First-ever pharmaceutical compulsory license 
October 06 2023
first-ever pharmaceutical compulsory license

In September, we reported that the Interinstitutional Technical Committee (ITC) recommended to the Ministry of Health (MinSalud) to declare the existence of reasons of public interest to subject two Dolutegravir (DGT) patents to compulsory licensing. In this regard, on the second of October of this year, MinSalud issued Resolution 1579, through which it officially adopted the ITC’s recommendation, confirming that, up to this point, there will be the first compulsory license for a pharmaceutical patent in Colombia.

In this way, MinSalud deemed the arguments against the ITC report presented by several interested third parties as unfounded and, on the other hand, agreed with the reasons given by the CTI, which were: i) alleged increase in HIV/AIDS cases in the country; ii) the need for the standardization of disease treatment to meet international standards; iii) the need for medical treatment to specific groups; and iv) the reduction of treatment costs.

In its resolution, MinSalud informed the Superintendence of Industry and Commerce that it should initiate the process for granting the respective compulsory license. However, various administrative and judicial mechanisms can be filed against this resolution, such as an appeal for reconsideration, an action for nullity, or a non-compliance action at the level of the Andean Community.