On May 27, 2016, the FAS of Russia published on its web site the draft road map for “Developing competition in health care” (hereinafter the “Draft”) which is planned to be approved by a respective resolution of the Government after public discussion.

The Draft provides certain measures for purposes of developing competition in health care, including improving the drug state registration procedure, enabling the mechanism of drug substitution, improving price regulations for VED,^[1] improving the law on state and municipal procurement of drugs and medical goods, etc.

The following proposals included in the Draft can be emphasized:

•      Cancellation of the requirement to perform local clinical research in the Russian Federation on condition that results of international research conducted in compliance with the rules of good clinical practice are available;

•      Procedure for faster simplified registration of drugs which have already been registered both in the EU and the US;

•      Requirement for pharmaceutical organizations to first offer consumers a cheaper substitute drug;

•      Requirement to provide information on all drugs having the same indications for use when considering the issue of including a drug into the vital and essential drugs list;

•      Approval of good laboratory practice rules, good clinical practice rules, rules of good practice in drug transportation and storage, rules of good practice of drug sale for medical use, and good pharmacy practice rules;

•      Rules for the remote sale of drugs (rules of drug delivery to consumers) for pharmacies.

The said changes will allow substantial improvements in the business conditions for pharmaceutical companies (simplification of the registration regime, facilitation of clinical research) and will have a positive impact on the development of competition on the market of substitute drugs. Furthermore, adoption of the good practice rules in various areas of health care will allow bringing Russian standards closer to international standards, which will improve the quality of drugs and health care services.

Irina Akimova  Of Counsel,  Head of Antitrust Practice                              Moscow   iakimova@cls.ru   Tel.: +7 (495) 970 1090

Dmitry Gavrilenko   Associate                   Moscow    dgavrilenko@cls.ru    Tel.: +7 (495) 970 1090

Additional notes

Should any questions arise in connection with the above or if you need any additional materials, please contact Irina Akimova or Dmitry Gavrilenko, Moscow Office of Capital Legal Services.

This Information letter keeps the clients of Capital Legal Services and other interested parties abreast of information that may, to any extent, affect their activity or cater to their particular interests. The opinions and commentaries expressed in this information letter shall not be deemed as legal opinions and do not cancel the need to obtain legal advice or legal opinion on separate issues.