OREANDA-NEWS. November 24, 2009. The Federal Antimonopoly Service (FAS Russia) has presented a draft Federal Law "On Introducing Amendments to Some Legislative Acts of the Russian Federation to the Expert Council for Developing Competition in Social Sphere and Health Care. The draft law provides for amendments to the Framework Legislation of the Russian Federation on Health Care and the Code of the Russian Federation on Administrative Violations; as well as proposals to the draft Federal Law "On Circulation of Medicines", reported the press-centre of FAS Russia.

The proposals include restrictions on activities of pharmaceutical companies and medical workers associated with promoting medications on the market, regulate the procedures for post-clinical research of medications, determine the procedures for preventing and regulating the conflict of interest of medical workers, and introduce administrative liability for violating those requirements and restrictions.

The novelty put forward by FAS Russia is introduction of the concept of a conflict of interests in relations between medical doctors and pharmaceutical companies. The draft law devised by the Antimonopoly Service defines it as a situation when a medical worker, who concluded an oral or a written agreement with an organization (institution) involved in pharmaceutical activities, has a possibility to obtain, personally or through a legal or actual representative of a pharmaceutical company, tangible benefits or other improper advantage in course of exercising medical activities, and the self-interest (direct or indirect) of a medical worker affects or can affect due execution of professional responsibilities because of a contradiction between the self-interest of a medical worker and the interests of a patient.

If a conflict of interests has developed or may develop, a medical worker must inform his/her supervisor in writing about the situation.

FAS Russia proposes to determine by law the restrictions for medical workers exercising their professional activities.

FAS Russia proposes to fine medical workers 20,000-30,000 Rubles for failure to inform about a conflict of interests. The Antimonopoly Service suggests putting Roszdravnadzor in charge of the enforcement of this norm.

Under the FAS Russia's draft law pharmaceutical companies are forbidden to conclude agreements with medical workers for distribution of medications, and provide false or incomplete information regarding medicines to be prescribed to the patients.

Failure by a pharmaceutical company, a pharmaceutical worker or a representative of a pharmaceutical company to observe the statutory restrictions will be punishable by an administrative fine - for individuals from 10,000 to 30,000 Rubles, for officials - from 30,000 to 50,000 Rubles or disqualification for a period from one year to two years , and for legal entities - from one hundredth to fifteen hundredth of the income gained by the violator from selling goods (works, services) on the market where the violation was committed but no less than 300,000 Rubles.

Summing up the discussion, the Expert Council decided to form two Working Groups, comprising representatives of pharmaceutical companies and medical community, to revise the proposals for the above draft laws.