Best International Practices — the Foundation for the Common Market of Medicines within the Eurasian Economic Union (EAEU)

Prior to the launch of the common market of medicines on the territory of the EAEU member states, a unique round table for the regulators and the pharmaceutical industry, the “International experience of the creation of a regional market of medicines” (experience and example of the European Union & Eurasian Economic Union), was held in Moscow. The Eurasian Economic Commission (EEC), the Association of International Pharmaceutical Manufacturers (AIPM), and the European Federation of Pharmaceutical Industries and Associations (EFPIA) were co-organizers of the event.

According to the Treaty on the Eurasian Economic Union and the Agreement on Unique Principals and Rules of Medicines’ Circulation on the Territory of the Eurasian Economic Union, the regional pharmaceutical market will commence operations from January 1, 2016. The top-priority documents intended to ensure the work of the common market are based on best international practices, experience of the European Union and recommendations from the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). At the moment their adjustment and approval is in process. Subsequently, the work towards improving the regulation will be continued, taking into account international trends in regulatory science and law enforcement.

Among the participants at the round table were the Minister for Technical Regulation Issues, Member of the Eurasian Economic Commission Collegium, Valery Koreshkov, First Deputy Director of the Institute of Legislation and Comparative Law under the Government of the Russian Federation, Anatoly Kapustin, Director of the Technical Regulation and Accreditation Department of the Eurasian Economic Commission, Vasily Boitsov, Head of the Executive Department EU and International Affairs of the Federal Institute for Drugs and Medical Devices (BfArM), Birka Lehmann, Director General of the European Federation of Pharmaceutical Industries and Associations (EFPIA), Richard Bergström, Vice-Chairperson of the Co-ordination Group for Mutual Recognition and Decentralized Procedures of the Medical Products Agency of Sweden, Christer Backman, and representatives of the regulatory authorities of all EAEU member states.

The agenda discussed included the most important issues concerning the creation and development of a common market of medicines in the Eurasian Economic Union. The round table consisted of various working formats, including a plenary session with the participation of over 200 specialists, a professional conversation between speakers, regulators and the media, an exchange of experiences during over an hour-and-a-half questions and answers part, and a special meeting of the regulatory authorities. The event was held at a high organizational and intellectual level and received a wealth of positive feedback from the professional community.

“The pharmaceutical market is an area of special social significance. There is every reason to believe that the establishment since January 01, 2016 of a single market for pharmaceuticals within the EAEU will allow, on the one hand, to improve the quality, effectiveness and safety of pharmaceuticals in favor of consumers, and, on the other hand, to remove barriers at all stages of the life cycle of pharmaceuticals”, - emphasized Valery Koreshkov, Minister on Technical Regulation Issues and Member of the Eurasian Economic Commission Collegium.

"In order to implement effectively the Agreement on Unique Principals and Rules of Medicines’ Circulation on the Territory of the Eurasian Economic Union and form the single market, serious work should be conducted within the Union and its bodies, as well as at the national level of the EAEU member states. It is very important to ensure a harmonized and coordinated approach. In this regard, at the level of the Supreme Eurasian Economic Council – as the supreme body of the EAEU – we may be required to decide on the conditions and timeline for harmonization of the national legislation of the Member States of the EAEC in the field of medicines. In addition, the business community can also actively be involved in the formation of the the renewed system of regulation. These processes should not be considered as an exclusive duty of the public authorities," said Anatoly Kapustin, First Deputy Director of the Institute of Legislation and Comparative Law under the Government of the Russian Federation.

“This year marks 50 years of European Union pharmaceutical legislation as well as the 20th Anniversary of the EMA (European Medicines Agency). To this end, as the Eurasian Economic Union seeks deeper regulatory integration, there is a lot to learn from the EU experience in creating a common regulatory system, while aiming for higher standards,” Richard Bergström, Director General of European Federation of Pharmaceutical Industries and Associations (EFPIA), commented.

“There is no doubt that regional integration is the determining factor for the economic growth of the EAEU member states. The formation of a common market of medicines will help to achieve a new level of healthcare, which is in best interests of the population. Due to the expected start of the operation of the regional market and the entry into force of the rules of supranational law within a few months, national regulations must also undergo a major shift towards harmonization and unification in accordance with generally accepted international standards, which will require extra effort and training from the EAEU regulatory authorities,” thinks Vladimir Shipkov, AIPM Executive Director.