginine)* NovoRapid® FlexPen®;glucagon*(GlucaGen®HypoKit)

March 2022

Novartis

Ukrainian Ministry of Health108 different antibiotics and painkillers from the Sandoz portfolio

March 2022

Roche

Multiple (unnamed)

ceftriaxone* (Rocephin®)

2 March 2022

Ingelheim

Daiichi Sankyo

107*These medicines are listed on the 2022
World Health Organization Model List of
Essential Medicines (WHO EML)**This medicine is listed as a therapeutic alternative to a medicine on the WHO
EML

1 March 2022

Access to Medicine Index 2022 ▶ Product Delivery

Monitoring the delivery of donations
Nine out of 20 companies show evidence of taking steps to ensure that the
donated products reach the recipient organisation (e.g., local non-governmentalorganisations). Only seven companies show evidence of tracking donations until
reached by the end user, being the patient. The remaining four companies takeminimal steps to track their donations to the patient. Some approaches to monitor
donations until the end-user include periodic field visits and distribution reports,
in addition to other receipt and utilisation feedback. Other methods used include
using online tools and platforms to track allocation. These kinds of online tracking
tools can be valuable in increasing transparency and helping diagnose supply issues
early on.

FIGURE 87 Less than half of companies
demonstrate evidence of monitoring
donations until reached by the end-user being

Patient

the patient

4
7

20
companies
9

Minimalsteps

Boehringer Ingelheim has a programme thatallows it to periodically track, monitor and maintain visual surveillance of product donations via
satellite observation throughout the supply chain.
This method is used to ensure that the company’s
supply chain is secure from the NGO partner tothe end user.

Recipientorganisation

Conclusions
Given the critical role of ad hoc donations in supporting health systems in times ofneed, it is important that companies hold all their donation practices to high standards, so that quality medicines reach those in need, in a timely manner. Data from

Roche monitors the delivery of donations untildelivery at the receiving organisation. The
receiving organisation is contractually obliged toprovide Roche with a comprehensive report on
the delivery of the donation. Beyond the receivingorganisation, Roche’s policy on philanthropic
donations also states that the partnerships andagreements with organisations receiving Roche
philanthropic donations are expected to assure
reporting of project evaluation and data regarding
the effect of any programme.

the 2022 Index shows that just under half of companies in scope publicly share
their commitments to engage in ad hoc donations that comply with WHO guidelines. More companies can publicly commit to adhere to these standards to holdthemselves, and their partners, accountable for quality and timely donations.
Index data also shows that less than half of companies show evidence of taking
clear steps to ensure that donations reach patients at the last mile. More effort
is needed in this area to monitor both distribution and use. This includes not only
tracking donations until they reach district-level medical stores but also ensuringthat the medicines are able to be utilised by the patients that need them.
While ad hoc donations can be a temporary solution to addressing public healthneeds in critical times, these donations should not be used in place of sustainable
access strategies such as technology transfers, health systems strengthening initiatives and equitable pricing strategies.

R E FE R E N CES
1	Devi S. Humanitarian accessdeal for Tigray. The Lancet.
2020;396(10266):1871.
doi:10.1016/
S0140-6736(20)32669-6

1082	European Federation of
Pharmaceutical Industries
and Associations (EFPIA).
Pharmaceutical industry response to the war in
Ukraine. Published March
10, 2022. Accessed August30, 2022. https://www.efpia.
eu/news-events/the-efpia-view/efpia-news/pharmaceutical-industry-response-to-the-war-in-ukraine/3	McDonald S, Fabbri A, Parker
L, Williams J, Bero L. Medical
donations are not always free:
an assessment of compliance of medicine and medical device donations withWorld Health Organization
guidelines (2009–2017). Int
Health. 2019;11(5):379-402.
doi:10.1093/inthealth/ihz004

4	Winning A. Africa calls for
donated vaccines with shelf
life of 3 to 6 months | Reuters.
Published January 20, 2020.
Accessed June 20, 2022.
https://www.reuters.com/
world/africa/africa-cdc-saysit-plans-talk-merck-about-covid-pill-2022-01-20/

5	World Health Organization.
Guidelines for Medicine
Donations, Revised 2010.
3rd ed.; 2010. Accessed
June 17, 2022. https://www.
who.int/publications/i/
item/9789241501989

Access to Medicine Index 2022 ▶ Product Delivery

I NCLUSIVE BUSI N ESS M O D E LS

Are companies engaging ininclusive business models
to reach underserved
populations?

The World Bank’s International Finance Corporation estimates that 76% of theworld’s population is living at the base of the income pyramid (BoP), including 4
billion people (61% of the world population) living on USD 1-8 per day, and 1.2 bil-

Relatively poor
4 billion people$1-$8 per day

lion people (15% of the world population) living on less than USD 1 per day.1 Whilethese figures are concerning, they likely under-represent the true number of people who live in poverty, without access to basic goods, services, and opportunities.
Certain vulnerable groups such as children/youth, indigenous people, migrants andWORLD
INCOMEPYRAMID

women face additional barriers to access due to factors like stigma and economic
constraints.
Globally, individuals at the BoP spend more than half of their household incomeon pharmaceuticals, often purchased from pharmacies without a prescription,
instead of hospitals or clinics, as these facilities are often less accessible.2 When
individuals living at the BoP cannot afford to pay for healthcare, treatment may bedelayed until conditions worsen, which can lead to higher costs of treatment down
the line.
Pharmaceutical companies are often reluctant to conduct business in BoP communities despite the combined high purchasing power of the population as a whole
and the high individual household expenditure on health. This may be caused byvarious overlapping factors, including low profit margins, low levels of health-seeking behaviour and a lack of market information, logistics infrastructure and qualified
healthcare personnel. Although a variety of these factors may be missing in somecommunities, pharmaceutical companies can leverage existing assets in BoP communities and develop inclusive business solutions to address barriers and ensure
people living at the BoP have access to quality and affordable medicines.

Defining inclusive business models
The United Nations Development Programme (UNDP) defined inclusive businessmodels in its 2008 report Creating Value for All - Strategies for Doing Businesswith the Poor: “Inclusive business models include the poor on the demand side
as clients and customers, and on the supply side as employees, producers andbusiness owners at various points in the value chain. They build bridges between
business and the poor for mutual benefit. The benefits from inclusive businessmodels go beyond immediate profits and higher incomes. For business, they
include driving innovations, building markets and strengthening supply chains.
For the poor, they include higher productivity, sustainable earnings and greater
empowerment."3109

Very poor
1.2 billion people< $1 per day

Access to Medicine Index 2022 ▶ Product Delivery

What are inclusive business models in the context of access to medicine?
The Index assesses inclusive business models that address access-to-medicine barriers that prevent BoP communities from attaining adequate healthcare. It is important that these models include clear plans or evidence of financial sustainability andallow business operations to continue and develop. Models should be revenue-generating or revenue neutral, thus creating value for both BoP communities and businesses. In that sense, inclusive business models are not a company social responsi-

FIGURE 88 More companies are scaling up

bility programme or a charity, but instead are an additional way of doing business.

existing inclusive business models thanpiloting new models

What are the inclusive business models in scope of this analysis?
In 2022, a total of 51 inclusive business models were included for analysis out of 62
models identified and assessed based on company data submissions and informa-

19

51
Modelstion from the public domain. The remaining 11 initiatives were excluded from analysis as they did not serve the BoP or other vulnerable groups, or were considered,

Scaled-up
32

for example, philanthropic capacity building initiatives or pricing strategies such as

Novartis stands
out for scaling-up the mostmodels, while
also piloting newmodels.

patient assistance programmes that are not inherently financially sustainable.
PilotedOverall, 15 companies have scaled up a combined total of 32 inclusive businessmodels (e.g., to more disease areas or more countries), which is five times as manymodels as the previous Index.

FIGURE 89 Few inclusive business models in
the Index serve specific vulnerable groups
that are highly represented within the BoP
According to data analysed by the Index, 26 of
the 51* inclusive business models in scope serve
individuals living at the BoP. Few models serve
specific vulnerable groups, such as women,children/youth and rural communities.

Base of the income pyramid

26

Women

12

Children/youth

11

Rural communities

10

People living with HIV

2People living with physical disabilities

2

Older adults

2

Indigenous populations

1

0

10

20

30

40

50

60

40

50

60

Number of inclusive business models

Nearly half of inclusive business models cover non-communicable diseases(NCDs)
Inclusive business models covering NCDs are prevalent, while models aiming toaddress health needs that disproportionately impact BoP populations, such as
neglected tropical diseases (NTDs), are lacking. Models should not be driven by
the potential to produce earnings, but by the potential to achieve positive patient
outcomes, particularly for low-income populations. This means that in addition
to NCDs like cancer or Alzheimer’s disease, companies should engage in inclusive
business models that address diseases that disproportionately impact low-income
populations, such as NTDs.

FIGURE 90 Nearly half of inclusive businessmodels cover non-communicable diseases
Caption: Almost half of the 51* inclusive businessmodels cover NCDs, followed by communicablediseases, maternal and neonatal healthconditions, and NTDs. Five models are not shownin the figure as the exact disease/condition was
not specified.

110* Inclusive business models can cover
more than one vulnerable group/diseasecategory. Therefore the sum of models
across all groups/categories exceeds 51.

Non-communicable diseases

25

Communicable diseases

17

Maternal and neonatal health conditions

9

Neglected tropical diseases

4

0

10

20

30

Number of inclusive business models

Access to Medicine Index 2022 ▶ Product Delivery

Inclusive business models are highly concentrated in sub-Saharan Africa
Inclusive business models assessed in the Index are highly concentrated in sub-Saharan Africa, particularly Kenya (23), Nigeria (14) and Uganda (13). Some models
were active in South Asia (particularly in India, with five models) as well as a few
countries in East Asia (Cambodia and Vietnam with four models and the Philippines
with five). Kenya, Uganda, Ghana and Nigeria had the highest number of models
launched during the period of analysis (four each), with Kenya and Nigeria having
most scale-ups within the analysis period (19 and 10, respectively).
These countries may have multiple inclusive business models active, as theypresent companies with factors which facilitate business development, such as government disease prioritisation, existing infrastructure, or non-governmental organisation (NGO) activity.

FIGURE 91 Most models are concentrated in Kenya, Nigeria and Uganda
There are 51* inclusive business models in scope of the 2022 Index.
Collectively, these models cover 85 (79%) of the 108 countries in scope.
However, most models are concentrated in a selection of countries in
sub-Saharan Africa.

Number of inclusive business models●0● 1 to 4● 5 to 8● 9 to 12● 13 to 16● 17 or more
● Countries not in scope

111* Inclusive business models active in morethan one country are represented morethan once in this map. Therefore, the sumof models across all countries exceeds 51.

Most models are active in Kenya(23), Nigeria (14) and Uganda (13)Access to Medicine Index 2022 ▶ Product Delivery

I NCLUSIVE BUSI N ESS M O D E LS

How are companies reaching
low-income markets using
new inclusive businessmodels?

Traditional business planning in high-income countries often includes sufficient
market data and resources that can be used to plan a business model. In LMICs,
piloting inclusive business models can be more challenging, as companies face barriers such as lack of market data, lack of government reimbursement, and lack ofinfrastructure. Companies must account for these barriers when piloting new inclusive business models in LMICs by taking time to develop and be adaptable.
Novo Nordisk, Pfizer and Sanofi launch new models
During the period of analysis, Novo Nordisk, Pfizer and Sanofi launched initiatives
that aim to address access constraints to products in the companies' portfolios.
These models have the potential to address access constraints at the BoP, however, limited evidence was shown of plans for outcome measurements that capturechange in affordability and availability of medicines.

Pfizer, An Accord for a Healthier WorldIn 2022, Pfizer launched its An Accord for a Healthier World which aims to provide all its patented medicines and vaccines at not-for-profit prices to 45 lower-income countries. Pfizer also reports that as new medicines and vaccines arelaunched, they will be added to the Accord Portfolio on a not-for-profit basis. A
variety of patent-protected medicines and vaccines are made available throughthe Accord that helps treat, prevent and manage a variety of diseases, such as
infectious diseases including COVID-19, pneumonia, and meningitis, certain cancers including advanced kidney cancer and types of leukaemia and breast cancer,
and both inflammatory and rare diseases. Pfizer is currently working with Accord
partners to identify mechanisms to reduce the length of time it takes for theseproducts to reach countries covered by the Accord. In five countries, including
Rwanda, Ghana, Uganda, Senegal and Malawi, Pfizer is working with healthcare
officials to identify areas where Accord partners can address factors like limited
diagnostic capacity, supply chain efficiency and healthcare worker education.

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Access to Medicine Index 2022 ▶ Product Delivery

Sanofi, Global Health Unit

Novo Nordisk, iCARE

In 2021, Sanofi launched its Global Health Unit, which will

Novo Nordisk is now expanding its strategies through acontinue to expand the company’s work with local gov-

comprehensive approach to access in LMICs. The iCARE

ernments, stakeholders, intergovernmental agencies andinitiative was launched in 2021 as a business-integrated

NGOs to increase access to its medicines. Sanofi plans formodel aimed at improving access to diabetes treatment inthis unit’s remit to cover 40 LMICs, seeking to improve

49 countries in sub-Saharan Africa, through four areas ofaccess to 30 medicines for both communicable andwork (Capacity, Affordability, Reach and Empowerment).

non-communicable diseases (NCDs), most of which are

The initiative aims to substantially increase the number

listed on the World Health Organization (WHO) Model Listof people with diabetes accessing insulin in sub-Saharanof Essential Medicines (EML). Through the Global Health

Africa (with the exception of South Africa) by 2025. iCARE

Unit, Sanofi has shared a commitment to expand access to

has been launched in seven pilot countries so far, Ethiopia,

analogue insulins, aiming to reach 300,000 insulin-depend-

Ghana, Côte d'Ivoire, Kenya, Nigeria, Sudan and Tanzania.

ent patients by 2030, which is in comparison to its 2021

The initiative targets challenges such as affordability

reach of 15,000 patients. Sanofi also aims for the unit to bebarriers impeding access to care for vulnerable patients,

self-financed by charging patients just enough to cover the

procurement and supply chains (including last-mile distri-cost of treatment. This will be implemented through thebution) barriers, mark-ups, inadequate forecasting, health-sale of products under a new brand (Impact®) at a lower

care practitioners’ capacity, knowledge gaps in diabetes

price. The unit also aims to strengthen health systems bymanagement, and patient education. Outcome measure-establishing an impact fund to support start-up companies

ments are conducted across the four work areas: capacityand other innovators involved in the development of sus-

(e.g. number of HCPs trained), affordability (e.g. number oftainable healthcare in the 40 LMICs within the unit’s remit.

patients receiving insulin through the programme), reach

Outcome measurements include the number of patients(e.g. number of new distributors onboarded in at least two

provided with Impact® brand medicines and the number ofcountries), and empowerment (e.g. number of patients

beneficiaries reached by programmes, for example patientsreached through the patient support programme).

diagnosed or healthcare practitioners (HCPs) trained.

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Access to Medicine Index 2022 ▶ Product Delivery

I NCLUSIVE BUSI N ESS M O D E LS

How are companies
measuring impact and scaling
inclusive business models?

Several companies have scaled up inclusive business models during the analysis
period, while taking some steps to measure impact on factors like availability andaffordability. While some companies take steps to measure both business performance and social value, this is not a common practice that companies take acrossall business models. Although there is no universally accepted impact measurement
framework for assessing the social and business value of inclusive business models,some companies demonstrate evidence that can be used to inform further discussion on effective impact measurements. A good outcome measurement for an
inclusive business model captures short and long-term patient reach and patient
outcomes in a way that identifies value to BoP populations.

AbbVie expands the Access to Care Program to more

Pfizer supports the scale-up of an inclusive clinic

facilities

Through the Pfizer Foundation’s Global Health Innovation

AbbVie’s Access to Care (ATC) Program, launched in 2002

Grants (GHIG) programme, the company supported thethrough Abbott and now through AbbVie, facilitates accessscale-up of Jacaranda Health. Jacaranda Health is an

to the company’s HIV medication in LMICs. Through ATC,

inclusive clinic that partners with governments to deploy

AbbVie also builds HIV treatment capacity, knowledge andaffordable and scalable solutions to decrease maternalclinical skills through peer-to-peer initiatives for healthcare

deaths and increase access to maternal health services

workers in fifteen African countries such as South Africa

through Universal Health Coverage (UHC). Jacaranda

and Zambia.

Health works in government hospitals, where the majority

Scale-up: AbbVie reports that it has expanded this initiativeof underserved mothers and babies in Kenya receive care.

to more facilities in countries where the programme was

Scale-up: To scale-up this initiative, the Pfizer Foundation

active during the analysis period.

supported the implementation of artificial intelligence

Outcomes: AbbVie reports that it measures both countries

detection and referral for pregnancy danger signs into aand patients served, including an additional breakdown ofdigital health platform and expanded pregnancy danger

children served. The company also measures population

sign detection.

health outcomes like percentage reduction in mortality,

Outcomes: To track trends and lessons learned in inclusivereflected by WHO findings. Related to the direct impact ofbusiness models for low-resource settings, Pfizer part-ATC, AbbVie measures the increase in numbers of patientsners with Innovations in Healthcare (IiH) hosted by Dukeable to afford care. The total number of HIV patients

University. This partner leads programme evaluation forserviced by the ATC program over the past five years

GHIG models like Jacaranda Health, providing guidance toincreased from 266 million in 2017 to 421 million in 2021.

individual grantees and identifying learnings from acrossthe entire cohort of grantees to help inform the Pfizer
Foundation's investment strategy. In 2022, Jacaranda
Health has reported several outcomes, including that 85%
of pregnant women flagged with a danger sign via the digital health platform now go to a hospital.

114

Access to Medicine Index 2022 ▶ Product Delivery

Novartis continues to scale up its long-running model

Novartis builds in outcome measurement as a core

The Novartis Healthy Family programmes, launched inelement of its model covering NCDs

2007, are social business models that build local and sus-

Novartis Access®, launched in 2015, offers a portfolio of

tainable healthcare capabilities for populations at the BoP

on- and off-patent medicines addressing key noncom-

through country-tailored programmes. This is the long-municable diseases (NCDs), including cardiovascular

est-running model since the Index began collecting datadiseases, type 2 diabetes, respiratory illnesses and breast

on inclusive business models in 2014. The programmes

cancer. The Novartis Access portfolio is offered as aare operational in India (Arogya Parivar), Kenya (Familia

basket to governments, NGOs and other institutional

Nawiri), Uganda (Familia Nawiri) and Vietnam (Kung Kong

customers in lower-income countries at a price of USD 1

Khoe). They address social issues that impact access to

per treatment, per month. To manage their chronic con-healthcare, such as education, infrastructure and distribu-

dition long-term and depending on public subsidy levels,

tion. The social activities are independent from commercial

patients in participating countries may either receive

operations but are financed through the sale of a selection

Novartis Access medicines free of charge or be able toof Novartis products.

purchase them at a low price. The model is offered to

Scale-up: Programmes within the four countries haveunderserved patient populations who are not covered

expanded. In India, for example, the programmes are

by national or private mechanisms in ten countries (e.g.

expanding into ophthalmology through a network of part-

Ethiopia, Kenya, Nigeria, Pakistan, Rwanda, Tanzania,

nerships including with Aravind Eye Care System, one of

Uganda, Venezuela, Vietnam and Mongolia.

the largest providers of eye care in the world. Since 2021,

Scale-up: Since 2020, the portfolio of products offered

the programme has reached additional areas in Vietnam,

has been expanded in Vietnam and Pakistan. Novartis has

including three provinces and three states. Novartis has

also signed an agreement with the Mongolian govern-also started community engagement discussions in Mexico

ment to launch Novartis Access© in the country. Novartis

to explore the feasibility of programme implementation.

reported that baseline assessments to inform country

Outcomes: According to the Novartis in Society Integrated

expansions were underway in both Laos and Cambodia.

Report 2021, since 2007, the combined outreach for all

Outcomes: Based on learnings from outcome measure-

projects across the four countries has delivered health edu-

ments of Novartis Healthy Family, the company worked

cation to more than 75 million people. Novartis reports on

to build monitoring and evaluation as a core element

several outputs in its 10-year report such as revenues gen-of Novartis Access®. Local teams who manage the pro-erated, country presence, and number of health education

gramme in each country define and measure predeter-

meetings. The report also outlines barriers the company

mined outcomes through local implementing partners.

faced in measuring outcomes, such as the inability to prac-

These KPIs (e.g., total patients reached versus patientstically and scientifically prove social impact. Novartis now

reached through access approaches) are tracked via local

reports that it measures outcomes, including the number

progress reports with updated and consolidated dataof patients filling prescriptions, at what prices, and howreported in the Novartis in Society reports.

many are returning regularly.
MSD supports the expansion of an inclusive business model to addressmaternal health
M-TIBA is a mobile platform launched by PharmAccess, Safaricom and CarePay,that allows people to save, borrow, and share money for healthcare at low costs.
Scale up: In Kenya and Tanzania, MSD is supporting the expansion of M-TIBA
to include maternal health services through MomCare, which is a new platformthat links patients, providers, and payers to improve the financing and delivery ofmaternity care. The digital platform helps families create ‘health wallets’ to savemobile money and pay for health services from affiliated providers. It also offers'bonuses' to providers who successfully deliver the full continuum of quality
maternity care to patients.
Outcomes: Through data collection, M-TIBA provides insights in healthcare
needs and costs. In 2021, partners reported that in Kenya, data from the first participating cohort to the ninth, showed that the percentage of ‘good’ patient journeys increased from 40% to 76%. Several other outcomes were reported, suchas utilisation of contraceptives and family planning counselling. As of late 2020,
over 20,000 women are connected via MomCare in Kenya and Tanzania.

115

Access to Medicine Index 2022 ▶ Product Delivery

Conclusions
Analysis of inclusive business models from companies in scope of the Index suggests that companies are scaling up existing models, but piloting relatively few.
While scale-ups can help broaden the patients reached with these models, it isimportant that companies tailor their models to specifically reach even the lowest
tiers of the income pyramid. When scaling up, attention should be paid to measuring the value to BoP populations. When rigorous measurements and transparent
reporting show that an inclusive business model is successful in improving accessto healthcare and allows modest profit for the company, further investments can bemade to scale up.
Based on the sample that was assessed by the Index, companies’ inclusive business models are highly concentrated in a few countries in sub-Saharan Africa. In
addition to engaging in inclusive business models in these countries, companies
have an opportunity to pilot new models that serve access needs of people in additional countries, even when existing infrastructure is yet to be established. Whenpiloting new models, companies should consider the unique health needs of the
populations they plan to serve, which may include targeting additional disease categories, such as NTDs or maternal health.
Three inclusive business models from Novo Nordisk, Pfizer and Sanofi werelaunched during the analysis period that show particular potential for improving
access to medicines for underserved populations living in LMICs. However, clear
steps are needed to measure and report patient reach, especially measuring thevalue brought to patients at the BoP and other vulnerable groups. More companies
can launch models like these, to improve access to their portfolios, and engage inmore financially sustainable ways of reaching underserved populations, where otherbusiness models may fall short.

R E FE R E N CES
1.	Business Call to Action United Nations
Global Compact. Implementing Inclusive
Business Models: How Businesses Can
Work with Low-Income Communities.;
2015. Accessed June 21, 2022. https://www.unglobalcompact.org/library/3161

116

2.	Hammond AL, Kramer William J.,
Katz RS, Tran JT, Walker C. The Next
4 Billion: Market Size and Business
Strategy at the Base of the Pyramid.;2007.

3.	United Nations Development
Programme. Creating Value for All:
Strategies for Doing Business with the
Poor.; 2008.

Access to Medicine Index 2022 ▶ Product Delivery

SU PPLY, QUALIT Y AN D MAN U FACTU RI NG

How do companies help
safeguard the supply andquality of their products?

The importance of strengthening supply chains to ensure access in LMICs
Supply chains in low-and middle-income countries (LMICs) are often very complex,

Supply chain

involving multiple stakeholders along the value chain from manufacturing to import,

A supply chain is a system of organ-

wholesale and retail, with several auxiliary roles involved at each level.1,2 In LMICs

isations, people, and activities thatchallenges in demand forecasting due to lack of data, lack of trained supply chain

support the movement of a productstaff and unexpected manufacturing disturbances (e.g., due to natural disasters

or service from supplier to customer

or contaminations) can impede the continuous supply of medicines. When supply

by facilitating the flow of material,

chains function poorly, communities are burdened with increased costs, circulation

information, and financial resources.

of substandard and falsified medicines and frequent stockouts.

The core functions of a supply chain
are carried out in three phases:

The impact and lessons of COVID-19

manufacturing, procurement, andRecent global crises, such as the COVID-19 pandemic, have brought the impact of

distribution.1,2

supply disruption on global health security to the fore. The 2021 Index highlighted
efforts made by companies in the wake of the pandemic to augment supply, prevent shortages, and ensure availability of essential medicines in LMICs. The Index
found that companies had taken steps to ensure continuous supply during the
pandemic, such as building cold chain capacity and moving buffer stocks closer toregions where they would be deployed. Although COVID-19 emphasised how crucial
continuous pharmaceutical supply chains are, momentum must not be lost.
It is important that lessons learned from the pandemic be harnessed tostrengthen supply chains so that they are better able to handle future disruptions.
Companies have a responsibility to strengthen their own supply chains to ensure
continuous supply of high-quality products, while paving the way for smoother supply of products outside their own portfolio.
What can companies do to build capacity for manufacturing safe and effective
medicines in LMICs?
Manufacturing is the first step in the pharmaceutical supply chain, making it a pivotal moment to ensure the supply of safe and effective medicines to LMICs. The
Index assesses what companies are doing to build capacity of third-party manufacturers to improve supply and prepare for future production needs in the LMICs in
scope.
The manufacturing capacity building initiatives assessed in the 2022 Index areconcentrated in India, China and Brazil. While continuing to build manufacturing
capacity in these countries can help with regional supply, more efforts are needed
to improve manufacturing capacity in regions, such as sub-Saharan Africa, that rely
heavily on imported pharmaceutical goods.

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Access to Medicine Index 2022 ▶ Product Delivery

FIGURE 92 Manufacturing capacity building is concentrated in India,
China and Brazil
India, China and Brazil are covered by 20, 13 and 12 of 55* initiatives,
respectively.

Number of initiatives● None● 1 to 4● 5 to 9● 10 to 14● 15 or more
● Countries not in scope

GO O D M A N U FAC T U R I N G PR AC T I CE

Company: Pfizer
Description: Starting in 2019, Pfizer External Supply Operating Unit hired dedicated teams of colleagues based in emerging markets, including in Egypt, towork proactively with local contract manufacturing organisation (CMO) partners
to improve compliance with quality, environment, health and safety (EHS) standards. The overall goal of this initiative is to ensure supply to patients in Egypt,
including for medicines that the government has mandated in-country manufacturing for. These teams provide oversight and support to Pfizer’s local partners
and are comprised of experts in operations, quality, supply chains, procurementand EHS. Pfizer measures outcomes (e.g., technical transfer timelines, numberof repeat quality audit findings), shares them with CMOs and works with themto continuously improve. For example, for CMOs in Egypt that produce antibiotics, Pfizer has evaluated the performance of the CMO with respect to theAnti-Microbial Resistance (AMR) Industry Alliance and responsible manufacturing framework. Currently Pfizer is assessing sourcing even more products from
CMOs in Egypt as well as other Africa Middle East territories.

FIGURE 93 How are companies engaging in
manufacturing capacity building?**
Almost all of the manufacturing capacity building
examples seen in the Index are technology
transfers. Fewer initiatives involve upskilling local

Technology transfer
10

Packaging

Manufacturing Practices (GMP). Even fewer than
20% of initiatives involve improving
Environmental, Health and Safety (EHS)
Standards or increasing packaging and/orlabelling capacity of third-party manufacturers.

118

19

Environment, Health and Safety

manufacturers to be able to achieve Good

*Initiatives that are active in more than
one country are counted more thanonce in this figure. Therefore, the total
number of initiatives shown in this map
exceeds 55.

42

Good Manufacturing Practices**Initiatives that cover more than one typeof activity are included more than once inthis figure. This means that the sum of all
initiatives exceeds 55.

5

0

10

20

30

40

50

60

Access to Medicine Index 2022 ▶ Product Delivery

Majority of companies involved in technology transfers to build manufacturing

Contract manufacturing

capacity in LMICs

organisations (CMOs)

Out of the 55 manufacturing capacity building initiatives analysed in this Index,

CMOs in the pharmaceutical industry

technology transfers are the most common form of manufacturing capacity build-are companies that work with phar-ing that companies are involved in, accounting for 42 initiatives. Technology trans-

maceutical companies on a contract

fers can shorten supply chains and improve regional availability of medicines, bybasis to perform drug manufactur-

localising production closer to where products will be distributed.

ing and/or development services

Pharmaceutical companies may initiate a technology transfer for several reasons.

from pre-formulation to commercial

Companies often outsource production to CMOs in LMICs to supply their respec-

development. By outsourcing pro-tive regions.

duction, pharmaceutical companies

Technology transfers can also be made in combination with exclusive or non-ex-

can increase manufacturing capac-

clusive voluntary licence agreements that can allow one or multiple local manufac-

ity and allow the company to focus

turers to enter the market, potentially lowering prices. Companies can also trans-

resources on drug discovery or

fer technology to manufacturers in LMICs where they have issued a non-assert

marketing.

declaration. Non-assert declarations are pledges by rights holders not to enforce
patents in certain territories or under certain conditions, allowing a generic version

Technology transfersof a patented medicine to be produced. Index data shows that less than a third ofTechnology transfer for drug manu-

companies’ technology transfers are part of licensing agreements or non-assert

facturing is the process of transfer-declarations.

ring documentation and professional

Gilead stands out due to its efforts to provide licensing partners with a technol-

expertise (e.g., know-how and asso-

ogy transfer of manufacturing processes for active pharmaceutical ingredients, asciated data) to another site capable

well as finished products for HIV, hepatitis C and more recently the COVID-19 anti-of reproducing the process. Most

viral medication remdesivir (Veklury®). Recently, AstraZeneca licensed its COVID-19

transfers take place over a period of

vaccine to multiple manufacturers in LMICs in combination with technology trans-

several years where ongoing support

fer packages.

and training is provided to the local
manufacturer. Often skills are built inareas that can be applied broadly to

FIGURE 94 Most technology transfers are not conducted in

the manufacturer beyond the prod-

combination with licensing agreements

uct being transferred, for example,

Most companies' technology transfer initiatives are carried out via

processes for ensuring GMP andcontracting agreements that do not include a licence to market the finishedsafety.

product. The remaining examples include exclusive licences, or non-exclusive
voluntary licences where multiple generic manufacturers can manufacture
the drug. One technology transfer is conducted in combination with a
non-assert declaration.*
Technology transfers with
non-assert declaration*
1

Technology
transfers to CMO(no licence)42
total techtransfers

Technology transfers with
exclusive voluntary licence

7
4Technology transfers with
non-exclusive voluntary licence30
Gilead provides its licensing partners forseveral of its HIV, Hepatitis C products(and now remdesivir) with a technology
transfer of manufacturing processes
that includes technology transfer for
active pharmaceutical ingredients, aswell as finished products. Licensees may
set their own pricing for finished products and may sell active pharmaceuticalingredients to other licensees.

119*Non-assert declarations are pledges byrights holders not to enforce patents incertain territories or under certain conditions, allowing a generic version of a patented medicine to be produced.

Access to Medicine Index 2022 ▶ Product Delivery

Transferring technology to enable local manufacturing can have multiple benefits,
from improving regional availability to lowering the cost of medicines to the patient.
However, there are some barriers to localisation that may deter companies fromextending their supplier base beyond a select few manufacturers with existing
expertise. For example, transferring technology to a manufacturer in a country lacking regulatory capacity for GMP inspection and enforcement could delay or prevent
project completion.
While these barriers may make localisation more difficult in some countries,
there are several LMICs, such as Nigeria, where governments are working to
improve the domestic pharmaceutical sector through mechanisms like policy intervention and investment. Companies can work with governments to localise production in order to continue to reach those markets.

C A SE S T U DY: SA N O FI

Responding to government calls for local manufacturing through capacity
building
Since 2015, Sanofi has been working with May & Baker Nigeria Plc. to produce
some of its products, including the antibiotic metronidazole (Flagyl®). May &Baker is one of the approximately 180 approved local manufacturers inspectedby the Nigerian Agency for Food and Drug Administration and Control (NAFDAC).
In Nigeria a new government regulation stipulates that as of 1 May 2019, a newly
registered imported product is given a maximum period of ten years (five years
of initial registration plus another five years of renewal registration) to migrate
to local production or be refused sales in Nigeria.3 This legislation requires local
manufacturers to meet the often strict Good Manufacturing Practices (GMP)
requirements required by originator companies to be able to manufacture. In
response to this new legislation, Sanofi proactively trained May & Baker onhygiene and on-site safety provisions. To be able to transfer technology for twoof its products, Sanofi also built capacity for reading and analysis of analyticalmeters, process validation, production of validation batches and protocols, aswell as reporting for pharmaceutical products. The insights gained by May &Baker through these trainings can be applied to all pharmaceutical products produced by the company.

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Access to Medicine Index 2022 ▶ Product Delivery

Most companies now demonstrate best practice on combatting substandard

WHO defines substandard products

and falsified products

as those that are authorised but

Pharmaceutical companies can help combat the issue of substandard and falsified

fail to meet its quality standards or

products by:specifications, and it defines falsified• Implementing policies or procedures for reporting substandard and falsified prod-

products as those that deliberately or

ucts to national regulatory authorities and/or World Health Organization (WHO)fraudulently mispresent their identity,

Rapid Alert, especially when local regulatory systems are weak or compromised;composition or source.

• Ensuring that reporting takes place in a timely manner (i.e., within ten workingdays) to minimise the harm to public health;• Establishing a policy or procedure that stipulates a faster reporting timeframe
when laboratory analysis is not required and visual inspection is sufficient to confirm falsification.

FIGURE 95 How many companies
demonstrate best practice on combatting

In the 2021 Index, only six companies demonstrated best practice by implementing

substandard and falsified products?

all three of these criteria: Astellas, AstraZeneca, Eisai, GSK, Novartis and Takeda.
In the 2022 Index, two more companies newly demonstrate best practice: Rocheand Johnson & Johnson. For Daiichi Sankyo, the situation differs among subsidiar-100%

ies regarding policies and procedures for reporting confirmed cases of substandard80%

and falsified medicines to health authorities, and with regard to timely reporting.

60%

Six other companies provide evidence of a policy that ensures timely reporting ofcases of substandard and falsified cases, although they do not provide evidence of40%

shortened timelines for reporting these cases that do not require laboratory anal-

20%

ysis for confirmation. These companies are Bayer, Boehringer Ingelheim, Bristol
Myers Squibb, Merck, Novo Nordisk and Sanofi.

0%

14

6

2021

12

8

2022

Companies demonstrating best practiceon combatting substandard and falsified
products

FIGURE 96 The majority of companies have a

FIGURE 97 Most companies commit to

FIGURE 98 Nine companies have a policy

policy for reporting substandard and falsified

reporting cases of substandard and falsified

that stipulates a faster reporting timeframe

products

products within ten days

when visual inspection is sufficient to confirm
falsification

Gilead and MSD do not provide
evidence of a policy or approach
1

2
6
20
companies

20companies

121

17 companies have apolicy for reportingcases of substandard
and falsified medicine
to relevant healthauthorities

20
companies

9

14

17
AbbVie takes
a case-by-caseapproach forreporting cases ofsubstandard andfalsified medicines

11

Timeline for reporting
substandard and falsified
cases to relevant healthauthorities not specified

Companies report
to relevant healthauthorities in lessthan 10 days

No timeline
distinction

Shortened timeframe forreporting visually confirmed
cases of substandard andfalsified to relevant healthauthorities

Access to Medicine Index 2022 ▶ Product Delivery

What steps can companies take to ensure continuous supply of medicines in
LMICs?
Beyond supporting manufacturers in LMICs to manufacture high-quality products,
companies also have a responsibility to ensure that medicines in their own portfolios reach the people who need them. Furthermore, companies’ ability to invest
resources into building resilient supply chains allows them to pave the way for the
supply of products outside of their portfolio through mechanisms like knowledge
sharing.
Communicating with stakeholders about issues impacting the supply chain
Collaboration with local manufacturers, distributors and logistics providers isnecessary in order to identify bottlenecks and improve capacity for appropriate
supply chain and manufacturing management. Below are some examples of how
companies are communicating and collaborating with stakeholders to mitigate
supply interruptions:• Dedicating local logistics teams from within the company to serve as a mediator
between the company’s central inventory management and local stakeholders(e.g., governments, purchasers, hospitals) to communicate demand and supply of
products;• Developing user-friendly portals to simplify communication between distributors
and suppliers;• Implementing clearly defined notification procedures for stockouts to communicate with local authorities;• Holding pre-emptive meetings with managers from local manufacturing sites andother stakeholders involved in supply to collaborate and plan early on for issues
that may impact supply; or• Holding regularly scheduled (e.g., monthly) meetings with governments to discuss in-country requirements and demand fluctuations.
Ensuring resilience in the Active Pharmaceutical Ingredient supply market
Supply chains come under threat when manufacturers rely on a small numberof Active Pharmaceutical Ingredient (API) suppliers. When the sole supplier ofthese ingredients is compromised (e.g., through regional conflict or contamination
issues), bottlenecks are created and supply of essential products is delayed. Even
relying on a diverse range of suppliers within one country may pose a threat to supply chain stability. Companies can deploy several strategies to mitigate the risk of
API shortages.

FIGURE 99 Most companies combine dual API sourcing and buffer
stocks to mitigate supply risks
The most reported approach to mitigating API supply risks was combining
multiple API suppliers with a buffer stock of API. MSD does not show
evidence of a strategy to mitigate API shortages.
Multiple API

In-house

API buffer

Number of

suppliers

APIs

stockscompanies

●

6

●

4

●
●
●

122

●

3

●

3

●

●

2

●

●

1

Takeda has teams that evaluate demand
development across the organisation andassess new API suppliers where needed
to ensure business continuity. Takeda also
holds appropriate levels of stock of API and
excipients at several manufacturing sites
within its supply chains, including when
there are unforeseen supply disruptionsat prior levels of internal or external
manufacturing.

Access to Medicine Index 2022 ▶ Product Delivery

The importance of keeping buffer stocks of finished products
Nineteen of the 20 companies have strategies for managing buffer stocks. In addition to managing buffer stocks of APIs, companies can also keep buffer stocks offinished products in local or regional distribution centres. By working with customers and other stakeholders to understand demand, companies can build in a safetymargin to ensure that medicines are available when demand surges. Keeping safety
stocks in different regions where they will be distributed can be more impactful for
ensuring continuous supply than holding safety stocks at company warehouses in
only a few corners of the world.
Examples of buffer stock policies and their use
Novartis

SanofiWith the introduction of a rapid response platform,

Sanofi’s inventory policy sets target levels for each sub-Novartis uses dynamic safety stocks which are flexible andsidiary of the company. Inventory levels are set for active

can be increased or decreased depending on the need (e.g.,

ingredients, semi-finished, and finished products, for all

for products with low shelf-life, new products with unsta-

products the company supplies. Decisions about inventory

ble demand). Novartis used this buffer stock strategy withlevels are based on factors like where the product is con-sacubitril/valsartan (EntrestoTM) in the Philippines. When it

sidered vital, the complexity of the manufacturing processlaunched in the Philippines in 2016, Novartis operated withand the number of sources for the raw materials used to

an increased safety stock of eight weeks.

manufacture the final product.

There were three reasons why Novartis decided tohave a higher safety stock: (1) Unstable demand – there
was uncertainty in how healthcare practitioners andpatients would react to the medicine. Novartis anticipateda potential increase in demand, because of feedback fromother country organisations which launched ahead of thePhilippines; (2) Shelf-life is 36 months; (3) Minimum order
quantity coverage was up to three months.

Strengthening supply chains in LMICs
Pharmaceutical companies can act as facilitators in guiding supply chain reform to
improve supply of products to those who need them in LMICs. AstraZeneca, GSK,Johnson & Johnson, Novartis and Takeda stand out in terms of sharing the maximum number of capacity building initiatives possible, all meeting all Good PracticeStandards (see Appendix IV). These initiatives have clearly-defined and measurable goals/objectives, aim for sustainability or have long-term aims, and measureoutcomes.
In working with distributors to supply their own products, pharmaceutical companies can build capacity for further supply of other products through training on
various supply topics (e.g., documentation, cold-chain transports, Good Distribution
Practices, demand forecasting). Besides distributors, companies can also build
capacity of other stakeholders, such as university students interested in working in
the field of supply chain management, or supply chain stakeholders in a country’s
Ministry of Health. Furthermore, pharmaceutical companies can build capacity indetecting substandard and falsified medicines. This can include preventing circulation of falsified versions of their own medicines, as well as sensitising stakeholders
about detection of these dangerous alternatives circulating the market. Companies
can also support last-mile delivery, and overall data collection and management toimprove supply.

123

Access to Medicine Index 2022 ▶ Product Delivery

FIGURE 100 Few initiatives focus on detecting substandard andfalsified medicines outside a company’s own supply chain
Out of the 58* supply chain capacity building initiatives assessed, about half
include distributor support. The least common form of capacity building
seen is supporting the detection of substandard and falsified medicines inthe supply chain.
Distributor support

28

Supply chain competency

30

18

Data-sharing

40

15

Last-mile

43

10

Substandard and falsified medicines

48

5

0

53

10

20

30

40

50

60

70

B U I LD I N G C A PACI T Y O F SU PPLI ERS TO SU PPO RT

SU PPLY CH A I N CO M PE T EN CY B U I LD I N G

R ESPO NSI B LE SU PPLY CH A I N PR AC T I CES

Initiative: People Who Deliver Strategic Training Executive

Initiative: Pharmaceutical Supply Chain Initiative (PSCI)Programme (STEP 2.0)

Companies involved: AbbVie, AstraZeneca, Bayer,

Companies involved: GSK, Johnson & Johnson, MSD

Boehringer Ingelheim, Bristol Myers Squibb, Eisai, Gilead,

Description: The STEP 2.0 programme was launched in

GSK, Johnson & Johnson, Eli Lilly, Merck, MSD, Novartis,

2016 by People Who Deliver, a global coalition hosted

Novo Nordisk, Pfizer, Roche, Sanofi, Takeda

by the UN Children's Fund (UNICEF), and includes Gavi,

Description: The PSCI is a non-profit business membership

the Vaccine Alliance, the Global Fund to Fight AIDS,

organisation formed in 2006 that aims to bring together

Tuberculosis and Malaria (the Global Fund), United States

members to define, establish and promote responsible

Agency for International Development (USAID) and the

supply chain practices, human rights, environmental sus-

International Federation of Pharmaceutical Wholesalers

tainability and responsible business. The PCSI created a set(IFPW). It is as an evolution of the STEP programme,of principles for supply practices related to ethics, labour,

launched in 2016, to address a lack of supply chain skills

health & safety, environment and management systems. All

and a need for improved leadership skills at the middle

PSCI members are expected to support and incorporate

management, senior leader/executive level, whether it is

the principles into their key supplier documents and agree-

at a central medical store or Head of Procurement at thements. In addition to the principles, the PSCI also includes

Ministry of Health. STEP 2.0 provides healthcare person-a supplier collaborative auditing programme and builds

nel with the non-technical leadership training, skills, andcapacity of suppliers involved. Several companies reportcompetencies that are engrained in private sector supply

adopting PSCI principles into their supply chain frame-

chain managers so that immunisation managers can effec-

works. AbbVie, for example, reports that through PSCI-

tively fulfil their roles. The initiative is focused on helping

based sustainability audits, the percentage of suppliers thatto solve critical gaps in supply chain competencies related

have a programme and goals in place to reduce waste gen-to project and people management, problem solving

eration increased from 77% in 2019 to 86% in 2021.

skills, communication skills and professional development.
Pharmaceutical company partners such as GSK, Johnson& Johnson and MSD have supported this initiative throughdelivering leadership classes to supply chain leaders, utilising their supply chain expertise.

124*Initiatives may include more than one
activity and in this case are counted morethan once in this figure. Therefore, thesum of initiatives exceeds 58.

Access to Medicine Index 2022 ▶ Product Delivery

SU BS TA N DA R D A N D FA L SI FI ED M ED I CI N ESDATA SH A R I N G

Initiative: Fight the Fakes

Initiative: Strengthening Pandemic Response andCompanies involved: All companies

Preparedness and Health Supply Chains with the World

Description: : At the end of 2020, a new multi-stakeholder

Food Programme (WFP)

non-profit association was launched that aims to raise

Company involved: Takeda

awareness about the dangers of substandard and falsified

Description: Takeda’s five-year project with the WFP aims

medicines. GSK has been involved with this initiative since

to develop an approach to strengthening supply chainsits inception but formally became a member in 2021. Fight

that deal with inventory inefficiencies, reactive supply

the Fakes Alliance and its members work collectively tochain processes and low data quality and availability. A key

tackle the growing global burden of substandard and falsi-

component of this project is to help the WFP update its

fied medicines to safeguard public health and strengthen

information systems to be able to efficiently organise thehealth systems. GSK supports the Fight the Fakes aware-transport and storage for its partners for essential healthness campaigns by training customs, law enforcement

supplies throughout the world and track near real-time all

and regulatory authorities and wholesalers, giving them

the way to the last-mile recipients. The newly developed

the tools to detect suspected falsified medicines. GSKControl Tower information system consists of three inter-

reported that the training reached over 2,000 individuals

faces tailored to the needs of the different stakeholders

in China, Colombia, El Salvador, Guatemala, Mexico, Peru,

involved in the execution of partner supply requests. The

Philippines, and Vietnam, as well as other countries outside

initiative includes several other digital tools that were

the scope of the Index.

developed to gather data via crowd-sourced updates (e.g.,
population density, location of health facilities) or facilitate

D IS T R I B U TO R SU PPO RT/ DATA SH A R I N G

planning and Key Performance Indicator measurement of

Initiative: Neglected tropical disease (NTD) Supply Chain

health partners.

Forum
Companies involved: Eisai, GSK, Johnson & Johnson,
Merck, MSD, Pfizer
Description: The NTD Supply Chain Forum is a public–private partnership that was established in 2012 to serve as
the platform for engagement for NTD supply chain experts
from WHO, pharmaceutical companies, non-governmentalorganisations, donor organisations, ministries of health, andlogistics providers. Its mission is to support endemic countries in the control/elimination of NTDs by strengthening
supply chains to improve access to drugs and diagnostics.

125Access to Medicine Index 2022 ▶ Product Delivery

Conclusions
Companies are taking steps to ensure continuous supply of their products in LMICs
through actions such as holding buffer stocks of finished products, diversifying API
sourcing, and communicating with stakeholders in the supply chain about potential
supply risks. While companies generally perform well in taking steps to ensure continuous supply of their own products, their performance varies in terms of building
capacity for manufacturing and supply through third parties in LMICs.
Since the COVID-19 pandemic, companies have increased their engagement in
manufacturing capacity building, specifically through technology transfer agreements for COVID-19 vaccines and medicines. However, efforts are still focused on
emerging markets (i.e., India, China, Brazil). The pandemic has shown that relying
on a select few manufacturers leaves countries vulnerable to vaccine nationalism,
export bans, and shortages. This extends beyond COVID-19 vaccines, to other lifesaving medicines and diagnostics for other diseases. Companies should seek out
partnerships with manufacturers in LMICs to localise production, improve regional
availability and build manufacturing capacity for current and future supply of products in LMICs.
While building manufacturing capacity in LMICs is important for long-term global
health security, this alone is not enough to ensure a rapid and effective response to
future public health emergencies. Distribution through effective supply chains is a
crucial step in ensuring continuous supply, and companies have a role to play in thisarea. Pharmaceutical companies’ expertise in supply chain practices can be instrumental outside of the supply of their own products, however, a quarter of companies perform below average in terms of building supply chain capacity. Companies
can work in partnerships to build capacity of third-party supply chain stakeholders,in areas like data sharing, last mile support, and mitigating the circulation of substandard and falsified medicines.

R E FE R E N CE S
1.	Yadav P. Health Product Supply
Chains in Developing Countries:
Diagnosis of the Root Causes ofUnderperformance and an Agenda
for Reform. Health Syst Reform.
2015;1(2):142-154. doi:10.4161/23288
604.2014.968005

126

2.	Pisa M, McCurdy D, Chalkidou K, etal. Improving Global Health Supply
Chains through Traceability.; 2019.
Accessed October 31, 2022. https://www.cgdev.org/sites/default/
files/improving-global-health-supply-chains-through-traceability.pdf

3.	Fatokun O. Fostering local productionof essential medicines in Nigeria. Bull
World Health Organ. 2020;98(7):507.
doi:10.2471/BLT.19.249508

Best Practices

Best Practices are shared to accelerate adoption of similar
practices by other companies, and to help raise the overalllevel of standard practice to achieve greater access to medicine. Each Best Practice has been shown to meet at least
some of the following criteria:• Proven effectiveness• Sustainability• Replicability• Alignment with external standards / stakeholder
expectations
The 2022 Access to Medicine Index has identified 19 Best
Practices across the Technical Areas analysed. There arethree Best Practices in Governance of Access, six in Research& Development, and ten in Product Delivery. Some of these
focus on a single company, while other Best Practices draw
on examples from several companies.

127

Access to Medicine Index 2022 ▶ Best Practices
GOVERNANCE OF ACCESS – GOVERNANCE & STRATEGY

Six companies promote and reward the effective delivery of accessinitiatives at top levels
A S T R A ZEN EC A , GSK , J O H NSO N & J O H NSO N , N OVA RT IS ,PFIZER , TA KEDA

Location: Global
Focus: n/a
Action: Incentivising top-level managers with financial andnon-financial rewards to achieve access targets and objectives, establishing senior-level responsibility
Aim: To reinforce governance of access through incentive
structures
When responsibility for access strategies lies directly with a

30,000 staff, including senior leaders.

company’s board of directors, this helps to ensure top-level

Novartis continues to perform well in this area throughaccountability for access, prioritisation of goals and keeping

embedding its Access Principles (APs) into governance struc-targets on track. GSK, Novartis, Pfizer and Takeda remaintures. Its five-year roadmap for ESG strategy and activities

leaders in this area, as in the previous Index, and they areincludes key priorities to accelerate AP commitments. A per-now joined by AstraZeneca and Johnson & Johnson. All six

formance management process applied worldwide and withcompanies maintain access as a pillar of their business oper-

short- and long-term incentives helps to foster a high-per-ations, make board-level committees responsible for accessformance culture. Targets align with ESG strategic priorities

strategies and deploy financial and non-financial short- andincluding access, and mid- to long-term targets include

long-term incentives, for the CEO, relevant senior executives,

implementing access strategies for all new medicines, tiered

and in-country and regional management. The companies also

pricing for launches in pharmaceuticals and oncology busi-

disclose how access aligns with overall strategy.

ness units, and reduction of the time lag between launches in

GSK announced in 2021 that of its six new Environmental,
Social, and Governance (ESG) focal areas, two will be access/high- and lower-income countries.
AstraZeneca’s Access to Healthcare strategy sets goals for

global health and health security. As part of the assessment

equitable access, affordability and pricing and health system

for achieving operational business objectives, GSK uses

resilience, and uses financial and non-financial rewards toarea-specific metrics to measure success in delivery for all

incentivise the CEO, some senior executives and in-country/

executive directors. GSK plans to increase accountability

regional managers to achieve these goals.

through a leadership bonus plan that considers the achieve-

Johnson & Johnson’s overarching business strategy

ment of strategic/operational business objectives per area.

includes an access-to-medicine strategy embedded in its

Takeda has developed a corporate philosophy dashboard

global public health (GPH) unit. Access and GPH are strategic

to outline access KPIs for its Executive Team. For seniorpriorities and executive committee members (including theexecutives and in-country managers in two units (growth andCEO) are evaluated for performance on these. Its Health for

emerging markets), it uses financial and non-financial incen-

Humanity Goals 2025 provide KPIs with outcomes rewarded

tives to promote access strategies. It also reports that it has

via short- and long-term incentives for senior management.

increased the weighting for access-related incentives for sen-

The company also incentivises leaders to achieve access goals

ior managers and country managers from five to ten percent

through award programmes, continued learning, rotationaland has formed an Access Excellence Committee to monitor

development programmes, secondments, employee engage-and evaluate access planning and metrics in accordance withment and empowerment programmes and volunteering

Takeda’s Access Framework.

opportunities.

Pfizer continues to commit to holding leadership account-128

able for societal and environmental impact. Having exam-

More companies need incentives linked to accessined how best to link compensation with ESG performance,

Some companies do not yet incentivise access to medicine

Pfizer’s compensation committee adopted the ESG scorecard,or offer incentives to only a subset of staff. Increasingly,

which took effect in 2022. The company says this will help

the industry standard is to incentivise all top-level manag-

determine funding for its annual short-term incentive planers to perform for the long-term with access in mind. The

and strengthen its commitment to ESG initiatives. Globally,

Index looks for companies to link incentives more closely to

implementation of the scorecard will cover approximately

access-related metrics.

Access to Medicine Index 2022 ▶ Best Practices
GOVERNANCE OF ACCESS – GOVERNANCE & STRATEGYTo quantify the outcomes of their access programmes, twocompanies use partnerships to measure impact and shareknowledge of best practice
G I LE A D A N D TA KEDA

Location: Low- and middle-income countries
Action: Establishing partnerships to support monitoring andevaluation of access activities
Aim: To determine whether access programmes are successful and identify best practices

Access programmes funded by the private sector are increas-

to determine “what works”. In 2019, it began working with

ing in number and scope. Even so, research shows that out-

Innovations in Healthcare (IiH), a non-profit founded by Duke

comes are not always evaluated effectively. When activities

Medicine, McKinsey & Company and the World Economiclack proper monitoring and evaluation, it can be difficult toForum, to develop its Access to Health Impact framework.

demonstrate if they made an impact or were successful. As

This framework, launched in 2021 and recognised by thecompanies work to improve access to medicine, it is impor-Index, can be used to independently measure health systemtant to ensure activities remain effective. Reliable measurescontexts, therapeutic areas and patient experiences.

are especially needed in low- and middle-income countries

Takeda has now made its associated guidebook and data

where most access programmes operate, and outcomes maycollection template available for public use. These enable thelack certainty.

design, measuring and evaluation of progress and outcomes

Several companies have partnerships to help them meas-

for global health programmes sponsored by the private sec-

ure outcomes for access programmes. Gilead and Takeda go

tor. The framework provides metrics to support live adapta-

further with partnerships that are increasing their abilities

tions for real-time developments, with the goal of ensuring

to share knowledge and improve best practice globally. Bothaccess programmes have the intended impact and can opti-

companies aim to evaluate access programmes objectively,

mise and maximise resources. Takeda aims to implementwith a focus on impact and quality of outcomes. For exam-

the framework across health sectors, and in collaborationple, this could include evaluating the impact training has onwith IiH is using the methodology and framework to evaluate

a community, as opposed to quantity and output of activities

outcomes for its flagship Takeda Blueprint for Innovative(i.e., the total number of people trained).

Healthcare Access, in Meru county, Kenya.

Gilead asked Boston University (BU) to evaluate its access

Sharing best practice through collaborations

programme for tenofovir disoproxil fumarate (Viread®), withFor companies, there may be challenges in extracting dataa view of expanding this to other treatments. Within the lat-from access programmes to check whether interventions are

est period of the Index analysis, BU’s report highlighted bene-

working. Partnerships established by Gilead and Takeda show

fits and areas for improvement, finding that voluntary licens-that collaboration can enable more efficient collection of data

ing had resulted in “the steepest increases in availability ofand be used to evaluate future efforts, even generating tools

medicines to patients in need”.1 Gilead has since expanded its

with wider application. Partnerships can also help to ensurevoluntary licensing programme to include other HIV therapies

that evaluative work contributes to sharing best practice. The

and hepatitis C treatments. Following publication of the BU’s

Index looks for companies to engage with relevant and local

report, in 2021-2022 two sets of Gilead employees (from its

stakeholders, including universities, to consider local needs

Global Patient Solutions unit and cross-functional partners)

and improve access to medicine.

attended training sessions by BU researchers in monitoringand evaluation for access activities. Through this partnership,
Gilead is identifying best practices and finding ways to incorporate them into ongoing partnership activities.
Takeda leads in its recognition that while more companies
are funding access programmes, many are finding it difficult
1 Wirtz V J, Ray M, Rockers P, Laing R. Evaluation of the Gilead Access Program. 2020.

129

Access to Medicine Index 2022 ▶ Best Practices
GOVERNANCE OF ACCESS – GOVERNANCE & STRATEGY

Three companies have changed their business models to tackle
access barriers and reach more people with their products
GSK , PFIZER A N D SA N O FI

Location: Global
Action: Creating new models to offer pipeline and portfolio
products in low- and middle-income countries (LMICs) ataffordable prices
Aim: To increase the availability and affordability of medicinesand vaccines among poorer populations

Several companies have access strategies that cover sometargeting priority neglected diseases and infectious diseases

or all products and portfolios. However, the 2022 Index finds

in lower-income countries. GSK has since announced a 10-yearthat many countries do not benefit from these strategies, withinvestment of GBP 1 billion to accelerate R&D in infectious dis-

low-income countries consistently overlooked. Three com-eases that disproportionately affect lower-income countries.

panies lead in evolving strategies to cover a broad range of

Separately ViiV Healthcare, which is majority-owned by GSK,

treatments in LMICs, helping to ensure patients have access tocreated a global health and access forum to focus on govern-

essential and life-saving medicines at affordable prices.

ance for access-related discussions across its portfolio.

Of Sanofi’s four strategic pillars, two (Affordable Access andPfizer announced An Accord for a Healthier World in May

Vulnerable Communities) prioritise access. In April 2021 Sanofi

2022. The initiative aims to create sustainable, equitable

unveiled its new strategy with the creation of Sanofi Global

access to high-quality healthcare for up to 1.2 billion people.

Health (GHU), a non-profit unit dedicated to increasing access

Pfizer commits to providing all 23 of its patent-protected

to essential medicines in the poorest countries. Throughmedicines and vaccines (and future products) to 45 low- and

GHU, the Impact® brand was launched, which is a new brandlower-middle-income countries on a not-for-profit basis, toof standard-of-care medicines for non-profit distribution totreat and prevent diseases such as COVID-19, pneumonia,

at-risk populations. Impact®, which includes insulin and gliben-

meningitis, cancer and inflammatory and rare diseases. Fiveclamide amongst others, will allow Sanofi to distribute 30 ofcountries (Ghana, Malawi, Rwanda, Senegal and Uganda)

its medicines to 40 lower-income countries, addressing condi-

quickly joined the Accord, and Rwanda received its first ship-tions including diabetes, cancer, malaria, tuberculosis and car-ment of 1,500 treatment courses in August 2022.

diovascular disease. GHU has also established a global health

Pfizer commits to fostering collaborations to address fac-

impact fund to support start-up companies and innovators totors that limit access, including diagnosis, education and infra-

deliver scalable, sustainable health solutions in underserved

structure. For example, Pfizer and Rwanda’s Ministry of Healthregions. The aim is to provide access to a broad portfolio ofare providing healthcare workers with professional education

medicines, covering a range of therapeutic areas, in manyand training. Pfizer is also exploring partnerships to support

countries while also strengthening local health systems andRwandan medical specialists and diagnostic enhancements,

funding local support programmes and businesses.

and to establish a telemedicine consultation platform to connect healthcare professionals in Rwanda with global experts.

GSK announced in June 2021 that it wanted to positively

130

impact more than 2.5 billion lives over the next ten years,

Increasing access through a widened scopeincluding 1.3 billion people in LMICs. Having spun off its

People at the base of the income pyramid are frequently

consumer healthcare business, ‘New GSK’ covers infectious

overlooked for access to medicine. Sometimes companies

diseases, HIV, oncology and immunology, aims to lead infocus on only a narrow range of countries (e.g., upper-middle

Environmental, Social, and Governance (ESG) and focuses on

income countries) and/or products (e.g., those targeting com-

six areas including pricing/access and global health.

municable diseases). Companies can address this by widening

A dedicated global health group, established in August

their scope while increasing specificity, considering how to2021, now reports to the company’s chief global health officer.

help the world’s most vulnerable populations by examining all

This measures success in health impacts, such as patient

relevant means to make essential medicines more available

reach and progression in developing medicines and vaccines

and affordable.

Access to Medicine Index 2022 ▶ Best Practices
RESEARCH & DEVELOPMENT – ACCESS PLANNING

Bayer’s systematic planning policy helps it develop quality accessplans to make products available swiftly and widely  
BAY ER

Location: Low- and middle-income countries
Focus: R&D pipeline projects for communicable andnon-communicable diseases (NCDs)
Action: Implementing a systematic policy to develop accessplans and having access plans in place that include many
countries in scope of the Index
Aim: To make all successful products available soon after
launchPharmaceutical companies need to plan ahead to ensure

For example, for finerenone (Kerendia®), developed forthat new products, once launched, are quickly accessible andpatients with chronic kidney disease associated with type 2

affordable for people in low- and middle-income countries

diabetes, it has a comprehensive plan across 29 countries(LMICs).

in scope (including low-income countries) and a strategy togain regulatory approval in a wide range of countries. It has

Bayer introduced a new systematic access planning policy

multiple innovative measures and a clear objective to increasein 2021. It now commits to develop access plans for all its

access by considering affordability for patients.

pipeline candidates (both in-house and collaborative) andFor vericiguat (Verquvo®), developed with MSD to treat

aims to register new products in LMICs within 12 months ofpatients with heart failure, Bayer has an access plan covering

first global launch. Bayer’s structured access planning process

24 countries in scope including several low-income countries.

begins during Phase I of clinical trials, and specific accessThis also considers innovative pricing strategies to ensure

plans are created during Phase II. The new policy also aims toaffordability.

address barriers to access and opportunities for inclusion of
LMICs in access planning during the R&D stage.

As the industry shifts toward systematic access planning

access plans in place for all late-stage R&D projects. However,during R&D, more companies are mainstreaming and inte-

Bayer leads in its geographic scope, applying its process to a

grating access planning in their pipelines. Bayer demonstrates

wide number of countries in scope of the Index and seeking

best practice through planning for accelerated access in ato register candidates in a large number of LMICs, rather

large number of countries in scope and leading in access plan-

than focus on a small cohort of emerging markets. For thening for NCDs.

late-stage candidates analysed, Bayer had eight access plansthat included, on average, 26 countries in scope of the Index(compared to the industry average of six countries). Of these,
63% include at least one low-income country (far above theindustry average of 15%).
Bayer performs well in access planning for both communicable and non-communicable diseases (NCDs), providing
evidence of a tailored approach for each R&D project. In general, for all companies, access plans for R&D projects targeting
communicable diseases are more comprehensive than thosefor NCDs. This is because R&D projects for communicable diseases are often donor-funded and created in partnership withaccess-oriented organisations to facilitate widespread access.
Bayer leads in access planning for late-stage R&D pipeline
products for NCDs, demonstrating best practice not just in
the quality of plans overall, but for the breadth of countries inwhich it plans to register products – a necessary first step foraccess.

131

Next steps

The 2022 Index has identified six companies that now haveAccess to Medicine Index 2022 ▶ Best Practices
RESEARCH & DEVELOPMENT – REGULATORY APPROVALS

Four companies lead in securing regulatory approvals for
medicines in their R&D pipelines to treat diseases that
disproportionately affect people in LMICs
BAY ER GSK , J O H NSO N & J O H NSO N , SA N O FI

Location: n/a
Focus: Neglected tropical diseases (NTDs) and other infectious diseases
Action: Securing regulatory approval for medicines at the endof the R&D pipeline to treat diseases that disproportionately
affect people in LMICs
Aim: To improve access to effective treatment for NTDs andother infectious diseases
Often, there is little financial incentive for companies totafenoquine (Krintafel/Kozenis), which was first approved indevelop products for NTDs and other infectious diseases,

adults in 2018. In March 2022, in partnership with Medicines

which have a disproportionate burden in LMICs. While thefor Malaria Venture, GSK secured marketing approval from2022 Index finds an overall decrease in R&D activity focused

the Therapeutic Goods Administration (TGA) for a novel, 50

on such diseases, some companies are continuing to invest

mg dispersible tablet that facilitates administration in chil-R&D resources in targeting neglected diseases, leading todren, it also submitted it to Brazil’s regulatory authority inpositive R&D outcomes. The 2022 Index has identified four

November 2021 and plans further regulatory submissions incompanies (Bayer, GSK, Johnson & Johnson and Sanofi) thatmalaria-endemic countries.

have secured approval for six important treatments shownin clinical trials to be safe and effective. Each new productJohnson & Johnson gained approval for its two-shot Ebola

received approval from a stringent regulatory authority, andvaccine regimen (Zabdeno® and Mvabea®) from the European

addresses a gap identified as priority areas for R&D. Each

Medicines Agency (EMA) in 2020. Its access plan includes

product is covered by a multi-faceted access plan.

WHO prequalification, strengthening of health systems andcapacity building initiatives through its vaccination monitoring

Bayer gained Food Drug and Administration approval for

platform Vxnaid™, and product donations. This approval rep-

paediatric nifurtimox (Lampit®), for Chagas disease in chil-resents significant progress in efforts to prevent the spreaddren, in August 2020. Nifurtimox is currently registered forof Ebola.

adults and children in several Latin American countries, andthe company is working to expand registration to additional

Sanofi’s fexinadozole, which treats T.b. gambiense humanendemic high disease-burden countries. Bayer’s Fludora

African trypanosomiasis (sleeping sickness), secured FDA

Co-Max (a space-spray vector control product, effective forapproval in July 2021. The company, which partners with

combatting Aedes mosquito-borne viruses such as dengue,

WHO and the Drugs for Neglected Diseases initiative, plans

Zika and Chikungunya) was prequalified by the World Healthto submit the product for WHO prequalification and to work

Organization (WHO) in October 2020. Bayer launched it thewith WHO to manage administration through a donation

following month and has received regulatory approvals inprogramme. It will also apply to the EMA for an extension ofCôte d’Ivoire, Vietnam and Mexico. It has also been filed forindications to treat a variation of the disease (T.b. rhodiense)

registration in India, Indonesia, Iraq, the Philippines and Brazil.

in endemic countries in sub-Saharan Africa.

GSK (through ViiV Healthcare) gained FDA approval in June

Further R&D investment needed to close gaps

2020 for its paediatric label extension and formulation of

In securing regulatory approval for products that are needed,

dolutegravir (Tivicay PD), used to treat HIV/AIDS. This wasthese four companies can be credited for their achievements

supported by a robust access plan that included use of anand for exemplifying action and investment. R&D remains aequitable pricing strategy, non-exclusive royalty-free volun-

top priority for the creation of effective treatments for manytary licensing, a partnership with The International Maternaldiseases, such as leishmaniasis and lymphatic filariasis, andPediatric Adolescent AIDS Clinical Trials (IMPAACT) Network,

new formulations and/or vaccines (such as microneedle

WHO prequalification and WHO Collaborative Procedure forpatches for measles and rubella). More companies can now

Accelerated Registration.

act to address these R&D needs.

GSK has also developed a new paediatric formulation for132

Access to Medicine Index 2022 ▶ Best Practices
RESEARCH & DEVELOPMENT – CAPACITY BUILDING

By validating conditions for flexible storage, Novo Nordisk aims to
reduce the burden of diabetes management and increase access toinsulin products
N OVO N O R D ISK

Location: More than 50 low- and middle-income countries
Focus: Diabetes
Action: Re-evaluating the thermal stability of human insulin
products and gaining regulatory approval to revise guidanceand create safe conditions for flexible storage
Aim: To reduce the burden of diabetes management and theneed for continuous cold storage

Diabetes is a growing problem worldwide, but especially inalso initiated engagements with humanitarian actors tolow- and middle-income countries (LMICs) where aroundsupport future use on the ground. In September 2022, insu-

three-quarters of the 527 million adults with diabetes live.

lin human (rDNA) (Actrapid®) and isophane human insulin

As a result, access to insulin is an increasingly urgent global(rDNA) (Insulatard®) became the first human insulins tohealth priority. Current estimates show insulin is needed by

be prequalified by the World Health Organization (WHO).

more than 72 million people, yet only about half of thoseAccording to WHO, the storage guideline update will greatly

who depend on the life-saving treatment have access to it.

facilitate the use of products where access to refrigeration

Novo Nordisk demonstrates best practice with a proactive

is limited. Novo Nordisk is also supporting WHO’s Global

approach to increasing access to reliable insulin products.

Diabetes Compact by addressing thermostability as a barrier
to access.

Addressing thermostability as a barrier to access

They could, for example, look at how adaptive R&D might

kept cool from the moment of manufacture until the productremove barriers for the storage and administration of theirenters use. Insulin can lose effectiveness when exposed to

products.

high temperatures, so regulatory guidance requires unopened
products to be stored in a refrigerator (at 2–8°C). Wheninfrastructure for refrigerated storage or supply chain refrigeration is unavailable or unaffordable, strict storage conditions restrict access to insulin for people with diabetes. Thisis particularly the case in LMICs, and in situations of humanitarian emergency and/or environments with challenging temperature conditions.
In 2021, a joint study from Médecins Sans Frontières
and the University of Geneva suggested such insulins
could be stored safely without refrigeration for up to fourweeks. To meet the requests of these humanitarian actors,
Novo Nordisk reassessed the thermal stability of its shortand intermediate-acting products insulin human (rDNA)(Actrapid®) and isophane human insulin (rDNA) (Insulatard®),both of which have been authorised in the EU since 2002
and are widely used in LMICs. Novo Nordisk used its data
to seek a label extension and obtain a positive opinion fromthe European Medicines Agency. It has since updated storage guidance, which now states that its insulins can now be
stored in environments of up to 30°C without refrigeration
for four weeks before opening.
National submissions by Novo Nordisk to revise storage
guidance in more than 50 LMICs are ongoing. The company

133

Where Novo Nordisk leads, other companies can follow.

Standard guidance is that human insulin products must beAccess to Medicine Index 2022 ▶ Best Practices
RESEARCH & DEVELOPMENT – ACCESS PLANNING

Six companies stand out in access planning for late-stage R&D
projects, with two companies leading
A S T ELL A S , BO EH R I N G ER I N G ELH EI M , J O H NSO N & J O H NSO N ,M ERCK , N OVA RT IS , TA KEDA

Location: Low- and middle-income countries (LMICs)
Focus: Access planning during the R&D stage
Action: Planning for access for every single late-stage R&D
project in scope
Aim: To create access plans for all late-stage pipeline candidates (from Phase II onwards) to ensure new products are
made swiftly available swiftly in LMICs
Companies need to plan for access during R&D to ensure

licensing, patent waivers, equitable pricing, sufficiency of sup-products, once launched, are made available in LMICs. Accessply, WHO prequalification, product donations, access throughplans help to identify and address barriers to ensure compa-

clinical trials and expanded access programmes.

nies can make products available without delay. By disclosing evidence of access planning, companies increase theirNovartis also excels in the quality of its access plans and,accountability by allowing the Index to track commitments toespecially, in creating comprehensive plans early in clinicalregister products and reach patients.

development. It implements plans systematically and gets thePreviously, no company had access plans for all late-stage

process underway for all innovative drug projects by Phase II.

projects. In 2022, six companies have reached the milestone

In addition, individual access plans include many componentsof having access plans for all R&D late-stage projects inspecific to a project, for example equitable pricing strategies

scope.

that are tailored to different markets and plans to use local
partnerships to strengthen health systems.

Astellas, Boehringer Ingelheim, Johnson & Johnson, Merck,
Novartis and Takeda now demonstrate best practice by

Action needed to increase the quality and depth of access

implementing access planning for all late-stage R&D pro-plans

jects from Phase II of clinical trials, including planning for

Many companies have developed detailed access plans foraccess to the product in at least one country in scope of the

R&D projects targeting infectious diseases such as tubercu-

Index. Other companies, including GSK and Sanofi are not far

losis, malaria and HIV, in partnership with access-oriented

behind, with plans for most R&D projects.

organisations such as the Drugs for Neglected Diseases initia-

A first step in access planning is the commitment to reg-tive or Medicines for Malaria Venture. By comparison, projects

istering products in LMICs to ensure they can be made avail-targeting NCDs, lacking such support are less likely to be cov-

able. Companies must also consider other factors, including

ered by comprehensive access plans. Yet, as the Index’s anal-

ensuring products have sustainable supply chains and areysis of the companies’ R&D efforts shows, projects targeting

affordable. Takeda and Novartis currently lead in the quality

NCDs – especially cancers – dominate the pipeline.

of their access plans.

To ensure these products reach the people who need themin LMICs, companies can look to increase the quality and

Takeda, which has a relatively small pipeline compared to the

expand the geographic reach of access plans for R&D candi-

other companies in scope, was recognised in the 2021 Index

dates targeting NCDs. Furthermore, while innovative cancer

for a strong project-specific access plan for its dengue vac-

treatments may require high levels of health practitioner

cine, including a global strategy for filing for registration and aexpertise for administration, companies can address with

global distribution network. Since then, Takeda has strength-

health systems strengthening and capacity building initiatives.

ened this access plan as the project has progressed throughthe pipeline.

134

All companies can also make improvements in the geographic scope, quality and depth of their access plans. On

Takeda takes a structured approach that considers all

average, access plans cover just six of the 108 countries inelements as early as pre-Phase II. For late-stage candidates,

scope, and most companies focus on registering products inincluding for non-communicable diseases (NCDs) such ascountries where they conduct clinical trials, usually a small

epilepsy and cancer, it takes a systematic approach by con-cohort of emerging markets such as in Brazil, China, India,

sidering multiple factors: registration, non-exclusive voluntary

Mexico, Thailand and Colombia.

Access to Medicine Index 2022 ▶ Best Practices
RESEARCH & DEVELOPMENT – CAPACITY BUILDINGGSK and Novartis build R&D capacity to map the human genome
across Africa and improve treatments via GRADIENT
GSK , N OVA RT IS

Aim: For local researchers to build knowledge and R&D

Location: Burkina Faso, Mali, South Africa

capacity, to publish and present on scientific forums and to

Focus: Malaria, tuberculosis

develop a database that will be publicly available

Action: Building R&D capacity by supporting local scientists
in different African regions through fellowships and grants to
support independent research, including funding for the studyof genetic diversity and impacts on response to therapeutic
products

As few pharmacogenomic data have been collected fromunderstanding of medicine efficacy and toxicity in African

people living in Africa, those used to develop medicines comeregions. Annotated genetic variants, for example, could

mostly from outside the continent. Genomics differ bothinform ongoing and future research on malaria and tuber-

between and within continents, so this may affect the efficacy

culosis, and show how genetic factors affect responses toof individuals’ response to treatment – and thus, possibly,

treatment. Researchers and institutions will initiate and leadalso for major diseases with a high burden in African coun-research, owning data from studies but ensuring its availabil-tries, such as malaria and tuberculosis. More genomic data

ity to the public via a database.

is needed to improve the process of drug development and

GSK and Novartis oversee the initiative via a joint steering

improve our understanding of efficacy and tolerability of cur-committee. Their partner, the South African Medical Researchrent treatments.

