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.

37

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

38

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.

39

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.

40