Russia is tightening its control over the quality of both locally-produced and imported medicines and medical devices (“Medical Products”). Starting from 23 January 2015, the manufacture of Medical Products without a licence, the sale or import of improper, substandard or unregistered Medical Products, as well as the counterfeit of packaging or of documentation of such products will carry criminal liability for individuals.
With the entry into force of Federal Law No. 532-FZ dated 31 December 2014 on 23 January 2015, both the individuals who actually breached the above statutory requirements regarding the circulation of Medical Products (e.g. a worker employed on a plant where substandard Medical Products are manufactured, or a pharmacy assistant knowingly selling a counterfeit medicine) and the corporate officers of the entity employing such individuals are now at risk of facing a maximum prison term of eight or ten years, depending on the statutory requirements breached. Those convicted may also have to pay a fine of up to RUB 3 million (approx. EUR 40,780) or equal to their personal income for a period of up to three years. Some offences may also result in the offender’s disqualification from the holding of certain positions for a maximum of three or five years, again depending on the breach. If the commission of the offence has led to the death of two or more persons, then the maximum prison term, fine and/or disqualification period prescribed by law will be even higher than those stated above.
The improper, falsified or counterfeit Medical Products will also be confiscated in order to be either destroyed or exported from Russia at the expense of the offender. Previously this rule only applied to medicines, but it has now been extended to medical devices.
The introduction of criminal liability for those involved in the marketing of Medical Products in breach of the above requirements is consistent with the current trend of increasing state control over the quality of Medical Products in Russia through new legislation. Related significant policy developments include the recent introduction of (i) mechanisms for the confirmation of medicines’ conformity to GMP standards and (ii) increased powers for the public health state supervisory bodies (on which we previously reported and which were signed into law word-for-word on 22 December 2014).
The adoption of legal deterrents to combat the practices of bad faith pharmaceutical and medical-device market players in Russia can be seen as a positive step that should contribute to cleaning up the industry and to bringing the local environment closer to the best international practices.