Gilead Sciences Inc.
Rank 8 in 2016
Falls 5 places to 13th due to a comparatively poor performance in governance and compliance. It maintains a strong performance in some areas, for example, in its licensing strategy and its application of equitable pricing strategies across a high proportion of its products.
Falls 6 places to 18th. It does not have direct board responsibility for its access approach, and does not commit to measuring the impact of its access initiatives.
Falls 15 places to 16th. Comparatively poor performance, with below-average transparency and lacking components of an internal control system looked for by the Index.
Falls 2 places to 18th. Gilead performs on average in access planning, lags in R&D investment transparency and performance, and lacks a public policy for post-trial access.
Rises 5 places to 2nd. Strong registration commitment and transparency, with a leading performance in the application of equitable pricing strategies.
Falls 2 places to 3rd. Leading performance in its licensing approach compared to peers, but falls in patent filing/enforcement policy.
Rises 5 places to 13th. Improves performance against new metrics, with initiatives in three areas of Capacity Building.
Rises 2 places to 11th. Maintains three donation programmes focused on NTDs, but fails to provide evidence of its sustainability.
Expand access plans across pipeline. Gilead has an opportunity to develop a pipeline-wide approach to planning for access. For example, Gilead's access planning process currently focuses on HIV/AIDS and hepatitis B and C. The company can also expand such planning to R&D projects for projects targeting communicable diseases, including presatovir for the treatment of RSV, and non-communicable diseases, including three late-stage oral anti-cancer agents.
Strengthen transparency, policies and procedures to ensure compliance. Gilead falls behind peers due to overall lack of transparency across the Market Influence and Compliance Technical Area. Gilead can publicly disclose which stakeholder groups (e.g., patient groups in countries in scope) the company participates in and whether it provides financial support to such groups. The company can also publicly disclose whether political contributions have been made in low- and middle-income countries. The company can improve its internal control framework to ensure compliance through the implementation of a fraud-specific risk assessment, and procedures to segregate duties. It can also help improve responsible sales practices by decoupling sales incentives from sales targets.
Expand access further by maximising effectiveness of licensing approach. Gilead consistently applies inter- and intra-country equitable pricing strategies and licensing approaches across its portfolio. Gilead can maximise the effectiveness of its licensing-based approach by reviewing generic company activity in countries within the scope of agreed licences where Gilead does not have sales. In cases where generic company activity is absent/limited, Gilead can consider proactively registering and pricing equitably within these countries to facilitate competition and access, or by identifying mechanisms within licences to incentivise generic market entry. Gilead commits to filing its newest products in scope for registration in countries in scope within 12 months of first market approval.
Change since 2016
- Developed a comprehensive process to develop access plans for all R&D projects targeting HIV/AIDS, viral hepatitis B and C and leishmaniasis during development.
- Launched the Gilead Public Health Award: Viral Hepatitis Program in 2017 to provide research grants to researchers in low- and middle-income countries focused on viral hepatitis care and treatment.
- Joined the MenStar Coalition that was launched in 2018 and aims to improve diagnosis and treatment of HIV in men, particularly in sub-Saharan Africa.
- Expanded its HIV licences signed with the MPP to include three additional countries with the inclusion of Malaysia and Ukraine as middle-income countries within the scope of the Index.
- Received FDA approval for the first pangenotypic hepatitis C treatment, sofosbuvir/velpatasvir (Epclusa®) in June 2016, followed by FDA approval for the second, sofosbuvir/velpatasvir/voxilaprevir (Vosevi®) in July 2017
Pipeline and Portfolio
for diseases and countries in scope
Comparatively small pipeline: 22 R&D projects (all medicines) for diseases in scope.
Clinical candidates: 18, including remdesivir for the treatment of Ebola and emtricitabine and tenofovir alafenamide (Descovy®) for HIV pre-exposure prophylaxis.
Regulatory approvals: 4, including sofosbuvir/velpatasvir (Epclusa®) for the treatment of hepatitis C virus (pan-genotypic).
R&D focus: non-communicable diseases (cancer) and communicable diseases (HIV/AIDS and viral hepatitis B and C)
Access provisions: for 8 projects, all with registration and equitable pricing strategies and plans for non-exclusive voluntary licensing and WHO prequalification.
Comparatively small portfolio: 18 products (all medicines) for diseases in scope.
Portfolio focus: communicable diseases (HIV/AIDS and viral hepatitis B and C).
Essential medicines: 44% of Gilead's medicines are currently listed on the 2017 WHO Model List of Essential Medicines (WHO EML).
First-line treatments: 44% of Gilead's medicines have first-line indications for diseases in scope.
One business unit: Human Therapeutics, which has five therapeutic areas (HIV/AIDS, liver diseases, haematology and oncology, inflammatory and respiratory diseases and cardiovascular diseases).
M&A news: 2017 acquisition of Kite Therapeutics, specialising in cancer immunotherapy products; acquisition of Cell Design labs, Inc., specialising in cell-based therapies for cancer and other diseases.
Presence in emerging markets: In 2018, Gilead reports sales in 32 countries in scope.
* Neglected Tropical Diseases, while also communicable, are highlighted separately throughout the Index. See Appendix II.
** See Appendix IV for definition.