Council, joins them on an administrative steering committee.
Both committees meet regularly, dividing roles, strategic

Africa Genomic Research Approach for Diversity anddecision-making and consultation. Other partners include

Optimising Therapeutics (GRADIENT)

local universities and public research institutions, and scien-

GSK and Novartis address this need through GRADIENT,

tific reviewers (both local and international experts) who will

an initiative established in 2018 as a consortium to support

provide input to ensure quality. GRADIENT will also help build

high-quality scientific research that investigates links inscientific infrastructure and publish its outcomes.

genetic diversity across different regions in Africa. Threefunding mechanisms are used to support local scientists inPaving the way for tailored treatments in low- and middle-

different African regions to help build R&D capacity: fellow-

income countries (LMICs)

ships in academic institutions to collect and analyse data on

Clearly, genetics have an impact on how medicines work indeterminants of drug response; support for hypothesis-driven

individuals. By funding the creation of an open dataset toresearch focused on understanding genetic regional variation

highlight how continental differences may influence thera-in drug response; and a seed fund for projects to explore new

peutic outcomes, GSK and Novartis make a valuable step toresearch goals arising from the first two. GSK and Novartis

increase understanding. The ambitions and possible impacts

have jointly committed GBP 2.8 million to fund this over fiveof GRADIENT stand out: it sets long-term goals to obtain ayears, and actively support its projects.

dataset which has the potential for widespread benefit. Filling
this gap could help many people in LMICs affected by malaria

Opportunities to further research into malaria andand tuberculosis, and if expanded to include other diseases

tuberculosis

the project could help many more.

In 2021, GRADIENT asked African researchers to submit

knowledge to build capacity in LMICs to follow suit. Training,ing malaria and tuberculosis. It will give priority to researcheducating and clinical trials in LMICs remain important forthat aims to collect data from under-represented regions inaccess, but initiatives such as GRADIENT (and its creation

Africa and improve the scientific robustness of inconsistentof new datasets) may pave the way for tailored treatments,

data. Proposals from Burkina Faso, Mali and South Africa

increase positive impacts in low-resource settings, and help

were chosen, and researchers and institutions are now being

open new markets.

funded to build knowledge, publish/present on scientificfora and develop a public genomic dataset to further the135

The Index encourages companies with resources andresearch proposals on the relevance of diversity when treat-Access to Medicine Index 2022 ▶ Best Practices
RESEARCH & DEVELOPMENT – CAPACITY BUILDING

Takeda is supporting researchers in LMICs to build local R&D
capacity for clinical trials and adapt treatments to meet on-theground needs
TA KEDA

Location: India, Kenya, Nigeria, Vietnam
Focus: Expansion of R&D capacity
Action: Supporting local researchers in low- and middle-income countries (LMICs) in a variety of ways to build R&D
capacity, including for clinical trials
Aim: To address local health concerns and increase capacity
by empowering and supporting local researchers to adapt andrepurpose existing treatments and technologies
In many LMICs, there is a significant need to expand capac-

metal poisoning) to treat bites. Previously tested only in white

ity for clinical research, but researchers often struggle toEuropean men, doses were assessed in 64 Kenyan volunteers

get funding to advance their ideas. At the same time, thosewith a goal to develop a ‘snakebite pill’.

familiar with local health needs may see ways to repurpose

Three further trials were funded in 2021, including in India

therapeutic products that are already available. Building R&D

for chronic pancreatitis, and in Nigeria for both triple negative

capacity through this initiative can offer the potential to makebreast cancer and paediatric chronic ear infections. In 2022,

big impacts while reducing reliance on new R&D and expen-

ReGRoW has opened a new round of submissions. Its partner

sive, hard-to-obtain medicines.

research institutions will measure outcomes, and CWR willreport on outcomes for patients, clinical adoption of repur-

Takeda demonstrates best practice with ReGRoW

posed therapies, data presented or published in top scientific(Repurposing Grants for the Rest of the World), whichjournals, securing of follow-on funding and the planning, start

provides scientists and clinicians with grants of up to USD

or completion of follow-on clinical trials.

50,000 dollars to investigate repurposing approved thera-with local needs in LMICs, trains local researchers and funds

expand funding for clinical research in LMICs, address local

equipment. It also addresses gaps in clinical trial capacity

health concerns and lower development costs through use

and education/training and uses quantitative and qualitativeof therapies known to be safe and effective. Founded in 2018assessments by multiple parties. Takeda has earmarked addi-

and now part of Takeda’s global health strategy, the initiative

tional funding to support capacity building and patient careis governed and funded by its Centre for Health Equity andbeyond the existing programme and to allow local partners toPatient Affairs and run in partnership with the NGO Cures

retain talent and capacity.

Within Reach (CWR) and local research institutions.

With its drive to repurpose existing therapies, ReGRoW

CWR selects research proposals through a two-stage

is both innovative and sustainable. Other companies should

review process supported by ReGRoW’s science advisory

look to invest in similar initiatives. When researchers in LMICs

board. Takeda then reviews and approves these, and bothare facilitated to identify needs locally and supported toparties make agreements with local stakeholders, ensuring

take ownership of their research and capacity, there is great

local needs are addressed. Takeda R&D employees support

potential to improve access to medicine.

project teams with research training, virtual monthly meetings, mentoring, emails and phone calls. On-site visits are carried out twice a year.
ReGrow’s global reachIn 2020, ReGRoW funded three trials selected from morethan 30 submissions from 12 LMICs across four continents.
Trials focused on a rare paediatric liver disease in Vietnam,
tuberculosis in Nigeria and snakebite envenoming in Kenya.
A project team for the latter built on work from the UK’s
Liverpool School of Tropical Medicine to run a Phase I clinical
trial,1 which looked at repurposing unithiol (used for heavy

136

ReGRoW demonstrates good practice, as it aligns activities

pies to treat diseases in their communities. ReGRoW aims to

1 L.-O. Albulescu et al. Preclinical validation of a repurposed metal chelator as an early-intervention therapeutic for hemotoxic snakebite. Science Translational Medicine. Vol. 12,
May 6, 2020. doi: 10.1126/scitranslmed.aay8314.

Access to Medicine Index 2022 ▶ Best Practices
PRODUCT DELIVERY – EQUITABLE ACCESS STRATEGIES

Bayer applies a variety of methods to reach different population
segments and provide access
BAY ER

Focus: Reproductive health

Location: Afghanistan, Bangladesh, Benin, Bolivia, Brazil,

Action: Implementing a multilayer holistic approach which

Chad, Colombia, Cote d’Ivoire, Cambodia, China, Democratic

uses different strategies to improve access to contraceptives

Republic of Congo, Dominican Republic, Egypt, Ethiopia,

in public and private markets

Ghana, Guatemala, Kenya, Madagascar, Nigeria, Paraguay,

Aim: To expand access to contraception in low- and mid-

Rwanda, Senegal, Tanzania, Togo, Uganda, Venezuela, Zambia,

dle-income countries (LMICs)

Zimbabwe

An estimated 200 million women in LMICs who want to avoid

systems in 39 countries, including 20 countries in scope ofpregnancy currently are not using safe and effective means of

the Index.

contraception.1 Being able to prevent or control the timing ofBayer also uses supranational agreements. Working withconception and pregnancy can help women and girls to deter-

the international procurers United Nations Population Fundmine their own path in life, strengthen women’s role in soci-(UNFPA) and the US Agency for International Development

ety, and create many positive impacts across communities.

(USAID), it negotiates supply agreements to expand access tocontraceptives at affordable prices in eligible countries, con-

Bayer demonstrates best practice through its holistic

sidering a country’s ability to pay. In 2021, both UNFPA andapproach. The company aims to provide modern contracep-

USAID added IUD levonorgestrel-releasing Mirena® to theirtion to 100 million women in LMICs by 2030 by expanding

commodity procurement catalogues, which will make it avail-access to its levonorgestrel-releasing intrauterine devices

able for widespread procurement through regular commodity

intrauterine devices (Mirena® and LNG-IUS). Intrauterine

procurement channels.3

devices (IUDs) are an effective, long acting and reversible con-

In some countries, IUD levonorgestrel-releasing Mirena®

traceptive option, that is well suited to family planning pro-is available only in the private market. To expand sustain-

grammes in LMICs. Clinical trials have found IUDs to be moreable access, Bayer supplies IUD levonorgestrel-releasing

effective at preventing pregnancy than pills, patches or rings,

Mirena® to branches of the social marketing organisationand hormonal IUDs such as Bayer’s last for up to five years

DKT International to countries in scope, including Benin, Côteand are cost-effective.2 IUDs also require less maintenanced’Ivoire, Ethiopia, Senegal, Tanzania, Togo and Uganda, using

than contraceptive pills or injections and depend less heavily

a price point that reflects local socioeconomic status andon supply chains, although they do require insertion fromhealth system maturity. The company is also involved in joint

trained healthcare practitioners.

capacity building initiatives.

Bayer leads with its strategy to meet demand using vari-

Bayer’s commitment to reach 100 million women depends

ous means for access in different contexts, even in the sameon a long-term supportive supply security strategy to increase

country. Since 2021, Bayer has developed a multi-faceted

manufacturing. It belongs to the Hormonal IUD Access Groupstrategy that covers both public and private markets and(HIAG) and, based on its estimates for demand, plans totailors this according to country circumstance using dona-

expand manufacturing from a sole site in Finland to a secondtion programmes, supranational agreements, engagementin Costa Rica, where it will invest USD 200 million.

with local authorities and procurement via domestic tenders.
Bayer also supports capacity building activities through train-

Next steps

ing initiatives such as virtual training modules, demonstration

To ensure women in more LMICs have access to affordable

products and counselling material.

contraception, Bayer could commit to extending the same

Bayer works with the non-profit Population Council

price offered to supranational procurers to non-eligible coun-through a joint initiative, International Contraceptive Accesstries or implement pricing strategies that consider relevant(ICA) foundation, to provide its levonorgestrel-releasing

payers' ability to pay such as country-tiered pricing. Other

intrauterine system LNG IUS via a wide-ranging donation pro-companies could follow Bayer’s example by developing strat-

gramme. LNG IUS is similar to Mirena®, but is exclusively pro-egies that are more layered and holistic, combining and apply-

duced for the programme and is only distributed in resource-

ing different modes to reach more people.

poor settings. By 2022, ICA had donated 184,000 LNG IUS

137

1 United Nations Population Fund. (2021). Family Planning. https://www.unfpa.org/
family-planning#readmore-expand
2 Ali, M., Folz, R. & Farron, M. Expanding choice and access in contraception: an assessment of intrauterine contraception policies in low and middle-income countries. BMC
Public Health 19,

3 Population Council. (2021). Mirena® added to UNFPA and USAID Product Catalogs.
https://www.popcouncil.org/news/lng-ius-added-to-unfa-and-usaid-product-catalogs

Access to Medicine Index 2022 ▶ Best Practices
PRODUCT DELIVERY – EQUITABLE ACCESS STRATEGIES

Novartis is maximising patient reach by tailoring its strategies
according to the ability of countries and individuals to pay for
medicine
N OVA RT IS

Aim: To maximise patient reach across the income pyramid in

Location: Egypt, Ethiopia, India, Mexico, the Philippines,

countries

Rwanda, South Africa, Thailand, Uganda
Focus: Cardiovascular disease, cancer and migraine
Action: Creating access strategies including the consideration of relevant payers’ ability to pay, and product and market
characteristics

Equitable pricing strategies play a significant part in increas-

as Kryxana (available for 20% less than the private price foring access to medicine. To maximise the availability of key

hospitals on a buy-out basis) and offers financial assistance via

products to those with less income, companies are expected

the Access to Innovative Care Foundation by covering up toto apply access strategies to these products across LMICs.

25% of co-payment costs for patients paying out of pocket or

However, when setting pricing strategies, companies do not

via insurance. This solution bridges a gap while Novartis works

always integrate into their pricing approach a payer's ability towith public health bodies and practitioners to get ribociclib

pay for a product.

included in standard treatment guidelines. In India, it applies
an innovative strategy to supply this via an EMB for the pri-

Novartis uses additional layers of strategy to increase patientvate market, reducing price and capping payment for patientsreach. To address affordability in low- and middle-income

during treatment. Novartis will launch ribociclib (Kryxana) incountries, the company has launched emerging market

low-income African countries including Ethiopia, Rwanda andbrands (EMBs), which are generally priced significantly lower

Uganda in 2023, and is working closely on this with ministries

than the original brands. Novartis continues to lead by tailor-of health and the Clinton Health Access Initiative (CHAI).

ing its strategies for several products in countries in different

For erenumab (Aimovig®), which treats migraine, the com-income classifications (upper-middle income, lower-middle

pany uses a strategy in Thailand that keeps pricing flat acrossincome and low-income). Here, the Index highlights the com-doses and provides certain doses to patients free of charge

pany's approach for three products.

in the period of analysis, patient reach increased from 213

Regarding Novartis’s heart failure treatment sacubitril/

to 260. In Egypt, where patient reach has grown from 164

valsartan (Entresto®), all three examples submitted by theto 272, Novartis uses equitable pricing and offers the same

company for analysis in the 2022 Index are high-quality

price in private and public markets. It also has a support pro-strategies that address affordability. In Mexico, working withgramme for patients paying out of pocket and with low-pre-the main national institutional payers, including the largest

mium insurance, and a micro-finance scheme. In Ethiopia, theLatin American health payer IMSS, it has expanded access

EMB brand Pasurta will soon be launched at a price lower

to hospitals with different specialities and types of services,

than the global originator. Novartis expects 50 patients will

and increased patient reach more than a hundredfold. In

receive treatment in 2022, with reach growing to around 500

India’s self-pay private market, it launched an EMB and hasby 2026.

partnered with two local companies (Lupin and Cipla) to138

expand access and launch co-marketed local EMBs (Azmarda

Next steps

and Cidmus). India now has three brands of the same prod-

Novartis stands out for its creative approach to maximising

uct at three prices: Novartis’s Vymada sacubitril/valsar-

patient reach. As well as applying tiered pricing strategies fortan (Entresto®) EMB has reached 250,000 patients while

several products, it uses EMBs and other non-pricing initia-

Azmarda and Cidmus have (between them) been used totives such as payment caps, microfinance and patient assis-

reach an additional 92,000 people. In Ethiopia, the company

tance programmes. It could now tailor these programmes

has applied additional flexibility on price for its EMB (Uperio)

further and consider using questionnaires and assessment

to patients paying out-of-pocket in the private sector.

by third-party vendors to assess affordability. Novartis could

Novartis has strong access strategies for ribociclib

also provide more data on how it updates information about(Kisqali®), a medicine to treat breast cancer. For example, it

all relevant payers’ ability to pay and could disclose how it will

demonstrates best practice in South Africa, using a novel com-

keep prices affordable in a climate of rising inflation and pro-bination to increase access: it has launched an EMB branded

duction costs.

Access to Medicine Index 2022 ▶ Best Practices
PRODUCT DELIVERY – EQUITABLE ACCESS STRATEGIES

Three companies stand out with strong equitable access strategies
across different country income classifications
GSK (T H RO U G H V I I V H E A LT H C A R E), PFIZER , TA KEDA

Location: • Colombia, India, Uganda (GSK)• Mexico, India, Uganda (Pfizer)• Philippines, Rwanda, Thailand (Takeda)
Focus: Products indicated for cancer and HIV/AIDS
Action: Applying access strategies that consider ability to pay
across upper-middle, lower-middle and low-income countries
Aim: To reach additional patients across the income pyramid
and in differing economies

Establishing equitable pricing strategies is only one part ofcontinuing with strategies including tiered discounts in thethe equation in product delivery. Strategies need to be moreprivate market, based on co-payment. In India (a lower-mid-

comprehensive, both for companies and patients, to ensure

dle income country), in 2021 Pfizer introduced a differential

maximum reach across the income pyramid. GSK, Pfizer andapproach in a new patient assistance programme, using ques-

Takeda demonstrate best practice by addressing accessibility

tionnaires and independent evaluation to assess affordability.

and affordability in their access strategies, showing evidence

In Uganda (a low-income country), its compassionate use pro-of tailoring their access strategies to meet the needs of coun-gramme allows it to make the product available to patientstries in different income brackets.

before the product has entered the market.

GSK (via its majority-owned business specialising in HIV

Takeda was recognised in the 2021 Index for its accessproducts, ViiV Healthcare), demonstrates a comprehensive

strategy for its non-Hodgkin's lymphoma treatment brentuxi-

approach to expanding access to its HIV product abacavir,

mab vedotin (Adcetris®) in Thailand (an upper-middle income

dolutegravir and lamivudine (ALD) (Triumeq®). Its accesscountry). Takeda provides evidence of growth in patient reachstrategies include tailored equitable pricing strategies, vol-and uses a third-party organisation to provide data that ena-

untary licensing accompanied by technology transfers, andbles it to tailor prices for individual patients. In the Philippines

health systems strengthening initiatives.

(a lower-middle income country), where it maintains a patient

In Colombia (an upper-middle income country) and India

assistance programme (PAP), it also works with the gov-

(a lower-middle income country), ViiV Healthcare commits

ernment to secure funding for medicines and support for

to applying a flexible pricing approach that factors in grossdiagnostic testing. In addition, it has collaborated with thenational income and public health need. Prices are then refined

Philippine Cancer Society to provide financial aid to patients.

based on local affordability, domestic healthcare system

In Rwanda (a low-income country), once the product is regis-

funding, purchasing patterns and volumes, and accessibility

tered, it plans to use inter-country pricing, a PAP and a third-

for those living with HIV/AIDS. In Uganda (a low-income coun-party organisation for evaluative data. Here, it demonstratestry), ViiV Healthcare provides extensive support for healthbest practice by providing patient forecasts to help anticipate

systems strengthening activities through its Positive Action

demand for the product.

programme. ViiV Healthcare uses voluntary licences, enabling139

generic medicine manufacturers to develop, manufacture

Next steps

and market dolutegravir and dolutegravir-based fixed dose

The best comprehensive access strategies reflect the needs

combinations, including abacavir, dolutegravir and lamivudineof a particular country for a specific product. Differentiation(ALD). For example, ViiV Healthcare does not currently supply

is key to increasing affordability, and companies should seek

ALD in India, but partners with two India-based generic med-

to understand all barriers to access and in each case allow

icine manufacturers (Mylan Laboratories Ltd and Aurobindo

tailoring for affordability. GSK stands out in this area. Pfizer

Pharma) that hold voluntary licences to expedite development

and Takeda deserve credit for increasing patient reach sinceof more affordable paediatric dispersible formulations of ALD.

the last Index. Other companies have yet to follow suit, andPfizer uses high-quality access strategies to expand

all three that lead still have room to improve. All companies

access to palbociclib (Ibrance®), used to treat breast cancer.

should look to apply comprehensive high-quality strategies

In Mexico (an upper-middle income country), compared towith consistency, increasing patient reach and widening boththe previous Index, Pfizer has increased patient reach bytheir geographic and product scope.

Access to Medicine Index 2022 ▶ Best Practices
PRODUCT DELIVERY – LICENSING

Novartis sets a precedent by agreeing non-exclusive voluntary
licence for a cancer compound
N OVA RT IS

Location: Low- and middle-income countries (LMICs)
Focus: Nilotinib (Tasigna®)
Action: Signing a non-exclusive voluntary licensing agreement
for a cancer medicine with Medicines Patent Pool (MPP)
Aim: To facilitate production by generic medicine manufacturers of nilotinib

There is a clear need for better access to cancer treatment. It

Novartis sets a precedent in licensing an innovative,

is estimated that by 2030 approximately three quarters of all

on-patent cancer medicine via MPP. The primary patent for

deaths caused by cancer will occur in LMICs.1 This is despite

nilotinib expires in 2023 but secondary patents continue. The

the fact that many cancers are now treatable, provided local

medicine is also the first non-communicable disease (NCD)

healthcare systems can swiftly identify disease and effective

product to be licenced in this way. The company deserves

treatment is made available and affordable.

credit for its achievement and efforts, facilitated by MPP,

While national governments are mainly responsible forestablishing cancer care systems, pharmaceutical companies

to create new pathways for the licensing of medicines for
non-communicable diseases.

can do more to increase access to quality-assured medicines
in LMICs, such as those for cancer. One way is to choose to

Extending NEVLs to reach more people

licence them through MPP, which works with patent hold-Novartis’ voluntary licence for nilotinib is a promising step.

ers and sublicensees (manufacturers) to facilitate voluntary

The Index looks for companies to extend this approach tolicensing on public health-oriented terms and conditions, forother products – or the compounds required to make thoseexample by widening the geographic scope of licences andproducts – especially those for cancer and other NCDs whichmaking provision for access clauses.

are currently unaffordable to many people living in LMICs.

Engaging with MPP helps companies be more transparent
and can also improve the quality of licensing agreements. In
assessing the quality of a voluntary licence, the Index considers multiple factors such as whether a licence is agreed
before approval for launch or later in the product’s lifecycle,
or whether it includes restrictions, such as restrictions on
manufacturers making active pharmaceutical ingredients orcompounds, and on supply in countries where patents are
infringed. Companies are also assessed on whether they
provide the option for technology transfer – an important element for licensing, but not yet sufficiently common.
Novartis demonstrates best practice by licensing its cancer compound nilotinib via MPP as part of the Access to
Oncology Medicines (ATOM) Coalition. In May 2022, it was
the first company to join ATOM, a global initiative to improveaccess to essential cancer medicines in low- and lower-middle
income countries and increase diagnosis and care capacity. Through this, it is granting MPP a “freedom to operate
licence” for sublicensing to generic medicine manufacturers
to make and distribute its medicine in designated countries,
currently the licence covers 44 countries, 43 of which are inscope of the Index. It will reinvest royalties into ATOM.

140

1 Pramesh C, Badwe R, Bhoo-Pathy N, et al. Priorities for cancer research in low- and middle-income countries: a global perspective, Nat Med; 2022. https://doi.org/10.1038/
s41591-022-01738-x

Access to Medicine Index 2022 ▶ Best Practices
PRODUCT DELIVERY – PRODUCT ACCESS AND RESPONSIBLE MANUFACTURING (TECH TRANSFERS)

Three companies build local capacity through voluntary licences
and technology transfers to manufacturers
B R IS TO L M Y ERS SQ U I B B , G I LE A D, GSK (T H RO U G H V I I V

Aim: To build manufacturing capacity and increase affordabil-

H E A LT H C A R E)

ity of products, improving access to treatments for infectious

Location: Brazil, China, Egypt, India, Pakistan, South Africa

diseases in LMICs

Focus: Infectious diseases (HIV, hepatitis C, COVID-19)
Action: Voluntarily licensing products to manufacturers inlow- and middle-income countries (LMICs) in combination
with a technology transfer

Increasingly, companies are widening access to their products

Medium- and long-term outcomes include the inclusion ofthrough non-exclusive voluntary licensing (NEVL). NEVLs

TDF in treatment guidelines and data on the procurement of

have the potential to improve access, as if there is uptake ofgeneric TDF.1 A 2019 study2 evaluated how NEVLs for hepa-

the licence from generic medicine manufacturers, supply andtitis C medicines from Gilead and from Bristol Myers Squibb

affordability can increase as generic versions enter the market.

affected access to treatment. Importantly, this looked atWhen companies choose to engage in technology trans-

patient reach, and found that NEVLs were associated with afers with licensees, they can improve and speed up regionalsignificant increase in numbers of people accessing treatment.

availability of medicines, while building manufacturing capac-

Bristol Myers Squibb also works with MPP and both it andity that can be used for the future production of medicines.

ViiV Healthcare combine NEVLs with technology transfers

Bristol Myers Squibb, Gilead and GSK (via its majority-owned

and partner to build capacity. In 2011 Bristol Myers Squibb

business specialising in HIV products, ViiV Healthcare) standbegan the technology transfer for its product atazanavirout for voluntarily licensing some of their products, while also

(Reyataz®), transferring manufacture and distribution to

supporting local manufacturers to build technical capacity

Farmanguinhos, a technical-scientific unit of Fundação

through technology transfers.

Oswaldo Cruz (Fiocruz) and to Nortec Quimica, a local manufacturer of active pharmaceutical ingredients.

Expanding accessibility through NEVLs

ViiV Healthcare has four NEVLs in place with the MPP

Gilead leads in this area, working since 2006 to voluntarilyfor HIV products. Beginning in May 2017, GSK (through ViiV

license almost all its on-patent products in scope of the Index,

Healthcare) has partnered with the Clinton Health Accessincluding carrying out extensive technology transfers to

Initiative to establish two public-private partnerships for sup-generic manufacturers. The company has NEVLs covering its

ply and use in LMICs. Each partnership works with two generichepatitis C and HIV treatments, which include ten products.

manufacturers with paediatric voluntary licences to expedite

For example, its voluntary licence for its HIV medicine teno-

the development and market entry of more affordable genericfovir disoproxil fumarate (TDF) includes technology transfer

child-friendly formulations of dolutegravir and the fixed-dose

agreements with generic manufacturers.

combination product abacavir/lamivudine/dolutegravir.

In 2020, the company agreed to a new NEVL for remdesivir(Veklury®), a medication for COVID-19. It now licenses or sub-More local partnerships needed to drive progress

licenses medicines to more than 25 third-party manufacturers

When considering whether and how to license their products

in LMICs. Gilead reports that it initiates technology transfer

to manufacturers in LMICs, companies should consider theahead of regulatory approval and provides ongoing assistancelocal and regional availability of their medicines as well as

to support product safety and stability after the technology

future manufacturing capacity.

transfer is complete. It also partners with Medicines Patent

Currently, only a few examples of NEVLs in the Index are

Pool (MPP) for licences for TDF, tenofovir alafenamide, bicte-

supported by technology transfer packages, and most activ-

gravir, cobicistat, elvitegravir and emtricitabine, all of which

ity centres on COVID-19, hepatitis and HIV/AIDS. The Index

are compounds for products targeting HIV.

encourages companies to consider how to combine these

Outcomes are measured by external stakeholders includ-measures and apply the approach across multiple therapeuticing governments, generic manufacturers, the World Healthareas. Companies also need to be fully compliant and trans-

Organization (WHO), donors, clinicians, medical provid-

parent about their commitments and are encouraged to part-ers and patients. Reported short-term outcomes of thener with other stakeholders.

approach include quality assurance and market registration.
141

1 Wirtz V J, Ray M, Rockers P, Laing R. Evaluation of the Gilead Access Program; 2020.
https://sites.bu.edu/accessanalytics/files/2021/07/BU-Gilead-Report.pdf

2 Simmons B, Cooke G, Miraldo M. Effect of voluntary licences for hepatitis C medicines
on access to treatment: a difference-in-differences analysis. Lancet Glob Health. 2019.
https://pubmed.ncbi.nlm.nih.gov/31362914/

Access to Medicine Index 2022 ▶ Best Practices
PRODUCT DELIVERY – PRODUCT ACCESS

AstraZeneca facilitates the affordable supply of its medicines andvaccines by publishing information about its patents
A S T R A ZEN EC A

Location: Global
Focus: All products in the company’s portfolio
Action: Annually disclosing the patent status for all 32 products in its portfolio, including biological products
Aim: To promote access to medicine by being transparent
about its intellectual property information and where it
enforces patents

The transparent management of intellectual property, includ-

information including numbers, brand names and nature,

ing information about where patents are filed and enforced,

expiry dates (including the platform technology expiry datecan facilitate the affordable supply of medicines by support-

for vaccines) and jurisdiction. On its website, it discloses pat-ing market entry by generic medicine manufacturers andent status in the US, China, EU and Japan.

informing decision-making by international procurers. For
example, clear and reliable information that a pharmaceutical

Increased access through a decrease of patentcompany will not enforce its patents in a particular country

enforcement

can provide a signal to generic medicine manufacturers in

AstraZeneca’s transparency, particularly about biologicalthat country that they can begin the process of making a

products such as vaccines, sets a benchmark. If more compa-

generic version of the product.

nies increase the quantity and quality of patent disclosures,
this will facilitate opportunities for manufacturers to launchCompanies demonstrate best practice when they publish

generic versions of the products, expand the market and ulti-

the status of all their patents, including biological products.

mately increase the availability of products.

Although disclosure of information on biological products is

To improve access, companies can combine transpar-

often complex as multiple patents may be attached, it is alsoency in disclosure with a commitment not to enforce pat-

an important step in addressing barriers to access.

ents in LMICs. AstraZeneca commits not to file for patents

Many companies use Pat-INFORMED (Patent Informationof countries where they do not file for or enforce patents

Organization (WIPO) database. Of the 20 companies in scope(Boehringer Ingelheim in 61, Merck in 90 and Sanofi in 71).

of the Index, 19 publish information about their patents.

Companies can also consider how to measure outcomes andBoehringer Ingelheim is the only company in scope that does

develop metrics to track, for example, how patent disclosures

not disclose patent status anywhere. Many companies use

for specific products can increase patient reach.

the database on Pat-INFORMED to share information about
the status of their patents, which is an encouraging first step
but does not represent full disclosure. On their own websites,
companies can provide more product-specific details, forexample disclosing the numbers and expiry dates of each of
their patents.
The Index looks at different sources for disclosure of patentstatus (whether a product is on- or off-patent), including the
FDA (US), Health Canada, CIPC (South Africa) and MedsPaL(see Appendix I). Of all companies in scope, AstraZeneca
demonstrates best practice. It is the only one to publish
patent status and information on its website for all of its 32
products in scope for analysis. This includes biological products, such as the two vaccines in scope. Following quality
standards for transparency, AstraZeneca publishes annual

142

in 80 countries, and three other companies disclose a list

Initiative for Medicines), a World Intellectual Property

Access to Medicine Index 2022 ▶ Best Practices
PRODUCT DELIVERY – PRODUCT ACCESS

Eleven companies share IP assets through agreements that could
speed up the development of NTD products
A B BV I E, BAY ER , DA I I CH I SA N K YO, EISA I , GSK , J O H NSO N &Aim: To accelerate the development of products for NTDs

J O H NSO N , M ERCK , MSD, PFIZER , N OVA RT IS , TA KEDA

Location: Global
Focus: Neglected tropical diseases (NTDs)
Action: Sharing intellectual property (IP) with third-party
researchers at public research institutions or drug discovery
initiatives

Pharmaceutical companies hold a wide array of intellectual(BVGH/WIPO) and/or through open libraries of compounds.

property (IP) assets that are valuable to product develop-

Companies help facilitate access to resulting innovations in

ment, from unpublished clinical trial data to libraries of tar-various ways, such as encouraging the publication of findings,

get-specific compounds. While some companies are resistantcommitting to lowering costs, or generally through granting

to sharing IP, others take a more open approach to promoteroyalty-free licences to the IP assets shared.

access, often resulting in innovations that benefit low- andmiddle-income countries (LMICs).
The 2022 Index has found that the number of R&D pro-

Merck leads, with the most examples of new IP sharing agreements that target NTDs. It partners with BVGH/WIPO tojects targeting NTDs has fallen since the last iteration of theshare IP and has also done so through its Open Global HealthIndex, even though there are many NTDs for which new or

Library, a platform through which researchers can apply for

improved treatments are urgently needed, such as myce-compounds directly and receive additional information liketoma and river blindness. Choosing to share IP assets withcompound structures after results are shared.

third-party researchers is one way that companies can help
to accelerate R&D for under-researched diseases such asMore R&D needed for under-researched diseases

NTDs, even if they lack active projects in the R&D pipeline. By

The Index now looks for more companies to contribute tosharing IP assets, pharmaceutical companies are also helping

accelerate R&D efforts for under-researched diseases, includ-to accelerate R&D for new products, averting duplication of

ing NTDs. Companies can engage in new IP-sharing agree-

efforts and enabling researchers to continue the work compa-

ments that have access clauses enabling resulting innovations

nies have started.

to be accessible in LMICs through mechanisms such as granting royalty-free access to IP assets they have provided or

IP sharing: filling gaps in pipelines
In 2009, Bayer and Sanofi shared assets with the Drugs for
Neglected Diseases initiative (DNDi) and Médecins Sans
Frontières to develop a better treatment for sleeping sickness(human African trypanosomiasis) and Chagas disease. The
resulting product, fexinidazole, received a positive responseby the European Medicines Agency in 2019 to replace a complex and toxic medication that killed around 5% of people ittreated. When companies are open with IP assets, they canaccelerate R&D and help introduce life-saving products in
LMICs.
In 2022, eleven companies (AbbVie, Bayer, Daiichi Sankyo,
Eisai, GSK, Johnson & Johnson, Merck, MSD, Pfizer, Novartis
and Takeda) stand out for engaging in recent IP-sharing
agreements made with third-party researchers for thedevelopment of new products for NTDs. Companies share
their IP through partners such as DNDi and BIO Venturesfor Global Health/World Intellectual Property Organization

143

encouraging publication of research results.

Access to Medicine Index 2022 ▶ Product Delivery
PRODUCT DELIVERY – HEALTH SYSTEMS STRENGTHENING

By taking its cervical cancer programme online and testing foreffectiveness, Roche avoided interruptions in access to care due to
COVID-19
RO CH E

Location: Tanzania, India, Uganda
Focus: Cervical cancer
Action: Taking an existing programme (NJIA) online to ensure
activities continued during COVID-19 pandemic-related disruptions, and monitoring its effectiveness
Aim: To strengthen health systems by increasing awarenessof cervical cancer and access to screening and treatment

When the COVID-19 pandemic disrupted travel and accessOutcome measuring needed to extend offline successes

activities, Roche took a proactive approach to prevent inter-

Any company that is developing or shifting to the use of

ruptions by launching an online version of NJIA, its leadership

online tools needs to consider how to measure outcomes todevelopment programme to prevent cervical cancer.

test whether these tools can replicate or improve upon the

The 2021 Index recognised this initiative for best practise,in which Roche partners with Pepal and others to target

Offline, for example, NJIA measures how its interventions

resource-limited settings and strengthen prevention ser-strengthen the capacity of frontline health leaders and com-vices. Founded in Tanzania in 2015, it was soon expanded topares changes in behaviours and knowledge to help improveIndia and Uganda. It uses a four-level model to train leaders

measures. Roche can now look at how to extend offline suc-through self-evaluation, peer and line-manager surveys,

cesses online by leveraging engagement and/or extending

and tests pre- and post-participation in an immersion week.

measurement to include pre- and post-survey learning or

Through multi-stakeholder multinational partnerships, NJIA

understanding of screening elements.

has so far invested more than 28,000 hours in leadershipdevelopment, and tested 60+ innovations.
In 2021, despite COVID-19 pandemic disruptions, NJIA
widened its geographic scope to include three new regionsin Tanzania. It also launched an online version of the training
programme (iNJIA) and invited 57 partners (government
health professionals and NGO staff) to take part virtuallyalongside 48 participants from Roche. Nearly all those
involved reported being engaged and inspired by the virtual
experience, with most Roche participants saying that learning
could be leveraged.
Through iNJIA, Roche provides a sustainable solution
which, if regular in-person activities are disrupted, can allow
stakeholders to be involved online with in-person workshops.
It has measured and reported on the outcomes of this digital
adaptation. Separately, Roche also launched a website toconsolidate and make available tools and innovations used bygovernments, NGOs and health charities to reduce the incidence of cervical cancer in low-resource settings.
While COVID-19 lockdowns and surges caused somecompanies to cease or delay health systems strengthening
activities, others worked to scale up initiatives and develop
online tools. Roche stands out for its proactive measures toadapt, avoid interruption and ensure its programme remained
productive.

144

impacts of offline models.

Access to Medicine Index 2022 ▶ Best Practices
PRODUCT DELIVERY – HEALTH SYSTEMS STRENGTHENING

Novo Nordisk's CDiC expands access to diabetes care for young
people and children in 22 countries in scope of the Index
N OVO N O R D ISK , RO CH E

Location: Sub-Saharan Africa, South Asia and East Asia
Focus: Children and young people aged under 25 with type 1
diabetes
Action: Using partnerships to strengthen health systems andaddress their sustainability in low- and middle-income countries (LMICs)
Aim: To integrate type 1 diabetes care for children and young
people into health systems in LMICs
Cases of diabetes are surging worldwide, but many patients

disclose outcomes of its work through CDiC. The company

who require insulin do not have access to a reliable andcommissioned a third-party review by University College

affordable supply. Of an estimated 1.2 million young people

London to assess the programme in Bangladesh and Kenyaaround the world with type 1 diabetes, those in low-resource

and analyse the path for insulin provision and healthcare

settings are less likely to have adequate access to healthcare

infrastructure for diagnosis and treatment.1 In their report,

including diagnosis and life-saving insulin. Novo Nordisk,

researchers found indirect costs remained a substantial bar-which leads the global insulin market, holding almost half ofrier to care and reliance on external funding and delivery inthe share of the total insulin market globally in 2021, demon-a high-turnover staffing environment created vulnerabilities

strates best practice through its efforts to make provision

for long-term sustainability. By commissioning a third-partyof supplies for diabetes care more sustainable. Roche also

review, Novo Nordisk demonstrates its transparent approachdemonstrates best practice for its supporting role in thisto measuring impact and seeking insight into future steps

initiative.

that need to be taken to improve the CDiC programme andpromote its long-term sustainability.

Changing Diabetes in Children Programme
Novo Nordisk established Changing Diabetes in Children

Strengthening local health systems through partnerships(CDiC) in 2009 to improve access to care for children with

As companies work to achieve sustainability and integrate

type 1 diabetes in LMICs. Operating in 22 countries in scope

activities in local systems, they can find great value throughof the Index, it collaborates with governments, local partners

partnership. The Index expects companies to continue

and others to raise public awareness of diabetes, strengthen

working with international and local partners to find ways

healthcare capacity and increase access to human insulin

to develop sustainable models and strengthen health sys-

through the donation of these products and other necessary

tems locally, and to expand this approach. This could include

commodities. Roche is also a partner in CDiC and provides

strengthening data registry systems, which are used bycommodities such as glucometers and test strips to young

countries for purposes including diabetes surveillance, clinicalpeople enrolled in the programme. CDiC has already reachedmanagement, and supporting cost estimations. It could also

34,000 young people in low-resource settings and aims toinclude incorporating long-term strategies that improve fore-

reach 100,000 by 2030. Since the last Index, it has expanded

casting and supply. Companies should ensure that they mon-its geographic footprint to eight new countries.

itor and publicly disclose the outcomes of their programmes,

Novo Nordisk has taken steps to address aspects ofthe programme's sustainability through partnerships withstakeholders like local governments and the World Diabetes
Foundation. Through these partnerships Novo Nordisk is
working to support integration of type 1 diabetes care foryoung people into national non-communicable disease
responses of partnering governments. The company is also
piloting a non-donation model in Ghana, Indonesia and Peru,
where health insurance schemes are available that reimburse
human insulin for young people with type 1 diabetes.1
Novo Nordisk has also taken steps to measure and publicly

145

1 Palmer T, Jennings H, Shannon G, et al. Improving access to diabetes care for children:
An evaluation of the changing diabetes in children project in Kenya and Bangladesh.
Pediatr Diabetes. 2021. doi:10.1111/pedi.13277

in order to gather valuable insights and improve future strategies for expanding access.

Access to Medicine Index 2022 ▶ Best Practices
PRODUCT DELIVERY – HEALTH EQUITY (VULNERABLE POPULATIONS AND INCLUSIVE BUSINESS MODELS)

Four companies are scaling up inclusive business models to
help improve the affordability of medicine, especially for noncommunicable diseases
A S T R A ZEN EC A , N OVA RT IS , RO CH E, TA KEDA

Location: Sub-Saharan Africa
Focus: Non-communicable diseases (NCDs) including sickle
cell disease, cancer, hypertension and diabetes
Action: Scaling inclusive business models to increase accessto medicines for low-income populations
Aim: To improve the affordability and availability of medicinesthat treat NCDs

The burden of NCDs is rising in low- and middle-income coun-Roche set up the Nigerian Cancer Health Fund in 2017, aiming

tries (LMICs), yet appropriate healthcare remains unavailable

to help the 84% of the Nigerian population living at the BoP

and unaffordable to many people living in these countries.

afford treatment for breast, colorectal and prostate cancer.

Inclusive business models focus on individuals at the base

The model generates and shares data with the government onof the income pyramid (BoP) and can contribute to the future

the disease burden through a consortium with other pharma-

affordability and availability of care. These models build

ceutical companies, diagnostics companies and private insur-

bridges between businesses and vulnerable populations forance companies. The model mobilises government support,

mutual benefit, which can go beyond immediate profits andfor instance through including the use of digital wallets forhigher incomes.

patients to pay for treatment. It also measures the number of

AstraZeneca, Novartis, Roche and Takeda demonstratepatients treated, their survival rates, and their quality of life.

evidence of scaling up inclusive business models within theirprogrammes to directly address the need for affordable NCD

Takeda launched Blueprint for Innovative Healthcare Accessmedicines among BoP populations. All feature partnerships

in partnership with local and regional partners in 2019. Initiallywith a wide range of stakeholders including governments,

piloted in Kenya, the initiative has expanded to other LMICs

institutions, academic partners, and NGOs. Roche and Takeda

including Rwanda, Tanzania, Uganda and Nigeria. In these fivealso partner in the Blueprint for Innovative Healthcare Access.

countries, partners work to enhance local standards of care,increase disease awareness and improve supply chains. The

AstraZeneca began its Healthy Heart Africa (HHA) initiative ininitiative also provides access to medicines and healthcare

2014. Aiming to reach 10 million people with elevated blood

products. Takeda addresses affordability barriers by estab-pressure across Africa by 2025, it commits to tackling thelishing a revolving pharmacy fund, providing financial support

increasing burden of cardiovascular disease with low-costand guidance, enrolling patients onto local healthcare insur-

branded antihypertensive medicines, made available to BoP

ance provisions, and through patient assistance programmes.

populations. HHA also provides mentorship, equipment andBy the end of 2021, the initiative has already screened overtraining to healthcare workers and since 2014 has conducted

200,000 people for diabetes, hypertension and cancers andmore than 27 million screenings, identifying circa 5.3 million

has referred over 12,000 for healthcare.

people with elevated blood pressure. It has trained over
9,000 healthcare workers in hypertension and initiated theEstablishing inclusive business models to bring benefits

set-up of more than 950 treatment facilities.*

for underserved populations
Inclusive business models can be effective in bringing criticalNovartis aims to extend the lives of people with sickle cell

products and services to populations who are often over-disease (SCD) in sub-Saharan Africa, through its Africa SCD

looked in normal business operations. Where their products

programme. It will work with governments to accelerate

are needed to address high burdens of disease, more com-

access to affordable hydroxyurea (HU) treatment and develop

panies can develop scalable, financially sustainable inclusive

a paediatric formulation. Other aims are to strengthen thebusiness models to address the unmet needs those at thedevelopment pipeline and local clinical trial capability, deploy

BoP. When companies expand these models, scale-up shoulda digital health app for patients allowing for monitoring andbe based on impact evaluations that include factors such as

evaluation, and leverage data and insights for intensified

patient reach and health outcomes.

advocacy and policy work. So far, it has delivered more than
20,000 HU treatments.
146* At publication, these numbers were lower, based on data initially submitted by
AstraZeneca. This was corrected on 29 November 2022 to include data up to the endof the period of analysis for the Index, 31 May 2022.

Company Report Cards

The 2022 Access to Medicine Index includes a set of 20 company Report Cards that provide detailed overviews of eachcompany’s performance. Companies are different in the way
they operate, where they operate, and in their portfolio ofinvestigational and marketed products, all of which can have
implications for access. Each Report Card includes a summary of the company’s strengths and weaknesses, drivers
behind changes in its ranking, as well as any best and innovative practices.
The Report Cards are divided into six sections:
PE R FO R MAN CE

Explanation of the company’s position in the 2022 Index and asummary of its access-to-medicine performance. Performanceis broken down into Technical Areas. It describes the key drivers behind any movement, and the main areas where the company scores well or poorly compared to peers.
CHAN G ES S I N CE 202 1

Update on where the company’s access-to-medicine performance has changed most notably since the 2021 Index. It
includes new or expanded commitments, strategies, activities
and programmes.
O PPO RTU N ITI ES

Tailored opportunities for the company to improve access to
medicine, taking account of its R&D pipeline, product portfolio, current equitable pricing strategies and approach to IP
management, among other factors.
SALES & O PE R ATI O N S

General description of the company’s operations, recent mergers & acquisitions, revenue per region and geographical reach.
PI PE LI N E & PO RTFO LI O SU M MARY

Analysis of the company’s pipeline of R&D projects as well as
portfolio of marketed products that fall within the scope of
the Index. This section looks at the size and focus of the company’s pipeline and portfolio, whether the company has products that are considered first-line or are on the WHO Model
List of Essential Medicines and whether it is conducting priority R&D and planning for access during development.
PE R FO R MAN CE BY TECH N I C AL AR E A

Overview of the company’s performance in each TechnicalArea measured by the Index. The Report Card performancepoints have been structured to be comparable between companies, while still describing the company’s individual programmes, initiatives and approach.
147

Access to Medicine Index 2022 ▶ Company report cards

RA N KSCO R E19

1.84

17 (2021)*

AbbVie Inc
Stock exchange: NYSE • Ticker: ABBV • HQ: North Chicago, Illinois, USA • Employees: ~50,000

PERFORMANCE IN THE 2022 INDEX
19th place. AbbVie is in the lower ranks across all Technical
Areas. It engages in R&D for neglected tropical diseases but
lacks access plans for R&D projects in the pipeline. It engages
in non-exclusive voluntary licensing but has a comparatively

How score was achieved
3.43

Governance of Access
0.78

Research & Development

1.98

Product Delivery

poor performance in capacity building.

0

1

Governance of Access: 15th place. AbbVie performs below

2

3

Average

Leader4

5

average in this area. It has an access-to-medicine strategy, but
only has some compliance controls in place to mitigate therisk of non-compliance in countries in scope of the Index. It

Product Delivery: 18th place. AbbVie performs poorly indiscloses the outcomes of only a subset of its access-to-med-this area. The company has an average performance in its

icine activities.

approach to inclusive business models and supplying products through supranational procurers. However, its perfor-

Research & Development: 20th place. AbbVie performs

mance with regard to healthcare practitioner- and self-ad-

poorly in this area. AbbVie has a small-sized priority pipeline

ministered products is below average. The company engages

compared to its peers. The company does not have a frame-

in non-exclusive voluntary licencing for two compounds, ena-

work in place for systematic access planning and does notbling generic supply in 79 countries. AbbVie engages in healthhave access plans for any of its late-stage pipeline candidates.

systems strengthening initiatives but doesn't publicly disclose

It does not engage in R&D capacity building.

outcomes for most of these.

OPPORTUNITIES FOR ABBVIECHANGES SINCE THE 2021 INDEX

Develop access-related incentives for senior management. AbbVie has an access-to-• Established an ESG council to further strategic, enterprise-

medicine strategy, the Global Integrated Access Strategy (IAS), which serves as thealigned delivery on AbbVie’s ESG Framework which includes

foundation and starting point for regional (area level) and country (affiliate level) accessglobal patient access and affordability as a key material

strategies. Financial and non-financial incentives, oriented toward long-term goals, fordriver.

the CEO and in-country managers can be linked to this strategy.

• Newly established access strategy, the Global Integrated

Develop a structured access planning framework and ensure all late-stage R&D• Developed an Executive Council on Neglected Diseases thatprojects have comprehensive access plans. AbbVie can develop a formal accesscoordinates across the company to contribute innovativeplanning framework and accordingly apply access plans considering availability,

technologies, diverse compounds for screening, andaffordability and sustainable supply for all its projects, no later than Phase II. For

scientific expertise to partners to help address neglected

Strategy, covering all therapeutic areas.

example, it can disclose access plans for flubentylosin, an investigational treatment forriver blindness being developed in collaboration with DNDi.

tropical diseases.
• Announced a research collaboration with Scripps Research
to develop antiviral treatments for COVID-19.

Expand access to its hepatitis C product, glecaprevir/pibrentasvir (Mavyret®),through equitable pricing and/or increased non-exclusive voluntary licensing. AbbVie
can increase patient reach for glecaprevir/pibrentasvir, indicated for the treatmentof chronic hepatitis C infection. It can expand its existing voluntary licence for thisproduct to countries with a high burden of this disease such as the Republic of Moldova,
Mongolia and Uzbekistan, or increase access by applying an equitable pricing strategy inthese countries.
AbbVie can expand access to innovative medicines for cancer and women’s healthproducts. The company can implement equitable access strategies and expand
registration of products such as elagolix (Orilissa®) for endometriosis. AbbVie can filefor registration in countries where the disease burden of endometriosis is the highest
such as Algeria, Mongolia and Papua New Guinea.

148

All companies were assessed based on
information that was valid in the latest
period of analysis (ending at 31 May2022). This data was either submitted bycompanies, found in the public domain or
was accessible through other sources.

The term LMICs is used to denote all
low- and middle-income countries inscope of the Index, except when analysing
companies’ access strategies where
the use of LMIC refers to lower-middle
income countries as per the World Bank

income groups classification. Likewise, theterms LIC and UMIC refer to low income
countries and upper-middle income
countries.
*In the 2021 Index, dense ranking wasused. In the 2022 Index, standard

competitive ranking is used. Therefore, adirect comparison with AbbVie's previous
rank is not possible.

Access to Medicine Index 2022 ▶ Company report cards

SALES AND OPERATIONSBusiness segments: Pharmaceutical sciences

AbbVie's products are sold in 81 out of 108

Therapeutic areas: Aesthetics, eye care,countries in scope of the Index. AbbVie has

Net revenue by segment (2021) – in USD

gastroenterology, immunology, neuroscience,sales offices in 17 countries, and sells via

Pharmaceutical sciences

oncology, virology, women's health and othersuppliers and/or pooled procurement in an		

specialty areas.

additional 64 countries.

Total

56.20 bn
56.20 bn

Product categories: Pharmaceuticals
M&A news: AbbVie acquired Syndesi
Therapeutics in March 2022 for USD 130 million
upfront payment.

Sales by geographic region60

Net revenue (Bn USD)

Sales in countries in scope

50
40
30
20
10
0

In scope, has sales offices
In scope, any sales

2017

2018

International

In scope, no sales

2019

2020

2021

USA

Not in scope

SAMPLE OF PIPELINE AND PORTFOLIO ASSESSED BY THE INDEXPIPELINE for diseases in scope

PORTFOLIO as selected for analysis by the Index

AbbVie has a total of 42 R&D projects in scope with six of these projects

AbbVie has 19 medicines in scope, 14 of which are on patent and twotargeting a priority disease. The other 36 R&D projects target othercontraceptive methods. 37% of the medicines (7) are on the WHO

diseases in scope. Of the projects targeting priority diseases, the focus

EML. The off-patent medicines target mainly non-communicable

is on HIV/AIDS (two projects). Of the projects targeting other diseases indiseases (NCDs) such as hypertensive heart disease (2), cancer (1) andscope, the focus is on oncology (31).

endometriosis (1). Furthermore, there is one off-patent medicine forNine R&D projects are in late-stage development that target either apreterm birth complications. The on-patent medicines mainly target NCDs,priority disease (2) or address a public health need in LMICs (7).* Evidence

such as mental health conditions (5) and cancer (2) and communicableof access planning was not reported for any of these projects.

diseases such as HIV/AIDS (2), and hepatitis C (2). In addition, one productis for endometriosis, one for migraine and other products target preterm
birth complications.

42 projects in the pipeline

21 products as selected for analysis by the Index†

Communicable**4

Communicable**

Neglected tropical2

Neglected tropical 0Maternal and neonatal 013

Non-communicableMultiple categories 02

Multiple categories
0

20
30
40
50
projects in the pipeline

10

20
30
40
50
products on the market

15

2

0

2

1

1

0

0

6

Contraceptives

Targets established R&D priorities

Addresses needs of LMICs*

8

3

4

0

0

Other projects in scope

13

6

2

0

0 21

*50 diseases and 243 product gaps inscope have been established as a priority by global health stakeholders. For
other diseases, the Index used a set of criteria to determine which projects in thepipeline offer a clear public health benefit to patients in LMICs. Only projects inthe clinical phase of development were
included for this analysis.
**Neglected tropical diseases, while also
communicable, are highlighted separately
throughout the Index.
***Other includes projects that have atechnical lifecycle and projects that fol-

Other‡

Total

1

Vaccines

Other

Non-EML1

Diagnostics

Total

0

Other***

0Registration/approval

50Phase III1

Phase II

11

4

Phase I3

off patent

Pre-clinical

Medicines on patent

Discovery

WHO EML

Breakdown of products
WHO EDL

10

Breakdown of projects

149

2

Maternal and neonatal

36

Non-communicable
0

4

14

2
0

0
0

low a different development cycle (e.g.
diagnostics).
†Products included in the analysis wereselected using a set of criteria determinedby stakeholder consensus.
‡Other includes vector control products.

0

Access to Medicine Index 2022 ▶ Company report cards

AbbVie Inc

GOVERNANCE OF ACCESSRANK 15SCORE 3.43

Has an access-to-medicine strategy with meas-

activities. It discloses its commitments, measur-of some components looked for by the Index:

urable objectives, integrated within the overall

able goals, objectives and targets for improving

audits (both internal and external) and formal

corporate strategy. AbbVie performs strongly.

access to medicine in countries in scope of theprocesses to ensure third-party compliance with

It has an access strategy, the Global Integrated

Index. For example, the company publicly sharescompany standards. However, AbbVie does not

Access Strategy (IAS), which serves as the foun-

how it contributes to the achievement of thedisclose to the Index whether there is fraud-spe-

dation and starting point for product specific

UN SDG3 targets. It shares the outcomes of its

cific risk assessment done in countries in scope

strategies at the regional (area) and country (affil-

access-to-medicine activities for only a subsetof the Index. Additionally, there is no evidenceiate) level. The IAS covers all of the therapeuticof initiatives, although it does so in a centralisedof a continuous monitoring system of activi-

areas in which the company is involved, includ-manner within its ESG Action Report.

ties or country-based assessments. No breaches

ing Immunology and Oncology and Specialty.

in countries in scope of the Index were publicly

The highest responsibility for access lies directly

Performs above average in responsible pro-with the board, with its Public Policy committee

motional practices. AbbVie's sales agents are

responsible for corporate responsibility aspects,

not incentivised solely on sales volume targets.

Does not publicly support the Doha Declaration

including access.

It does not publicly disclose information relatedon TRIPS and Public Health. AbbVie does

to transfers of values to healthcare profession-

not publicly share any support of the Doha

Provides evidence of financial access-relatedals (HCPs) in countries in scope of the Index (e.g.

Declaration on TRIPS and Public Health. There

incentives at the executive level. AbbVie per-payments for attending events or promotionalis evidence of industry association lobbying on

forms average in this area. It demonstrates

activities) unless required by local regulations, nor

IP and the usage of TRIPS flexibilities, namely ofevidence of having access-related incentives fordoes it disclose a policy limiting such transfers,

compulsory licensing, by national governments insenior executives under its key material driver ofbut it does have global, international, and local

some countries in scope of the Index. As a mem-Patient Affordability and Accessibility within its

policies for engaging with HCPs.

ber of the industry association, AbbVie, like all

ESG framework.

found in the period of analysis.

other member companies in scope of the Index, is
Has some compliance controls to ensure that

Publicly discloses outcomes of a subset ofgovernance efforts are not undermined by

its access-to-medicine activities. AbbVie per-non-compliant or corrupt activities. AbbVie has

forms well in transparency regarding accessan average performance, demonstrating evidence

RESEARCH & DEVELOPMENTRANK 20by default connected to this activity.

SCORE 0.78

No structured process for access planning

Many projects address a public health need in

Does not publicly disclose R&D investment

reported. AbbVie does not report a structured

LMICs.* The company does not disclose evidence

data disaggregated by disease category, prod-

process to develop access plans during R&D. Theof access plans for any of the late-stage projects.

uct type or phase of development. However,company did not report a structured timeline

In this analysis, AbbVie has seven late-stage R&D

AbbVie does disclose fully disaggregated R&D

for the development of access plans for its R&D

projects that target a disease and/or product gap

investment data to Policy Cures Research.

projects.

not yet established as a priority by global healthstakeholders. These projects are all deemed by

No R&D capacity building initiatives included

A small-sized priority R&D pipeline compared

the Index to offer a clear benefit for people living

for evaluation. There is no evidence — in theto its peers. AbbVie has six projects, including

in LMICs.* Primarily, these projects are first-in-

public domain or disclosed to the Index — of

two late-stage candidates in its pipeline that tar-class molecules. Most target cancer. AbbVie did

R&D capacity building initiatives active during the

get a priority product gap. The priority pipeline

not disclose evidence of access plans for any ofperiod of analysis that met inclusion criteria forfocuses on various diseases, including HIV/AIDS,

the late-stage projects.

evaluation. AbbVie's performance is below aver-onchocerciasis and tuberculosis. AbbVie did not

age in this area.

disclose evidence of access plans for any latestage projects.
PRODUCT DELIVERYRANK 18SCORE 1.98

No public commitment not to enforce patents

via the Pat-INFORMED database. AbbVie dis-research institutions or drug discovery initiatives

in countries in scope. AbbVie does not have acloses patent information such as grant number

established during the current analysis period

public policy that sets out its approach to filingand jurisdiction.

that meet all inclusion criteria for evaluation. The

for or enforcing patents in LMICs.

150

company does have existing agreements of thisPerforms below average in terms of sharing

nature in place that were established before the

Publicly discloses information on patent status.

intellectual property (IP) assets with third-

current period of analysis and meet all inclusion

Like most of its peers, AbbVie publicly discloses

party researchers. AbbVie does not report

criteria for evaluation.

the patent statuses for small molecules in scopeon any new IP-sharing agreements with public*50 diseases and 243 product gaps inscope have been established as a priority
by global health stakeholders. For otherdiseases, the Index used a set of criteria
to determine which projects in the pipeline offer a clear public health benefit topatients in LMICs. Projects in the clinicalphase of development were included forthis analysis.

Access to Medicine Index 2022 ▶ Company report cards

Uses licensing and non-assert declarations toa call-to-action stakeholder’s meeting to ele-ing the access needs of populations at the baseenable generic supply. AbbVie has non-exclusive

vate neonatology to treat neonates at three keyof the income pyramid (including other under-

voluntary licensing agreements in place for two

Ugandan hospitals. Patient reach is not available.

served populations) in LMICs. The Access to Carecompounds. Its licence for glecaprevir/pibren-

Program facilitates the availability of the com-

tasvir (Mavyret®), a treatment for hepatitis C,

Has few access strategies for self-adminis-

pany's HIV medications in LMICs in addition toencompasses 79 countries within the scope oftered products for some countries in scope ofproviding continuing medical education in 15

the Index, including 54 middle income countries.

this analysis. AbbVie has a below average perfor-

African countries to increase treatment capacity,mance in this area. For one of the three products

knowledge and clinical skills.

Filed to register new products in one coun-assessed, evidence of an access strategy in coun-try in scope on average. AbbVie did not disclose

tries of all assessed income levels (UMIC, LMIC,

Shows average performance in terms of ensur-

evidence of filing for registration any of its new

LIC) was found publicly. For example, the non-ex-

ing continuous supply of medicines in LMICs.

products in more than half of the top ten highclusive voluntary license with the Medicines

AbbVie has a system in place to work with rel-burden countries. Among new products, gleca-

Patent Pool (MPP) for glecaprevir/pibrentasvir

evant stakeholders to communicate issues that

previr/pibrentasvir (Mavyret™), for viral hepatitis(Mavyret®) is still active. Patient reach evidence is

may affect the supply chain, manages a bufferC, has been filed in two countries within the

not disclosed.

stock of relevant products, and works with sev-

scope of the Index. Among old products with theeral active pharmaceutical ingredient suppliers.

same indication, its most widely filed is ombitas-

No manufacturing capacity building initiatives

However, there is no evidence that the company

vir/paritaprevir/ritonavir/dasabuvir (Viekira®),included for analysis. There is no evidence — intransfers technology to local manufacturers or is

filed in 13 countries relevant to the Index, includ-

the public domain or disclosed to the Index — of

involved in supply chain capacity building initia-

ing high burden countries such as Republic ofmanufacturing capacity building initiatives active

tives that meet inclusion criteria for evaluation.

Moldova and Ukraine. None of AbbVie's products

during the period of analysis that met inclusionconsidered for analysis are filed for registration

criteria for evaluation. AbbVie's performance is

Has a case-by-case approach for reportingin LICs.

below average in this area.

substandard and falsified (SF) medicines in

Has access strategies for its supranationallyNo supply chain capacity building initiatives

strates evidence of reporting SF medicines toprocured products in scope. AbbVie performs

included for analysis. There is no evidence — inrelevant regulatory authorities and the WHO, on aabove average in securing access for products

the public domain or disclosed to the Index — ofcase-by-case basis. It does not disclose evidence,procured supranationally. For the two prod-

supply chain capacity building initiatives active

publicly or to the Index, that it requires reporting

ucts assessed in this category, lopinavir/ritonavir

during the period of analysis that met inclusion

to occur within the timeframe of ten days looked(Aluvia®/Kaletra) and ritonavir (Norvir®), AbbVie

criteria for evaluation. AbbVie's performance isfor by the Index, nor does it provide evidence ofhas procurement agreements with the Global

below average in this area.

shortened time frames for reporting cases whichcountries in scope of the Index. AbbVie demon-

Fund. The price agreed is disclosed and publicly

only require visual inspection to be confirmed.

available. The company applies pricing strate-

None of the five health systems strengthen-gies that consider relevant payers' ability to pay

ing initiatives included meets all Good Practice

Donates in response to expressed need andin Algeria, a non-eligible Global Fund country, andStandards. AbbVie's performance is below aver-monitors delivery. AbbVie has public policies

it provides evidence of patient reach for both theage in this area. The number of initiatives meetingand supply processes in place to ensure ad hoc

products.

all inclusion criteria is higher than average but

donations are carried out rapidly in response to

fewer initiatives meet all Good Practice Standards

expressed need, and it shows some evidence of

Has access strategies for only one health-(GPS) than what is average for this indicator. In

monitoring the delivery of donations.

care practitioner administered product in

the Partnership with Baylor College of Medicine

scope of this analysis. AbbVie has a below aver-International Pediatric AIDS Initiative (BIPAI),

Has no long-term donation programmes forage performance in this area. For one of the

AbbVie aims to reduce mortality, increase adher-

neglected tropical diseases or malaria that are

three products assessed, the company pro-ence and decrease rate of patients lost to follow

eligible for analysis. However, AbbVie is engaged

vides evidence of access strategies in UMIC andup among children and families affected by HIV/in other structured donation programmes such

LIC country examples. It makes efforts to reach

AIDS in Romania and Malawi. This initiative meetsas the programme whereby it has been donating

additional patients through donations and has ini-

all GPS.

beractant (Survanta®) for infant respiratory dis-tiatives to strengthen the healthcare systems. For

151

tress syndrome to six countries in scope of theexample, AbbVie applies a cost-plus pricing strat-

Has engaged in scaling up one inclusive busi-

egy for beractant (Survanta®) in Uganda thatness model (IBM) but has not shown evidence

is aligned across sub-Saharan Africa. The com-of its involvement in piloting any new IBMspany provides education through expert trainingthat meet all inclusion criteria. AbbVie performs

and peer-to-peer mentorship, as well as throughaverage in the use of IBMs aimed at meet-

Index since 2015 through Direct Relief.

Access to Medicine Index 2022 ▶ Company report cards

RA N KSCO R E16

2.46

14 (2021)*

Astellas Pharma Inc
Stock exchange: TSE • Ticker: 4503 • HQ: Tokyo, Japan • Employees: 14,522

PERFORMANCE IN THE 2022 INDEX
16th place. Astellas performs below average, with a weak
performance in Product Delivery, where it has a comparatively
poor performance for its equitable access strategies.
However, it has strengthened its R&D access planning

How score was achieved
4.29

Governance of AccessResearch & Development

2.05

Product Delivery

2.18

processes.

01

Governance of Access: 8th place. Astellas performs well in

2

3

Average

Leader4

5

this area. It has an access-to-medicine strategy that is integrated within the overall corporate strategy and a robust setof compliance controls to mitigate the risk of non-compliancein countries in scope of the Index, but the responsibility of its

Product Delivery: 16th place. Astellas performs below average

access-to-medicine strategy lies indirectly with the board.

in this area. It applies access strategies for two of its products
in some countries in scope of the Index. The company newly

Research & Development: 13th place. Astellas has a below

engages in a high-quality supply chain capacity building initia-

average performance in this area. It has a structured accesstive but lacks engagement in other areas such as manufactur-

planning process in place and applies this to all late-stage

ing capacity building and inclusive business models.

pipeline candidates. However, it has a small-sized priority
R&D pipeline compared to peers and does not engage in R&D
capacity building.

OPPORTUNITIES FOR ASTELLASCHANGES SINCE THE 2021 INDEX

Establish direct board-level responsibility for access to medicine. Astellas has• Launched Corporate Strategic Plan in 2021 with Accessan access-to-medicine strategy. The Sustainability Advisory Panel, responsible for

to Health, including the implementation of its access-to-

this strategy, reports to the CEO. Instead, the CEO can become a member of the
Sustainability Advisory Panel, putting the responsibility for the access-to-medicine
strategy at the board level.

medicine strategy, as part of its sustainability strategic goal.
• The Astellas Global Health Foundation awarded a threeyear grant to the Academic Model Providing Access to
Healthcare (AMPATH) for a programme that will provide

Expand the geographic coverage of access plans to include more lower-middle and400,000 people in Kenya with access to mental health

low-income countries. Astellas has access plans in place for all late-stage candidates.

programmes.

For example, it has access plans in place for zolbetuximab (IMAB362), indicated foroesophageal cancer, in six countries in scope of the Index. These are all upper-middle
income countries. Astellas can increase the number of countries in scope of the Index
included in R&D access plans and specifically focus on low- and lower-middle income
countries with the highest burden of disease, such as Mongolia, Malawi and Zimbabwe.
Expand access to innovative medicines for non-communicable diseases. The company
can increase affordability and supply through equitable access strategies and/or nonexclusive voluntary licensing to products such as gilteritinib (Xospata®) for leukaemia
and ipragliflozin (Suglat®) for diabetes. These products can further be filed forregistration in countries within the scope of the Index, especially where the burden of
disease is the highest, such as Ethiopia and Bolivia for gilteritinib and Guyana, Sri Lanka
and Suriname for ipragliflozin.

152

All companies were assessed based on
information that was valid in the latest
period of analysis (ending at 31 May2022). This data was either submitted bycompanies, found in the public domain or
was accessible through other sources.

The term LMICs is used to denote all
low- and middle-income countries inscope of the Index, except when analysing
companies’ access strategies where
the use of LMIC refers to lower-middle
income countries as per the World Bank

income groups classification. Likewise, theterms LIC and UMIC refer to low income
countries and upper-middle income
countries.
*In the 2021 Index, dense ranking wasused. In the 2022 Index, standard

competitive ranking is used. Therefore, adirect comparison with Astellas' previous
rank is not possible.

Access to Medicine Index 2022 ▶ Company report cards

SALES AND OPERATIONSBusiness segments: Pharmaceutical

Astellas' products are sold in 49 out of 108

Therapeutic areas: Immunology, oncology

countries in scope of the Index. Astellas

Revenue by segment (2021) – in JPY

and urology.

has sales offices in 14 countries, and sells via

Pharmaceutical

Product categories: Innovative medicines

suppliers and/or pooled procurement in an		

M&A news: Astellas acquired its own shares andadditional 35 countries.

Total

1,323.00 bn
1,323.00 bn

cancelled its treasury stock in March 2022 for
JPY 29.4 billion.

Sales by geographic region
Revenue (Bn JPY)

Sales in countries in scope

1,400
1,200
1,000
800
600
400
200
0

In scope, has sales offices
In scope, any sales

2017

2018

2019

International/Others

In scope, no sales

Europe/Canada/Australia

Not in scope

2020

2021

China/Taiwan/Hong Kong
Japan

USA

SAMPLE OF PIPELINE AND PORTFOLIO ASSESSED BY THE INDEXPIPELINE for diseases in scope

PORTFOLIO as selected for analysis by the Index

Astellas has a total of 23 R&D projects in scope, with six projects target-

Astellas has six medicines in scope, four of which are on patent. 50% of

ing a priority disease. The other 17 R&D projects target other diseases inthese medicines (3) are on the WHO EML. The off-patent medicines target

scope. Projects targeting priority diseases include schistosomiasis, Chagas

cancer (1) and HIV/AIDS (1). The on-patent medicines target cancer (3) anddisease and leishmaniasis. Of projects targeting other diseases in scope,diabetes mellitus (1).

the focus is oncology (14 projects).
Four R&D projects are in late-stage development that target either a priority disease (1) or address a public health need in LMICs (3).* Evidence ofaccess planning was in place for 100% of these projects.

23 projects in the pipeline

6 products as selected for analysis by the Index†

Communicable**3

Communicable** 0

Neglected tropical3

Neglected tropical 0Maternal and neonatal 0

Maternal and neonatal 0

17

0

20
30
40
50
projects in the pipeline

10

20
30
40
50
products on the market

Pre-clinical

Phase I

Phase II

Phase III

Registration/approval

Other***

Total

Vaccines

4

1

0

0

1

0

0

6

Contraceptives

Targets established R&D priorities

1

3

off patent

2

0

2

0

0

0

0

0

Addresses needs of LMICs*

1

1

1

1

0

4

Other projects in scope

9

2

1

1

0

13

Other

the clinical phase of development were
included for this analysis.
**Neglected tropical diseases, while also
communicable, are highlighted separately
throughout the Index.
***Other includes projects that have atechnical lifecycle and projects that fol-4

Medicines on patent

Diagnostics*50 diseases and 243 product gaps inscope have been established as a priority by global health stakeholders. For
other diseases, the Index used a set of criteria to determine which projects in thepipeline offer a clear public health benefit to patients in LMICs. Only projects in

Total

Discovery

WHO EML

Breakdown of products

Other

10

Breakdown of projects

153

1

Multiple categories

WHO EDL

05

Non-communicableMultiple categories 0

Non-EML

Non-communicable

‡

0
0

0
0

low a different development cycle (e.g.
diagnostics).
†Products included in the analysis wereselected using a set of criteria determinedby stakeholder consensus.
‡Other includes vector control products.

0

Access to Medicine Index 2022 ▶ Company report cards

Astellas Pharma Inc

GOVERNANCE OF ACCESSRANK 8SCORE 4.29

Has an access-to-medicine strategy with meas-ing premature deaths from non-communicablefraud-specific risk assessment, country risk-based

urable objectives, integrated with the overall

diseases by 2030. It facilitates accountabil-assessment, a continuous system to monitor

corporate strategy. Astellas performs strongly.

ity and transparency by consistently sharing theactivities, audits (both internal and external, cov-

It has an access strategy integrated across theoutcomes of its access-to-medicine activities,

ering third parties and in all countries where it

company business as one of its strategic goals inincluding its response to COVID-19, in a cen-

operates) and has formal processes to ensure

its Corporate Strategic Plan. The strategy cov-

tralised manner within its Access Accelerated

compliance with company standards by thirders all therapeutic areas in which the company isinitiative Year 4 Report.

parties. No breaches in countries in scope of

involved. The highest responsibility for access lies

the Index were publicly found in the period of

indirectly with the board, with the Sustainability

Performs above average in responsible promo-

Advisory Panel overseeing social activities, includ-tional practices. Astellas’ sales agents are noting access.

solely incentivised on sales volume targets. The

Publicly supports the Doha Declaration oncompany, however, sets sales incentives at the

TRIPS and Public Health. Astellas publicly shares

Provides evidence of financial access-related

individual level for agents. Astellas does not pub-support of the Doha Declaration on TRIPS andincentives at the executive level. Astellas per-licly disclose information related to transfers of

Public Health with regard to the Least Developed

forms well. It incentivises some senior executives

values to healthcare professionals in countries inCountries. However, it expresses reservations onto perform on certain access-related factors withscope of the Index (e.g., payments for attending

the use of compulsory licensing and states that

financial rewards. The CEO also has access-re-events or promotional activities) unless required

it does not believe IP protection is a primary fac-

lated incentives linked to its remuneration plan.

by local regulations, but it has a policy and guid-

tor in limiting access to health. There is evidence

ance limiting such transfers at the global level,of industry association lobbying on IP and theincluding in countries in scope of the Index.

usage of TRIPS flexibilities, namely compulsory

Publicly discloses outcomes of its
access-to-medicine activities. Astellas performs

analysis.

licensing, by national governments in some coun-strongly in transparency of access activities. It

Has a robust set of compliance controls totries in scope of the Index. As a member of the

publicly discloses commitments on improving

ensure that governance efforts are not under-industry association, Astellas, like all other mem-social sustainability, measurable goals, objectives,

mined by non-compliant or corrupt activities.

ber companies in scope of the Index, is by default

and targets for improving access to medicine in

Astellas performs strongly, demonstrating evi-

connected to this activity.

countries in scope of the Index, towards reduc-dence of all components looked for by the Index:

RESEARCH & DEVELOPMENTRANK 13SCORE 2.05

Access planning processes encompass all pro-tel in partnership with the Pediatric Praziquantel

These plans focus mainly on registration prepara-

jects in the pipeline. Astellas has a structured

Consortium.

tion in countries in scope.

R&D. The process is intended to be applied to allSome projects address a public health need in

Does not publicly disclose R&D investment

R&D projects (both in-house and collaborative)

LMICs,* with 100% (3/3) of late-stage candi-data disaggregated by disease category, prod-

for diseases in scope of the Index.

dates covered by access plans. In this analysis,

uct type or phase of development. Astellas does

Astellas has three late-stage R&D projects thatnot disclose disaggregated R&D investment data

A small-sized priority R&D pipeline comparedtarget a disease and/or product gap not yet

to global health organisations.

to its peers. Astellas has six projects, including

established as a priority by global health stake-one late-stage candidate in its pipeline that tar-holders. These projects are all deemed by the

No R&D capacity building initiatives included

gets a priority product gap. The company focuses

Index to offer a clear public health benefit forfor evaluation. There is no evidence — in theon various priority areas, including schistosomi-

people living in LMICs.* Primarily, these pro-public domain or disclosed to the Index — ofasis, Chagas disease and leishmaniasis. Astellas

jects have clinical trials in countries in scope of

R&D capacity building initiatives active during thehas an access plan in place for its late-stage can-the Index and/or are first-in-class molecules.

period of analysis that met inclusion criteria fordidate targeting a priority product gap. This plan

Most target cancer. Astellas provides evidence ofevaluation. Astellas' performance is below aver-is for the development of paediatric praziquan-access plans for all three late-stage candidates.

age in this area.

process in place to develop access plans during

PRODUCT DELIVERYRANK 16SCORE 2.18

Publicly commits not to enforce patents inthe patent statuses for small molecules in scope

third-party researchers. Astellas engaged incountries in scope. Astellas publicly pledges

via the Pat-INFORMED database. Astellas dis-

one new IP-sharing agreement with third-party

to neither file for nor enforce patents in Least

closes patent information such as filing date,research institutions or drug discovery initiatives

Developed Countries and LICs.

grant number, grant date and jurisdiction.

established during the current analysis period

Publicly discloses information on patent status.

Is an average-performing company in terms ofcompany does have existing agreements of thisLike most of its peers, Astellas publicly discloses

sharing intellectual property (IP) assets withnature in place that were established before thethat meets all inclusion criteria for evaluation. The

154*50 diseases and 243 product gaps inscope have been established as a priority
by global health stakeholders. For otherdiseases, the Index used a set of criteria
to determine which projects in the pipeline offer a clear public health benefit topatients in LMICs. Projects in the clinicalphase of development were included forthis analysis.

