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Colombia to Challenge AIDS Drug Patents

Over 120 Signatories Worldwide Support Move to Expand Medicine Access

Bogotá – Colombia will soon decide whether to authorize price-cutting generic competition with a critical patented AIDS drug, directly challenging pharmaceutical industry power under a new health ministry resolution in one of the hemisphere’s most influential states. In anticipation of the decision, more than 120 civil society organisations and prominent individuals wrote Colombian Minister of Health Guillermo Alfonso Jaramillo to support expanding access to dolutegravir, calling the move a “stand for health justice.”

The health ministry resolution proposes “compulsory licenses” allowing Colombia to make or import generic dolutegravir without permission from the patent owner, ViiV Healthcare (a joint venture of GlaxoSmithKline, Pfizer and Shionogi). Dolutegravir is recommended as the preferred first-line treatment for people living with HIV, including pregnant women, as per the guidance of the World Health Organization. Generics are available internationally for a fraction of ViiV’s price.

The move marks a significant defeat for the patent-based pharmaceutical industry, which long had relied on Colombia as a cornerstone of support for global patent policy and U.S. and European commercial interests abroad. Letter signatories urged the Colombian government to move forward, noting that high prices for HIV treatment “impede the goal of an AIDS-free generation and contribute to preventable suffering and death.” Letter signatories include Public Citizen, Médecins Sans Frontières (MSF) Access Campaign, Global Humanitarian Progress Corporation Colombia, People’s Vaccine Alliance, Health GAP, AIDS Healthcare Foundation, Partners In Health, and AVAC.

Generic dolutegravir is available to millions of people worldwide through licenses with the Medicines Patent Pool, a Swiss foundation. However, ViiV excluded Colombia and many populous middle-income countries from the license, maintaining its high-price monopoly.

Colombia has formed an interagency committee to make a recommendation on the proposed license.

Francisco Viegas, Medical Innovation Policy Advisor from MSF Access Campaign released the following statement: 

We welcome Colombia’s announcement to take steps toward enabling access to more affordable generic versions of dolutegravir. This commitment underscores the belief that people’s lives should take precedence over corporations’ profits.

“MSF has used a dolutegravir-based first-line regimen extensively in programs in Africa and Asia, and has seen the benefits to patients with fewer side effects and lower risk of resistance. WHO recommended regimens should be available to all People Living with HIV (PLHIV) [wherever they live. However, MSF and Ministries of Health in some middle-income countries like Colombia, struggle to provide dolutegravir, due to ViiV’s patent and high prices. A compulsory license resulting in access to affordable generic versions of dolutegravir could substantively change this situation.”

Luz Marina Umbasia Bernal, director of Global Humanitarian Progress Corporation Colombia released the following statement:

“This is a bold move by the government of Colombia, with huge international support. We look forward to working with the Ministry to ensure that this process moves forward and that people living with HIV in Colombia enjoy the same access to this essential medicine that people in many other nations enjoy. Colombia is setting a precedent for the region, removing barriers in the use of health safeguards stipulated in TRIPS and balancing trade rights with the right to health and life.” 

Peter Maybarduk, Public Citizen’s access to medicines director based in Washington, D.C., released the following statement:

“Colombia is taking back power after the extreme inequity of COVID and challenging a major pharmaceutical company in order to ensure affordable AIDS treatment and health justice for its people. The example will inspire further action in the Americas and among other middle-income countries, with practical benefits for health and losses for pharma.”