Therapeutic setting: orphan patients ask to simplify the import of medicines
Russia has adopted, but not implemented, a law on the import of newly registered medicines in the country. It was assumed that at first they could be imported in original packages, where the information was presented in a foreign language. In 2024, a corresponding law was passed, but a government decree that should determine the specifics of the import and circulation of such medicines has not appeared. The All-Russian Union of Patients appealed to the Ministry of Health on behalf of orphan patients (they are the ones who primarily need such drugs) and asked to speed up the development of the document. The agency reported that the project is already undergoing regulatory procedures.
What is the difficulty of importation
Orphan patients — those who have been diagnosed with rare diseases, such as spinal muscular atrophy or cystic fibrosis, cannot always receive the foreign medicines they need on time. This is due to the lack of a government decree that simplifies the importation of newly registered drugs into Russia. The All-Russian Union of Patients appealed to the Ministry of Health with a request to return to the development of this document and accelerate its adoption.
"For patients with orphan diseases and their families, the issue of timely access to therapy is not formal, but vital," the letter says (Izvestia has it). "In many cases, we are talking about treatment that cannot be postponed, since delay can lead to a deterioration in health, loss of time that cannot be returned, and a decrease in the effectiveness of medical care."
The organization recalled that amendments to the law, which provide for the possibility of importing and circulating original orphan and (or) high-tech medicines in foreign packaging in Russia within 12 months after registration, were adopted back in January 2024. It was assumed that the Ministry of Health would issue a permit for the import of such drugs in foreign packaging within ten days, but with a sticker in Russian containing the necessary information about the drug. But the relevant government decree, which was supposed to determine the rules of import and circulation, has not been adopted.
"The public discussion of the draft resolution was completed back in October 2024, and the conclusion on the regulatory impact assessment was prepared in July 2025. However, the draft has not yet been adopted," the letter says.
As a result, a paradoxical situation has developed: orphan patients often begin therapy in the period before the drug is registered, when the drug has not yet been registered and is imported based on decisions of councils and medical commissions at the conclusion of the Ministry of Health, the All-Russian Union of Patients explained to Izvestia.
"But as soon as the drug is registered, it can no longer be imported using the mechanism for unregistered drugs, which entails risks of interruptions in treatment and does not allow new patients to be initiated until the drug is imported in Russian packages," the organization explained.
The press service of the Ministry of Health confirmed to Izvestia that they had received an appeal and informed them that the draft government decree developed by the Russian Ministry of Health was "currently undergoing regulatory procedures."
"The need for orphan medicines is ensured by the joint efforts of the Russian Ministry of Health, which implements simplified registration of such medicines, manufacturers who carry out their timely release into civil circulation, and regions that carry out procurement procedures in a timely manner," the ministry said.
Why do we need changes in the law?
Starting from September 1, 2024, Russia was actually allowed to import original orphan and high-tech drugs in foreign packaging, which would close the gap between the registration of the drug and its physical appearance on the market in Russified packaging, Polina Gabai, lawyer, chairman of the Board of Founders of the National Analytical and Expert Center for Healthcare, confirmed to Izvestia. According to her, the Russification of packaging can usually take from six to nine months.
"The time gap between the registration of a drug and its appearance on the market is typical for many drugs, but this problem is acutely felt in the orphan niche: in most cases, we are talking about alternative therapy, without which the disease begins to progress," she added.
She called the situation real and quite typical for Russian regulation: the legislator took a step towards patients, but the subordinate regulation, without which the norm does not work, is stuck.
— The problem is that the law itself is not self-executing, it requires a government by-law defining the specifics of importing such medicines. Formally, there is a legitimate opportunity, but there is no working mechanism," said Polina Gabai.
The adoption of the resolution should eliminate the "dead period" immediately after the registration of the drug, the expert noted. She stressed that the patient community is not asking for an extension of rights, but for the launch of a norm that is already provided for by federal law.
In fact, the legislation should have provided for an independent mechanism for the admission of certain categories of drugs, Irina Gritsenko, a lawyer in the field of medical law, confirmed to Izvestia. The amendments introduced an independent basis for the application of a special procedure — the affiliation of a medicinal product to the category of registered original orphan medicines and high-tech medicines.
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