Access to Medicine Index 2022 ▶ Company report cards

current Index cycle and meet all inclusion criteria

the UMIC example provided. Evidence of patient

populations) in LMICs. Astellas performs below

for evaluation.

reach is available for two products in UMICs.

average in this area.

No use of licensing agreements. Astellas does

No manufacturing capacity building initiatives

Performs above average in terms of ensur-

not engage in voluntary licensing for products inincluded for analysis. There is no evidence — ining continuous supply of medicines in LMICs.

scope of the Index. It publicly states it would con-the public domain or disclosed to the Index — of

Although there is no evidence of technology

sider granting non-exclusive voluntary licences inmanufacturing capacity building initiatives active

transfer initiatives that meet inclusion criteria forcertain circumstances.

during the period of analysis that met inclusion

evaluation, Astellas does have a system in place tocriteria for evaluation. Astellas' performance iswork with relevant stakeholders to communicate

below average in this area.

issues that may affect the supply chain, has a dual

Filed to register new products in two countries
in scope on average. Astellas did not disclose

active pharmaceutical ingredient sourcing strat-

evidence of filing for registration any of its new

The one supply chain capacity building ini-egy for some products and is involved in supply

products in any of the top ten high burden coun-tiative included for analysis meets all Good

chain capacity building initiatives. The company

tries. Among old products, its most widely filed isPractice Standards. Astellas' performance ismanages a buffer stock of relevant products inenzalutamide (Xtandi™), for prostate cancer, filed

average in this area. The number of initiatives

countries with Astellas warehouses and oth-in 40 countries in scope of the Index. The productmeeting all inclusion criteria is lower than aver-erwise works to ensure that third parties havereaching most LICs is micafungin (Mycamine®),age and fewer initiatives meet all Good Practicerelevant stocks.

used in HIV/AIDS complications, filed in six of theStandards (GPS) than what is average for this27 LICs within scope of the Index.

indicator. The Astellas Global Health Foundation

Has a policy for reporting substandard and fal-

partners with Academic Model Providing Accesssified medicines in countries in scope of theAstellas is not eligible for assessment of supra-

to Healthcare (AMPATH) to build ancillary support

Index in less than ten days. Astellas has a policy

nationally procured products.

services including pharmaceutical supply chains,for reporting falsified medicines within ten days

electronic health records and medical supplies toto national health authorities and the WHO, but

Has access strategies for some of the health-deliver mental health services in Kenya. This initi-

applies a separate process to substandard med-care-practitioner-administered products inative meets all GPS.

icines. It provides evidence of shortened time

scope of this analysis. Astellas performs below

frames for reporting for cases which only require

average in this area. For one of the two prod-

One of the four health systems strengthen-visual inspection by experts to be confirmed anducts assessed, the company provides evidence

ing initiatives included meets all Good Practice

are not contingent upon laboratory analysis.

of pricing strategies considering some affordabil-Standards. Astellas' performance is below aver-ity factors for all assessed income levels (UMIC,

age in this area. The number of initiatives meeting

Donates in response to expressed need and

LMIC, LIC). For example, Astellas applies a pric-

all inclusion criteria is average but fewer initia-

monitors delivery. Astellas has public policies

ing strategy that considers relevant payers’ ability

tives meet all GPS than what is average for thisand supply processes in place to ensure ad hoc

to pay for micafungin (Mycamine®) in a UMIC.

indicator. The Astellas Global Health Foundation

donations are carried out rapidly in response toPatient reach is available for one product only inawarded a grant to the END Fund which works

expressed need, and it monitors the delivery of

a UMIC.

to deliver neglected tropical disease (NTD)

donations.

treatments through mass drug administration
Has access strategies for some of its self-ad-mechanisms designed to control and eliminate

Has no long-term donation programmes forministered products for some countries in

NTDs in the Democratic Republic of Congo. This

neglected tropical diseases (NTDs) or malaria

scope for this analysis. Astellas performs below

initiative meets all GPS.

that are eligible for analysis under this indicator. Astellas is not engaged in any structured

average in this area. For one of the three prod-155

ucts assessed, the company provides examples

Has no inclusive business models that meet

donation programmes for NTDs or malaria whereof access strategies which consider affordability

all inclusion criteria. There is no evidence thatelimination, eradication or control goals are pos-factors in countries of all assessed income levels

Astellas has engaged in the piloting or scale-up ofsible and that are eligible for analysis under this(UMIC, LMIC, LIC). For example, Astellas applies

any inclusive business models that aim to meetindicator.

a pricing strategy that considers relevant pay-

the access needs of populations at the base ofers’ ability to pay for enzalutamide (Xtandi™) in

the income pyramid (including other underserved

Access to Medicine Index 2022 ▶ Company report cards

RA N KSCO R E33.93

7 (2021)

AstraZeneca plc
Stock exchange: LSE • Ticker: AZN • HQ: Cambridge, United Kingdom • Employees: 83,100

PERFORMANCE IN THE 2022 INDEX
3rd place. AstraZeneca ranks among the top three companies
in the Index. The company performs well in all three Technical
Areas, particularly in its approach to patent transparency andsharing of intellectual property assets. It has strengthened

How score was achieved
4.43

Governance of Access
3.03

Research & Development

4.29

Product Delivery

its performance in R&D access planning, as well as

01

manufacturing and supply chain capacity building.

2

3

Average

Leader4

5

Governance of Access: 2nd place. AstraZeneca has a strong
performance in this area. It has an access-to-medicine strat-

the companies. Furthermore, it performs well in R&D capac-

egy integrated into its overall corporate strategy and a robust

ity building.

set of compliance controls to mitigate the risk of non-compliance in countries in scope of the Index. It also incentivises its

Product Delivery: 1st place. AstraZeneca leads in this area. In

senior executives, the CEO and in-country and regional man-all product categories, it applies tailored access strategies

agers to perform on access-to-medicine goals.

across different country income classifications. It also excels
in its approach to access strategies for supranationally pro-Research & Development: 6th place. AstraZeneca performs

cured products. The company has shared the highest number

well in this area. It has a structured access planning processof intellectual property assets to third-party research-in place and applies this to nearly all late-stage candidates.

ers. Furthermore, the company has piloted both new andAlthough its priority pipeline is small compared to its peers,scaled-up existing inclusive business models and it engages in

it has the largest pipeline for non-communicable diseases ofmany high-quality capacity building initiatives across all fields.

OPPORTUNITIES FOR ASTRAZENECACHANGES SINCE THE 2021 INDEX

Improve the quality and geographic coverage of access plans. AstraZeneca has project-• Created a dedicated vaccines and immune therapies

specific access plans in place for almost all late-stage R&D candidates. These plans focus
mostly on registration in the emerging markets of Brazil, India and China. In its plans, thecompany can include more access components such as equitable pricing and licensing.

unit for COVID-19 vaccine and antibody treatments andthe existing portfolio for respiratory viral disease.
• Initiated two global training programmes —Furthermore, it can expand the geographic coverage of these plans to focus more on low-

Parexcel and UNIFY — to expand the pool of under-

income countries. For example, the access plan for nirsevimab, indicated for the prevention

represented principal investigators and clinical researchof respiratory syncytial virus, can be expanded to include more than five countries in scopeof the Index.

coordinators.
• Supplied more than two billion doses of COVID-19
vaccine (Vaxzevria) to LMICs at not-for-profit throughBring equitable pricing initiatives to scale. Through the Healthy Heart Africa (HHA)
initiative, the company identifies different levels of ability to pay and affordability in markets
to inform its pricing model. AstraZeneca can consider expanding the pricing model of HHA

private licensing agreements.
• Supplied its COVID-19 vaccine (Vaxzevria) through the
COVAX facility.

to other countries in sub-Saharan Africa that are not part of the programme yet, such

• Initiated new partnerships with the UK Royal Academy

as those with the highest burden of hypertensive disease, including the Central Africanof Engineering to strengthen healthcare innovation

Republic. The company can apply the HHA model to cover more therapeutic areas such as
diabetes and oncology.

across Africa.
• Expanded the Healthy Heart Africa (HHA) programme
to Senegal, Côte d’Ivoire, Rwanda and Nigeria. This

Expand access to its diabetes medicine, dapagliflozin (Farxiga/Forxiga®), through non-initiative aims to improve access to end-to-end

exclusive voluntary licensing and/or equitable pricing. The company has an access strategy

hypertension management and was recently expanded

for dapagliflozin across upper-middle income countries, lower-middle income countries andlow-income countries, including one of the countries with the highest burden of disease

to more therapeutic areas such as diabetes.
• Joined the Access to Oncology Medicines (ATOM)

for diabetes. AstraZeneca can provide evidence of implementing access strategies in

Coalition, a new global initiative that aims to improveother countries with high burdens of disease such as Sri Lanka, Kiribati and Micronesia foraccess to essential cancer medicines in LMICs.

example via equitable pricing and/or non-exclusive voluntary licensing agreements.
Expand access to cancer products such as osimertinib (Tagrisso®), through equitablepricing and/or non-exclusive voluntary licensing. The company has equitable accessstrategies in place in UMICs and LMICs. The company can provide evidence of expanding
access to the product in LICs and countries where the burden of the disease is highest, suchas China, Armenia and Thailand.

156

All companies were assessed based on
information that was valid in the latest
period of analysis (ending at 31 May2022). This data was either submitted bycompanies, found in the public domain or
was accessible through other sources.

The term LMICs is used to denote all
low- and middle-income countries inscope of the Index, except when analysing
companies’ access strategies where
the use of LMIC refers to lower-middle
income countries as per the World Bank

income groups classification. Likewise, theterms LIC and UMIC refer to low income
countries and upper-middle income
countries.

Access to Medicine Index 2022 ▶ Company report cards

SALES AND OPERATIONSBusiness segments: Pharmaceutical

AstraZeneca's products are sold in 62 out

Therapeutic areas: Biopharmaceuticalsof 108 countries in scope of the Index.

Revenue by segment (2021) – in USD(including cardiovascular, immunology,

AstraZeneca has sales offices in 19 countries,

Pharmaceuticalmetabolism, renal and respiratory), oncology andand sells via suppliers and/or pooled		rare diseases.

procurement in an additional 43 countries.

Total

37.42 bn
37.42 bn

Product categories: Innovative medicines andvaccines.
M&A news: AstraZeneca acquired Alexion
Pharmaceuticals in July 2021 for USD 13.3 billion.

Sales by geographic region
40

Revenue (Bn USD)

Sales in countries in scope

30
20
10
0

In scope, has sales offices
In scope, any sales

2017

2018

2019

Established Rest of WorldIn scope, no sales

EuropeNot in scope

2020

2021

Emerging Markets

USA

SAMPLE OF PIPELINE AND PORTFOLIO ASSESSED BY THE INDEXPIPELINE for diseases in scope

PORTFOLIO as selected for analysis by the Index

AstraZeneca has a total of 105 R&D projects in scope with four of these

AstraZeneca has 30 medicines in scope, 25 of which are on patent, andprojects targeting priority diseases. The other 101 R&D projects target

two vaccines. 22% of these medicines and vaccines (7) are on the WHO

other diseases in scope. Of the projects targeting priority diseases, theEML. The off-patent medicines target mainly non-communicable diseases

focus is on COVID-19 (three projects). Of the projects targeting other dis-

(NCDs) such as hypertensive heart disease (2), asthma (2) and cancer (1).

eases, the focus is on oncology (62).

The on-patent medicines also mainly target NCDs, such as diabetes mel-

Twenty-five R&D projects are in late-stage development that target

litus (8), cancer (8), and different respiratory diseases (7). In addition, theeither a priority disease (3) or address a public health need in LMICs (22).*

portfolio includes a COVID-19 vaccine and an influenza vaccine.

Evidence of access planning was in place for 96% of these projects: threetargeting a priority disease and 21 addressing a public health need in LMICs.

105 projects in the pipeline

32 products as selected for analysis by the Index†

4

Maternal and neonatal 1

Maternal and neonatal 0100

Non-communicable1

Multiple categories
040 60 80 100 120
projects in the pipeline

10

20
30
40
50
products on the market

Phase I

Phase II

Phase III

Registration/approval

Other***

Total

0

0

0

2

0

2

0

4

Contraceptives

Targets established R&D priorities

off patent

Addresses needs of LMICs*

5

5

4

0 27

Diagnostics

Other projects in scope

24 34 13

3

0 74

Other

*50 diseases and 243 product gaps inscope have been established as a priority by global health stakeholders. For
other diseases, the Index used a set of criteria to determine which projects in thepipeline offer a clear public health benefit to patients in LMICs. Only projects in13

the clinical phase of development were
included for this analysis.
**Neglected tropical diseases, while also
communicable, are highlighted separately
throughout the Index.
***Other includes projects that have atechnical lifecycle and projects that fol-

‡

Total

Pre-clinical

Vaccines

Medicines on patent

Other

Discovery

WHO EML

Breakdown of products
WHO EDL

20

Breakdown of projects

157

29

Non-communicableMultiple categories 002Communicable**

Neglected tropical 0

Non-EML

Communicable**

Neglected tropical 0

25

3 22
3

2

5

1

1

2

0

0

0
0

0
0

low a different development cycle (e.g.
diagnostics).
†Products included in the analysis wereselected using a set of criteria determinedby stakeholder consensus.
‡Other includes vector control products.

0

Access to Medicine Index 2022 ▶ Company report cards

AstraZeneca plc

GOVERNANCE OF ACCESSRANK 2SCORE 4.43

Has an access-to-medicine strategy with meas-

goals, objectives and 2025 targets for improv-

the Index: fraud-specific risk assessment, coun-urable objectives, integrated within the overall

ing access to healthcare in countries in scope.

try risk-based assessment, a continuous system

corporate strategy. AstraZeneca performs

It facilitates accountability and transparency by

to monitor activities, audits (both internal andstrongly. It has an access to healthcare strat-

consistently sharing the outcomes of its accessexternal, covering third parties and in all coun-egy integrated within its core business, beyond

to healthcare programmes, including its Healthy

tries where it operates) and has formal processes

philanthropy. The strategy covers all therapeu-

Heart Africa and Healthy Lung initiatives, in a cen-

to ensure compliance with company standards

tic areas the company is involved in. The highest

tralised manner within its ESG Report.

by third parties, including contract language andresponsibility for access lies directly with thetraining on the AstraZeneca Code of Ethics. No

board, with a dedicated board of directors mem-

Performs above average in responsible pro-breaches in countries in scope of the Index were

ber responsible for sustainability, including accessmotional practices. AstraZeneca’s sales agents

publicly found in the period of analysis.

to healthcare.

are not solely incentivised on sales volume
targets. The company, however, does not dis-Publicly supports the Doha Declaration on

Provides evidence of financial and non-financial

close the level at which sales incentives are set.

TRIPS and Public Health. AstraZeneca pub-access-related incentives at the executive level.

AstraZeneca does not publicly disclose informa-

licly shares support of the Doha Declaration on

AstraZeneca performs strongly. It incentivises

tion related to transfers of values to healthcare

TRIPS and Public Health, but expresses reser-

select senior executives and in-country managers

professionals in countries in scope of the Index

vations on its provisions, namely on the use of

to perform on access to medicine with finan-(e.g. payments for attending events or pro-compulsory licensing. There is evidence of indus-

cial and non-financial rewards and the CEO has

motional activities) unless required by local

try association lobbying on IP and the usage ofaccess-related incentives linked to its ESG perfor-

regulations, but has policies on third party

TRIPS flexibilities, namely of compulsory licens-mance. For example, AstraZeneca's "Contribution

engagement, which can limit compensation anding, by national governments in some countries into society KPI" measures progress on annual andgovern contributions and other items to health-scope of the Index. As a member of the industry

long-term targets and includes "Access to health-care professionals under certain circumstances.

association, AstraZeneca, like all other mem-care" as one of three pillars of sustainability.

ber companies in scope of the Index, is by default
Has a robust set of compliance controls to

Publicly discloses outcomes of its

ensure that governance efforts are not under-access-to-medicine activities. AstraZeneca per-mined by non-compliant or corrupt activities.

forms strongly in transparency of access activities.

AstraZeneca performs strongly, demonstrat-

It publicly discloses commitments, measurable

ing evidence of all components looked for by

RESEARCH & DEVELOPMENTRANK 6connected to this activity.

SCORE 3.03

Access planning processes encompass all

CEPI and Gavi and a licensing agreement with

AstraZeneca does not not disclose disaggre-

projects in the pipeline. AstraZeneca has a

Serum Institute of India (SII) to supply one billion

gated R&D investment data to global healthstructured process in place to develop accessdoses for LMICs.

organisations.

applied to all R&D projects (both in-house andMany projects address a public health need inThree of the five R&D capacity building ini-

collaborative) for diseases in scope of the Index.

LMICs,* with 95% (21/22) of late-stage pro-tiatives included meet all Good PracticeIn general, AstraZeneca begins developing accessjects covered by access plans. In this analysis,

Standards. AstraZeneca's performance is aboveplans for R&D projects in Phase II/III of clinicalAstraZeneca has 22 late-stage R&D projects in its

average in this area. The number of initiatives

development.

pipeline that target a disease and/or product gap

meeting all inclusion criteria is higher than aver-

not yet established as a priority by global healthage and more initiatives meet all Good Practice

A small-sized priority R&D pipeline comparedstakeholders. These projects are all deemed byStandards (GPS) than what is average for thisto its peers, with access plans in place for 100%

the Index to offer a clear public health benefit forindicator. For example, AstraZeneca's collabora-(3/3) of the late-stage candidates analysed.

people living in LMICs.* Primarily, these projects

tion with the Cancer Research and Clinical Trials

AstraZeneca has four projects, including three

concern clinical trials in countries in scope of theCentre (CRCTC) builds R&D oncology capacity inlate-stage candidates in its pipeline, that target

Index and/or are first-in-class molecules. These

Vietnam through treatment development, med-a priority product gap. These focus mostly on

projects target several diseases including cancer

ical research and continuous medical education.

coronaviral diseases. Of AstraZeneca's three late-

and kidney diseases. AstraZeneca provides evi-

This initiative meets all GPS.

stage candidates targeting a priority product gap,

dence of access plans for 21 of these projects.

all have evidence of access plans. These include

These plans focus mainly on registration prepara-commitments to register in countries in scope oftion in countries in scope of the Index.

plans during R&D. The process is intended to be

the Index. Furthermore, the plan for the COVID-

158

19 vaccine (Vaxzevria) includes manufacturing,

Publicly discloses disaggregated R&D invest-

procurement and distribution agreements withment data by phase of development. However,*50 diseases and 243 product gaps inscope have been established as a priority
by global health stakeholders. For otherdiseases, the Index used a set of criteria
to determine which projects in the pipeline offer a clear public health benefit topatients in LMICs. Projects in the clinicalphase of development were included forthis analysis.

Access to Medicine Index 2022 ▶ Company report cards

PRODUCT DELIVERYRANK 1SCORE 4.29

Public commitment not to enforce patents in

Has access strategies for the majority ofstructure, awareness programmes and training ofcountries in scope. AstraZeneca publicly pledges

healthcare practitioner-administered products

stakeholders along the patient journey.

to neither file for nor enforce patents in a sub-in scope of this analysis. AstraZeneca performs

set of Index countries. This commitment applies

above average in this area compared to otherHas engaged in scaling up two and piloting

to 80 countries in scope of the Index, of which

companies. For all five products assessed, thetwo inclusive business models. AstraZeneca

all Least Developed Countries and LICs in scope,company provides examples of access strategies

performs above average in the use of inclusive

and a subset of LMICs and UMICs. In sub-Saharanwhich consider affordability in UMICs and LMICs.

business models aimed at meeting the access

Africa, all countries are part of the commitment

It makes efforts to reach additional patients usingneeds of populations at the base of the income

beside Ghana, Kenya, Nigeria and South Africa.

pricing strategies that consider relevant payers'

pyramid (including other underserved popula-

The policy covers all products in the scope of theability to pay and additional financing mecha-tions) in LMICs. As part of the One Young World

Index and publicly discloses the list of countries.

nisms. For example, AstraZeneca set a direct

Lead2030 programme, AstraZeneca has awarded

distribution system for healthcare centres infunding to BIVE, a model that facilitates access to

Publicly discloses detailed information on pat-

Uganda to ensure supply stability and price reduc-timely, high quality and affordable private health-ent status. AstraZeneca publicly discloses on its

tion of goserelin acetate (Zoladex®). Evidence ofcare services for more than 19,000 Colombian

website information relating to the status of its

an increase in patient reach in Uganda is provided.

people, the majority being low-income coffee

patents for all products in its Index portfolio. This

farmers.

includes brand name, nature of the patent, patent

Has access strategies for the majority of its

number, expiry date and jurisdiction.

self-administered products for countries in

Performs above average in terms of ensur-

scope of this analysis. AstraZeneca has an above

ing continuous supply of medicines in LMICs.

Performs above average in terms of sharing

average performance in this area. For three of

AstraZeneca is involved in technology transfers

intellectual property (IP) assets with third-

the five products assessed, the company pro-with third-party manufacturers in LMICs, and has

party researchers. AstraZeneca engaged invides examples of access strategies whicha system in place to work with relevant stake-14 new IP-sharing agreements with third-party

consider affordability in countries of all assessedholders to communicate issues that may affectresearch institutions or drug discovery initiatives

income levels (UMIC, LMIC, LIC). It makes efforts

the supply chain, works with several active phar-established during the current period of analysis

to reach additional patients using pricing strate-

maceutical ingredient (API) suppliers/produces

that meet all inclusion criteria for evaluation. The

gies that consider relevant payers' ability to pay

in-house APIs, manages a buffer stock of relevant

company does have existing agreements of thisand patient assistance programmes. For example,

products and is involved in supply chain capacity

nature in place that were established before theAstraZeneca has secured public reimbursementbuilding initiatives.

current period of analysis and meet all inclusionof osimertinib (Tagrisso®) in Egypt, where patient

criteria for evaluation.

reach has increased.

Uses licensing agreements to enable generic

All five manufacturing capacity building ini-

the Index in less than ten days. AstraZeneca has

supply. AstraZeneca has private, voluntary licens-tiatives included for analysis meet all Gooda policy for reporting SF medicines to national

ing agreements in place for one product, its

Practice Standards. AstraZeneca is a leader

health authorities within five days. It provides evi-

COVID-19 vaccine (Vaxzevria). Details of thesein this area. The number of initiatives meeting

dence of shortened time frames for reporting

agreements are not publicly available.

all inclusion criteria is higher than average andcases which only require visual inspection to be

more initiatives meet all Good Practice Standards

confirmed and aims to report within three work-

Filed to register new products in ten countries(GPS) than what is average for this indicator.

ing days when packaging is sufficient to assess

in scope on average. AstraZeneca filed two out

For example, AstraZeneca has conducted a fullthe case.

of nine newer products in a subset of high bur-technology transfer to Siam Biosciences for its

den disease countries. Among new products, its

COVID-19 vaccine (Vaxzevria).

Has a policy for reporting substandard and falsified (SF) medicines in countries in scope ofindicated for leukaemia, filed in 23 countries

All five supply chain capacity building initi-

icies and supply processes in place to ensure adin scope of the Index, including Ecuador andatives included for analysis meet all Goodhoc donations are carried out rapidly in response

Ukraine among the top ten high burden disease.

Practice Standards. AstraZeneca is one of theto expressed need, and it monitors the delivery of

Durvalumab (Imfinzi®) has been registered in 22

leaders in this area. The number of initiatives

donations until they reach the patient.

countries within the scope of the Index, five of

meeting all inclusion criteria is higher than aver-which are high-burden countries (China, Republic

age and more initiatives meet all GPS than what

Has no long-term donation programmes forof Moldova, Thailand, Ukraine and Vietnam).

is average for this indicator. For example, in theneglected tropical diseases or malaria that

None of its products assessed are filed for regis-

United for Health Partnership with the Egyptian

are eligible for analysis under this indicator.

tration in any LIC.

Government, AstraZeneca provides support andHowever, AstraZeneca is engaged in anothereducation to governmental pharmacists throughstructured donation programme: the Cambodia

Has access strategies for its supranation-a structured programme that involves supply

Breast Cancer Initiative whereby it has been

ally procured product in scope of this analysis.

chain management training and scholarships.

donating anastrozole (Arimidex®) and fulvestrant

AstraZeneca leads in securing access for its prod-

159

Donates in response to expressed need andmonitors delivery. AstraZeneca has public pol-most widely filed is acalabrutinib (Calquence®),(Faslodex®) to Cambodia since 2008.

uct procured supranationally. For the product

Four of the five health systems strengthen-assessed in this category, the COVID-19 vaccine

ing initiatives included meet all Good Practice(Vaxzevria), it demonstrates access strategies

Standards. AstraZeneca's performance is above

both in countries eligible for supply from suchaverage in this area. The number of initiatives

procurers and in countries that procured themeeting all inclusion criteria is higher than aver-

vaccine outside the supranational agreement.

age and more initiatives meet all GPS thanThe company provides evidence of an addi-

what is average for this indicator. For example,

tional access strategy to increase patient reach.

AstraZeneca's new initiative PUMUA aims to build

Evidence of patient reach is available.

capacity for asthma care in Africa through infra-

Access to Medicine Index 2022 ▶ Company report cards

RA N KSCO R E9

3.36

13 (2021)

Bayer AG
Stock exchange: XFRA • Ticker: BAYN • HQ: Leverkusen, Germany • Employees: 99,637

PERFORMANCE IN THE 2022 INDEX
9th place. Bayer ranks among the top ten companies of theIndex. It performs strongly in access strategies for healthcare
practitioner-administered products. The company has also
strengthened its performance in inclusive business models

How score was achieved
4.29

Governance of Access
2.65

Research & Development

3.49

Product Delivery

and in access planning during R&D.

0

1

Governance of Access: 8th place. Bayer performs well in this2

3

Average

Leader4

5

area. It has an access-to-medicine strategy integrated into
its overall corporate strategy, although the strategy covers
only some of its therapeutic areas. It incentivises senior executives and in-country and regional managers to perform on

the Index compared to its peers. However, the company’s per-access-to-medicine goals and has a robust set of complianceformance in R&D capacity building is below average.

controls to mitigate the risk of non-compliance in countries in
Product Delivery: 9th place. Bayer has an above average per-scope of the Index.

formance. The company has comprehensive access strategies
Research & Development: 10th place. Bayer's performance isfor some of its products but lacks access strategy examples

average in this area. It now has a structured access planningin low-income countries for its self-administered products.

process in place and applies this to most late-stage pipeline

Bayer has also both scaled-up and piloted inclusive businesscandidates. Although it has a small-sized priority R&D pipe-

models and performs well in supply chain capacity building.

line, its access plans include the most countries in scope of

OPPORTUNITIES FOR BAYERCHANGES SINCE THE 2021 INDEX

Ensure all late-stage R&D projects have comprehensive access plans. Bayer has• Established an ESG committee in January 2022 at the

introduced a structured process for access planning beginning in Phase II of clinicaldevelopment. It has access plans in place for 80% of late-stage candidates analysed. The
company can expand its access plans to all R&D projects from Phase II onwards.

supervisory board level.
• Invests over EUR 400 million to construct a production site
for contraceptives in Costa Rica and expand a production
site in Finland, both of which will supply to LMICs.

Expand access to on-patent cancer products in lower-middle and low-income• Introduced a structured framework to include accesscountries, such as darolutamide (Nubeqa®). Bayer has access strategies in UMICs
for darolutamide, indicated for prostate cancer. The company can provide evidenceof expanding access to the product via equitable access strategies and registration inlower-middle income countries, low-income countries and countries with a high burdenof disease such as Guyana and Suriname. In addition, the company can expand accessto sorafenib (Nexavar®), indicated for thyroid and liver cancer, via equitable accessstrategies and registration in LICs and in countries with a high burden of disease such as
Bolivia, Guinea and Gambia.

planning in the development process early on for all its
pipeline projects (both in-house and collaborative).
• Received first approval for nifurtimox (Lampit®) indicatedfor paediatric Chagas disease.
• Began to report disaggregated R&D investment data to
Policy Cures Research.
• Opened two new hubs in Pakistan and the Philippines
for The Challenge Initiative (TCI), a platform that enables
governments to scale up family planning approaches for the

Expand technology transfer initiatives for reproductive health commodities toadditional countries. Bayer has previously transferred technology for its hormonal

urban poor.
• Extended its commitment with the World Healthcontraceptive products to manufacturers in LMICs such as Algeria and Morocco. Bayer

Organization (WHO) for an additional five years to

can expand the geographic scope of these technology transfers to build manufacturing

accelerate control and elimination of neglected tropicalcapacity and improve regional availability in countries or regions with specific accessdiseases including the donation of medicines for treatment

gaps.

of chagas disease and African trypanosomiasis (sleeping
sickness), estimated at USD 8 million.
• Donated over USD 3.8 million in products to the UNFPA
as well as USD 1 million for logistical supply chain support
during the COVID-19 pandemic.
• Received WHO Prequalification (PQ) (RH100) for
levonorgestrel-releasing intrauterine system (Mirena®).
All contraceptive products sold under supranational
programmes have now received WHO PQ.

160

All companies were assessed based on
information that was valid in the latest
period of analysis (ending at 31 May2022). This data was either submitted bycompanies, found in the public domain or
was accessible through other sources.

The term LMICs is used to denote all
low- and middle-income countries inscope of the Index, except when analysing
companies’ access strategies where
the use of LMIC refers to lower-middle
income countries as per the World Bank

income groups classification. Likewise, theterms LIC and UMIC refer to low income
countries and upper-middle income
countries.

Access to Medicine Index 2022 ▶ Company report cards

SALES AND OPERATIONSBusiness segments: Consumer health, crop

Bayer's products are sold in 95 out of 108

science and pharmaceutical.

countries in scope of the Index. Bayer has sales

Net sales by segment (2021) – in EUR

Therapeutic areas: Cardiology, oncology,

offices in 38 countries, and sells via suppliers

Crop science

20.21 bn

ophtalmology, radiology and women's health.

and/or pooled procurement in an additional 57

Pharmaceutical

18.35 bn

Product categories: Innovative medicines.

countries.

Consumer health5.29 bn

M&A news: Bayer acquired Vividion

		Therapeutics in August 2021 for USD 1.5 billion.

Total

Sales in countries in scope

Sales by geographic region

43.85 bn

Net sales (Bn EUR)

50
40
30
20
10
0

In scope, has sales offices
In scope, any sales

2017

2018

2019

Europe/Middle East/Africa

In scope, no sales

Latin America

Not in scope

2020

2021

Asia-PacificNorth America

SAMPLE OF PIPELINE AND PORTFOLIO ASSESSED BY THE INDEXPIPELINE for diseases in scope

PORTFOLIO as selected for analysis by the Index

Bayer has a total of 29 R&D projects in scope with ten of these pro-

Bayer has 13 medicines in scope and seven contraceptive methods andjects targeting priority diseases. The other 19 R&D projects target otherdevices. Of the medicines, eight are on patent. Of the 20 medicines anddiseases in scope. Six projects concern vector control products. Of the pro-contraceptive products, 55% (11) are on the WHO EML. In addition, thejects targeting priority diseases, the focus is on malaria (three projects). Of

company markets 13 vector control products. The off-patent medicines

the projects targeting other diseases, the focus is on kidney diseases (4)target mainly women health, these include contraceptive methods (5) andand oncology (10).

target neglected tropical diseases, such as human African trypanosomia-

Ten R&D projects are in late-stage development that target either a prior-sis (3). The on-patent medicines mainly target non-communicable diseases

ity disease (4) or address a public health need in LMICs (6).* Evidence ofsuch as cancer (5) and kidney diseases (2). The vector control products

access planning was in place for 80% of these projects: four targeting a pri-target communicable diseases such as dengue and chikungunya (8) andority disease and four addressing a public health need in LMICs.

malaria (12).

29 projects in the pipeline

33 products as selected for analysis by the Index†

Communicable**5

Communicable**

6

Neglected tropical5

Neglected tropical4

Maternal and neonatal

6

Non-communicable

8

Maternal and neonatal 0

19

Multiple categories 0

10

20
30
40
50
products on the market

Pre-clinical

Phase I

Phase II

Phase III

Registration/approval

Other***

0

0

1

1

2

4 10

Total

Discovery

2

Targets established R&D priorities

Addresses needs of LMICs*

4

2

0

4

0 10

Other projects in scope

3

3

2

1

0

*50 diseases and 243 product gaps inscope have been established as a priority by global health stakeholders. For
other diseases, the Index used a set of criteria to determine which projects in thepipeline offer a clear public health benefit to patients in LMICs. Only projects in9

the clinical phase of development were
included for this analysis.
**Neglected tropical diseases, while also
communicable, are highlighted separately
throughout the Index.
***Other includes projects that have atechnical lifecycle and projects that fol-

Total

Breakdown of products
WHO EML

Breakdown of projects

161

9
0

20
30
40
50
projects in the pipeline

Other

10

Non-EML0

Multiple categories

WHO EDL

Non-communicable

8

Medicines on patent2

6

off patent

5

0

5

Vaccines000Contraceptives

43

Diagnostics
Other‡

7
0

0

13 13

low a different development cycle (e.g.
diagnostics).
†Products included in the analysis wereselected using a set of criteria determinedby stakeholder consensus.
‡Other includes vector control products.

Access to Medicine Index 2022 ▶ Company report cards

Bayer AG

GOVERNANCE OF ACCESSRANK 8SCORE 4.29

Has an access-to-medicine strategy with meas-

publicly discloses its commitments, measura-dence of all components looked for by the Index:

urable objectives, integrated within the overall

ble goals, objectives and targets for sustainability

fraud-specific risk assessment, country risk-based

corporate strategy. Bayer performs strongly. It

and improving access to medicine in countries

assessment, a continuous system to monitor

has an access strategy aiming at increasing thein scope of the Index. It facilitates accountabil-

activities, audits (both internal and external, cov-

societal impact of its business activities. The

ity and transparency by consistently sharing theering third parties and in all countries where it

strategy covers most therapeutic areas in which

outcomes of its access-to-medicine activities inoperates) and has formal processes to ensure

the company is involved, mainly focusing on wom-a centralised manner within its Patient Accesscompliance with company standards by third

en’s health and access to contraceptives. The

Charter and ESG Report.

parties. No breaches in countries in scope ofhighest responsibility for access lies directly with

the Index were publicly found in the period of

the board, with the Chief Sustainability Officer.

Performs above average in responsible pro-Furthermore, in 2022 Bayer established an ESG

motional practices. Bayer’s sales agents arecommittee at supervisory board level to oversee

not solely incentivised on sales volume targets.

Publicly supports the Doha Declaration onaccess-related goals.

However, Bayer sets sales incentives at the indi-

TRIPS and Public Health. Bayer publicly sharesvidual level for agents. The company does notsupport of intellectual property rights in line with

Provides evidence of financial and non-financial

publicly disclose information related to transfers

the TRIPS Agreement, while highlighting a needaccess-related incentives at the executive level.

of values to healthcare professionals in countries

for appropriate measures in place for the devel-

Bayer performs strongly. It incentivises its seniorin scope of the Index (e.g. payments for attending

opment of innovative products. There is evidence

executives and in-country managers to take action

events or promotional activities) unless requiredof industry association lobbying on intellectualon access to medicine with financial and non-fi-

by law, but it does have a Fair Market Value policy

property and the usage of TRIPS flexibilities,

nancial rewards. The CEO also has access-related

to facilitate appropriate transfers.

namely of compulsory licensing, by national gov-

incentives linked to sustainability goals.

ernments in some countries in scope of the Index.
Has a robust set of compliance controls to

As a member of the industry association, Bayer,

Publicly discloses outcomes of its

ensure that governance efforts are not under-

like all other member companies in scope of theaccess-to-medicine activities. Bayer performs

mined by non-compliant or corrupt activities.

Index, is by default connected to this activity.

strongly in transparency of access activities. It

Bayer performs strongly, demonstrating evi-

RESEARCH & DEVELOPMENTRANK 10SCORE 2.65

Access planning processes encompass all pro-notable example is the development of paediat-

jects in the pipeline. Bayer has a structured

ric nifurtimox (Lampit®) to treat Chagas disease.

Does not publicly disclose R&D investment

process in place to develop access plans during

Registration in additional endemic high dis-data disaggregated by disease category, prod-

R&D. The process is intended to be applied to allease-burden countries is planned for this project.

uct type or phase of development. However,R&D projects (both in-house and collaborative)

162

analysis.

Bayer does disclose fully disaggregated R&D

for diseases in scope of the Index. Bayer begins

Some projects address a public health need indeveloping access plans for R&D projects no later

LMICs,* with 67% (4/6) of late-stage projects

than Phase II of clinical development.

covered by access plans. In this analysis, Bayer

Two R&D capacity building initiatives included

has six late-stage R&D projects that target a dis-for evaluation. Neither initiative included for

A small-sized priority R&D pipeline comparedease and/or product gap not yet established as aanalysis meet all Good Practice Standards. Bayer's

to its peers, with access plans in place for 100%priority by global health stakeholders. These pro-performance is below average in this area. The(4/4) of the late-stage candidates analysed.

jects are all deemed by the Index to offer a clear

number of initiatives meeting all inclusion criteria

Bayer has ten projects, including four late-stage

public health benefit for people living in LMICs.*

is lower than average and fewer initiatives meetcandidates, in its pipeline that target a prior-Primarily, these projects concern clinical trials in

all Good Practice Standards than what is aver-ity product gap. These focus on various disease

countries in scope of the Index and/or are first-

age for this indicator. Bayer builds R&D capacity

areas including malaria, Chagas disease, Zika,

in-class molecules. The projects mainly focus on

in Vietnam, by providing technical assistance todengue and chikungunya. Of Bayer's four late-cancer and kidney diseases. Bayer provides evi-

PATH in developing an affordable and sustainablestage candidates targeting a priority product gap,

dence of access plans for four of these projects.

COVID-19 vaccine.

all have evidence of access plans. These plans

These access plans mainly focus on plans forrange from registration to a partnership with theregistration in countries in scope and the devel-

Drugs for Neglected Diseases initiative (DNDi). A

opment of an equitable pricing strategy.

*50 diseases and 243 product gaps inscope have been established as a priority
by global health stakeholders. For otherdiseases, the Index used a set of criteria
to determine which projects in the pipeline offer a clear public health benefit topatients in LMICs. Projects in the clinicalphase of development were included forthis analysis.

investment data to Policy Cures Research.

Access to Medicine Index 2022 ▶ Company report cards

PRODUCT DELIVERYRANK 9SCORE 3.49

Public commitment not to enforce patents inegies in countries of all assessed income levels

ments in countries in scope of the Index to scalecountries in scope. Bayer publicly pledges to(UMIC, LMIC, LIC). It also makes efforts to reachup high-impact family planning approaches forneither file for nor enforce patents. This commit-

additional patients through donations, suprana-

the urban poor. This initiative meets all GPS.

ment applies in LICs only, for all its products intional agreements and tenders. For example, in

scope of the Index.

Brazil, Bayer has donated this product throughHas engaged in scaling up three and piloting

the International Contraceptive Access (ICA)

two inclusive business models. Bayer performs

Publicly discloses information on patent status.

Foundation. In Egypt, Bayer reached an agree-

above average in the use of inclusive business

Like most of its peers, Bayer discloses the pat-ment with the Ministry of Health to include

models aimed at meeting the access needs ofent statuses for small molecules in scope via thethe contraceptive in the government’s Family

populations at the base of the income pyra-

Pat-INFORMED database. Bayer discloses pat-

Planning sector, and it will be provided for freemid (including other underserved populations) in

ent information such as filing date, grant number,to patients that cannot afford the contracep-

LMICs. Through the Bayer Foundation's Women

grant date and jurisdiction.

tive price while strengthening the health system

Empowerment Award, Bayer annually awards

via healthcare practitioner training and aware-

EUR 25,000 to scale the social enterprises of five

Performs below average in terms of sharing

ness campaigns. Bayer provides evidence of an

female entrepreneurs across sub-Saharan Africa.

intellectual property (IP) assets with third-

increase in patient reach.

An example from this cycle is Whispa health, aparty researchers. Bayer does not report on any

platform that connects users to local medical

new IP-sharing agreements with public research

Has access strategies for its self-administeredcentres, with the aim to be Africa's preferred sex-

institutions or drug discovery initiatives estab-

products for some countries in scope for thisual and reproductive health access provider.

lished during the current analysis period thatanalysis. Bayer performs below average in thismeet all inclusion criteria for evaluation. The

area. For three of the five products assessed,

Performs above average in terms of ensuring

company does have existing agreements of thisthe company provides evidence of pricing strat-

continuous supply of medicines in LMICs. Bayernature in place that were established before theegies considering payers' ability to pay in UMIC

is involved in technology transfers with third-

current period of analysis and meet all inclusionand LMIC country examples. Bayer was able toparty manufacturers in LMICs, and has a systemcriteria for evaluation.

secure rivaroxaban (Xarelto®) full reimbursementin place to work with relevant stakeholders toin Colombia in January 2022. In addition, it intro-

communicate issues that may affect the sup-No use of licensing agreements. Bayer does

duced a new patient programme that offers theply chain, has established multi-source networks

not engage in voluntary licensing for products infirst treatment cycle free of charge and supports

for active pharmaceutical ingredients in addition

scope of the Index.

patients in obtaining reimbursement coverage.

to in-house production and is involved in supply

Evidence that about 500 patients have been

chain capacity building initiatives. The company

Filed to register new products in six countries

included in the programme since December 2021

also manages a buffer stock of relevant products

in scope on average. Bayer did not disclose evi-is provided.

based on local medical needs assessments that

dence of filing for registration any of its new

inform supply risk management.

products in more than half of the top ten high

One of the three manufacturing capacity build-burden countries. Among old products, its mosting initiatives included meets all Good PracticeHas a policy for reporting substandard and fal-

widely registered is rivaroxaban (Xarelto®), an

Standards. Bayer's performance is average insified (SF) medicines in countries in scope of

antithrombotic medicine for several indications,this area. The number of initiatives meeting all

the Index in less than ten days. Bayer has a pol-including prevention of stroke. It has been filed

inclusion criteria is average but fewer initiatives

icy for reporting SF medicines to national healthin 68 countries within scope of the Index, includ-

meet all Good Practice Standards (GPS) thanauthorities within seven days for the most severeing 12 LICs. Bayer has filed rivaroxaban andwhat is average for this indicator. For the initia-

risk category. It does not provide evidence ofsorafenib (Nexavar), indicated for liver and thy-

tive that met all GPS, since 2019, Bayer has built

shortened time frames for reporting cases whichroid cancer, in more than half of the top ten highmanufacturing capacity of its partners by mak-only require visual inspection to be confirmed.

burden countries. sorafenib has been filed ining it mandatory for all contract manufacturing

Ecuador, Ethiopia, Honduras, Mongolia, Thailand

organisation sites to be audited according to

Donates in response to expressed need andand Vietnam.

the industry-wide Pharmaceutical Supply Chain

monitors delivery. Bayer has public policies

Initiative (PSCI) standards.

and supply processes in place to ensure ad hoc

Has access strategies for all its supranation-

donations are carried out rapidly in response toally procured products in scope of this analysis.

All three supply chain capacity building ini-

expressed need, and it monitors the delivery ofBayer has an average performance in securing

tiatives included for analysis meet all Good

donations.

access for products procured supranationally. For

Practice Standards. Bayer's performance isthree of the four products assessed in this cate-above average in this area. The number of initia-

Publicly commits to the achievement of elim-

gory, the company demonstrates that it applies

tives meeting all inclusion criteria is average, but

ination, eradication or control goals in two

the same pricing strategies both in UNFPA coun-more initiatives meet all GPS than what is average

structured donation programmes for neglected

tries eligible for supply from such procurers andfor this indicator. For example, Bayer is a partner

tropical diseases or malaria. In one programme,

in at least one country not eligible. The company

in the PSCI where it helps suppliers meet PSCI

Bayer publicly commits to controlling Chagas

provides evidence of patient reach, reporting

standards in several LMICs including India, China,

disease in endemic countries in Latin America

that between 24 and 25 million women received

Kenya and Nigeria.

as well as eliminating human African trypano-access to modern contraception annually during163

somiasis in endemic countries in Africa. The
Three of the four health systems strengthen-company publicly commits to donating nifurtimox

ing initiatives included meet all Good Practice(Lampit®) and suramin (Germanin®) for as long as

Has access strategies for the healthcare prac-

Standards. Bayer's performance is average inneeded until goals are reached.

titioner-administered product in scope of this

this area. The number of initiatives meeting all

analysis. Bayer performs above average in thisinclusion criteria is average and an average num-area. For the product assessed, levonorgestrel-re-

ber of initiatives meet all GPS for this indicator.

leasing intrauterine system (Mirena®/LNG-IUS),

For example, Bayer is a partner in The Challenge

the company provides examples of access strat-

Initiative (TCI) — a platform that enables govern-

the reporting period.

Access to Medicine Index 2022 ▶ Company report cards

RA N KSCO R E13

2.93

12 (2021)

Boehringer Ingelheim
Stock exchange: N/A • HQ: Ingelheim am Rhein, Germany • Employees: 52,391

PERFORMANCE IN THE 2022 INDEX
13th place. Boehringer Ingelheim is a middle-performing
company. The company has an average performance inGovernance of Access and Research and Development but
performs below average in Product Delivery. Boehringer

How score was achieved
4.00

Governance of Access
2.23

Research & Development

3.02

Product Delivery

Ingelheim has improved its R&D access planning framework

0

1

but does not publicly disclose the patent status of its
products via Pat-INFORMED.

2

3

Average

Leader4

5

small-sized priority pipeline and has an average performance
Governance of Access: 12th place. Boehringer Ingelheim

in R&D capacity building.

has an average performance in this area. It has a clear
access-to-medicine strategy and discloses outcomes of its

Product Delivery: 14th place. Boehringer Ingelheim has aaccess-to-medicine activities, but it lacks a continuous systembelow average performance in this area. The company has

to monitor activities as part of its compliance framework foraccess strategies for all its products but lacks examples incountries in scope of the Index.

low-income countries. It builds capacity in supply chains, manufacturing and health systems, though some initiatives lackResearch & Development: 12th place. Boehringer Ingelheim

evidence of certain quality standards such as public disclosure

has an average performance in this area. It has introduced aof outcomes. The company shares intellectual property assets

structured access planning framework and applies this to allwith third party researchers but does not publicly disclose thelate-stage pipeline candidates. However, the company has apatent status of its products via Pat-INFORMED.

OPPORTUNITIES FOR BOEHRINGER INGELHEIM

CHANGES SINCE THE 2021 INDEX

Improve the quality of access plans for late-stage R&D projects. Boehringer Ingelheim• Newly demonstrates access-related incentives for senior-

has introduced a new policy to systemically plan for access before Phase II of clinicaldevelopment and has plans in place for all late-stage candidates analysed. For noncommunicable diseases the company’s access plans focus mostly on registration incountries in scope of the Index. For example, for projects such as iclepertin (BI 425809)
for schizophrenia and BI 456906 for diabetes, Boehringer Ingelheim can include moreaccess components such as equitable pricing and licensing in its plans.

level executives.
• Created a Vulnerability Framework with input from different
organisations to ensure that its access-to-medicine
strategies are reaching all vulnerable populations.
• Newly demonstrates evidence that sales incentives aredecoupled from sales volume targets.
• Improved access planning during R&D by broadening its

Improve transparency of the patent status of its products. Boehringer Ingelheim

framework and implementing it to its entire pipeline, as well

publicly commits to not file for or enforce patents in 61 countries within the scope of theas ensuring that all access planning begins in pre-clinicalIndex, including all Least Developed Countries and low-income countries and a subset oflower-middle income countries and upper-middle income countries. The company candisclose detailed patent information publicly, either on its website or via Pat-INFORMED,
including for its biological products.

development.
• Established an office in Kenya to serve some of the mostvulnerable communities in sub-Saharan Africa and exploring
equitable access initiatives in the region.
• Committed (together with Boehringer Ingelheim Stiftung)Improve access to products on the WHO Model List of Essential Medicines (EML).

EUR 150 million into antibiotic R&D of which EUR 40 million

Boehringer Ingelheim engages in equitable pricing for some of its products. The

is already invested in the Antimicrobial Resistance (AMR)

company has seven products on the WHO EML. The company can further expand access

Action Fund, joint venture Aurobac and invested in fiveto these products, such as dabigatran (Pradaxa®), for prevention of stroke, and afatinib
dimaleate (Giotrif®/Gilotrif®), for lung cancer, via equitable pricing in LICs. Boehringer

biotech companies.
• Created the investment vehicle Boehringer Ingelheim Social

Ingelheim can engage in non-exclusive voluntary licencing for patented medicines forEngagement, endowed with EUR 50 million to provide

type 2 diabetes mellitus, such as empagliflozin (Jardiance®).

financing for impact to social businesses in vulnerable
communities, as an extension of Making More Health.
• Launched the new cervical cancer screening initiative
Together Women Can in partnership with AMPATH in
Kenya.

164

All companies were assessed based on
information that was valid in the latest
period of analysis (ending at 31 May2022). This data was either submitted bycompanies, found in the public domain or
was accessible through other sources.

The term LMICs is used to denote all
low- and middle-income countries inscope of the Index, except when analysing
companies’ access strategies where
the use of LMIC refers to lower-middle
income countries as per the World Bank

income groups classification. Likewise, theterms LIC and UMIC refer to low income
countries and upper-middle income
countries.

Access to Medicine Index 2022 ▶ Company report cards

SALES AND OPERATIONSBusiness segments: Animal health,

M&A news: Boehringer Ingelheim signed anbiopharmaceutical contract manufacturing,

option to acquire Trutino Biosciences in Junehuman pharmaceutical and other sales.

2022.

Net sales by segment (2021) – in EUR

Therapeutic areas: Cardiometabolic diseases,

Human pharmaceutical

15.29 bn

Animal health4.30 bncancer immunology, central nervous system

Boehringer Ingelheim's products are sold in

Biopharmaceutical contract manufacturing 0.92 bn

diseases, immunology, oncology and respiratory

71 out of 108 countries in scope of the Index.

Other sales

0.03 bndiseases.

Boehringer Ingelheim has sales offices in 17

Discontinued operations

0.08 bn

Product categories: Animal health, biosimilars

countries, and sells via suppliers and/or pooled		and innovative medicines.

procurement in an additional 54 countries.

Total

Sales by geographic region
30

Net sales (Bn EUR)

Sales in countries in scope

20.62 bn

25
20
15
10
5
0

In scope, has sales offices
In scope, any sales

2017

2018

Asia/Africa/Australia

In scope, no sales

2019

2020
Europe2021
Americas

Not in scope

SAMPLE OF PIPELINE AND PORTFOLIO ASSESSED BY THE INDEXPIPELINE for diseases in scope

PORTFOLIO as selected for analysis by the Index

Boehringer Ingelheim has a total of 35 R&D projects in scope with two ofBoehringer Ingelheim has 20 medicines in scope, 15 of which are on patent.

these projects targeting priority diseases. Thirty-three R&D projects target

60% of these medicines (11) are on the WHO EML. In addition, the com-other diseases in scope. Of the projects targeting other diseases, the focus

pany markets one vector control product. The off-patent medicines target

is on oncology (19), kidney diseases (6), neurology (3), COPD (2), diabetes

mainly non-communicable diseases (NCDs) such as chronic obstructive(1) and heart disease (1). Eight R&D projects are in late-stage development

pulmonary disease and asthma (2), ischaemic heart disease and stroke (2)that target either a priority disease (1) or address a public health need inand diabetes mellitus (1). The on-patent medicines also target the same

LMICs (7).* Evidence of access planning was in place for 100% of these

NCDs as well as hypertensive heart disease (3) and cancer (1).

projects.

35 projects in the pipeline

21 products as selected for analysis by the Index†

2

Communicable** 0

Maternal and neonatal 0

Maternal and neonatal 033

Non-communicableMultiple categories 0
0

20
30
40
50
projects in the pipeline

10

20
30
40
50
products on the market

Breakdown of products

0

0

1

0

0

0

2

Contraceptives

Addresses needs of LMICs*

9

3

3

1

0 16

Other projects in scope

16

1

0

0

0

*50 diseases and 243 product gaps inscope have been established as a priority by global health stakeholders. For
other diseases, the Index used a set of criteria to determine which projects in thepipeline offer a clear public health benefit to patients in LMICs. Only projects in17

the clinical phase of development were
included for this analysis.
**Neglected tropical diseases, while also
communicable, are highlighted separately
throughout the Index.
***Other includes projects that have atechnical lifecycle and projects that fol-Diagnostics
Other

‡

Total

1

Targets established R&D priorities

Other

0

Vaccines

WHO EDL

0

Total

0

Other***

0Registration/approval

50Phase III1

Phase II

8

4

Phase I7

off patent

Pre-clinical

Medicines on patent

Discovery

Non-EML

10

Breakdown of projects

165

20

Non-communicableMultiple categories 001

Neglected tropical

WHO EML

Communicable**

Neglected tropical 0

15

0
0

0
1

low a different development cycle (e.g.
diagnostics).
†Products included in the analysis wereselected using a set of criteria determinedby stakeholder consensus.
‡Other includes vector control products.

1

Access to Medicine Index 2022 ▶ Company report cards

Boehringer Ingelheim

GOVERNANCE OF ACCESSRANK 12SCORE 4.00

Has an access-to-medicine strategy with meas-

tries in scope of the Index. It shares the outcomesnal) covering third parties and in all countries

urable objectives, integrated within its overallof its access-to-medicine activities in a central-

where it operates, country risk-based assess-corporate strategy. Boehringer Ingelheim per-ised manner directly on its website and within its

ments and formal processes to ensure third-party

forms strongly. It has an Access to Healthcare

annual report.

compliance with company standards. It does

Approach, part of its "Sustainable Development

not, however demonstrate adequate evidence– For Generations" framework, which includes

Performs above average in responsible pro-of a continuous system to monitor activities. No

both human and animal health. The strategy cov-

motional practices. Boehringer Ingelheim’s sales

breaches in countries in scope of the Index wereers all therapeutic areas in which the company

agents are not solely incentivised on sales volume

publicly found in the period of analysis.

is involved, namely non-communicable diseases

targets. However, the company sets incentives(NCDs). The highest responsibility for access lies

based on sales targets at the individual level for

Publicly supports the Doha Declaration on

directly with the board.

agents. It publicly discloses information related

TRIPS and Public Health. Boehringer Ingelheim

to transfers of values to healthcare professionals

publicly shares support of the Doha Declaration

Provides evidence of financial or non-finan-

in countries in scope of the Index (e.g., paymentson TRIPS and Public Health. It views thecial access-related incentives at the executive

for attending events or promotional activities)

Declaration as a mechanism offering more juridi-

level. Boehringer Ingelheim performs above aver-according to law and industry association and has

cal certainty to countries which may intend to useage. It demonstrates evidence of access-related

global and local policies governing such trans-

the system. There is evidence of industry asso-

incentives for senior executives and in-country

fers to ensure compliance with the applicableciation lobbying on intellectual property and the

managers.

regulations.

usage of TRIPS flexibilities, namely of compulsory

Publicly discloses outcomes of its

Has compliance controls to ensure that gov-

tries in scope of the Index. As a member of theaccess-to-medicine activities. Boehringer

ernance efforts are not undermined byindustry association, Boehringer Ingelheim, like all

Ingelheim performs above average in transpar-

non-compliant or corrupt activities. Boehringer

other member companies in scope of the Index, isency of access activities. It publicly discloses

Ingelheim demonstrates evidence of the following

by default connected to this activity.

commitments, measurable goals, objectives andcomponents assessed by the Index: fraud-specifictargets for improving access to medicine in coun-risk assessment, audits (both internal and exter-

licensing, by national governments in some coun-

RESEARCH & DEVELOPMENTRANK 12SCORE 2.23

Access planning processes encompass all pro-dates covered by access plans. In this analysis,

Ingelheim does not disclose disaggregated R&D

jects in the pipeline. Boehringer Ingelheim has

Boehringer Ingelheim has seven projects in late-investment data to global health organisations.

a structured process in place to develop accessstage development, that target a disease and/orplans during R&D. The process is intended to be

product gap not yet established as a priority by

One R&D capacity building initiative included

applied to all R&D projects (both in-house andglobal health stakeholders. These projects are all

for analysis meets all Good Practice Standards.

collaborative) for diseases in scope of the Index.

deemed by the Index to offer a clear public health

Boehringer Ingelheim's performance is average

Boehringer Ingelheim begins developing accessbenefit for people living in LMICs.* Primarily,in this area. The number of initiatives meeting allplans for R&D projects before Phase II of clinicalthese projects have clinical trials in countries ininclusion criteria is lower than average and fewer

development.

scope of the Index and/or are first-in-class mol-initiatives meet all Good Practice Standards thanecules. The projects mainly focus on cancer andwhat is average for this indicator. Boehringer

A small-sized priority R&D pipeline comparedkidney diseases. Boehringer Ingelheim provides

Ingelheim's Research Beyond Borders (RBB) ini-

to peers. Boehringer Ingelheim has two projects,

evidence of access plans for all seven late-stage

tiative enables 30 research collaborations withincluding one late-stage candidate in its pipeline

projects. These plans focus mainly on registration

universities and research organisations in coun-that target a priority product gap. This project ispreparation in countries in scope of the Index.

tries in scope of the Index to advance drug

supported by an access plan.

discovery in areas of high unmet medical need.
Does not publicly disclose R&D investment

Many projects address a public health need indata disaggregated by disease category, prod-

LMICs,* with 100% (7/7) of late-stage candi-

uct type or phase of development. Boehringer

PRODUCT DELIVERYRANK 14SCORE 3.02

Public commitment not to enforce patents in

Countries and LICs in scope of the Index and apeers, Boehringer Ingelheim does not disclose

countries in scope. Boehringer Ingelheim publicly

subset of LMICs and UMICs.

the patent status of its products for diseases

commits to not file for or enforce patents. This166

in scope of the Index on their website nor incommitment applies to 61 countries within theDoes not publicly disclose information on pat-scope of the Index, of which all Least Developed

ent statuses on their website. Unlike all its*50 diseases and 243 product gaps inscope have been established as a priority
by global health stakeholders. For otherdiseases, the Index used a set of criteria
to determine which projects in the pipeline offer a clear public health benefit topatients in LMICs. Projects in the clinicalphase of development were included forthis analysis.

Pat-INFORMED.

Access to Medicine Index 2022 ▶ Company report cards

Performs above average in terms of shar-

Has access strategies for some of its self-ad-

inclusive business models aimed at meeting theing intellectual property (IP) assets withministered products for some countries inaccess needs of populations at the base of thethird-party researchers. Boehringer Ingelheim

scope of this analysis. Boehringer Ingelheim has

income pyramid (including other underserved

engaged in three new IP-sharing agreements withan average performance in this area. The com-

populations) in LMICs. The Healthy Entrepreneurs

third-party research institutions or drug discovery

pany provides examples of access strategies insocial start-up trains over 8,000 entrepreneurs toinitiatives established during the current analysis

UMICs and LMICs for the five products assessed.

enable them to sell healthcare products in remoteperiod that meet all inclusion criteria for evalua-

It makes efforts to reach additional patients using

villages and reaches more than 10 million individ-

tion. The company also has existing agreements

pricing strategies that consider payers' ability touals on a yearly basis.

of this nature in place that were established

pay and additional access strategies. The com-

before the current Index cycle.

pany is able to provide evidence of patient reach

Has an average performance in ensuring contin-

for three products in UMIC and LMIC country

uous supply of medicines in LMICs. Boehringer

examples provided.

Ingelheim is involved in supply chain capacity

No use of licensing agreements. Boehringer
Ingelheim does not engage in voluntary licensing

building initiatives in LMICs. The company also
One of the three manufacturing capacity build-

has a system in place to work with relevant stake-ing initiatives included meets all Good Practiceholders to communicate issues that may affectNo evidence of new products in scope.

Standards. Boehringer Ingelheim's perfor-

the supply chain, manages a buffer stock of rel-

Boehringer Ingelheim did not disclose evi-mance is average in this area. The number ofevant products and is involved in technology

dence of filing for registration any new products.

initiatives meeting all inclusion criteria is aver-transfer initiatives. The company works with mul-Among old products, its most widely filed prod-

age but fewer initiatives meet all Good Practicetiple active pharmaceutical ingredient suppliers

uct, empagliflozin (Jardiance®), mainly used inStandards (GPS) than what is average for thisfor some products and otherwise keeps buffer

individuals with type 2 diabetes, has been filed forindicator. In the initiative that meets all GPS, thestocks to mitigate supply risks.

registration in 37 countries in scope of the Index,

company co-develops, and teaches, a compre-

three among the highest disease burden (Guyana,

hensive course on quality drug manufacturing in

Has a policy for reporting substandard and fal-

Sri Lanka and Mexico). Uganda and Yemen arecollaboration with the East China University ofsified (SF) medicines in countries in scope

the low-income countries where Boehringer

Science and Technology, Fudan University andof the Index in less than ten days. Boehringer

Ingelheim has registered its products analysed

the Shanghai Pharmaceutical School.

Ingelheim has a policy for reporting SF medi-

for products in scope of the Index.

under this indicator.

cines to national regulatory authorities within
One of the three supply chain capacity build-seven days. It discloses to the Index, but not pub-Has access strategies for its supranationally

ing initiatives included meets all Good Practice

licly, whether it has quicker reporting time frames

procured product in scope for this analysis.

Standards. Boehringer Ingelheim's performancefor cases that only require visual inspection to be

Boehringer Ingelheim has an average perfor-

is average in this area. The number of initiatives

confirmed.

mance in securing access for its product procured

meeting all inclusion criteria is average but fewer

supranationally. Boehringer Ingelheim supplies its

initiatives meet all GPS than what is average for

Donates in response to expressed need andrabies vaccine (Rabisin®), through PAHO, and it

this indicator. Healthy Entrepreneurs manages amonitors delivery. Boehringer Ingelheim has

shared evidence of access strategies in countries

fully integrated end-to-end supply chain throughpublic policies and supply processes in place tonot eligible to benefit from such procurement.

training community health entrepreneurs on

ensure ad hoc donations are carried out rapidly in

The company provides evidence of an increase inhealth and business in addition to how to educate

response to expressed need, and it monitors theanimal vaccinations reach over the last two years.

and advise its customers.

delivery of donations until they reach the patient.

Has few access strategies for its healthcare

Two of the four health systems strengthen-Publicly commits to the achievement of elim-

practitioner-administered products in scopeing initiatives included meet all Good Practiceination, eradication or control goals in oneof this analysis. Boehringer Ingelheim performs

Standards. Boehringer Ingelheim's performance

structured donation programme for neglected

below average in this area. It provides evidence

is average in this area. The number of initiatives

tropical diseases or malaria. Boehringerof access strategies in UMICs and LMICs, but

meeting all inclusion criteria is average but fewer

Ingelheim is publicly committed to supporting theno evidence for LICs for the two products ana-

initiatives meet all GPS than what is average forgoal of zero human dog-mediated rabies deaths

lysed. It makes efforts to reach additional patients

this indicator. For example, the Pakistan-Rabies-

by 2030: it includes donating the rabies vaccine

using pricing strategies that consider the payer's

Free Campaign is a health systems strengthening(Rabisin®) in six countries in scope of the Index.

ability to pay and by entering into collaboration

initiative done in collaboration with the Indus

with a public-private partnership. For example,

Hospital in Karachi that aims to involve com-

Boehringer Ingelheim has entered into collab-

munities in mass rabies vaccination campaigns

oration with The Defeat-NCD Partnership toand ultimately reduce the incidence of rabies in

improve access and affordability to its quality

Pakistan. This initiative meets all GPS.

assured medicines across low resource countries.

167

Practically, institutions are now able to pro-

Has engaged in scaling up three and pilot-

cure these medicines through The Defeat-NCD

ing two inclusive business models. Boehringer

Partnership’s Essential NCD Supplies Facilities.

Ingelheim performs above average in the use of

Access to Medicine Index 2022 ▶ Company report cards

RA N KSCO R E

15

2.60

19 (2021)*

Bristol Myers Squibb
Stock exchange: NYSC • Ticker: BMY • HQ: New York, United States • Employees: 32,200

PERFORMANCE IN THE 2022 INDEX
15th place. Bristol Myers Squibb performs below average in
two of three Technical Areas. The company has performed
below average for access strategies, yet it performs strongly
in health systems strengthening. It has improved in accessHow score was achieved
3.86

Governance of Access
1.80

Research & Development

2.69

Product Delivery

planning in R&D but has a small-sized priority pipeline.

01

Governance of Access: 14th place. Bristol Myers Squibb has

2

3

Average

Leader4

5

an average performance in this area. It has an access-to-medicine strategy integrated within the overall corporate strategy.
It provides evidence of financial and non-financial access-re-

Product Delivery: 15th place. Bristol Myers Squibb has a below

lated incentives at the executive level but does not disclose

average performance in this area. The company has strength-

whether in-country managers or the CEO are also incentiv-

ened its performance in manufacturing capacity building byised toward access goals.

participating in technology transfers, yet its performance inequitable access strategies is below average for certain prod-

Research & Development: 17th place. Bristol Myers Squibb

ucts. It engages in high quality health systems strengthen-performs poorly in this area. The company has a structured

ing initiatives but lacks involvement in supply chain capac-

access planning process in place, but it does not apply this toity building. The company has non-exclusive voluntary licens-all late-stage candidates. The company has an average perfor-

ing agreements in place for two compounds to enable genericmance in R&D capacity building.

supply in LMICs.

OPPORTUNITIES FOR BRISTOL MYERS SQUIBBCHANGES SINCE THE 2021 INDEX

Develop access-related incentives for senior management. Bristol Myers Squibb has• Launched the first ever Global Access Report, which

an access strategy linked to sustainability goals, which includes all therapeutic areas inhighlights Bristol Myers Squibb’ efforts and progress

which the company is involved. Financial and non-financial incentives for the CEO andtowards advancing access to healthcare and health equity

in-country managers can be tied to the achievement of the sustainability goals underglobally.

their access strategy. The incentives can also be oriented toward long-term goals.

• Newly demonstrates evidence that sales agent incentives

Ensure all late-stage R&D projects have comprehensive access plans. Bristol Myers• Introduced a structured framework to include accessare decoupled from sales volume targets.
Squibb can develop access plans for all projects from Phase II of clinical development.
The company has plans in place for 73% of late-stage projects. These plans primarily

planning in all its pipeline projects.
• Started a new capacity building initiative with multiple

consist of commitments to registering products in countries where clinical trials for thatpartners to support sustainable and effective administration

product have been conducted. Access plans for nivolumab (Opdivo®) and pomalidomide

of innovative therapies for the treatment of cancer in(Pomalyst®), indicated for multiple cancer types, can also include additional accesscomponents such as equitable pricing.

LMICs.
• Newly licensed the >4000-member library to Medicinesfor Malaria Venture (MMV) in addition to donating USD 1

Improve access to on-patent cancer drugs on WHO Model List of Essential Medicines(EML). Bristol Myers Squibb has four on-patent products on the WHO EML, including
dasatinib (Sprycel®), a product indicated for imatinib-resistant chronic myeloid

million to support the missions of both MMV and Drugs for
Neglected Diseases initiative (DNDi).
• Joined the Access to Oncology Medicines (ATOM) Coalition,

leukaemia. The company provides access to dasatinib in at least one upper-middle
income country via an equitable pricing strategy and to low-income countries and lower-a new global initiative that aims to improve access toessential cancer medicines in LMICs.

middle income countries via the Max Foundation donation programme. Bristol Myers• Acquired a global exclusive license to develop, manufacture

Squibb can expand access to the product via registration, equitable pricing and non-and commercialise Rockefeller’s novel monoclonal antibody

exclusive voluntary licensing agreements in more countries, especially those where theduo treatment against COVID-19.

burden of disease is the highest, such as Afghanistan, Haiti and Ethiopia.

168

All companies were assessed based on
information that was valid in the latest
period of analysis (ending at 31 May2022). This data was either submitted bycompanies, found in the public domain or
was accessible through other sources.

The term LMICs is used to denote all
low- and middle-income countries inscope of the Index, except when analysing
companies’ access strategies where
the use of LMIC refers to lower-middle
income countries as per the World Bank

income groups classification. Likewise, theterms LIC and UMIC refer to low income
countries and upper-middle income
countries.
*In the 2021 Index, dense ranking wasused. In the 2022 Index, standard

competitive ranking is used. Therefore,
a direct comparison with Bristol Myers
Squibb's previous rank is not possible.

Access to Medicine Index 2022 ▶ Company report cards

SALES AND OPERATIONSBusiness segments: Pharmaceutical.

Bristol Myers Squibb's products are sold in

Therapeutic areas: Cardiovascular disease,38 out of 108 countries in scope of the Index.

Revenue by segment (2021) – in USD

fibrotic disease, haematology, immunology andBristol Myers Squibb has sales offices in 7

Pharmaceuticaloncology.

countries, and sells via suppliers and/or pooled		Product categories: Innovative medicines.

procurement in an additional 31 countries.

Total

46.39 bn
46.39 bn

M&A news: Bristol Myers Squibb acquired
Turning Point Therapeutics in June 2022 for
USD 76.00 per share.

Sales by geographic region
50

Revenue (Bn USD)

Sales in countries in scope

40
30
20
10
0

In scope, has sales offices
In scope, any sales

2017

2018

Rest of WorldIn scope, no sales

2019

2020

Europe

USA

2021

Other

Not in scope

SAMPLE OF PIPELINE AND PORTFOLIO ASSESSED BY THE INDEXPIPELINE for diseases in scope

PORTFOLIO as selected for analysis by the Index

Bristol Myers Squibb has a total of 53 R&D projects in scope with one pro-

Bristol Myers Squibb has 15 medicines in scope, 12 of which are on patent.

ject targeting a priority disease. This project targets COVID-19. The other

33% of these medicines (5) are on the WHO EML. The off-patent medicines

52 R&D projects target other diseases in scope. These projects mainly

target mainly non-communicable diseases such as cancer (2) and thalas-

focus on oncology (47 projects).

saemia (1). The on-patent medicines mainly target cancer (9), HIV/AIDS (2)Eleven R&D projects are in late-stage development that target either a pri-and viral hepatitis C (1).

ority disease (1) or address a public health need in LMICs (10).* Evidenceof access planning was in place for 73% of these projects: none targeting apriority disease and eight addressing a public health need in LMICs.

53 projects in the pipeline

15 products as selected for analysis by the Index†

Communicable** 1

Communicable**

Neglected tropical 0

Neglected tropical 0Maternal and neonatal 0

Maternal and neonatal 052

Non-communicableMultiple categories 0
0

40
60
80
100
projects in the pipeline

10

20
30
40
50
products on the market

0

0

1

0

0

0

1

Contraceptives

Addresses needs of LMICs*

4

3

5

2

0 14

Diagnostics

Other projects in scope

25 10

2

1

0 38

Other

*50 diseases and 243 product gaps inscope have been established as a priority by global health stakeholders. For
other diseases, the Index used a set of criteria to determine which projects in thepipeline offer a clear public health benefit to patients in LMICs. Only projects inthe clinical phase of development were
included for this analysis.
**Neglected tropical diseases, while also
communicable, are highlighted separately
throughout the Index.
***Other includes projects that have atechnical lifecycle and projects that fol-

‡

Total

0

Targets established R&D priorities

Other

0

Vaccines

WHO EDL

0

Total

0

Other***

0Registration/approval

30Phase III2

Phase II

8

1

Phase I4

off patent

Pre-clinical

Medicines on patent

Discovery

Non-EML

Breakdown of products
WHO EML

20

Breakdown of projects

169

12

Non-communicableMultiple categories 0
0

3

12

0
0

0
0

low a different development cycle (e.g.
diagnostics).
†Products included in the analysis wereselected using a set of criteria determinedby stakeholder consensus.
‡Other includes vector control products.

0

Access to Medicine Index 2022 ▶ Company report cards

Bristol Myers Squibb

GOVERNANCE OF ACCESSRANK 14SCORE 3.86

Has an access-to-medicine strategy with meas-

ble goals, objectives and sustainability targets,

the Index: fraud-specific risk assessment, coun-urable objectives. Bristol Myers Squibb performs

including enhancing patient access to medi-

try risk-based assessment, a continuous systemstrongly. Its strategy is fully integrated withincines. It facilitates accountability and transparency

to monitor activities, audits (both internal andthe overall corporate strategy and covers all ofby consistently sharing the outcomes of its

external, covering third parties and in all coun-

the therapeutic areas in which the company isaccess-to-medicine activities in a centralised

tries where it operates) and has formal processes

involved. The highest responsibility for access lies

manner within its Global Access Report.

to ensure compliance with company standards bydirectly with the board, with the Board Chair andthird parties. No breaches in countries in scope

CEO responsible for final decisions regarding the

Performs above average in responsible pro-of the Index were publicly found in the period ofdevelopment of each product's access strategy

motional practices. Bristol Myers Squibb's sales

analysis.

and programs.

agents are not solely incentivised on sales volume. However, the level at which sales targets are

Does not publicly support the Doha Declaration

Provides evidence of financial and non-financial

set varies at the individual, team, business unit,

on TRIPS and Public Health. Bristol Myers

access-related incentives at the executive level.

national and global level, as well as by therapeu-

Squibb does not publicly share any support of theBristol Myers Squibb performs below average. It

tic area. It publicly discloses information related

Doha Declaration on TRIPS and Public Health.

incentivises its senior executives to take action

to transfers of value to healthcare professionals

There is evidence of industry association lob-on access to medicine with financial and non-fi-

in countries in scope of the Index (e.g., payments

bying on IP and the usage of TRIPS flexibilities,

nancial rewards. It does not disclose, however,for attending events or promotional activities) in

namely of compulsory licensing, by national gov-

whether in-country managers or the CEO are also

accordance with laws and regulations.

ernments in some countries in scope of the Index.

incentivised toward access goals.

As a member of the industry association, Bristol
Has a robust set of compliance controls to

Myers Squibb, like all other member companies

Publicly discloses outcomes its access-to-med-ensure that governance efforts are not under-in scope of the Index, is by default connected toicine activities. Bristol Myers Squibb performs

mined by non-compliant or corrupt activities.

this activity.

strongly in transparency of access activities.

Bristol Myers Squibb performs strongly, demon-

It publicly discloses commitments, measura-strating evidence of all components looked for by

RESEARCH & DEVELOPMENTRANK 17SCORE 1.80

Access planning processes encompass all pro-

Bristol Myers Squibb has ten late-stage R&D pro-

One R&D capacity building initiative included

jects in the pipeline. Bristol Myers Squibb has

jects that target a disease and/or product gap

for analysis meets all Good Practice Standards.

a structured process in place to develop accessnot yet established as a priority by global healthBristol Myers Squibb's performance is averageplans during R&D. The process is intended to

stakeholders. These projects are all deemed byin this area. The number of initiatives meet-

be applied to all R&D projects (both in-house

the Index to offer a clear public health benefit

ing all inclusion criteria is lower than averageand collaborative) for diseases in scope of thefor people living in LMICs.* Primarily, these pro-and fewer initiatives meet all Good PracticeIndex. The phase at which access planning begins

jects concern clinical trials in countries in scopeStandards than what is average for this indicator.

depends on the product.

of the Index and/or are first-in-class molecules.

