The government of Colombia has issued its first-ever compulsory license to enable access to generic versions of the key HIV medicine dolutegravir, without permission from the patent owner, ViiV Healthcare.

Dolutegravir is recommended as part of the preferred first-line antiretroviral treatment regimen for people living with HIV, including during pregnancy, as per the guidance of the World Health Organization (WHO). Dolutegravir has fewer side effects and a lower risk of developing resistance. 

UNAIDS has described the move as an “important breakthrough in public health measures” that  breaks “the monopoly”, and could mean that the price of the life-saving medicine is reduced by as much as 80%.

“When the power to produce health technologies is held by a few companies, the result all too often is that countries can’t afford the high prices and people who need newer products cannot access them,” said Luisa Cabal, UNAIDS Regional Director for Latin America and the Caribbean.

“This decision provides the government with the legal conditions to manufacture or purchase more affordable versions of this essential first-line antiretroviral treatment for all people living with HIV in Colombia, including Venezuelan migrants”, said Ms Cabal.

“We are confident that this decision will have an impact across the whole region and beyond, as many middle-income countries are struggling to access generic markets of key health products to prevent and treat HIV infection.”

Prohibitive costs

This move has also been welcomed by Médecins Sans Frontières (MSF), Public Citizen and Global Humanitarian Progress Corporation Colombia.

⚡️⚡️⚡️Breaking News: Colombia issues its first compulsory license (CL) for the HIV drug dolutegravir bringing the price down from US$1,224 per patient per year by ViiV to $44 through generics. This proves the power of generic competition!!! https://t.co/yPSpAFzJyJ

— Shailly Gupta (@Shaillytweeting) April 25, 2024

“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,” said Dr Carmenza Gálvez, MSF’s medical coordinator for Colombia and Panama.

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. 

The Global Fund buys generic dolutegravir for $22.80 per patient per year, while Pan-American Health Organization (PAHO) can procure it for $44 – but Colombia cannot access these prices. 

According to the Colombian government, the estimated cost of dolutegravir sold by ViiV under the brand name, Tivicay, is around $1,224 per patient per year in 2023.  If Colombia can procure the generics for $44, it will be able to treat 27 people for what it is paying for one person at present.

According to UNAIDS, Colombia hosts the largest number of Venezuelan migrants in the world (2.9 million as of October 2022), and “recent studies have shown a 0.9% HIV prevalence among this migrant population, almost double the 0.5% HIV prevalence among the country’s adult population”.

Compulsory licensing is a provision in the World Trade Organization (WTO) Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS Agreement). It enables governments to supply its citizens with generic versions of patented treatments either through domestic production or imports, ensuring health products’ prices are affordable.

The 2001 WTO Declaration on the TRIPS agreement and public health reaffirmed the rights of member states to make use of all flexibilities in the TRIPS agreement to protect public health, including compulsory licenses. More recently, in the 2021 Political Declaration on HIV/AIDS, countries committed to make use of TRIPS flexibilities, specifically geared to promoting access to medicines.