A box of Dolutegravir tablets.
The Ministry of Health declared this Monday the patent of a drug “of public interest”, which was the previous step to deprive the company that sells it of exclusive rights and grant a compulsory license. If successful, it would be the first license of its kind in the country. This is Dolutegravir, a drug used in HIV patients whose patent in Colombia belongs to the British pharmaceutical company ViiV Healthcare, which specializes in HIV drugs and AIDS treatments.
The ministry argues in an official statement that the declaration is due to the need to cover the general population as there is a “high HIV prevalence” in the migrant population. Almost 3 million foreigners live in Colombia, the vast majority of whom are Venezuelans. ViiV Healthcare, which holds the license for the drug until 2026, has 10 days to file an appeal for reconsideration. It is defined by Minister Guillermo Alfonso Jaramillo, who made the decision to declare it of public interest. The lab has not commented on the announcement.
The government’s aim is to reduce the price of the drug and avoid “a situation of lack of access” to HIV treatments. At the time of publication of this article, the regulated commercial price for a bottle containing 30 tablets of 50 mg dolutegravir is COP 401,574 (approximately US$95), according to the National Commission on Drug and Medical Device Prices.
Opening the patent would allow the government to offer a generic version of the drug at a cheaper price, while ViiV Healthcare could continue to sell it at current costs. According to The High Cost Account, a technical organization of the health system that acts as a fund for payments for the most expensive diseases, 8% of HIV patients in Colombia use this antiviral.
The statement is the result of a process the ministry initiated in June to examine the possibility of subjecting dolutegravir patents to compulsory licensing. Since then, ViiV Helathcare and its main shareholder, the pharmaceutical company GlaxoSmithKline, as well as several industry unions have spoken out against it. For example, the Colombian Intellectual Property Association or the Afidro labor union. Some asked to negotiate with ViiV to sell the state to them at a lower price, others agreed to the government’s proposal.
The ministry went ahead and formed an interagency technical committee with delegates from the ministries of health and commerce and the department of national planning. The committee met in early August and recommended that the patents be declared in the public interest and then subject to compulsory licensing. The ministry explains that it made the decision to make this change because it has a “duty to ensure access to health promotion, protection and recovery services for all people” under Article 49 of the Constitution.
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Although ViiV Healthcare did not comment on Monday’s statement, it responded to the committee’s conclusions in August. He said he disagreed with the decision and argued that there was “no clarity about the origin of the information contained in the report,” according to the MinSalud communiqué.
Carolina Gómez, a specialist lawyer in patent and health issues, explains via telematics that the process from a declaration of public interest to a compulsory license is unknown. “Nobody knows because it was never done,” he claims. “It is a process that the Industry and Commerce Regulatory Authority must carry out. There is a general rule in the sole circular of this institution but it has not been published,” he added.
The only time the country declared a drug of public interest was in 2016 when the government of Juan Manuel Santos used imatinib, a drug used to treat some types of cancer. On this occasion, the government ultimately negotiated a lower purchase price in the face of internal and external pressure, but failed to achieve the required license.
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