The Constitutional Court of the Russian Federation approved the issuance of compulsory licenses for vital medicines

The Constitutional Court of Russia has recognized as legitimate the practice of issuing compulsory licenses to Russian pharmaceutical companies to produce analogues of foreign drugs without the consent of their owners if there is a risk of a shortage of original medicines due to sanctions or high prices for vital medicines.

According to TASS, the decision was made during the consideration of a case concerning a Vertex drug manufactured in the United States for the treatment of cystic fibrosis, a disease included in the list of rare diseases for which budgetary financing is used.

In the case of Vertex, its shipments to Russia through the sole distributor, Sanofi Russia— began in 2021. However, later an Argentine company developed a cheaper analogue of the drug, which was distributed in the Russian market by MIK LLC. The company tried to negotiate a license with the patent holder, but failed to reach an agreement.

In court, MIC justified the need for a compulsory license by the risks of shortages due to sanctions and high prices for the original. Although the court of first instance rejected the claim, the appellate authorities, including the Intellectual Property Rights Court and the Supreme Court of the Russian Federation, decided to grant a compulsory license, supporting the possibility of importing the medicine.

The Court stressed that compulsory licensing can be used as a means of protecting citizens' social rights, especially in cases where medicines depend on people's lives and health. The court also stressed that companies whose patents belong to jurisdictions that support international sanctions against Russia play a special role in this matter. This creates risks of drug shortages, which, according to the court, is a justification for issuing compulsory licenses.

The government has expanded the list of vital drugs. What you need to know

In December last year, the Ministry of Health excluded 20 drugs from the list of vital and essential medicines (VED). Eight new drugs used in the treatment of anemia, neutropenia, recurrent pericarditis, tuberculosis and a number of oncological diseases were also added to the list.

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