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.

61

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

6213

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.

63

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.

64

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-