Colombia makes landmark decision to declare the HIV medicine dolutegravir of public interest, allowing the country to purchase or manufacture more affordable, generic versions of the HIV medicine
BOGOTÁ/GENEVA, 4 October 2023-UNAIDS applauds the government of Colombia for declaring the HIV medicine dolutegravir of public interest. This important breakthrough in public health measures will allow the government to issue a compulsory license, breaking the monopoly, and making it much more affordable for the Colombian government to purchase or manufacture. The new decision 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. "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."
The World Health Organization recommends dolutegravir as the preferred first-line and second-line HIV treatment for all populations. As well as being effective, treatments incorporating dolutegravir-based regimens have demonstrated greater adherence, due to fewer side effects, while presenting enhanced, safety, and reduced likelihood of drug resistance.
"This decision represents a milestone for public health in Colombia. Since the Ministry of Health initiated the administrative procedures earlier this year, over 120 civil society organizations, other government agencies, academia and international organizations including UNAIDS supported this process," said Andrea Boccardi Vidarte, UNAIDS Director for the Andean Countries. "Through our local, regional and global offices, UNAIDS will continue supporting the government on the implementation of this landmark decision."
For every one person the Colombian government is able to put on the branded name dolutegravir. It estimates that with this new decision, for the same price, it will be able to put 28 people on the less expensive, but just as effective, generic version. A huge increase in reach which will save lives.
Colombia had already issued national guidelines in 2021 to prioritize dolutegravir as the recommended first-line antiretroviral treatment, in line with WHO recommendations. However, the high price of dolutegravir has remained an obstacle to expanding access and making it widely available to people living with HIV in the country.
This ruling will save lives in Colombia and across the region. The country hosts the largest number of Venezuelan migrants in the world (2.9 million as of October 2022). 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.
"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.
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.
UNAIDS
The Joint United Nations Programme on HIV/AIDS (UNAIDS) leads and inspires the world to achieve its shared vision of zero new HIV infections, zero discrimination and zero AIDS-related deaths. UNAIDS unites the efforts of 11 UN organizations-UNHCR, UNICEF, WFP, UNDP, UNFPA, UNODC, UN Women, ILO, UNESCO, WHO and the World Bank-and works closely with global and national partners towards ending the AIDS epidemic by 2030 as part of the Sustainable Development Goals. Learn more at unaids.org
