Colombia will be able to produce and import on a large scale a generic and affordable drug for HIV. This has been determined by the Andean Community Court of Justice in the litigation it had with two foreign pharmaceutical companies over the use of the dolutegravir patent. The decision authorizes the State to use it without the consent of its holders, a battle that the left-wing government of Gustavo Petro has committed to. The losers are the plaintiffs ViiV Healthcare, a British company specialized in HIV treatments, and the Japanese Shionogi. Both argued that the compulsory license imposed by the Ministry of Health in 2024, in an unprecedented decision that authorized the manufacture and import of the drug for reasons of public interest, was illegal.
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In its ruling, the court concluded that Colombia did not violate the Andean regulations governing patent protection and endorsed the use of compulsory licenses in cases of public interest, such as access to HIV treatments. The pharmaceutical companies claimed that the Government did not sufficiently justify the measure nor clearly define aspects such as its duration, scope, or economic compensation for the patent holders. They also questioned that prior avenues such as direct negotiation had not been exhausted. The court rejected these arguments and pointed out that States can grant this type of license when there is a valid justification, with leeway to set its conditions case by case, without the need for authorization from the companies.
The origin of the litigation dates back to October 2023, when the Ministry of Health declared the drug as of public interest, and to April 2024, when it formalized the compulsory license. It was an unprecedented decision in Colombia. Although the government of former president Juan Manuel Santos had initiated the same process with imatinib, a treatment for some types of cancer, it ultimately negotiated a lower price with the pharmaceutical company owning the patent, so the process never reached compulsory licensing.
In the case of dolutegravir, the Government authorized other manufacturers to produce or import generic versions without the patent owner’s permission, aiming to reduce prices and expand access. It was then that the pharmaceutical companies sued the State alleging that this measure violated their intellectual property rights.
The regional court’s decision consolidates one of the most ambitious measures of the Petro Government regarding access to medicines and grants it a victory on the health front, a sector deteriorated under its administration and in a context marked by criticism of its system management. Amid financing problems, difficulties in access to services, and tensions with insurers, the ruling represents a relief for the Executive and reinforces its commitment to intervene in the pharmaceutical market to lower treatment costs.
The decision also comes at a time of high pressure: this Wednesday, the state National Cancer Institute announced that it will not attend to new cancer patients referred by Nueva EPS, the country’s main insurer and also owned and managed by the Executive. The prestigious clinic argues the lack of a contract guaranteeing payments, another of several episodes that highlight the magnitude of the crisis.
The Government has celebrated the ruling of the court based in Quito. In a statement, the Ministry of Health has assured that “this measure guarantees a balance between health protection and intellectual property regulation” and that it will “strengthen access to treatments and advance towards greater equity in health.” President Petro has also claimed the ruling as a victory and stated that his Government has “reduced the price of AIDS medicine to the maximum” – although dolutegravir is a drug for the treatment of HIV, the virus that, without treatment, can lead to that disease.
The price reduction has indeed been significant. According to the National Drug Price Commission, a bottle of 30 tablets of 50 mg cost around 480,000 pesos in 2023 (about 95 dollars at the exchange rate then), before the compulsory license. After the entry of generic versions, the cost has dropped to about 15,000 pesos per bottle (a little over four dollars), which represents a reduction of more than 90% and allows for substantially expanded coverage. That change, in any case, applies only through public distribution systems and the EPS, not in common pharmacies, where the price remains at 480,000 pesos.
Beyond this specific case, the ruling represents a victory for States in the discussion about their ability to intervene in patents in public health contexts, a debate that has gained special relevance after the Covid-19 pandemic. In that sense, the court sets a precedent that grants leeway to countries in their effort to prioritize access to essential treatments in an affordable and broad manner. And, concretely, it paves the way for Colombia and other countries subject to Andean regulations (Peru, Ecuador, and Bolivia) to decree other compulsory licenses, as long as the requirements that the Court reviewed and validated in the dolutegravir case are met.