On February 11, 2016 the Federal Law “On Ratifying the Agreement on Common Principles and Rules for the Circulation of Medical Devices (Medical Goods and Medical Equipment) Within the Framework of the Eurasian Economic Union” and Federal Law “On Ratifying the Agreement on Common Principles and Rules for the Circulation of Pharmaceuticals within the Framework of the Eurasian Economic Union” (Agreements) came into force.
The entry of the federal laws into force signals the launch ofn the single market for pharmaceuticals and medical devices, which has great international significance. It must be noted that the launch of the single pharmaceutical market in the Eurasian Economic Union (EAEU), as announced by the Treaty on the Eurasian Economic Union of May 29, 2014 and then scheduled for January 1, 2016, was postponed due to the delayed ratification of the agreements by the Russian Federation – the last remaining EAEU member to ratify.
It is expected that a number of the Eurasian Economic Commission (EEC) Decisions developed in 2015 with the purpose of regulating relations and institutions on the single pharmaceutical market, establishing good practices for registration of medicines and the common register of medicines, will be adopted by the end of March. Such EEC decisions are not subject to ratification and will have a direct effect on the member states.
For all market players a single pharmaceutical space will mean new opportunities as a result of unifying the rules and regulations, as well as new challenges: a number of issues such as the transition period for drugs’ registration, the procedure for determining the interchangeability of the drug at the registration stage, different interpretations of rules by the regulators remain unresolved.
In addition, in May 2015, the EEC has received the status and powers of the new supranational antitrust authority. In accordance with the Treaty on the EAEU, the Commission monitors compliance with the general rules for competition in the cross-border markets. These powers include not only the conduct of antitrust investigations, but also field audits together with national regulators. The creation of the single pharmaceutical market might result in new antitrust risks that need to be evaluated in a timely manner.