Bristol Myers Squibb supports the sustaina-

Most target cancer. These plans primarily relate

ble and effective administration of innovative

A small-sized priority R&D pipeline comparedto Bristol Myers Squibb's commitment to register

therapies for the treatment of cancer in LMICs

to its peers, with no access plans in place.

in the countries where it is carrying out clinical tri-

through its Innovative Cancer Medicines (ICM)

Bristol Myers Squibb has one late-stage candi-als. Therefore, plans for registration in countries

partnership with the Parker Institute for Cancer

date in its pipeline that targets a priority productwithin scope of the Index apply to eight pipeline

Immunotherapy and the Clinton Health Accessgap. This is the clinical development of abata-projects.

Initiative.

cept (Orencia®) to treat COVID-19. Bristol Myers
Squibb did not submit evidence of an access plan

Does not publicly disclose R&D investment

for this project.

data disaggregated by disease category, product type or phase of development. Bristol Myers

Some projects address a public health need

Squibb does not disclose disaggregated R&D

in LMICs,* with 80% (8/10) of late-stage pro-investment data to global health organisations.

jects covered by access plans. In this analysis,

170*50 diseases and 243 product gaps inscope have been established as a priority
by global health stakeholders. For otherdiseases, the Index used a set of criteria
to determine which projects in the pipeline offer a clear public health benefit topatients in LMICs. Projects in the clinicalphase of development were included forthis analysis.

Access to Medicine Index 2022 ▶ Company report cards

PRODUCT DELIVERYRANK 15SCORE 2.69

No public commitment not to enforce pat-country non-eligible to benefit from The Globalof the leaders in this area. The number of ini-

ents in countries in scope. Bristol Myers Squibb

Fund supranational procurement agreement.

tiatives meeting all inclusion criteria is higher

does not have a public commitment not to

The company provides evidence of patient reach,than average and more initiatives meet all Good

file or enforce patents in LMICs. Bristol Myers

reporting that through the MPP license, 2.1 million

Practice Standards than what is average for thisSquibb commits to ensure that its patents dopatients per year were reached.

indicator. For example, the company collabo-

not prevent inexpensive HIV/AIDS therapy inrates with University Research Co. (URC) on the

resource-constrained countries and regions such

Has few access strategies for its health-Multinational Lung Cancer Control Program — a

as sub-Saharan Africa and India.

care practitioner-administered products inlung cancer programme implemented in sevenscope of this analysis. Bristol Myers Squibb

countries to improve access to early diagnosis by

Publicly discloses information on patent sta-

performs below average in this area. It pro-addressing barriers to care.

tus. Like most of its peers, Bristol Myers Squibb

vides evidence of access strategies in UMICs anddiscloses the patent statuses for small molecules

LMICs for three products assessed. For example,

Has no inclusive business models that meetin scope via the Pat-INFORMED database. Bristol

in China, it ensured the inclusion of two can-all inclusion criteria. There is no evidence that

Myers Squibb discloses this information also incer drugs nivolumab (Opdivo®) and ipilimumab

Bristol Myers Squibb has engaged in the piloting

other websites regarding a subset of products.

(Yervoy®) on private insurance lists. To maxim-

or scale-up of any inclusive business models that

ise patient reach, Bristol Myers Squibb works

aim to meet the access needs of populations at

Is an average-performing company in terms ofwith a charity organisation, Cancer Foundation

the base of the income pyramid (including othersharing intellectual property (IP) assets withof China, to implement a patient assistance pro-

underserved populations) in LMICs. Bristol Myers

third-party researchers. Bristol Myers Squibb

gramme whereby Bristol Myers Squibb shares

Squibb performs below average in this area.

engaged in one new IP-sharing agreement withthe medicines' costs with the patient. Evidence

third-party research institutions or drug discoveryof an increase in patient reach through theseShows average performance in terms of ensur-

initiatives established during the current analysis

approaches is available.

ing continuous supply of medicines in LMICs.

period that meets all inclusion criteria for evalua-

Bristol Myers Squibb manages a buffer stock oftion. The company does have existing agreements

Has few access strategies for its self-admin-

relevant products, is involved in technology trans-of this nature in place that were establishedistered products for some countries in scopefers to local manufacturers in LMICs, and shows

before the current period of analysis and meet allof this analysis. Bristol Myers Squibb performs

evidence of working with stakeholders to com-

inclusion criteria for evaluation.

below average in this area. It provides evidence

municate issues that may impact the supplyof access strategies in countries of all assessed

chain. The company does not show evidence ofUses licensing to enable generic supply. Bristol

income levels (UMIC, LMIC, LIC) for one of theefforts to work with multiple active pharmaceuti-

Myers Squibb has non-exclusive voluntary licens-

two products assessed, dasatinib (Sprycel®), an

cal ingredient suppliers or engage in supply chain

ing agreements in place for two compounds (foroncology medicine. Bristol Myers Squibb demon-

capacity building initiatives that meet inclusion

the diseases in scope). Its broadest licence, forstrated to consider relevant payers' ability tocriteria for evaluation.

atazanavir sulfate (Reyataz®), encompasses 97

pay by securing public reimbursement of dasat-

countries within the scope of the Index, including

inib and lenalidomide (Revlimid®) in Mexico and

Has a policy for reporting substandard and fal-

71 middle-income countries.

Morocco respectively, where public coveragesified (SF) medicines in countries in scope ofis approximately 83% and 30% of the popula-

the Index in less than ten days. Bristol Myers

Filed to register new products in four countries

tion. Evidence that demonstrates patient reach

Squibb has a policy for reporting SF medicines toin scope on average. Bristol Myers Squibb did

through these approaches is available.

relevant health authorities within the timeframe

not disclose evidence of filing for registration anyof ten days looked for by the Index. There is noof its new products in more than half of the top

The one manufacturing capacity building ini-

evidence found publicly of a shortened timeframe

ten high burden countries. Among old products,

tiative included for analysis meets all Goodfor reporting cases which only require visual

its most widely filed is lenalidomide (Revlimid),

Practice Standards. Bristol Myers Squibb's per-inspection to be confirmed.

for non-Hodgkin lymphoma, filed for registration

formance is average in this area. The number ofin 20 countries in scope of the Index, including

initiatives meeting all inclusion criteria is lower

Donates in response to expressed need andthree high burden countries (Bolivia, Ecuador andthan average and fewer initiatives meet all Good

monitors delivery. Bristol Myers Squibb hasPeru). Eight out of its ten products analysed have

Practice Standards than what is average for thispublic policies and supply processes in place tobeen filed for registration in one LIC.

indicator. From 2011 until February 2022, theensure ad hoc donations are carried out rapidly incompany was involved in a technology transfer

response to expressed need, and it shows someHas access strategies for its supranationallyagreement to expand access to atazanavir sulfate

evidence of monitoring the delivery of donations.

procured product in scope for this analysis.

(Reyataz®) in Brazil.
Has no long-term donation programmes for

Bristol Myers Squibb has an average performancein securing access for its product procured supra-

No supply chain capacity building initiatives

neglected tropical diseases or malaria thatnationally. The company demonstrates strategies

included for analysis. There is no evidence — inare eligible for analysis under this indicator.

both in countries eligible for supply from suchthe public domain or disclosed to the Index — ofHowever, the company is engaged in anotherprocurers and in at least one non-eligible coun-supply chain capacity building initiatives active

structured donation programme: the Max Accesstry. For example, it provides atazanavir sulfate

during the period of analysis that met inclusion

Solutions programme where it donates dasati-(Reyataz®) at a not-for-profit price through acriteria for evaluation. Bristol Myers Squibb's per-nib (Sprycel®) for leukaemia to 29 countries since

supranational agreement with The Global Fund.

formance is below average in this area.

2017.

Bristol Myers Squibb has also signed a non-vol-171

untary licensing agreement with the Medicine

All five health systems strengthening initi-

Patent Pool (MPP) to facilitate access to 97 coun-

atives included for analysis meet all Good

tries in scope of the Index, including Algeria, a

Practice Standards. Bristol Myers Squibb is one

Access to Medicine Index 2022 ▶ Company report cards

RA N KSCO R E17

2.20

16 (2021)*

Daiichi Sankyo Co, Ltd
Stock exchange: TSE • Ticker: 4568 • HQ: Tokyo, Japan • Employees: 16,033

PERFORMANCE IN THE 2022 INDEX
17th place. Daiichi Sankyo is in the lower ranks across all
Technical Areas. It has a weak performance in responsible
promotional practices and implementation of compliance
controls. Furthermore, the company lacks access strategies

How score was achieved
3.43

Governance of Access
1.63

Research & Development

2.17

Product Delivery

for the majority of its products assessed. However, it

0

1

performs well in health systems strengthening.

2

3

Average

Leader4

5

Governance of Access: 15th place. Daiichi Sankyo performs below average in this area. It has an integrated

access plans in place for most late-stage candidates. However,access-to-medicine strategy, but it provides very little infor-

it does not engage in R&D capacity building.

mation related to responsible promotional practices and lacks
some compliance controls, namely a continuous system to

Product Delivery: 17th place. Daiichi Sankyo performs poorly

monitor activities, fraud-specific risk assessment and a coun-in this area. The company has a strong commitment not to

try risk-based assessment to mitigate the risk of non-compli-

enforce or file patents in the majority of the countries inance in countries in scope of the Index.

scope (including low- and lower-middle income countries).
It applies a few access strategies, yet only in upper-middle

Research & Development: 18th place. Daiichi Sankyo per-income countries. It has shown evidence of technology trans-

forms poorly in this area. It has a general access planning pro-fer initiatives and high-quality health systems strengthen-cess in place and applies this to a subset of pipeline projects.

ing initiatives yet does not engage in supply chain capacity

The company has an average-sized priority pipeline and hasbuilding.

OPPORTUNITIES FOR DAIICHI SANKYOCHANGES SINCE THE 2021 INDEX

Ensure that governance structures do not vary across subsidiaries. Daiichi Sankyo’s• Appointed a Head of Access to Healthcare who iscurrent governance structures related to responsible promotional practices andsubstandard and falsified medicines vary by subsidiary. It can ensure that such

responsible for improving access to healthcare andaddressing and resolving issues related to access.

governance structures apply across all subsidiaries. This includes its approach todecoupling of sales targets from sales volume, policies that address responsible• Incorporated improving access to healthcare as a materiality
in its current mid-term plan.

interactions with and appropriate payments to healthcare professionals and policies that• Established an Emerging and Re-emerging Infectious

address the timely reporting of confirmed cases of substandard and falsified medicines

Diseases Research Special Team (EReDS) to address

to health authorities.

emerging and re-emerging infectious diseases.
• Participated in the AMR Action Fund, which was established

Develop a structured access planning framework and ensure all late-stage R&D

to support the clinical development of new antimicrobial

projects have comprehensive access plans. Daiichi Sankyo can continue to improveagents and to achieve a sustainable antimicrobial market,

access planning by developing a structured access planning framework. The company
has access plans in place for 75% of late-stage R&D projects. It can apply access plans toall projects in the pipeline from Phase II onwards.

with a total contribution of USD 20 million.
• Implemented a general access planning framework for asubset of its R&D pipeline.
• Launched two new initiatives in Nepal and Zimbabwe to

Improve access to patented cardiovascular products on the WHO Model List of
Essential Medicines (EML). Daiichi Sankyo has two patented products on the WHO

address breast and cervical cancer care and awareness.
• Signed a joint research agreement and will share its

EML, edoxaban (Lixiana®), indicated for ischaemic heart disease and stroke, andcompound libraries with the non-profit public-private

amlodipine/olmesartan medoxomil (Azor®/Sevikar®), for hypertensive heart disease.

partnership Medicines for Malaria Venture (MMV) to screen

The company has an equitable access strategy for edoxaban that covers UMICs. Daiichi
Sankyo can further expand access to both this product and to amlodipine/olmesartan

compounds against new Plasmodium biological targets.
• Signed a joint research agreement with the non-medoxomil via registration, equitable pricing and/or non-exclusive voluntary licensing in

profit public-private partnership Drugs for Neglected

lower-income countries and high burden countries such as the Republic of Moldova.

Diseases initiative (DNDi) to screen compounds against
Trypanosoma cruzi. Daiichi Sankyo provided a library of
35,000 compounds.

172

All companies were assessed based on
information that was valid in the latest
period of analysis (ending at 31 May2022). This data was either submitted bycompanies, found in the public domain or
was accessible through other sources.

The term LMICs is used to denote all
low- and middle-income countries inscope of the Index, except when analysing
companies’ access strategies where
the use of LMIC refers to lower-middle
income countries as per the World Bank

income groups classification. Likewise, theterms LIC and UMIC refer to low income
countries and upper-middle income
countries.
*In the 2021 Index, dense ranking wasused. In the 2022 Index, standard

competitive ranking is used. Therefore, adirect comparison with Daiichi Sankyo's
previous rank is not possible.

Access to Medicine Index 2022 ▶ Company report cards

SALES AND OPERATIONSBusiness segments: Healthcare (OTC) products,

Daiichi Sankyo's products are sold in 35 out

prescription drugs and other.

of 108 countries in scope of the Index. Daiichi

Revenue by segment (2021) – in JPY

Therapeutic areas: Cell therapy, central nervous

Sankyo has sales offices in four countries, and

Prescription drugs

977.98 bn

system diseases, oncology, rare diseases,

sells via suppliers and/or pooled procurement in

Healthcare (OTC) products

64.70 bn

vaccines and other disease areas.

an additional 31 countries.

Other

2.20 bn

Product categories: Consumer health products,

		

generic drugs, innovative medicines andTotal

1,044.89 bn

vaccines.
M&A news: None since May 2020.

Sales by geographic region
1,200

Revenue (Bn JPY)

Sales in countries in scope

1,000
800
600
400
200
0

In scope, has sales offices
In scope, any sales

2017

2018

Rest of WorldIn scope, no sales

2019
Europe

2020

2021

Japan

North America

Not in scope

SAMPLE OF PIPELINE AND PORTFOLIO ASSESSED BY THE INDEXPIPELINE for diseases in scope

PORTFOLIO as selected for analysis by the Index

Daiichi Sankyo has a total of 35 R&D projects in scope with 16 of these pro-

Daiichi Sankyo has 12 medicines in scope, nine of which are on patent. 33%

jects targeting priority diseases. The other 19 R&D projects target otherof these medicines (4) are on the WHO EML. In addition, the company mar-diseases in scope. Of the projects targeting priority diseases, the focus iskets three diagnostics and two vaccines. The off-patent medicines target

on lower respiratory infections (three projects), Chagas disease (2), malaria

mainly non-communicable diseases (NCDs) such as hypertensive heart(2) and tuberculosis (2). Of the projects targeting other diseases, the focus

disease (1) and ischaemic heart disease (1), and a communicable disease,is on oncology (15).

lower respiratory infections (1). The on-patent medicines mainly target

Four R&D projects are in late-stage development that target either a pri-

NCDs, such as hypertensive heart disease (3), ischaemic heart disease (2)ority disease (1) or address a public health need in LMICs (3).* Evidence ofand cancer (2). Daiichi Sankyo’s preventative vaccines target tetanus andaccess planning was in place for 75% of these projects: one targeting a pri-pertussis. The diagnostics in scope are for tuberculosis (3).

ority disease and two addressing a public health need in LMICs.
35 projects in the pipeline

17 products as selected for analysis by the Index†

12

Communicable**

Neglected tropical 0Maternal and neonatal 0

Maternal and neonatal 020

Non-communicableMultiple categories 0
0

20
30
40
50
projects in the pipeline

10

20
30
40
50
products on the market

3

0

0

1

0

1

16

Contraceptives

Addresses needs of LMICs*

3

2

1

0

0

6

Diagnostics

Other projects in scope

4

5

3

1

0

13

Other

*50 diseases and 243 product gaps inscope have been established as a priority by global health stakeholders. For
other diseases, the Index used a set of criteria to determine which projects in thepipeline offer a clear public health benefit to patients in LMICs. Only projects inthe clinical phase of development were
included for this analysis.
**Neglected tropical diseases, while also
communicable, are highlighted separately
throughout the Index.
***Other includes projects that have atechnical lifecycle and projects that fol-

‡

Total

11

Targets established R&D priorities

Other

0

Vaccines

WHO EDL

0

Total

2

Other***

0Registration/approval

3

2

Phase III1

Phase II

7

2

Phase I2

off patent

Pre-clinical

Medicines on patent

Discovery

Non-EML

Breakdown of products
WHO EML

10

Breakdown of projects

173

10

Non-communicableMultiple categories 007Communicable**3

Neglected tropical

9

0
3

3
0

low a different development cycle (e.g.
diagnostics).
†Products included in the analysis wereselected using a set of criteria determinedby stakeholder consensus.
‡Other includes vector control products.

0

Access to Medicine Index 2022 ▶ Company report cards

Daiichi Sankyo Co, Ltd

GOVERNANCE OF ACCESSRANK 15SCORE 3.43

Has an access-to-medicine strategy with meas-

performs average in transparency of accessgovernance efforts are not undermined byurable objectives, integrated within its overall

activities. It publicly discloses its commitments,

non-compliant or corrupt activities. Daiichi

corporate strategy. Daiichi Sankyo performs

objectives and targets related to improving

Sankyo performs below average, demonstrat-

well. Its strategy is focused on expanding medical

access to medicine in countries in scope of theing evidence of some components looked for byaccess to oncology products, with a key theme ofIndex, namely with its capacity building initiatives.

the Index: audits and formal processes to ensure

the strategy being "how to deliver oncology prod-

It shares the outputs of a subset of its capacity

third-party compliance with company standards.

ucts around the world". The strategy covers somebuilding initiatives, although it does so in a cen-

There is no evidence, publicly found or disclosedof the therapeutic areas the company is involved

tralised manner directly on its website.

to the Index, of a continuous system to moni-in, but mainly focuses on oncology products.

tor activities, fraud-specific risk assessment or

The highest responsibility for access is indirectly

Performs below average in responsible pro-country risk-based assessment. No breaches inwith the board, with its Global Management

motional practices. Daiichi Sankyo’s policies

countries in scope of the Index were publicly

Committee.

governing promotional practices vary by subsid-

found in the period of analysis.

iary. It does not publicly disclose whether sales
Provides evidence of financial and non-finan-

agents are solely incentivised on sales volume

Publicly supports the Doha Declaration on

cial access-related incentives at the executive

targets and not other targets, nor the level at

TRIPS and Public Health. Daiichi Sankyo pub-level. Daiichi Sankyo performs well. It incentivises

which sales incentives are set. It does not disclose

licly shares a general statement on the Doha

its senior executives and in-country managers towhether it shares information related to transfers

Declaration on TRIPS and Public Health, but

perform on access to medicine with financial andof values to healthcare professionals in countries

expresses reservations on its provisions, stating

non-financial rewards, as part of its CSR goals.

in scope of the Index (e.g. payments for attendingthat the use of compulsory licensing should be

The CEO also has access-related incentives.

events or promotional activities), nor does it dis-carefully exercised. As a member of the industry

close a policy limiting such transfers.

association, Daiichi Sankyo, like all other mem-

Publicly discloses outcomes of a subset of its
access-to-medicine activities. Daiichi Sankyo
RESEARCH & DEVELOPMENT

ber companies in scope of the Index, is by default
Has some compliance controls to ensure thatRANK 18

connected to this activity.

SCORE 1.63

Access planning processes encompass someSome projects address a public health need in

uct type or phase of development. However,projects in the pipeline. Daiichi Sankyo has

LMICs,* with 67% (2/3) of late-stage candidates

Daiichi Sankyo does disclose fully disaggregateda general process in place to develop accesscovered by access plans. In this analysis, Daiichi

R&D investment data to Policy Cures Research.

plans during R&D. The process is intended to be

Sankyo has three late-stage R&D projects in its

applied to a subset of R&D projects for diseases

pipeline that target a disease and/or product gap

No R&D capacity building initiatives includedin scope of the Index.

not yet established as a priority by global healthfor evaluation. There is no evidence — in thestakeholders. These projects are all deemed bypublic domain or disclosed to the Index — of

An average-sized priority R&D pipeline com-

the Index to offer a clear public health benefit for

R&D capacity building initiatives active during thepared to peers, with an access plan in place

people living in LMICs.* Primarily, these projects

period of analysis that met inclusion criteria forfor its late-stage candidate. Daiichi Sankyo has

are first-in-class molecules. Most target cancer.

evaluation. Daiichi Sankyo's performance is below

16 projects, including one late-stage candidate,

Daiichi Sankyo provides evidence of access plansaverage in this area.

in its pipeline that target a priority product gap.

for two of these projects.

These projects target several diseases. Daiichi
Sankyo's late-stage candidate is supported by an

Does not publicly disclose R&D investment

access plan.

data disaggregated by disease category, prod-

PRODUCT DELIVERYRANK 17SCORE 2.17

Public commitment not to enforce patents incules in scope via the Pat-INFORMED database.

company does have existing agreements of thiscountries in scope. Daiichi Sankyo publicly com-

It discloses patent information such as filing date,nature in place that were established before themits to neither file for nor enforce patents. This

grant number, grant date and jurisdiction.

current period of analysis and meet all inclusioncommitment applies in sub-Saharan African coun-174

criteria for evaluation.

tries (with the exception of South Africa), Least

Performs above average in terms of sharing

Developed Countries and LICs, and in a subset ofintellectual property (IP) assets with third-

No use of licensing agreements. Daiichi Sankyo

LMICs and UMICs.

party researchers. Daiichi Sankyo engaged indoes not engage in voluntary licensing for prod-

three new IP-sharing agreements with third-party

ucts in scope of the Index.

Publicly discloses information on patent sta-

research institutions or drug discovery initiatives

tus. Like most of its peers, Daiichi Sankyo publicly

established during the current analysis period

discloses the patent statuses for small mole-that meet all inclusion criteria for evaluation. The*50 diseases and 243 product gaps inscope have been established as a priority
by global health stakeholders. For otherdiseases, the Index used a set of criteria
to determine which projects in the pipeline offer a clear public health benefit topatients in LMICs. Projects in the clinicalphase of development were included forthis analysis.

Access to Medicine Index 2022 ▶ Company report cards

Filed to register one new product in one coun-all inclusion criteria is lower than average andHowever, the company does have a system in

try in scope. Daiichi Sankyo did not disclose

fewer initiatives meet all Good Practice Standards

place to work with relevant stakeholders to com-

evidence of filing for registration any of its new(GPS) than what is average for this indicator. In

municate issues that may affect the supply chain,products in any of the top ten high burden coun-

the initiative that meets all GPS, which was active

works with several active pharmaceutical ingredi-

tries. Its most widely filed product, edoxaban

from 2002 until 2020, the company worked toent suppliers, manages a buffer stock of relevant(Lixiana®) indicated for stroke prevention amongstrengthen Vietnam's capacity to produce vac-

products and transfers technology to local manu-

other uses as an anticoagulant, has been filedcines through the POLYVAC project.

facturers in LMICs.

of the Index, including three high burden dis-No supply chain capacity building initiatives

Has procedures in place for reporting substand-ease countries (China, Indonesia and Vietnam).

included for analysis. There is no evidence — inard and falsified (SF) medicines for several

None of its eligible products are filed for registra-

the public domain or disclosed to the Index — ofcountries in scope of the Index in less than tention in LICs.

supply chain capacity building initiatives active

days. Daiichi Sankyo provides evidence of report-

during the period of analysis that met inclusioning SF medicines to relevant national healthDaiichi Sankyo is not eligible for assessment of

criteria for evaluation. Daiichi Sankyo's perfor-

authorities within five days depending on the

supranationally procured products.

mance is below average in this area.

region. The company reports aiming at reportingHas an access strategy for a country in scope of

All three health systems strengthening ini-risk. Depending on the subsidiary, it provides evi-the analysis for its healthcare-practitioner-ad-

tiatives included for analysis meet all Gooddence of shortened time frames for reporting

ministered products. Daiichi Sankyo performs

Practice Standards. Daiichi Sankyo's performancecases which only require visual inspection to be

below average in this area. The company provides

is average in this area. The number of initiatives

confirmed.

data on access strategies for the cancer drug tras-

meeting all inclusion criteria is lower than averagetuzumab deruxtecan (ENHERTU®) applied in two

but an average number of initiatives meet all GPS

Donates in response to expressed need and

UMICs. Evidence of patient reach is not available.

for this indicator. For example, through the compa-

monitors delivery. Daiichi Sankyo has public pol-ny's new initiative in Nepal, Daiichi Sankyo expands

icies and supply processes in place to ensure ad

Has few access strategies for its self-admin-

screening services and improves resident knowl-

hoc donations are carried out rapidly in response

istered products for some countries in scopeedge about breast and cervical cancers throughto expressed need, and it shows some evidence

for this analysis. Daiichi Sankyo performs below

screening camps and public awareness activities.

of monitoring the delivery of donations.

average in this area. The company provides exam-

This initiative meets all GPS.

for registration in 12 countries within the scope

within three days if the case presents a serious

Has no long-term donation programmes forples of access strategies in UMICs for four of thefive products assessed, including efforts to reachHas no inclusive business models that meetneglected tropical diseases (NTDs) or malaria

additional patients using pricing strategies that

all inclusion criteria. There is no evidence thatthat are eligible for analysis under this indi-consider relevant payers’ ability to pay. For exam-

Daiichi Sankyo has engaged in the piloting orcator. Daiichi Sankyo is not engaged in any

ple, the company secured national reimbursement

scale-up of any inclusive business models thatstructured donation programmes for NTDs orof one product and provides evidence of meeting

aim to meet the access needs of populations

malaria where elimination, eradication or control

national payer price expectations. Patient reach isat the base of the income pyramid (including

goals are possible and that are eligible for analysis

provided for two access strategies in UMIC coun-other underserved populations) in LMICs. Daiichi

under this indicator.

tries, but the company does not provide examples

Sankyo performs below average in this area.

in LMICs or LICs for any of the products.
Performs above average in terms of ensur-

175

One of the two manufacturing capacity build-ing continuous supply of medicines in LMICs.

ing initiatives included meets all Good PracticeDaiichi Sankyo does not show evidence of its

Standards. Daiichi Sankyo's performance is aver-involvement in supply chain capacity building ini-

age in this area. The number of initiatives meeting

tiatives meeting inclusion criteria for evaluation.

Access to Medicine Index 2022 ▶ Company report cards

RA N KSCO R E

12

2.95

11 (2021)

Eisai Co, Ltd
Stock exchange: TSE • Ticker: ESALY • HQ: Tokyo, Japan • Employees: ~10,000

PERFORMANCE IN THE 2022 INDEX
12th place. Eisai has an average performance. The company
has an average performance in access strategies for productson the market. Eisai engages in R&D for priority diseases, but
the majority of late-stage pipeline projects do not have an

How score was achieved
4.14

Governance of Access
2.03

Research & Development

3.13

Product Delivery

access plan. It performs well by having processes in place to0

1

ensure the continuous supply of medicines in LMICs.

2

3

Average

Leader4

5

Governance of Access: 10th place. Eisai has an average performance in this area. It has a clear access-to-medicine strategy
that is integrated into its overall corporate strategy, althoughlate-stage candidates. It has an average performance in R&D

the strategy does not fully extend across its pipeline and port-

capacity building.

folio. It also has a robust set of compliance controls to mitigate the risk of non-compliance in countries in scope of the

Product Delivery: 13th place. Eisai has an average perfor-

Index, but it shares the outcomes of its access-to-medicine

mance in this area. It has access strategies in place for mostactivities for only a subset of initiatives.

of its products in upper-middle and lower-middle income
countries. The company engages in high-quality supply chain

Research & Development: 14th place. Eisai has a below aver-capacity building but has a comparatively poor performanceage performance in this area. It has an average-sized prior-in terms of health systems strengthening and manufacturing

ity pipeline, but only applies access plans to a small number ofcapacity building.

OPPORTUNITIES FOR EISAICHANGES SINCE THE 2021 INDEX

Ensure all late-stage R&D projects have comprehensive access plans. Eisai has a• Established a pharmaceutical sales subsidiary in Vietnam.

structured process in place for R&D access planning that encompasses some projects• Signed the Kigali Declaration, the successor to the London

in the pipeline. The company has access plans in place for 14% of late-stage projects

Declaration, in June 2022, positioning neglected tropicalanalysed. These plans are for projects developed in partnership with DNDi. Eisai canapply access plans to all projects in the pipeline from Phase II onwards, for example,
lecanemab for Alzheimer’s disease.

diseases as an important area of focus.
• Participated in the AMR Action Fund, which was establishedto support the clinical development of new antimicrobial
agents and to achieve a sustainable antimicrobial market,

Expand registration of epilepsy medicines. Eisai has one of the largest portfolios
of on-patent antiepileptic products among the companies in scope. Its antiepileptic
perampanel (Fycompa®) is currently not registered in any of the ten countries in scopein collaboration with more than 20 leading pharmaceuticalcompanies.
• Supported a project led by CA Medlynks which aims towith the highest burden of epilepsy. The company can register this product in thosebuild a new structure for the efficient testing framework

countries, including Guyana and Haiti.

for COVID-19 in Kenya through the setup of PCR testinglaboratories, along with procurement of equipment

Expand access strategies to reach populations in low-income countries. For its breast
cancer treatment eribulin (Halaven®), Eisai deploys equitable access strategies andnecessary for testing and training of screening technicians.
• Expanded the long-term donation programme ofpatient assistance programmes in at least two lower-middle income countries. The

diethylcarbamazine tablets to combat lymphatic filariasis

company can expand such strategies to low-income countries and other countries within Nepal.

a high burden of breast cancer, such as Armenia, Papua New Guinea and Morocco.
Expand supply chain capacity building to more disease areas. Eisai has one existing
supply chain capacity building initiative that meets all Good Practice Standards, focusing
on neglected tropical diseases. The company can work with local partners to expand its
capacity building efforts to more diseases the company focuses on, such as epilepsy, incountries that have a high burden of disease, including Uganda.

176

All companies were assessed based on
information that was valid in the latest
period of analysis (ending at 31 May2022). This data was either submitted bycompanies, found in the public domain or
was accessible through other sources.

The term LMICs is used to denote all
low- and middle-income countries inscope of the Index, except when analysing
companies’ access strategies where
the use of LMIC refers to lower-middle
income countries as per the World Bank

income groups classification. Likewise, theterms LIC and UMIC refer to low income
countries and upper-middle income
countries.

Access to Medicine Index 2022 ▶ Company report cards

SALES AND OPERATIONSBusiness segments: Pharmaceutical business

Eisai's products are sold in 33 out of 108

and other business.

countries in scope of the Index. Eisai has sales

Revenue by segment (2021) – in JPY

Therapeutic areas: Oncology and neurology.

offices in 8 countries, and sells via suppliers

Pharmaceutical business626.28 bn

Product categories: Innovative medicines.

and/or pooled procurement in an additional 25

Other business

129.95 bn

M&A news: Eisai acquired Arteryex Inc. in April

countries.

		

2022.

Total

756.23 bn

Sales in countries in scope

Sales by geographic region
Pharma revenue (Bn JPY)

700
600
500
400
300
200
100
0

In scope, has sales offices
In scope, any sales

2017
EMEA

In scope, no sales

Americas

Not in scope

2018

2019

2020

Asia/Latin America
Japan

2021
China

OTC and others

SAMPLE OF PIPELINE AND PORTFOLIO ASSESSED BY THE INDEXPIPELINE for diseases in scope

PORTFOLIO as selected for analysis by the Index

Eisai has a total of 49 R&D projects in scope with 23 of these projects tar-

Eisai has 11 medicines in scope, six of which are on patent. 18% of the med-

geting priority diseases. The other 26 R&D projects target other diseases

icines (2) are on the WHO EML. The off-patent medicines (5) mainly target

in scope. Of the projects targeting priority diseases, the focus is on malaria

mental health (2). One product targets the neglected tropical disease lym-

(13 projects). Of the projects targeting other diseases, the focus is on

phatic filariasis and one further product is for cardiovascular diseases. The

Alzheimer's disease (6) and oncology (18).

on-patent medicines mainly target epilepsy (3) and oncology (2). In addi-

Fourteen R&D projects are in late-stage development that target either ation, one product is for Alzheimer’s disease.

priority disease (3) or address a public health need in LMICs (11).* Evidenceof access planning was in place for 14% of these projects: one targeting apriority disease and one addressing a public health need in LMICs.

49 projects in the pipeline

11 products as selected for analysis by the Index†
17

Communicable**Communicable** 0

6Maternal and neonatal 0

Maternal and neonatal 026

Non-communicableMultiple categories 0
0

20
30
40
50
projects in the pipeline

20
30
40
50
products on the market

Registration/approval

Other***

2

0

0 23

6

2

3

5

Vaccines000Contraceptives

00Addresses needs of LMICs*

3

3

4

4

1

15

Diagnostics

Other projects in scope

8

3

0

0

0

11

Other

*50 diseases and 243 product gaps inscope have been established as a priority by global health stakeholders. For
other diseases, the Index used a set of criteria to determine which projects in thepipeline offer a clear public health benefit to patients in LMICs. Only projects inthe clinical phase of development were
included for this analysis.
**Neglected tropical diseases, while also
communicable, are highlighted separately
throughout the Index.
***Other includes projects that have atechnical lifecycle and projects that fol-

‡

Total

Phase III10

off patent

Other

Phase II

1

Medicines on patent

WHO EDL

Phase I

10 9

Total

Pre-clinical

Breakdown of products

Discovery

Targets established R&D priorities

10

Non-EML

10

Breakdown of projects

177

10

Non-communicableMultiple categories 001

Neglected tropical

WHO EML

Neglected tropical

6

0
0

0
0

low a different development cycle (e.g.
diagnostics).
†Products included in the analysis wereselected using a set of criteria determinedby stakeholder consensus.
‡Other includes vector control products.

0

Access to Medicine Index 2022 ▶ Company report cards

Eisai Co, Ltd

GOVERNANCE OF ACCESSRANK 10SCORE 4.14

Has an access-to-medicine strategy with meas-

medicine in countries in scope of the Index. It

system to monitor activities, audits (both inter-urable objectives. Eisai has an above average

shares the outcomes of its access-to-medi-

nal and external, covering third parties and in all

performance. Its strategy is fully integrated withincine activities for a subset of initiatives, althoughcountries where it operates), formal processes

the overall corporate strategy and states a com-it does so in a centralised manner in its Valueto ensure third-party compliance with company

mitment to long-term sustainability solutions,

Creation Report and directly on its website,

standards and country risk-based assessments.

including affordable pricing. It covers some ofincluding outcomes of activities supporting theNo breaches in countries in scope of the Index

the therapeutic areas in which the company iselimination of NTDs such as lymphatic filariasis.

were publicly found in the period of analysis.

cer. The highest responsibility lies directly with

Performs above average in responsible pro-

Publicly supports the Doha Declaration on

the board.

motional practices. Eisai’s sales agents are

TRIPS and Public Health. Eisai publicly shares

not solely incentivised on sales volume targets.

support of the Doha Declaration on TRIPS andProvides evidence of financial and non-financial

Sales agent incentives are set at the individual,

Public Health, highlighting that Article 31b (cov-access-related incentives at the executive level.

team and country levels. It does not publicly dis-ering the use of compulsory licences) provides

Eisai performs well. It incentivises its in-coun-close information related to transfers of values tobalance between the protection of both IP andtry managers, including country-level corporate

healthcare professionals in countries in scope of

public health under appropriate circumstances.

officers or regional managers, to take action on

the Index (e.g. payments for attending events or

There is evidence of industry association lobbying

access to medicine with financial and non-finan-

promotional activities), unless required by local

on IP and the usage of TRIPS flexibilities, namely

cial rewards. The CEO also has access-related

regulations. The company has a country-specificof compulsory licensing, by national governments

incentives, linked, for example, to initiatives aim-

policy limiting transfers of values to healthcare

in some countries in scope of the Index. As a

ing at eliminating neglected tropical diseases

professionals.

member of the industry association, Eisai, like all

involved, including Alzheimer’s disease and can-(NTDs).

other member companies in scope of the Index, is
Has a robust set of compliance controls to

Publicly discloses outcomes of a subset of its

ensure that governance efforts are not under-access-to-medicine activities. Eisai performs

mined by non-compliant or corrupt activities.

average in transparency of access activities. It

Eisai performs strongly, demonstrating evi-

discloses its commitments, measurable goals,

dence of all components looked for by the Index:

objectives and targets for improving access tofraud-specific risk assessment, a continuous

RESEARCH & DEVELOPMENTRANK 14SCORE 2.03

Access planning processes encompass someMany projects address a public health need in

Eisai does disclose fully disaggregated R&D

projects in the pipeline. Eisai has a structured

LMICs,* with 9% (1/11) of late-stage candidates

investment data to Policy Cures Research.

process in place to develop access plans during

covered by access plans. In this analysis, Eisai

R&D. The process is intended to be applied to ahas 11 late-stage R&D projects that target a dis-

One of the two R&D capacity building ini-

subset of R&D projects (both in-house and col-ease and/or product gap not yet established as atiatives included meets all Good Practicelaborative) for diseases in scope of the Index.

priority by global health stakeholders. These pro-Standards. Eisai's performance is average in thisjects are all deemed by the Index to offer a clear

area. The number of initiatives meeting all inclu-

An average-sized priority R&D pipeline com-public health benefit for people living in LMICs.*sion criteria is lower than average and fewer

pared to peers, with 33% (1/3) of late-stage

Primarily, these projects concern clinical trials in

initiatives meet all Good Practice Standards

candidates supported by access plans. Eisai has

countries in scope of the Index and/or are first-(GPS) than what is average for this indicator.

23 projects including three late-stage candidates

in-class molecules. The projects mainly focus on

Notably, Eisai partners with Seeding Labs toin its pipeline that target a priority product gap.

cancer and Alzheimer's disease. Eisai provides

improve access to laboratory equipment for the

The company's priority pipeline focuses mostly

evidence of an access plan for one of the late-scientific community in countries in scope of theon malaria. Of Eisai's three late-stage candidates

stage candidates. This plan concerns registration

Index. This initiative meets all GPS.

targeting a priority product gap, there is evidence

preparation in countries in scope of the Index.

of an access plan for one. This access plan for178

by default connected to this activity.

fosravuconazole as a treatment for patients with

Does not publicly disclose R&D investment

eumycetoma is in partnership with the Drugs fordata disaggregated by disease category, prod-

Neglected Diseases initiative (DNDi).

uct type or phase of development. However,*50 diseases and 243 product gaps inscope have been established as a priority
by global health stakeholders. For otherdiseases, the Index used a set of criteria
to determine which projects in the pipeline offer a clear public health benefit topatients in LMICs. Projects in the clinicalphase of development were included forthis analysis.

Access to Medicine Index 2022 ▶ Company report cards

PRODUCT DELIVERYRANK 13SCORE 3.13

Public commitment not to enforce patentsa patient assistance programme to reach addi-

what is average for this indicator. One exam-

in countries in scope. Eisai publicly pledges totional patients. In India, Eisai company has aple of an initiative included for evaluation is theneither file for nor enforce patents in all Least

licensing agreement with Viatris to allow second

partnership with CA Medlynks Kenya and the gov-

Developed Countries and LICs. This commitment

brand manufacturing and increase access in theernment of Meru County to construct a screening

applies to infectious diseases, neglected tropicalcountry. The company provides evidence of how

framework for COVID-19 in Kenya.

diseases and maternal and neonatal diseases.

patient reach has been increased through theseapproaches in India.

Publicly discloses information on patent status.

ness model but has not shown evidence of its

Like most of its peers, Eisai publicly discloses theHas access strategies for its self-adminis-

involvement in scaling up any existing inclusive

patent statuses for small molecules in scope via

tered products for some countries in scope forbusiness models that meet all inclusion crite-

the Pat-INFORMED database. Eisai discloses pat-this analysis. Eisai has an average performanceria. Eisai performs below average in the use ofent information such as filing date, grant number,in this area. The company provides examples ofinclusive business models aimed at meeting the

grant date and jurisdiction.

access strategies in UMICs and LMICs for all threeaccess needs of populations at the base of the

products assessed, including efforts to reach

income pyramid (including other underserved

Is an average-performing company in terms ofadditional patients using pricing strategies that

populations) in LMICs. The One-stop Online

sharing intellectual property assets with third-

consider relevant payers’ ability to pay. For exam-

Service Platform: Yin Fa Tong in partnership withparty researchers. Eisai engaged in one newple, Eisai implemented the lenvatinib (Lenvima®)

JD Health is a joint venture that aims to create a

IP-sharing agreement with third-party research

Easy Access Program (LEAP) in the Philippines,

new solution that provides medical, health, andinstitutions or drug discovery initiatives estab-

which offers two free boxes for every purchase oflifestyle services specifically for the elderly, espe-

lished during the current analysis period thatone box (of the same dose) to all patients regard-cially those with dementia and their families.

meets all inclusion criteria for evaluation. The

less of their income since May 2017. The company

company does have existing agreements of thisprovides evidence of how patient reach has been

Performs above average in terms of ensuring

nature in place that were established before theincreased through these approaches.

continuous supply of medicines in LMICs. Eisai

current period of analysis and meet all inclusion

is involved in technology transfers with thirdTwo manufacturing capacity building initiatives

party manufacturers in LMICs, and has a system

included for analysis. Neither manufacturing

in place to work with relevant stakeholders to

No use of licensing agreements. Eisai does not

capacity building initiative included for analysis

communicate issues that may affect the supply

engage in voluntary licensing for products inmeets all Good Practice Standards (GPS). Eisai's

chain, works with several active pharmaceuti-

scope of the Index. It publicly states it would con-performance is below average in this area. The

cal ingredient (API) suppliers/produces in-housesider granting non-exclusive voluntary licences in

number of initiatives meeting all inclusion criteria

APIs, manages a buffer stock of relevant products

certain circumstances.

is lower than average and fewer initiatives meetand is involved in supply chain capacity building

all GPS than what is average for this indicator. In

initiatives.

criteria for evaluation.

No evidence of filing for registration its newone of the included initiatives, since 2013 Eisai

product in any country in scope. Eisai did nothas built and improved pharmaceutical manufac-

Has a policy for reporting substandard and fal-

disclose evidence of filing for registration its new

turing capacity of an Indian local manufacturer,

sified (SF) medicines in countries in scopeproduct in any of the top ten high burden coun-

Saurav, to supply diethylcarbamazine for lym-of the Index in less than ten days. Eisai has atries. Among old products, its most widely filed

phatic filariasis elimination.

policy for reporting SF medicines to national

product, eribulin (Halaven®), indicated for breast

health authorities and the WHO within 24 hours

cancer, has been filed for registration in 31 coun-

The one supply chain capacity building initiative

to seven days. It provides evidence of short-tries within scope of the Index, including threeincluded for analysis meets all Good Practiceened reporting time frames for cases which only

high burden disease countries, such as Morocco

Standards. Eisai's performance is average in thisrequire visual inspection to be confirmed based

and Pakistan. Eisai filed two of its seven products

area. The number of initiatives meeting all inclu-

on the Risk Evaluation Committee.

assessed in one LIC.

sion criteria is lower than average and fewer
initiatives meet all GPS than what is average for

Donates in response to expressed need andEisai is not eligible for assessment of suprana-

this indicator. NTD Supply Chain Forum is a mul-monitors delivery. Eisai has public policies andtionally procured products.

ti-partner initiative that aims to deliver the drugs

supply processes in place to ensure ad hoc dona-of neglected tropical diseases for donations fromtions are carried out rapidly in response to

Has access strategies for the healthcare prac-

the first to last mile and tracks progress and logis-

expressed need, and it monitors the delivery oftitioner-administered product in scope of thistics improvement of operations in countries indonations.

analysis. Eisai performs above average in thisscope of the Index.
Publicly commits to the achievement of elim-area. The company provides examples of access179

Has engaged in piloting one inclusive busi-

strategies which consider affordability in both aThree health systems strengthening initia-

ination, eradication or control goals in one

UMIC and an LMIC for the only product assessed,

tives included for evaluation. None of the threestructured donation programme for neglected

including efforts to reach additional patients using

health systems strengthening initiatives included

tropical diseases or malaria. Since 2013, Eisai

pricing strategies that consider relevant payers’

for analysis meet all GPS. Eisai's performance ispublicly commits itself to eliminating lymphatic

ability to pay. For example, Eisai obtained national

below average in this area. The number of initi-

filariasis by donating diethylcarbamazine tablets

reimbursement in China for eribulin (Halaven®),atives meeting all inclusion criteria is lower thanin 25 countries in scope of the Index for an unlim-a breast cancer medicine as well as implemented

average and fewer initiatives meet all GPS thanited period of time.

Access to Medicine Index 2022 ▶ Company report cards

RA N KSCO R E20

1.79

18 (2021)*

Eli Lilly & Co
Stock exchange: NYSE • Ticker: LLY • HQ: Indianapolis, Indiana, United States • Employees: ~35,000

PERFORMANCE IN THE 2022 INDEX
20th place. Eli Lilly is in the lower ranks across all Technical
Areas. The company has a small priority R&D pipeline andhas no structured process for access planning during R&D.
Its Governance of Access policies are comparatively poor,

How score was achieved
3.29

Governance of Access
1.90

Research & Development
1.31

Product Delivery

with no publicly-available evidence found of responsible

0

1

promotional practices and top-level incentivisation to achieveaccess-related goals.

2

3

Average

Leader4

5

framework in place for R&D projects. It has a small-sized priGovernance of Access: 19th place. Eli Lilly performs poorly

ority pipeline compared its peers, with plans for registrationin this area. It has an access-to-medicine strategy centred

for most late-stage pipeline candidates. Eli Lilly does not par-around its Lilly 30x30 programme and publicly discloses out-

ticipate in R&D capacity building.

comes of its access-to-medicine initiatives, but it discloses
little information related to responsible promotional practices

Product Delivery: 20th place. Eli Lilly performs poorly in thisand lacks evidence of access-related incentives for its seniorarea. It does not disclose, neither publicly nor to the Index,

executives and in-country and regional managers as well as

access strategies for its products nor examples of manufac-

some compliance controls to mitigate the risk of non-compli-

turing and supply chain capacity building initiatives. However,ance in countries in scope of the Index.

the Index identified several high-quality health systems
strengthening initiatives in which the company participates.

Research & Development: 16th place. Eli Lilly performs below

The company has a non-exclusive voluntary licensing agree-

average in this area. Eli Lilly does not have an access planningment in place for one compound.

OPPORTUNITIES FOR ELI LILLYCHANGES SINCE THE 2021 INDEX

Review sales incentive structure. Eli Lilly has an access-to-medicine strategy integrated• Extended support in 2021 to the Pioneering Antimicrobial

within its overall corporate strategy and incentivises its CEO to achieve access-tomedicine goals. It can decouple sales incentives for its sales agents from sales volume incountries in scope of the Index.

Subscriptions to End Upsurging Resistance (PASTEUR) Act.
• Disclosed progress in patient reach through the Lilly 30x30
Programme, reaching 11.6 million people in 2021 out of the
30 million 2030 goal.

Develop a structured access planning framework and ensure all late-stage R&D
projects have comprehensive access plans. Eli Lilly has access plans in place for 76% oflate-stage R&D projects. The company can develop a structured access planning process
in order to develop access plans for all late-stage R&D projects. For example, Eli Lilly can
expand access plans for tirzepatide for type 2 diabetes, and new cancer treatments suchas sintilimab, to include further access commitments beyond registration of the productin countries where it is conducting clinical trials.

• Issued a royalty-free, non-exclusive voluntary license forbaricitinib (a drug repurposed to treat COVID-19) to three
Indian drug makers.
• Invested USD 100 million into the newly launched
Antimicrobial Resistance (AMR) Action Fund.
• Expanded the initiative in partnership with Life for a Childto provide free immediate care as well as build sustainablediabetes care models for vulnerable populations. Starting in

Expand registration of medicines. Eli Lilly did not disclose any evidence of new data

February 2021, the partners plan to expand access to careregarding registration filings. The company can expand registration of new products

for youth with diabetes from approximately 23,000 in 2020

such as selpercatinib (Retevmo®/Retsevmo®), indicated for thyroid and lung cancer, andto approximately 150,000 in 65 countries over the next 10

analogue insulins such as insulin lispro (Lyumjev™) and insulin glargine (Basaglar®).

years.
• Committed USD 14.4 million in a new partnership with

Expand access strategies to patented cancer products. Eli Lilly can expand access to

UNICEF to help improve health outcomes for 10 million

its patented cancer products, such as abemaciclib (Verzenio®) for breast cancer, by

children and adolescents living with chronic, non-applying different access strategies, such as equitable pricing. Additionally, it can engage

communicable diseases (NCDs) through 2025.

in non-exclusive voluntary licensing for this product to enable generic supply, as it did forbaricitinib (Olumiant®) for the treatment of COVID-19, in India.

180

All companies were assessed based on
information that was valid in the latest
period of analysis (ending at 31 May2022). This data was either submitted bycompanies, found in the public domain or
was accessible through other sources. For

the 2022 Index, Eli Lilly declined to submit
data to the Access to Medicine Index.
The term LMICs is used to denote all
low- and middle-income countries inscope of the Index, except when analysing
companies’ access strategies where

the use of LMIC refers to lower-middle
income countries as per the World Bank
income groups classification. Likewise, theterms LIC and UMIC refer to low income
countries and upper-middle income
countries.

*In the 2021 Index, dense ranking wasused. In the 2022 Index, standard
competitive ranking is used. Therefore, adirect comparison with Eli Lilly's previous
rank is not possible.

Access to Medicine Index 2022 ▶ Company report cards

SALES AND OPERATIONSBusiness segments: Human pharmaceutical

Eli Lilly’s products are sold in 72* out of

products.

108 countries in scope of the Index. Eli Lilly

Therapeutic areas: Diabetes, immunology,

has sales offices in 14 countries and sells via

Human pharmaceutical products

neuroscience, oncology and other therapies.

suppliers and/or pooled procurement in 68*

		Product categories: Innovative medicines.

countries.

Total

M&A news: Eli Lilly acquired Prevail

Revenue by segment (2021) – in USD
28.32 bn
28.32 bn

*In 2016, Eli Lilly reported sales in 72 countries.

Therapeutics Inc. in January 2021 for USD
747.4 million. Eli Lilly also acquired Protomer
Technologies in July 2021 for USD 1 billion.

Sales by geographic region
50

Revenue (Bn USD)

Sales in countries in scope

40
30
20
10
0

2017

In scope, has sales offices

2018

2019

Other foreign countries

In scope, sales unknownUSA

Not in scope

2020
Europe

2021
Japan

China

SAMPLE OF PIPELINE AND PORTFOLIO ASSESSED BY THE INDEXPIPELINE for diseases in scope

PORTFOLIO as selected for analysis by the Index

Eli Lilly has a total of 45 R&D projects in scope with three of these pro-Eli Lilly has 26 medicines in scope, 18 of which are on patent. 19% of thesejects targeting priority diseases. The other 42 R&D projects target othermedicines are on the WHO EML (5). The off-patent medicines target

diseases in scope. Of the projects targeting priority diseases, the focus is

non-communicable diseases (NCDs) such as diabetes (5), cancer (1) andon COVID-19 (three projects). Of the projects targeting other diseases, theunipolar depressive disorders (1). The on-patent medicines target NCDs

focus is on diabetes mellitus (13), oncology (12) and ischaemic heart dis-such as diabetes (9), cancer (4) cardiovascular disease (1) and migraine (2).

ease (7).
Seventeen R&D projects are in late-stage development that target either apriority disease (3) or address a public health need in LMICs (14).* Evidenceof access planning was in place for 76% of these projects: three targeting apriority disease and ten addressing a public health need in LMICs.
45 projects in the pipeline

26 products as selected for analysis by the Index†

3

Maternal and neonatal 0

Maternal and neonatal 042

Non-communicableMultiple categories 0
0

20
30
40
50
projects in the pipeline

10

20
30
40
50
products on the market

Breakdown of products

0

0

0

0

3

0

3

Contraceptives

Addresses needs of LMICs*

5

4

7

3

0 19

Diagnostics

Other projects in scope

15

3

3

2

0 23

Other

*50 diseases and 243 product gaps inscope have been established as a priority by global health stakeholders. For
other diseases, the Index used a set of criteria to determine which projects in thepipeline offer a clear public health benefit to patients in LMICs. Only projects inthe clinical phase of development were
included for this analysis.
**Neglected tropical diseases, while also
communicable, are highlighted separately
throughout the Index.
***Other includes projects that have atechnical lifecycle and projects that fol-

‡

Total

0

Targets established R&D priorities

Other

0

Vaccines

WHO EDL

0

Total

0

Other***

0Registration/approval

80Phase III

4

Phase II

17

4

Phase I1

off patent

Pre-clinical

Medicines on patent

Discovery

Non-EML

10

Breakdown of projects

181

24

Non-communicableMultiple categories 002Communicable**

Neglected tropical 0

WHO EML

Communicable**
Neglected tropical 0

18

0
0

0
0

low a different development cycle (e.g.
diagnostics).
†Products included in the analysis wereselected using a set of criteria determinedby stakeholder consensus.
‡Other includes vector control products.

0

Access to Medicine Index 2022 ▶ Company report cards

Eli Lilly & Co

GOVERNANCE OF ACCESSRANK 19SCORE 3.29

Has an access-to-medicine strategy with

It publicly discloses its commitments, objec-

Index: a continuous system to monitor activities,

measurable objectives, integrated with its cor-

tives and targets related to improving access toaudits, formal processes to ensure third-party

porate strategy. Eli Lilly performs well. It has an

medicine in countries in scope of the Index. It

compliance with company standards and country

access-to-medicine strategy, which covers somefacilitates accountability and transparency by con-risk-based assessments in every country or regionof the therapeutic areas in which the company

sistently sharing the outcomes of its Lilly 30x30

where there is an Ethics & Compliance officer

is involved. The strategy is centred around theProgramme in a centralised manner within its

present. There is no evidence, publicly found or

Lilly 30x30 programme, which focuses on dis-

ESG report.

disclosed to the Index, of a fraud-specific riskeases that disproportionately affect people inassessment. No breaches in countries in scope

resource-limited settings. The highest responsi-

Performs comparatively poorly in responsibleof the Index were publicly found in the period ofbility lies indirectly with the board, with a seniorpromotional practices. Eli Lilly does not dis-analysis.

executive responsible for access strategies andclose whether sales agents are incentivised onreporting to the Executive Committee, which ismeasures other than sales volume. There is evi-

Does not publicly support the Doha Declaration

chaired by the CEO.

dence that the company sets incentives basedon TRIPS and Public Health. Eli Lilly doeson sales targets at the individual level for agents.

not publicly share any support of the Doha

Provides evidence of financial access-re-

It does not publicly disclose information related

Declaration on TRIPS and Public Health, but dis-lated incentives at the executive level. Eli Lilly

to transfers of values to healthcare professionals

closed to the Index that its position aligns withperforms well. The CEO has access-related

in countries in scope of the Index (e.g. payments

IFPMA. There is evidence of industry association

incentives linked to its ability to drive the 30x30

for attending events or promotional activities),

lobbying on intellectual property and the usage ofstrategy and ensure progress. Eli Lilly does notunless required by local regulations or trade

TRIPS flexibilities, namely of compulsory licens-disclose, however, whether senior executives andassociations.

ing, by national governments in some countries inin-country managers are also incentivised toward

scope of the Index. As a member of the industry
Has compliance controls to ensure that gov-

association, Eli Lilly, like all other member compa-

ernance efforts are not undermined bynies in scope of the Index, is by default connected

Publicly disclose outcomes of its

non-compliant or corrupt activities. Eli Lillyto this activity.

access-to-medicine activities. Eli Lilly performs

has an average performance, demonstrating evi-strongly in transparency of access activities.

dence of some components looked for by theaccess goals.

RESEARCH & DEVELOPMENTRANK 16SCORE 1.90

No structured process for access planning

pricing for its bebtelovimab, a monoclonal anti-

policy whereby once a product is approved, it

reported. Eli Lilly does not report a structured

body therapeutic for COVID-19. Through the Bill

commits to registering it in all countries where

process to develop access plans during R&D. The& Melinda Gates Foundation, Eli Lilly provided

clinical trials have taken place. Therefore, planscompany did not report a structured timeline

doses of bamlanivimab free of charge in Rwanda

for registration in countries where clinical trials

for the development of access plans for its R&D

and Morocco.

are being carried out apply to 10 of the 14 late-projects.

stage projects.
Many projects address a public health need in

182

A small-sized priority R&D pipeline compared

LMICs,* with 71% (10/14) of late-stage candi-

Does not publicly disclose R&D investment

to peers, with access plans in place for 100%

dates covered by access plans. In this analysis,

data disaggregated by disease category, prod-(3/3) late-stage candidates. Eli Lilly has three

Eli Lilly has 14 late-stage R&D projects that

uct type or phase of development. Eli Lilly does

late-stage candidates in its pipeline that target atarget a disease and/or product gap not yet

not disclose disaggregated R&D investment datapriority product gap. These focus on COVID-19.

established as a priority by global health stake-to global health organisations.

The company did not disclose any access plans

holders. These projects are all deemed by thefor these late-stage projects. However, evidence

Index to offer a clear public health benefit for

No R&D capacity building initiatives includedof access plans for all three COVID-19 projects

people living in LMICs.* Primarily, these pro-for evaluation. There is no evidence — in thewas found in the public domain. For example, Eli

jects concern clinical trials in countries in scope

public domain or disclosed to the Index — of

Lilly has issued royalty-free, non-exclusive vol-of the Index and/or are first-in-class molecules.

R&D capacity building initiatives active during theuntary licenses to accelerate and expand theThese projects focus on several diseases includ-

period of analysis that met inclusion criteria foravailability of baricitinib (Olumiant®) to treat

ing Alzheimer's disease, diabetes mellitus (type 1

evaluation. Eli Lilly's performance is below aver-

COVID-19 in India. This plan also considers dona-and 2), cancer and cardiovascular diseases. The

age in this area.

tions and registration in countries in scope. Elicompany did not disclose any access plans for

Lilly considers supply, demand, and equitable

the late-stage projects. However, Eli Lilly has a*50 diseases and 243 product gaps inscope have been established as a priority
by global health stakeholders. For otherdiseases, the Index used a set of criteria
to determine which projects in the pipeline offer a clear public health benefit topatients in LMICs. Projects in the clinicalphase of development were included forthis analysis.

Access to Medicine Index 2022 ▶ Company report cards

PRODUCT DELIVERYRANK 20SCORE 1.31

Public commitment not to enforce patents inbaricitinib tablets to the Indian government for

any inclusive business models that aim to meetcountries in scope. Eli Lilly publicly pledges toeligible hospitalised COVID-19 patients in India.

the access needs of populations at the base ofneither file for nor enforce patents. This com-

On May 4 2021, Eli Lilly announced it would

the income pyramid (including other underserved

mitment, available online in the "2018 UNGC

donate doses of barcitinib and bamlanivimab/

populations) in LMICs. Eli Lilly performs below

Communication on Progress" report, applies to all

etesevimab to Direct Relief. This donation would

average in this area.

Least Developed Countries.

enable the humanitarian organisation to provide
COVID-19 therapies at no cost to LMICs mostShows average performance in terms of ensur-

Publicly discloses information on patent status.

heavily impacted by the pandemic. The number

ing continuous supply of medicines in LMICs. Eli

Like most of its peers, Eli Lilly publicly discloses

of doses donated was not disclosed.

Lilly has a system in place to work with relevant

the patent statuses for small molecules in scope

stakeholders to communicate issues that may

via the Pat-INFORMED database. Eli Lilly includes

No evidence of access strategies for any of its

affect the supply chain, manages a buffer stock of

information about patents, including filing date,self-administered products in scope for thisrelevant products, and produces in-house active

grant number, grant date and jurisdiction.

analysis. Eli Lilly has not disclosed, neither pub-pharmaceutical ingredients to prevent shortages.

licly nor to the Index, access strategies for any ofHowever, there is no evidence that the company

Performs below average in terms of sharing

the five products, assessed in this category. Fouris involved in technology transfers to manufac-

intellectual property (IP) assets with third-

products in this category are indicated for dia-turers in LMICs or supply chain capacity building

party researchers. Eli Lilly engaged in one newbetes mellitus treatment and one product is ainitiatives that meet the inclusion criteria for

IP-sharing agreement with third-party research

cancer treatment.

evaluation.

lished during the current analysis period that

No manufacturing capacity building initiatives

Has a policy for reporting substandard and fal-meets all inclusion criteria for evaluation. The

included for analysis. There is no evidence — insified (SF) medicines in countries in scope ofcompany does not have existing agreements ofthe public domain or disclosed to the Index — ofthe Index. Eli Lilly provides evidence of a policy

this nature in place that were established before

manufacturing capacity building initiatives active

for reporting SF medicines to relevant national

the current period of analysis and meet all inclu-

during the period of analysis that met inclusion

health authorities. However, it does not disclose,

sion criteria for evaluation.

criteria for evaluation. Eli Lilly's performance ispublicly or to the Index, evidence that it requires

below average in this area.

reporting to occur within the timeframe of ten

institutions or drug discovery initiatives estab-

Uses licensing agreements to enable genericdays looked for by the Index. Eli Lilly also does not

supply. Eli Lilly has a non-exclusive voluntary

No supply chain capacity building initiatives

provide evidence of shortened time frames forlicensing agreement in place for one compound,included for analysis. There is no evidence — inreporting cases which only require visual inspec-

baricitinib (Olumiant®) in India. Details of thisthe public domain or disclosed to the Index — oftion to be confirmed.

agreement are not publicly available.

supply chain capacity building initiatives active
during the period of analysis that met inclusion

Donates in response to expressed need andNo evidence of filing for registration new prod-

criteria for evaluation. Eli Lilly's performance ismonitors delivery. Eli Lilly has public policies

ucts in any country in scope on average. Eli Lilly

below average in this area.

and supply processes in place to ensure ad hoc

did not disclose evidence of filing for registration
any of its analysed products.

donations are carried out rapidly in response to
Two of the four health systems strengthen-expressed need, and it monitors the delivery of

ing initiatives included meet all Good Practice

donations until they reach the patient.

Eli Lilly is not eligible for assessment of supra-

Standards. Eli Lilly's performance is average innationally procured products.

this area. The number of initiatives meeting all

Has no long-term donation programmes forinclusion criteria is average but fewer initiatives

neglected tropical diseases or malaria thatHas access strategies for one of its healthcare

meet all Good Practice Standards (GPS) thanare eligible for analysis under this indicator.

practitioner-administered products in scope ofwhat is average for this indicator. For example,

However, the company is engaged in other struc-

this analysis. Eli Lilly performs below average in

Eli Lilly is a partner in the Africa Health Worker

tured donation programmes, such as the Life forthis area. For one of five products assessed in thisTraining Initiative with Living Goods and Last Milea Child programme where it donates insulin lis-

category, examples of access strategies in LMIC

Health which explores novel approaches to train-pro (Humalog®), an analogue insulin used to treat

were found publicly. For example, the company

ing and retaining community health workers. This

type 1 diabetes mellitus, in 23 countries since

has issued royalty-free, non-exclusive voluntary

initiative meets all GPS.

2009.

licences to three Indian drug makers, Cipla, Sun

183

Pharmaceuticals and Lupin, to manufacture andHas no inclusive business models that meet all

distribute baricitinib (Olumiant®) to treat COVID-

inclusion criteria. There is no evidence that Eli

19. In addition, Eli Lilly has donated 400,000

Lilly has engaged in the piloting or scale-up of

Access to Medicine Index 2022 ▶ Company report cards

RA N KSCO R E14

2.84

14 (2021)

Gilead Sciences
Stock exchange: NASDAQ • Ticker: GILD • HQ: Forster City, California, United States • Employees: 14,000+

PERFORMANCE IN THE 2022 INDEX
14th place. Gilead has an average overall performance. The
company performs well in access strategies for its productson the market, but for R&D it has few access plans in place.
Gilead engages widely in non-exclusive voluntary licencing but

How score was achieved
3.43

Governance of Access
1.93

Research & Development

3.18

Product Delivery

has a comparatively poor performance in capacity building

0

1

and aspects of governance of access.

2

3

Average

Leader4

5

Governance of Access: 15th place. Gilead performs below
average in this area. It has an access-to-medicine strategy,
although it is not fully integrated into the overall corporate
strategy. There is evidence of access-related incentives for

Product Delivery: 12th place. Gilead shows an average per-its senior executives and CEO, but it lacks evidence of someformance in this area. The company has access strategies incompliance controls to mitigate the risk of non-compliance inplace for all products assessed in all country income classi-

countries in scope of the Index, namely a fraud-specific risk

fications. Gilead leads for engagement in non-exclusive vol-assessment and a continuous system to monitor activities.

untary licensing, with the highest number of licensing agreements of all companies in scope but has comparatively poor

Research & Development: 15th place. Gilead performs below

performance in health systems strengthening and supply

average in this area. It has a structured access planning frame-

chain capacity building.

work but does not apply this to all its late-stage candidates. It
has an average performance in R&D capacity building.

OPPORTUNITIES FOR GILEAD

CHANGES SINCE THE 2021 INDEX

Implement robust framework to mitigate non-compliance. Gilead has country risk-• Established a partnership with Boston University to train

based assessments, third-party monitoring and auditing in place. It can strengthen

its Global Patient Solutions employees and cross-functional

these processes to mitigate the risk of non-compliant or corrupt activities occurring

partners within Gilead on monitoring and evaluation bestin countries in scope of the Index by incorporating additional control mechanisms into
its operations, such as a continuous system to monitor activities and fraud-specific risk
assessments.

practices.
• Joined an initiative with the Partnership for Health
Advancement in Vietnam (HAIVN) to address barriers that
limit viral hepatitis diagnosis and care at primary healthcare

Ensure all late-stage R&D projects have comprehensive access plans. Gilead developed

facilities in Vietnam and the Philippines.

access plans for 24% of late-stage projects. The company can develop access plans for• Opened a Paediatric Drug Development Centre of

all late-stage R&D projects, particularly projects targeting HIV/AIDS and hepatitis B. For

Excellence, focused on developing new paediatricexample, it can improve the quality of access plans for lenacapavir (Sunlenca®), a longacting inhibitor for treatment and prevention of HIV, by including additional components

formulations for its portfolio of medicines.
• Announced USD 24 million in grants to help reduce healthsuch as registration preparation, equitable pricing and/or non-exclusive voluntarydisparities, improve access to quality healthcare, advancelicensing.

medical education and support local communities mostimpacted by the HIV epidemic and COVID-19 pandemic. The

Expand registration filings of HIV products. Gilead has filed bictegravir/emtricitabine/
tenofovir alafenamide (Biktarvy®) in one of the ten countries with the highest burdenof HIV. It can take steps to file its HIV products for registration in more high-burdencountries, such as Mozambique, Namibia and the Central African Republic.

Zeroing In: Ending the HIV/AIDS Epidemic programme, will
support 116 organisations in 41 countries.
• Provided funds to support a global non-profit, FIND, in its
project to help eliminate hepatitis C virus (HCV) amongpeople incarcerated in India.

Extend public commitments to donation programme for visceral leishmaniasis (VL).

• Joined the Access to Oncology Medicines (ATOM) Coalition,

Gilead has a long-term donation programme that aims to eliminate VL in endemic

a new global initiative that aims to improve access tocountries since 2011 in partnership with WHO by donating liposomal amphotericin B

essential cancer medicines in LMICs.

(AmBisome®). Gilead has extended its public commitment until 2025. The company
can publicly commit to extending the duration of its donation programme until VL iseliminated in endemic countries. The company can also expand the donation programme
to more countries where VL is endemic such as Brazil and Somalia.

184

All companies were assessed based on
information that was valid in the latest
period of analysis (ending at 31 May2022). This data was either submitted bycompanies, found in the public domain or
was accessible through other sources.

The term LMICs is used to denote all
low- and middle-income countries inscope of the Index, except when analysing
companies’ access strategies where
the use of LMIC refers to lower-middle
income countries as per the World Bank

income groups classification. Likewise, theterms LIC and UMIC refer to low income
countries and upper-middle income
countries.

Access to Medicine Index 2022 ▶ Company report cards

SALES AND OPERATIONSBusiness segments: Pharmaceutical

Gilead's products are sold in 41 out of 108

Therapeutic areas: Fibrotic diseases,

countries in scope of the Index.** Gilead has

Revenue by segment (2021) – in USD

inflammatory diseases, oncology and viralsales offices in 6 countries, and sells via suppliers

Pharmaceuticaldiseases.

and/or pooled procurement in an additional 35		Product categories: Innovative medicines.

countries.

Total

27.31 bn
27.31 bn

M&A news: Gilead acquired MYR GmbH in March
2021 for USD 1.45 billion.

Sales by geographic region
50

Revenue (Bn USD)

Sales in countries in scope

40
30
20
10
0

In scope, has sales offices
In scope, any sales

2017

2018

Rest of WorldIn scope, no sales

2019

2020

EuropeUSA

2021

Not in scope

SAMPLE OF PIPELINE AND PORTFOLIO ASSESSED BY THE INDEXPIPELINE for diseases in scope

PORTFOLIO as selected for analysis by the Index

Gilead has a total of 48 R&D projects in scope with 17 of these projects

Gilead has 20 medicines in scope, 16 of which are on patent. 40% of thesetargeting a priority disease. The other 31 R&D projects target other dis-

medicines (8) are on the WHO EML. The off-patent medicines target

eases in scope. Of the projects targeting priority diseases, the focus is on

mainly communicable diseases, such as HIV/AIDS, hepatitis B as well as

HIV/AIDS (11 projects). Of the projects targeting other diseases in scope,neglected tropical diseases such as leishmaniasis. One other product tar-

the focus is on oncology (27).

gets cardiovascular diseases. The on-patent medicines mainly target viral

Seventeen R&D projects are in late-stage development that target either ainfections: HIV/AIDS (8), hepatitis B (1), hepatitis C (4) and coronaviral dis-priority disease (12) or address a public health need in LMICs (5).* Evidence

eases (1). Two medicines target cancer.

of access planning was reported for 24% of these projects: four targeting apriority disease and none addressing a public health need in LMICs.

48 projects in the pipeline

20 products as selected for analysis by the Index†
20

Communicable**

Maternal and neonatal 028

Non-communicable3

Non-communicableMultiple categories 0Multiple categories 0
0

20
30
40
50
projects in the pipeline

10

20
30
40
50
products on the market

6

0

4

1

1

9

2

0

17

Contraceptives

Targets established R&D priorities

Addresses needs of LMICs*

1

3

2

0

0

Other projects in scope

9

6

8

2

0 25

*50 diseases and 243 product gaps inscope have been established as a priority by global health stakeholders. For
other diseases, the Index used a set of criteria to determine which projects in thepipeline offer a clear public health benefit to patients in LMICs. Only projects inthe clinical phase of development were
included for this analysis.
**Neglected tropical diseases, while also
communicable, are highlighted separately
throughout the Index.
***Other includes projects that have atechnical lifecycle and projects that fol-

Other

‡

Total

0

Vaccines

Other

Non-EML0

Diagnostics

Total

0

Other***

0Registration/approval

40Phase III1

Phase II

11

3

Phase I5

off patent

Pre-clinical

Medicines on patent

Discovery

WHO EML

Breakdown of products
WHO EDL

10

Breakdown of projects

185

1

Neglected tropical

Maternal and neonatal 0016Communicable**

Neglected tropical 0

16

0
0

0
0

low a different development cycle (e.g.
diagnostics).
†Products included in the analysis wereselected using a set of criteria determinedby stakeholder consensus.
‡Other includes vector control products.

0

Access to Medicine Index 2022 ▶ Company report cards

Gilead Sciences

GOVERNANCE OF ACCESSRANK 15SCORE 3.43

Has an access-to-medicine strategy withaccess initiatives, including for HCV and HIV/AIDS

company standards. It does not, however, disclose

measurable objectives. Gilead has an averageand its partnership with Boston University to eval-to the Index whether it has a continuous sys-

performance. Its strategy is not fully integrated

uate its voluntary licensing program, although it

tem to monitor activities, or a fraud-specific risk

within the overall corporate strategy, but it does

does so in a centralised manner within its Year inassessment. No breaches in countries in scope

have a business rationale. The access strategy

Review 2021 Report.

of the Index were publicly found in the period of

is based on partnerships, and the company sees

analysis.

access as part of its corporate values. It cov-

Performs above average in responsible promo-

ers some of the therapeutic areas in which thetional practices. Gilead discloses to the Index, but

Does not publicly support the Doha Declarationcompany is involved. The highest responsibil-

not publicly, whether sales agents are incentivisedon TRIPS and Public Health. Gilead does

ity for access lies directly with the board, namely

solely on sales volume targets. There is evidence

not publicly share any support of the Doha

with the Nominating and Corporate Governancethat the company sets incentives based on sales

Declaration on TRIPS and Public Health. It under-

Committee overseeing pricing and access issues.

targets at the individual level for sales agents. It

stands that TRIPS flexibilities, such as compulsory

does not publicly disclose information related tolicensing, may play a role in responding to national

Provides evidence of financial access-relatedtransfers of values to healthcare professionals inpublic health emergencies in the absence of vol-incentives at the executive level. Gilead per-countries in scope of the Index (e.g. payments for

untary licensing, but it should only be used byforms strongly. It incentivises its senior executives

attending events or promotional activities) except

governments as a last resort when all otherand in-country managers to take action on accessas required by law, but does have a policy for lim-

options have been exhausted. There is evidence

to medicine. The CEO also has incentives, linked

iting such transfers.

of industry association lobbying on intellectual

to its performance in expanding access to HCV

property and the usage of TRIPS flexibilities,
Has some compliance controls to ensure thatnamely of compulsory licensing, by national gov-

governance efforts are not undermined byernments in some countries in scope of the Index.

Publicly discloses outcomes of a subset of its

non-compliant or corrupt activities. Gilead has

As a member of the industry association, Gilead,

access-to-medicine activities. Gilead performs

an average performance, demonstrating evi-like all other member companies in scope of theaverage in transparency of access activities. It

dence of some components looked for by theIndex, is by default connected to this activity.

publicly discloses its commitments, measurable

Index: audits (both internal and external, covering

goals, objectives and targets for improving accessthird parties and in all countries where it oper-

in countries in scope of the Index. It shares infor-

ates), country risk-based assessments and formal

mation on the outcomes of only a subset of its

processes to ensure third-party compliance withproducts.

RESEARCH & DEVELOPMENTRANK 15SCORE 1.93

Access planning processes encompass allplans, the availability and affordability of projects

projects in the pipeline. Gilead has a structured

in development are considered.
Two of the three R&D capacity building ini-

process in place to develop access plans
during R&D. The process is intended to beSome projects address a public health needtiatives included meet all Good Practiceapplied to all R&D projects (both in-house andin LMICs.* In this analysis, Gilead has five late-Standards. Gilead's performance is averagecollaborative) for diseases in scope of the Index.

stage R&D projects that target a disease and/in this area. The number of initiatives meeting

In general, Gilead begins developing accessor product gap not yet established as a prior-

all inclusion criteria is average and an averageplans for R&D projects in Phase II/III of clinicality by global health stakeholders. These projects

number of initiatives meet all Good Practicedevelopment.

are all deemed by the Index to offer a clear pub-Standards for this indicator. Notably, Gilead's

lic health benefit for people living in LMICs.*

Public Health Award: Viral Hepatitis Program, pro-

An average-sized priority R&D pipeline com-

Primarily, these projects are first-in-class mole-vides a grant to support early-stage researchpared to peers, with access plans in place forcules. Most target cancer. Gilead did not disclosescientists in countries within the scope of the(33%) 4/12 of the late-stage candidates. Gilead

evidence of access plans for any of the five late-Index. This enables applicants to develop inno-

has 17 projects, including 12 late-stage candidates

stage projects.

vative strategies for the prevention, care andin its pipeline that target a priority product gap.

