FAS is asked to compulsorily license dolutegravir prescribed to patients with HIV

The expert community is asking the Federal Antimonopoly Service (FAS) to assist in issuing a compulsory license for dolutegravir, an anti-HIV drug purchased in 2023 for 10 billion rubles. The authors of the idea believe that this will reduce prices for the medicine and reduce its shortage. Manufacturers of generic drugs are expected to support this initiative. However, the owner of the original product, the rights to which are protected in Russia until 2029, the British GSK is ready to challenge the violation of patent rights for dolutegravir.

The FAS asked Zdravresurs, an association of experts involved in monitoring the availability of treatment for socially significant diseases, to issue compulsory licensing in Russia for dolutegravir, prescribed to patients with HIV. Kommersant has a copy of the appeal to the department. The FAS told Kommersant that they are studying information received from Zdravresurs.

The association insists that a compulsory license for dolutegravir is necessary in the context of a budget deficit. In 2023, government customers purchased dolutegravir for 10 billion rubles, of which 2.8 billion rubles came from the 2024 budget. The Ministry of Health has been using funds allocated for future periods for the third year in a row, while the total budget for the centralized purchase of antiretroviral therapy has not increased, the authors of the appeal to the FAS indicate. According to them, in total, in 2023, the ministry purchased 100 thousand courses of dolutegravir, while 160 thousand people should receive the drug. As a result, in 2023, the Patient Control movement received 324 reports of drug shortages from 47 regions.

The Ministry of Health told Kommersant that the regions are provided with dolutegravir for more than 3.5 months. The supply of the drug under a three-year contract concluded in 2021 has been completed, and under two more contracts from 2023, dolutegravir will be delivered before February 1 of this year, the ministry clarified.

In Russia, the original dolutegravir under the trade name Tivicay, protected by an EAEU patent until 2029, is supplied by the British GSK. The company told Kommersant that Tivicay is available in Russia, is produced at the facilities of Servier Rus and is delivered on time in accordance with the terms of the contracts. In the event of patent infringement or threatened infringement, GSK “reserves the right to pursue all appropriate remedies.”

A compulsory license, Zdravresurs concludes, is needed due to the urgent need to further reduce prices for medicine and will make it accessible to many patients. Price reductions are possible due to the introduction of generics to the market. According to the state register of medicines, an analogue of dolutegravir was registered in December 2023 only by R-Pharm, which declined to comment. In 2023, a number of pharmaceutical companies, including ChemRar, Pharmstandard, Pharmasintez, Promomed, Advance Pharma, conducted bioequivalence studies of the drug.

ChemRara told Kommersant that they are at the stage of obtaining a registration certificate for their drug, adding that they are ready to apply to the government to obtain a compulsory license in the event of a shortage in the market. Advance Pharma says it is “exploring the possibilities” of registering the drug, “including on the basis of a voluntary or compulsory license.” Promomed added that they do not plan to allow violations of the legitimate interests of third parties and are working on all legal remedies. ChemRar, Promomed and Advanced Pharma assure that their production capacity will cover the need for the drug.

The Civil Code of the Russian Federation allows for the issuance of a compulsory license “in case of extreme necessity” related to “ensuring the defense and security of the state, protecting the life and health of citizens.” The FAS explained to Kommersant that we are talking about situations where a medicine cannot be replaced, and the patent holder cannot or refuses to cover the citizens’ need for this drug.

Senior lawyer of the corporate practice of FTL Advisers Anastasia Semenova believes that the authorities will most likely be able to classify the situation as an emergency related to ensuring the health of citizens and issue a license. Dolutegravir is one of the most modern drugs with a low number of side effects, and its acquisition “costs the state several times more” than in other EAEU countries, the expert points out. In Brazil, the price per package at the current rate is about 2.4 thousand rubles, in Belarus – about 2.6 thousand rubles, Zdravresurs gives examples in the letter. In the Russian Federation, the maximum price is almost 5.6 thousand rubles. without VAT. At the same time, GSK claims that it is ready to discuss issues related to ensuring the availability of dolutegravir for patients in Russia.

Polina Gritsenko