The Federal Antitrust Service of Russia prepared a draft road map for “Developing competition in health care”

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.