186

to global health organisations.

treatment of viral hepatitis.

These projects focus mainly on HIV/AIDS, hep-

Does not publicly disclose R&D investment

atitis B and COVID-19. Of Gilead's 12 late-stage

data disaggregated by disease category, prod-

candidates targeting a priority product gap, four

uct type or phase of development. Gilead does

have evidence of an access plan in place. In thesenot disclose disaggregated R&D investment data

*50 diseases and 243 product gaps inscope have been established as a priority
by global health stakeholders. For otherdiseases, the Index used a set of criteria
to determine which projects in the pipeline offer a clear public health benefit topatients in LMICs. Projects in the clinicalphase of development were included forthis analysis.

Access to Medicine Index 2022 ▶ Company report cards

PRODUCT DELIVERYRANK 12SCORE 3.18

No public commitment not to enforce pat-tary licensing agreements for HIV/AIDS products.

how to access several data sources to ensure

ents in countries in scope. Gilead does not have

In addition, Gilead has a long-term donation

continuous supply in multiple countries.

a public commitment to not file nor enforce pat-partnership with WHO. In Mexico, a non-eligi-

ents in low- to middle-income countries.

ble country to benefit from the procurement

Two of the five health systems strengthen-agreement, Gilead does not apply the same priceing initiatives included meets all Good Practice

Publicly discloses information on patent status.

offered via such agreement, but it implements aStandards. Gilead's performance is average in

Like most of its peers, Gilead discloses the pat-tiered pricing policy. Evidence of additional accessthis area. The number of initiatives meeting all

ent statuses for small molecules in scope via thestrategies is not provided but the company shares

inclusion criteria is higher than average but fewer

Pat-INFORMED database. Gilead discloses pat-patient reach data.

initiatives meet all GPS than what is average forent information such as filing date, grant number,this indicator. For example, Gilead is partnering
Has access strategies for its healthcare prac-with the Vatican and others to reach people living

titioner-administered product for countries

with HIV/AIDS in the rural Shinyanga and Simiyu

Is an average-performing company in terms

in the scope of the analysis. Gilead performs

regions of Tanzania and quickly connect them toof sharing intellectual property (IP) assets

above average in this area. It provides examples

care. The programme aims to enable screening

with third-party researchers. Gilead engaged inof access strategies in countries of all assessedof 300,000 people and provide treatment for all

one new IP-sharing agreement with third-party

income levels (UMIC, LMIC, LIC) for the prod-

those diagnosed. This initiative meets all GPS.

research institutions or drug discovery initiatives

uct assessed. For example, Gilead has a voluntaryestablished during the current analysis period

licensing programme for remdesivir (Veklury®),

Has engaged in piloting one inclusive businessthat meets all inclusion criteria for evaluation. The

which includes a technology transfer to genericmodel and has scaled up two existing inclusivecompany does have existing agreements of thismanufacturers developing this product and abusiness models during the current analy-

nature in place that were established before thewaiver of royalties on COVID-19 therapies forsis period. Gilead performs above average in thecurrent Index cycle and meet all inclusion criteria

use during the pandemic. The company reported

use of inclusive business models aimed at meet-for evaluation.

that these efforts resulted in a four-fold increase

ing the access needs of populations at the base ofin production during the peak of the COVID-19

the income pyramid (including other underserved

Uses licensing to enable generic supply. Gilead

surge in India, from 3 million vials to 13 million

populations) in LMICs. Gilead continues to sup-is the company with the highest number ofvials. In addition, Gilead donated vials to meet

port the M-TIBA mobile wallets programme, which

licensing agreements. It has non-exclusive volun-

the patients’ immediate needs in India. Evidence

provides access to better healthcare by connect-tary licensing agreements in place for 11 marketedof patient reach in the three country examples is

ing people directly to healthcare payers and clinics

compounds (for diseases in scope). Its broadest

provided.

through a health wallet on their mobile phones.

vir/ledipasvir (Harvoni®), sofosbuvir/velpatasvir

Has access strategies for all its self-adminis-

Performs above average in terms of ensuring(Epclusa®), sofosbuvir/velpatasvir/voxilaprevir

tered products for countries in scope for thiscontinuous supply of medicines in LMICs. Gilead(Vosevi®) encompass 92 countries within theanalysis. Gilead leads in this area. Examples ofis involved in technology transfers with third-

scope of the Index, including 67 middle income

access strategies in countries of all assessed

party manufacturers in LMICs, and has a system incountries. Gilead's recent license for remdesivir

income levels (UMIC, LMIC, LIC) are provided forplace to work with relevant stakeholders to com-

(Veklury®) includes nine sublicensees and cov-

all its products assessed. The company makes

municate issues that may affect the supply chain,ers 90 countries in scope, including 67 middle

efforts to reach additional patients through flat

works with several active pharmaceutical ingre-

income countries.

pricing strategies in LICs and non-exclusive vol-dient (API) suppliers/produces in-house APIs,

untary licensing agreements. Evidence of tiered

and manages a buffer stock of relevant prod-

Filed to register new products in six countries

pricing policies considering public payers' abil-ucts. However, there is no evidence to show thatin scope on average. Gilead did not disclose evi-

ity to pay is available, such as in the Dominican

the company is involved in supply chain capacity

dence of filing for registration any of its new

Republic for sofosbuvir/velpatasvir (Epclusa®),building initiatives.

products in more than half of the top ten highwhere the company reached 3,078 patients.

grant date and jurisdiction.

licences, for sofosbuvir (Sovaldi®), sofosbu-

Does not have a policy for reporting substand-burden countries. Among old products, its mostwidely filed is tenofovir alafenamide (Vemlidy®),

One of the four manufacturing capacity build-ard and falsified (SF) medicines in countries

indicated for viral hepatitis (B and C), filed in 35

ing initiatives included meets all Good Practicein scope of the Index. Gilead does not disclose,countries in scope of the Index, including threeStandards. Gilead's performance is average inpublicly or to the Index, evidence of a policy inof the top 10 high burden countries (Myanmar,

this area. The number of initiatives meeting allplace to report SF medicines to the relevant

Egypt and Cambodia). Emtricitabine/tenofo-

inclusion criteria is higher than average but fewer

health authorities.

vir alafenamide (Descovy®), for HIV/AIDS, has

initiatives meet all Good Practice Standards

been filed for registration in seven of the top 10(GPS) than what is average for this indicator. In

Donates in response to expressed need andhigh burden countries (Botswana, Central African

the initiative that meets all GPS, Gilead builds

monitors delivery. Gilead has public policies

Republic, Mozambique, Namibia, South Africa,

manufacturing capacity of its licensees in LMICs

and supply processes in place to ensure ad hoc

Zambia and Zimbabwe).

by initiating technology transfers for generic HIV/donations are carried out rapidly in response to

AIDS and hepatitis C treatments ahead of regula-

expressed need, and it monitors the delivery of

tory approval.

donations.

Gilead has an average performance in securing

One supply chain capacity building initiative

Publicly commits to the achievement of elim-

access for the product procured supranationally.

was included for analysis but does not meet all

ination, eradication or control goals in one

The company demonstrates strategies in coun-

Good Practice Standards. Gilead's performance

structured donation programme for neglected

tries eligible for supply from procurers and also

is below average in this area. The number of ini-

tropical diseases or malaria. Since 2011, Gilead

in at least one non-eligible country. For exam-

tiatives meeting all inclusion criteria is lower thanpublicly committed itself to contribute to theple, Gilead’s price for amphotericin b liposome

average and fewer initiatives meet all GPS thanelimination of visceral leishmaniasis by donat-(AmBisome®) is USD 16.25, and it is the same inwhat is average for this indicator. The Gilead GPS

ing amphotericin B liposome (AmBisome™) in six

all 116 countries covered by the company's volun-

Dashboard training initiative teaches licensees

countries in scope of the Index until 2025.

Has access strategies for its supranationallyprocured product in scope for this analysis.

187

Access to Medicine Index 2022 ▶ Company report cards

RA N KSCO R E1

4.06

1 (2021)

GSK plc
Stock exchange: LSE • Ticker: GSK • HQ: Brentford, UK • Employees: 90,096

PERFORMANCE IN THE 2022 INDEX
1st place. GSK leads by ensuring its overarching access to
medicine strategy is applied broadly to encompass both
R&D and delivery of products on the market. GSK leads inthe Research & Development Technical Area and performs

How score was achieved
4.43

Governance of Access
3.78

Research & Development

4.11

Product Delivery

strongly across all assessment criteria measured by the Index.

0

1

Governance of Access: 2nd place. GSK has a strong per-2

3

Average

Leader4

5

formance in this area. It has an integrated access-to-medicine strategy with direct board-level responsibility forcapacity building and has an access planning framework thataccess-to-medicine and incentivises its senior executives,

covers all projects in the pipeline.

the CEO and in-country and regional managers to perform
on access-to-medicine goals. It discloses outcomes of its

Product Delivery: 2nd place. GSK performs strongly in thisaccess-to-medicine activities and has a robust set of compli-

area by applying tailored access strategies across differ-ance controls to mitigate the risk of non-compliance in coun-ent country income classifications in all product catego-tries in scope of the Index.

ries. The company also excels in high-quality capacity building initiatives, leading in manufacturing and supply chain

Research & Development: 1st place. GSK leads in this area.

capacity building. Through ViiV Healthcare, the company

The company has the largest priority pipeline of all companies

engages in non-exclusive voluntary licensing to enable genericin scope with access plans in place for the majority of late-

supply, with three such licensing agreements in place for one

stage pipeline candidates. It also performs strongly in R&D

compound.

OPPORTUNITIES FOR GSKCHANGES SINCE THE 2021 INDEX

Ensure all late-stage R&D projects have comprehensive access plans with

• Established a new, dedicated Global Health Group, a non-commercial

a wide geographic scope. GSK has access plans in place for 89% of latestage candidates analysed. It can expand these plans and apply them to allgroup aimed at enhancing pipeline progression of needed medicines andvaccines in low and lower-middle income countries.

projects in the pipeline from Phase II onwards. Furthermore, it can broaden• ViiV Healthcare, a global specialist HIV company majority owned by GSK,

the geographic scope of existing plans to include more countries in scope

established a Global Health & Access forum which provides focus on andof the Index.

governance for access-related discussions across its portfolio.
• Signed two agreements with Gavi and UNICEF to supply the RTS,S/AS01

Apply access strategies for its COPD product, umeclidinium bromide(Incruse®), in lower-income countries. GSK has access strategies in place

malaria vaccine (Mosquirix) for routine child immunisation in endemic
countries following a recommendation by the WHO.

across all country income classifications for two of its three products• Received regulatory approval for tafenoquine paediatric dose in Marchtargeting chronic obstructive pulmonary disease (COPD), fluticasone

2022, representing the first new relapse prevention treatment for P.

propionate/salmeterol xinafoate (Seretide®) and salbutamol sulfate

vivax malaria in over 60 years.

(Ventolin®). However, strategies for umeclidinium bromide are focused on• ViiV Healthcare signed a non-exclusive voluntary licensing agreement

upper-middle income countries and lower-middle income countries, such

relating to dolutegravir in four countries within the scope of the Index,

as Brazil and El Salvador. The company can expand these strategies to low-and (after the period of analysis) a new voluntary licensing agreement

income countries and countries with the highest disease burden of COPD,

with the MPP to improve access to cabotegravir long-acting for HIV pre-such as Nepal and India.

exposure prophylaxis.
• GSK reaffirmed its long-term commitment to donate albendazole

Expand albendazole (Zentel®) donation and other efforts to control(Zentel®) until the elimination of lymphatic filariasis as a public healthsoil-transmitted helminthiasis. Since 2011, GSK’s albendazole donation

problem is achieved globally. In addition, 200 million tablets a year will be

programme, carried out in partnership with WHO, has been targeted at• GSK expects to positively impact health of more than 2.5 billion people

the 2022 Index cycle, the company extended the donation programmewithin the next ten years, with an ambition of 1.3 billion people in low-

to include pre-school aged children as an additional at-risk group andexpanded its public commitment to donating until 2025. GSK can further

188

donated until 2025 to treat soil-transmitted helminthiases.

controlling soil-transmitted helminthiasis in at-risk populations. During

and lower-middle income countries.
• A generic formulation of Tivicay paediatric dose, a child-friendly

expand its public commitment by including other at-risk populations (e.g.,

dispersible tablet formulation, reached children in 29 Index countries lesswomen of child-bearing age).

than a year after US FDA approval.

All companies were assessed based on
information that was valid in the latest
period of analysis (ending at 31 May2022). This data was either submitted bycompanies, found in the public domain or
was accessible through other sources.

The term LMICs is used to denote all
low- and middle-income countries inscope of the Index, except when analysing
companies’ access strategies where
the use of LMIC refers to lower-middle
income countries as per the World Bank

income groups classification. Likewise, theterms LIC and UMIC refer to low income
countries and upper-middle income
countries.

Access to Medicine Index 2022 ▶ Company report cards

SALES AND OPERATIONSBusiness segments: Consumer healthcare*,

GSK's products are sold in 92 out of 108

pharmaceuticals and vaccines.

countries in scope of the Index. GSK has sales

Turnover by segment (2021) – in GBPTherapeutic areas: Respiratory, HIV, Immuno-

offices in 27 countries, and sells via suppliers

Pharmaceuticals

17.73 bn

inflammation, Oncology; Vaccines: Meningitis,

and/or pooled procurement in an additional 65

Vaccines

6.78 bn

Shingles and Influenza.

countries.

Consumer healthcare*

9.61 bn

Product categories: Consumer health products*,

		

innovative medicines and vaccines.

Total*As of July 2022, GSK no longer has a consumer healthcare business.

M&A news: GSK acquired Sierra Oncology in
April 2022 for USD 1.9 billion.

Sales by geographic region
40

Turnover (Bn GBP)

Sales in countries in scope

34.11 bn

30
20
10
0

In scope, has sales offices
In scope, any sales

2017

2018

USA

In scope, no sales

Europe

2019

2020

2021

Rest of WorldNot in scope

SAMPLE OF PIPELINE AND PORTFOLIO ASSESSED BY THE INDEXPIPELINE for diseases in scope

PORTFOLIO as selected for analysis by the Index

GSK has a total of 107 R&D projects in scope with 81 projects of these pro-

GSK has 42 medicines in scope, 23 of which are on patent, and 20 vaccines.

jects targeting priority diseases. The other 26 R&D projects target other

48% of the medicines (20) are on the WHO EML. In addition, the com-diseases in scope. Of the projects targeting priority diseases, the focus ispany markets one platform technology. The off-patent medicines target

on HIV/AIDS (15 projects), COVID-19 (15), tuberculosis (14) and malaria (10).

communicable diseases (CDs) (9) such as HIV/AIDS (4) and hepatitis B (2);Of the projects targeting other diseases in scope, the focus is on oncol-

non-communicable diseases (NCDs) (9) such as mental health (3) and cardi-ogy (14). Thirty-five R&D projects are in late-stage development that target

ovascular diseases (4); and neglected tropical disease such as leishmaniasis

either a priority disease (25) or address a public health need in LMICs (10).*(1). The on-patent medicines target CDs such as HIV/AIDS (10) and NCDs

Evidence of access planning was in place for 89% of these projects: 23 tar-such as pulmonary diseases (6) and cancer (1). GSK’s preventative vaccines

geting a priority disease and eight addressing a public health need in LMICs.

(20) target CDs such as meningitis (6), rotavirus diarrhoea and malaria. The

Additionally, GSK provides evidence of access plans for two projects inplatform technology targets COVID-19.

Phase I of clinical development.
107 projects in the pipeline

63 products as selected for analysis by the Index†
78

Communicable**

Maternal and neonatal 023

Non-communicable22

Non-communicableMultiple categories 0Multiple categories 0

0

40
60
80
100
projects in the pipeline

20
30
40
50
products on the market

3

81

Contraceptives

Phase I

8

Pre-clinical5Addresses needs of LMICs*

7

1

6

3

0

17

Diagnostics

Other projects in scope

4

2

3

0

0

9

Other

*50 diseases and 243 product gaps inscope have been established as a priority by global health stakeholders. For
other diseases, the Index used a set of criteria to determine which projects in thepipeline offer a clear public health benefit to patients in LMICs. Only projects inthe clinical phase of development were
included for this analysis.
**Neglected tropical diseases, while also
communicable, are highlighted separately
throughout the Index.
***Other includes projects that have atechnical lifecycle and projects that fol-

‡

Total

0

25 13 15 12

Other

20

Vaccines

WHO EDL

19

20 0

Total

6

Other***

16

13

Registration/approval

7

off patent

Phase III

Medicines on patent

Phase II

Non-EML

Breakdown of products

Discovery

Targets established R&D priorities

10

WHO EML

20

Breakdown of projects

189

1

Neglected tropical

Maternal and neonatal 1

040

Communicable**

5

Neglected tropical

23

0

0

0

0
1

low a different development cycle (e.g.
diagnostics).
†Products included in the analysis wereselected using a set of criteria determinedby stakeholder consensus.
‡Other includes vector control products.

1

Access to Medicine Index 2022 ▶ Company report cards

GSK plc

GOVERNANCE OF ACCESSRANK 2SCORE 4.43

Has an access-to-medicine strategy with meas-

access to medicine in countries in scope of thefraud-specific risk assessment, country risk-based

urable objectives, integrated within its overall

Index. It facilitates accountability and transpar-assessment, a continuous system to monitor

corporate strategy. GSK performs strongly. Itency by consistently sharing the outcomes ofactivities, audits (both internal and external, cov-

has a comprehensive access-to-medicines andits access-to-medicine activities in a central-ering third parties and in all countries where it

vaccines strategy, along with ViiV Healthcare,ised manner within its Annual Report and ESG

operates) and has formal processes to ensure

dedicated to HIV/AIDS. The strategy covers

Performance Report.

third-party compliance with company standards.

all therapeutic areas in which the company is

No breaches in countries in scope of the Index

involved. The highest responsibility for access lies

Performs well in responsible promotional

directly with the board, namely with its Corporate

practices. GSK’s sales agents are not solely incen-

Responsibility Committee responsible for global

tivised on sales volume targets. In addition, it

Publicly supports the Doha Declaration on

health and access strategies.

sets a capped variable pay component of incen-

TRIPS and Public Health. GSK publicly sharestives based on individual sales targets. It does notsupport of the Doha Declaration on TRIPS andProvides evidence of financial and non-finan-

publicly disclose information related to transfers

Public Health and states that there are flexibili-

cial access-related incentives at the executiveof values to healthcare professionals in coun-ties which can allow countries to address theirlevel. GSK performs strongly. It incentivises its

tries in scope of the Index, unless required by law

public health needs. There is evidence of indus-

senior executives and in-country managers toor by local regulations, but it has a policy limit-

try association lobbying on IP and the usage oftake action on access to medicine with finan-

ing such transfers, i.e. prohibiting payments for

TRIPS flexibilities, namely of compulsory licens-cial and non-financial rewards. The CEO also has

promotional activities in certain countries based

ing, by national governments in some countries inaccess-related incentives included in its annual

on their scores in the Transparency International

scope of the Index. As a member of the industry

bonus plan.

Corruption Perceptions Index.

association, GSK, like all other member compa-

Publicly discloses outcomes of its

Has a robust set of compliance controls toaccess-to-medicine activities. GSK performs

ensure that governance efforts are not under-strongly in transparency of access activities.

mined by non-compliant or corrupt activities.

It publicly discloses commitments, measura-

GSK performs strongly, demonstrating evi-

ble goals, objectives and targets for improving

dence of all components looked for by the Index:

were publicly found in the period of analysis.

nies in scope of the Index, is by default connected

RESEARCH & DEVELOPMENTRANK 1SCORE 3.78

Access planning processes encompass all pro-ViiV Healthcare’s cabotegravir extended-re-Does not publicly disclose R&D investment

jects in the pipeline. GSK has a structured

lease injectable suspension (Apretude) became

data disaggregated by disease category, prod-

process to develop access plans during R&D.

the first long-acting injectable for pre-exposure

uct type or phase of development. However,

The process is intended to be applied to all R&D

prophylaxis of HIV to receive stringent regulatory

GSK does disclose fully disaggregated R&D

projects (both in-house and collaborative) for

authority (SRA) approval, following its approval byinvestment data to Policy Cures Research.

diseases in scope of the Index. In general, GSK

the US FDA.
All five R&D capacity building initiatives

begins developing access plans for R&D projects
Many projects address a public health needincluded for analysis meet all Good Practicein LMICs,* with 80% (8/10) of late-stage pro-Standards. GSK leads in this area. The num-

GSK has the largest priority R&D pipeline com-jects covered by access plans. In this analysis,

ber of initiatives meeting all inclusion criteria ispared to its peers, with access plans in place

GSK has ten late-stage candidates in its pipelinehigher than average and more initiatives meet allfor (92%) 23/25 of late-stage candidates. GSKthat target a disease and/or product gap not yet

Good Practice Standards than what is averagehas 81 projects including 25 late-stage candi-

established as a priority by global health stake-for this indicator. For example, in collaboration

dates in the pipeline that target a priority gap.

holders. These projects are all deemed by thewith Novartis, the GRADIENT project researches

The priority pipeline focuses mostly on HIV/AIDS,

Index to offer a clear public health benefit for

genetic diversity across different regions in Africa

COVID-19, tuberculosis and malaria. Of GSK’s 25

people living in LMICs.* Primarily, these projects

and its potential impact on response to therapeu-

late-stage candidates targeting a priority producthave clinical trials conducted in countries in scopetics. Local researchers are supported to explore

gap, 23 have evidence of an access plan in place.

of the Index or are being developed for paediatricresponses to drugs used to treat several diseases,

Additionally, it has access plans in place for two

indications. The projects focus on several disease

including malaria and tuberculosis.

Phase I projects. These plans contain a range ofareas including cancer, asthma and kidney dis-components that are conducive to access, includ-eases. GSK provides evidence of access plans foring commitments to register in countries in scopeeight of these projects. These plans focus mainlyof the Index, applying for WHO prequalification

on registration preparation in countries in scopeand plans to ensure sustainable supply. Notably,of the Index.

in Phase II of clinical development.

190

to this activity.

*50 diseases and 243 product gaps inscope have been established as a priority
by global health stakeholders. For otherdiseases, the Index used a set of criteria
to determine which projects in the pipeline offer a clear public health benefit topatients in LMICs. Projects in the clinicalphase of development were included forthis analysis.

Access to Medicine Index 2022 ▶ Company report cards

PRODUCT DELIVERYRANK 2SCORE 4.11

Public commitment not to enforce patents

in the private sector in Tunisia, a country not eli-

Four of the five health systems strengthen-in countries in scope. GSK publicly pledges

gible to benefit from UNICEF supranational

ing initiatives included meet all Good Practice

to neither file for nor enforce patents in Least

procurement. The price is defined using a tiered

Standards. GSK's performance is above average

Developed Countries and LICs. For non-pricing policy model that considers patients’ abil-in this area. The number of initiatives meeting all

G20 LMICs, GSK may file for patents but can

ity to pay. According to GSK, 49,000 vaccinations

inclusion criteria is higher than average and moreallow licenses to supply generic versions of its

were procured.

initiatives meet all GPS than what is average for

medicines.

this indicator. For example, in the Frontline HealthHas access strategies for all its healthcare

Worker Programme, GSK has invested over GBP

Publicly discloses information on patent status.

practitioner administered products in scope of

10 million in the Index period to support frontline

Like most of its peers, GSK discloses the pat-this analysis. GSK performs above average in thishealth services in lower income countries provid-

ent statuses for small molecules in scope via thearea. The company provides examples of afforda-

ing education, skills and capacity building for local

Pat-INFORMED database. GSK discloses patent

ble access strategies in all assessed income levels

healthcare systems.

information, including filing date, grant number,(UMIC, LMIC, LIC) for its hepatitis B vaccine

grant date and jurisdiction.

(Engerix® B), one of the three products assessed

Has engaged in piloting one inclusive businessin this category. It makes efforts to reach addi-

model (IBM) and has scaled up two existing

Performs above average in terms of sharing

tional patients through pricing strategies that

IBMs during the current analysis period. GSK

intellectual property assets with third-party

consider relevant payers' ability to pay and patient

performs above average in the use of IBMs aimed

researchers. GSK engaged in new IP-sharing

assistance programmes (PAPs). For example, theat meeting the access needs of populations atagreements with third-party research institutions

company extended the PAP for mepolizumab

the base of the income pyramid (including otheror drug discovery initiatives established during(Nucala®) in India by offering further discounts

underserved populations) in LMICs. In one exam-

the current analysis period that meet all inclu-

for patients completing the first month of treat-ple, GSK's Project Respire is supporting patientssion criteria for evaluation. The company does

ment. GSK provides evidence that the strategy

with uncontrolled asthma in low-income counties

have existing agreements of this nature in place

has been able to increase patient reach and treat-in Lagos State, Nigeria through a multi-pronged

that were established before the current period

ment adherence.

approach including educating general practition-of analysis and meet all inclusion criteria forers and offering discounts on medication.
Has access strategies for its self-adminis-

evaluation.

tered products for some countries in scope of

Performs above average in terms of ensur-

Uses licensing to enable generic supply. ViiV

this analysis. GSK has an above average perfor-

ing continuous supply of medicines in LMICs.

Healthcare has three non-exclusive voluntarymance in this area. For three of the five products

GSK is involved in technology transfers with third-

licensing agreements in place for one compound

assessed, GSK provides examples of access strat-

party manufacturers in LMICs, and has a system in(for diseases in scope). Its adult licence, its UMIC

egies that consider affordability in all assessed

place to work with relevant stakeholders to com-license, and its paediatric licence for dolutegra-

income levels (UMIC, LMIC, LIC). GSK also pro-municate issues that may affect the supply chain,vir (Tivicay® and Tivicay PD), which encompasses

vides evidence of additional access strategies

works with several active pharmaceutical ingredi-

104 countries relevant to the Index, including 82

such as a non-exclusive voluntary licensing andent suppliers, manages a buffer stock of relevant

low-income and lower-middle income countries.

health systems strengthening. For example, in

products and is involved in supply chain capacity

For abacavir, ViiV Healthcare has a paediat-

Colombia, GSK implemented 'parity pricing'§ andbuilding initiatives.

ric licence that covers 104 countries in scope.

competitor-based pricing for abacavir/dolutegra-

After the period of analysis, ViiV Healthcare has

vir/lamivudine (Triumeq®). GSK reports that, in the

Has a policy for reporting substandard and fal-announced a voluntary licensing agreement for

current analysis period, it supplied the treatment

sified (SF) medicines in countries in scope ofcabotegravir long-acting for HIV PrEP, that will

to 7,350 people in Colombia living with HIV/AIDS.

the Index in less than ten days. GSK has a pol-allow selected generic manufacturers to develop,

icy for reporting SF medicines to national healthmanufacture and supply generic versions of the

All five manufacturing capacity building ini-authorities and the WHO within five days. It pro-product.

tiatives included meet all Good Practicevides evidence of shortened reporting timeStandards. GSK is a leader in this area. The num-

frames for cases which only require visual inspec-

Filed to register new products in 11 countries

ber of initiatives meeting all inclusion criteria istion to be confirmed. In urgent situations wherein scope on average. GSK filed one of its newhigher than average and more initiatives meet all

there is a significant risk of patient harm, the pol-products in more than half of the top ten highGood Practice Standards (GPS) than what is aver-icy is designed to enable GSK to respond quickly.

burden countries. Dolutegravir (Tivicay PD), a

age for this indicator. Since 2017, ViiV Healthcare

new product indicated for paediatric HIV/AIDS,in partnership with Clinton Health Access

Donates in response to expressed need andis filed in seven high burden disease countries

Initiative has established public-private partner-

monitors delivery. GSK has public policies andand six of the 27 low-income countries in scope

ships that benefit generic manufacturers. These

supply processes in place to ensure ad hoc dona-of the Index. Abacavir/dolutegravir/lamivudine

partnerships build capacity to manufacture dis-

tions are carried out rapidly in response to(Triumeq®), indicated for HIV/AIDS, is widely filed

persible tablets for paediatric dolutegravir andexpressed need, and it monitors the delivery ofin 27 countries relevant to the Index, including in

Triumeq®. This initiative meets all GPS.

donations until they reach the patient.

three high burden disease countries.

191

All five supply chain capacity building initiatives

Publicly commits to the achievement of elim-

Has access strategies for all supranationally

included meet all Good Practice Standards.

ination, eradication or control goals in two

procured products in scope of this analysis.

GSK is one of the leaders in this area. The num-

structured donation programmes for neglected

GSK performs above average in securing accessber of initiatives meeting all inclusion criteria is

tropical diseases or malaria. GSK has publicly

for products procured supranationally. For thehigher than average and more initiatives meetcommitted itself since 1998 to contribute to thefive products assessed in this category, GSK

all GPS than what is average for this indicator.

elimination of lymphatic filariasis by donating

demonstrates strategies both in countries eligi-

For example, through the Strategic Training foralbendazole (Zentel®) in 38 countries in scope of

ble for supply from such procurers and in at least

Executives Programme (STEP 2.0), GSK invested

the Index until goals are reached.

one non-eligible country. For example, GSK sup-GBP 1.4 million to train 78 immunisation supply

plies its MMR vaccine (Priorix®) through tenders

chain managers in 15 Gavi countries.

§The company sells all dolutegravir-containing regimens at the same price. Under
this pricing approach, the private insurers,
called Health Maintenance Organisations(HMOs), pay the cost of dolutegravir
as the core agent, while costs for otheragents in the treatment are covered by
GSK.

Access to Medicine Index 2022 ▶ Company report cards

RA N KSCO R E2

4.03

3 (2021)

Johnson & Johnson
Stock exchange: NYSE • Ticker: JNJ • HQ: New Brunswick, New Jersey, USA • Employees: 141,700

PERFORMANCE IN THE 2022 INDEX
2nd place. Johnson & Johnson is a leading company anddemonstrates strong performance across all three Technical
Areas. The company performs strongly across all assessment
criteria including access strategies, R&D access planning and

How score was achieved
4.43

Governance of Access
3.73

Research & Development

4.09

Product Delivery

capacity building.

0

1

Governance of Access: 2nd place. Johnson & Johnson has

2

3

Average

Leader4

5

a strong performance in this area. It has an access-to-medicine strategy integrated into its overall corporate strategy and a robust set of compliance controls to mitigate thein R&D capacity building and has an access planning frame-risk of non-compliance in countries in scope of the Index. It

work that covers all projects in the pipeline.

also incentivises its senior executives, the CEO and in-country and regional managers to perform on access-to-medicine

Product Delivery: 3rd place. Johnson & Johnson performs

goals and discloses the outcomes of its access-to-medicine

strongly in this area. The company engages in high-qual-

activities.

ity capacity building initiatives across all fields (i.e., manufacturing, supply chain and health systems strengthening). The

Research & Development: 2nd place. Johnson & Johnson is acompany applies access strategies broadly, with several prod-

leading company in this area. The company has a large-sized

ucts having strategies across all country income classifica-priority pipeline compared its peers with access plans in placetions. It leads in its approach to access strategies for suprana-

for all late-stage pipeline candidates. It also performs strongly

tionally procured products.

OPPORTUNITIES FOR JOHNSON & JOHNSONCHANGES SINCE THE 2021 INDEX

Improve the quality of access plans for R&D projects for non-communicable diseases.

• Expanded the scope of its Global Public Health organisation

Johnson & Johnson has access plans in place for all its late-stage R&D projects inthe pipeline. The company can plan beyond registration by including more accesscomponents such as equitable pricing plans for each project, including cetrelimab,a monoclonal antibody in development for bladder cancer, and aprocitentan, an

to include a focus on Global Surgery, including obstetricfistula.
• Launched new Health for Humanity 2025 Goals, including agoal on Global Access Plans.

investigational treatment for hypertension.

• Shipped approximately 270 million doses of the Johnson &Expand supply chain process reviews to more countries. Johnson & Johnson’s• Entered into IP licensing agreements and conducted

Johnson COVID-19 vaccine to Africa at a not-for-profit price.
Global Public Health unit conducted supply chain process reviews in sub-Saharan

voluntary technology transfers for its COVID-19 vaccine

African countries including Kenya, Uganda and Nigeria. These reviews revealed a gap

across 10 manufacturing facilities, including in India andin leadership skills in the supply chain. In response, the company launched the PublicSouth Africa.

Health Supply Chain CEO Forum. The company can conduct needs assessments in• Announced an agreement to provide its COVID-19 vaccine

further countries in sub-Saharan Africa and expand the forum to additional countries

technology to South Africa-based Aspen SA Operations

where supply chain leadership gaps are seen.

(Pty) Ltd to manufacture its own branded vaccine.
• Received WHO Prequalification for its Ebola vaccine (Ad26.

File patented medicines for HIV for registration in more countries. Johnson &ZEBOV-GP) (Zabdeno®) and Ebola vaccine (MVA-BN-Filo)Johnson’s antiretrovirals darunavir/cobicistat (Prezcobix®/Rezolsta®) and darunavir/
cobicistat/emtricitabine/tenofovir alafenamide (Symtuza®) have been filed in 12 and 5
countries in scope of the Index respectively. Both products can be filed for registrationin countries with a high burden of disease, such as Mozambique, South Africa and(Mvabea®)• Announced several initiatives to help find the ‘Missing
Millions’ of undiagnosed people living with TB, including
with the Global Fund.

Zimbabwe.

• Launched a network of Global Health Discovery Centers to

Expand access to patented products in countries with the highest burden of disease.

• Completed Phase 1 clinical study evaluating dengue-specificaccelerate innovation and tackle pandemic threats.
Johnson & Johnson has access strategies in some LMICs for canagliflozin (Invokana®),
indicated for type 2 diabetes mellitus, and for ibrutinib (Imbruvica®), indicated forleukaemia. The company can apply access strategies such as equitable pricing and/or
non-exclusive voluntary licensing to expand patient reach, particularly in countries inscope of the Index where the burden of disease is the highest, such as Sri Lanka (fordiabetes) and Afghanistan (for leukaemia).

antiviral for treatment and prophylactic use.
• Invested USD 100 million into the newly launched
Antimicrobial Resistance (AMR) Action Fund.
• Commenced the first interventional clinical trial for
schizophrenia in Africa.
• Marked over 2 billion doses of mebendazole (Vermox®)
donated since 2006.

192

All companies were assessed based on
information that was valid in the latest
period of analysis (ending at 31 May2022). This data was either submitted bycompanies, found in the public domain or
was accessible through other sources.

The term LMICs is used to denote all
low- and middle-income countries inscope of the Index, except when analysing
companies’ access strategies where
the use of LMIC refers to lower-middle
income countries as per the World Bank

income groups classification. Likewise, theterms LIC and UMIC refer to low income
countries and upper-middle income
countries.

Access to Medicine Index 2022 ▶ Company report cards

SALES AND OPERATIONSBusiness segments: Consumer health, medical

M&A news: Johnson & Johnson acquired

technologies and pharmaceutical.

Momenta Pharmaceuticals, Inc. in October 2020

Sales by segment (2021) – in USD

Therapeutic areas: Cardiovascular, immunology,

for USD 6.5 billion.

infectious diseases, metabolism, neuroscience,

Consumer health

14.64 bn

Pharmaceutical

52.08 bn
27.06 bnoncology, pulmonary hypertension and otherJohnson & Johnson's products are sold in 95

Medical technologies

diseases.

out of 108 countries in scope of the Index.

		Product categories: Consumer health products,

Johnson & Johnson has sales offices in 24

Total

innovative medicines, medical technologies andcountries and sells via suppliers and/or pooled

vaccines.

procurement in an additional 71 countries.

Sales by geographic region
100

Sales (Bn USD)

Sales in countries in scope

93.78 bn

80
60
40
20
0

In scope, has sales offices
In scope, any sales

2017
USA

In scope, no sales

2018

2019

2020

2021

International

Not in scope

SAMPLE OF PIPELINE AND PORTFOLIO ASSESSED BY THE INDEXPIPELINE for diseases in scope

PORTFOLIO as selected for analysis by the Index

Johnson & Johnson has a total of 101 R&D projects in scope with 64 ofJohnson & Johnson has 26 medicines in scope, 19 of which are on patent,these projects targeting priority diseases. The other 37 R&D projects tar-and two vaccines. 42% of the medicines (11) are on the WHO EML. The

get other diseases in scope. Of the projects targeting priority diseases, theoff-patent medicines target the neglected tropical diseases soil-transmit-

focus is on viral hepatitis (B and C) (12 projects), HIV/AIDS (11 projects), andted helminthiasis and echinococcosis and the non-communicable diseases

tuberculosis (11 projects). Of the projects targeting other diseases in scope,(NCDs) (6) relating to cancer (3), mental health conditions (2) and kidney

the focus is on oncology (25). Forty R&D projects are in late-stage develop-

diseases. The on-patent medicines target communicable diseases such as

ment. These target either a priority disease (19) or address a public health

HIV/AIDS (8) and tuberculosis, and NCDs such as cancer (5), mental healthneed in LMICs (21).* Evidence of access planning was in place for 100% ofconditions (2), diabetes (2) and Alzheimer's disease. The company also hasthese projects.

two vaccines targeting Ebola and COVID-19.

101 projects in the pipeline

28 products as selected for analysis by the Index†
55

Communicable**

Maternal and neonatal 036

Non-communicable16

Non-communicableMultiple categories 0Multiple categories 0
0

40
60
80
100
projects in the pipeline

20
30
40
50
products on the market

Other***

5

3 64

13

5

2

7

Vaccines

0

2

2

Contraceptives

00Addresses needs of LMICs*

4

7

13

1

0 25

Diagnostics

Other projects in scope

9

2

1

0

0 12

Other

*50 diseases and 243 product gaps inscope have been established as a priority by global health stakeholders. For
other diseases, the Index used a set of criteria to determine which projects in thepipeline offer a clear public health benefit to patients in LMICs. Only projects inthe clinical phase of development were
included for this analysis.
**Neglected tropical diseases, while also
communicable, are highlighted separately
throughout the Index.
***Other includes projects that have atechnical lifecycle and projects that fol-

‡

Total

Registration/approval

7

6

off patent

Other

Phase III8

Medicines on patent

WHO EDL

Phase II

9

Non-EML

Phase I

23 9

Total

Pre-clinical

Breakdown of products

Discovery

Targets established R&D priorities

10

WHO EML

20

Breakdown of projects

193

1

Neglected tropical

Maternal and neonatal 1

0

11Communicable**

9

Neglected tropical

19

0
0

0
0

low a different development cycle (e.g.
diagnostics).
†Products included in the analysis wereselected using a set of criteria determinedby stakeholder consensus.
‡Other includes vector control products.

0

Access to Medicine Index 2022 ▶ Company report cards

Johnson & Johnson

GOVERNANCE OF ACCESSRANK 2SCORE 4.43

Has an access-to-medicine strategy with meas-in scope of the Index. It facilitates accountabil-

try risk-based assessment, a continuous systemurable objectives, integrated within its overall

ity and transparency by consistently sharing theto monitor activities, audits (both internal andcorporate strategy. Johnson & Johnsons per-outcomes of its access-to-medicine activities inexternal, covering third parties and in all coun-forms strongly. Its access strategy, embedded ina centralised manner within its annual Health fortries where it operates) and has formal processes

its Global Public Health unit and Janssen Access

Humanity Goals Progress Scorecard.

to ensure third-party compliance with company

and Pricing Principles, covers all therapeutic

standards. No breaches in countries in scope ofareas in which the company is involved. The high-

Performs above average in responsible pro-the Index were publicly found in the period of

est responsibility for access lies directly with the

motional practices. Johnson & Johnson’s sales

analysis.

board, namely with the Science & Technology

agents are not solely incentivised on sales volume

Committee.

targets. The company, however, sets sales incen-

Publicly supports international agreements,

tives at the individual level for agents. It does not

such as the Doha Declaration on the TRIPS

Provides evidence of financial and non-financial

publicly disclose information related to transfers

agreement. Johnson & Johnson publicly rec-access-related incentives at the executive level.

of values to healthcare professionals in countries

ognises and supports international agreements

Johnson & Johnson performs strongly. It incen-

in scope of the Index (e.g. payments for attend-

including the TRIPS Agreement, and states thattivises its senior executives, including its CEO

ing events or promotional activities) except as

it advocates for strong intellectual property (IP)and members of the Executive Committee, andrequired by law or national/regional trade asso-

systems that promote innovation. The company

regional managers to take action on access tociations (e.g., EFPIA), though it has policies andexpresses reservations on compulsory licensing,

medicine with financial and non-financial rewards.

procedures in place limiting transfers of values tonamely that it should be limited to certain circum-

Senior management, including the CEO, have

healthcare professionals in countries in scope ofstances when alternatives are exhausted. There

enterprise-level targets as well as access-related

the Index. In addition, the company reports not

is evidence of industry association lobbying on

performance indicators, including KPIs to improveusing sales and marketing representatives for

IP and the usage of TRIPS flexibilities, namely

access to medicine, as part of their annual goals

some products related to diseases in scope, suchof compulsory licensing, by national govern-and objectives.

as HIV/AIDS medicines.

ments in some countries in scope of the Index. As

Publicly discloses outcomes of its

Has a robust set of compliance controls to& Johnson, like all other member companies inaccess-to-medicine activities. Johnson &ensure that governance efforts are not under-

scope of the Index, is by default connected to thisJohnson performs strongly in transparency of

mined by non-compliant or corrupt activities.

activity.

access activities. It publicly discloses commit-

Johnson & Johnson performs strongly, demon-

ments, measurable goals, objectives and targets

strating evidence of all components looked for by

for improving access to medicine in countries

the Index: fraud-specific risk assessment, coun-a member of the industry association, Johnson

RESEARCH & DEVELOPMENTRANK 2SCORE 3.73

Access planning processes encompass all pro-range of components including equitable pricing

first-in-class molecules. The projects mainly target

jects in the pipeline. Johnson & Johnson has

strategies and plans for registration in countries

cancer. Johnson & Johnson provides evidence ofa structured process in place to develop accessin scope of the Index. Notably, the access plan

access plans for all 21 eligible projects.

plans during R&D. The process is intended to be

for the two-shot regimen Ebola vaccine (Ad26.

applied to all R&D projects (both in-house and

ZEBOV-GP) (Zabdeno®) and Ebola vaccine (MVA-

Does not publicly disclose R&D investment

collaborative) for diseases in scope of the Index.

BN-Filo) (Mvabea®) is multifaceted, comprising ofdata disaggregated by disease category, prod-

In general, Johnson & Johnson begins developing

WHO prequalification, health systems strength-

uct type or phase of development. However,access plans for R&D projects in Phase II of clini-ening and capacity building initiatives through theJohnson & Johnson does disclose fully disag-cal development.

Johnson & Johnson vaccination monitoring plat-gregated R&D investment data to Policy Cures

form Vxnaid™, and product donations.

Research.

to peers, with access plans in place for 100%Many projects address a public health need in

All five R&D capacity building initiatives included(19/19) of the late-stage candidates. Johnson

LMICs,* with 100% (21/21) of late-stage projects

for analysis meet all Good Practice Standards.

& Johnson has a priority R&D pipeline of 64 pro-covered by access plans. In this analysis, Johnson

Johnson & Johnson leads in this area. The number

jects, including 19 late-stage projects that target a& Johnson has 21 late-stage R&D projects thatof initiatives meeting all inclusion criteria is higher

priority gap. The company focuses on various pri-target a disease and/or product gap not yet estab-than average and more initiatives meet all Good

ority areas, including viral hepatitis (B and C), HIV/lished as a priority by global health stakeholders.

Practice Standards than what is average for thisAIDS and tuberculosis. Of Johnson & Johnson's

These projects are all deemed by the Index toindicator. For example, the Johnson & Johnson

19 late-stage candidates targeting a priority prod-offer a clear public health benefit for people living

Global Public Health R&D Fellowship Program pro-uct gap, all have evidence of an access plan in

in LMICs.* Primarily, these projects have clinical tri-

vides training in drug development to mid-career

place. It provides evidence of access plans with a

als in countries in scope of the Index and/or are

African doctors and scientists.

A large-sized priority R&D pipeline compared194*50 diseases and 243 product gaps inscope have been established as a priority
by global health stakeholders. For otherdiseases, the Index used a set of criteria
to determine which projects in the pipeline offer a clear public health benefit topatients in LMICs. Projects in the clinicalphase of development were included forthis analysis.

Access to Medicine Index 2022 ▶ Company report cards

PRODUCT DELIVERYRANK 3SCORE 4.09

Public commitment not to enforce patents inwith the African Vaccine Acquisition Trust (AVAT)

Standards. Johnson & Johnson is one of thecountries in scope. Johnson & Johnson has had

as well as two advance purchase agreements withleaders in this area. The number of initiatives

a specific policy since 2012 not to enforce thethe South African government.

meeting all inclusion criteria is higher than aver-patents it owns and controls on the antiretro-

age and more initiatives meet all Good Practiceviral drug darunavir (Prezista®) in sub-Saharan

Has access strategies for the majority ofStandards than what is average for this indicator.

Africa and Least Developed Countries. In 2015,

healthcare practitioner-administered products

For example, Johnson & Johnson Global Public

it expanded the geographical scope of the policyin scope of this analysis. Johnson & Johnson

Health developed Vxnaid™, a vaccination moni-for paediatric products used in LMICs.

performs above average in this area. For three of

toring platform which supports adherent vaccine

the five products assessed, the company provides

administration in the framework of clinical studies

Publicly discloses information on patent sta-examples of access strategies which consider

or campaigns, including support of the Rwandantus. Like most of its peers, Johnson & Johnson

affordability in countries of all assessed income

Ministry of Health’s large-scale Ebola vaccination

discloses the patent statuses for small mole-levels (UMIC, LMIC, LIC). The company makes

campaign. The company’s ultimate goal is for thecules in scope via the Pat-INFORMED database.

efforts to reach additional patients using strate-

platform to be available on a more global scale.

Johnson & Johnson discloses patent information

gies considering relevant payers' ability to pay. For

including filing date, grant number, grant date andexample, Johnson & Johnson secured bendamus-

Has engaged in scaling up two and piloting four

jurisdiction.

tine hydrochloride (Ribomustin®) reimbursement

inclusive business models. Johnson & Johnson

in both public institutions and private healthperforms above average in the use of inclusive

Performs above average in terms of sharing

insurance in Brazil. The company provides evi-business models aimed at meeting the accessintellectual property (IP) assets with third-

dence of how patient reach has been increased

needs of populations at the base of the income

party researchers. Johnson & Johnson engaged

through the approaches used in some of the

pyramid (including other underserved popu-

in two new IP-sharing agreements with third-

country examples provided.

lations) in LMICs. Johnson & Johnson Impact

party research institutions or drug discovery

Ventures, a fund within the Johnson & Johnson

initiatives established during the current analysis

Has access strategies for the majority of its

Foundation, helped to scale up South Lakeperiod that meet all inclusion criteria for evalua-self-administered products for countries in

Medical Center, a specialised low-cost primarytion. The company does have existing agreements

scope for this analysis. Johnson & Johnson per-care hospital in Naivasha, Kenya that runs a hub-of this nature in place that were establishedforms above average in this area. For two of theand-spoke healthcare model.

before the current Index cycle and meet all inclu-

five products assessed, the company provides

sion criteria for evaluation.

examples of access strategies which consider

Performs above average in terms of ensur-

affordability in countries of all assessed income

ing continuous supply of medicines in LMICs.

Uses licensing to enable generic supply.

levels (UMIC, LMIC, LIC). It makes efforts to reachJohnson & Johnson is involved in technology

Johnson & Johnson has a non-exclusive vol-additional patients through pricing strategies con-transfers with third-party manufacturers in LMICs,

untary licensing agreement for one compoundsidering relevant payers' ability to pay and patientand has a system in place to work with relevant(for diseases in scope). Its licence for rilpivirine

assistance programmes. For example, in an LIC

stakeholders to communicate issues that may(Edurant®) encompasses 83 countries in scope,for one cancer product, it provided evidence ofaffect the supply chain, works with several active

including 57 middle income countries. It has also

pricing and non-pricing strategies to ensure con-pharmaceutical ingredient suppliers, manages aissued a non-assert declaration for one patented

tinuous patient care while implementing healthbuffer stock of relevant products and is involved

compound in scope, darunavir (Prezista®).

systems strengthening initiatives. Johnson &in supply chain capacity building initiatives.

Johnson provides evidence of patient reach.
Filed to register new products in 15 countries in

Has a procedure for reporting substandard andscope on average. Johnson & Johnson has filed

Four of the five manufacturing capacity build-falsified (SF) medicines in countries in scope

filed six products in at least one country in scopeing initiatives included meet all Good Practiceof the Index in less than ten days. Johnson &of the Index with the highest burden of disease

Standards. Johnson & Johnson's performance

Johnson has a procedure for reporting SF med-(for products that could be assessed with availa-

is above average in this area. The number of ini-

icines to national health authorities within fiveble global burden of disease data, which excludes

tiatives meeting all inclusion criteria is higher

days. The company reports aiming at report-

COVID-19). Among new products, its most widely

than average and more initiatives meet all Gooding within two days if the case presents a direct

filed is the Johnson & Johnson COVID-19 vac-

Practice Standards (GPS) than what is averageand serious or life-threatening risk to patient orcine, rapidly authorized in 41 countries withinfor this indicator. For example, the company col-healthcare professional. It distinguishes quicker

the scope of the Index, 13 of which are LICs.

laborated with Aspen Pharmacare Limited, areporting time frames for cases which only

Examples include Somalia, Sudan and Uganda.

manufacturer in South Africa to transfer tech-require visual inspection to be confirmed.

Johnson & Johnson also received emergency use

nology to produce the Johnson & Johnson

waivers or import permits in 31 countries in scope

COVID-19 vaccine. This initiative meets all GPS.

metformin (Vokanamet®/Invokamet®) has been

All five supply chain capacity building initi-

lic policies and supply processes in place tofiled in 18 countries within the scope of the Index,

atives included for analysis meet all Good

ensure ad hoc donations are carried out rapidly inincluding one high burden disease country.

Practice Standards. Johnson & Johnson is one

response to expressed need, and it monitors theof the leaders in this area. The number of initia-delivery of donations.

Has access strategies for all supranationally

tives meeting all inclusion criteria is higher thanprocured products in scope for this analysis.

average and more initiatives meet all GPS thanPublicly commits to the achievement of elim-

Johnson & Johnson leads in securing access forwhat is average for this indicator. For example,

ination, eradication or control goals in one

products procured supranationally. For the four

the company is involved in the Strategic Training

structured donation programme for neglected

products assessed in this category, the company

Executives Programme (STEP 2.0) which is atropical diseases or malaria. Johnson & Johnson

demonstrates strategies both in countries eligi-

targeted leadership and change management

publicly commits to supporting the control of

ble for supply from such procurers, and also in

solution that trains public health supply chainsoil-transmitted helminthiasis as a public healthat least one country not eligible for such supply.

managers and leaders in LMICs.

problem through its donation of mebendazole

For example, the company supplied its Johnson

195

Donates in response to expressed need andmonitors delivery. Johnson & Johnson has pub-of the Index. Among old products, canagliflozin/(Vermox®) until the end of 2025 in 51 countries in& Johnson COVID-19 vaccine at a not-for-profit

All five health systems strengthening initiatives

price via a supranational procurement agreement

included for analysis meet all Good Practicescope of the Index.

Access to Medicine Index 2022 ▶ Company report cards

RA N KSCO R E18

2.15

15 (2021)*

Merck & Co, Inc
Stock exchange: NYSE • Ticker: MRK • HQ: Rahway, New Jersey, US • Employees: ~68,000

PERFORMANCE IN THE 2022 INDEXHow score was achieved

18th place. MSD performs below average in two of the

3.14

Governance of Accessthree Technical Areas. In Governance of Access, there was

2.38

Research & Development

no publicly-available evidence found of policies governing

1.75

Product Delivery

responsible promotional practices. In the Product Delivery
Technical Area, it performs below average in its approach01

to equitable access strategies. Research & Development
however, the company has strengthened its access planning

2

3

Average

Leader4

5

framework and has access plans in place for several latestage candidates in the pipeline.
Governance of Access: 20th place. MSD performs poorly inaccess planning framework in place, but evidence was notthis area. It has an access-to-medicine strategy with measura-found that it applies this to all late-stage candidates. It has a

ble objectives integrated within its overall corporate strategy,

small-sized priority pipeline but does participate in R&D capac-

but there is no evidence that sales incentives are decoupled

ity building.

from sales volume targets, nor is there evidence that senior
management and in-country/regional managers are incentiv-

Product Delivery: 19th place. MSD performs poorly in thisised to perform on access-related goals. It also lacks evidence

area. One access strategy was identified for one product inof a robust set of compliance controls to mitigate the risk ofan upper-middle income country. MSD has an average per-non-compliance in countries in scope of the Index.

formance with regard to its participation in inclusive businessmodels. The company engages in health systems strengthen-

Research & Development: 11th place. MSD has an average per-ing and supply chain capacity building, but evidence of engage-formance in this area. The company now has a structured

ment in manufacturing capacity building was not found.

OPPORTUNITIES FOR MERCK & CO

CHANGES SINCE THE 2021 INDEX

Organise governance of access. MSD has an access-to-medicine strategy, guided by its• Entered into an agreement with UNICEF to supply up

Access to Health Statement of Guiding Principles. Financial and non-financial incentives

to 3 million courses of COVID-19 antiviral molnupiravir

for senior executives, the CEO and in-country managers can be linked to this strategy.
Furthermore, the company can decouple sales incentives for its sales agents from sales
volume in countries in scope of the Index.

(Lagevrio®) to LMICs through the first half of 2022.
• Invested USD 100 million into the newly launched
Antimicrobial Resistance (AMR) Action Fund.
• Licensed its COVID-19 antiviral molnupriravir (Lagevrio®)

Ensure all late-stage R&D projects have comprehensive access plans. MSD has an R&D
access planning process in place and project-specific access plans for 43% of its late-

through the Medicines Patent Pool, covering 106 countries,
95 within the scope of the Index.

stage R&D projects. The company can apply this process to all late-stage R&D projects,• Agreed with UNICEF to establish the world’s first global

including tedizolid (Sivextro®) for S. pneumoniae, islatravir (MK-8591) for the treatment

Ebola vaccine stockpile of the Zaire ebolavirus vaccineof HIV infection and its chikungunya virus vaccine (V184).

(Ervebo®).
• Issued a USD 1 billion sustainability bond to support projects

Expand access to patented medicines on the WHO Model List of Essential Medicines.

and partnerships that contribute to the advancement of

MSD has a non-exclusive voluntary license in place for paediatric raltegravir (Isentress®),

the UN SDGs including access to healthcare and infectiousfor HIV, with one generic company already manufacturing it under this licence. The

disease research and development and to support initiatives

company can expand access to raltegravir in countries with a high disease burden bythat address access barriers and strengthen health systems.

expanding registration and applying equitable pricing. The company can also expand
access to products such as pembrolizumab (Keytruda®), which has multiple cancer
indications, through equitable pricing strategies and/or non-exclusive voluntary
licensing.

196

All companies were assessed based on
information that was valid in the latest
period of analysis (ending at 31 May2022). This data was either submitted bycompanies, found in the public domain or
was accessible through other sources. For

the 2022 Index, MSD declined to submit
data to the Access to Medicine Index.
The term LMICs is used to denote all
low- and middle-income countries inscope of the Index, except when analysing
companies’ access strategies where

the use of LMIC refers to lower-middle
income countries as per the World Bank
income groups classification. Likewise, theterms LIC and UMIC refer to low income
countries and upper-middle income
countries.

*In the 2021 Index, dense ranking wasused. In the 2022 Index, standard
competitive ranking is used. Therefore, adirect comparison with MSD's previous
rank is not possible.

Access to Medicine Index 2022 ▶ Company report cards

SALES AND OPERATIONSBusiness segments: Animal health,

MSD’s products are sold in 81* out of 108

pharmaceuticals and other segments.

countries in scope of the Index. MSD has sales

Therapeutic areas: Cardiovascular, diabetes,

offices in 15 countries and sells via suppliers and/Animal health4.70 bnhospital acute care, immunology, neuroscience,or pooled procurement in 66* countries.

Pharmaceuticals

43.02 bn

Other segment sales

0.02 bnoncology and virology.

Net sales by segment (2020) – in USD*In 2016, MSD reported sales in 81 countries.

Product categories: Animal health, innovative		

medicines and vaccines.

Total

47.75 bn

M&A news: MSD acquired Acceleron Pharma Inc.
in November 2021 for USD 11.5 billion.
Sales by geographic region
50

Net sales (Bn USD)

Sales in countries in scope

40
30
20
10
0

2017

In scope, has sales offices
In scope, sales unknown
Not in scope

2018

2019

2020

2021

USA

Europe, Middle East and Africa

Japan

Asia Pacific (other than China and Japan)

Latin America

China

Other

SAMPLE OF PIPELINE AND PORTFOLIO ASSESSED BY THE INDEXPIPELINE for diseases in scope

PORTFOLIO as selected for analysis by the Index

MSD has a total of 47 R&D projects in scope with 13 of these projects targeting priority diseases. The other 34 R&D projects target other diseases
in scope. Of the projects targeting priority diseases, the focus is on HIV/AIDS (five projects). Of the projects targeting other diseases in scope, thefocus is on oncology (29).
Twenty-eight R&D projects are in late-stage development that target
either a priority disease (10) or address a public health need in LMICs(18).* Evidence of access planning was reported in these sections for 43%of these projects: three targeting a priority disease and nine addressing apublic health need in LMICs.

MSD has 37 medicines in scope, 23 of which are on patent, and 13 vaccines. 32%of the medicines (12) are on the WHO EML. In addition, the company markets
one vector control product and four contraceptive methods and devices. The
off-patent medicines target mainly non-communicable diseases (NCDs) (12) suchas mental health (1) and cardiovascular diseases (4), cancer (2), asthma (2) andmigraine (1); communicable diseases (CD) (3) such as HIV/AIDS, tuberculosis andhepatitis C. The on-patent medicines target CDs such as HIV/AIDS (5), hepatitis C (3), respiratory and other prioritised infections; and NCDs such as diabetes(6), cancer (3) and mental health (1). MSD's preventative vaccines (10) target CDs
such as measles (2) and lower respiratory infections, and NCDs such as cancer(2). One vaccine is indicated for immunisation against HPV-related cervical cancer.

47 projects in the pipeline

55 products as selected for analysis by the Index†
13

1

Multiple categories
0

20
30
40
50
projects in the pipeline

10

20
30
40
50
products on the market

Discovery

Pre-clinical

Phase I

Phase II

Phase III

Registration/approval

Other***

Total

Breakdown of products

Vaccines

0

0

3

3

5

2

0

13

Contraceptives

Targets established R&D priorities

Medicines on patentoff patent

Addresses needs of LMICs*

0

8

5

5

0 18

Diagnostics

Other projects in scope

0 14

1

1

0 16

Other‡*50 diseases and 243 product gaps inscope have been established as a priority by global health stakeholders. For
other diseases, the Index used a set of criteria to determine which projects in thepipeline offer a clear public health benefit to patients in LMICs. Only projects inthe clinical phase of development were
included for this analysis.
**Neglected tropical diseases, while also
communicable, are highlighted separately
throughout the Index.
***Other includes projects that have atechnical lifecycle and projects that fol-

2

21

23

10 4

14

12

1

13

2

2

Total

10

Breakdown of projects

197

24

Non-communicableMultiple categories 004Maternal and neonatal

32

Non-communicable

Other

1

1

Non-EML

Maternal and neonatal

25

Communicable**
Neglected tropical

WHO EML1

WHO EDL

Communicable**
Neglected tropical

4
0

0
1

low a different development cycle (e.g.
diagnostics).
†Products included in the analysis wereselected using a set of criteria determinedby stakeholder consensus.
‡Other includes vector control products.

1

Access to Medicine Index 2022 ▶ Company report cards

Merck & Co, Inc

GOVERNANCE OF ACCESSRANK 20SCORE 3.14

Has an access-to-medicine strategy with meas-ency by consistently sharing the outcomes of its

third parties and in all countries where it oper-

urable objectives, integrated within its overall

MSD for Mothers initiatives in a centralised man-ates) and formal processes to ensure third-party

corporate strategy. MSD performs strongly. It

ner directly on its website.

compliance with company standards. There ishas an access strategy, guided by its Access tono evidence, publicly found or disclosed to the

Health Statement of Guiding Principles, which

Performs comparatively poorly in responsible

Index, of fraud-specific risk assessment, country

covers all therapeutic areas in which the company

promotional practices. MSD does not disclose

risk-based assessment, or a continuous system

is involved. The highest responsibility for access

whether its sales agents are not solely incentiv-

to monitor activities. No breaches in countries

lies indirectly with the board, namely with theised on sales volume targets. There is evidencein scope of the Index were publicly found in the

Public Policy and Responsibility Council reportingthat the company sets incentives based on sales

period of analysis.

to the Executive Committee.

targets at the individual level for agents. It has
Guiding Principles for ethical business practices

Publicly supports the Doha Declaration on

Does not provide evidence of financial or

involving the medical and scientific community

TRIPS and Public Health. MSD publicly shares

non-financial access-related incentives atand discloses information related to transfers of

support of the Doha Declaration on TRIPS andthe managerial level. Merck's performance isvalues to healthcare professionals in countries

Public Health but expresses reservations on

below average. The company does not disclosein scope of the Index in accordance with law andits provisions. That is, it challenges compulsory

access-related incentives for senior executives or

local regulations and association guidance (e.g.

licensing, stating it should only be used in very

in-country managers.

payments for attending events or promotional

limited circumstances. There is evidence of indus-

activities).

try association lobbying on IP and the usage of

Publicly discloses outcomes of its

TRIPS flexibilities, namely of compulsory licens-

access-to-medicine activities. MSD performs

Has some compliance controls to ensure that

ing, by national governments in some countries instrongly in transparency of access activities.

governance efforts are not undermined byscope of the Index. As a member of the industry

It publicly discloses commitments, measura-

non-compliant or corrupt activities. MSD per-association, MSD, like all other member compa-

ble goals, objectives, and targets for improving

forms relatively poorly, demonstrating evidence

nies in scope of the Index, is by default connected

access to medicine in countries in scope of theof some components looked for by the Index:

to this activity.

Index. It facilitates accountability and transpar-

audits (both internal and external, covering

RESEARCH & DEVELOPMENTRANK 11SCORE 2.38

Access planning processes encompass all pro-For example, MSD agreed a non-exclusive vol-register in countries in scope apply to nine ofjects in the pipeline. The company reported nountary licensing agreement with the Medicines

these projects.

information to the Index about its access planning

Patient Pool for its COVID-19 antiviral molnupira-processes. However, evidence of this was identi-vir (MK-4482 and EIDD-2801) before it received

Does not publicly disclose R&D investment

fied in the public domain. MSD has a structured

emergency regulatory authorisation.

data disaggregated by disease category, product type or phase of development. However,process to develop access plans during R&D. The

198

process is intended to be applied to all R&D pro-

Many projects address a public health need in

MSD does disclose fully disaggregated R&D

jects for diseases in scope of the Index. In general,

LMICs*, with 50% (9/18) of late-stage projects

investment data to Policy Cures Research.

MSD begins developing access plans for R&D pro-supported by access plans. In this analysis, MSD

jects in Phase II of clinical development.

has 18 late-stage R&D projects that target a

One R&D capacity building initiative included

disease and/or product gap not yet established

for analysis meets all Good Practice Standards.

A small-sized priority R&D pipeline compared

as a priority by global health stakeholders. These

MSD's performance is average in this area. The

to peers, with evidence of access plans for

projects are all deemed by the Index to offer

number of initiatives meeting all inclusion criteria

30% (3/10) of the late-stage candidates. MSD

a clear public health benefit for people living

is lower than average and fewer initiatives meethas 13 projects, including ten late-stage candi-

in LMICs.* Primarily, these projects concern

all Good Practice Standards than what is averagedates in its pipeline, that target a priority productclinical trials in countries in scope of the Index

for this indicator. The company did not participate

gap. These projects focus mostly on HIV/AIDS.

or are first-in-class projects. Most target cancer.

in the Access to Medicine Index data submis-

Of MSD's ten late-stage candidates targeting a

The company did not participate in the Accesssion. However, based on information in the publicpriority product gap, three have evidence of an

to Medicine Index data submission. However,domain, one initiative could be included for anal-

access plan in place. The company did not par-MSD has a policy whereby once a product isysis. In this initiative, MSD partners with Seeding

ticipate in the Access to Medicine Index dataapproved, it commits to registering it in all

Labs to improve access to laboratory equipment

submission. However, evidence of access planscountries where clinical trials for the productfor the scientific community in LMICs.

for three projects was found in the public domain.

have taken place. Therefore, commitments to*50 diseases and 243 product gaps inscope have been established as a priority
by global health stakeholders. For otherdiseases, the Index used a set of criteria
to determine which projects in the pipeline offer a clear public health benefit topatients in LMICs. Projects in the clinicalphase of development were included forthis analysis.

Access to Medicine Index 2022 ▶ Company report cards

PRODUCT DELIVERYRANK 19SCORE 1.75

Public commitment not to enforce patents

Has an access strategy for its healthcare prac-

Has engaged in scaling up two inclusive busi-

in countries in scope. MSD publicly pledges totitioner-administered products in scope of thisness models but has not shown evidence ofneither file for nor enforce patents. This commit-

analysis. MSD performs below average in securing

its involvement in piloting any new inclusive

ment applies in LICs.

access for healthcare practitioner-administeredbusiness models that meet all inclusion crite-

products. Evidence of an access strategy that con-ria. MSD performs average in the use of inclusive

Publicly discloses information on patent sta-siders some affordability factors was found in

business models aimed at meeting the accesstus. Like most of its peers, MSD discloses the

China for pembrolizumab (Keytruda®), an oncol-

needs of populations at the base of the income

patent statuses for small molecules in scope via

ogy product. No evidence of access strategies forpyramid (including other underserved popula-

the Pat-INFORMED database. MSD discloses

the remaining products were found in the public

tions) in LMICs. In Kenya, MSD is supporting thepatent information such as filing date, grant num-domain, nor was evidence regarding patient reach,expansion of M-TIBA to include maternal healthber, grant date and jurisdiction. Additionally, iteither publicly or to the Index. The products are anservices through Mom Care, a new platform that

discloses US patent numbers for its entire US

oncology treatment, antibiotics and a product tar-links patients, providers and payers to improve

portfolio of vaccines and biologics.

geting ischaemic heart disease.

the financing and delivery of maternity care.

Performs below average in terms of sharing

No evidence of access strategies for any of

Performs below average in terms of ensuring

intellectual property (IP) assets with third-

its self-administered products in scope of thiscontinuous supply of medicines in LMICs. MSD

party researchers. MSD does not report on any

analysis. MSD has not disclosed, either publicly orshows evidence of its involvement in supply chain

new IP-sharing agreements with public research

to the Index, access strategies for any of the fivecapacity building initiatives and transfers tech-

institutions or drug discovery initiatives estab-

products assessed by the Index in this category.

nology with third-party manufacturers in LMICs.

lished during the current analysis period that

The products are diabetes treatments, a productHowever, there is no evidence that the company

meet all inclusion criteria for evaluation. The

targeting asthma and one targeting migraine.

works with relevant stakeholders to communicatecompany does have existing agreements of thisissues that may affect the supply chain, maintains

nature in place that were established before theNo manufacturing capacity building initiatives

a network of several active pharmaceutical ingre-

current period of analysis and meet all inclusion

included for analysis. There is no evidence — indient suppliers, nor manages a buffer stock of

criteria for evaluation.

the public domain or disclosed to the Index — ofrelevant products.

manufacturing capacity building initiatives active
Uses licensing to enable generic supply. MSD

during the period of analysis that met inclu-

Does not disclose a policy for reporting sub-has a non-exclusive voluntary licensing agree-sion criteria for evaluation. MSD's performance isstandard and falsified (SF) medicines inment in place for two compounds (for diseases

below average in this area.

countries in scope of the Index. MSD does notin scope). Its licence for its paediatric formulation

disclose, publicly or to the Index, evidence of aof raltegravir (Isentress®), indicated for HIV/AIDS,

Both supply chain capacity building initiatives

policy in place to report SF medicines to relevant

encompasses 89 countries within the scope ofincluded for analysis meet all Good Practice

health authorities. However, it publicly discloses

the Index including 59 middle income countries.

Standards. MSD's performance is average in thishaving a global Product Integrity Strategy on

MSD also has a licence for its COVID-19 antiviral,area. The number of initiatives meeting all inclu-

tackling counterfeit products, and reports thatmolnupiravir (Lagevrio®), agreed with 27 subli-

sion criteria is lower than average but an average

it responds in alignment with local regulatorycensees, covering 95 countries relevant to thenumber of initiatives meet all Good Practicerequirements.

Index including 68 middle income countries.

Standards (GPS) for this indicator. For example, MSD is a member of the Neglected TropicalDonates in response to expressed need andNo evidence of filing for registration new prod-

Disease (NTD) Supply Chain Forum which pro-monitors delivery. MSD has public policies

ucts in any country in scope on average. MSD

vides a common platform for all partners to comeand supply processes in place to ensure ad hoc

did not disclose evidence of filing for registration

together and explore options to manage the NTD

donations are carried out rapidly in response to

any of its analysed products.

drug supply chain.

expressed need, and it monitors the delivery of

Has access strategies for all its supranation-

One of the two health systems strengthen-ally procured products in scope of this analysis.

ing initiatives included meets all Good Practice

Publicly commits to the achievement of elim-

MSD performs below average in securing accessStandards. MSD's performance is below average

ination, eradication or control goals in twofor products procured supranationally. For all

in this area. The number of initiatives meeting all

structured donation programmes for neglectedof the three products assessed in this category,inclusion criteria is lower than average and fewer

tropical diseases or malaria. In one programme,

examples of strategies both in countries eligi-

initiatives meet all GPS than what is average forfor over 15 years MSD has publicly committed

ble for supply from such procurers and in at least

this indicator. For example, MSD for Mothers is a

to supporting the elimination of onchocercia-

one non-eligible country were found publicly. For

USD 650 million global initiative, contributing thesis and lymphatic filariasis by donating ivermectin

example, the company has a tiered pricing policy

company's scientific and business expertise and(Mectizan®) in 27 countries in scope of the Index

for vaccines, including the pneumococcal vac-financial resources to address preventable mater-

until goals are achieved.

cine polyvalent (23-valent) (Pneumovax®23).

nal deaths through supporting quality maternity

Information regarding patient reach was notcare and access to modern contraception. This

found in the public domain.

initiative meets all GPS.

donations.

199

Access to Medicine Index 2022 ▶ Company report cards

RA N KSCO R E53.72

8 (2021)

Merck KGaA
Stock exchange: XFRA • Ticker: MRK • HQ: Darmstadt, Germany • Employees: 60,334

PERFORMANCE IN THE 2022 INDEX
5th place. Merck performs strongly and is now in the top fiveof the Index. Merck excels in R&D access planning and it
performs well in its approach to patent transparency. It also
engages in high-quality capacity building initiatives across

How score was achieved
4.14

Governance of Access
3.40

Research & Development

3.78

Product Delivery

all fields and has an average performance in Governance of0

1

Access.

2

3

Average

Leader4

5

Governance of Access: 10th place. Merck has an average performance in this area. It has a clear access-to-medicine strategy that is integrated into its overall corporate strategy, butframework in place and has access plans for all late-stage

it does not extend across its pipeline and portfolio. It dis-candidates. The company excels in R&D capacity building.

closes the outcomes of its access-to-medicine activities andhas a robust set of compliance controls to mitigate the risk

Product Delivery: 5th place. Merck performs well in thisof non-compliance in countries in scope of the Index, but it

area. Merck performs strongly in sharing intellectual prop-

provides limited evidence on access-related incentives forerty assets with third-party researchers. It has improved in

its CEO and no evidence of access-related incentives for

its approach to equitable access strategies, yet the focus isin-country and regional managers.

mostly on upper-middle and lower-middle income countries.
Merck engages in high-quality capacity building initiatives

Research & Development: 4th place. Merck performs strongly

across all fields (i.e., manufacturing, supply and health sys-in this area. The company has a structured access planningtems strengthening).

OPPORTUNITIES FOR MERCK KGaA

CHANGES SINCE THE 2021 INDEX

Improve the quality of access plans for R&D projects for cancer. Merck has access• Added “country segmentation” to compliance risk

plans in place for all late-stage R&D candidates. Most of these plans, focus solely
on registration in countries in scope of the Index. Merck can expand its access plans
beyond registration to consider more access components such as equitable pricing andlicensing.

management in all countries where Merck actively operates
to classify countries in terms of their risk exposure.
• Donated research instruments and materials to the Eijkman
Institute for Molecular Biology to support in its efforts inaccelerating COVID-19 vaccine development research in

Expand manufacturing capacity building efforts beyond vaccines. Merck started the
Merck Africa Biologics and Vaccine Initiative (MABVI), which aims to develop integrated

Indonesia.
• The Merck Family Foundation donated EUR 100,000 tosolutions to deploy innovative manufacturing technologies that enable local biologics

Business for Health Solutions (BHS), an initiative in which

manufacturing across Africa. The initiative is currently active in eight countries in scope

Merck employees dedicate time to build capacity in the localof the Index and focuses on vaccines. Merck can expand this initiative to focus on further

African healthcare sector. The initiative will be expanded to

products such as biological treatments. The company can also regularly monitor and

up to six healthcare companies in western Africa.

share impact.

• Expanded its long-term donation programme to adult

Expand access to cancer treatments. Merck implemented access strategies for• Successfully completed the clinical development oftreatment for the elimination of schistosomiasis in Rwanda.
avelumab (Bavencio®) in at least one upper-middle income country and one lowermiddle income country. The company can increase patient reach through registration,

the potential new medication (arpraziquantel) to treat
schistosomiasis in children as of 6 years of age and below.

equitable pricing and/or non-exclusive voluntary licensing, especially in countries where• Submitted the WHO prequalification dossier of an

the burden of bladder cancer is the highest such as Egypt, Armenia and the Republic of

optimised praziquantel (Cesol® 600) formulation.

Moldova.

200

All companies were assessed based on
information that was valid in the latest
period of analysis (ending at 31 May2022). This data was either submitted bycompanies, found in the public domain or
was accessible through other sources.

The term LMICs is used to denote all
low- and middle-income countries inscope of the Index, except when analysing
companies’ access strategies where
the use of LMIC refers to lower-middle
income countries as per the World Bank

income groups classification. Likewise, theterms LIC and UMIC refer to low income
countries and upper-middle income
countries.

Access to Medicine Index 2022 ▶ Company report cards

SALES AND OPERATIONSBusiness segments: Electronics, healthcare andMerck's products are sold in 89 out of 108

life sciences.

countries in scope of the Index. Merck has sales

Net sales by segment (2021) – in EUR

Therapeutic areas: Endocrinology, fertility,

offices in 20 countries, and sells via suppliersLife sciences

8.99 bngeneral medicine, immunology, immuno-

and/or pooled procurement in an additional 69

Healthcare

7.09 bnoncology and neurology.

countries.

Electronics

3.61 bn

Product categories: Diagnostics, innovative		

medicines and medical devices.

