Baker & McKenzie : Restrictions in healthcare and advertising of medicines

The Russian pharmaceuticals market is about to see yet more substantial new developments in its regulatory framework, which this time are related to interaction with healthcare professionals and to the advertising of medicines.

The Russian Federal Antimonopoly Service ("FAS") recently distributed draft amendments to Russian legislation (including to the still pending draft of the Federal Law on the Circulation of Medicines). These amendments are intended to significantly restrict the interaction between pharmaceuticals companies and Russian healthcare professionals. They are currently the subject of extensive discussion between FAS and representatives of the pharmaceutical industry in Russia.

The key points which FAS intends to introduce through the new regulations are as follows:

  • Detailed rules regarding conflicts of interest of healthcare professionals (resulting from their interaction with pharmaceutical companies);
  • Prohibition on visits of representatives of pharmaceutical companies to medical professionals at their workplace and during working hours;
  • Further restrictions upon pharmaceutical companies making gifts or donations to medical professionals, healthcare institutions and pharmacies;
  • Restrictions on events organized for medical professionals by pharmaceutical companies; and
  • New rules regulating "post-clinical" trials of medicines (as distinct from the rules governing clinical trials themselves) occurring after a medicine is registered in Russia (among other things, providing for a maximum number of participating patients).

Additionally, amendments to Article 24 of Federal Law No. 38-FZ on Advertising dated March 13, 2006 have been introduced into the Russian Parliament. These amendments suggest a whole new version of Article 24, the provision that governs the advertising of medicines.

Most importantly, it is proposed to extend to all medicines the regulatory regime currently applicable only to prescription medicines: advertising of medicines will be totally prohibited except in places where medical or pharmaceutical exhibitions, seminars, conferences or other similar events are held, or in specialized printed publications intended for medical and pharmaceutical professionals only.

Questions regarding this issue may be addressed to Paul Melling, Partner at Baker & McKenzie, London (+44 20 7919 1000), Alexey Trusov, Partner, and Sergei Lomakin, Associate, at Baker & McKenzie, Moscow (+7 495 787 2700), or to Maxim Kalinin, Partner, at Baker & McKenzie, St. Petersburg (+7 812 303 9000).