Colombia’s Minister of Health has asked the country’s patent office to issue a compulsory licence for an antiretroviral drug, dolutegravir, which is still protected by a patent issued to ViiV Healthcare.

Minister of Health and Social Protection Guillermo Alfonso Jaramillo issued a Declaration of Public Interest on Wednesday indicating that he was taking this step to enable the country to import cheaper generic versions of the HIV medicine.

According to the minister, people living with HIV pay $100 a month for the drug, which is 50 times more expensive than the generic version available through the Pan American Health Organisation. 

The Colombian government estimates that it will be able to put 28 people on generic dolutegravir for the same cost as one person currently on the patented drug. 

HIV cases have increased by 31% over the past year in the country, with some 18,410 people now living with HIV. In addition, the country has experienced an influx of people from Venezuela seeking HIV treatment.

Compulsory licensing allows national authorities to license a third party to produce a generic version of a patented product before the drug’s patent expires. 

According to the World Trade Organization’s (WTO) Agreement on Trade-Related Aspects of  Intellectual Property Rights (TRIPS Agreement), governments are allowed to issue compulsory licenses in when it is in the public interest to do so.

Could set a precedent for the region

The health ministry’s move comes after more than 120 civil society organisations and prominent individuals petitioned Jaramillo to issue a compulsory license.

Dolutegravir is the preferred treatment for people living with HIV, according to the WHO. Generic dolutegravir is available to other countries through voluntary licenses with the Medicines Patent Pool (MPP). 

“In its voluntary license signed with MPP, ViiV excluded Colombia and many populous middle-income countries, maintaining its monopoly and its ability to charge high prices in the country,” according to Médecins Sans Frontières. 

“Colombia’s declaration helps open pathways to neighbouring countries like Brazil following suit to access more affordable generics. Colombia’s patent office is expected to issue a compulsory license under the declaration.”

Francisco Viegas, MSF Access Campaign’s medical innovation policy advisor, said that  Colombia’s declaration “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”.

“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,” added Viegas.

“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.”

“This decision represents a milestone for public health in Colombia,” said Andrea Boccardi Vidarte, UNAIDS Director for the Andean Countries in a statement. 

“Through our local, regional and global offices, UNAIDS will continue supporting the government on the implementation of this landmark decision.”

ViiV Healthcare is a joint venture of GlaxoSmithKline, Pfizer and Shionogi that specializes in the treatment of HIV.

Image Credits: UNAIDS.