Opening of the Procedure for Compulsory Licensing of Dolutegravir in Colombia

On June 2, 2023, the Ministry of Health and Social Protection of Colombia initiated ex officio the administrative procedure to subject the patents of the drug Dolutegravir to compulsory licensing on grounds of public interest. In Resolution 0881, the Ministry states that the primary objective of this procedure is to guarantee affordable and equitable access to treatment of the Human Immunodeficiency Virus (HIV).

The resolution is grounded on several studies that have revealed a concerning upward trend in the incidence of HIV cases in the Colombian population. According to the Surveillance System in Public Health (SIVIGILA), between the years 2018 and 2022, there has been a progressive increase in cases, rising from 14,064 to 18,410. Additionally, the same situation is observed among individuals from abroad, mainly from Venezuela, with an increase in HIV diagnoses from 410 cases in 2018 to 615 cases in 2022.

While HIV infection has been successfully controlled, and the life expectancy of affected individuals has improved globally, the resolution highlights that the high cost of the Dolutegravir medication, used as a foundation in preferred treatment regimens, has limited the healthcare system’s capacity to provide coverage for the affected population and compromised the efficient use of available resources.

The primary objective of the resolution is to initiate ex officio the administrative procedure to declare the existence of reasons of public interest for subjecting the patents of medications containing the active ingredient Dolutegravir to compulsory licensing. This measure would affect four patents related to pharmaceutical compositions that include the said active ingredient, all held by VIIV HEALTHCARE COMPANY and SHIONOGI & CO., LTD.

To conduct a comprehensive analysis, the resolution establishes an Interinstitutional Technical Committee responsible for examining the documents submitted within the framework of this procedure. This committee will be responsible for requesting additional information, obtaining technical support from other entities or experts in the field, and ultimately recommending to the Minister of Health and Social Protection the decision to declare or not the existence of reasons of public interest to subject the patents of medications containing the active ingredient Dolutegravir to compulsory licensing.

It is essential to emphasize that if the compulsory licensing is applied in accordance with the provisions of the Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) of the World Trade Organization (WTO), as set out in the Doha Declaration on the TRIPS Agreement and Public Health, it should not affect the overall protection of intellectual property rights. On the contrary, this mechanism seeks to establish a balance between the rights of patent holders and the public interest in health, allowing broader and more affordable access to essential medications while safeguarding intellectual property rights.

The complete resolution is available in Spanish at: www.minsalud.gov.co/Normatividad_Nuevo/Resolution%20No.%20881%20of%202023.pdf