Total

19.69 bn

M&A news: Merck KGaA acquired Exelead in
February 2022 for approximately USD 780
million.
Sales by geographic region
25

Net sales (Bn EUR)

Sales in countries in scope

20
15
10
5
0

In scope, has sales offices
In scope, any sales

2017

2018

Middle East/Africa

In scope, no sales

Latin America

Not in scope

2019

2020

2021

Asia-Pacific
EuropeNorth America

SAMPLE OF PIPELINE AND PORTFOLIO ASSESSED BY THE INDEXPIPELINE for diseases in scope

PORTFOLIO as selected for analysis by the Index

Merck has a total of 68 R&D projects in scope with 33 of these projects

Merck has 13 medicines in scope, two of which are on patent. 38% of thesetargeting priority diseases. The other 35 R&D projects target other dis-

medicines (5) are on the WHO EML. In addition, the company markets twoeases in scope. Of the projects targeting priority diseases, the focus is on

diagnostics for HIV/AIDS. The off-patent medicines target non-communica-

schistosomiasis (13 projects) and malaria (11). Of the projects targetingble diseases (9) such as cardiovascular diseases (5), cancer (1) and diabetes

other diseases, the focus is on oncology (34).

(3). Furthermore, the company markets chloroquine for malaria and prazi-

Thirteen R&D projects are in late-stage development that target either aquantel for parasitic worm infections. The on-patent medicines target

priority disease (3) or address a public health need in LMICs (10).* Evidence

cancer (2).

of access planning was in place for 100% of these projects.

68 projects in the pipeline

15 products as selected for analysis by the Index†
18

Communicable**

Maternal and neonatal 032

Non-communicable11

Non-communicable

5

Multiple categories 0
0

20
30
40
50
projects in the pipeline

Phase II

Phase III

Registration/approval

Other***

1

1

0

2

12 33

Addresses needs of LMICs*

13

7

1

2

0 23

Other projects in scope

4

4

0

0

4

*50 diseases and 243 product gaps inscope have been established as a priority by global health stakeholders. For
other diseases, the Index used a set of criteria to determine which projects in thepipeline offer a clear public health benefit to patients in LMICs. Only projects in12

the clinical phase of development were
included for this analysis.
**Neglected tropical diseases, while also
communicable, are highlighted separately
throughout the Index.
***Other includes projects that have atechnical lifecycle and projects that fol-

Total

Phase I

0

Other

Pre-clinical

17

Total

Discovery

Targets established R&D priorities

20
30
40
50
products on the market

Breakdown of products
WHO EML

Breakdown of projects

10

WHO EDL

10

Non-EML

0

201

1

Neglected tropical

Maternal and neonatal 0
Multiple categories

3

Communicable**

13

Neglected tropical

Medicines on patent

0

2

2

off patent

5

6

11
0

Vaccines

00Contraceptives

00

Diagnostics
Other

‡

0
2

2
0

low a different development cycle (e.g.
diagnostics).
†Products included in the analysis wereselected using a set of criteria determinedby stakeholder consensus.
‡Other includes vector control products.

0

Access to Medicine Index 2022 ▶ Company report cards

Merck KGaA

GOVERNANCE OF ACCESSRANK 10SCORE 4.14

Has an access-to-medicine strategy with meas-strongly in transparency of access activities. It

dence of all components looked for by the Index:

urable objectives, integrated within the overallpublicly discloses commitments, including on

fraud-specific risk assessment, country risk-based

corporate strategy. Merck performs well. It has

combating NCDs, measurable goals, objectives

assessment, a continuous system to monitora Global Health strategy focused on availabil-

and targets for improving access to medicine

activities, audits (both internal and external, cov-

ity, affordability, awareness and accessibility. The

in countries in scope of the Index. It facilitatesering third parties and in all countries where it

strategy covers some of the therapeutic areas inaccountability and transparency by consistently

operates) and has formal processes to ensure

which the company is involved, with a focus on

sharing the outcomes of its access-to-medi-

third-party compliance with company standards.

the elimination of schistosomiasis, malaria, andcine activities in a centralised manner within its

No breaches in countries in scope of the Index

the prevention and control of non-communicable

Sustainability Report.

were publicly found in the period of analysis.

sibility for access lies directly with the CEO of

Has an average performance in responsible

Publicly supports the Doha Declaration on

Healthcare at Merck, who manages Global Healthpromotional practices. Merck’s sales agents are

TRIPS and Public Health. Merck publicly shareson behalf of the Executive Board.

not solely incentivised on sales volume targets.

support of the Doha Declaration on TRIPS andHowever, additional details on how the company

Public Health, but expresses reservations on

Provides evidence of financial and non-financial

addresses sales incentives for sales agents are

the implementation of its provisions. That is, it

access-related incentives at the executive level.

unavailable. It does not publicly disclose informa-

highlights compulsory licensing as a risk of under-

Merck performs well. It incentivises the CEO andtion related to transfers of values to healthcare

mining innovation. There is evidence of industry

other senior executives with objectives related

professionals in countries in scope of the Index

association lobbying on IP and the usage ofto sustainability. It publicly states that the CEO's(e.g. payments for attending events or promo-

TRIPS flexibilities, namely of compulsory licens-Long-Term Incentive Plan (LTIP) is connected to ational activities), unless required by law or by local

ing, by national governments in some countries in

Sustainability Factor consisting of three sustaina-

regulations, though it has policies and procedures

scope of the Index. As a member of the industry

bility indicators, and the goal of the first indicatorin place limiting transfers of values to healthcare

association, Merck, like all other member compa-

is to achieve human progress for more than one

professionals.

nies in scope of the Index, is by default connecteddiseases (NCDs) in LMICs. The highest respon-billion people by 2030 through sustainable sci-to this activity.
Has a robust set of compliance controls toence and technology.

ensure that governance efforts are not underPublicly discloses outcomes of its

mined by non-compliant or corrupt activities.

access-to-medicine activities. Merck performs

Merck performs strongly, demonstrating evi-

RESEARCH & DEVELOPMENTRANK 4SCORE 3.40

Access planning processes encompass all pro-

WHO prequalification, priority registration in

Does not publicly disclose R&D investment

jects in the pipeline. Merck has a structured

high burden African countries, engagement withdata disaggregated by disease category, prod-

process in place to develop access plans during

access-oriented funding organisations and local

uct type or phase of development. Merck does

R&D. The process is intended to be applied to all

manufacturing arrangements to ensure equitable

not disclose disaggregated R&D investment data

R&D projects (both in-house and collaborative) forand sustainable access and supply.

to global health organisations.

begins developing access plans for R&D projects in

Many projects address a public health need in

All five R&D capacity building initiatives

Phase II or earlier of clinical development.

LMICs,* with 100% (10/10) of late-stage candi-

included for analysis meet all Good Practicedates covered by access plans. In this analysis,

Standards. Merck leads in this area. The num-

An average-sized priority R&D pipeline com-

Merck has ten late-stage R&D projects that target

ber of initiatives meeting all inclusion criteria ispared to its peers, with evidence of accessa disease and/or product gap not yet designatedhigher than average and more initiatives meet allplans in place for 100% (3/3) of late-stage can-as a priority by global health stakeholders. These

Good Practice Standards than what is average fordidates. Merck has 33 projects, including threeprojects are all deemed by the Index to offer athis indicator. For example, Merck partners withlate-stage candidates that target a priority prod-

clear public health benefit for people living in

Seeding Labs, to improve access to lab equip-

uct gap. The priority pipeline focuses mainly

LMICs.* Primarily, these projects are first-in-classment for the scientific community in countries

on schistosomiasis and malaria. There is evi-molecules. All target cancer. Merck provides evi-in scope of the Index. Additionally, Merck is thedence of access plans for all three of Merck's

dence of access plans for all ten of these projects.

founding sponsor of the TeleScience platform, anlate-stage candidates. Notably, the access plan

These plans focus mainly on registration prepara-

online platform that provides teaching and train-

for the potential new treatment option for schis-tion in countries in scope of the Index.

ing to scientists in LMICs.

diseases in scope of the Index. In general, Merck

tosomiasis (arpraziquantel) includes plans for202*50 diseases and 243 product gaps inscope have been established as a priority
by global health stakeholders. For otherdiseases, the Index used a set of criteria
to determine which projects in the pipeline offer a clear public health benefit topatients in LMICs. Projects in the clinicalphase of development were included forthis analysis.

Access to Medicine Index 2022 ▶ Company report cards

PRODUCT DELIVERYRANK 5SCORE 3.78

Public commitment not to enforce patents in

Has access strategies for its self-administered

The company has engaged in both scaling up

countries in scope. Merck publicly pledges to

products for some countries in scope of thisand piloting one inclusive business model.

neither file for nor enforce patents. This commit-

analysis. Merck performs below average in thisMerck performs above average in the use ofment applies to all Least Developed Countries

area. The company provides examples of accessinclusive business models aimed at meeting theand LICs as well as in a subset of LMICs andstrategies which consider affordability in UMIC

access needs of populations at the base of the

UMICs, a total of 90 countries in scope of theand LMIC contexts for three of the five products

income pyramid (including other underserved

Index.

assessed. Evidence of access strategies in LICs

populations) in LMICs. CURAFA™ points of care

was not provided. Merck makes efforts to reachfor integrated healthcare services, piloted in

Publicly discloses detailed information on pat-

additional patients using pricing strategies that

Kenya, aim to provide primary healthcare accessent status. Like most of its peers, Merck publicly

consider relevant payers' ability to pay. For exam-

to underserved populations in low-income com-discloses the patent statuses for small mole-ple, in Egypt, the company participates in tenders

munities in emerging economies.

cules in scope via the Pat-INFORMED database.

to supply the diabetes medicine metformin/glib-

Additionally, Merck discloses the type of patents

enclamide (Glucovance®) and it has initiatives to

Performs above average in terms of ensuring

and their expiry dates on its website for a subset

assist patients in disease management. The com-continuous supply of medicines in LMICs.

of products in scope of the Index.

pany provides evidence of the number of patients

Merck is involved in technology transfers withreached by this product in Egypt and Mexico.

third-party manufacturers in LMICs, and has a sys-

Performs above average in terms of sharing

tem in place to work with relevant stakeholders

intellectual property (IP) assets with third-

Three of the five manufacturing capacity build-to communicate issues that may affect the supply

party researchers. Merck engaged in 17 newing initiatives included meet all Good Practicechain, works with several active pharmaceuti-

IP-sharing agreements with third-party researchStandards. Merck's performance is above aver-cal ingredient (API) suppliers/produces in-house

institutions or drug discovery initiatives estab-

age in this area. The number of initiatives meeting

APIs, manages a buffer stock of relevant products

lished during the current analysis period that

all inclusion criteria is higher than average andand is involved in supply chain capacity building

meet all inclusion criteria for evaluation. The

more initiatives meet all Good Practice Standards

initiatives.

company does have existing agreements of this(GPS) than what is average for this indicator. For

nature in place that were established before theexample, the Pediatric Praziquantel Consortium

Has a policy for reporting substandard and fal-current period of analysis and meet all inclusionaims to reduce the global disease burden of schis-sified (SF) medicines in countries in scope of

criteria for evaluation.

tosomiasis by addressing the medical need of

the Index in less than ten days. Merck provides

infected children aged six and below. One of theevidence of reporting confirmed SF medicines to

No use of licensing agreements. Merck does

goals of this program, led by Merck, is to establish

the relevant national health authorities within ten

not engage in voluntary licensing for products ina sustainable and affordable manufacturing anddays. When authorities request a visual assess-scope of the Index. It publicly states it would con-supply chain that involves sites in LMICs. This ini-

ment of an obvious counterfeit product (e.g.,sider granting non-exclusive voluntary licences intiative meets all GPS.

obvious artwork errors or a non-existing batchcertain circumstances.

number), Merck commits to provide conclusions
Three of the five supply chain capacity build-of the assessment to the relevant health authori-

Filed to register new products in six countries

ing initiatives included meet all Good Practiceties in less than ten days.

in scope on average. Merck did not disclose evi-

Standards. Merck's performance is above aver-dence of filing for registration any of its newage in this area. The number of initiatives meeting

Donates in response to expressed need andproducts in more than half of the top ten highall inclusion criteria is higher than average andmonitors delivery. Merck has public policies

burden countries. Among old products, its most

more initiatives meet all GPS than what is aver-and supply processes in place to ensure ad hoc

widely registered is bisoprolol (Concor®/Concor®

age for this indicator. Merck has been a member

donations are carried out rapidly in response toCOR), indicated for cardiovascular diseases, filedof CAMP-N Supply Chain Technical Working

expressed need, and it monitors the delivery ofin 63 countries relevant to the Index, includingGroup since its launch in 2017. This coalition of

donations.

four high burden countries (Republic of Moldova,

government agencies, private sector entities,

Syrian Arab Republic, Ukraine and Uzbekistan)

non-governmental organisations, philanthropic

Publicly commits to the achievement of elim-

and ten LICs.

foundations and academic institutions is ded-

ination, eradication or control goals in one

icated to increasing access to medicines andstructured donation programme for neglected

Merck is not eligible for assessment of supra-

health products for NCDs. This initiative meetstropical diseases or malaria. Since 2007, Merck

nationally procured products.

all GPS.

has publicly committed to supporting the elimina-

Has access strategies for some healthcare

Two of the five health systems strengthen-(Cesol®) in 43 countries in scope of the Index

practioner-administered products in scopeing initiatives included meet all Good Practice

until goals are reached.

of this analysis. Merck's performance is above

Standards. Merck's performance is average

average in this area.* For one of the two prod-in this area. The number of initiatives meetingucts assessed, the company provides examples

all inclusion criteria is higher than average butof access strategies in countries of all assessed

fewer initiatives meet all GPS than what is aver-income levels (UMIC, LMIC, LIC). The company

age for this indicator. For example, Merck andmakes efforts to reach additional patients using

the NALA Foundation Partnership to Eliminate

pricing mechanisms that consider payers' abil-

Schistosomiasis combines treatment, research

ity to pay and has implemented strategies toand development and health education andensure patients' access to a product not availa-

WASH (water, sanitation and hygiene) to support

ble on the market yet. Merck provides evidence

the elimination of this neglected tropical diseaseof how patient reach has been increased throughin Ethiopia. This initiative meets all GPS.

tion of schistosomiasis by donating praziquantel

the approaches used in the UMIC and LMIC country examples.

203* The description of Merck’s performancein PP4 (HCP-administered products) was
corrected from "average" to "above average" on 1 Dec 2022. This typographicalerror did not impact the underlying analysis or scoring.

Access to Medicine Index 2022 ▶ Company report cards

RA N KSCO R E4

3.87

2 (2021)

Novartis AG
Stock exchange: SWX • Ticker: NOVN • HQ: Basel, Switzerland • Employees: ~108,000

PERFORMANCE IN THE 2022 INDEX
4th place. Novartis ranks among the top five companies in the
Index. Novartis has comprehensive access plans in place for all
late-stage candidates in the pipeline and performs strongly inhigh-quality capacity building initiatives across all fields. The

How score was achieved
3.43

Governance of Access

3.70

Research & Development

4.08

Product Delivery

company leads in its approach to access strategies for self-

01

administered products.

2

3

Average

Leader4

5

Governance of Access: 15th place. Novartis performs below
average in this area. It has integrated access-to-medicine into
its corporate strategy under the Novartis Access Principles
and has a robust set of compliance controls to mitigate therisk of non-compliance in countries in scope of the Index.

Product Delivery: 4th place. Novartis performs strongly in thisHowever, the company was found to be the subject of a legal

area. The company has high quality access strategies in placesettlement during the period of analysis based on conduct byacross all country income classifications for a subset of its

a former subsidiary.

products. It has scaled up and piloted the highest number ofinclusive business models of all companies. It also performs

Research & Development: 3rd place. Novartis performs strongly

strongly in capacity building across all fields (i.e., manufac-

in this area. It has an access planning framework and applies

turing, supply chain and health systems strengthening). The

this to all its late-stage pipeline candidates. Novartis performs

company is engaging in non-exclusive voluntary licensing tostrongly in R&D capacity building and leads by publicly disclos-enable generic supply of a non-communicable disease prod-

ing R&D investments for priority neglected diseases.

uct in LMICs, the first agreement of its kind.

OPPORTUNITIES FOR NOVARTISCHANGES SINCE THE 2021 INDEX

Expand technology transfers to more countries. Novartis reports seven• Established an ESG Council which co-creates and oversees thetechnology transfers to build manufacturing capacity. Capacity building
is focused on countries like China, India and Brazil which have wellestablished pharmaceutical markets. The company can engage in further

development of the ESG strategy, formulates ESG targets and raises
relevant topics to the Trust & Reputation Committee.
• Created an Access Solutions Center of Excellence within Novartis

technology transfers in countries where its products address a high disease

Corporate Affairs and Global Health to provide guidance on the Accessburden, aiming to expand access and regional availability. For example,

Principles implementation across the full organisation (Pharma, Oncology,

Novartis can transfer technology for its products indicated for chronic

Global Health, R&D).

obstructive pulmonary disease or products in its oncology portfolio.

• New ESG framework will prioritise access as one of the two mostExpand the geographic scope of the CancerPath to Care initiative. In• Publicly disclosed disaggregated R&D expenses on priority diseases

important materiality topics.
2022, Novartis announced the expansion of its donation and capacity
building efforts for cancer products beyond chronic myeloid leukaemia(CML) through partnership with The Max Foundation called CancerPath toCare. Novartis will continue to support the Foundation with the delivery ofthe donation treatments for breast cancer, CML and rare cancers. Novartis
can work with partners to expand donations and capacity building efforts
through this initiative to more countries with a high disease burden.

(excluding COVID-19) and separately for malaria.
• Joined the Neglected Tropical Disease Supply Chain Forum in 2021 withits Leprosy Donation programme to the World Health Organisation.
• Entered a partnership with Save the Children to launch a pilot community
health project tackling child mortality in Kenya’s Kibera and Mathareslums.
• Joined the Access to Oncology Medicines (ATOM) Coalition, a new global
initiative that aims to improve access to essential cancer medicines in

Expand access to breast cancer and cardiovascular products. Novartis hasaccess strategies in place for its breast cancer product, ribociclib (Kisqali®),

LMICs.
• As part of ATOM Coalition, agreed to a non-exclusive voluntary license

in at least one upper-middle income country and lower-middle income(NEVL) with the Medicines Patent Pool (MPP) for nilotinib, indicated forcountry, and has committed to implementing an access strategy in at least

leukaemia, becoming the first company to have signed a NEVL for an

three low-income countries (LICs) in the future. Novartis can provide
evidence of implementing additional access strategies for ribociclib in LICs.

oncology medicine.
• Issued a EUR 1.85 billion sustainability-linked bond (SLB), reinforcing its

In addition, it can expand patient reach via non-pricing access strategies

commitment to ESG principles and the 2025 Patient Access Targets. The

such as non-exclusive voluntary licences (NEVLs). For example, Novartis

first of its kind in the healthcare industry and the first SLB incorporating

has announced a NEVL for nilotinib (Tasigna®), indicated for leukaemia.

social targets.

Novartis could also pursue a NEVL for ribociclib.

204

All companies were assessed based on
information that was valid in the latest
period of analysis (ending at 31 May2022). This data was either submitted bycompanies, found in the public domain or
was accessible through other sources.

The term LMICs is used to denote all
low- and middle-income countries inscope of the Index, except when analysing
companies’ access strategies where
the use of LMIC refers to lower-middle
income countries as per the World Bank

income groups classification. Likewise, theterms LIC and UMIC refer to low income
countries and upper-middle income
countries.

Access to Medicine Index 2022 ▶ Company report cards

SALES AND OPERATIONSBusiness segments: Sandoz (generics andArctos Medical in September 2021, GSK's

biosimilars) and Innovative Medicines.

cephalosporin antibiotics business in October

Net sales by segment (2021) – in USD

Therapeutic areas: Oncology, cardiovascular,

2021, Gyroscope Therapeutics in December

Innovative Medicines

renal and metabolism, Respiratory and2021 and Kedalion Therapeutics in June 2022.

Sandozallergy, Immunology, hepatology and42.00 bn9.63 bn		dermatology, Neuroscience, Infectious diseases,

Novartis' products are sold in 72 out of 108

Ophthalmology.

countries in scope of the Index. Novartis

Product categories: Innovative medicines,

has sales offices in 43 countries, and sells via

generic medicines, biosimilars.

suppliers and/or pooled procurement in an

M&A news: Novartis acquired Vedere Bio in

additional 29 countries.

Total

51.63 bn

October 2020, Cadent in December 2020,
Sales by geographic region
60

Net sales (Bn USD)

Sales in countries in scope

50
40
30
20
10
0

In scope, has sales offices
In scope, any sales

2017

2018

EuropeIn scope, no sales

2019

United States

2020

2021

Asia/Africa/Australasia

Canada and Latin America

Not in scope

SAMPLE OF PIPELINE AND PORTFOLIO ASSESSED BY THE INDEXPIPELINE for diseases in scope

PORTFOLIO as selected for analysis by the Index

Novartis has a total of 53 R&D projects in scope with 22 of these pro-Novartis has 46 medicines in scope, 25 of which are on patent. 48% ofjects targeting a priority disease. The other 31 R&D projects target otherthese medicines (22) are on the WHO EML. The off-patent medicinesdiseases in scope. Of the projects targeting priority diseases, the focus istarget non-communicable diseases (NCDs) (14) such as cardiovascular dis-on malaria (11 projects) and Chagas disease (5). Of the projects targeting

eases (6) mental health conditions (2) and cancer (3); neglected tropicalother diseases in scope, the focus is on oncology (22).

diseases such as leprosy (2), communicable diseases such as tuberculosis

Seventeen R&D projects are in late-stage development that target either(3); and one product for maternal haemorrhage. The on-patent medicines

a priority disease (6) or address a specific need in LMICs (11).* Evidence of

mainly target NCDs (25) such as cancer (10), respiratory diseases (6), cardi-

access planning was in place for 100% of these projects.

ovascular diseases (3) and diabetes (2). In addition, one targets hepatitis B.

53 projects in the pipeline

46 products as selected for analysis by the Index†
15

7

Maternal and neonatal 031

Non-communicable

Maternal and neonatal

1
37
2Multiple categories
0

20
30
40
50
projects in the pipeline

20
30
40
50
products on the market

Phase II

Phase III

Registration/approval

Other***

Total

10

2

4

4

1

0

1

22

Contraceptives

off patent

Addresses needs of LMICs*

8

5

6

0

0 19

Diagnostics

Other projects in scope

9

3

0

0

0 12

Other

*50 diseases and 243 product gaps inscope have been established as a priority by global health stakeholders. For
other diseases, the Index used a set of criteria to determine which projects in thepipeline offer a clear public health benefit to patients in LMICs. Only projects inthe clinical phase of development were
included for this analysis.
**Neglected tropical diseases, while also
communicable, are highlighted separately
throughout the Index.
***Other includes projects that have atechnical lifecycle and projects that fol-

‡

Total

Phase I

Vaccines

Medicines on patent

Other

Pre-clinical

WHO EML

Breakdown of products

Discovery

Targets established R&D priorities

10

WHO EDL

10

Breakdown of projects

205

4
2

Non-communicableMultiple categories 00Communicable**
Neglected tropical

Non-EML

Communicable**
Neglected tropical

3 22

25

19

2

21

0

0

0

0

0

0
0

0
0

low a different development cycle (e.g.
diagnostics).
†Products included in the analysis wereselected using a set of criteria determinedby stakeholder consensus.
‡Other includes vector control products.

0

Access to Medicine Index 2022 ▶ Company report cards

Novartis AG

GOVERNANCE OF ACCESSRANK 15SCORE 3.43

Has an access-to-medicine strategy with meas-

access to medicine in countries in scope of theassessment, a continuous system to monitor

urable objectives, integrated within its overall

Index. It facilitates accountability and transpar-

activities, audits (both internal and external, cov-

corporate strategy. Novartis performs strongly.

ency by consistently sharing the outcomes of

ering third parties and in all countries where it

Its strategy is embedded in its Novartis Accessits access-to-medicine activities in a centralised

operates) and has formal processes to ensure

Principles and has a tailored approach for sub-Sa-

manner within its Novartis in Society Integrated

third-party compliance with company standards.

haran Africa. The strategy covers all therapeutic

Report.
Does not publicly take a position of support

areas in which Novartis is involved. The highest
responsibility for access at Novartis lies directly

Performs above average in responsible pro-on the Doha Declaration on TRIPS and Publicwith the board, namely with the Governance,

motional practices. Novartis’ sales agents are

Health. Novartis does not publicly take a position

Sustainability and Nomination Committee

not solely incentivised on sales volume targets.

of support of the Doha Declaration on TRIPS and(GSNC).

However, the company sets sales incentives at

Public Health as a whole, but it does publicly sup-the individual level for agents. Novartis does not

port, and/or adopts policies that it states exceed,

Evidence of access-related incentives at the

publicly disclose information related to transfers

several of the individual flexibilities embodied byexecutive level. Novartis performs strongly.

of values to healthcare professionals in countries

the Doha Declaration. Novartis also supports theNovartis incentivises its senior executives andin scope of the Index (e.g., payments for attending

use of compulsory licensing in exceptional cir-in-country managers to take action on access toevents or promotional activities), unless required

cumstances to address situations that require an

medicine with financial and non-financial rewards.

by law or by local regulations, but it does haveextraordinary or urgent response to a pressing

The CEO and Executive Committee havepolicies and procedures in place limiting transfers

public need. There is evidence of industry asso-

access-related incentives included in their perfor-of values to healthcare professionals.

ciation lobbying on intellectual property and themance targets.

usage of TRIPS flexibilities, namely of compulsory
Has a robust set of compliance controls tolicensing, by national governments in some coun-

Publicly discloses outcomes of its

ensure that governance efforts are not under-tries in scope of the Index. As a member of theaccess-to-medicine activities. Novartis performs

mined by non-compliant or corrupt activities.

industry association, Novartis, like all other mem-strongly in transparency of access activities.

Novartis performs strongly, demonstrating evi-ber companies in scope of the Index, is by default

It publicly discloses commitments, measura-dence of all components looked for by the Index:

connected to this activity.

ble goals, objectives and targets for improving

fraud-specific risk assessment, country risk-based

RESEARCH & DEVELOPMENTRANK 3SCORE 3.70

Access planning processes encompass all pro-access to products in LMICs by involving national

Publicly discloses disaggregated R&D invest-

jects in the pipeline. Novartis has a structured

regulatory authorities in sub-Saharan Africa who

ment data for priority diseases, neglected

process in place to develop access plans dur-

will participate actively in the assessment in order

tropical diseases and stages of development.

ing R&D. The process is intended to be applied

to reduce approval timelines.

In addition, Novartis also discloses fully disag-

to all R&D projects (both in-house and collabora-

206

gregated R&D investment data to Policy Curestive) for diseases in scope of the Index. In general,

Many projects address a public health need in

Novartis begins developing access plans for R&D

LMICs,* with 100% (11/11) of late-stage projects

projects in Phase II of clinical development.

covered by access plans. In this analysis, Novartis

Four of the five R&D capacity building ini-has 11 late-stage R&D projects that target a dis-tiatives included meet all Good Practice

An average-sized priority R&D pipeline com-ease and/or product gap not yet established as aStandards. Novartis' performance is above aver-pared to its peers, with access plans in placepriority by global health stakeholders. These pro-age in this area. The number of initiatives meetingfor 100% (6/6) of late-stage projects. Novartis

jects are all deemed by the Index to offer a clear

all inclusion criteria is higher than average andhas 22 projects, including six late-stage candi-

public health benefit for people living in LMICs.*

more initiatives meet all Good Practice Standards

dates in its pipeline, that target a priority productPrimarily, these projects concern clinical trials inthan what is average for this indicator. For exam-

gap. These projects mainly focus on malaria.

countries in scope of the Index and/or are first-

ple, for the Ghana Sickle Cell Disease (SCD)

Novartis' six late-stage candidates targeting a pri-in-class molecules or first-in-formulation projects.

Scientist Training Program, Novartis partners

ority product gap have access plans in place. The

Projects target several diseases in scope of thewith the Sickle Cell Foundation of Ghana to trainplans consider the availability and affordability ofIndex including cancer, chronic obstructive pul-scientists that are working in the field of SCD.

projects in development. For two projects target-monary disease and sickle cell disease. Novartis

Training includes remote mentoring of scientists

ing malaria, Novartis plans to expediate access byprovides evidence of access plans for all 11 late-

and a Postdoctoral Fellowship in natural productregistering via the Marketing Authorization forstage projects which mainly focus on equitable

drug discovery at Novartis research labs.

Global Health Products (MAGHP) procedure in

pricing strategies and registration preparation in

Switzerland. This aims to improve and accelerate

countries relevant to the Index.

*50 diseases and 243 product gaps inscope have been established as a priority
by global health stakeholders. For otherdiseases, the Index used a set of criteria
to determine which projects in the pipeline offer a clear public health benefit topatients in LMICs. Projects in the clinicalphase of development were included forthis analysis.

Research.

Access to Medicine Index 2022 ▶ Company report cards

PRODUCT DELIVERYRANK 4SCORE 4.08

Public commitment not to enforce patents inthis analysis. Novartis' performance is above

countries in scope. Novartis publicly pledges toaverage is this area.* For two of the four prod-

neither file for nor enforce patents. This commit-

ucts assessed, the company provides examples

All five health systems strengthening initiatives

ment applies in all Least Developed Countries,of access strategies which consider affordability

included for analysis meet all Good Practice

LICs and a subset of LMICs.

in countries of all assessed income levels (UMIC,

Standards. Novartis is one of the leaders in this

LMIC, LIC). Novartis makes efforts to reach addi-

area. The number of initiatives meeting all inclu-

Publicly discloses information on patent sta-tional patients using pricing strategies consideringsion criteria is higher than average and moretus. Like most of its peers, Novartis discloses therelevant payers' ability to pay. For example, theinitiatives meet all GPS than what is average forpatent statuses for small molecules in scope via

company launched an Emerging Market Brand of

this indicator. For example, in the Strengthening

the Pat-INFORMED database. Novartis discloses

crizanlizumab (Adakveo®), a treatment for sickle

the Translational Ecosystem for Lifesaving Local

patent information, including filing date, grantcell disease in India. Known as Ryverna, the prod-

Access initiative, Novartis and academic part-number, grant date and jurisdiction.

uct is currently available at a lower price than theners have developed and are piloting a logistics

original brand in several Indian national accounts,

management information system with the aim

Performs above average in terms of sharing

in accordance with the Novartis Global Oncology

to reduce supply chain bottlenecks and improve

intellectual property (IP) assets with third-

Pricing Tiers Guidance, and the company isaccess to medicines.

party researchers. Novartis engaged in threeworking for inclusion in further state tenders. In

new IP-sharing agreements with third-party

addition, Novartis implemented a patient support

Has engaged in scaling up four and piloting threeresearch institutions or drug discovery initiatives

programme to supply the medicine at no cost to

inclusive business models. Novartis leads in theestablished during the current analysis period

eligible patients. Novartis provides evidence ofuse of inclusive business models aimed at meet-that meet all inclusion criteria for evaluation. The

how patient reach has been increased throughing the access needs of populations at the base ofcompany does have existing agreements of thisthese approaches.

the income pyramid (including other underserved

nature in place that were established before thepopulations) in LMICs. The Novartis Biome SSA iscurrent period of analysis and meet all inclusion

Has access strategies for the majority of

an innovation hub that was initiated in November

criteria for evaluation.

self-administered products in scope of this2021 and spearheads the development of inno-

analysis. Novartis leads in this area. For four ofvative local sustainable business models andUses licensing agreements to enable generic

the five products assessed, the company provides

technology-driven solutions to improve access to

supply. After the period of analysis, Novartis

examples of access strategies in countries of allhealthcare in the sub-Saharan Africa region.

signed a non-exclusive licensing agreement withassessed income levels (UMIC, LMIC, LIC), includ-

the Medicines Patent Pool (MPP) for its oncology

ing efforts to reach additional patients applying

Performs above average in terms of ensur-

medicine, nilotinib (Tasigna®), the first agree-

pricing strategies considering relevant payers'

ing continuous supply of medicines in LMICs.

ment of its kind for a non-communicable diseaseability to pay. For example, in India, Novartis sup-Novartis is involved in technology transfers withproduct.

plies nilotinib (Tasigna®) and ribociclib (Kisqali®)third-party manufacturers in LMICs, and has a sys-

through national tenders. In addition, the com-

tem in place to work with relevant stakeholders

Filed to register new products in 15 countries

pany provides access to nilotinib to patients

to communicate issues that may affect the supply

in scope on average. Novartis has filed one out

in out-of-pocket segments via the Novartis

chain, works with several active pharmaceuti-of ten of its most recently registered products in

Oncology Access program, a contributions

cal ingredient (API) suppliers/produces in-househalf of the relevant top 10 high burden countries.

model where the company bears the majority

APIs, manages a buffer stock of relevant products

Among new products, Erenumab (Aimovig®), indi-of the cost. The programme also includes dis-and is involved in supply chain capacity building

cated for migraine, has been filed for registrationease counselling activities to improve complianceinitiatives.

in five high burden countries in scope of the Index

and adherence to the treatment. Novartis pro-(Brazil, Egypt, Indonesia, Thailand and Vietnam).

vides evidence of how patient reach has been

Has a policy for reporting substandard and falsi-

Among old products, its most widely registered

increased through the approaches used.

fied (SF) medicines in countries in scope of theIndex in less than ten days. Novartis has a pol-is sacubitril/valsartan (Entresto™), indicated for
ischaemic heart disease, filed for registration in

Four of the five manufacturing capacity build-icy for reporting SF medicines to both national

48 countries relevant to the Index, including fiveing initiatives included meet all Good Practice

health authorities and the WHO within seven days.

high burden disease countries (Armenia, Egypt,

Standards. Novartis' performance is above aver-

The policy classifies incidents following categories

Republic of Moldova, Ukraine and Uzbekistan).

age in this area. The number of initiatives meeting

according to the impact or potential impact andall inclusion criteria is higher than average anddegree of severity, which may enable faster action.

Has access strategies for all supranationallymore initiatives meet all Good Practice Standards

procured products in scope of this analysis.

(GPS) than what is average for this indicator. For

Donates in response to expressed need andNovartis has an average performance in secur-

example, since 2019 Novartis has worked on themonitors delivery. Novartis has public policies

ing access for products procured supranationally.

Hibiscus transfer project, supporting contractand supply processes in place to ensure ad hoc

For two of the four products assessed in thismanufacturers to improve the quality of their pro-donations are carried out rapidly in response tocategory, it demonstrated strategies both induction and reduce their carbon footprint.

expressed need, and it shows evidence of mon-countries eligible for supply from such procurers

207

pharmacies and non-governmental organisations.

itoring the delivery of donations to recipient

and in at least one non-eligible country. For exam-

All five supply chain capacity building initi-

ple, the company offers the same price in South

atives included for analysis meet all Good

Africa for the malaria medicine artemether/lume-

Practice Standards. Novartis is one of the lead-

Publicly commits to the achievement of elim-

fantrine (Riamet®/Coartem®) as it does in theers in this area. The number of initiatives meeting

ination, eradication or control goals in two

Global Fund eligible countries. Novartis provides

all inclusion criteria is higher than average andstructured donation programmes for neglected

evidence of patient reach, reporting that approx-

more initiatives meet all GPS than what is aver-tropical diseases or malaria. In one programme,

imately 26,000 patients in South Africa haveage for this indicator. Through the Value Chain

Novartis publicly commits itself to contribut-

received the product through the public channel

Academy, Novartis offers educational workshops

ing to the elimination of leprosy by donating thein the period from April 2020 to February 2022.

for quality in supply, falsified medicines and sup-combination of clofazimine (Lamprene®), dap-

ply chain management. These courses are offeredsone (Dapsone) and rifampicin (Rimactane®)

Has access strategies for its healthcare prac-

to several supply chain stakeholders includingfrom 2000 to 2025 in 83 countries in scope oftitioner- administered products in scope ofgovernmental associations, distributors, hospital

the Index.

* The description of Novartis’ performance in PP4 (HCP-administered products) was corrected from "average" to"above average" on 1 Dec 2022. This typographical error did not impact the underlying analysis or scoring.

organisations.

Access to Medicine Index 2022 ▶ Company report cards

RA N KSCO R E11

2.97

10 (2021)

Novo Nordisk A/SStock exchange: Nasdaq Copenhagen • Ticker: NOVO-B • HQ: Bagsværd, Denmark • Employees: 48,478

PERFORMANCE IN THE 2022 INDEX
11th place. Novo Nordisk has an average overall performance.
It performs strongly in Governance of Access where it has
an access-to-medicine strategy integrated into its overall
corporate strategy. The company also engages in some high-How score was achieved
4.43

Governance of Access1.48

Research & Development

3.39

Product Delivery

quality capacity building initiatives. However, it performs

01

comparatively poorly in Research & Development, where it
has a small pipeline.

2

3

Average

Leader4

5

Governance of Access: 2nd place. Novo Nordisk has a strong
performance in this area. It has an access-to-medicine strat-

for access planning during R&D and does not engage in R&D

egy integrated into its overall corporate strategy and acapacity building initiatives. It has a small-sized R&D pipeline

robust set of compliance controls to mitigate the risk ofcompared to its peers.

non-compliance in countries in scope of the Index. It incentivises its senior executives, including the CEO, and in-coun-

Product Delivery: 10th place. Novo Nordisk has an averagetry and regional managers to perform on access-to-medicine

performance in this area. Novo Nordisk engages in high-qual-

goals and discloses the outcomes of its access-to-medicine

ity capacity building initiatives across all fields (i.e., manu-

activities.

facturing, supply chain and health systems strengthening). It
has access strategies for most of its products in all country

Research & Development: 19th place. Novo Nordisk per-income classifications but does not share IP assets with third-

forms poorly in this area. The company has a general process

party researchers.

OPPORTUNITIES FOR NOVO NORDISKCHANGES SINCE THE 2021 INDEX

Develop a structured access planning framework and ensure all late-stage R&D• Embedded social responsibility criteria (both access andprojects have comprehensive access plans. Novo Nordisk has access plans in placeenvironmental) into the R&D strategic processes acrossfor 78% of late-stage projects analysed. It can develop a structured framework fortherapy areas, thereby ensuring such considerations andaccess planning and ensure these plans cover all late-stage R&D projects. For example,
the access plan for its once-weekly Insulin icodec, can be expanded to include accesscomponents such as equitable pricing.

strategic decisions take place.
• Re-evaluated the thermal stability of short-acting andintermediate-acting human insulin products and will seeknational approvals of more flexible storage conditions in

Measure and share outcomes of iCARE. The iCARE initiative was launched in 2021 asa business-integrated model aimed towards improving access to diabetes treatment in
49 countries in sub-Saharan Africa. To scale up this initiative and support integration

relevant LMICs following the positive scientific opinion fromthe European Medicines Agency.
• Invested USD 50 million into the newly launched

into local health systems, Novo Nordisk can track and share short and long-term patient

Antimicrobial Resistance (AMR) Action Fund through theoutcomes as part of its impact evaluation of this programme, in addition to outcomes

Novo Nordisk Foundation and USD 25 million through thesuch as patient reach and volumes of insulin sold.

company itself.
• Extended the Changing Diabetes in Children initiative until

Expand access to innovative products. Novo Nordisk has an equitable pricing strategy,

2030, launching the programme in ten new countries.

that applies to recombinant human insulins for all Least Developed Countries, all low-Entered into a collaboration with Harvard University School

income countries (LICs), and some middle-income countries with large low-incomeof Public Health with the aim to improve data, research,

populations. It can expand this equitable pricing strategy to long-acting analogue
insulins, such as insulin degludec (Tresiba®), and to other innovative diabetes medicines,
such as liraglutide (Victoza®).

innovation and capacity building in type 1 diabetes in LMICs.
• Launched the iCARE initiative based on learnings from theBase of the Pyramid Program. iCARE is a sustainable andfully integrated business model aimed at improving access

Expand registration to insulins listed in the WHO Model List of Essential Medicines.
Novo Nordisk has filed long-acting analogue insulin degludec (Tresiba®) for registrationin 48 countries within the scope of the Index. The company has not filed this productfor registration in any additional countries in scope since 2017. The company can expand

to affordable diabetes treatment in the Novo Nordisk
Middle Africa region.
• Expanded its humanitarian programme with the launch of
the Senselet project in Ethiopia and DonateAble.

registration for this product, especially in countries such as Bolivia and Cameroon, where
human insulins have already been filed. In addition, Novo Nordisk can expand registrationof human insulins in LICs, such as Sierra Leone, Somalia and South Sudan.

208

All companies were assessed based on
information that was valid in the latest
period of analysis (ending at 31 May2022). This data was either submitted bycompanies, found in the public domain or
was accessible through other sources.

The term LMICs is used to denote all
low- and middle-income countries inscope of the Index, except when analysing
companies’ access strategies where
the use of LMIC refers to lower-middle
income countries as per the World Bank

income groups classification. Likewise, theterms LIC and UMIC refer to low income
countries and upper-middle income
countries.

Access to Medicine Index 2022 ▶ Company report cards

SALES AND OPERATIONSBusiness segments: Biopharm, diabetes andNovo Nordisk's products are sold in 87 out

obesity care.

of 108 countries in scope of the Index. Novo

Net sales by segment (2021) – in DKKTherapeutic areas: Biopharmaceuticals,

Nordisk has sales offices in 28 countries, andDiabetes and obesity care

121.60 bn

diabetes care, obesity care and other serious

sells via suppliers and/or pooled procurement inBiopharm

19.20 bnchronic diseases.

an additional 59 countries.

		

Product categories: Innovative medicines.

Total

140.80 bn

M&A news: Novo Nordisk acquired Dicerna
Pharmaceuticals, Inc. in December 2021 for DKK
573 million.

Sales by geographic region
Net sales (Bn DKK)Sales in countries in scope

140
120
100
80
60
40
20
0

In scope, has sales offices
In scope, any sales

2017

2018

Rest of world

In scope, no sales

2019

2020

China

EMEA

2021

North America

Not in scope

SAMPLE OF PIPELINE AND PORTFOLIO ASSESSED BY THE INDEXPIPELINE for diseases in scope

PORTFOLIO as selected for analysis by the Index

Novo Nordisk has a total of 18 R&D projects in scope with one project tar-

Novo Nordisk has 14 medicines in scope, eight of which are on patent. 36%

geting a priority treatment gap. 17 projects target other diseases in scope.

of these medicines (5) are on the WHO EML. Most medicines are indicated

The focus of these projects is on diabetes (11 projects).

for the treatment of diabetes.

Nine R&D projects are in late-stage development that target either a priority disease (1) or address a specific need in LMICs (8).* Evidence of accessplanning was in place for 78% of these projects: one targeting a priority
disease and six addressing a public health need in LMICs.

18 projects in the pipeline

14 products as selected for analysis by the Index†

Communicable** 0Communicable** 0

Neglected tropical 0

Neglected tropical 0

1Multiple categories 0
0

20
30
40
50
projects in the pipeline

10

20
30
40
50
products on the market

Breakdown of products

0

0

0

0

1

0

1

Contraceptives

Addresses needs of LMICs*

0

2

5

1

0

8

Diagnostics

Other projects in scope

5

4

0

0

0

9

Other

*50 diseases and 243 product gaps inscope have been established as a priority by global health stakeholders. For
other diseases, the Index used a set of criteria to determine which projects in thepipeline offer a clear public health benefit to patients in LMICs. Only projects inthe clinical phase of development were
included for this analysis.
**Neglected tropical diseases, while also
communicable, are highlighted separately
throughout the Index.
***Other includes projects that have atechnical lifecycle and projects that fol-

‡

Total

0

Targets established R&D priorities

Other

0

Vaccines

WHO EDL

0

Total

0

Other***

0Registration/approval

60Phase III

3

Phase II

6

3

Phase I2

off patent

Pre-clinical

Medicines on patent

Discovery

Non-EML

10

Breakdown of projects

209

13

Non-communicableMultiple categories 001Maternal and neonatal

17

Non-communicable

WHO EML

Maternal and neonatal

8

0
0

0
0

low a different development cycle (e.g.
diagnostics).
†Products included in the analysis wereselected using a set of criteria determinedby stakeholder consensus.
‡Other includes vector control products.

0

Access to Medicine Index 2022 ▶ Company report cards

Novo Nordisk A/S

GOVERNANCE OF ACCESSRANK 2SCORE 4.43

Has an access-to-medicine strategy with meas-in scope of the Index. It facilitates accountabil-continuous system to monitor activities, audits

urable objectives, integrated within its overall

ity and transparency by consistently sharing the(both internal and external, covering third par-corporate strategy. Novo Nordisk performs

outcomes of its access-to-medicine activities,

ties and in all countries where it operates) andstrongly. Its Defeat Diabetes strategy is structured

including its Changing Diabetes in Children pro-has formal processes to ensure third-party com-around three focus areas: Prevention, Innovation

gramme, in a centralised manner within its Year inpliance with company standards. No breaches

and Access and Affordability, and includes an

Review report.

in countries in scope of the Index were publicly

Access to Insulin Commitment focused on lower-

found in the period of analysis.

ing the ceiling price for LMICs and humanitarian

Performs above average in responsible promo-

settings globally. The strategy covers all thera-tional practices. Novo Nordisk’s sales agents are

Does not publicly support the Doha Declaration

peutic areas in which the company is involved.

not solely incentivised on sales volume targets.

on TRIPS and Public Health. Novo Nordisk does,

The highest responsibility for access lies directly

However, the company sets sales incentives at

however, publicly state that health emergencies

with the board, namely with the CEO, under thethe individual level for agents. Novo Nordisk pub-requiring exceptions to intellectual property (IP)supervision of the Board of Directors.

licly discloses information related to transfers ofrights can and should be accommodated undervalues to healthcare professionals in countries in

the international legal framework, but only underProvides evidence of financial and non-financial

scope of the Index (e.g. payments for attending

extraordinary circumstances. It does not sup-access-related incentives at the executive level.

events or promotional activities), where required

port the routine use of compulsory licensing (e.g.

Novo Nordisk performs strongly. It incentivises

by law and/or by local regulations, including con-absence of local manufacturing should never be

its senior executives and in-country leaders tosent related regulation, and it has policies anda ground for issuing compulsory licenses). Theredeliver on its access to care objectives. The CEO

procedures in place governing transfers of values

is evidence of industry association lobbying on

also has access-related incentives, linked to long-to healthcare professionals.

IP and the usage of TRIPS flexibilities, namely ofterm social targets.

compulsory licensing, by national governments in
Has a robust set of compliance controls

some countries in scope of the Index. As a mem-

Publicly discloses outcomes of its

designed to ensure that governance efforts

ber of the industry association, Novo Nordisk,

access-to-medicine activities. Novo Nordisk

are not undermined by non-compliant orlike all other member companies in scope of theperforms strongly in transparency of access activ-

corrupt activities. Novo Nordisk performs

Index, is by default connected to this activity.

ities. It publicly discloses commitments, including

strongly, demonstrating evidence of all compo-

Access to Insulin, measurable goals, objectives

nents looked for by the Index: fraud-specific risk

and targets for improving access in countries

assessment, country risk-based assessment, a

RESEARCH & DEVELOPMENTRANK 19SCORE 1.48

A general process for access planning is dis-

Some projects address a public health need in

Does not publicly disclose R&D investment

closed. Novo Nordisk has a general process in

LMICs,* with 75% (6/8) of late-stage projects

data disaggregated by disease category, prod-

place to include access-oriented principles for its

covered by access plans. In this analysis, Novo

uct type or phase of development. Novo Nordisk

R&D projects targeting diseases and countries

Nordisk has eight late-stage R&D projects that

does not disclose disaggregated R&D investment

within the scope of the Index.

target a disease and/or product gap not yet des-data to global health organisations.

ignated as a priority by global health stakeholders.

210

A small-sized priority R&D pipeline compared

These projects are all deemed by the Index toNo R&D capacity building initiatives included

to its peers, Novo Nordisk has one late-stage

offer a clear public health benefit for people living

for evaluation. There is no evidence — in the

project in its pipeline that targets a priority

in LMICs.* Primarily, these projects are first-in-classpublic domain or disclosed to the Index — of

product gap. Eptacog alfa (NovoSeven®) was

molecules and/or they significantly reduce the

R&D capacity building initiatives active during therecommended for approval for the treatment ofadministrative burden or healthcare costs com-period of analysis that met inclusion criteria forsevere postpartum haemorrhage by the European

pared with existing products. Most target diabetes

evaluation. Novo Nordisk's performance is below

Medicines Agency during the period of analysis.

mellitus or ischaemic heart disease. Novo Nordisk

average in this area.

For this project, Novo Nordisk provides evidence

provides evidence of access plans for six of thesethat they are considering plans for registration inprojects. These plans focus mainly on registration

several countries in scope of the Index.

preparation in countries in scope of the Index.

*50 diseases and 243 product gaps inscope have been established as a priority
by global health stakeholders. For otherdiseases, the Index used a set of criteria
to determine which projects in the pipeline offer a clear public health benefit topatients in LMICs. Projects in the clinicalphase of development were included forthis analysis.

Access to Medicine Index 2022 ▶ Company report cards

PRODUCT DELIVERYRANK 10SCORE 3.39

Public commitment not to enforce patents(UMIC, LMIC, LIC). It makes efforts to reachthirds of people with diabetes. This initiativein countries in scope. Novo Nordisk publicly

additional patients using pricing strategies thatmeets all GPS.

pledges to neither file for nor enforce patents.

consider relevant payers' ability to pay and dona-This commitment applies in Least Developed

tions. For example, the company’s Access to

Has engaged in both scaling up and pilotingCountries and LICs.

Insulin Commitment involves the provision of

one inclusive business model. Novo Nordisk

biphasic human insulin (Mixtard®), insulin humanperforms above average in the use of inclusive

Publicly discloses detailed information on pat-(rdna) (Actrapid®) and isophane human insu-

business model aimed at meeting the accessent status. Novo Nordisk publicly discloses

lin (Insulatard®) in 76 LMICs, including Ethiopia,

needs of populations at the base of the income

the patent statuses for biologics on its website

Sudan and Congo, Dem. Rep. at ceiling prices set

pyramid (including other underserved popula-and for small molecules via the Pat-INFORMED

at USD 3 per vial. Novo Nordisk provides evidence

tions) in LMICs. iCARE is a sustainable and fully

database. Novo Nordisk’s disclosure includes

of how patient reach has increased. For exam-

integrated business model aimed at improv-

information about patents, patent number andple, 76,740 patients in Ethiopia were reached ining access to affordable diabetes treatment injurisdiction.

the current period of analysis, compared to 7,291

the Novo Nordisk Middle Africa region throughpatients reached previously.

capacity building, safeguarding affordable insulin,

Performs below average in terms of sharing

strengthening supply chains and patient support

intellectual property (IP) assets with third-

Both manufacturing capacity building initiatives

party researchers. Novo Nordisk does not report

included for analysis meet all Good Practiceon any new IP-sharing agreements with publicStandards. Novo Nordisk's performance is aver-

Performs above average in terms of ensuring

research institutions or drug discovery initiatives

age in this area. The number of initiatives meeting

continuous supply of medicines in LMICs. Novo

established during the current analysis period

all inclusion criteria is lower than average but

Nordisk is involved in technology transfers withthat meet all inclusion criteria for evaluation. The

an average number of initiatives meet all Good

third-party manufacturers in LMICs, and has a sys-

company does not have existing agreements ofPractice Standards (GPS) for this indicator. For

tem in place to work with relevant stakeholders

this nature in place that were established before

example, Novo Nordisk is actively working withto communicate issues that may affect the supply

the current period of analysis and meet all inclu-

governments in countries in scope of the Index tochain, produces in-house active pharmaceuticalsion criteria for evaluation.

ensure access to affordable diabetes treatment.

ingredients, manages a buffer stock of relevant

The company conducts detailed technical assess-products and is involved in supply chain capacity

No use of licensing agreements. Novo Nordisk

ments and due diligence of potential partners as abuilding initiatives.

does not engage in voluntary licensing for prod-

foundation of the capacity building projects.

and education.

Has a policy for reporting substandard and fal-ucts in scope of the Index.
Two of the three supply chain capacity build-sified (SF) medicines in countries in scope ofFiled to register new products in 17 countries ining initiatives included meet all Good Practicethe Index in less than ten days. Novo Nordisk

scope on average. Novo Nordisk did not discloseStandards. Novo Nordisk's performance is aver-has a policy for reporting SF medicines to rele-

evidence of filing for registration any of its newage in this area. The number of initiatives meetingvant health authorities within seven days. It does

products in more than half of the top ten highall inclusion criteria is average and an average

not provide evidence of shortened reporting timeburden countries. Among new products, none

number of initiatives meet all GPS for this indi-frames for cases which only require visual inspec-

have been filed in LICs. Among old products, its

cator. The Sustainable Healthcare Supply Chaintion to be confirmed.

most widely registered is isophane human insu-

Programme in Ethiopia aims to 1) strengthenlin (Insulatard®), for diabetes mellitus, filed in 83

long-term supply of Ethiopian specialists in phar-

Donates in response to expressed need andcountries within the scope of the Index, includ-

maceutical supply chain handling 2) enhancemonitors delivery. Novo Nordisk has public pol-ing four of the top ten high burden countries

institutional capacity to handle supply chains oficies and supply processes in place to ensure ad(Guyana, Mexico, Sri Lanka and Suriname).

non-communicable disease medicines and 3)

hoc donations are carried out rapidly in responsestrengthen responsiveness of the humanitarian

to expressed need, and it monitors the delivery of

medical supply chain. This initiative meets all GPS.

donations.

Novo Nordisk is not eligible for assessment ofsupranationally procured products.

211

Four of the five health systems strengthen-Has no long-term donation programmes for

Novo Nordisk is not eligible for assessment of

ing initiatives included meet all Good Practiceneglected tropical diseases or malaria that

healthcare practitioner-administered products.

Standards. Novo Nordisk's performance is above

are eligible for analysis under this indicator.

average in this area. The number of initiatives

However, the company is engaged in another

Has access strategies for its self-administeredmeeting all inclusion criteria is higher than aver-structured donation programme: Changing

products for the majority of countries in scope

age and more initiatives meet all GPS than what

Diabetes in Children where it has donated insu-of this analysis. Novo Nordisk performs above

is average for this indicator. For example, Cities

lin human (rdna) (Actrapid®), isophane human

average in this area. For four of the five prod-

Changing Diabetes (CCD) is a partnership pro-insulin (Insulatard®)' and biphasic human insulin

ucts assessed, the company provides examples

gramme to accelerate the prevention of diabetes(Mixtard®) to 21 countries in scope of the Indexof access strategies which consider afforda-

and obesity by addressing the systemic change

since 2009.

bility in countries of all assessed income levels

in urban environments: which are home to two-Access to Medicine Index 2022 ▶ Company report cards

RA N KSCO R E6

3.62

4 (2021)

Pfizer Inc
Stock exchange: NYSE • Ticker: PFE • HQ: New York, New York, United States • Employees: ~79,000

PERFORMANCE IN THE 2022 INDEX
6th place. Pfizer leads in Governance of Access, excelling in its
approach to incentivising responsible promotional practices.
It performs well in the other two Technical Areas, engaging in
high-quality capacity building initiatives across all fields, andHow score was achieved
4.57

Governance of Access
3.15

Research & Development

3.61

Product Delivery

performing well in access planning and strategies.

0

1

Governance of Access: 1st place. Pfizer leads in this area. It

2

3

Average

Leader4

5

has an integrated access-to-medicine strategy with directboard-level responsibility for access to medicine and incentives for its senior executives, including the CEO, and in-country and regional managers. It discloses outcomes of its

in its pipeline. The company has an average-sized priority

access-to-medicine activities, has a robust set of compliancepipeline and performs well in R&D capacity building.

controls to mitigate the risk of non-compliance in countries
in scope of the Index and demonstrates best responsible pro-

Product Delivery: 6th place. Pfizer performs well in this area.

motional practices relative to other companies in scope of the

The company has comprehensive access strategies in place

Index.

for its products, but for healthcare-practitioner administered products the strategies focus mostly on upper-middle

Research & Development: 5th place. Pfizer performs well inand lower-middle income countries. It engages in high-quality

this area. Pfizer has a structured access planning framework

capacity building initiatives across all fields (i.e., manufactur-and has access plans for the majority of late-stage candidates

ing, supply chain and health systems strengthening).

OPPORTUNITIES FOR PFIZERCHANGES SINCE THE 2021 INDEX

Improve access planning for R&D projects for non-communicable diseases. Pfizer has• Launched ‘An Accord for a Healthier World' in May 2022,

access plans in place for 64% of projects for non-communicable diseases. These plans

which commits to provide all its current and future patentprimarily focus on registration preparation in countries in scope. Pfizer can establish

protected medicines and vaccines available in the Unitedaccess plans for all projects from Phase II onwards, including danuglipron for type

States or European Union on a not-for-profit basis to 45

2 diabetes. Furthermore, it can enhance existing plans to incorporate more accesscomponents such as equitable pricing and sustainable supply.

LMICs.
• Received FDA Emergency Use Authorisation for the oral
antiviral medicine nirmatrelvir/ritonavir (Paxlovid®) andExpand technology transfers to manufacturers in more LMICs. Pfizer has transferredtechnology for the on-patent pneumococcal vaccine (Prevnar 13®) and the COVID-19

signed a procurement agreement with UNICEF to supply up
to 4 million treatment courses in LMICs.

vaccine (Comirnaty®) to manufacturers in Brazil and South Africa. Pfizer can partner• Adopted the ESG Scorecard, which will be used as a tool towith more manufacturers in LMICs to build manufacturing capacity and improve local

assist in determining the funding for the annual short-term

availability of additional products such as subcutaneous depo medroxyprogesterone
acetate (Sayana Press®), a long-acting reversible contraception.

incentive plan.
• Received FDA regulatory approval for its COVID-19 vaccine,(Comirnaty®) and filed for registration in 37 countries in

Measure and share outcomes of An Accord for a Healthier World. In 2022, Pfizer
launched its An Accord for a Healthier World which aims to provide all its patented

scope of the Index.
• Established new COVID-19 partnerships with UPS

medicines and vaccines at not-for-profit prices to 45 lower-income countries. To scale

Foundation, Zipline, and Global Environment andup this initiative and support integration into local health systems, Pfizer can track andTechnology Foundation among others to address vaccine

share both short- and long-term patient outcomes as part of its impact evaluation ofthis programme, in addition to outcomes such as patient reach and product volumes
sold.

supply and delivery issues in LMICs.
• Supplied its COVID-19 vaccine (Comirnaty®) through the
COVAX facility and pledged to provide 2 billion doses to
LMICs in 2021 and 2022.

Expand access to on- and off-patent cancer treatments to low-income countries.
Pfizer has access strategies for four of its cancer treatments, including on-patentproduct palbociclib (Ibrance®) for breast cancer and off-patent product vincristine212• Invested USD 100 million into the newly launched
Antimicrobial Resistance (AMR) Action Fund.
• Signed a non-exclusive voluntary licensing agreement with

(Vincristine) for leukaemia, in upper-middle income countries and lower-middle income

the Medicines Patent Pool (MPP) for nirmatrelvir/ritonavircountries. Pfizer can expand access to these products in low-income countries as part of(Paxlovid®), used as an oral COVID-19 treatment. This

its commitment to An Accord for a Healthier World.

agreement covers 95 countries.

All companies were assessed based on
information that was valid in the latest
period of analysis (ending at 31 May2022). This data was either submitted bycompanies, found in the public domain or
was accessible through other sources.

The term LMICs is used to denote all
low- and middle-income countries inscope of the Index, except when analysing
companies’ access strategies where
the use of LMIC refers to lower-middle
income countries as per the World Bank

income groups classification. Likewise, theterms LIC and UMIC refer to low income
countries and upper-middle income
countries.

Access to Medicine Index 2022 ▶ Company report cards

SALES AND OPERATIONSBusiness segments: Biopharmaceutical products

Pfizer's products are sold in 98 out of 108

and consumer health.

countries in scope of the Index. Pfizer has sales

Revenue by segment (2020) – in USD

Therapeutic areas: Hospital care, immunology,

offices in 27 countries, and sells via suppliers

Biopharmaceutical products

inflammation, internal medicine, oncology, rare

and/or pooled procurement in an additional 71		diseases and vaccines.

countries.

Total

41.91 bn
41.91 bn

M&A news: Pfizer acquired Arena
Pharmaceuticals in March 2022 for USD 6.7
billion.

Sales by geographic region
100

Revenue (Bn USD)

Sales in countries in scope

80
60
40
20
0

In scope, has sales offices
In scope, any sales

2017
USA

In scope, no sales

2018

2019

2020

2021

International

Not in scope

SAMPLE OF PIPELINE AND PORTFOLIO ASSESSED BY THE INDEXPIPELINE for diseases in scope

PORTFOLIO as selected for analysis by the Index

Pfizer has a total of 57 R&D projects in scope with 21 of these projects targeting priority diseases. The other 36 R&D projects target other diseases
in scope. Of the projects targeting priority diseases the focus is on coronaviral diseases (six projects) and lower respiratory tract infections (5). Of
the projects targeting other diseases in scope, the focus is on oncology(22).
Twenty-six R&D projects are in late-stage development that target eithera priority disease (13) or address a public health need in LMICs (13).*
Evidence of access planning is in place for 85% of these projects: 13 targeting a priority disease and nine addressing a public health need in LMICs.

Pfizer has 84 medicines in scope, 18 of which are on patent, and five vaccines.
56% of the medicines (47) are on the WHO EML. In addition, the company
markets four contraceptive methods and devices. The off-patent medicines
target communicable diseases (CDs) (15) such as HIV/AIDS (4) malaria (3) andtuberculosis (5); non-communicable diseases (NCDs) (46) such as cancer (26),cardiovascular diseases (10) and mental health conditions (3). One off-patent medicine is indicated for the treatment of the neglected tropical diseasesoil-transmitted helminthiasis. The on-patent medicines target CDs such as
respiratory infections (3), HIV/AIDS (1) and NCDs such as cancer (12), stroke(1) and unipolar depressive disorders (1). Pfizer's preventative vaccines (5) target CDs such as meningitis (3), lower respiratory infections and COVID-19.

57 projects in the pipeline

93 products as selected for analysis by the Index†
15

Communicable**133

Non-communicable

660Multiple categories 1
0

20
30
40
50
projects in the pipeline

20

40
60
80
100
products on the market

Phase I

Phase II

Phase III

Registration/approval

Other***

2

2

3

7

3

0 21

Total

off patent

2

16

18

45 21

66

Total

Pre-clinical4

Medicines on patent

Other

Discovery

Breakdown of products
WHO EDL

10

Breakdown of projects

Vaccines

4

1

5

Contraceptives

3

1

4

Addresses needs of LMICs*

12

9

3

1

0 25

Diagnostics

Other projects in scope

4

4

2

1

0

Targets established R&D priorities

213

Maternal and neonatal

Non-EML02

Non-communicable1

Multiple categories

Neglected tropical

WHO EML

Maternal and neonatal

24

Communicable**

7

Neglected tropical*50 diseases and 243 product gaps inscope have been established as a priority by global health stakeholders. For
other diseases, the Index used a set of criteria to determine which projects in thepipeline offer a clear public health benefit to patients in LMICs. Only projects in11

the clinical phase of development were
included for this analysis.
**Neglected tropical diseases, while also
communicable, are highlighted separately
throughout the Index.
***Other includes projects that have atechnical lifecycle and projects that fol-

Other

‡

0

0
0

low a different development cycle (e.g.
diagnostics).
†Products included in the analysis wereselected using a set of criteria determinedby stakeholder consensus.
‡Other includes vector control products.

0

Access to Medicine Index 2022 ▶ Company report cards

Pfizer Inc

GOVERNANCE OF ACCESSRANK 1SCORE 4.57

Has an access-to-medicine strategy with meas-

public health, including new commitments in

Pfizer performs strongly, demonstrating evi-

urable objectives, integrated within its overall

response to the COVID-19 pandemic, measur-

dence of all components looked for by the Index:

corporate strategy. Pfizer performs strongly. Itsable goals, objectives and targets for improving

fraud-specific risk assessment, country risk-based

access strategy is integrated within its Purpose

access to medicine in countries in scope of theassessment, audits (both internal and external,

Blueprint, which outlines Pfizer's strategic direc-

Index. It facilitates accountability and transpar-covering third parties and in all countries where ittion, and covers all therapeutic areas in which theency by consistently sharing the outcomes of its

operates), formal processes to ensure third-party

company is involved, including rare diseases. The

access-to-medicine activities, including its pro-compliance with company standards and a con-highest responsibility for access lies directly withgress on SDG3-related targets, in a centralised

tinuous system to monitor activities. No breaches

Pfizer's executive management team with board

manner within its ESG Report.

in countries in scope of the Index were publicly

oversight, namely with the Corporate Governancefound in the period of analysis.
Performs well in responsible promotional& Sustainability Committee.

practices. Pfizer’s sales agents are not solely

Publicly supports the Doha Declaration on

Provides evidence of financial and non-financial

incentivised on sales volume targets. The com-

TRIPS and Public Health. Pfizer publicly sharesaccess-related incentives at the executive level.

pany does not set incentives at the individual

support of the Doha Declaration on TRIPS and

Pfizer performs strongly. It incentivises its seniorlevel. It has a global policy on interactions with

Public Health, but expresses reservations on its

executives and in-country managers to perform

healthcare professionals, but does not publicly

provisions, namely on the use of compulsory

on access to medicine with financial and non-fi-

disclose information related to transfers of values

licensing. There is evidence of industry associa-

nancial rewards. The CEO also has access-related

to healthcare professionals in countries in scopetion lobbying on intellectual property (IP) and the

incentives linked to the Purpose Blueprint goals,of the Index (e.g. payments for attending events

usage of TRIPS flexibilities, namely of compulsory

including improving access through partnerships.

or promotional activities), unless required by law

licensing, by national governments in some coun-or by local regulations.

tries in scope of the Index. As a member of the

Publicly discloses outcomes of its

industry association, Pfizer, like all other member

access-to-medicine activities. Pfizer performs

Has a robust set of compliance controls tocompanies in scope of the Index, is by default con-strongly in transparency of access activities.

ensure that governance efforts are not under-

nected to this activity.

It publicly discloses its commitment to global

mined by non-compliant or corrupt activities.

RESEARCH & DEVELOPMENTRANK 5SCORE 3.15

Access planning processes encompass all pro-

was still in development. The agreement allows

data disaggregated by disease category, prod-

jects in the pipeline. Pfizer has a structured

sub-licensees to produce generic versions of the

uct type or phase of development. Pfizer does

process in place to develop access plans during

drug for supply in countries in scope of the Index.

not disclose disaggregated R&D investment data

R&D. The process is intended to be applied to all

to global health organisations.

R&D projects (both in-house and collaborative)

Many projects address a public health need infor diseases in scope of the Index.

LMICs,* with 69% (9/13) of the late-stage pro-Three of the five R&D capacity building ini-

jects covered by access plans. In this analysis,

tiatives included meet all Good Practice

An average-sized priority R&D pipeline com-

Pfizer has 13 late-stage R&D projects that target aStandards. Pfizer's performance is above aver-pared to its peers, with access plans in placedisease and/or product gap not yet established asage in this area. The number of initiatives meetingfor 100% (13/13) of the late-stage candidates.

a priority by global health stakeholders. These pro-

all inclusion criteria is higher than average andPfizer has 21 projects including 13 late-stage

jects are all deemed by the Index to offer a clear

more initiatives meet all Good Practice Standards

candidates in its pipeline that target a prior-public health benefit for people living in LMICs.*

than what is average for this indicator. For exam-

ity product gap. These projects focus mostly on

Primarily, these projects have clinical trials in coun-ple, in collaboration with the Wellcome Trust,

lower respiratory tract infections and coronaviraltries in scope of the Index or are first-in-classthe SPIDAAR program (Surveillance Partnershipdiseases. All of Pfizer’s 13 late-stage candidates

molecules. Most target cancer. Pfizer provides evi-to Improve Data for Action on Antimicrobial

targeting a priority product gap have access plans

dence of access plans for nine of these projects.

Resistance) builds antimicrobial resistance (AMR)

in place. Notably, Pfizer signed a non-exclusive

These plans focus mainly on registration prepara-

surveillance capacity in Africa by tracking resist-voluntary licensing agreement with the Medicinestion in countries in scope of the Index.

ance patterns to better understand the burden of

Patent Pool (MPP) for its COVID-19 antiviral nirmatrelvir (PF-07321332) when the compound214*50 diseases and 243 product gaps inscope have been established as a priority
by global health stakeholders. For otherdiseases, the Index used a set of criteria
to determine which projects in the pipeline offer a clear public health benefit to

AMR on patients living in LMICs.
Does not publicly disclose R&D investment

patients in LMICs. Projects in the clinicalphase of development were included forthis analysis.

Access to Medicine Index 2022 ▶ Company report cards

PRODUCT DELIVERYRANK 6SCORE 3.61

Public commitment not to enforce patents inin scope of this analysis. Pfizer's performance

The number of initiatives meeting all inclusion cri-countries in scope. Pfizer publicly pledges not tois above average in this area.* The company

teria is higher than average and more initiatives

enforce patents in Least Developed Countries.

provides examples of access strategies whichmeet all GPS than what is average for this indica-consider affordability in both UMICs and LMICs

tor. For example, the Ghana Sickle Cell Disease

Publicly discloses information on patent status.

for the five products assessed, yet falls short at

Newborn Screening and Comprehensive Care

Like most of its peers, Pfizer publicly discloses

providing examples for LICs. It makes efforts to

Program seeks to advance the study and treat-

the patent statuses for small molecules in scope

reach additional patients using pricing strate-

ment of sickle cell disease (SCD) across Ghana

via the Pat-INFORMED database. It discloses thegies considering relevant payers' ability to pay.

and, ultimately, other countries in sub-Saharanpatent status of its entire small molecule port-

For example, while Pfizer is negotiating with the

Africa, by piloting and testing a newborn screening

folio. The information includes filing date, grantnational authority in Ghana for the inclusion ofprogram for SCD including introducing treatment

number, grant date and jurisdiction.

the ceftaroline fosamil (Zinforo®) in the National

protocols and understanding the willingness andInsurance Scheme, the company has initiated aability of families to enroll in follow-up care.

Performs above average in terms of sharing

patient affordability programme in 2021, which

intellectual property (IP) assets with third-

offers the product at 50% of the total cost andHas engaged in scaling up four inclusive busi-

party researchers. Pfizer engaged in two newpatients are allowed to complete payment overness models but has not shown evidence of its

IP-sharing agreements with third-party research

60 days. Pfizer provides evidence of how patient

involvement in piloting any new inclusive busi-

institutions or drug discovery initiatives estab-reach has been increased through this approach.

ness models that meet all inclusion criteria.

lished during the current analysis period that

Pfizer performs average in the use of inclusive

meet all inclusion criteria for evaluation. The

Has access strategies for most of its self-admin-

business models aimed at meeting the accesscompany does have existing agreements of thisistered products in the scope of this analysis.

needs of populations at the base of the income

nature in place that were established before thePfizer performs above average in this area. For

pyramid (including other underserved popula-current Index cycle and meet all inclusion criteria

four of the five products assessed, the company

tions) in LMICs. The Pfizer Foundation supported

for evaluation.

provides examples of access strategies in coun-

the development and implementation of a dengue

tries of all assessed income levels (UMIC, LMIC,

reduction programme through Reach52. Reach52

Uses licensing to enable generic supply. Pfizer

LIC), including efforts to reach additional patients

aims to bring high-quality healthcare to remotehas one non-exclusive voluntary licensing agree-using pricing strategies considering relevant pay-

and rural areas through data-driven programs thatment in place for one compound (for diseases

ers' ability to pay for the treatments. For example,

leverage a network of community health workers

in scope). Its licence for nirmatrelvir/ritonavir

Pfizer Mexico implemented a pricing strategy for

empowered by Reach52’s digital health platform.

(Paxlovid®), agreed with 38 sublicensees, encom-

lorlantinib (Lorbrena®) as second line of NSCLC

passes 95 countries, with 93 countries relevant totreatment that considers public sector afforda-

Performs above average in terms of ensuring

the Index, including 66 middle income countries.

bility. While in the private market, Pfizer Mexico

continuous supply of medicines in LMICs. Pfizer

offers tiered discounts for lorlantinib based on theis involved in technology transfers with third-

Filed to register new products in 14 countries

remaining insurance policy coverage from insur-

party manufacturers in LMICs, and has a system

in scope on average. Pfizer did not disclose evi-

ance providers and the ability of patients to pay,in place to work with relevant stakeholders todence of filing for registration any of its newreceiving first line and subsequent lines of NSCLC

communicate issues that may affect the supply

products in more than half of the top ten high bur-treatment. The company provided evidence of

chain, produces the majority of its active pharma-den countries (for products that could be assessed

patient reach increase for three products in UMIC

ceutical ingredients in-house, manages a buffer

with available global burden of disease data, whichand LMIC country examples.

stock of relevant products and is involved in sup-excludes COVID-19). Among new products, its

ply chain capacity building initiatives.

most widely registered is the COVID-19 vaccine

All five manufacturing capacity building ini-

(Comirnaty®), rapidly authorized in 37 countries intiatives included for analysis meet all GoodHas a policy for reporting substandard and fal-scope of the Index. Bevacizumab-bvzr (Zirabev),

Practice Standards. Pfizer is a leader. The num-sified (SF) medicines in countries in scope ofindicated for colorectal cancer among other can-ber of initiatives meeting all inclusion criteria is

the Index. Pfizer has a policy for reporting SF

cer types, has been filed in four of the top ten

higher than average and more initiatives meet all

medicines to the relevant national health author-

high burden disease countries such as Democratic

Good Practice Standards (GPS) than what is aver-ities but does not specify time frames. Instead,

People's Republic of Korea, Thailand and Ukraine.

age for this indicator. For example, the company

Pfizer reports that it follows locally mandated

is working with both The Biovac Institute in Southtime frames. It does not provide evidence of

Has access strategies for all supranationally pro-

Africa as well as Eurofarma in Brazil to transfer

shortened reporting time frames for cases which

cured products in scope for this analysis. Pfizer

technology to manufacture the COVID-19 vac-

only require visual inspection to be confirmed.

performs above average in securing access for its

cine for distribution in the African Union and Latin

products procured supranationally. For the five

America respectively.

demonstrates strategies both in countries eligi-

Two of the five supply chain capacity build-and supply processes in place to ensure ad hoc

ble for supply from such procurers and in at leasting initiatives included meet all Good Practice

donations are carried out rapidly in response to

one non-eligible country. For example, the com-

Standards. Pfizer's performance is above aver-

expressed need, and it monitors the delivery ofpany supplied COVID-19 vaccine (Comirnaty®)

age in this area. The number of initiatives meeting

donations.

in Rwanda via multiple supply pathways, includ-

all inclusion criteria is higher than average but an

ing via the COVAX Facility. This supply supported

average number of initiatives meet all GPS for

Publicly commits to the achievement of elim-

the local government in achieving their target

this indicator. Pfizer has partnered with Zipline, toination, eradication or control goals in one

vaccination rate aligned with local policy recom-

test and develop an end-to-end distribution solu-

structured donation programme for neglected

mendations. The price offered is a not-for-profit

tion for COVID-19 vaccines in Ghana in order totropical diseases or malaria. Pfizer publicly

price and consistent across all supply pathways.

safely distribute these to the last mile and reduce

commits to contributing to the elimination of tra-In 2021, around 7.4 million doses were supplied inwaste to expiry. This initiative meets all GPS.

choma by donating azithromycin (Zithromax®)

support of the government's vaccination program.

from 1998 to 2030 in 29 countries in scope ofAll five health systems strengthening initiatives

215

Donates in response to expressed need andmonitors delivery. Pfizer has public policies

products assessed in this category, the company

Has access strategies for the majority ofincluded for analysis meet all Good Practice

healthcare practitioner-administered productsStandards. Pfizer is one of the leaders in this area.

