Restrictions on Import of Unregistered Medicinal Drugs and Medical Devices Can be Amended

24 April 2023
Anzhelika Kalashyan
Associate
Nadezhda Fedotova
Associate

The State Duma has adopted in the first reading amendments to article 238.1 of Criminal Code, establishing liability for circulation of unregistered medicinal drugs and devices in Russia1.

The bill proposes to exclude from note 3 to the article 238.1 a case of non–criminalization – the existence of a recommendation by the World Health Organization for the use of appropriate unregistered medicinal drugs and devices.

As of now, according to this note 3, liability for sale and/or importation into the territory of the Russian Federation for the purpose of sale is excluded if:

  • such medicinal drugs and devices are not manufactured in the Russian Federation
  • sale and/or import of medicinal drugs or devices are allowed in accordance with the legislation on the circulation of medicinal drugs and legislation in the field of health protection, respectively
  • these medicinal drugs or devices are recommended for use by the World Health Organization.

Thus, if this bill is adopted, the sale or import into the territory of the Russian Federation for the purpose of selling of unregistered medicinal drugs or devices recommended for use by the World Health Organization, but not provided for by legislation on the circulation of medicines and legislation in the field of health protection, on a large scale (that is, worth more than RUB 100,000) will entail criminal liability in the form of2:

  • forced labor for a period of 3 to 5 years with or without deprivation of the right to hold certain positions or engage in certain activities for a period of up to 3 years
  • imprisonment for a term of 3 to 5 years with a fine of RUB 500,000 to 2,000,000 or in the amount of the convicted person’s salary or other income for a period of 6 months to 2 years or without it, with deprivation of the right to hold certain positions or engage in certain activities for up to 3 years or without it.

Similar amendments are proposed to Article 6.33 of the Code of Administrative Offences, which establishes administrative liability for the sale or import into the territory of the Russian Federation of unregistered medicinal drugs and devices worth less than RUB 100,0003. The bill also passed the first reading in the State Duma and, if adopted, will entail liability for the import of these unregistered goods even with the recommendation of the World Health Organization:

  • for citizens – an administrative fine in the amount of RUB 70,000 to 200,000
  • for officials – an administrative fine in the amount of RUB 100,000 to 600,000
  • for sole proprietors – an administrative fine in the amount of RUB 100,000 to 600,000 or administrative suspension of activity for up to 90 days
  • for legal entities – an administrative fine in the amount of RUB 1,000,000 to 6,000,000 or administrative suspension of activity for up to 90 days.

Such a change in the regulation of the circulation of unregistered medicinal drugs and devices may have a negative impact on importers because they well be required to narrow down the list of imported drugs and medical devices to the territory of the Russian Federation, as well as for patients due to the potential lack of access to abovementioned products on the Russian market. Moreover, the issue of liability for the circulation of goods, the delivery of which was carried out before the entry into force of these amendments, and the sale of which on the territory of the Russian Federation will be carried out after the amendments’ entry into force, remains unanswered.

1 Bill No. 103499-8 “On amendments to Article 238.1 of the Criminal Code of the Russian Federation” // URL: https://sozd.duma.gov.ru/bill/103499-8
2 At the same time, liability may be tightened, for example, in the case of harm to human health due to the commission of such actions
3 Bill No. 103500-8 “On amendments to Article 6.33 of the Code of Administrative Offences of the Russian Federation” // URL: https://sozd.duma.gov.ru/bill/103500-8