OREANDA-NEWS. December 03, 2012. The Expert Council of the Federal Antimonopoly Service (FAS Russia) for Developing Competition in the Field of Medical Products Circulation discussed one of the most pressing issues on the market - substitutability of medical products, reported the press-centre of FAS Russia.

No.323 Federal Law “On Protecting Health of Citizens in the Russian Federation” of 21st November 2011 introduces the concept of substitutability of medical products. Under Article 38, medical products can be recognized substitutes if they are comparable by their functional purpose, quality and technical characteristics and are able to substitute each other. From 1st January 2013 information about substitute medical products will be entered in the State Register of medical products and organizations producing and fabricating medical products.

Representatives of the Ministry of Health Care and Social Development, Roszdravnadzor [the Federal Agency on Surveillance in Healthcare], the Ministry of Industry and Trade, professional medical associations, non-governmental patient organizations and manufacturers of medical products took part in the Expert Council.

Opening the meeting, the Head of FAS Department for Control over Social Sphere and Trade, Timophei Nizhegorodtsev, gave a detailed account of the problems of competition on the market of medical products, the factors adversely affecting development of health care, particularly, by eliminating competition in this field, specifics of the work and plans of the antimonopoly body aimed at ensuring equal access of actors to the markets.

The Council discussed the concepts and interpretation of equivalency, conformity, substitutability of medical products, the problems of using medical consumables, the practice of medical-technical assignments in competitive bidding for supplying medical products for state and municipal needs, the problems and barriers for determining substitutability of medical products.

Speakers included the Executive Director of the International Medical Devices Manufacturers Association (IMEDA), Alexander Tretyakov, and the Head of a Department of the “Centre for Monitoring and Clinical Feasibility Studies” Federal State Budgetary Institution at Roszdravnadzor, Vladimir Antonov.

Vladimir Antonov proposed to base substitutability of medical products on conformity of their purpose; technical, functional and technological characteristics; and efficiency of medical devices. He also proposed an algorithm for determining substitutability of medical products and approaches to resolving potential substitutability problems.

The Council will continue devising criteria and methodology for determining substitutability of medical products. Participants of the Council meeting and all interested persons can forward proposals and comments on the issues in question, particularly an algorithm for determining substitutability of medical products, to soc@fas.gov.ru

Summing up the discussion, Timophei Nizhegorodtsev, pointed out: “The issues of substitutability of goods, including medical products, are crucial for supporting competition and effective spending of budgetary funds”.