* The description of Pfizer’s performancein PP4 (HCP-administered products) was
corrected from "average" to "above aver-age" on 1 Dec 2022. This typographicalerror did not impact the underlying analysis or scoring.

the Index.

Access to Medicine Index 2022 ▶ Company report cards

RA N KSCO R E10

3.23

9 (2021)

Roche Holding AG
Stock exchange: SIX • Ticker: ROG.SW • HQ: Basel, Switzerland • Employees: 100,920

PERFORMANCE IN THE 2022 INDEX
10th place. Roche ranks among the top ten companiesof the Index. The company performs well in Research &Development, strengthening its performance in R&D accessplanning. The company has an average performance inHow score was achieved
4.00

Governance of Access
2.88

Research & Development

3.22

Product Delivery

Governance of Access, but its strategies for equitable access0

1

are below average for some products.

2

3

Average

Leader4

5

Governance of Access: 12th place. Roche has an average performance in this area. It has an access-to-medicine strategy

stage pipeline candidates. The company has a small-sized pri-integrated into its corporate strategy and publicly discloses

ority pipeline and has an average performance in R&D capac-

outcomes of its access-to-medicine activities. However, it

ity building.

lacks a fraud-specific risk assessment as part of its compliance framework to mitigate the risk of non-compliance in

Product Delivery: 11th place. Roche has an average perfor-

countries in scope of the Index and a formal policy to limit

mance in this area. The company provides evidence of com-transfers of values to healthcare professionals in countries inprehensive access strategies for a subset of products, yet thescope of the Index.

focus is mostly on upper-middle and lower-middle income
countries. Roche engages in high-quality supply chain capac-

Research & Development: 8th place. Roche performs above

ity building and health systems strengthening initiatives, but

average in this area. Roche has a structured access planning

its involvement in manufacturing capacity building is compar-

framework, with access plans in place for the majority of late-

atively poor.

OPPORTUNITIES FOR ROCHECHANGES SINCE THE 2021 INDEX

Ensure all late-stage R&D projects have comprehensive access plans. Roche has access• Expanded the Global Access Program in 2021 to include

plans in place for 90% of late-stage R&D projects. These predominantly focus on plansmolecular PCR diagnostic tests for COVID-19.

for registration filings. The company can expand existing plans beyond commitments• Expanded the proportion of access plans in its pipeline.

to register in countries where it is conducting clinical trials to include more access• Roche initiated a clinical trials framework, activating thecomponents such as equitable pricing and licensing.

first pharma sponsored oncology trial in East Africa.
• Suspended patents on tocilizumab (Actemra®/

Expand access strategies for oncology products. Roche has seven on-patent medicines

RoActemra®) in LMICs after the World Health Organization

listed on the WHO Model List of Essential Medicines, including erlotinib (Tarceva®),(WHO) recommended it as a treatment for severe

a first-line treatment for lung cancer, and atezolizumab (Tecentriq®), indicated for
multiple cancer types. Roche applies access strategies for erlotinib in upper-middle
income countries, including an intra-country pricing strategy in Peru. It can apply similarequitable access strategies and non-exclusive voluntary licensing in lower-middle

COVID-19.
• Entered a partnership with The Global Fund to support
LMICs in strengthening critical diagnostics infrastructure.
• Received WHO prequalification for HIV and HCV tests, andincome countries and low-income countries with high burden of lung cancer such as

WHO guidelines now include cobas® MTB and cobas® MTB-

Tunisia and Vietnam.

RIF/INH tests.
• Launched a human papillomavirus (HPV) self-sampling

Expand manufacturing capacity building activities to additional countries. Roche isinvolved in technology transfer initiatives to regional manufacturers in Bangladesh,
China and Algeria to improve availability of the company’s oncology products. Throughsolution, expanding cervical cancer screening options forpatients living in areas with limited healthcare resources.
• Joined the Access to Oncology Medicines (ATOM) Coalition,

partnerships to build local manufacturing capacity, including technology transfers,

a new global initiative that aims to improve access to

Roche can improve availability of its products in more countries, such as Nigeria, Ghana

essential cancer medicines in LMICs.

and South Africa.

216

All companies were assessed based on
information that was valid in the latest
period of analysis (ending at 31 May2022). This data was either submitted bycompanies, found in the public domain or
was accessible through other sources.

The term LMICs is used to denote all
low- and middle-income countries inscope of the Index, except when analysing
companies’ access strategies where
the use of LMIC refers to lower-middle
income countries as per the World Bank

income groups classification. Likewise, theterms LIC and UMIC refer to low income
countries and upper-middle income
countries.

Access to Medicine Index 2022 ▶ Company report cards

SALES AND OPERATIONSBusiness segments: Diagnostics andRoche's products are sold in 93 out of 108

pharmaceuticals.

countries in scope of the Index. Roche has sales

Sales by segment (2021) – in CHF

Therapeutic areas: Diabetes care,

offices in 31 countries, and sells via suppliers

Pharmaceuticals

45.04 bnhaemophilia A, immunology, infectious diseases,

and/or pooled procurement in an additional 62

Diagnostics

17.76 bn

neuroscience, oncology and ophtalmology.

countries.

		

M&A news: Roche acquired GenMark

Total

62.80 bn

Diagnostics in March 2021 for USD 1.8 billion.

Sales by geographic region
80

Sales (Bn CHF)

Sales in countries in scope

60
40
20
0

In scope, has sales offices
In scope, any sales

2017

2018

2019

Africa/Australia/Oceania

In scope, no sales

EuropeNot in scope

2020

2021

Asia

Latin America

North America

SAMPLE OF PIPELINE AND PORTFOLIO ASSESSED BY THE INDEXPIPELINE for diseases in scope

PORTFOLIO as selected for analysis by the Index

Roche has a total of 87 R&D projects in scope, with 17 of these projects

Roche has 29 medicines in scope, 23 of which are on patent, and 81 diag-targeting priority diseases. The other 70 R&D projects target other dis-nostics. 41% of the medicines (12) are on the WHO EML. In addition, theeases in scope. In total, 14 of the 87 projects are diagnostic R&D projects.

company markets 13 platform technologies. The off-patent medicines tar-

Of the projects targeting priority diseases the focus is on hepatitis B (fiveget communicable diseases (CDs) (3) such as hepatitis C, malaria and lower

projects). Of the projects targeting other diseases in scope, the focus is on

respiratory infections and non-communicable diseases (NCDs) (4) such as

oncology (53).

cancer (2) and cardiovascular diseases (2). The on-patent medicines tar-

Twenty R&D projects are in late-stage development that target either a

get NCDs such as cancer (15) and kidney diseases (2), and CDs such as HIV/priority disease (5) or address a public health need in LMICs (15).* Evidence

AIDS and coronaviral diseases. The platform technologies target respira-of access planning was in place for 90% of these projects: five targeting a

tory infections, diabetes, cancer and other diseases in scope of the Index.

priority disease and 13 addressing a public health need in LMICs.
87 projects in the pipeline

123 products as selected for analysis by the Index†

17

Maternal and neonatal 174

Non-communicableMultiple categories 1

4

Multiple categories
0

40
60
80
100
projects in the pipeline

20

40
60
80
100
products on the market

0

17

Vaccines

0

0

4

3

0

2

8

17

Contraceptives

Targets established R&D priorities

Addresses needs of LMICs*

1

9

1

1

Other projects in scope

23 11 141

4 53

*50 diseases and 243 product gaps inscope have been established as a priority by global health stakeholders. For
other diseases, the Index used a set of criteria to determine which projects in thepipeline offer a clear public health benefit to patients in LMICs. Only projects in5

the clinical phase of development were
included for this analysis.
**Neglected tropical diseases, while also
communicable, are highlighted separately
throughout the Index.
***Other includes projects that have atechnical lifecycle and projects that fol-

Other‡

Total

Non-EML0

Diagnostics

Total

0

Other***

0Registration/approval

60Phase III1

Phase II

16

5

Phase I7

off patent

Pre-clinical

Medicines on patent

Discovery

WHO EML

Breakdown of products

Other

20

Breakdown of projects

217

4

Maternal and neonatal

68

Non-communicable
038Communicable**
Neglected tropical 0

WHO EDL

Communicable**
Neglected tropical 0

23

0
81

81

13 13

low a different development cycle (e.g.
diagnostics).
†Products included in the analysis wereselected using a set of criteria determinedby stakeholder consensus.
‡Other includes vector control products.

Access to Medicine Index 2022 ▶ Company report cards

Roche Holding AG

GOVERNANCE OF ACCESSRANK 12SCORE 4.00

Has an access-to-medicine strategy with meas-

access-to-medicine activities, including its Global

uous system to monitor activities, audits (bothurable objectives, integrated within its overall

Access Programme, in a centralised mannerinternal and external, covering third parties andcorporate strategy. Roche performs strongly. Its

within its Annual Report.

in all countries where it operates) and has formal

strategy is focused on understanding local barri-processes to ensure third-party compliance withers to access and covers all therapeutic areas theHas an average performance in responsible

company standards. There is no evidence, publicly

company is involved in. The highest responsibil-

promotional practices. Roche’s sales agents arefound or disclosed to the Index, of fraud-spe-

ity for access lies directly with the board, namely

not solely incentivised on sales volume targets.

cific risk assessment. No breaches in countries

with the Corporate Governance and Sustainability

However, the company sets sales incentives atin scope of the Index were publicly found in theCommittee.

the individual level for agents. Roche has an inter-

period of analysis.

nal tracking mechanism but does not publicly
Provides evidence of financial and non-finan-disclose information related to transfers of values

Publicly supports the Doha Declaration on

cial access-related incentives at the executive

to healthcare professionals in countries in scope

TRIPS and Public Health. Roche publicly shareslevel. Roche performs well. It incentivises its CEO,of the Index (e.g. payments for attending events

support of the Doha Declaration on TRIPS andsenior executives and in-country managers toor promotional activities), unless required by law

Public Health, but expresses reservations on its

perform on access to medicine with financial andor by local regulations. The company does notprovisions, namely on the effectiveness of com-

non-financial rewards.

place limits on transfers of value to healthcare

pulsory licensing to lower drug prices. Thereprofessionals, but reports setting remuneration inis evidence of industry association lobbying online with fair market value.

intellectual property (IP) and the usage of TRIPS

Publicly discloses outcomes of its
access-to-medicine activities. Roche performs

flexibilities, namely of compulsory licensing, bystrongly in transparency of access activities. It

Has some compliance controls to ensure thatnational governments in some countries in scope

publicly discloses its commitments, measura-

governance efforts are not undermined byof the Index. As a member of the industry asso-

ble goals, objectives and targets for improving

non-compliant or corrupt activities. Roche has

ciation, Roche, like all other member companies

access to medicine in countries in scope of the

an average performance, demonstrating evi-in scope of the Index, is by default connected to

Index. It facilitates accountability and transpar-

dence of some components looked for by thethis activity.

ency by consistently sharing the outcomes of its

Index: country risk-based assessment, a contin-

RESEARCH & DEVELOPMENTRANK 8SCORE 2.88

Access planning processes encompass all pro-the Index, a new pricing policy, WHO prequalifica-

Does not publicly disclose R&D investment

jects in the pipeline. Roche has a structured

tion, patent waivers in LMICs, product donations

data disaggregated by disease category, prod-

process in place to develop access plans during

and scaling up production capacity to meet

uct type or phase of development. Roche does

R&D. The process is intended to be applied to all

demands.

not disclose disaggregated R&D investment data

R&D projects for diseases in scope of the Index.

to global health organisations.
Many projects address a public health need in

An average-sized priority R&D pipeline com-

LMICs,* with 87% (13/15) of late-stage projects

Two of the three R&D capacity building ini-pared to its peers, with access plans in place

covered by access plans. In this analysis, Roche

tiatives included meet all Good Practicefor 100% (5/5) of the late-stage candidates.

has 15 late-stage R&D projects that target a dis-Standards. Roche's performance is average

Roche has 17 projects including five late-stage

ease and/or product gap not yet established as ain this area. The number of initiatives meeting

candidates in its pipeline that target a priority

priority by global health stakeholders. These pro-

all inclusion criteria is average and an average

product gap. These focus mostly on hepatitis B

jects are all deemed by the Index to offer a clear

number of initiatives meet all Good Practiceand coronaviral diseases. Roche has access planspublic health benefit for people living in LMICs.*

Standards (GPS) for this indicator. For exam-in place for all five late-stage priority candidates.

Primarily, these projects concern clinical trials

ple, Roche builds R&D capacity by educating

These plans mainly concern registration prepa-

in countries in scope of the Index. Most target

lab researchers through its Fondation Roche

ration in countries in scope of the Index. Notably,

cancer or Alzheimer's disease. Roche provides

Recherche en Afrique scholarship programme.

the access plan for tocilizumab (Actemra®/

evidence of access plans for 13 of these projects.

This initiative provides scholarships to students

RoActemra®) for the treatment of COVID-19 uses

These plans mostly relate to an intention to reg-in Côte d'Ivoire to increase the number of skilled

a multifaceted approach that considers availa-

ister in countries where Roche is carrying out

medical laboratory technicians and meets all GPS.

bility, affordability and supply. The plan includes

clinical trials.

registration preparation in countries in scope of218*50 diseases and 243 product gaps inscope have been established as a priority
by global health stakeholders. For otherdiseases, the Index used a set of criteria
to determine which projects in the pipeline offer a clear public health benefit topatients in LMICs. Projects in the clinicalphase of development were included forthis analysis.

Access to Medicine Index 2022 ▶ Company report cards

PRODUCT DELIVERYRANK 11SCORE 3.22

Public commitment not to enforce patents inassessed. Examples of access strategies in LICs

area. The number of initiatives meeting all inclu-

countries in scope. Roche publicly pledges towere not provided. Roche makes efforts to reachsion criteria is higher than average and moreneither file for nor enforce patents in all Least

additional patients using patient assistance pro-initiatives meet all GPS than what is average

Developed Countries and LICs within the scope

grammes (PAPs). For example, Roche applies

for this indicator. For example, Project ECHO®

of the Index. Roche does not file nor enforce

differential pricing for pertuzumab (Perjeta®) in(Extension for Community Health Outcomes)

patents for its antiretroviral HIV medicines in

Egypt based on the patients' ability to pay, and itaims to help broaden access to best practice can-sub-Saharan Africa.

implements both pricing and non-pricing support

cer treatment in LMICs by training and mentoring

to out-of-pocket patients through a PAP while

healthcare personnel in underserved areas.

Publicly discloses information on patent status.

strengthening the health systems with capac-

Like most of its peers, Roche discloses the patent

ity building initiatives. Roche provides evidence

Has engaged in scaling up three inclusive busi-

statuses for small molecules in scope via the Pat-of how patient reach has been increased throughness models but has not shown evidence of its

INFORMED database. Roche’s disclosure includes

the approaches used, reporting that patient reachinvolvement in piloting any new inclusive busi-

information about patents, patent number andhas more than doubled in 2021.

ness models that meet all inclusion criteria.

jurisdiction.

Roche performs average in the use of inclusive
Has access strategies for its self-adminis-

business models aimed at meeting the access

Performs below average in terms of sharing

tered products for few countries in scope ofneeds of populations at the base of the income

intellectual property (IP) assets with third-

this analysis. Roche performs below averagepyramid (including other underserved popula-party researchers. Roche does not report on any

in this area. The company provides examples oftions) in LMICs. Project TRACMA aims to solve

new IP-sharing agreements with public researchaccess strategies which consider payers’ afforda-

access hurdles of breast cancer patients in Angola

institutions or drug discovery initiatives estab-bility in UMICs and LMICs for one of the fourand provide therapies to the patients who canlished during the current analysis period that

products assessed: alectinib (Alecensa®), a can-benefit from them.

meet all inclusion criteria for evaluation. The

cer drug. This included efforts to reach additional

company does have existing agreements of thispatients using pricing strategies that consider

Performs above average in terms of ensuring

nature in place that were established before therelevant payers’ ability to pay. For example, thecontinuous supply of medicines in LMICs. Roche

current period of analysis and meet all inclusioncompany has implemented a four-tiered pricing

is involved in technology transfers with third-

criteria for evaluation.

strategy for alectinib in the Philippines, the ALIVE

party manufacturers in LMICs, and has a system

programme, based on the country's profile andin place to work with relevant stakeholders to

No use of licensing agreements. Roche does

patients' economic status. In addition, the com-

communicate issues that may affect the supply

not engage in voluntary licensing agreements forpany created a PAP to reduce the out-of-pocket

chain, works with several active pharmaceuti-

products in scope of the Index.

costs for patients. Roche has further initiatives tocal ingredient (API) suppliers/produces in-housesupport medicine access such as deferred pay-

APIs, manages a buffer stock of relevant products

Filed to register new products in 22 countries

ment schemes and capacity building initiatives toand is involved in supply chain capacity buildingin scope on average. Roche has filed for registra-

strengthen the healthcare system. Evidence ofinitiatives.

tion one of its newest products in eight of the top

patient reach increase is provided.
Has a policy for reporting substandard and fal-ten high burden countries. This product, Elecsys®
Chagas, used for diagnosis and screening ofNone of the manufacturing capacity build-sified (SF) medicines in countries in scope of

Chagas disease, has been filed for registration ining initiatives included for analysis meet all

the Index. Roche has a policy for reporting SF

15 countries in scope of the Index. The majority ofGood Practice Standards. Roche's performance

medicines to relevant health authorities, but

Roche's products considered for analysis have notis below average in this area. The number of ini-does not strictly specify the reporting timeframe.

been filed for registration in LICs.

tiatives meeting all inclusion criteria is lower

Roche, however, states that reporting typicallythan average and fewer initiatives meet all Goodoccurs within 24 hours once a case is confirmed.

Has access strategies for its supranationally

Practice Standards (GPS) than what is average

Earlier reporting prior to the end of the investiga-

procured products in scope of this analysis.

for this indicator. In one of the included initia-

tion is possible when visual inspection is sufficientRoche performs below average in securing accesstives starting in 2018, Roche built manufacturing

for confirmation.

for products procured supranationally. The com-capacity by transferring technology for secondarypany supplies three products assessed via its

packaging of bevacizumab (Avastin), trastu-

Donates in response to expressed need andGlobal Access Program (GAP), developed in con-zumab (Herceptin®) and rituximab (MabThera®)

monitors delivery. Roche has public policies

sultation with international partners includingin Algeria.

and supply processes in place to ensure ad hoc

CHAI, PEPFAR, USAID, UNITAID and the Global

donations are carried out rapidly in response toFund. Roche did not provide examples of how

Three of the four supply chain capacity build-

expressed need, and it monitors the delivery ofaccess was secured for countries not eligible foring initiatives included meet all Good Practice

donations until they reach the patient.

the GAP. However, Roche has been expanding theStandards. Roche's performance is above aver-

GAP by including new diagnostics for HPV-related

age in this area. The number of initiatives meeting

Has no long-term donation programmes for

cervical cancer, tuberculosis and hepatitis in 2019all inclusion criteria is higher than average andneglected tropical diseases (NTDs) or malaria

and molecular PCR diagnostic tests for COVID-19

more initiatives meet all GPS than what is aver-that are eligible for analysis under this indi-

in 2021. The company demonstrated expansion

age for this indicator. For example, the Global

cator. Roche is not engaged in any structuredof patient reach: to date over 11 million children

Philanthropic Secondment Program provides

donation programmes for NTDs or malaria where

have been tested for HIV with Roche tests.

the mechanism to share Roche employee exper-

elimination, eradication or control goals are pos-tise with NGOs that are helping to improve global

sible and that are eligible for analysis under thisHas access strategies for the majority ofhealth and education, including the topic of sup-indicator.

healthcare practitioner-administered products

ply chain, logistics and project management.

in scope of this analysis. Roche's performance219

is above average in this area.* The company pro-All five health systems strengthening initiatives

vides examples of access strategies in bothincluded for analysis meet all Good Practice

UMICs and LMICs for four of the five productsStandards. Roche is one of the leaders in this

* The description of Roche’s performancein PP4 (HCP-administered products) was
corrected from "average" to "above average" on 1 Dec 2022. This typographicalerror did not impact the underlying analysis or scoring.

Access to Medicine Index 2022 ▶ Company report cards

RA N KSCO R E8

3.47

5 (2021)

SanofiStock exchange: EPA • Ticker: SAN • HQ: Paris, France • Employees: 95,442

PERFORMANCE IN THE 2022 INDEX
8th place. Sanofi ranks among the top ten companies in the
Index. The company has strong policies governing access to
medicine and patent transparency. It leads in applying accessstrategies for supranationally procured products and engages

How score was achieved
4.43

Governance of Access
2.88

Research & Development

3.53

Product Delivery

in R&D for neglected tropical diseases.

0

1

Governance of Access: 2nd place. Sanofi has a strong per-2

3

Average

Leader4

5

formance in this area. It has an integrated access-to-medicine strategy with direct board-level responsibility foraccess-to-medicine and incentives for its senior executives,
including the CEO, and in-country and regional managers. It

Product Delivery: 8th place. Sanofi performs well in thisdiscloses outcomes of its access-to-medicine activities andarea. The company applies comprehensive access strate-

has a robust set of compliance controls to mitigate the risk ofgies for healthcare-practitioner administered products, with

non-compliance in countries in scope of the Index.

the majority covered by strategies across all country income
classifications. However, the strategies for self-adminis-

Research & Development: 8th place. Sanofi performs above

tered products tend to focus on upper-middle and lower-mid-average in this area. It has a structured access planning frame-dle income countries. The company engages in high-qual-

work and applies this to most of its late-stage pipeline candi-

ity health systems strengthening and manufacturing capacity

dates. The company has an average-sized priority pipeline andbuilding initiatives. It has strengthened its performance withperforms well in R&D capacity building.

respect to inclusive business models.

OPPORTUNITIES FOR SANOFICHANGES SINCE THE 2021 INDEX

Ensure all late-stage R&D projects have comprehensive access plans.

• Established Sanofi Global Health Unit, a non-profit unit aimed at

Sanofi has access plans in place for 81% of its late-stage projects. It can

providing access to essential medicines and care through affordable

apply plans to all late-stage candidates from Phase II onwards, including

prices and supporting local capacity building with programmes for

the Pneumococcal Conjugate Vaccine (Skypac, SP0202).

specific low and lower-middle income countries.
• Through the Global Health Unit, Sanofi has shared a commitment to

Expand registration of analogue insulins. Sanofi has six analogue insulins
in its portfolio. Insulin glargine (Toujeo®) has been filed in 30 countries
within scope of the Index. Sanofi can expand the registration of thisproduct as well as insulin lispro (Admelog®) and Insulin aspart Sanofi,
especially in countries with a high burden of diabetes such as Sri Lanka,

expand access to analogue insulins, namely glargine and glulisine, withthe target to reach 300,000 insulin-dependent patients by 2030.
• Launched a new brand of standard care medicines called Impact®. These
medicines are produced by Sanofi for non-profit distribution by the
Sanofi Global Health Unit to at-risk populations in 40 LMICs.

Guyana and Suriname.

• Integrated a new CSR strategy which places more focus on Access via its

Expand access to insulin and diabetes products. For insulin glargine• Announced the development of a global access plan for all new products,

Affordable Access and Vulnerable Communities strategic pillars.
(Lantus®), Sanofi implements access strategies considering payers' ability

with aims to make them available within two years post first launch

to pay in at least one upper-middle income country and one lower-middle

wherever this can make an impact for patients (including in countries

income country. The company can apply access and pricing strategies

within scope of the Index).

in low-income countries (LICs) to improve the affordability of diabetes• Sought regulatory authorisation alongside GSK for its COVID-19 vaccine.

medicines such as glimepiride/metformin (Amaryl® M) and insulin• Renewed partnership with the World Health Organization (WHO) to fightglargine in LICs, following through on the commitments made through theneglected tropical diseases and eliminate sleeping sickness before 2030

company's Global Health Unit.

through its long-term donation programme of pentamidine eflornithine,
melarsoprol and fexinidazole.

Measure and share outcomes of Sanofi Global Health Unit. In 2021, Sanofi• Joined the Access to Oncology Medicines (ATOM) Coalition, a new global

launched its Global Health Unit, which will expand on the company’s work

initiative that aims to improve access to essential cancer medicines inwith partners to increase access to 30 of its medicines for communicableand non-communicable diseases. To scale up this initiative and support

LMICs.
• Issued EUR 1.5 billion bond linked to access to medicine.

integration into local health systems, Sanofi can track and share both
short- and long-term patient outcomes as part of its impact evaluation ofthis programme, in addition to outcomes such as patient reach and productvolumes sold.

220

All companies were assessed based on
information that was valid in the latest
period of analysis (ending at 31 May2022). This data was either submitted bycompanies, found in the public domain or
was accessible through other sources.

The term LMICs is used to denote all
low- and middle-income countries inscope of the Index, except when analysing
companies’ access strategies where
the use of LMIC refers to lower-middle
income countries as per the World Bank

income groups classification. Likewise, theterms LIC and UMIC refer to low income
countries and upper-middle income
countries.

Access to Medicine Index 2022 ▶ Company report cards

SALES AND OPERATIONSBusiness segments: Pharmaceuticals, Vaccines

April 2021. Additionally it acquired Translate Bio

and Consumer healthcare.

in September 2021, Kadmon Holdings, Inc. in

Net sales by segment (2021) – in EUR

Therapeutic areas: Oncology, Immunology &November 2021, Origimm Biotechnology GmbH

Pharmaceuticals

Inflammation, Neurology, Rare Blood Disorders,in December 2021 and Amunix Pharmaceuticals,

Vaccines

6.32 bn

Rare Diseases, Diabetes and Cardiovascular

Inc. in February 2022.

Consumer healthcare

4.47 bn

Diseases.

26.97 bn		Product categories: Innovative medicines,

Sanofi's products are sold in 92 out of 108

Vaccines and Consumer health products.

countries in scope of the Index. Sanofi has sales

M&A news: Sanofi acquired Kiadis Pharma N.V.,

offices in 36 countries, and sells via distributors

Kymab Group Ltd. and Tidal Therapeutics inin an additional 56 countries.

Total

Sales by geographic region40

Net sales (Bn EUR)

Sales in countries in scope

37.76 bn

30
20
10
0

In scope, has sales offices

2017

In scope, any sales

USA

In scope, no sales

2018

2019

2020

2021

EuropeOther countries

Not in scope

SAMPLE OF PIPELINE AND PORTFOLIO ASSESSED BY THE INDEXPIPELINE for diseases in scope

PORTFOLIO as selected for analysis by the Index

Sanofi has a total of 37 R&D projects in scope, with 16 projects targeting a

Sanofi has 65 medicines in scope, 12 of which are on patent, and 15 vaccines.

priority disease. The other 21 R&D projects target other diseases in scope.

54% of the medicines (35) are on the WHO EML. In addition, the company

Of the projects targeting priority diseases, the focus is on lower respiratory

markets four platform technologies. The off-patent medicines target com-

tract infections (seven projects). Of the projects targeting other diseases inmunicable diseases (11) such as tuberculosis (6), malaria (3) and HIV/AIDS (1);scope, the focus is on oncology (14) Twenty-one R&D projects are in late-non-communicable diseases (NCDs) (36) such as diabetes (6), cardiovascu-

stage development that target either a priority disease (8) or address alar diseases (10), mental health conditions (10); and certain neglected tropical

public health need in LMICs (13).* Evidence of access planning was in placediseases. The on-patent medicines target mainly NCDs such as cancer (3),for 81% of these projects: six targeting a priority disease and 11 addressing

diabetes (3) and kidney diseases (2). Sanofi's preventive vaccines (15) targeta public health need in LMICs.

diseases such as tetanus, meningitis and yellow fever.

37 projects in the pipeline

84 products as selected for analysis by the Index†
15

Communicable**

Maternal and neonatal 1

1850

Non-communicableMultiple categories 02

Multiple categories
0

20
30
40
50
projects in the pipeline

40
60
80
100
products on the market

Pre-clinical

Phase I

Phase II

Phase III

Registration/approval

Other***

Total

3

2

2

3

3

1

16

Contraceptives

Medicines on patent

2 10

12

off patent

33 20

53
15

Addresses needs of LMICs*

0

3

5

5

0

13

Diagnostics

Other projects in scope

5

3

0

0

0

8

Other

*50 diseases and 243 product gaps inscope have been established as a priority by global health stakeholders. For
other diseases, the Index used a set of criteria to determine which projects in thepipeline offer a clear public health benefit to patients in LMICs. Only projects inthe clinical phase of development were
included for this analysis.
**Neglected tropical diseases, while also
communicable, are highlighted separately
throughout the Index.
***Other includes projects that have atechnical lifecycle and projects that fol-

Total

Discovery

Vaccines

2

Targets established R&D priorities

Other

Breakdown of products
WHO EML

Breakdown of projects

20

WHO EDL

10

Non-EML

Non-communicable

221

7Neglected tropical

Maternal and neonatal 0024Communicable**

4

Neglected tropical

‡

14

1

0

0

0
0

0
4

low a different development cycle (e.g.
diagnostics).
†Products included in the analysis wereselected using a set of criteria determinedby stakeholder consensus.
‡Other includes vector control products.

4

Access to Medicine Index 2022 ▶ Company report cards

Sanofi

GOVERNANCE OF ACCESSRANK 2SCORE 4.43

Has an access-to-medicine strategy with meas-

closes commitments, measurable goals, objectives

Sanofi performs strongly, demonstrating evi-

urable objectives, integrated within its overall

and targets for improving access to medicine

dence of all components looked for by the Index:

corporate strategy. Sanofi performs strongly. Its

in countries in scope of the Index. It facilitates

fraud-specific risk assessment, country risk-based

access to healthcare strategy, recently revamped

accountability and transparency by consistently

assessment, a continuous system to monitor

in 2021, is integrated in the activities of its three

sharing the outcomes of its access-to-medicine

activities, audits (both internal and external, cov-

core global business units: Sanofi Pasteur, Sanofi

activities in a centralised manner within its Accessering third parties and in all countries where it

Genzyme and General Medicines and its stan-to Healthcare Programmes Report and in its quar-

operates) and has formal processes to ensure

dalone business unit, Consumer Healthcare. A fifth

terly results press release.

third-party compliance with company standards.

non-profit business unit was created, Sanofi Global

No breaches in countries in scope of the Index

Health. The strategy covers all therapeutic areas

Performs well in responsible promotional prac-

in which the company is involved. The highest

tices. Sanofi's Sales Incentive Plan is primarily

responsibility for access lies directly with board-

driven by sales volume, but qualitative compo-

Publicly supports the Doha Declaration onlevel members seated on the Corporate Social

nents are adjusted depending on the specific

TRIPS and Public Health. Sanofi publicly shares

Responsibility (CSR) committee.

situation. The company sets sales incentives at

support of the Doha Declaration on TRIPS andthe national level for agents in most of the coun-

Public Health, but expresses reservations on

Provides evidence of financial and non-finan-

tries that are in scope of the Index. It has a policy

its provisions, stating that compulsory licensing

cial access-related incentives at the executive

on service engagement with scientific experts, butshould only be used in extraordinary and very lim-

level. Sanofi performs strongly. It incentivises

it does not publicly disclose information related toited circumstances. There is evidence of industry

its senior executives and in-country managers

transfers of values to healthcare professionals inassociation lobbying on intellectual property andto take action on access to medicine with finan-countries in scope of the Index (e.g. payments forthe usage of TRIPS flexibilities, namely of com-cial and non-financial rewards. The CEO also has

attending events or promotional activities), unlesspulsory licensing, by national governments inaccess-related incentives beyond CSR goals.

required by law or by local regulations.

some countries in scope of the Index. As a mem-

Publicly discloses outcomes of its access-to-­Has a robust set of compliance controls toother member companies in scope of the Index, ismedicine activities. Sanofi performs strongly inensure that governance efforts are not under-

by default connected to this activity.

transparency of access activities. It publicly dis-mined by non-compliant or corrupt activities.

were publicly found in the period of analysis.

ber of the industry association, Sanofi, like all

RESEARCH & DEVELOPMENT222

RANK 8SCORE 2.88

Access planning processes encompass all pro-in countries in scope of the Index. Notably, Sanofi

projects. These plans mostly relate to planningjects in the pipeline. Sanofi has a structured

partners with Drugs for Neglected Diseases initi-

registration in countries where it is conducting

process in place to develop access plans dur-

ative (DNDi) for two projects using fexinidazole

clinical trials.

ing R&D. The process is intended to be applied

to treat for two different types of human African

to all R&D projects (both in-house and collabora-trypanosomiasis. These access plans include

Publicly discloses disaggregated R&D invest-tive) for diseases in scope of the Index. In general,

WHO prequalification, a donation programmement data for phase of development. In

Sanofi begins developing access plans for R&D

managed by WHO and plans for registration in

addition, Sanofi also discloses fully disaggregatedprojects in Phase II of clinical development.

countries with a high burden of disease.

R&D investment data to Policy Cures Research.

An average-sized priority R&D pipeline com-Some projects address a public health need inThree of the four R&D capacity building ini-pared to its peers, with access plans in place for

LMICs,* with 85% (11/13) of late-stage projects

tiatives included meet all Good Practice

75% (6/8) of the late-stage candidates. Sanofi

covered by access plans. In this analysis, Sanofi

Standards. Sanofi's performance is above aver-has 16 projects, including eight late-stage candi-has 13 late-stage R&D projects that target a dis-age in this area. The number of initiatives meeting

dates in its pipeline that target a priority productease and/or product gap not yet established as a

all inclusion criteria is higher than average andgap. The company focuses on various priority

priority by global health stakeholders. These pro-more initiatives meet all Good Practice Standards

areas, including lower respiratory tract infec-

jects are all deemed by the Index to offer a clear

than what is average for this indicator. For exam-tions, coronaviral diseases and human African

public health benefit for people living in LMICs.*ple, through the Sanofi Global Site Partnership,

trypanosomiasis. Of Sanofi’s eight late-stage can-Primarily, these projects concern clinical trials in

Sanofi partners with over 80 institutes to build

didates targeting a priority product gap, there iscountries in scope of the Index and/or are first-

clinical trial capacity in countries in scope of theevidence of an access plan for six. These plans

in-class molecules. Most target cancer. Sanofi

Index.

prioritise WHO prequalification and registration

provides evidence of access plans for 11 of these*50 diseases and 243 product gaps inscope have been established as a priority
by global health stakeholders. For otherdiseases, the Index used a set of criteria
to determine which projects in the pipeline offer a clear public health benefit topatients in LMICs. Projects in the clinicalphase of development were included forthis analysis.

Access to Medicine Index 2022 ▶ Company report cards

PRODUCT DELIVERYRANK 8SCORE 3.53

Publicly pledges not to enforce patents. Sanofi

for treatments. For example, Sanofi supplies its

all inclusion criteria is higher than average andpublicly pledges to neither file for nor enforce

meningitis vaccine (Menactra®) via tenders run

more initiatives meet all GPS than what is aver-patents. This commitment applies in all Least

by international and local public authorities in 23

age for this indicator. For example, the My Child

Developed Countries and LICs and in a subset ofcountries in scope of the Index, of which six are

Matters programme was initiated by the Sanofi

LMICs and UMICs.

LICs. The company offers a price that is adjusted

Espoir Foundation in 2006 in order to fight child-to local tenders' specifications and considers

hood cancer and reduce health inequalities

Publicly discloses information on patent status.

countries' ability to pay. In parallel, it supports

worldwide. This initiative meets all GPS.

Sanofi publicly discloses on its website infor-

local healthcare systems by providing training tomation relating to the status of its patents for

public managers. This training includes cold chain

Has engaged in both scaling up and piloting

products on the WHO Model List of Essential

management and vaccination surveillance. Sanofi

one inclusive business model. Sanofi per-Medicines (EML).

provides evidence of how patient reach has been

forms above average in the use of inclusive

increased through these approaches.

business models aimed at meeting the access

Performs below average in terms of sharingneeds of populations at the base of the income

intellectual property (IP) assets with third-

Has access strategies for its self-administeredpyramid (including other underserved popula-party researchers. Sanofi does not report on any

products for some countries in scope of thistions) in LMICs. The Sanofi Global Health Unit is

new IP-sharing agreements with public researchanalysis. Sanofi has an average performance ina new non-profit unit that sells and/or donates

institutions or drug discovery initiatives estab-this area. For one of the five products assessed,

30 of Sanofi's products at affordable prices tolished during the current analysis period thatthe company provides examples of access strat-

approximately 40 low and lower-middle income

meet all inclusion criteria for evaluation. The

egies in countries of all assessed income levels

countries.

company does have existing agreements of this(UMIC, LMIC, LIC), including efforts to reachnature in place that were established before theadditional patients through pricing strategies

Performs above average in terms of ensuring

current period of analysis and meet all inclusionthat consider local payers' ability to pay and dis-continuous supply of medicines in LMICs. Sanofi

criteria for evaluation.

ease management initiatives. For example, Sanofi

is involved in technology transfers with third-

ensured the inclusion of glimepiride/metformin

party manufacturers in LMICs, and has a system

No use of licensing agreements. Sanofi does

(Amaryl® Min) in Colombia’s mandatory nationalin place to work with relevant stakeholders to

not engage in voluntary licensing agreements forhealth plan which offers 100% coverage to eligible

communicate issues that may affect the supply

products in scope of the Index.

patients. The company has additional strategies

chain, works with several active pharmaceuti-

to improve disease early diagnosis, treatment

cal ingredient (API) suppliers/produces in-house

Filed to register new products in 14 countries

adherence and patient health outcomes. Sanofi

APIs, manages a buffer stock of relevant products

in scope on average. Sanofi did not disclose evi-

provides evidence of patient reach, reporting thatand is involved in supply chain capacity building

dence of filing for registration any of its new

approximately 920 patients receive the treat-

initiatives.

products in more than half of the top ten highment yearly.
Has a policy for reporting substandard and fal-burden countries. Among new products, its mostwidely filed is the booster vaccine (Tetraxim),

Four of the five manufacturing capacity build-sified (SF) medicines in countries in scope ofindicated for tetanus and pertussis prevention,

ing initiatives included meet all Good Practicethe Index in less than ten days. Sanofi has a pol-filed in 38 countries within the scope of the Index,

Standards. Sanofi's performance is above aver-icy for reporting SF medicines to national healthincluding four high burden disease countries andage in this area. The number of initiatives meeting

authorities or the WHO within seven days. It does

eight LICs.

all inclusion criteria is higher than average andnot provide evidence of shortened reporting time

more initiatives meet all Good Practice Standards

frames for cases which only require visual inspec-

Has access strategies for all supranationally(GPS) than what is average for this indicator. Fortion to be confirmed.

procured products in scope for this analy-

example, Sanofi has been working with the May

sis. Sanofi leads in securing access for products& Baker manufacturing site since 2015. The com-

Donates in response to expressed need andprocured supranationally. For the five products

pany provides training on hygiene, on-site safety

monitors delivery. Sanofi has public policies

assessed in this category, the company demon-and good manufacturing practice. This initiativeand supply processes in place to ensure ad hoc

strates strategies both in countries eligible formeets all GPS.

donations are carried out rapidly in response tosupply from such procurers and in at least one

expressed need, and it monitors the delivery of

non-eligible country. For example, the company

One of the five supply chain capacity build-offers the same terms to Brazil and Mexico foring initiatives included meets all Good Practicethe influenza trivalent vaccine (Vaxigrip® TIV) as

Standards. Sanofi's performance is average in

Publicly commits to the achievement of elim-

it does for PAHO-eligible countries. Sanofi pro-this area. The number of initiatives meeting all

ination, eradication or control goals in one

vides evidence of how patient reach has been

inclusion criteria is higher than average but fewer

structured donation programme for neglected

increased through these approaches.

initiatives meet all GPS than what is average fortropical diseases or malaria. Sanofi publicly com-this indicator. Sanofi partnered with the Vietnam

mits to contributing to the elimination of humanHas access strategies for the majority ofVaccine Joint Stock Co. to build capacity in supply

African trypanosomiasis by donating pentamidine

healthcare practitioner-administered products

chain planning. This includes improving forecast-(Pentacarinat®), eflornithine (Ornidyl®), melar-in scope of this analysis. Sanofi performs above

ing and warehouse planning to meet vaccine

soprol (Arsobal®) and fexinidazole (Fexinidazole

average in this area. For three of the five prod-

demand. This initiative meets all GPS.

Winthrop®) in 21 countries in scope of the Index

ucts assessed, the company provides examples

223

donations until they reach the patient.

until goals are reached.

of access strategies in countries of all assessed

Four of the five health systems strengthen-income levels (UMIC, LMIC, LIC), including efforts

ing initiatives included meet all Good Practice

to reach additional patients through pricing strat-

Standards. Sanofi's performance is above aver-egies considering relevant payers' ability to pay

age in this area. The number of initiatives meeting

Access to Medicine Index 2022 ▶ Company report cards

RA N KSCO R E7

3.51

6 (2021)

Takeda Pharmaceutical Co, Ltd
Stock exchange: NYSE • Ticker: TAK • HQ: Tokyo, Japan • Employees: 47,347

PERFORMANCE IN THE 2022 INDEX
7th place. Takeda ranks among the top ten countries in
the Index. The company performs strongly in Governanceof Access and engages in high-quality capacity building
initiatives across all fields. Despite having a small pipeline, it

How score was achieved
4.43

Governance of Access
2.98

Research & Development

3.55

Product Delivery

also performs well in Research & Development, by applying

01

comprehensive access plans to all late-stage pipeline
candidates.

2

3

Average

Leader4

5

dates. The company also performs strongly in R&D capacity
Governance of Access: 2nd place. Takeda performs strongly

building. However, it has a small-sized priority pipeline com-in this area. It has an integrated access-to-medicine strategy

pared to its peers.

with direct board-level responsibility for access to medicine
and incentives for its senior executives, including the CEO,

Product Delivery: 7th place. Takeda performs well in this area.

and in-country and regional managers. It discloses outcomes

It leads in applying access strategies for healthcare practi-

of its access-to-medicine activities and has a robust set oftioner-administered products across all country income levels

compliance controls to mitigate the risk of non-compliance in

but it has a comparatively poor performance for sharing intel-

countries in scope of the Index.

lectual property assets, with no evidence of engaging in newagreements during the period of analysis. It has a strong per-Research & Development: 7th place. Takeda performs above

formance in supply chain capacity building and health systems

average in this area. It has a structured access planning frame-

strengthening but shows average performance in building

work and applies this to all of its late-stage pipeline candi-

manufacturing capacity.

OPPORTUNITIES FOR TAKEDACHANGES SINCE THE 2021 INDEX

Expand the geographic coverage of project-specific access plans for non-

• The launch of Corporate Philosophy Dashboard, including the launchcommunicable diseases. Takeda has comprehensive access plans in placeof the Growth and Emerging Market Transformation and Aspiration

for all late-stage R&D projects analysed. The company can increase theDashboard which provides a framework of measuring progress against

number of countries included in these plans. For example, the access planfor mobocertinib (Exkivity™) for lung cancer can be expanded to include
more low- and lower-middle income countries.

priorities included access metrics.
• Successful completion of an innovative digital authentication technology
pilot in Kenya which will allow the authentication of Takeda products andnow preparing for launch readiness in higher risk markets.

Expand registration of cancer products. Takeda has four on-patent• Evaluating a novel field and rapid analytical technology based on time-cancer medicines in its portfolio, including non-Hodgkin lymphoma

domain nuclear magnetic resonance (TD-NMR) that has been adapted

treatment brentuximab vedotin (Adcetris®). This product has been filed

for testing biologics and vaccines counterfeit suspects to provide

in 21 countries in scope of the Index, including three countries with a highimmediate results.

burden of non-Hodgkin lymphoma. The company can further expand the• Sought regulatory authorization for its dengue vaccine candidate (TAK-registration of this product, especially in countries where the burden of003). Takeda is participating in the EMA’s first-ever parallel assessment

non-Hodgkin lymphoma is the highest, such as Myanmar, Afghanistan andof a medicinal product for use in the European Union (EU), and throughSuriname.

the EU-M4all procedure for countries outside of the EU.
• Joined the Antimicrobial Resistance (AMR) action fund, which was

Expand the use of tools to assess patients' ability to pay and determine
differential prices to more products and countries. Takeda developed asophisticated Patient Assistance Tool to assess individual patients' ability

established to support the clinical development of new antimicrobial
agents and to achieve a sustainable antimicrobial market.
• Scaled up the Blueprint for Innovative Healthcare Access initiative

to pay. The company can apply this tool to more of its products, such as its

concept to Nigeria in partnership with BIO Ventures for Global Healthlung cancer treatment brigatinib (Alunbrig®), in countries where the tool is(BVGH) to build diagnostic and treatment capacity and in Uganda andalready being applied for other products. The patient assistance tool andintra-country pricing strategies can be applied in more countries in scopewith a high burden of lung cancer such as China and Thailand.

Tanzania with the International Cancer Institute (ICI).
• Partnered with UNITAR and the local authorities of Rwanda and South
Africa to launch the new Value-based Healthcare (VBHC) Hub, whichfacilitates locally led initiatives that will promote and advance theimplementation of VBHC models in low-income and resource-limited
settings.
• Takeda takes a co-leadership role in the Corona Accelerated R&D in
Europe (CARE) programme.

224

All companies were assessed based on
information that was valid in the latest
period of analysis (ending at 31 May2022). This data was either submitted bycompanies, found in the public domain or
was accessible through other sources.

The term LMICs is used to denote all
low- and middle-income countries inscope of the Index, except when analysing
companies’ access strategies where
the use of LMIC refers to lower-middle
income countries as per the World Bank

income groups classification. Likewise, theterms LIC and UMIC refer to low income
countries and upper-middle income
countries.

Access to Medicine Index 2022 ▶ Company report cards

SALES AND OPERATIONSBusiness segments: Pharmaceuticals.

Takeda's products are sold in 37 out of 108

Therapeutic areas: Oncology, Rare Diseases,

countries in scope of the Index. Takeda has

Revenue by segment (2021) – in JPY

Neuroscience, Gastroenterology (GI) and Plasma

sales offices in 21 countries, and sells via

Pharmaceuticals

Derived Therapies.

suppliers and/or pooled procurement in an		Product categories: Innovative medicines andadditional 16 countries.

Total

3,569.01 bn
3,569.01 bn

vaccines.
M&A news: In March 2021, Takeda announced
it would acquire Maverick Therapeutics for
USD 525 million. Takeda acquired GammaDelta
Therapeutics in November 2021.
Sales by geographic region
Revenue (Bn JPY)

Sales in countries in scope

4,000
3,000
2,000
1,000
0

In scope, has sales offices
In scope, any sales

2017

2018

Rest of world

In scope, no sales

Europe/Canada

Not in scope

2019

2020

Asia (ex Japan)
Japan

2021
Latin America

Russia/CIS

USA

SAMPLE OF PIPELINE AND PORTFOLIO ASSESSED BY THE INDEXPIPELINE for diseases in scope

PORTFOLIO as selected for analysis by the Index

Takeda has a total of 21 R&D projects in scope with 11 of these projects tar-

Takeda has 16 medicines in scope, 12 of which are on patent, and one vac-geting priority diseases. The other ten R&D projects target other diseases

cine. 42% of these medicines (5) are on the WHO EML. The off-patentin scope. Of the projects targeting priority diseases, the focus is on coro-

medicines target non-communicable diseases (NCDs) such as cancer (1),naviral diseases (6). Of the projects targeting other diseases in scope, thecardiovascular diseases (2) and kidney diseases (1). The on-patent med-focus is on oncology (7).

icines target NCDs (12) such as diabetes (5), cancer (4), cardiovascular

Four R&D projects are in late-stage development that target either a pri-diseases (2) and kidney diseases (1). Takeda's preventative vaccine targets

ority disease (1) or address a public health need in LMICs (3).* Evidence oflower respiratory infections.

access planning was in place for 100% of these projects.

21 projects in the pipeline

17 products as selected for analysis by the Index†

9

Neglected tropical 0Maternal and neonatal 0

Maternal and neonatal 0

10Multiple categories 0
0

20
30
40
50
projects in the pipeline

0

1

8

1

0

0

1

0

11

Contraceptives

Addresses needs of LMICs*

1

0

2

1

0

4

Diagnostics

Other projects in scope

3

3

0

0

0

6

Other

*50 diseases and 243 product gaps inscope have been established as a priority by global health stakeholders. For
other diseases, the Index used a set of criteria to determine which projects in thepipeline offer a clear public health benefit to patients in LMICs. Only projects inthe clinical phase of development were
included for this analysis.
**Neglected tropical diseases, while also
communicable, are highlighted separately
throughout the Index.
***Other includes projects that have atechnical lifecycle and projects that fol-

‡

Total

0

Total

1

0

Other***

0Registration/approval

4

1

Phase III12

1

Phase II

11

3

Phase I1

off patent

Pre-clinical

Medicines on patent

Vaccines

Targets established R&D priorities

225

20
30
40
50
products on the market

Breakdown of products

Discovery

Breakdown of projects

10

Other

10

WHO EDL

016

Non-communicableMultiple categories 0

Non-EML

Non-communicable1

Communicable**2

WHO EML

Communicable**
Neglected tropical000

low a different development cycle (e.g.
diagnostics).
†Products included in the analysis wereselected using a set of criteria determinedby stakeholder consensus.
‡Other includes vector control products.

0

Access to Medicine Index 2022 ▶ Company report cards

Takeda Pharmaceutical Co, Ltd

GOVERNANCE OF ACCESSRANK 2SCORE 4.43

Has an access-to-medicine strategy with meas-ency by consistently sharing the outcomes offraud-specific risk assessment, country risk-based

urable objectives, integrated within its overall

its access-to-medicine activities in a centralised

assessment, a continuous system to monitor

corporate strategy. Takeda performs strongly.

manner within its Access to Medicines Progress

activities, audits (both internal and external, cov-

Its strategy, called The Corporate Philosophy,

Report and its Annual Integrated Report.

ering third parties and in all countries where it

aims to increase sustainable access of innova-

operates) and has formal processes to ensure

tive medicines globally and covers all therapeutic

Performs above average in responsible pro-third-party compliance with company standards

areas in which the company is involved. The high-motional practices. Takeda’s sales agents arewhich has recently been updated and enhanced.

est responsibility for access lies directly with thenot solely incentivised on sales volume tar-

No breaches in countries in scope of the Index

board, namely the CEO of the Takeda Executive

gets. Employee KPIs are based on company

were publicly found in the period of analysis.

Team.

or global KPIs which are then passed onto thebusiness unit or function. It does not publicly dis-Publicly supports the Doha Declaration on

Provides evidence of financial and non-financial

close information related to transfers of values

TRIPS and Public Health. Takeda publicly sharesaccess-related incentives at the executive level.

to healthcare professionals (HCPs) in the bulk of

support of the Doha Declaration on TRIPS and

Takeda performs strongly. It incentivises its sen-countries in scope of the Index (e.g., payments for

Public Health, but expresses reservations on its

ior executives and in-country managers in Growthattending events or promotional activities), unlessprovisions, stating that it does not view compul-

and Emerging Markets units to take action onrequired by law or by local regulations. However,sory licensing as a sustainable solution and should

access to medicine with financial and non-finan-

Takeda reports that it has standard operating

only be use in exceptional circumstances and ascial rewards. The CEO also has access-related

procedures to control HCP engagement in alla last resort. There is evidence of industry asso-

incentives.

countries in scope of the Index and has imple-

ciation lobbying on IP and the usage of TRIPS

mented automation/digitalisation initiatives toflexibilities, namely of compulsory licensing, byincrease controls around HCP activities.

national governments in some countries in scope

Publicly discloses outcomes of its
access-to-medicine activities. Takeda performsof the Index. As a member of the industry asso-

strongly in transparency of access activities.

Has a robust set of compliance controls to

ciation, Takeda, like all other member companies

It publicly discloses commitments, measura-

ensure that governance efforts are not under-in scope of the Index, is by default connected toble goals, objectives and targets for improving

mined by non-compliant or corrupt activities.

this activity.

access to medicine in countries in scope of theTakeda performs strongly, demonstrating evi-

Index. It facilitates accountability and transpar-

dence of all components looked for by the Index:

RESEARCH & DEVELOPMENTRANK 7SCORE 2.98

Access planning processes encompass all pro-

The plan considers innovative methods to ensure

All five R&D capacity building initiatives

jects in the pipeline. Takeda has a structured

availability, affordability and supply.

included for analysis meet all Good PracticeStandards. Takeda leads in this area. The number

process in place to develop access plans during R&D. The process is intended to be appliedSome projects address a public health need in

of initiatives meeting all inclusion criteria is higher

to all R&D projects (both in-house and collabora-

LMICs,* with 100% (3/3) of late-stage projects

than average and more initiatives meet all Goodtive) in the company's pipeline. In general, Takeda

covered by access plans. In this analysis, Takeda

Practice Standards than what is average for thisbegins developing access plans for R&D projects

has three late-stage R&D projects that target

indicator. Takeda builds R&D capacity through thein Phase II or earlier of clinical development.

a disease and/or product gap not yet estab-following initiatives:lished as a priority by global health stakeholders.

- Strengthening clinical trial capacity in LMICs

A small-sized priority R&D pipeline compared

These projects are all deemed by the Index towith BIO Ventures for Global Health.

to its peers. Takeda has 11 projects, including

offer a clear public health benefit for people liv-

- Clinical care and lab capacity building with

one late-stage candidate in its pipeline that tar-ing in LMICs.* These projects have clinical trials

Partners in Health, AMPATH, Foundation for

get a priority product gap. These projects focus

in countries in scope of the Index or the projectCancer Care Tanzania (FCCT) and Healthcare

on communicable diseases including coronavi-

is a first-in-formulation treatment. They focus onPartners for Access (HPA).

ral diseases, Zika, malaria, dengue, chikungunyacancer and epilepsy. Takeda provides evidence- Instrumental Access Program with Seeding

and tuberculosis. There is evidence of an accessof access plans for all three late-stage projects.

Labs to strengthen local research and diagnos-

plan for Takeda’s late-stage candidate targeting

These access plans mainly focus on registration

tic capabilities.

a priority product gap. This plan for the dengue

preparation and continuous supply.

- ReGRoW (Repurposing Grants for the Rest of

vaccine candidate (TAK-003) is currently under-

226

the World) program with Cures Within Reachgoing regulatory review in the European Union

Does not publicly disclose R&D investment

fosters repurposing research to address healththrough the EU-Medicines for all (EU-M4all) pro-data disaggregated by disease category, prod-

inequities and improve access to medicines.

cedure which intends to facilitate patient access

uct type or phase of development. However,to essential medicines or vaccines that prevent

Takeda does disclose fully disaggregated R&D

or treat diseases of major public health interest.

investment data to Policy Cures Research.

*50 diseases and 243 product gaps inscope have been established as a priority
by global health stakeholders. For otherdiseases, the Index used a set of criteria
to determine which projects in the pipeline offer a clear public health benefit topatients in LMICs. Projects in the clinicalphase of development were included forthis analysis.

Access to Medicine Index 2022 ▶ Company report cards

PRODUCT DELIVERYRANK 7SCORE 3.55

Public commitment not to enforce patents inon the National List of Essential Medicines andachieve “healthy villages” by reducing preventablecountries in scope. Takeda publicly pledges tomore than 75% of patients can access it. Takeda

deaths among mothers and children by strength-

neither file for nor enforce patents. This commit-

provides evidence of patient reach.

ening training for 1,400 community healthment applies in Least Developed Countries andworkers and providing approximately 500,000
Has access strategies for its self-administeredpeople in local communities with healthcare-re-products for some countries in scope of thislated knowledge and services to prevent disease

Publicly discloses information on patent sta-analysis. Takeda has an average performanceand protect lives.

tus. Like most of its peers, Takeda discloses thein this area. The company provides examples

patent statuses for small molecules in scope viaof access strategies in countries of all assessed

Has engaged in scaling up one inclusive busi-

the Pat-INFORMED database. Takeda discloses

income levels (UMIC, LMIC, LIC) for two of theness model but has not shown evidence ofpatent information, including filing date, grant

five products assessed. It makes efforts to reach

its involvement in piloting any new inclusive

number, grant date and jurisdiction.

additional patients through pricing strategies

business models that meet all inclusion cri-that consider payers' ability to pay and patientteria. Takeda performs average in the use of

Performs below average in terms of sharing

affordability programmes (PAPs). For example,

inclusive business models aimed at meeting theintellectual property (IP) assets with third-

in Indonesia, for brigatinib (Alunbrig®) Takeda

access needs of populations at the base of theparty researchers. Takeda does not reportapplies an inter-country tiered pricing strategy.

income pyramid (including other underservedon any new IP-sharing agreements with public

In addition, it launched two projects: the Market

populations) in LMICs. Blueprint for Innovative

research institutions or drug discovery initiatives

Access Scheme programme in which patients

Healthcare Access in Rwanda, Tanzania, Uganda

established during the current analysis period

get fixed price reductions based on theirand Nigeria aims to save and improve the lives

that meet all inclusion criteria for evaluation. The

healthcare practitioner's discretion, and a PAP

of patients with cancer and other non-commu-

company does have existing agreements of thiswhich provides further cost reduction based on

nicable diseases using a practical framework tonature in place that were established before thea patient affordability assessment. Forecasted

sustainably strengthen healthcare systems at acurrent period of analysis and meet all inclusion

patient reach for the programme is available. In

local level and provide innovative affordability

criteria for evaluation.

addition, the company provides evidence of how

programmes.

LICs.

patient reach has been increased through the
No use of licensing agreements. Takeda does

approaches used.

Performs above average in terms of ensuring continuous supply of medicines in LMICs.

not engage in voluntary licensing for products inscope of the Index. It publicly states it would con-The one manufacturing capacity building ini-

Takeda is involved in technology transfers withsider granting non-exclusive voluntary licences intiative included for analysis meets all Good

third-party manufacturers in LMICs, and has a sys-certain circumstances.

Practice Standards. Takeda's performancetem in place to work with relevant stakeholders

is average in this area. The number of initia-

to communicate issues that may affect the supply

Filed to register new products in seven coun-tives meeting all inclusion criteria is lower thanchain, works with several active pharmaceuticaltries in scope on average. Takeda did not

average and fewer initiatives meet all Good

ingredient suppliers, manages a buffer stock ofdisclose evidence of filing for registration any

Practice Standards (GPS) than what is average

relevant products and is involved in supply chainof its new products in more than half of the top

for this indicator. From 2017 until 2021, Takeda

capacity building initiatives in LMICs.

ten high burden countries. Among old prod-

was involved in a partnership with Biological E.

ucts, its most widely filed is brentuximab vedotin

Limited in India where the company agreed to

Has a policy for reporting substandard and fal-

(Adcetris®), for the treatment of non-Hodg-

transfer technology to manufacture affordable

sified (SF) medicines in countries in scope ofkin lymphoma, is filed in 21 countries within the

combination vaccines for measles. This initiative

the Index in less than ten days. Takeda has ascope of the Index, including three high burden

meets all GPS.

policy expecting reporting of SF medicines tocountries (Ecuador, Peru and Ukraine).

national health authorities and the WHO within
All five supply chain capacity building initiatives

seven days. It provides evidence of shortened

Takeda is not eligible for assessment of supra-

included meet all Good Practice Standards.

reporting timeframes for cases which only require

nationally procured products.

Takeda is one of the leaders in this area. The

visual inspection to be confirmed.

number of initiatives meeting all inclusion criteria
Has access strategies for all its healthcare

is higher than average and more initiatives meet

Donates in response to expressed need andpractitioner-administered products in scope

all GPS than what is average for this indicator.

monitors delivery. Takeda has public policiesof this analysis. Takeda is leading in this area.

For example, Takeda’s five-year partnership withand supply processes in place to ensure ad hoc

For the two products assessed, the company

the World Food Programme (WFP) aims to makedonations are carried out rapidly in response toprovides examples of access strategies which

health systems and public health supply chainsexpressed need, and it monitors the delivery of

consider affordability in countries of all assessedmore resilient and enhance targeted countries'

donations until they reach the patient.

income levels (UMIC, LMIC, LIC). It makes efforts

ability to absorb and respond to health emergen-to reach additional patients using tiered inter-cies and pandemic preparedness. This initiative

Has no long-term donation programmes forcountry pricing strategies and intra-country

meets all GPS.

neglected tropical diseases or malaria thatare eligible for analysis under this indicator.

pricing strategies through patient assistance227

programmes. For example, Takeda evidenced an

All five health systems strengthening initiatives

However, the company is engaged in anotherincrease in patient reach of 41% through patient

included for analysis meet all Good Practice

structured donation programme: the Max Accessassistance programmes for Adcetris in Thailand

Standards. Takeda is one of the leaders in thisSolutions whereby it donates ponatinib (Iclusig®)

and the Philippines and the company developed aarea. The number of initiatives meeting all inclu-

for chronic myeloid leukaemia in 17 countries

pricing strategy that considers patients' ability tosion criteria is higher than average and moresince 2015.

pay for its oncology medicine leuprolide acetate

initiatives meet all GPS than what is average for(Enantone®) in Thailand. The product is listed

this indicator. For example, Healthy Village aims toAccess to Medicine Index 2022 ▶ Appendices

Appendices for the2022 Index

229

I Key parameters for evaluation

234

II Indicators and scoring guidelines

246

III Identifying best practices

247

IV The Good Practice Standards framework forcapacity building

228

249

V Guide to Report Cards

251

VI Definitions

254

VII Figures

256

VIII References

Access to Medicine Index 2022 ▶ Appendices

APPE N D IX I

Key parameters for evaluation
PI PE LI N E AN D PO RTFO LI O

of this medicine as a monotherapy for another form of leukaemia or in
combination with a medicine that had also previously been approved for

R&D pipeline and product portfolio inclusion process

leukaemia would be excluded.

The Index team reviewed both marketed products and projects in com-

2. If a medicine that had previously been approved for a specific cancer

panies’ R&D pipelines, prior to including them for analysis. This review

type is being developed for the same cancer type, but in combina-

ensured the products and projects were within the scope of the 2022

tion with a medicine that has not received an approval for treating thisIndex and met relevant inclusion criteria.

cancer type, the project was included. Where multiple projects were

Furthermore, before scoring and analysis began, companies’ products

ongoing for a single cancer type and the medicine(s) had not yet been

and R&D projects were verified and updated against public sources ofapproved for this cancer type, the latest stage of development was

information to ensure that the most up-to-date and accurate pipelines andincluded. Projects were pre-populated and clustered by multiple group

portfolios were represented. Public data could include pipeline and port-

indications if these indications were being examined as a group within

folio information found on company websites, in approvals from stringent

the same clinical trial(s) (e.g., a Phase II trial of a medicine for patientsregulatory authorities, the website clinicaltrials.gov and information on rel-with breast, lung and colorectal cancer was counted as one project forevant product development partnership pipelines. Companies were given

all three cancer types; if a new chemical or biological entity was being

the opportunity to verify ongoing R&D projects and notified the Index team

tested in a Phase II trial for breast cancer only and in a Phase II trial forwhen a project had been divested or discontinued, while also confirmingcolorectal cancer only, these projects were listed separately).

each product in their portfolios. These final pipelines and product portfolios were then entered into the final datasheets and sent to companies at

Product types in scope

the beginning of the data collection cycle.

This scope is deliberately broad in order to capture the wide-ranging product types available to support the prevention, diagnosis and treatment

Inclusion criteria for R&D projectsof relevant conditions and diseases in the 108 countries covered by the

For R&D projects the following inclusion criteria were utilised:

Access to Medicine Index.

1. Projects which target a disease, condition or pathogen within the disease scope of the Index and belong to a product type in scope (asMedicines

detailed below) were included in the pipeline if they fell into one of the

All innovative and adaptive medicines, branded generics and generic medi-

following categories:

cines used to directly treat the target pathogen or disease process, regard-• Collaborative projects which the company continued to actively con-less of formulation, are included. Medicines used only for symptomatic

tribute resources and expertise to, during the period of analysis.

relief are not included.

• All projects which target a priority R&D product gap identified by
Policy Cures Research and/or WHO, regardless of the stage ofMicrobicides

development.

These include topical microbicides specifically intended to prevent HIV.

• Clinical-stage projects which do not target a priority R&D product gap
identified by Policy Cures Research and/or WHO, but do target a dis-

Therapeutic vaccines

ease, condition or pathogen within the scope of the Index.

This covers vaccines intended to treat infections.

The six lists that the Index uses to determine priority product gaps are:Preventive vaccines• WHO Priority Pathogen List (2017)1

This covers vaccines intended to prevent infections.

• WHO Initiative for Vaccine Research (2010)2

229• WHO R&D Blueprint (2022)3

Diagnostics• Policy Cures Research G-FINDER emerging infectious diseases (2020)4

This covers diagnostic tests designed for use in resource-limited settings• Policy Cures Research G-FINDER sexual & reproductive health (2020)5(i.e., designed to be cheaper, faster, more reliable and easier to use in the• Policy Cures Research G-FINDER neglected diseases (2021)6

field).

Cancer projects inclusion criteria

Vector control products

1. For cancer projects, R&D projects were included only if they contained

These include pesticides, biological control compounds and vaccines tar-a chemical or biological entity that had not previously been approved

geting animal reservoirs. Only chemical pesticides which are intended forfor a given cancer type before the period of analysis. For example, if a

global public health use and specifically aim to inhibit and kill vectors that

medicine had been approved as a monotherapy for one form of leukae-transmit diseases in scope of the Index are included. Likewise, only biologi-

mia before the period of analysis, further projects for the development

cal control interventions that specifically aim to kill or control vectors asso-

Access to Medicine Index 2022 ▶ Appendicesciated with transmitting Index-relevant diseases are included. Only veteri-

Determining patent status

nary vaccines specifically designed to prevent animal-to-human transmis-

Patent status for each product in scope of the Index was determinedsion of diseases covered by the Index are included.

through a process of external research combined with verification fromparticipating companies for the purpose of including or excluding prod-

Contraceptive methods & devices

ucts. This process was developed in consultation with experts from diverse

This covers instruments, apparatuses, appliances, implants and other sim-

constituencies. Patent status was first researched through the related reg-ilar or related articles intended to be used to control contraception (e.g.,

ulatory authority websites (i.e., South-African CIPC Intellectual Property

condoms or diaphragms). It also includes combination products that deliver

database,7 the US FDA Orange Book,8 Health Canada)9 and/or patent data-

medicines (e.g., hormone-delivery contraceptive rings).

bases (MedsPaL and Pat-INFORMED)10,11 and later verified with companies.
The Index clarifies that for the patent status in South Africa, if the infor-

Platform technologies

mation was not available, the Index looked at the status in the US and in

Only products that are specifically directed at meeting the needs of peoplesome cases (e.g., for biologics) in Canada. However, it is not intended to beliving in the countries covered by the Index are included. These comprise,a presentation of patent rights worldwide, nor does it capture all patents

for example, general diagnostic platforms, adjuvants, immunomodulatorsthat might apply to a product. It is therefore reasonable to assume that thisand delivery technologies and devices. Implants and platform technologies

Index may underreport where patents are in place. It should only be used

for reproductive health are also included in this category. Platform technol-

as a proxy description and cannot be used as an indication of patent statusogies that have utility for accelerating the development of health products

outside of South Africa and/or the US and Canada. In some instances, thefor ‘Disease X’, a term used by WHO to refer to currently unknown patho-

patent status of a particular product was identified as off-patent in Southgens that could cause a serious international epidemic, are also included.

Africa, the US or Canada but on-patent in other jurisdictions.

Process for registered product inclusion

Determining countries with high disease burdens

Registered products also went through a verification process. Products

The Index considers in which of the countries in scope each of the com-targeting a disease, condition or pathogen listed in the disease scope

panies have registered their ten most newly approved products. The Index(based on information from regulatory authorities such as U.S. Food andused data from the Institute for Health Metrics and Evaluation’s 2019

Drug Administration (FDA), the European Medicines Agency (EMA), theGlobal Burden of Disease (GBD)12 to determine which countries in scopeJapanese Pharmaceuticals and Medical Devices Agency (PMDA)) were

have the highest burden of disease. Countries in which companies haveincluded in the portfolio under several conditions:

filed for registration were compared to the ten countries in scope with the• Medicines which are:highest burden of disease for the main indication of that product.

- Patented• When a product has multiple indications, the burden of disease for the- Off-patent and listed on the 2021 WHO Model List of Essential

main indication is used for analysis. If a product has two main indications,

Medicines (EML) AND where it was determined that companies had

the five countries with the highest burden of disease for each indication

significant ability to shape the market, have a mean and/or medianare used, to complete the ten countries.

number of manufacturers <4.0 in a set of ten representative LMICs:
Brazil, China, Egypt, India, Mexico, Morocco, Philippines, South Africa,
Tunisia and Vietnam, per IQVIA MIDAS data; OR,• Since only one country in scope of the Index, Kosovo, was not in the
database, that country was not considered in the analysis for indicators
related with GBD.

- Off-patent and not listed on the 2021 WHO EML but listed as a first- or• By default, the data considered is for all ages. When there was a paedi-

second-line treatment for a disease in scope by one of the five sets ofatric product, the settings were modified to search only for that specificguidelines (WHO, Centers for Disease Control (CDC), National Instituteage group.

for Health and Care Excellence (NICE), National Comprehensive Cancer
Network (NCCN), European Society for Medical Oncology (ESMO))SCO R I N G

used by the Index team AND where it was determined that companies

Neutral scoring protocol

had significant ability to shape the market.

Neutral scoring is used to avoid double negative marking of a company• To determine where companies had significant ability to shape thefor the lack of a policy, strategy, programme or initiative whose score has

market, the Index team used IQVIA MIDAS data. Market dominance wasalready been impacted negatively once and for which the company cannot

defined for products:

meet the additional expectations. For example, when a company has no- Which have a mean and/or median number of manufacturers <4.0 in

R&D priority projects in their pipeline, it is assessed for scoring in the rel-a set of ten representative low- and middle-income countries (LMICs:

evant R&D indicator (RD1a). However, for the indicator relating to accessBrazil, China, Egypt, India, Mexico, Morocco, Philippines, South Africa,

plans for R&D priority projects (RD3a) a neutral score is applied, as theTunisia and Vietnam), per IQVIA MIDAS data OR

company has already been evaluated for not having R&D priority projects in- Where a listed company has >70% of the market share in these coun-

the pipeline. In that case, a proxy measure was identified for that indicator.

tries by volume of sales, per IQVIA MIDAS data.

The proxy measure includes the average score of the company across all• Diagnostics which are listed on the 2020 WHO Model List of Essential In
Vitro Diagnostics, with the addition of diagnostics for COVID-19.
• Vaccines, vector control products and platform technologies.

indicators within the Technical Area. In 2022, neutral scoring was applied
within the following areas: long-term donation programmes (PP2b), supranationally procured products: access strategies (PP3), healthcare practitioner-administered products: access strategies (PP4) and access-oriented
licensing (PPL4/PPL5).

230

Access to Medicine Index 2022 ▶ AppendicesScoring• COVID-19, due to its pandemic nature

Companies were assessed and scored by the Index in three Technical• Contraceptive methods, since these cannot be considered a disease

Areas: Governance of Access, Research & Development and Product• Thalassemia, since there is no GBD in IHME19

Delivery, with each area composed of several indicators. Analysis was car-

• In access strategies, for indicators PP3, PP4 and PP5 a maximum of fiveried out based using a wide range of sources including data submitted byproducts was evaluated per company. These products were identified

the companies themselves, independent reports and databases or docu-

using criteria such as either on patent or off patent, on EML and highments from WHO, other multilateral organisations and non-governmen-

market share. Companies received an opportunity to verify and adjust as

tal organisations. Public data sources, including information shared on

appropriate.

company websites, in annual reports and through local health authori-• For all four types of capacity building, PCB1, PCB2, PCB3 and RD6, com-ties, helped to triangulate data. The final scoring of the companies is thepanies could submit a maximum of five initiatives to be considered forresult of a multi-tiered analysis and quality assurance process, begin-analysis. This means that our analysis is not able to capture an overview

ning with scoring per company by the analyst during the first round of theof involvement in capacity building but instead an evaluation of the qual-

data collection period, followed by re-scoring after companies have pro-ity of selected examples.

vided further clarification in areas identified by the analyst. This was followed by verification by the analyst, including an extensive quantitative andLongitudinal comparability

qualitative check of each indicator for each company. The research man-Comparability between companies over successive indices is not always

ager and research lead perform a quality assurance check on all scores topossible or appropriate, especially when the scoring criteria of an indicator

ensure consistency, with senior management performing a final spot check.

had been refined. During the period of analysis, where trend analysis was

Each analyst then cross-checked their Technical Area ranking, before theuseful, the Index team compared raw data from past Indexes with raw data

final ranking was cross-checked and verified by the data coordinator andfrom 2022.

research manager.
Company comparability
R E VI E W PRO CESS

The objective of the Index is to produce a standardised relative ranking

Following clarification with companies, cross-check of company scoresof the 20 companies’ access-to-medicine performances. However, not all

and consultation with experts, the Index team wrote the various sections

companies are the same. Some have large portfolios and pipelines. Someof the Index report. The company report cards were fact checked by com-have a comparatively narrow disease focus. Some have a comparatively

panies and confidential information was requested to be lifted for publica-

narrow scope of country operations. Others have generic pharmaceuti-tion. Global health experts have provided reviews on each Technical Area

cal subsidiaries. Companies differ in size, geographical reach and capability

analysed in the Index. Following internal review by the Foundation’s man-for recording and reporting information. The Index uses various methods

agement team, the entire Index was reviewed by the Chair of the Expert

to correct for these variations between companies. In order to minimise

Review Committee (ERC), Professor Hans Hogerzeil.

the variability of information sourced from companies, all companies were
provided with training on the data submission process and the analytical

M E TH O D O LO GY LI M ITATI O N S

parameters for each indicator were clearly outlined during the data collec-

Limitations exist in every study of this design. Significant limitations spe-tion process. In addition, a clarification round was carried out, giving com-cific to this study are discussed here. These and other methodological lim-

panies an opportunity to provide additional data where there were gaps,

itations will be considered in the methodology review for the 2024 Accessinconsistencies or where clarifications were necessary.

to Medicine Index.

