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 atcontrolling soil-transmitted helminthiasis in at-risk populations. During
the 2022 Index cycle, the company extended the donation programme
to include pre-school aged children as an additional at-risk group andexpanded its public commitment to donating until 2025. GSK can further

41

donated until 2025 to treat soil-transmitted helminthiases.
• GSK expects to positively impact health of more than 2.5 billion people
within the next ten years, with an ambition of 1.3 billion people in lowand
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

42

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.

43

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.

44

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.