Russian Court restricts the authority of FAS for interchangeability of drugs

| By | Drug Procurement, FAS Russia, Ministry of Health Care

Today, the procurement of drugs is regulated by the Federal Law FZ-44, under which the state customer has the right to specify INN of the drug and other “product characteristics” in the description of the lot. In practice, in addition to INN, the institutions can specify the strength and dosage form of the drug, as this allows them to purchase the medicines that are more suitable for the patients.

By January 1, 2018, the Ministry of Health plans to establish a single database of interchangeable drugs and include this information in the state register of drugs.

In 2015, Biocad submitted to the Federal Antimonopoly Service (FAS) a request to recognize as interchangeable one of its product and a drug manufactured by Teva for the treatment of multiple sclerosis. In its response to request of the company submitted in February 2016, FAS said that the drugs are regulated by antimonopoly legislation and the agency believes that “all medicinal products with the same INN must be equivalent,” while the state customers, in turn, must ensure equal access to tenders for manufacturers of drugs with different strengths. The letter dated August 26, 2016 and signed by the head of FAS Igor Artemyev states that the decision on the request of Biocad should become a precedent for all regional bodies of the agency and from now on they must monitor the implementation of clarifications provided by FAS with regard to interchangeability of drugs in public tenders.

Teva tried to challenge in arbitration courts the results of specific auctions and, in 2017, appealed to the Supreme Court with a lawsuit, in which it demanded to invalidate the letter of FAS. In its judgment of July 24, the Supreme Court decided to satisfy the company’s claim and invalidate a number of paragraphs in the document sent by the agency to its regional bodies. In the opinion of the court, the letter of FAS in fact became a “mandatory order of general nature” while, according to the rules for determining the interchangeability of medicinal products for human use, only the “expert body,” i.e., the expert institution subordinated to the Ministry of Health, has the right to determine the interchangeability. The press service of FAS announced that the agency will appeal this Supreme Court decision.