The Working Group for Research on the Competition Issues in the Pharmaceutical Sector (hereinafter referred as the “Working Group”) was formed at the initiative of the Federal Antimonopoly Service (the FAS Russia) and the Italian Competition Authority in January 2012.
The key task of the Working Group is the elaboration of specific proposals on forming the competition environment in the pharmaceutical market and ensuring the availability of medicines to the consumers.
The Working Group determined the objectives of the Working Group, as follows:
1. exchange of experiences and approaches to enforcement of antimonopoly legislation in the pharmaceutical market;
2. coordination between the competition authorities-members of the Working Group when investigating violations of antimonopoly legislation.
The Working Group operates through consultation and exchange of non-confidential information among the members of the Working Group during and outside of the meetings, through organizing meetings with the relevant state authorities, businesses and other interested persons.
The first meeting of the Working Group was held on September 13, 2012 as part of the International Event “The Russian Competition Day” (September 11-13, Kazan, Republic of Tatarstan).
The meeting was attended by the members of the Working Group, and the members of the Headquarters for Joint Investigations of Violations of the Antimonopoly Legislation of the CIS countries, and representatives of the competition authorities of other countries (Austria, Serbia, Portugal, China, Finland, etc.).
During the first meeting, the Working Group discussed the issues of the development of competition in the pharmaceutical market, and the national experience of foreign competition authorities in the application of antimonopoly legislation in the pharmaceutical market.
Also, the participants of the first session of the Working Group identified priority issues for the research, namely:
- issues of methodology of defining the pharmaceutical market / market analysis;
- issues related to the promotion of the production and consumption of generic medicines;
- issues related to the suppression of unfair competition committed by pharmaceutical companies (attribution of diverse proven and / or unproven therapeutic properties for the same drugs in different jurisdictions);
- issues related to the agreements between the companies-manufacturers of original and generic drugs aimed at the delay of the release of competitive products in the relevant market;
- issues related to agreements between producers of original pharmaceuticals aimed at eliminating competition between them by way of the consolidation in certain markets and the creation of joint regional brands;
- issues related to patent abuse preventing the entry of generics to the market and aimed at an unjustified extension of patents;
- issues related to the bribery of officials, experts and health professionals in order to obtain the non-competitive advantage in the market for certain drugs;
- issues related to the unfair practices of the participants of the drugs’ distribution sector, and to the obtaining of unjustified incomes, etc.).
The next second meeting of the Working Group was held on the 21 of March 2013 in Moscow.
The meeting was attended by the members of the Working Group, and the members of the Headquarters for Joint Investigations of Violations of the Antimonopoly Legislation of the CIS countries, and representatives of the competition authorities of other countries (Austria, Serbia, Portugal, China, Finland, etc.).
During the second session, the Working Group discussed the issues devoted to methodology for determining the pharmaceutical market and analysis of the market.
The participants heard the reports on the issues: (1) methodology of determining pharmaceutical market, (2) pharmaceutical relevant market analysis, (3) EU and EU-National pharmaceutical case studies.
The participants also discussed the possibilities and limitations of using the experience of foreign competition authorities with regard to antitrust enforcement on the pharmaceutical markets, in the activities of competition authorities of the CIS.
During the meeting the participants have also discussed the Draft Report on the State of Competition in the pharmaceutical markets of the CIS countries.
The next meeting was decided to devote to discussion of the issues related to the promotion of the production and consumption of generic medicines;
The third meeting of the Working Group was held on the 9th of September 2013 in Irkutsk and was devoted to discussion of the following topics:
- The Report “ On the State of Competition in the Pharmaceutical Markets of the CIS Countries” prepared by the Headquarters based on the results of medicine prices research;
- Issues devoted to promotion of production and consumption of generic medicines.
It was also proposed to organize a unified platform to publish wholesale and retail price of medicines. WG participating agencies shall contribute to the platform.
The next session (# 4) will be devoted to discussion of the issues related to unfair competition among pharmaceutical companies (arrogating different and/or unconfirmed therapeutic features to same pharmaceuticals in various jurisdictions).
It will take place on the 11-12th of March 2014 in Moscow.
The 4th session of the Working Group was held on the 11 of March 2014 in Moscow.
The meeting was attended by the members of the Working Group, and the members of the Headquarters for Joint Investigations of Violations of the Antimonopoly Legislation of the CIS countries, and representatives of the competition authorities of other countries (India, Serbia, Korea, Romania, Bulgaria etc.).
During the second session, the Working Group discussed:
- issues regarding to unfair competition of the pharmaceutical companies (assignment of diverse and unconfirmed therapeutic characteristics to equal medicines produced in different jurisdictions).
- issues regarding to agreements concluded between companies-producers of originals and generics aimed at delaying of entry of competitive medicines at the corresponding markets.
It was also proposed to organize a unified platform to publish wholesale and retail price of medicines. WG participating agencies shall contribute to the platform.
The next session (# 5) will be devoted to discussion of the Issues related to agreements made by companies-producers of original medicines, which are directed at eliminating competition between them by creating associations in certain markets and by establishing joint regional brands