The Ministry of Health proposed to make the conditions for bringing to criminal and administrative responsibility for the import of unregistered medicines and medical products more specific. The current wording in the Criminal Code and the Code on Administrative Offences, according to the Ministry, decriminalizes the import of products whose safety has not been confirmed. This is reported by Farmatsevticheskiy Vestnik.
The Ministry of Health of the Russian Federation prepared and put it up for public discussion at regulation.gov.ru the draft law “On amendments to Article 238 of the Criminal Code of the Russian Federation”, which concerns the import of unregistered medicines or medical devices.
The document proposes to set out paragraph 3 of the note to Article 238.1 of the Criminal Code in a new version, according to which its effect
does not apply to cases of sale or import for the purpose of sale of unregistered medicines or medical products in Russia, if such products are not produced domestically and their circulation is allowed in accordance with the legislation.
In accordance with the current version, the article does not apply to the above cases, as well as if medicines and medical products are recommended for use by the World Health Organization (WHO).
“This wording means that if even one of two conditions is met, it actually decriminalizes the import into the Russian Federation and further sale of unregistered foreign medicines and medical devices, the safety of which has not been confirmed. It should also be noted that the WHO does not maintain lists with an identical name, i. e. “medicines and medical devices recommended by WHO”. The existing WHO Model Essential Medicines List (EML) uses international nonproprietary names without reference to a specific drug and its manufacturer,” the explanatory note says.
The Ministry of Health believes that these legal ambiguity “does not allow law enforcement agencies to make a reasonable procedural decision in case of detection of facts of trafficking in unregistered medicines and medical devices.”
In addition, the Ministry of Health offers to make appropriate amendments to Article 6.33 of the Code on Administrative Offences of the Russian Federation, which also proposes to exclude permission for the import of unregistered medicines and medical products if their use is recommended by WHO.
