Non-Voluntary Use of Patented Medicine to Increase Access to HIV Medicines in Colombia

December 5, 2023

To enhance the availability of HIV treatment for patients residing in Colombia, the Colombian government moves for use of dolutegravir-based compounds without permission from the patent owner.

Many originator drug companies scale their production and engage in licensing practices to make their products available globally. However, difficulties in access can still lead a diverse set of actors to exert efforts to increase availability and affordability of medicines in low- and middle-income countries. This can include negotiating with the originator to facilitate the market entry of generic products, including through pooled licensing schemes. Additional tools include governments’ implementation of flexibilities available under the Trade Related Aspects of Intellectual Property (TRIPS) agreement), such as compulsory licensing and government-use authorizations to use the medical product without the patent owner’s consent, effectively enabling production of a generic version before the drug’s original patent expires. In the 2001 WTO Doha Ministerial Conference, the rights of member states to make use of all flexibilities in the TRIPS agreement to protect public health were reaffirmed, as well as the freedom to determine the grounds upon which such licenses are granted.

illustrative image — (Image: Pixel image/iStock/Getty Images Plus/Getty Images)

Over the past decade, a sense of treatment optimism has prevailed in global health. With regard to HIV, a promising development included the advent of Dolutegravir (DTG), which in combination with other compounds, constitutes the preferred treatment for people living with HIV. This medication provides higher viral suppression, lower side effects, lower risk of discontinuing treatment, and lower risk of developing HIV drug resistance compared to older alternatives, such as Efavirenz (EFV)-based regimens.

Dolutegravir-based compounds are protected by patents over a broad geographic coverage until at least 2030, and licensing for their generic production does not include several populous middle-income countries.^[1] DGT-based compounds remain out of reach for many patients globally who cannot afford the medicine,^[2] and regional affordability disparities persist.^[3] With a high brand name/generic price ration,^[4] there remain challenges in pricing and availability.

The pressing public health need in Colombia, evidenced by an almost 30% increase in HIV cases last year, underscores the urgency of finding effective solutions. This urgency was echoed among others by calls from numerous global health activists, such as a July 2023 letter to the Colombian Health Minister in this regard.

Against this background, on October 4, 2023, the Colombian Ministry of Health and Social Protection took another step towards issuing a compulsory license to facilitate access to lower-cost generic versions of Dolutegravir. In a previous related resolution reached in June 2023, the Ministry noted that the impact of this measure could mean a significant reduction of more than 80% of DTG’s price. Colombia's pursuit of a compulsory license for DTG sheds light on the complexities of IP licensing schemes and pricing of medicines globally.