Legislative frameworks to combat illicit trade in medical products in Russia

• Civil Code of the Russian Federation
• Russian Federal Law on Circulation of Medicines dated 12 April 2010
• Russian Federal Law on Fundamentals in Healthcare Protection dated 21 November 2011
• Russian Code on Administrative Offences
• Criminal Code of the Russian Federation

Medical devices, veterinary medicines, biologically active supplements.

It is a separate group of crimes: the production, import and sale of non-registered, counterfeit or falsified medicines or medical devices, medicines or medical devices of improper quality.

Russia ratified the Medicrime convention in March 2018. The convention has been applicable in the country since 1 July 2018.

The import and sale of non-authorised, falsified, counterfeit or defective medicines can be deemed an administrative offence or a crime depending on the cost of non-compliant products.

If the cost of falsified or counterfeit medicines have been imported or sold does not exceed RUB 100,000 (approx. EUR 1,100), the wrongdoing will be qualified as administrative offence. This can result in a fine for individuals of up to RUB 600,000 (approx. EUR 7,000); and for legal entities of from RUB 1,000,000 up to RUB 5,000,000, or compulsory suspension of business for up to 90 days.

If the cost of falsified, counterfeit medicines or medicines of improper quality exceeds RUB 100,000 the action will be qualified as a crime and the perpetrator is at risk of a prison term of up to eight years. Moreover, if the administration of counterfeit or falsified medicines has led to the death of two or more persons, the prison term for the convicted may be increased to up to 12 years.

Those convicted may also have to pay a fine of up to RUB 3 million (approx. EUR 39,600) or equal to their personal income for up to three years. These offences may also result in the offender’s disqualification from holding certain positions for a maximum of three or five years, again depending on the breach.

There is no special liability for the falsification/counterfeiting of biologics. The same rules apply.

The Russian Federal Service on Surveillance in Healthcare (“Roszdravnadzor”) is mainly responsible for anti-counterfeiting activities regarding medicines.

The regulator reacts to notifications from citizens and legal entities about the detection of suspicious/potentially counterfeit or falsified products, and checks the received information. Furthermore, Roszdravnadzor conducts its own control measures aimed at preventing the circulation of counterfeit or falsified medicines and medical devices (e.g. test purchases, selecting samples, dawn raids).

Furthermore, if the importation or sale of falsified or counterfeit medicines or medical devices constitutes a crime (see the answer to question 5 above), then the Criminal Investigation Committee of the Russian Federation becomes involved. The criminal proceedings are managed by the Criminal Investigation Committee which has powers to perform interrogations, pretrial detentions, and transfer of materials to a court.

The manufacturers, MAHs or IP rights holders have a right to apply to the competent authorities, if they believe that there are illicit trade/counterfeit/falsified medicines on the market violating their lawful rights. The application should be supported with confirmation documents and other information that might be of importance to investigators.

Once the application is accepted by the authority and the investigation starts, the applicant might be engaged by the authorities to provide additional information and support, if needed. However, the applicant’s role is usually not very active as the investigation is further managed by the authorities.

Russian civil law allows the filing of a case to recover damages incurred by an illegal action, including the distribution of improper, counterfeit or falsified medicines (or other products).

In doing so, the applicant must evidence the cause-and-effect relationship between the counterfeiting/falsification of a medicine and the incurred damages. The amount of actual damages will be duly calculated and confirmed by documents. In addition to the actual damage, the plaintiff has a right to require compensation for moral damage. However, the amounts awarded by Russian courts as compensation for moral injury are traditionally low.

Only over-the-counter medicines can be sold online. Pharmacies licensed for pharmaceutical activities have the right to sell medicines online provided they comply with the requirements on distance sales of medicines stipulated by law, e.g. at least ten offline pharmacies and at least one year’s experience in pharmaceutical retail activity.

Before starting online sales of medicines, a pharmacy must obtain a special authorisation from the Russian healthcare authority.

Medical devices can be sold online without a special requirement; provided, however, the general requirements of the online sales of goods are observed, and the applicable provisions of the consumer laws are complied with.

Since 1 July 2020, the mandatory “track-and-trace” system has been in place in Russia. Each medicine is provided with a unique track-and-trace code which can be checked at any stage of the supply chain from the manufacturer until final consumer. The lack of such code is a mark of counterfeited/falsified product.

For the time being, the legislative framework in the sphere of combating illicit trading and other illegal activities involving counterfeited/falsified medicines appears to be sufficiently reasonable. No fundamental changes are expected in the near future.