Colombia Issues First-Ever Compulsory License, A Landmark Step for Expanding Access to Affordable HIV Treatment

April 24, 2024

Colombia Issues First-Ever Compulsory License, A Landmark Step for Expanding Access to Affordable HIV Treatment

Generic Dolutegravir Could Treat 27 People for The Price of One

BOGOTÁ/GENEVA/WASHINGTON, DC - Today, the government of Colombia issued its first-ever compulsory license (CL) for use by Colombia's Ministry of Health, to improve access to less-expensive generic versions of the key HIV medicine dolutegravir, without permission from the patent owner ViiV Healthcare (a joint venture of GlaxoSmithKline, Pfizer and Shionogi). Doctors Without Borders/Médecins Sans Frontières (MSF), together with Public Citizen and Global Humanitarian Progress Corporation Colombia, welcomed this landmark move, which is an encouraging example for countries in the region and beyond, on how a CL works in practice to improve access to medicines.

Dolutegravir is recommended as part of the preferred first-line treatment regimen for people living with HIV, including during pregnancy, as per the guidance of the World Health Organization (WHO). MSF uses a dolutegravir-based first-line HIV treatment regimen across its HIV/AIDS programmes, and has seen patients benefit from the fewer side effects the drug causes and a lower risk of developing resistance.

However, in many countries where MSF works, access to more affordable generic versions of dolutegravir remains a challenge. In Colombia, due to patent barriers and high prices, MSF has not yet been able to introduce dolutegravir in its medical programmes. Although generic versions of dolutegravir are available internationally for a fraction of ViiV's price through voluntary licenses with the Medicines Patent Pool (MPP), ViiV excluded Colombia and many middle-income countries from being able to benefit from its license with MPP, allowing ViiV to maintain its monopoly and continue to charge high prices in Colombia and other countries excluded from the license.

According to the Colombian government, the estimated cost of treatment of dolutegravir, as sold by ViiV under the brand name Tivicay, was ~US$1,224 per patient per year in 2023 in Colombia. This is an exorbitant markup when compared to the $22.80 or $44 per patient per year price of generic dolutegravir offered in 2023 through the Global Fund and Pan-American Health Organization (PAHO), respectively, and from which Colombia, however, could not procure.

The price available to the Ministry of Health under today's CL ($44 per patient per year) is therefore a huge step towards enabling affordable access to more affordable generic versions of dolutegravir for all people who need it, including by opening the door for MSF to introduce dolutegravir in our medical programmes.

Dr Carmenza Gálvez, medical coordinator for MSF in Colombia and Panama:

"Colombia's decision to issue a compulsory license for dolutegravir is great news because, until now, we have not been able to introduce dolutegravir in our medical operations, as the costs have been prohibitive. We therefore very much welcome today's decision and news of the more affordable generic price, as this will facilitate the use of dolutegravir in our first-line treatment of HIV for the survivors of sexual violence whom we serve in our medical operations in Colombia, and it will allow more and more people living with HIV in Colombia to access the most effective medicine."

Luz Marina Umbasia Bernal, director of Global Humanitarian Progress Corporation Colombia:

"The licensing of dolutegravir in Colombia will prevent HIV transmission, reach migrants who need treatment, support the financial sustainability of Colombia's health system, and promote equity and human rights of people living with HIV. At the regional level, implementing this mechanism generates a vital precedent for promoting access to essential medicines. It is necessary to move towards the elimination of HIV as a public health problem worldwide and contribute to compliance with the Sustainable Development Goals (SDGs). Latin American governments have the right to use TRIPS flexibilities to protect the health of their citizens."

Peter Maybarduk, Access to Medicines Director, Public Citizen:

"Colombia is planting a flag for global health equity. This will inspire new regional challenges to patent barriers and improve treatment access, towards an AIDS-free generation. Treatment activists have worked toward this decision for several years, helping Colombia stand up to pharma. Where global solutions fall short, countries can and must take control to secure access to medicines for all."

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