The State Duma of Russia adopted in the first reading a package of bills, including amendments to Article 238 of the Criminal Code, which introduce liability for the import and circulation of unregistered medicines and medical devices, even if they are not produced in Russia and they are recommended for use by the World Health Organization.
The import of unregistered medicines and medical devices was prohibited even before that. But the exception was what is recommended by WHO. WHO offers an indicative list of recommended international non-proprietary names (INN, in fact, these are the names of active substances).
The authors of the amendments believe that such an exception to the rule as drugs from the WHO list "actually decriminalizes the import into the country and the sale of unregistered foreign medicines and medical devices, the safety of which has not been confirmed." If the amendments are eventually adopted, then the illegal import of unregistered drugs that are on the WHO list will fall under articles 238.1 of the Criminal Code of the Russian Federation and 6.33. Code of Administrative Offenses.
The criminal article provides for forced labor from 3 to 5 years and fines from 500 thousand to 2 million rubles, the administrative one - fines of up to 6 million rubles for legal entities and the suspension of their activities. According to a representative of the Ministry of Health, the new law will limit the attempts of gray imports into Russia of drugs with unconfirmed safety and from dubious sources, TASS writes.
What will change for patients and legal entities “Formally, the draft law does not provide for any restrictions on the legal import of unregistered drugs: neither by legal entities nor by individuals,” the expert of the Treatment Preparedness Coalition explained. “During the COVID times [the law] introduced this wording about WHO so that drugs could be quickly brought in if necessary, and now they decided to remove it so that drugs simply recommended by WHO are not [uncontrolled] imported,” he says.
The Ministry of Health also emphasizes that the changes will not apply to the import of unregistered medicines and medical devices for personal use, if there are supporting documents, TASS reports. Therefore, the expert of the All-Russian Union of Patients, Alexei Fedorov, is sure that the amendments should not negatively affect conscientious market participants and patients. General rules and procedure for the import of unregistered drugs According to Art. 47 of the Law "On the Circulation of Medicines", individuals can import unregistered medicines for personal use. No special permissions are required for this.
Legal entities also have the right to import unregistered drugs for the provision of health care for a particular patient - but only after obtaining permission from the Russian Ministry of Health. To do this, a copy of the protocol of the conclusion of a medical commission or a council of doctors of a federal institution on prescribing an unregistered drug for health reasons to a patient must be submitted to the department, or an appeal from a regional executive authority about the need to import an unregistered drug for health reasons with a copy of the decision of the regional medical commission or council.
According to the law, after these documents, the Ministry of Health must give an opinion within 5 working days. The main problems with the import of drugs At the same time, in 2019, there were several arrests of individuals for the importation of unregistered drugs into Russia, in particular, the drug clobazam (trade name - Frizium), which is necessary for patients.
The story took place in the summer of 2022 with an adult patient with cystic fibrosis Natalia Demina. She said that in July a volunteer from one of the Russian foundations was bringing Trikafta to her from the USA. At the request of Natalia, the expensive drug was bought by the American fund Palm Of Hope. According to the patient, she had an import permit from the Ministry of Health. So that customs would not suspect that it was being transported for sale in Russia, the volunteer removed the factory packaging, the tablets in blister packs were from different series.
Since the cost of the drug is more than 10 thousand dollars (about 25 thousand dollars for a month of treatment, in the case of Natalia - for 2.5 months), it had to be transported through the "red corridor" - declared and paid a fee. The patient says that the volunteer could not do this, because the fund bought the medicine and gave it to the patient for free use. As a result,
Sheremetyevo customs officers confiscated the drug from the volunteer and sent it for examination. As a result, in February 2023, the court ruled to bring the volunteer to administrative responsibility for not declaring goods subject to declaration (Part 1, Article 16.2 of the Code of Administrative Offenses).
The fine was replaced with a warning, and Trikafta was returned - however, the drug expired in the same month. All this time, Natalya took the remaining supplies of the drug in a reduced dose, and her condition worsened. According to Natalya, three months ago, another person, who was transporting Trikafta, encountered the same situation as the volunteer who helped her.