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In Step to Expand People’s Access to HIV Treatment, Colombia Plans to Overcome Patent Barriers and Issue a Compulsory License

BOGOTÁ – The government of Colombia plans to overcome patent barriers to HIV treatment and import low-cost generic versions of the HIV medicine dolutegravir without permission from the patent owner, ViiV Healthcare (a joint venture of GlaxoSmithKline, Pfizer and Shionogi), under a declaration issued earlier this week by the ministry of health. The intended move, known as compulsory licensing or government use of patents, is a legitimate mechanism enshrined in international law. The declaration represents a direct challenge to the pharmaceutical industry in one of the hemisphere’s most influential states, and comes on the heels of more than 120 civil society organisations and prominent individuals petitioning the Colombian Minister of Health Guillermo Alfonso Jaramillo to support expanding access to the medicine.

Dolutegravir is recommended as the preferred first-line treatment for people living with HIV, including pregnant people, as per the guidance of the World Health Organization. Generic versions are available internationally for a fraction of ViiV’s price.

Generic dolutegravir is available to millions of people worldwide through voluntary licenses with the Medicines Patent Pool (MPP), an organization founded by Unitaid to pursue public health oriented licensing of medicines. However, in its voluntary license signed with MPP, ViiV excluded Colombia and many populous middle-income countries from being able to benefit from the license, maintaining its monopoly and its ability to charge high prices in the country. Colombia’s declaration helps open pathways to neighboring countries like Brazil following suit to access more affordable generics. Colombia’s patent office is expected to issue a compulsory license under the declaration.

Médecins Sans Frontières/Doctors Without Borders (MSF) has used a dolutegravir-based first-line HIV treatment regimen extensively in its HIV/AIDS programs in Africa and Asia, and in several Latin American countries, and has seen patients benefit from the fewer side effects the drug causes and a lower risk of resistance. However, due to patent barriers and the restrictive conditions that ViiV offers in its voluntary license signed with the MPP, access to more affordable generic versions of dolutegravir remains a challenge in many countries where MSF works. In Colombia, due to patent barriers and high prices, MSF is not able to introduce dolutegravir in its medical projects. A compulsory license to remove the patent barriers in the country will enable access to more affordable generic versions of dolutegravir for all people who need it.

Compulsory licensing is among the legal rights that governments have to restrict patent exclusivity. Compulsory licensing, discussed broadly during the COVID-19 pandemic, makes medicines more affordable and accessible, and is enshrined in World Trade Organization rules. The mechanism has been used by different countries’ governments to address access to medicines challenges, including to remedy anticompetitive practices or to facilitate government procurement. However, it remains underused in general to advance access to medicines specifically due to the political pressure and power from pharmaceutical corporations to suppress these legitimate mechanisms.

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

“We welcome Colombia’s Declaration of Public Interest, which puts forward convincing reasons to issue a compulsory license, and requests the Colombian Patent Office to do so to enable access to more affordable generic versions of dolutegravir, so that more people can be treated with this drug. This fully legitimate action by the Colombian government is the first of its kind from Colombia and is a significant act of leadership that clearly puts people and public health over corporations’ profits.

“Affordable access to WHO-recommended treatments should be available to all people living with HIV, so we hope to see the Colombian Patent Office issue this compulsory license in the coming weeks. We also urge other countries that struggle to supply dolutegravir to follow suit, like Brazil, where even though national production capacity of dolutegravir exists, it was halted because a patent was granted – a compulsory license by Brazil to allow access to more affordable generic versions of this drug could substantially change the lives of people with HIV.”

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

“Advocates across the Americas and worldwide are celebrating this courageous move by Minister Jaramillo to put the health of Colombians living with HIV before pharmaceutical industry profits. The government must now follow through and issue licenses to save lives in Colombia and in other nations that follow in its footsteps to remove patent barriers that serve to put the commercial interests of rich countries before the rest of us.”

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

“This critical progress for affordable HIV treatment is a resounding defeat for the drug giants. Patent power is the root of high drug prices. U.S. and European pharmaceutical corporations long relied on Colombia’s support to expand their global patent power. That unqualified support ends now. Colombia is standing for health justice in the wake of the extreme inequities of the Covid emergency.