The Russian Ministry of Health has published an order extending the provisions on the interdepartmental commission that determines drug shortage or a risk of shortage due to anti-Russian sanctions. The main provisions of the document are now valid until the end of 2027, and some points until the end of 2025.
According to the document, drugs in short supply must be included in the list of drugs in short supply within 10 working days from the date of the decision taken by the commission. The Commission determines the presence of a shortage, and also decides on a temporary permit for the use of unregistered drugs, if analogues of the drug in short supply are available in Russia. In addition, it is considering the possibility of selling and using medicines in packaging intended for other countries, and cancels previously issued permits if the shortage is eliminated.
A shortage is recognized if the manufacturer or supplier has ceased operations, as well as if the medicine has been deregistred in Russia. Other criteria include the absence of key components for the production of a particular drug, as well as its therapeutic analogues. Another reason for recognizing a shortage may be the conclusion on the fact by Roszdravnadzor.
Information about the drug, which was proposed to be recognized as drug in short supply, will be published in the register on the website of the Ministry of Health in the “Journal” section, no later than 6 working days before the meeting. If the shortage is resolved, the decision to exclude a drug from the list of drugs in short supply is made no earlier than 9 months after its inclusion in the list.
The commission consists of representatives of the Ministry of Health, the Ministry of Industry and Trade, the Federal Customs Service, Roszdravnadzor, the Federal Antimonopoly Service and other departments, and has at least 11 members. If necessary, other experts may be asked to participate in the examination of the situation, but without the right to vote. The Commission holds meetings as necessary, but no later than 20 days after the submission of the documents to be considered. Decisions are made by a majority vote, but some issues require unanimity. The results of the decisions have to be published in the form of conclusions on the website of the Ministry of Health.
The Ministry of Health extended the working procedure of the interdepartmental commission for drug shortage identification in March 2024 against the background of sanctions. The term of the commission’s operations had been supposed to expire at the end of 2024.
Earlier, the Ministry of Health approved the new composition of the Ethics Council, which was formed in 2022. The updated version includes seven specialists, while nine former members have been excluded. The Council evaluates the ethical validity of clinical trials of new drugs, including those intended for use in difficult situations (for example, military operations or drug shortages due to sanctions).