New laws enacted in Russia this week will see the manufacture of medicines coming both into the country and going out of it placed under heavier regulation in an attempt to stamp out counterfeits.
Under the new law a large range of new stipulations has been laid down that will see medicines: 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, now carry criminal liability for individuals.
The Federal Law No. 532-FZ will allow the Russian government to criminalise the individuals who actually breached the above statutory requirements regarding the circulation of medicines, 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.
Those convicted may also have to pay a fine of up to RUB3 million (around €40,000), 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.
This is a strong move forward from previous laws which saw criminals involved in counterfeiting only be prosecuted under health and safety laws.
This new piece of legislation now for the first time introduces a dedicated offense and is in keeping with the Medicrime treaty, which Russia signed three years ago.
Russia has suffered from a bad reputation when it comes to counterfeit medicines both from the view of import and exporting drugs.
This new law will go some way to reassure the Russian market and the markets it sells to that its supply chain is being cleaned up.