In several indicators that measure quantitative elements, in general, theIndex makes adjustments for company size. In the case of some R&D indi-

Disease, product scopes and country comparability

cators in this Index, the company’s pipeline size was used as an additional

The outputs analysed in this study and the findings generated relate only

differentiator to group companies together, so that both large and small

to the geographical, disease, product and company scopes, as determinedcompanies’ performances were scored relative to peers of similar size.

by the ERC during the methodology review process and as published in the
Access to Medicine Index Methodology 2022.
• Although the Foundation recognises that all products, diseases, countries, access and product initiatives are not the same, in general in mostTechnical Areas in this study they are treated equally. For example, in
R&D, nearly all compounds are treated equally if they meet the inclusion
criteria, regardless of their mechanism of action or expected efficacy.
• In the registration indicator PR1, the Index used data from the Institutefor Health Metrics and Evaluation’s 2019 Global Burden of Disease(GBD)12 results to prioritise the ten countries in scope with the highest
disability-adjusted life year (DALY) rate. These disease-specific subset
of countries with the highest burden of disease were given credit in thisindicator. However, global burden of disease was not considered for thefollowing indications:231

Access to Medicine Index 2022 ▶ Appendices

D ISE ASES I N SCO PE FO R TH E 2022 ACCESS TO M E D I CI N E I N D EX
Diseases are included based on their burden of disability-adjusted life years (DALYs) in countries in scope,13 WHO classifications and the relevance of pharmaceutical interventions.
With the new addition of thalassaemia, the disease scope forthe 2022 Index has expanded from 82 to 83 diseases, conditions and pathogens.

TABLE 6 Diseases, conditions and pathogens in scope of the 2022 Access to Medicine Index
Non-communicableCommunicable diseases

diseases (18)(23 + 1 disease category cov- (20)Neglected tropical diseases

Maternal and neonatal

Priority pathogens*(12)health conditions (10)ering 12 priority pathogens)
Alzheimer's disease

Arenaviral haemorrhagic

Buruli ulcer

fevers (Lassa fever)Anxiety disorders
AsthmaBunyaviral diseases
Coronaviral diseases

Chagas disease
Dengue and chikungunya

Birth asphyxia andAcinetobacter baumannii

birth trauma(carbapenem-resistant)Contraceptive

Campylobacter spp.

methods(fluoroquinolone-resistant)Hypertensive disor-

Enterobacteriaceae (carbape-ders of pregnancy

nem-resistant, 3rd generation
cephalosporin-resistant

Bipolar affective

Disease X

Dracunculiasis

disorderCancer**Diphtheria

Echinococcosis

Maternal abortion andEnterococcus faecium

miscarriage(vancomycin-resistant)Maternal haemorrhage

Haemophilus influenzae(ampicillin-resistant)

Chronic obstructive

Emergent non-polio

pulmonary disease

enteroviruses

Diabetes mellitus

Enteric disease

Foodborne trematodiases

Maternal sepsis

Helicobacter pylori

Human African

Neonatal sepsis andNeisseria gonorrhoeae (3rd gen-

Trypanosomiasis

infections

eration cephalosporin-resistant,(clarithromycin-resistant)fluoroquinolone-resistant)Endometriosis

Filoviral diseases

Leishmaniasis

Obstructed labour

Pseudomonas aeruginosa

Epilepsy

Henipaviral diseases

Leprosy

Other neonatal

Salmonella spp.

conditions(fluoroquinolone-resistant)

Preterm birth

Shigella spp.

complications(fluoroquinolone-resistant)(carbapenem-resistant)Hypertensive heart

HIV/AIDS

Lymphatic filariasis

diseaseIschaemic heart

Leptospirosis

disease

Mycetoma, chromoblastomy-

Staphylococcus aureus (methicil-

cosis and other deep mycoses

lin-resistant, vancomycin-intermediate and vancomycin-resistant)

Kidney diseases

Lower respiratory infections

Onchocerciasis

Migraine

Malaria

RabiesSchizophrenia

Measles

Scabies and other ectoparasites

Sickle cell disease

Meningitis

Schistosomiasis

StrokeOther prioritised antibacte-

Snakebite envenoming

Streptococcus pneumoniae(penicillin-non-susceptible)

rial-resistant infections*Thalassemia

Pertussis

Soil-transmitted helminthiasis

Unipolar depressive

Rheumatic fever

Taeniasis/cysticercosis

Sexually transmitted infec-

Trachomadisorders
tions (STIs)
Tetanus

Yaws

Tuberculosis
Viral hepatitis (B and C)
Yellow fever
Zika

232

*This refers to 12 species of bacteria withcritical, high, and medium antibiotic resistance defined by WHO, which are collectively referred to as 'other prioritised
antibacterial-resistant infections' by theIndex, and counted as one communicable disease.

** The 19 cancer types are collectively
counted as one non-communicabledisease.

Access to Medicine Index 2022 ▶ Appendices

CANCE RS I N SCO PE FO R TH E 2022 ACCESS TO M E D I CI N E I N D EX
Cancer remains in scope for the 2022 Index, with 19 cancer types included. The 18
cancer types in scope for the 2021 Index have been retained and osteosarcoma is
newly in scope. The inclusion of cancer types is based on high incidence both globally and in countries in the scope of the Index, using data from the Global Cancer
Observatory (GLOBOCAN, 2020).14 Ovarian and uterine cancer remain in scope as
they have comparably higher incidences compared to other sex-linked cancer types.
As in the methodologies for previous Indexes, products for the management of pain
and supportive treatments (for e.g., antiemetics) are not included.

TABLE 7 Cancer types in scope
Cancer types in scope (19)
BladderBrain, nervous system
BreastCervicalColorectal
Gallbladder
Head and neck
Kaposi sarcoma
Leukaemia
Liver
Lung
Non-Hodgkin lymphoma
Oesophageal
Osteosarcoma
Ovarian
Prostate
StomachThyroid
Uterine233

Access to Medicine Index 2022 ▶ Appendices

APPE N D IX I I

Indicators and scoring guidelines

A GOVERNANCE OF ACCESS 15%
Indicator
GA1

Governance structures & incentives

4

The company has a clear access-to-medicine strategy with

The company has a governance system that includes both direct

evidence of alignment with corporate/business strategy. It

board-level responsibility and accountability for its access-to-med-includes measurable objectives to improve access to medicine.

icine initiatives. To facilitate effective implementation of the strat-

The company demonstrates evidence that the strategy applies

egy, senior management (i.e., CEO and/or senior executives) andto a subset of the company’s portfolio and pipeline, within thein-country operational managers have access-to-medicine objectives and incentives to reward the effective delivery of initiatives

Index scope.
3

The company has an access-to-medicine strategy with a busi-

2

The company has no existing access-to-medicine strategy with

1

The company has made commitments to improve access to

0

The company neither has access-to-medicine strategy, nor hasthat improve access to medicine in countries and for diseases within
the Index scope.

ness rationale that covers all or some of their projects.

5 	The company has a board member or board-level committee
directly responsible for its access-to-medicine approach. Its

a business rationale but is in the process of implementing one.

CEO and/or senior executives have (long-term) access-related
objectives and incentives. Its regional and/or in-country man-medicine but does not have an access-to-medicine strategy.

agers also have objectives and incentives to improve access incommitments for improving access to medicine.

countries in scope of the Index.
4 	The company has a board member or board-level commit-

GA 3 Public disclosure of access-to-medicine outcomestee (directly or indirectly) responsible for its access-to-medi-

The company has time-bound measurable objectives, goals and tar-cine approach. There is evidence of access-related incentives

gets related to improving access to medicine in countries in scopein place at an executive or managerial level (for senior manage-of the Index. It publicly shares progress against such objectives,

ment or regional/in-country managers in countries in scope ofgoals and targets, as well as outcomes.

the Index.

5

The company publicly discloses its commitments to access to3 	The company has a board member or board-level committee

medicine, alongside targets, measurable goals, objectives, andresponsible for its access-to-medicine approach. There is no

outcomes (or plans to report outcomes when available) related

evidence of access-related incentives in place at an executive

to improving access to medicine in a consistent manner andor managerial level.

facilitates accountability and transparency by reporting targets

2 	The company has an executive manager or executive commit-

and outcomes directly on their website in a centralised mannertee, that directly reports to a board member or to a board-levelcommittee, responsible for its access-to-medicine approach.

with regular updates.
4

The company publicly discloses its commitments to access to

There is no evidence of access-related incentives in place at an

medicine, alongside targets, measurable goals, objectives, andexecutive or managerial level in countries in scope of the Index.

outcomes (or plans to report outcomes when available) related0 	The company has no board or executive level responsibility for

to improving access to medicine in a consistent manner andits access-to-medicine approach.

facilitates accountability and transparency by reporting targets
and outcomes, but reporting is not centralised or not updated

GA2 Access-to-medicine strategy
The company has an access-to-medicine strategy and demon-

regularly.
3

The company publicly discloses its commitment to access tostrates that it is integrated within its corporate strategy. The strat-

medicine, targets, and measurable goals, objectives, and out-

egy extends across the company’s portfolio and pipeline, within thecomes (centrally or non-centrally) related to improving accessIndex scope.
5

The company has a clear access-to-medicine strategy withto medicine, but not for all initiatives in which it is involved.
2

evidence of alignment with corporate/business strategy. It

medicine, targets, and measurable goals, objectives related toincludes measurable objectives to improve access to medicine.
The company demonstrates evidence that the strategy is inte-access to medicine.
1

The company publicly discloses commitments related to0

The company does not publicly disclose any of the above

grated through the application of it across the company’s portfolio and pipeline, within the Index scope.

The company publicly discloses its commitment to access toimproving access to medicine.
information.

234

Access to Medicine Index 2022 ▶ Appendices

GA4 Responsible promotional practices

5

The company has all of the above-mentioned elements in

by decoupling bonuses for sales agents from sales volumes only).

4

The company has 4 of the above-mentioned elements in place.

Further, it takes a voluntary approach to publicly disclose informa-

3

The company has at least 3 of the above-mentioned elements

2

The company has at least 2 of the above-mentioned elements

cal education, promotional activities, or other non-monetary values

1

The company has 1 of the above-mentioned elements in place.

directed at HCPs).

0

The company does not have any of the above-mentioned ele-

The company mitigates the risk of unethical sales practice (e.g.,place.

tion regarding actual transfers or its approach to transfers of value

in place.

to healthcare professionals in countries in the Index scope (e.g., payments for attending and/or speaking at events, continuing medi-

5in place.

The company takes a voluntary approach to publicly disclose

ments in place or does not disclose information.

information regarding actual transfers or its approach to transfers of value to healthcare professionals in countries in the Index

GA6 Incidence of breaches

scope. It has a policy to limit transfers of value to HCPs in coun-

The company has not been found to be the subject of negative legal

tries in scope. Sales agent incentives not driven exclusively by

rulings or settled cases for unethical marketing practices/corrupt

sales volume targets, and targets are not set at the individual

practices/ anti-competitive practices / misconduct in clinical trials

level.

in countries within the scope of the Index during the past two years.

3-4 The company publicly discloses information regarding actual5

criminal, civil or regulatory infractions in countries within thecare professionals in countries in the Index scope only whenscope of the Index during the past two years (pending cases,

required by law, regulation, or trade association. It has a policy

allegations and cases under appeal are not included).

to limit transfers of values to HCPs in countries in scope of the2

The company has not been the subject of any settlements fortransfers or its approach to transfers of value to health-3

The company has not been the subject of any criminal or civil

Index. Sales agent incentives are not driven exclusively by sales

infractions in countries within the scope of the Index, but it hasvolume targets, but some targets are set at the individual level.

been the subject of one breach of a code of practice in one of

The company publicly discloses information regarding actual

the countries within the scope of the Index.

transfers or its approach to transfers of value to health-2

The company has been the subject of more than one breach of0

The company has been the subject of at least one negative

care professionals in countries in the Index scope only whena code of practice in countries within the scope of the Index.

required by law, regulation, or trade association. There is apolicy to limit transfers of values to HCPs in coutnries in scoperuling or settlement in a country within the scope of the Index,

of the Index. Sales agent incentives are driven exclusively byover the period of analysis.

sales volume targets and targets are set at the individual level.
10

The company publicly discloses information regarding actual

GA7

Trade policy: IP and access to medicine

transfers or its approach to transfers of value to health-

The company publicly discloses its support of the policy flexi-

care professionals in countries in the Index scope only whenbilities intended to protect public health confirmed by the Doharequired by law, regulation, or trade association. It has no policy

Declaration on TRIPS and Public Health. Further, the company

to limit transfers of values to HCPs in countries in scope of theemploys an intellectual property (IP) strategy that is conducive

Index and sales agent incentives are driven (almost) exclusively

to access to medicine, operating in accordance with the interna-

by sales volume targets.

tional consensus on IP standards as it pertains to public health, con-

The company makes no disclosure regarding its approach tofirmed by the Doha Declaration. This is evidenced by an absence oftransfers of values to HCPs nor does it disclose its approach to

IP-related anti-competitive practices in relation to access to medi-

incentives for sales agents.

cine in countries in scope.
5

GA 5 Compliance controls

Declaration and the usage of TRIPS flexibilities. There is no

The company demonstrates that it has robust controls in place toevidence-based information that the company is involved in

mitigate the risk of non-compliance in its operations in countries in

IP-related anti-competitive practices* in relation to access toscope of the Index (i.e. in the areas of ethical marketing, anti-corruption, and clinical trials), which include the following components:

medicines.
4

The company publicly discloses general support for the Dohaa) fraud-specific risk assessment;

Declaration and the usage of TRIPS flexibilities, though res-b) country risk-based assessment;

ervations on its provisions can be expressed. There is no evi-c) a live/continuous monitoring system for compliance (other thandence-based information that the company is involved in

auditing);d) auditing and review mechanisms, which involve the use of bothinternal and external resources, apply to all third parties and all
countries where it has operations, based on risk assessment;e) formal processes in place to ensure compliance with these standards by third parties and the company demonstrates that it takes
enforcement action for non-compliance in countries in scope of
the Index.

235

The company publicly discloses support for the Doha

IP-related anti-competitive practices* in relation to access to
medicines.

Access to Medicine Index 2022 ▶ Appendices3

The company publicly discloses general support for the Doha
Declaration and the usage of TRIPS flexibilities, though reservations on its provisions can be expressed. However, it has
been involved in one IP-related anti-competitive practice* via
industry associations.

2

The company does not publicly support the Doha Declarationand the usage of TRIPS flexibilities and has been involvedin one IP-related anti-competitive practice* via industry
associations.

1

The company has been involved in more than one IP-related
anti-competitive practice* via industry associations.

0

The company has been directly involved in anti-competitive
IP-related practices*.

*Patenting in Least Developed Countries, lobbying against the usage of TRIPS
flexibilities by country governments within the Index scope (including throughtrade associations), lobbying for strengthening of IP standards beyond TRIPS incountries within the scope of the Index, evergreening.

236

Access to Medicine Index 2022 ▶ Appendices
B RESEARCH & DEVELOPMENT 30%
Indicator
R D1A

R&D pipeline: Prioritised diseases

2

The company has a structured process in place to develop

The company engages in the development of products that target

access plans for a subset of its R&D projects targeting dis-priority product gaps identified by global health research organi-eases and countries within the scope of the Index. The pro-sations.* This includes both innovative and adaptive R&D and bothcess includes consideration of different plans for different

in-house and collaborative R&D.

product types, disease targets and target populations.

5-1 The total size of each company's 'priority R&D' pipeline

1

within the scope of the Index that targets an externallyaccess-oriented principles for its R&D projects targeting dis-defined R&D gap from Policy Cures Research and/or WHO,eases and countries within the scope of the Index.

scaled across all companies and scored.
0

The company has a general process in place to include

0

The company has no projects within the scope of the Index

The company has no processes in place in this area or applies
access planning on an ad hoc basis.

in its research pipeline for which it targets specific needs incountries in scope as defined by Policy Cures Research and/

R D3A

The company provides evidence that its R&D projects for diseases*Currently, R&D priorities are categorised using lists from WHO and Policy
Cures Research.

R D1 B

Planning for access: Project-specific plans for prioritised
diseasesor WHO.

prioritised by WHO and Policy Cures Research are supported bydetailed commitments and strategies to improve access to prod-

R&D Pipeline: Other diseases

ucts in countries within the scope of the Index.

The company engages in the development of products that

5-1 The company’s late-stage R&D projects that meet externallyaddress a clear need in LMICs beyond the R&D priorities identi-

defined priorities identified by Policy Cures Research and/or

fied by global health research organisations.* This includes innova-

WHO are assessed on the breadth and depth of access plans

tive and adaptive R&D that, for example, addresses heat stability

in place for these projects, scaled across all companies andissues, targets populations for which further studies/specific for-scored.

mulations are needed (such as children and pregnant women, etc.)

0

The company provides no evidence of access plans for any

as determined by stakeholder consensus.

late-stage R&D projects that meet externally defined prior-

5-1 The total size of each company's pipeline that does not target

ities within the scope of the Index. Nor does it provide evi-

externally defined R&D gaps from Policy Cures Researchdence of any partnerships with access-oriented organisations

and/or WHO but meets stakeholder-informed criteria of pos-

for these projects.

sessing product characteristics or target populations that arehighly relevant to patients living in countries in scope, scaled0

Planning for access: Project-specific plans for other diseases
The company provides evidence that its R&D projects for dis-

The company has no projects within the scope of the Index ineases not prioritised by WHO and Policy Cures Research (but are

its research pipeline that meets stakeholder-informed criteria

deemed by the Index to have a public health in LMICs) are sup-of possessing product characteristics or target populations

ported by detailed plans to improve access to products in coun-that are highly relevant to patients living in countries in scopetries within the scope of the Index.

*Currently, R&D priorities are categorised using lists from WHO and Policy
Cures Research.

R D2

R D3 B

across all companies and scored.

5-1 The company’s late-stage R&D projects that do not meetexternally defined R&D priorities but do meet stakeholder-informed criteria of a clear relevance to patients in countries inPlanning for access: Structured framework

scope are assessed on the breadth and depth of access plans

The company has a process through which equitable access isin place for these projects, scaled across all companies andplanned for products successfully developed both in-house andcollaboratively.
5late-stage R&D projects that do not meet externally defined

to develop access plans during development for all its R&Dpriorities but do meet stakeholder-informed criteria of a

projects (both in-house and collaborative) targeting diseases

clear relevance to patients in countries in scope. Nor does it

and countries within the scope of the Index. The processprovide evidence of any partnerships with access-oriented

includes consideration of different plans for different productorganisations for these projects.

are initiated no later than Phase II of development.
The company has a structured process in place and commits
to develop access plans during development for all its R&D
projects (both in-house and collaborative) targeting diseases
and countries within the scope of the Index. The processincludes consideration of different plans for different producttypes, disease targets and target populations.

237

The company provides no evidence of access plans for any

The company has a structured process in place and commits

types, disease targets and target populations. Access plans
4

scored.
0

Access to Medicine Index 2022 ▶ Appendices

RD4

Disclosure of resources dedicated to R&D

RD6

Capacity building in R&D

The company publicly discloses the resources dedicated to its

The company increases local capacity for health research (includ-R&D activities which are conducted in-house and/or in collabo-

ing clinical trial capacity) and product development by undertak-

ration for diseases within the scope of the Index and suitable foring R&D capacity building initiatives in partnership with local uni-countries relevant to the Index.

versities and public sector research organisations in countries

5

The company publicly discloses its R&D investments, disag-within the scope of the Index. The Index assesses whether these

gregated at least at the following levels: disease, project andinitiatives meet all Good Practice Standards.*

phase of development.

5

3

The company publicly discloses its R&D investments dis-

initiatives that meet inclusion criteria, of which at least threeaggregated to some degree: disease category, producttype, aggregated phase of development (e.g., clinical versus

2

meet all Good Practice Standards.
4

ing initiatives that meet all inclusion criteria and all Good

gregated R&D investment data to organisations that present

Practice Standards OR the company provides evidence ofanonymised aggregate data for global health purposes, such

four R&D capacity building initiatives that meet inclusion cri-as Policy Cures Research.

teria, of which at least two meet all Good Practice Standards

The company publicly discloses its R&D investments dis-

OR the company provides evidence of five R&D capacity

aggregated to some degree: disease category, productbuilding initiatives that meet inclusion criteria, of which two

pre-clinical) etc.

meet all Good Practice Standards.
3

The company provides evidence of one to five R&D capac-

The company does not publicly disclose R&D investment data

ity building initiatives, of which one meets all Good Practicethat has been disaggregated at any level. However, it volun-

Standards OR the company provides evidence of two or

tarily discloses disaggregated R&D investment data to organ-

three R&D capacity building initiatives of which two meet all

isations that present anonymised aggregate data for global
health purposes, such as Policy Cures Research.
0

The company provides evidence of three R&D capacity build-

pre-clinical) etc. and the company voluntarily discloses disag-

type, aggregated phase of development (e.g., clinical versus
1

The company provides evidence of five R&D capacity building

Good Practice Standards.
2

The company does not publicly disclose R&D investment databuilding initiatives that meet inclusion criteria, of which nonethat has been disaggregated at any level and does not contribute data to Policy Cures Research.

The company provides evidence of at least two R&D capacity
meet all Good Practice Standards.

1

The company provides evidence of one R&D capacity building
initiative that meets inclusion criteria, but it does not meet all
Good Practice Standards.

0

The company does not provide any examples of R&D capacity building initiatives that meet all inclusion criteria.

*Has a good governance structure in place, has goals aligned with or support
institutional goals, measures progress or outcomes, aims for sustainability andlong-term impact.

238

Access to Medicine Index 2022 ▶ Appendices
C PRODUCT DELIVERY 55%
Indicator
PR1

Registration

PP2 B

Access strategies: Long-term donation programmes

The company files to register its most recently launched products*

The company engages in long-term, sustainable product donation

targeting diseases within the scope of Index in countries withinprogrammes for diseases where elimination, eradication or con-scope that have the highest disease burden.

trol goals are possible and publicly commits to the achievement of

5

The company filed all of its products in scope for registrationsuch goals.

in a majority of countries with the highest disease burden

5

and in a majority of countries in scope of the Index.

one long term donation programme for the achievement of

4-1 Scaled compared to peers. Number of newer products** thatelimination, eradication, or control goals with no time limit.

are filed for registration in number of countries with the high-3

est disease burden and in a number of countries in scope.

trol goals for a time-limited period.

number of countries with the highest disease burden and in a1

number of countries in scope of the Index.

The company is engaged in donation programmes which support elimination, eradication or control, but makes no public

The company provides no evidence of filing to register any ofcommitment regarding this engagement.

its products in scope that target diseases in the Index scope

NS Companies without structured donation programmes receive

in any countries in scope.
*Most recently launched refers to the date the product was first approved tobe marketed anywhere globally. The Index analyses information for up to 10 of
the company’s most recently launched products, depending on the size of thecompany’s portfolio.
**Newer product refers to a product that was first approved to be marketed in
the last 5 years anywhere globally, that targets diseases within scope.
***Older product refers to a product that was first approved to be marketedwithin the last 5 to 20 years anywhere globally, that targets diseases within
scope.

The company publicly commits to engage in long term donation programmes to support elimination, eradication, or con-Number of older products** that are filed for registration in0

The company publicly commits to remain engaged in at leasta neutral score. Moreover, companies with structured donation programmes that have no elimination, eradication, or
control goals also receive a neutral score.
PP3

Access strategies: Supranational products
The company applies access strategies to the products for which
it has marketing rights and that are supranationally procured*,through engaging with international procurers, advanced market
commitments etc. The company extends those strategies to coun-

PP2 A

Access strategies: Ad hoc donations

tries graduating from development assistance or countries that do

The company has policies and supply processes in place to ensure

not qualify for such assistance.

ad hoc donations* are carried out rapidly in response to expressed

5company meets all following criteria:

5

The company meets all of the following criteria with respecta) it applies equitable pricing strategies, takes affordability

to ad-hoc donations: a) it has policies/agreements/supply

into account and demonstrates using demographic and eco-processes in place to ensure all of its ad hoc donations

nomic factors to determine the price per programme;

are carried out rapidly in response to expressed needs; b)b) it applies the same terms of the supranational agreement

Company or its partners have policies/processes in place toin countries that do not qualify for assistance from these

ensure monitoring of the delivery of donations until receipt

mechanisms, or are/have graduated from these programmes;by the end-user, being the patient.

c) it applies additional non-pricing initiatives to maximize the

2.5 The company has policies/agreements/supply processes ind) it provides evidence to demonstrate how this approach

idly in response to expressed needs. However, neither thehas increased or is planned to increase the number ofensure monitoring of the delivery of donations until receipt
0reach across different segments of the population;

place to ensure all of its ad hoc donations are carried out rapcompany nor its partners have policies/processes in place topatients reached in the countries covered.
4-1 For a subset of its supranationally products in scope, theby the end-user, being the patient.

company meets a number of the following criteria:

The company meets none of the following criteria witha) it applies equitable pricing strategies, takes affordability

respect to ad hoc donations: a) it has policies/agreements/

into account and demonstrates using demographic and eco-supply processes in place to ensure all of its ad hoc donations

nomic factors to determine the price per programme;

are carried out rapidly in response to expressed needs; b)b) it applies the same terms of the supranational agreement

Company or its partners have policies/processes in place toor equitable access strategies in countries that do not qual-

ensure monitoring of the delivery of donations until receipt

ify for assistance from these mechanisms, or are/have gradu-by the end-user, being the patient.
*A gift of products for which there is no clear, defined long term strategy tocontrol, eliminate or eradicate a disease. This may include a company donating a range of medicines based on explicit needs of a country. Donations madeduring emergency situations, such as conflicts and natural disasters, are also
included here.

239

For all its supranationally procured products in scope, theneed.

ated from these programmes;c) it applies additional non-pricing initiatives to maximize thereach across different segments of the population;

Access to Medicine Index 2022 ▶ Appendicesd) it provides evidence to demonstrate how this approach has

4-1 For a subset of its healthcare practitioner-administered prod-

increased or is planned to increase the number of patients0

ucts in scope, the company meets X number of the following

reached in the countries covered by these programmes.

criteria in X number of selected countries:

For its supranationally procured products in scope, the com-a) it applies pricing strategies that take ability to pay perpany meets none of the above listed criteria.

payer types into account, within different segments of the

NS Companies without products that are supranationally pro-

population. It provides evidence that demographic and economic factors are considered to set the prices in the public

cured receive a neutral score.

and/or private sectors;
For this indicator, a maximum of five products was evaluated perb) it applies additional non-pricing initiatives to maximize thecompany, and identified using criteria such as either on-patent orreach across different segments of the population;

off-patent, on EML and high market share. Companies received anc) it provides evidence to demonstrate how this approach has

opportunity to verify and adjust as appropriate.

increased or is planned to increase the number of patientsreached in the countries’ examples selected;*Products for which international procurement, advanced market commitments or market-shaping facilities exist. These products include vaccines andproducts indicated for the treatment of HIV, tuberculosis, malaria and otherneglected tropical diseases. Companies which do not market these products
will not have this indicator applied to them.
For this indicator, a maximum of five products was evaluated per company,
and identified using criteria such as either on-patent or off-patent, on EML andhigh market share. Companies received an opportunity to verify and adjust as
appropriate.

PP4d) It applies initiatives to boost the health system's strength
to improve the availability of the products.
0

For its healthcare practitioner-administered products inscope, the company meets none of the above listed criteria.

NS Companies without healthcare practitioner-administeredproducts receive a neutral score.
*The characteristics of a population such as age, sex, income level, educationlevel, employment, etc.
**Healthcare practitioner-administered products are products that typicallyrequire either hospital administration of the product or the continued attention of a skilled healthcare professional for administration, such as an intravenously administered oncology medicine. Companies who do not market theseproducts will not have this indicator applied. For this indicator, a maximum of
five products was evaluated per company, and identified using criteria suchas either on patent or of patent, on EML and high market share. Companies
received an opportunity to verify and adjust as appropriate.

Access strategies: Healthcare practitioner-administeredproducts
The company takes into consideration both the relevant payer(s) ability to pay and the demographic* factors of a country to
determine its access strategy, with the aim to increase the reachof its healthcare practitioner-administered products** across theincome pyramid.
This is evidenced by:a) an approach which demonstrates how pricing strategies incor-

PP5

Access strategies: Self-administered products

porate factors which determine payer’s ability to pay for dif-

The company takes into consideration both the ability-to-pay offerent segments of the population (e.g., patients paying out ofthe payer and the demographic* factors of a country to deter-

pocket) and non-pricing initiatives (i.e., patient assistance pro-mine its access strategy, with the aim to increase the reach ofgrammes, donations, voluntary licensing, technology transfer,

its healthcare practitioner-administered products** across thehealth systems strengthening initiatives) complement thoseincome pyramid.

pricing strategies to maximize reach, andThis is evidenced by:b) evidence of how the approach has increased the patienta) an approach which demonstrates how pricing strategies incor-

number since the product was introduced, andporate factors which determine payer’s ability to pay for dif-c) plans to increase patient numbers for the following X years, andferent segments of the population (e.g., patients paying out ofd) it applies initiatives to boost the health system's strength topocket) and non-pricing initiatives (i.e., patient assistance programmes, donations, voluntary licensing, technology transfer,

improve the availability of the products.

health systems strengthening initiatives) complement those5

For all its healthcare practitioner-administered products inscope, the company meets all the following criteria for thepricing strategies to maximize reach, andb) evidence of how the approach has increased the patient

countries' examples selected:a) it applies pricing strategies that take into account the abil-

number since the product was introduced, andc) plans to increase patient numbers for the following X years.

ity to pay, per payer types within different segments of the
population. It provides evidence that demographic and economic factors are considered to set the prices in the public

For all its self-administered products in scope, the company
meets all the following criteria for the countries' examples

and/or private sectors;

selected:b) it applies additional non-pricing initiatives to maximize thea) it applies pricing strategies that take ability to pay perreach across different segments of the population;

payer types into account, within different segments of thec) it provides evidence to demonstrate how this approach has

population. It provides evidence that demographic and eco-increased or is planned to increase the number of patients

nomic factors are considered to set the prices in the publicreached in the countries’ examples selected;

and/or private sectors;d) it applies initiatives to boost the health system's strength
to improve the availability of the products.

240

5

Access to Medicine Index 2022 ▶ Appendicesb) it applies additional non-pricing initiatives to maximize the1

The company makes a public commitment not to patent, notreach across different segments of the population;

to enforce, or to abandon existing patents for a subset ofc) it provides evidence to demonstrate how this approach has

products in scope of the Index and/or in a specific region or

increased or is planned to increase the number of patients

regions (e.g., some LDCs and/or LICs).

reached in the countries’ examples selected.

0

The company makes no commitment in this area.

4-1 For a subset of its self-administered products in scope,
the company meets X number of the following criteria in X

PPL2

Patent status disclosure

number of selected countries:

The company publicly discloses the patent status of its productsa) it applies pricing strategies that take ability to pay perfor diseases relevant to the Index.

payer types into account, within different segments of the5

on-patent products within the Index scope. This informa-nomic factors are considered to set the prices in the publiction is updated periodically, and the standard of transparency

and/or private sectors;

achieved is analogous to or greater than that set out by theb) it applies additional non-pricing initiatives to maximize the

US FDA’s Orange Book* (expiry date of the patent included).

reach across different segments of the population;

0

The company publicly discloses the patent status for all

population. It provides evidence that demographic and eco-4

The company publicly discloses the patent status for a subsetc) it provides evidence to demonstrate how this approach hasof the on-patent products, within the Index scope. This infor-

increased or is planned to increase the number of patientsmation is updated periodically, and the standard of transpar-

reached in the countries’ examples selected.

ency achieved is analogous to or greater than that set out by

For its self-administered products in scope, the company

the US FDA’s Orange Book.

meets none of the above listed criteria.

Also, companies that disclose patent status for all on-patentproducts even if the standard of transparency achieved falls*The characteristics of a population such as age, sex, income level, educationlevel, employment, etc.
**Healthcare practitioner-administered products are products that typicallyrequire either hospital administration of the product or the continued attention of a skilled healthcare professional for administration, such as an intravenously administered oncology medicine. Companies who do not market theseproducts will not have this indicator applied. For this indicator, a maximum of
five products was evaluated per company, and identified using criteria suchas either on patent or of patent, on EML and high market share. Companies
received an opportunity to verify and adjust as appropriate.

shorts of that set out by the US FDA’s Orange Book.
3

The company publicly discloses the patent status for a subsetof the on-patent products, within the Index scope. This information is updated periodically, but the standard of transparency achieved is less than that set out by the US FDA’s
Orange Book.

2

The company publicly discloses patent status for a subset ofthe on-patent products within the Index scope. There is no

PPL1

Patent filing & enforcement

evidence that this information is updated periodically, and the

The company publicly commits to not filing for or enforcing pat-standard of transparency achieved is less than that set out by

ents related to diseases within the Index scope in Least Developed

the US FDA’s Orange Book. OR only off-patent products are

Countries (LDCs), low-income countries (LICs), and a subset ofdisclosed.

lower-middle income countries (LMICs) and upper-middle income0

countries (UMICs).
5*The FDA Orange Book includes product patent data, patent number andexpiry date.

The company makes a public commitment not to patent, notto enforce, or to abandon existing patents relating to all products for diseases in scope of the Index in all LDCs, LICs, and a4

3

IP sharing
In addition to existing agreements, the company provides evi-

The company makes a public commitment not to patent, notdence of newly sharing its intellectual property (e.g., molecules

to enforce, or to abandon existing patents relating to all prod-

library, patented compounds, unpublished data) through agree-

ucts in scope of the Index in all LDCs, LICs, and a subset ofments with public research institutions and/or drug discovery ini-

LMICs. Or all LDCs, LICs and a subset of LMICs and UMICs for

tiatives (e.g., WIPO Re:Search, Medicines for Malaria Venture) toa subset of products.

accelerate R&D for developing products targeting diseases rele-

The company makes a public commitment not to patent, notvant to the Index. These agreements include terms conducive toto enforce, or to abandon existing patents relating to all prod-

enabling access to medicine in countries in the scope of the Index.

LMICs.
The company makes a public commitment not to patent, notto enforce, or to abandon existing patents relating to all products in scope of the Index in all LDCs and/or LICs.

241

PPL3

subset of LMICs and UMICs.

ucts in scope of the Index in all LDCs, a subset of LICs, and2

The company makes no public disclosure in this area.

Access to Medicine Index 2022 ▶ Appendices

5-2 The company has previously made available its intellec-

1

0

PQ1

Ensuring continuous supply

tual property through agreements with research institutions

The company has a process in place to ensure continuous supply

or drug discovery initiatives as described above and theseof all its products within the Index scope in low- and middle-in-agreements remain valid. In addition, the new agreements

come countries (LMICs) and works to improve local supply capac-

that each company has made during the period of analysis

ity in LMICs through technology transfers and strengthening

are weighted, added together, ranked and scored accordingly.

supply chains. This process includes the following elements:

The company has previously made available its intellec-a) Working with relevant stakeholders (e.g., government agencies,

tual property through agreements with research institutions

distributors, hospitals, warehouses, wholesalers or other rele-or drug discovery initiatives as described above and thesevant networks) to communicate issues that may affect the supply

agreements remain valid.

chain;

The company does not provide evidence of sharing its intel-b) Managing a safety stock of relevant finished products;

lectual property.

c) Working with several active pharmaceutical ingredient (API)suppliers and/or producing in-house APIs to prevent shortages;

PPL4

Access-oriented quality licensing; andd) Working to enhance local third-party supply capacities and

PPL 5

Licensing: Geographic scope

strengthen supply chains in LMICs; andThe company engages in voluntary licensing agreements to enablee) Transferring technology to third-party manufacturers in LMICs

the generic supply of products in their portfolio. Licences areto build manufacturing capacity and improve regional availability.

non-exclusive, transparent and include access-oriented clauses to5facilitate the affordable supply of quality products in wide range ofvides an example of implementing these activities to improvecountries in scope of the Index.
5

The company has elements (a) through (e) in place and prosupply in at least one country in scope of the Index.

4-1 The elements that the company does implement are added,

The company has at least one NEVL (non-exclusive voluntary
licensing) that includes most of the designated access-ori-

weighted and summed together and companies are scoredrelative to one another.

ented clauses* in the terms of the voluntary licences it has
0agreed for products relevant to the Index, in all the countries

The company does not have elements (a) through (e) in placeor does not disclose information about them.

of scope of the Index.
4-3 The company has at least one NEVL that includes x of thedesignated access-oriented clauses* in the terms of the vol-Reporting substandard and falsified medicines

untary licences it has agreed for products relevant to the

The company has a policy/protocol for reporting substandard andIndex, in x countries of scope of the Index.

falsified (SF) medicines in countries within the scope of the Index

2-1 The company has at least one voluntary licence (VL) that

0

PQ2

that specifies timeframes for reporting to relevant stakeholders

includes x of the designated access-oriented clauses* in the(i.e., national regulatory authorities and WHO Rapid Alert).

terms of the voluntary licences it has agreed for products rel-5

The company provides evidence of a policy or approach toevant to the Index, in x countries of scope of the Index.

report confirmed cases of SF medicines as soon as possible

Companies without any VL for patented products within theand within ten working days to WHO Rapid Alert and local

Index scope, considering that their portfolio contains relevant

regulatory authorities, when visual inspection (e.g., confirma-

products to pursue a VL.

tion of mislabelling, confirmation of fake packaging) is suf-

NS Companies without any VL for patented products within theficient to establish that the product packaging is falsified.

Index scope, with no relevant products for pursuing a VL in

In cases where laboratory analysis is required for confirma-

the portfolio.

tion of substandard or falsified medicines, the policy should*1. Licence agreed prior to or shortly after approval of originator product, 2.
ability to manufacture and source active pharmaceutical agreements without
restriction, 3. ability to supply countries where no granted patents are infringed(including where compulsory licences are issued), 4. optional provision fortechnology transfer, 5. absence of no challenge clauses, 6. provision to facilitate rapid registration of product, 7. inclusion of quality assurance measures inline with WHO requirements, 8. affordability in small markets (if applicable).

require reporting of cases of SF medicines as soon as possible and within ten working days once this confirmation
has taken place to WHO Rapid Alert and/or local regulatory
authorities.
4

The company provides evidence of a policy or approach toreporting confirmed SF cases to WHO Rapid Alert and/or
local regulatory authorities within ten days of the confirmation in countries within the scope of the Index.

3

The company provides evidence of a policy or approach toreporting SF cases to WHO Rapid Alert and/or local regulatory authorities but does not specify a reporting timeframe.

242

Access to Medicine Index 2022 ▶ Appendices20

The company provides evidence/examples to the Index of

PCB2

Capacity building in supply chains

reporting cases of SF medicines on a case-by-case basis,

The company engages in supply chain capacity building initia-

in countries within the scope of the Index, to relevanttives, addressing local needs of supply chain stakeholders (e.g.,authorities

ministries of health, procurement, logistics and distribution agen-The company does not provide evidence of such a policy orcies) in countries within the scope of the Index. These initiatives

approach or provide examples of reporting SF medicines.

build capacity beyond the company’s own supply chain. The Index
assesses whether these initiatives meet Good Practice Standards.*

PCB1

Capacity building in manufacturing

5

The company engages in manufacturing capacity building initia-

ity building initiatives that meet inclusion criteria, of which attives in partnership with third-party manufacturers in countries inscope of the Index. The Index assesses whether these initiatives

least three meet all Good Practice Standards.
4

The company provides evidence of three supply chain capac-

meet Good Practice Standards.*

ity building initiatives that meet all inclusion criteria and all

5

The company provides evidence of five manufacturing capac-

Good Practice Standards OR the company provides evi-

ity building initiatives that meet inclusion criteria, of which atdence of four supply chain capacity building initiatives thatleast three meet all Good Practice Standards.

meet inclusion criteria, of which at least two meet all Good

The company provides evidence of three manufacturing

Practice Standards OR the company provides evidence of

capacity building initiatives that meet all inclusion criteria andfive supply chain capacity building initiatives that meet inclu-

4sion criteria, of which two meet all Good Practice Standards.

all Good Practice Standards OR the company provides evidence of four manufacturing capacity building initiatives that3

capacity building initiatives, of which one meets all Good

Practice Standards OR the company provides evidence of five

Practice Standards OR the company provides evidence of

manufacturing capacity building initiatives that meet inclu-

two or three supply chain capacity building initiatives of

The company provides evidence of one to five manufactur-

which two meet all Good Practice Standards.
2

which none meet all Good Practice Standards.

Practice Standards OR the company provides evidence of
two or three manufacturing capacity building initiatives of1

which none meet all Good Practice Standards.
1

The company provides evidence of one manufacturing capacity building initiative that meets inclusion criteria, but it does
not meet all Good Practice Standards.

0

The company does not provide any examples of manufacturing capacity building initiatives which meet all inclusion
criteria.

*guided by clear, measurable goals and/or objectives; measures outcomes; haslong term aims/aims for sustainability.

The company provides evidence of one supply chain capacity
building initiative that meets inclusion criteria, but it does notwhich two meet all Good Practice Standards.

meet all Good Practice Standards.

The company provides evidence of at least two manufacturing capacity building initiatives that meet inclusion criteria, of

The company provides evidence of at least two supply chain
capacity building initiatives that meet inclusion criteria, ofing capacity building initiatives, of which one meets all Good2

The company provides evidence of one to five supply chain

meet inclusion criteria, of which at least two meet all Goodsion criteria, of which two meet all Good Practice Standards.
3

243

The company provides evidence of five supply chain capac-

0

The company does not provide any examples of supply chain
capacity building initiatives which meet all inclusion criteria.

*Is guided by clear, measurable goals and/or objectives; measures outcomes;
has long term aims/aims for sustainability

Access to Medicine Index 2022 ▶ Appendices

PCB3

Health systems strengthening

PB M 1

Inclusive business models

The company engages in health systems strengthening initiatives

The company has contributed to the development and implemen-in partnership with local stakeholders in countries within scope

tation of scalable inclusive business models done in partnershipof the Index, addressing local needs, with outcomes clearly meas-that aim to meet the access needs of populations at the base of

ured. The initiative has processes in place to mitigate or preventthe income pyramid* in countries within scope of the Index. For all

conflicts of interest. The Index measures whether these initiatives

models, the company discloses resources invested into the model

meet Good Practice Standards.*

and there is evidence of, or projections for financial sustainability.

5

5

4

The company provides evidence of five health systems

more inclusive business models during the analysis period

at least three meet all Good Practice Standards.

as described above and has scaled up one or more existing

The company provides evidence of three health systems

inclusive business models.

strengthening initiatives that meet all inclusion criteria and4business models as described above but has not contributed

dence of four health systems strengthening initiatives thatto the development of new inclusive business models during

Practice Standards OR the company provides evidence of fivethe analysis period.
3

more inclusive business models during the analysis period asmeet inclusion criteria, of which two meet all Good Practicedescribed above but has not scaled up any existing inclusive

The company provides evidence of one to five health systems strengthening initiatives, of which one meets all Good
Practice Standards OR the company provides evidence of
two or three health systems strengthening initiatives ofwhich two meet all Good Practice Standards.
The company provides evidence of at least two health systems strengthening initiatives that meet inclusion criteria, of
which none meet all Good Practice Standards.

1

The company provides evidence of one health systems
strengthening initiative that meets inclusion criteria, but it
does not meet all Good Practice Standards.

0

The company does not provide any examples of health systems strengthening initiatives which meet all inclusion
criteria.

*Has good governance structures in place; publicly discloses outcomes; haslong term aims or achieves integration within the health system.

244

The company has contributed to the development of one orhealth system strengthening capacity building initiatives that
Standards.

2

The company has scaled up one or more existing inclusive

all Good Practice Standards OR the company provides evimeet inclusion criteria, of which at least two meet all Good3

The company has contributed to the development of one orstrengthening initiatives that meet inclusion criteria, of whichbusiness models during the analysis period.
0

No inclusive business models identified in this area that met
inclusion criteria described above.

*This may include vulnerable populations (e.g. children, girls and women, men
who have sex with men, people living with HIV) that face additional barriers toaccess.

Access to Medicine Index 2022 ▶ Appendices

The 2022 Access to Medicine Index indicator weights

TABLE 8 2022 Access to Medicine Index indicator weights
Technical area

Indicator

Description%

Governance of Access

GA1

Governance structures & incentives

2.14

15%

GA2

Access-to-medicine strategy

2.14

GA3

Public disclosure of access-to-medicine outcomes

2.14

GA4

Responsible promotional practices

2.14

GA5

Compliance Controls

2.14

GA6

Incidence of breaches

2.14

GA7

Trade policy: IP and access to medicine

2.14

Research &RD1a

R&D pipeline: Prioritised diseases

6.75

Development

RD1b

R&D Pipeline: Other diseases

4.50

RD2

Planning for access: Structured framework

2.25

RD3a

Planning for access: Project-specific plans for prioritised diseases

5.25

RD3b

Planning for access: Project-specific plans for other diseases

5.25

RD4

Disclosure of resources dedicated to R&D

3.00

RD6

Capacity building in R&D

3.00

Product Delivery

PR1

Registration

5.00

55%

PP2a

Access strategies: Ad hoc donations

2.00

PP2b

Access strategies: Long-term donation programmes

4.00

PP3

Access Strategies: Supranational products

6.50

PP4

Access Strategies: Healthcare practitioner-administered products

6.50

PP5

Access Strategies: Self-administered products

6.50

PPL1

Patent filing & enforcement

2.00

PPL2

Patent status disclosure

1.50

PPL3

IP sharing

1.50

PPL4

Access-oriented quality licensing

Grouped with PPL5

PPL5

Licensing: Geographic scope

2.50

PQ1

Ensuring continuous supply

3.00

PQ2

Reporting substandard and falsified medicines

3.00

PCB1

Capacity building in manufacturing

3.00

PCB2

Capacity building in supply chains

3.00

PCB3

Health systems strengthening

3.00

PBM1

Inclusive business models

2.00

30%

245

Access to Medicine Index 2022 ▶ Appendices

APPE N D IX I I I

Identifying best practices
The diffusion of best practices is one of the Access to Medicine Index’s mechanisms for supporting the pharmaceutical industry in achieving greater access to
medicine. Similarly, recognising those companies trialling or scaling up innovative
unique-in-industry policies or initiatives is an important way of acknowledging
those companies prepared to stand out from peers and to risk new approaches.
B EST PR AC TI CE S

Best practices are ones that can be accepted as being the most effective way ofachieving a desired end, relative to what the industry is currently doing in that area
and what stakeholder expectations are. It can also be described as a benchmark.
Best practices are not new practices – they have already been conceived of, appliedand proven to meet at least some of the following criteria:• Sustainability;• Replicability;• Alignment with external standards/stakeholder expectations; and• Proven effectiveness.
In different areas of analysis (for example, in Research & Development vs. inGovernance of Access) how a best practice is identified may be different. A bestpractice need not be unique amongst companies. A best practice might be an
example of a ‘gold standard’ of practice; a best-in-class policy; or a strategy, programme, product initiative or group of behaviours closely aligned with stakeholder
expectations. Best practices should be considered as the exemplar of positive practices in the corresponding research area in comparison to those of the other companies that submitted data within the current period of analysis. These best practices are identified based on evidence of progress submitted in the data collection
period and verified with public information and through consultation with experts,
where appropriate.
PRO CESSTo determine which of the company’s practices would be highlighted as best practice, the Foundation’s research team evaluated all aspects of company practices,compiling those that met the criteria used for the purpose of scoring with additional standards for each Technical Area, where necessary. Practices that met theseoutlined criteria were reviewed and finalised by the Foundation’s senior management with additional input from experts in the corresponding field, when required.

246

Access to Medicine Index 2022 ▶ Appendices

APPE N D IX IV

The Good Practice Standards framework forcapacity buildingThis framework has been developed to convey stakeholders’ expectations forgood practice in capacity building. The framework is tailored for four subthemes ofcapacity building included in the Index and is comprised of six standards. All company initiatives are measured against this framework.
Good Practice Standards for initiatives:• Has good governance structures in place (including for mitigating or preventing
conflicts of interest)• Goals align with or support the partnered institutional goals• Guided by clear, measurable goals or objectives• Includes regular monitoring, evaluation of outcomes• Publicly shares outcomes, including approaches, progress and learnings• Has long term aims or achieves integration within the health system
There are three basic criteria that all initiatives must meet:1) be active during the period of analysis, 2) take place in a country/countries inscope of the Index and 3) address a clearly defined local need. Initiatives in all subthemes are expected to be done in partnership, save in manufacturing where there
may be a direct engagement with contracted third-party manufacturers. Healthsystems strengthening initiatives must also have processes in place to prevent
conflict of interest; have clearly defined, measurable goals and/or objectives; andmeasure outcomes in order to be eligible. Initiatives are excluded if they do notmeet all inclusion criteria, with excluded initiatives not being considered for scoringor further analysis. Initiatives that meet all inclusion criteria are assessed against
the remaining Good Practice Standards.

247

Access to Medicine Index 2022 ▶ Appendices

Capacity building initiative flowchart
The chart provides a guide to the criteria by which submitted company initiatives areincluded for analysis in the Index and the criteria by which they are analysed. The chart isbroken down by subtheme/area of capacity building. The expectations from stakeholders
vary slightly for each area based on the nature of the activities which typically fall withinthat area. This chart was developed as a tool for companies to guide them in selection of
their five initiatives per area during the data collection process.

Start

Is the initiative active during theperiod of analysis?
Yes

Does the initiative take place in a

Inclusion criteria

country/countries in the scope of
the Index?

Good practice standards
used for analysis

Exclude from
AnalysisNo

Yes

Does the initiative address
local needs?
Yes

Which subtheme?

R&D

Manufacturing

Partnership with local
university or publicresearch institution?

No

Yes

Must build capacity ofthird-party or
unaffiliated manufacturers or work withexternal parties (i.e.
local universities);
in-house capacity
building excludedNo

Supply Chain

Health System Strengthening

Initiative done inpartnership?
No
The initiative should
build capacity beyond
company’s own supply
chain

Initiative done in partnership?*
Yes
Initiative has processes in place to mitigate
or prevent conflict of interest

Initiative has clearly defined, measurable
goals and/or objectives

Yes

Goals align with or
support institutional goals

Initiative has clearly
defined, measurable goals
and/or objectives

Initiative has clearly
defined, measurable goals
and/or objectives

Initiative publicly
discloses outcomes

Initiative measuresoutcomes

Initiative measuresoutcomes

Initiative measuresoutcomes

Partnership has good governancestructures in place

Initiative has long term
aims/
aims for sustainability

Initiative has long term
aims/
aims for sustainability

Initiative has longterm aims/
aims for sustainability

Initiative has long term aims/achieves
integration within the system*Done with appropriate, relevant partners, including local partners

248

No

Yes
Initiative measures outcomes
Yes

DS2

No

Yes

Yes

Partnership has good
governance structures in
place

No

No

Access to Medicine Index 2022 ▶ Appendices

APPE N D IX V

Guide to Report Cards
The Guide to Report Cards provides a description of each section of the Report
Cards for the 2022 Access to Medicine Index.

SectionDescription

SourceGeneral information

Stock exchange ticker(s)Annual reports and/or the(heading)

Location of Headquarters

company’s website

Number of employees
Change since theThis section provides an update of the company’s access to-medicine performance since the2021 Index

2021 Index. It covers:(text)• New commitments

Index analysis• New, expanded, or unchanged strategies, activities and programmes• Areas in which the company continues to perform particularly strongly or poorly• Interesting developments, initiatives or activities that can influence access to medicine• Notable new developments that have influenced its performance in the Index.
Performance in theThis section explains the company’s position in the 2022 Index, while summarising its

2022 index

access-to-medicine performance. It covers:(text)

Drivers behind its ranking, including a breakdown of performance for the three technical areas

Index analysis

assessed by the Index.
Main areas where the company scores well or poorly compared to peers.
How score wasThis graph shows the company’s scores in each of the Index’s three Technical Areas, bench-achievedmarked against the industry average and the leader’s score in each area. The company’s overall(graph)score is calculated using a weighted combination of these scores.

Opportunities

This section outlines tailored opportunities for the company to improve access to medicine,(text)

taking account of company-specific characteristics, business models, strategies, policies andIndex analysis

Index analysis

practices, such as its access-to-medicine strategy, compliance system, R&D pipeline, productportfolio, equitable pricing strategies and approach to IP management, as captured in the 2022
Index. Opportunities are aligned to global health priority lists, such as those developed by organisations including the Medicines Patent Pool (MPP) and Access to Oncology Medicines Coalition,
as well as to World Bank/UNDP global burden of disease data.
Sales in countries

This figure shows the countries in scope in which the company has sales.

in scope

Raw data submission to theIndex(figure)Sales by geographical This figure shows a geographic breakdown of the company’s gross or net sales/revenue/turn-

Company financial statements

regionover over the last two to five years. Sales are broken down into the geographic distribution(graph)reported by the company is used.

Pipeline for dis-

The company’s R&D pipeline is described using the following factors: total number of the pipe-

Verified pipeline submitted byeases and countries

line projects, number of projects targeting R&D priorities (as defined by G-FINDER and othercompany and public sourcesin scope

global health organisations) and the number of R&D projects and the number of other (non-pri- such as clinicaltrials.gov(text)

ority projects).
In addition, the pipeline section describes the total number of late-stage projects (i.e. from
Phase II onwards) that target a priority disease or have value to LMICs (as per Access to
Medicine Index methodology) and the percentage of these which have access plans in place.
These numbers are derived from the verified pipelines submitted by companies. Please refer tothe accompanying document for more specific guidance on how these figures were calculated.

Portfolio as selected

The product portfolio section indicates the number of medicines on patent and number ofData sources for the productfor analysis by the

medicines included in the 2021 WHO Model List of Essential Medicines. The number of vac-

portfolio are products submit-

Indexcines, contraceptives, diagnostics and other (which includes vector control products and plat-ted by the company for scor-

form technologies), are also indicated. The disease category mainly covered by the off-patenting and analysis in the Index,

and on-patent medicines is also mentioned, as well as examples of the main diseases covered by as well as any registered prodthose products.

ucts identified from the FDA,

(See Appendix I for inclusion criteria of products)

EMA, PMDA, and the company’s website

249

Pipeline projects per

This figure shows the company’s pipeline projects broken down by Index disease categories.

Company pipeline datadisease category

The disease category ‘Multiple categories’ includes projects targeting more than one diseasesubmission(graph)category.

Access to Medicine Index 2022 ▶ Appendices

Breakdown of pipe-

This figure shows the breakdown of active pipeline projects per phase of development. Projects Index analysis of products sub-line projects

fall into three categories:

mitted by the company for(graph)(1) Priority R&D;

scoring and analysis in the(2) Projects with value to LMICs;

Index(3) Other: The remaining projects in the company pipeline that do not fall into categories (1) and(2).
The ‘approval' phase of development in this figure also includes projects with ‘registration’ as
the phase of development.
Products per disease

This figure shows the total number of products in the company’s portfolio within the disease

Products submitted by thecategory

scope of the Index, broken down by Index disease categories. The disease category ‘Multiple

company for scoring and anal-(graph)categories’ includes medicines that are indicated for multiple diseases within the Index scope

ysis in the Index, as well as any

and that cover multiple disease categories (e.g., broad spectrum antibiotics). Contraceptive

registered products identified

methods and devices are included under maternal and neonatal health conditions.

from the FDA, EMA, PMDA, andthe company’s website

Breakdown ofThis figure shows the total number of the company’s products within the scope of the Index,

Products submitted by the­products (graph)broken down by type of products: medicines (on- and off-patent), vaccines, diagnostics, con-company for scoring and anal-

traceptives and other (which includes vector control products and platform technologies). In

ysis in the Index, as well as any

addition, the figure indicates number of products included in the WHO Model List of Essential

registered products identified

Medicines (2021).

from the FDA, EMA, PMDA, andthe company’s website

250

Performance byThis section outlines a detailed breakdown of company performance for each indicator in the­technical area (text)

three Technical Areas; Governance of Access, Research & Development and Product Delivery.

Index analysis

Access to Medicine Index 2022 ▶ Appendices

APPE N D IX VI

Definitions
Access plans

Adaptive product R&D

Working definition, used for analysis

Working definition, used for analysis

Plans to ensure that public health needs are taken into

The adaptation of existing/registered New Chemical Entities

consideration during R&D. Access plans can be developed(NCEs), New Biological Entities (NBEs) or other relevant

in-house or in collaboration and include commitments andmedicines, therapeutic and preventative vaccines, diagnostics,

strategies as well as more concrete access provisions: agreed-

vector control products, microbicides or other health prod-

upon measures typically developed in partnership to enforce

ucts that may address an unmet need in countries in scope,accountability. These plans facilitate availability, accessibilitye.g., new demographic segments (e.g., infants/children, preg-and affordability for patients in countries within the scope ofnant women), environmental conditions (e.g., heat-resistantthe Index (e.g., registration commitments, equitable pricing

formulations) or new formulations (e.g., oral formulations).

strategies, sufficient supply commitments, non-exclusive in
specified territories, waiving patent rights, royalty-free provi-

Affordability

sions and applying for WHO prequalification).

Working definition, used for analysis
A measure of the payer’s ability to pay for a product (whether

Access initiatives

or not they are the end user). The Index takes this into

Working definition, used for analysis

account when assessing pricing strategies for relevant prod-

An access initiative - within the context of the Access to

ucts. Pharmaceutical companies use many different criteria to

Medicine Index - is an initiative a company is involved in whichassess affordability.

seeks to address access to medicine constraints in low- andmiddle-income countries. This may or may not be in partner-

Base of the income pyramidship with others and may or may not involve improving access

The base of the income pyramid, also referred to sometimes

to specific pharmaceutical products. Where access initiatives

as the working poor, designates the people living on less thanrelate to products, it may be either an equitable pricing strat-

USD 8 a day.

egy, a non-exclusive voluntary licensing approach, technology
transfer or structured donation programme. Examples ofCompliance controls

access initiatives which do not involve products include, e.g.,

Working definition, used for analysis

awareness-raising activities in health system strengthening.

Compliance controls evaluated in the Index are processes

Where products are involved in an access initiative, this will

and structures aimed at minimising the risk of occurrence of

be clearly identified within the text of the Access to Medicine

non-compliant activities and/or behaviour of the company’s

Index report.

employees and, if applicable, the third parties the company
formally engages with across its operations in low- and mid-

Access-to-medicine strategy

dle-income countries.

Working definition, used for analysis

These processes include:

A strategy specifically intended to improve access to medicine,• Fraud-specific risk assessment to pro-actively identify vul-that includes all the typical elements of a strategy (a clear
rationale, targets, objectives and expected outcomes). In lowand middle-income countries where the company operates,
the strategy may apply to a defined set of diseases, products
or therapeutic areas, or to the whole pipeline and portfolio.

nerabilities for fraud and actual cases;• Auditing and review mechanisms conducted by external,
independent specialists, applying to third parties in all countries the company is operating;• A live/continuous monitoring system for compliance, otherthan financial auditing, to continuously monitor activities to

Ad hoc donation programmesWorking definition, used for analysis
A gift of products for which there is no clear, defined longterm strategy to control, eliminate or eradicate a disease. Thisfor noncompliant or corrupt activities in countries in scope
where the company is operating; andmay include a company donating a range of medicines based• Processes to ensure third party compliance (including e.g.,on the explicit needs of a country. Donations made duringcontractual agreements, training on codes of conduct).

emergency situations, such as conflicts and natural disasters,
are also included here.

251

detect discrepancies;• Country risk-based assessments to identify vulnerabilities

Access to Medicine Index 2022 ▶ Appendices

Budget impact

Good Practice Standards

Working definition, used for analysis

Working definition, used for analysis

An estimated measure of the cost of treatment with aA set of six standards that encompass good practice in capac-

given therapy for a given number of patients in a specificity building initiatives. These standards form a framework

population.

used for the assessment of company capacity building initiatives. See appendix IV for more information on Good Practice

Conflict of interest

Standards.

A conflict of interest is the conflict that arises when the commercial interests of a company are potentially at odds with

Healthcare practitioner-administered products

the interests of the partnership, the partner (i.e., local stake-Working definition, used for analysis

holders), or the health and well-being of the population the

Products that typically require either hospital administration

partnership intends to help.

of the product or the continued attention of a skilled healthcare professional for administration, such as an intravenously

Demographic factors

administered oncology medicine.

Working definition, used for analysis
Characteristics of a population such as age, sex, income level,

Innovative product R&D

education level, employment, etc.

Working definition, used for analysis
The development of New Chemical Entities (NCEs), New

Equitable pricing strategy

Biological Entities (NBEs) or other medicines, therapeutic andWorking definition, used for analysis

preventive vaccines, diagnostics, vector control products andA targeted pricing strategy which aims at improving accessmicrobicides which have not previously been approved forto medicine for those in need by taking the abilities to pay ofuse.

individuals and healthcare systems into account in a mannerthat is locally appropriate.

National reimbursement authority
Working definition, used for analysis

Ethical marketing

Governmental bodies with the authority to control, approve

Promotional activities that are aimed at the general public,

and determine pricing and reimbursement of medicinal prod-

patients, healthcare professionals/students and opinion lead-

ucts in a country.

ers in such a way that transparency, integrity, accuracy, clarity
and completeness of information can be ensured.

Non-exclusive voluntary licences
Working definition, used for analysis

Fair market value assessment

Non-exclusive voluntary licences are defined as the licences

Working definition, used for analysis

which enable - on a non-exclusive basis, and according toFair market value assessments define the appropriateness ofthe terms of the licence agreed - the manufacture andpayments made to healthcare professionals. These provide

supply of generic versions of patented medicines by otherstructure to ensure ethical interactions between the pharma-

manufacturers.

ceutical industry and HCPs they engaged with.
Non-pricing initiatives
Falsified medicine

Working definition, used for analysis

Medical products that deliberately/ fraudulently misrepresent

Actions taken to increase the number of patients reachedtheir identity, composition or source. [Definition from WHO,

through access methods other than price. Non-pricing initia-

2017]

tives applied may include, but are not limited to, non-exclusive
voluntary licensing, donations partnering with governments,

Good governance structures

patient assistance programmes, non-assert declarations,

Working definition, used for analysis

technology transfer and health systems strengthening

Good governance structures include three components: 1) the

initiatives.

structures put in place which establish clear roles, responsibilities and decision-making structures; 2) the systems ofcommunications whereby information is regularly conveyed
to all concerned; and 3) the transparency and accountability
for processes, decisions and outcomes of initiatives.

252

Access to Medicine Index 2022 ▶ Appendices

Outcomes

Substandard medical productsWorking definition, used for analysis

Also called ‘out of specification’, these are authorized medical

Outcomes are the results achieved by a company’s access-re-

products that fail to meet either their quality standards orlated activities. These can include short-term (e.g., an

specifications, or both. [Definition from WHO, 2017]

increased proportion of people with more knowledge on
diseases, symptoms or treatments) and/or medium- to long-

Supranationally procured products

term outcomes (e.g., patients retained in care; number ofWorking definition, used for analysis

patients diagnosed after community awareness and linkage

Products for which international pooled procurement,

to care programmes; availability of medicines at outlets).

advance market commitments, market-shaping facilities andOutcomes can also reflect on the country health system (e.g.,significant public funding and donor support exist. These

number of healthcare professionals trained).

products include vaccines and products indicated for thetreatment of HIV, tuberculosis, malaria, neglected tropical dis-Patient Assistance Programmes

eases and Maternal and Neonatal Health Conditions.

Working definition, used for analysis
Patient assistance programmes are defined as programmes

Structured donation programmes

initiated by pharmaceutical companies which provide financial

Working definition, used for analysis

assistance or free-of-charge medicines for a defined patient

A gift of products for which a defined strategy exists as to the

population with limited ability to pay.

type, volume and destination of donated products. Structured
donation programmes are long-term, targeted donation pro-

Period of analysis

grammes based on country needs, usually targeted to control,

For the 2022 Index, the time period for which data will beeliminate or eradicate a disease.

analysed covers company activities which must be ongoing
between 1 June 2020 and 31 May 2022, as this is the cycle ofVulnerable populations

the Index. Projects that have ended before 1 June 2020 are

Working definition, used for analysis

not included.

Vulnerable populations represent people at greater risk offacing stigma and additional barriers to access due to social,

Post-trial accesseconomic or health considerations. These populations are

The continued provision of treatment to clinical trial partici-

also disproportionately represented at the base of the income

pants who still require an intervention following the close ofpyramid. These can include, but are not limited to, children,the clinical trials in which they participated.

girls and women, members of the LGBTQIA+ community,
people living with HIV, etc.

Priority R&D
Working definition, used for analysis
R&D that addresses product gaps that are needed by people
living in low- and middle-income countries due to ineffective,
maladaptive or non-existent products for certain diseases,
conditions and pathogens in the scope of the Index. These
product gaps are defined as being those listed in a seriesof six priority lists developed by WHO and Policy Cures
Research, an independent research group.
Private sector
Working definition, used for analysis
Private sector refers to payer types such as private insurance
and patients paying out of pocket.
Self-administered productsWorking definition, used for analysis
Self-administered products are defined as those products
which patients can typically take or administer to themselves
without needing a skilled healthcare worker for regular usage.
These products may or may not be prioritised by governments or by the global health community (e.g., treatments
for non-communicable diseases such as diabetes, stroke andheart disease).

253

Access to Medicine Index 2022 ▶ Appendices

APPE N D IX VI I

Figures
13

Figure 1 Ranking per Technical Area

15

Figure 2 Just five of the 20 companies engage in R&D for49

emerging infectious diseases other than COVID-19
16

Figure 3 R&D pipeline empty for most emerging infectious

activity50

diseases17

Figure 4 Use of voluntary licences has increased, primarily due to
Figure 5 More companies now engage in voluntary licensing

18

Figure 6 Technology transfers for COVID-19 products areconcentrated in just a few of the 108 countries in scope of the50

Figure 7 Six companies now plan for access for all late-stage

Figure 31 R&D activity for NTDs such as leishmaniasis,onchocerciasis and Chagas disease decreases

50

Figure 32 Limited change in companies’ focus on R&D for priority
diseases

51

Index
19

Figure 30 HIV/AIDS and COVID-19 draw more R&D attention,
number of projects targeting NTDs decreases

new agreements for COVID-19 and cancer compounds
17

Figure 29 Progress in implementing a comprehensive set ofcompliance controls to prevent corrupt and non-compliant

Figure 33 More late-stage R&D projects have access planscompared to previous years

52	Figure 34 Percentage of products covered by access strategies in

products

upper-middle, lower-middle, and low-income countries

19

Figure 8 More R&D projects now covered by access plans- Healthcare practitioner-administered products

20

Figure 9 Products covered by an access strategy in at least one
upper-middle, lower-middle, and low-income country

20

Figure 10 Two thirds of products scope of this analysis* are notcovered by any access strategies in low-income countries

23

24

53
53
54

26

health systems strengthening initiatives have stagnated54

Figure 15 Technology transfers for COVID-19 are focused in India,
Brazil and South Africa

30

54

36

38

43
44
48
48

55

Figure 17 Almost all SRHR-related pipeline projects are directed

58

Figure 42 Governance of Access Ranking

towards cancer types, HIV/AIDS and hepatitis B

59

Figure 43 Do companies have strong access-to-medicine

Figure 18 Almost all SRHR priority projects in the pipeline are

strategies in place?

directed towards HIV/AIDS and hepatitis B, while many other59

diseases remain unaddressed

60

Figure 19 Number of registration filings in LMICs for SRHRrelated products defined as “essential” by the World Health60

Organization

60

Figure 20 Engagement in capacity building for SRHR varies

Figure 47 How are companies reporting progress on their access-61

Figure 48 How do companies monitor compliance?

Figure 21 Inclusive business models cover multiple SRHR-related

63

Figure 49 Research & Development Ranking

disease areas and health needs

65

Figure 22 Progress in number of companies with direct board65

Figure 23 Small increase in the number of companies with access

65

Figure 24 Clear signs of progress as all 20 companies now have
Figure 25 Significant increase in number of companies that have66

Figure: 52 More than half of projects are for non-communicable
Figure 53 By disease, how does the priority R&D pipeline break
down?

67

Figure 54 For many diseases, there are no products indevelopment to address treatment gaps

70

Figure 55 Number of companies with processes to systematicallyaddress access to medicine for all new products

71

Figure 27 Companies are making progress on decoupling agents’Figure 56 Six companies now plan for access for all late-stage
projects

71

Figure 28 Some signs of progress in applying specific compliance
controls

Figure: 51 What does each company pipeline look like?
diseases

Figure 26 More companies are increasing transparency about

rewards from sales targets

Figure 50 About a third of projects address a specific priority
R&D gap

level responsibility for access to medicine

their access-to-medicine activities

49

Figure 46 Are companies promoting ethical sales practices?

across fields

corporate strategy

49

Figure 45 Are access-related goals incentivised among senior

to-medicine activities?

integrated their access-to-medicine strategies into their overall
49

Figure 44 Is access to medicine a priority at the highest level?
management?

an access-to-medicine strategy
48

Figure 41 Use of inclusive business models continues to expand,with an emphasis on scaling up models

incentives for senior management
48

Figure 40 Stagnation in public disclosure of outcomes for healthsystems strengthening

for the majority of priority EIDs
35

Figure 39 Varied progress in measuring outcomes acrosscapacity building fields

Figure 16 While significant products have reached the market forsome EIDs, the companies in scope have nothing in the pipeline

Figure 38 More supply, manufacturing and R&D capacity building
initiatives meet all Good Practice Standards, but improvements in

Figure 14 Which LMICs are covered by NEVLs for COVID-19
products?

Figure 37 Number of companies sharing patent status data forsome products in their portfolios

portfolios?
26

Figure 36 Five products have been newly covered by voluntary
licences in the last two years*

Figure 12 How many companies have COVID-19 products?
Figure 13 What types of COVID-19 products are in companies'

Figure 35 Small increase in number of products included inaccess strategies outside of supranational agreements

Figure 11 Multiple R&D projects targeting COVID-19 have alreadyresulted in approved** and/or registered products

24- Self-administered products
52

Figure 57 19 of the 20 companies demonstrate evidence ofaccess planning

71

Figure 58 One in four projects have no access plans in any
countries in scope of the Index254

Access to Medicine Index 2022 ▶ Appendices72

Figure 59 Which countries are included in access plans?

72

Figure 60 Geographic reach of R&D access plans

73

Figure 61 At the R&D stage, a good access plan includes multiple

97
100

access components
74

Figure 62 Which access components do companies use?

78

Figure 63 Product Delivery Ranking

79
79
80

102

Figure 64 What types of products are in the companies’

publicly available
103

Figure 85 How do companies perform in patent policies?

Figure 65 What categories of diseases are covered by the106

Figure 86 Main stakeholders in medical donation supply chain

products in the companies’ portfolios?

108

Figure 66 How many products are in companies’ portfolios for
Figure 67 Products analysed with regards to registration

82

Figure 68 The ten countries in scope where the most products
have been filed for registration

patient
110
110

BoP
110

Figure 72 The top ten most widely filed on-patent products are

111

Figure 73 More than half of the companies are participating in

118

Figure 74 Breakdown of products analysed in this section

89

Figure 75 Overview of supranationally procured products in
scope

90

118
119

Figure 77 How do companies facilitate access to products in

121

Figure 78 Countries covered by supranational procurement

121

Figure 79 Products covered by country-specific access strategies

93

Figure 80 Where do companies provide access to their products

121

strategy?

Tables29

Table 1 Supranational procurement for vaccines in LMICs

29

Table 2 Examples of national procurement for vaccines in LMICs

34

Table 3 Products and R&D projects that target SRHR-relateddiseases and health needs

80

Table 4 What diseases are not covered by products in companies’
portfolios?

107
232

Table 5 Examples of company donations during the Ukraine crisis
Table 6 Diseases, conditions and pathogens in scope of the 2022
Access to Medicine Index

255

233

Table 7 Cancer types in scope

245

Table 8 2022 Access to Medicine Index indicator weights

Figure 97 Most companies commit to reporting cases ofsubstandard and falsified products within ten days

121

Figure 98 Nine companies have a policy that stipulates a faster
reporting timeframe when visual inspection is sufficient toconfirm falsification

122

and what types of strategies are applied?
94-95 Figure 81 How many products are being covered by an accessFigure 96 The majority of companies have a policy for reporting
substandard and falsified products

agreements
92

Figure 95 How many companies demonstrate best practice on
combatting substandard and falsified products?

countries outside of supranational agreements?
91

Figure 94 Most technology transfers are not conducted in
combination with licensing agreements

access to countries outside these agreements?
90

Figure 93 How are companies engaging in manufacturing
capacity building?

Figure 76 How many companies have products undersupranational agreements, and do they offer the same terms of

Figure 92 Manufacturing capacity building is concentrated inIndia, China and Brazil

facilitated pathways to register their products.
88

Figure 91 Most models are concentrated in Kenya, Nigeria andUgandamainly older products targeting non-communicable diseases
87

Figure 90 Nearly half of inclusive business models cover noncommunicable diseases

registration in LMICs after approval?
85

Figure 89 Few inclusive business models in the Index serve
specific vulnerable groups that are highly represented within thecompany registers its products in LMICs
Figure 71 How rapidly do companies file their products for

Figure 88 More companies are scaling up existing inclusive
business models than piloting new models

Figure 69 Which countries do companies register their products
Figure 70 There is considerable variation in how widely each

Figure 87 Less than half of companies demonstrate evidence ofmonitoring donations until reached by the end-user being the

in?

84

Figure 84 For less than 40% of the on-patent products incompanies’ portfolios, information about patent expiry dates iseach cancer type?

83

Figure 83 27 compounds are covered by licensing agreements by
the companies in scope

portfolios?

81

82

Figure 82 Among products covered by access strategies, forwhat percentage are companies tracking patient reach?

Figure 99 Most companies combine dual API sourcing and buffer
stocks to mitigate supply risks

124

Figure 100 Few initiatives focus on detecting substandard andfalsified medicines outside a company’s own supply chain

Access to Medicine Index 2022 ▶ Appendices

APPE N D IX VI I I

References
1.	World Health Organization.
Prioritization of Pathogens to
Guide Discovery, Research andDevelopment of New Antibiotics for
Drug-Resistant Bacterial Infections,
Including Tuberculosis. World HealthOrganization; 2017. Accessed July
5, 2022. https://apps.who.int/iris/handle/10665/311820
2.	World Health Organization. The
Initiative for Vaccine Research strategic plan 2010-2020. World HealthOrganization. Published 2010.
Accessed June 15, 2022. https://apps.
who.int/iris/handle/10665/70254
3. World Health Organization. R&D
Blueprint. Published 2022. Accessed
July 5, 2022. https://www.who.int/
teams/blueprint/about
4. Chapman N, Doubell A, Tuttle A, et al.
G-FINDER | Landscape of Emerging
Infectious Disease Research andDevelopment: Preventing the Next
Pandemic.; 2020. Accessed July 5,2022. https://www.policycuresresearch.org/analysis/
5.	Chapman N, Doubell A, GoldsteinM, et al. G-FINDER | Sexual andReproductive Health Research andDevelopment: Understanding theSpectrum.; 2020. Accessed July 5,2022. https://www.policycuresresearch.org/analysis/

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6.	Truong M, David S, Thakur S, etal. G-FINDER | Neglected Disease
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5, 2022. https://www.policycuresresearch.org/analysis/
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8.	U.S FOOD & DRUG
ADMINISTRATION. Orange Book:
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Accessed August 18, 2021. https://www.accessdata.fda.gov/scripts/
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9.	Government of Canada. Patent register. Accessed August 18, 2021.
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index-eng.jsp
10.	Medicines Patent Pool. MedsPaL.
Accessed August 18, 2021. https://www.medspal.org/?page=
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12.	Institute for Health Metrics and
Evaluation (IHME). Findings from the
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Seattle, WA: IHME, 202013.	Global Burden of Disease
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Tool | GHDx. http://ghdx. healthdata.
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14.	Global Cancer Observatory. Cancer
Today. https://gco.iarc.fr/today/
online-analysis-table. Accessed June22, 2021.

Access to Medicine Index 2022 ▶ Appendices

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