Gilead Sciences

Leading Practices

• Gilead has established an external advisory board, the Health Policy Advisory Board, as a platform for stakeholder engagement on ATM issues.
• The company has a high level of transparency in registration information for its HIV/AIDS medications, Viread and Truvada. It publicly discloses registration status at the country level.
• Gilead has established non-exclusive voluntary licensing agreements with 14 generics companies (13 in India and one in South Africa) for production of its HIV/AIDS products, covering a licensing territory of 95 developing countries including both least developed and developing countries.

Changes Compared to Index 2008

• Since Access to Medicine Index 2008 was published, Gilead's level of engagement and disclosure across all technical areas has increased.
• Gilead is developing two fixed-dose combinations (FDCs) for HIV/AIDS with Tibotec (a Johnson & Johnson subsidiary) and the "Quad", which combines four of Gilead's medicines).
• As of December 2009, Gilead's HIV/AIDS drugs, Viread and Truvada, were registered in 82 and 77 Access Program Countries, respectively, compared to Index 2008, where the two products were recorded as registered in 46 and 39 Access Program Countries, respectively (as of April 2008).
• In 2009, Gilead signed three new non-exclusive voluntary licensing agreements with Indian generics companies (Aptuit Laurus, Sequent and Cadila Healthcare) for production of its HIV/AIDS medicines.
• Gilead has begun monitoring and measuring the impact of its third-party generic licensees on ATM in areas such as number of patients receiving generic versions of Gilead's HIV medicines, price reductions, WHO prequalification and FDA tentative approvals received.
• In August 2009, the Indian Patent Office (IPO) rejected two patents sought by Gilead for Viread. The company has since filed an appeal. Rejection of the patent can have significant impact on the company's non-exclusive licensing practices. 

Suggested Areas for Improvement

• While Gilead's transparency level has improved substantially since Index 2008, the company still has limited public disclosure in several areas, including ATM-relevant public policies (including the company's stance on specific competition practices), marketing and promotional activities in Index Countries.
• Gilead currently performs below average in collaborative research for Index Diseases compared to sector peers and its ATM related research scope is limited to HIV/AIDS.
• The company underperforms in capacity advancement in the Index Countries, compared to its performance in the other technical areas.