HIV retroviral approved for use in Colombia: Dolutegravir to benefit thousands of patients

November 7, 2024

Green light for the use of Dolutegravir, a retroviral HIV drug. The SGCAN’s decision puts an end to the lawsuit investigating the breach of intellectual property rules. The drug is expected to benefit thousands of patients.

Retroviral contra el VIH, medicamento, pastas, Más Colombia

The General Secretariat of the Andean Community (SGCAN) issued a ruling in favor of Colombia establishing that the country has not breached the industrial property commitments of the Andean Community by implementing a compulsory license for the use of a HIV retroviral.

This ruling follows the Colombian government’s decision to allow the importation and production of Dolutegravir, a retroviral HIV drug crucial for treating the disease. The measure ensures that this anti-HIV drug reaches the most vulnerable populations, including Venezuelan migrants and people recently diagnosed in Colombia. We tell you what is behind the ruling.

retroviral anti-HIV drugs, medicines, pills, Más Colombia

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Colombia authorizes the use of Dolutegravir, HIV retroviral

In April, the Colombian Superintendency of Industry and Commerce (SIC) authorized the compulsory license, allowing the Ministry of Health and Social Protection to use this retroviral against HIV in its generic version.

This retroviral HIV drug is essential because, in essence, it blocks the replication of the virus, thus improving the quality of life of those affected. With this license, the government aims to ensure access to this anti-HIV retroviral for groups facing economic constraints and access barriers.

The measure provides for the distribution of this anti-HIV retroviral among people who are resistant to other treatments, newly diagnosed migrants and those who require post-exposure prophylaxis. In the current context of increasing HIV cases, this decision is an urgent public health response to curb the spread of the virus and ensure access to anti-HIV retroviral.

HIV retroviral, medicines, pastes, tablets, treatment of diseases, Más Colombia

Legal dispute over alleged intellectual property violations

The conflict began when the patent holders of Dolutegravir expressed their concern to the SGCAN in August 2024, claiming that the Colombian measure violated Andean intellectual property regulations. They argued that the license for the HIV retroviral lacked a defined time limit, which, in their view, could constitute a violation of the industrial property regime stipulated in Article 65 of Andean Decision 486.

This article allows compulsory licenses for exceptional situations, such as public health emergencies, when certain requirements are met to protect the rights of patent holders. However, the SGCAN concluded that, given the nature of the measure, it is not feasible to establish a specific duration for the licensing of the retroviral against HIV. The duration of this measure will depend on factors such as the epidemiological situation and the population’s access to this anti-HIV retroviral.

The agreement also stipulates that the Ministry of Health and Social Protection will compensate the patent holders with $0.11 per milligram of this anti-HIV retroviral in its generic form. This allows the Ministry to purchase 50 milligrams of this anti-HIV retroviral in a presentation of 30 tablets at a cost of approximately $15,000, which is considerably less than the price of the brand-name drug, which is around $450,000.

HIV retroviral, pills, tablets, medications, Más Colombia

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The SGCAN’s endorsement of Colombia’s decision to offer this anti-HIV retroviral represents a step forward in the construction of a public health model that prioritizes the well-being of the population. With this decision, the Andean Community supports the use of compulsory licenses to protect access to essential medicines, such as retroviral against HIV, in emergency situations.

This resolution also aims to reduce the number of new HIV cases in the country, which reached 9,389 in 2022. By facilitating access to this retroviral against HIV, it seeks to improve the quality of life of those living with the virus and reduce transmission. The inclusion of Venezuelan migrants as beneficiaries of the retroviral against HIV represents a public policy of attention to the most vulnerable groups, ensuring accessible and quality treatment in favor of a healthier and more equitable society.