Colombia has declared a vital drug, key in the fight against HIV infection, to be of public interest in order to prevent its patent. This drug, known as dolutegravir, is marketed by ViiV Healthcare.
With this declaration, Colombia’s Ministry of Health aims to nullify the current patent held by the British multinational for the sale of an antiretroviral medication that costs around 400,000 Colombian pesos per month per unit.
Health authorities in the country view dolutegravir as a crucial drug in the fight against HIV infection, especially for refugees and migrants who have limited access to treatment due to their often precarious legal and living situations in Colombia.
Dolutegravir: A Key Drug Against HIV
Dolutegravir belongs to a class of medications known as HIV integrase inhibitors. Its function is to reduce the amount of HIV in the blood and increase the number of immune cells that help combat infections in the body.
The patented dolutegravir costs more than 400,000 pesos, while its generic version would cost less than 11,000 pesos. This option would significantly reduce the high costs of antiretroviral treatments for the Colombian healthcare system.
According to Sandra Valderrama, Head of Infectious Diseases at the San Ignacio University Hospital of Javeriana University, “These types of medications are recommended as first-line treatments in Colombia and worldwide. They are highly effective and have a high safety profile. Patients using them have a low risk of developing adverse effects.”
Dr. Valderrama emphasized the importance of having high-quality medications, whether they are innovative or not. The appropriate evaluation of medications is essential for patient care, and this responsibility lies with INVIMA (the Colombian National Food and Drug Surveillance Institute) to ensure quality and provide the necessary health registration for use in Colombia.
“Government Public Use License”
Colombia is pursuing a “government public use license.” This legal mechanism allows a drug to lose its monopoly patent status, enabling it to be marketed in its generic form under a different brand name.
The decision by Colombian health authorities was made following a detailed study with input from experts in the scientific community, industry professionals, and government officials, as is customary in such cases.
To evaluate the final decision, an Interinstitutional Technical Committee was established from August 1 to August 18, 2023, recommending that dolutegravir’s patents be subjected to a “government public use license.”
The Challenge of Treating the Migrant Population
In Colombia, there are approximately 142,000 diagnosed citizens living with HIV who receive antiretroviral treatment. The challenge for healthcare authorities lies in the significant number of individuals who remain undiagnosed or, for various reasons, discontinue treatment. In addition to compromising their health, these individuals contribute to new HIV infections.
This situation is exacerbated by the large migrant population, primarily from Venezuela, that Colombia has received over the past five years. Between 2 and 3 million people have crossed the border fleeing their home country’s complex social and economic situation. Among them are individuals infected with HIV who require diagnosis and, most importantly, daily treatment to manage the disease and prevent its spread.
According to the Ministry of Health, the declaration of public interest will lead to a substantial decrease in the cost of antiretrovirals, increasing access to these drugs for those who need them. This is the first step in preventing the British pharmaceutical company that markets the medication from maintaining exclusive rights to dolutegravir. The patent is not set to expire until 2026.
High Costs Due to Patents
Experts view the Ministry of Health’s decision as a positive development. In comments to RCN Radio, Francisco Viegas, an advisor to Doctors Without Borders, stated that the main barrier to providing HIV treatment to patients is the high cost of medications. “This is not just a problem in Colombia but also throughout Latin America due to high infection rates.”
Viegas explained that such a move would help prevent the spread of the infection and reduce the economic burden on patients, as generic medications are 90% cheaper. Regarding dolutegravir, he noted that it is endorsed by the World Health Organization (WHO) and has no side effects.