Gilead Technology Transfers/Licensing Agreements
Active Since: 2006
Contributing to SDGs…
Since 2006, Gilead has been licensing its patented HIV and viral hepatitis medicines to generic manufacturers that have proven they can develop and commercialize high-quality, low-cost medicines in low- and middle-income countries. Gilead provides full technology transfers to its licensees and allows generic manufacturers to set their own prices.
The objective of Gilead’s technology transfers is to ensure that generic versions of Gilead medicines – in their intended composition – reach the patients who need them.
The initiative aims to leverage Gilead’s product-specific expertise by equipping local producers who are best prepared to conduct large-scale manufacturing with the technological tools to expand production.
Gilead makes it a priority to increase access to our medicines for people who can benefit from them, regardless of where they live or their economic status. We recognized that the greatest need for HIV treatment was in the least-developed parts of the world and that on our own, Gilead did not have sufficient capacity to meet global needs for HIV treatment in a cost-effective manner. For this reason, in 2006 Gilead began licensing its patented HIV and hepatitis B medicines to generic manufacturers that have proven they can develop and commercialize high-quality, low-cost medicines in low- and middle-income countries. In 2014, Gilead signed voluntary licensing agreements for our hepatitis C treatments, making generic products available in countries home to more than half of the globally infected population.
Gilead provides its licensees with a technology transfer of manufacturing processes for active pharmaceutical ingredients, as well as finished products. Licensees are then able to set their own pricing for finished products and may sell active pharmaceutical ingredients to other licensees.
Dedicated staff in Gilead’s Access Operations and Emerging Markets unit oversee these technology transfers, make resources from other parts of the company available to licensees as needed and provide ongoing assistance to licensees after the technology transfer is completed.
Licenses with generic manufacturers have no expiration and can be terminated by either party. Manufacturers hold licenses to produce generic versions of Gilead’s HIV and viral hepatitis treatments. The licensees receive assistance to ensure product safety and stability. Gilead also grants licensees future rights to produce generic versions of Gilead HIV and hepatitis medicines still under development, contingent upon regulatory approval. Gilead initiates technology transfers for these medicines ahead of regulatory approval to help licensees build production capacity as quickly as possible.
Gilead has an open line of communication with its generic licensees, meets with them regularly and is available to provide manufacturing guidance when needed to minimize any manufacturing disruptions. Royalties paid to Gilead by these generic manufacturers are reinvested into Gilead’s support activities to maintain its generic licensing program. In addition to providing licensees with manufacturing guidance when needed, Gilead also requires licensees to seek World Health Organization (WHO) pre-qualification or Food and Drug Administration (FDA) tentative approval for their products as a condition of the licenses.
Gilead was also the first innovator company to join the Medicines Patent Pool, which is a Unitaid-backed organization that works with pharmaceutical companies to expand global access to high-quality, low-cost antiretroviral therapy through the licensing of patents. Today, 10 patent holders have joined the Pool and license their compounds to 24 generic manufacturers.
SDGs THE PARTNERSHIP CONTRIBUTES TO
SDG 3: Good Health and Wellbeing
- 3.3: Communicable Diseases & NTDs
SDG 17: Partnerships for the Goals
RESULTS & MILESTONES
Gilead measures the progress of its technology transfers by total patients reached and WHO pre-qualifications and tentative FDA approvals received. To date, 12.6 million people in developing countries are on Gilead-based HIV treatments, 98 percent of whom are receiving licensed generic medicines. 1.7 million people in low- and middle-income countries have been treated with Gilead’s hepatitis C medicines, 1.3 million of whom received generics. Our generic licensees have received more than 30 WHO pre-qualifications and/or FDA tentative approvals for their products.
Since the launch of Gilead’s voluntary generic licensing program, competition among licensees has reduced the lowest price of a Gilead HIV generic therapy, tenofovir disoproxil fumarate, by 89 percent, to as low as $1.80 per patient per month. The lowest price of a Gilead hepatitis C generic therapy, sofosbuvir, is $10.
Today, over 25 generic manufacturers hold licenses to Gilead medicines. Generic versions of our HIV and hepatitis B medicines are available in 116 countries and generic hepatitis C treatments are available in 105 countries.
- Burkina Faso
- Cabo Verde
- Central African Republic
- Côte d'Ivoire
- Democratic Republic of the Congo
- Equatorial Guinea
- Sao Tome and Principe
- Sierra Leone
- South Africa
- South Sudan
- United Republic of Tanzania
- Antigua and Barbuda
- Bolivia (Plurinational State of)
- Dominican Republic
- El Salvador
- Saint Kitts and Nevis
- Saint Lucia
- Saint Vincent and the Grenadines
- Trinidad and Tobago
- Syrian Arab Republic
- Republic of Moldova
- Sri Lanka
- Lao People's Democratic Republic
- Papua New Guinea
- Solomon Islands
- Viet Nam
Infectious and Parasitic Disease
Vaccine preventable disease