Meeting of the Russian Trade and Industry Chamber’s Committee on entrepreneurship in healthcare and medical industry

11.12.2013

Заседание Комитета ТПП РФ по предпринимательству в здравоохранении и медицинской промышленности    28.11.13.

Russian Trade and Industry Chamber’s Committee on entrepreneurship in healthcare and medical industry, the Entrepreneurs Union’s Commission for the health industry, the Entrepreneurs Union Commission pharmaceutical and medical industries, together with the Coordinating Council in the field of medicines and medical devices at Ministry of Health and the Ministry of Industry held a joint meeting on "Legislation of medical treatment products. Legal regulation. Law enforcement practice. Government support of the medical industry."

The meeting was attended by Deputy Minister of Health of the Russian Federation , Chairman of the Coordination Council in the field of medicines and medical devices Igor Kagramanian, interim leader of Roszdravnadzor Mikhail Murashko, Director of drug treatment provision and regulation of medical devices of Ministry of Health of Russia Elena Maksimkina, Executive Director of the Department of Pharmaceutical and Medical industry of Russia Olga Kolotilova co-chair of the Commission Russian Entrepreneurs Union pharmaceutical and medical industries Yuri Kalinin, the executive director of the IMEDA Association Alexander Tretyakov, president of the association "Zdravmedtech" Alexander Ruchkin, as well as representatives of Russian and foreign medical industry.

The Chairman of the Committee for Entrepreneurship in Health and Medical Industry Valery Sergienko opened and chaired the meeting.

After discussing the results of the joint meeting of the Committee for Entrepreneurship in health and medical industry, the Entrepreneurs Union’s Commission for the health industry, the Entrepreneurs Union’s Commission of pharmaceutical and medical industry on the issue dated 04 July 2013, decisions of the Coordinating Council in the field of medicines and medical devices at Ministry of Health of Russia, the meeting noted:

Russian Ministry of Industry, Ministry of Health and Roszdravnadzor together with professional NGOs carried out a large amount of work to improve the legislative regulation of medical devices.

At the same time the existing system of health care products is not perfect and hinders the development of the medical industry. Absence of a law on the treatment of medical products , technical regulations for their safety, the availability of excess requirements for registration of medical devices in the organization and conduct of examination of their quality , efficacy and safety , responsibility for conducting clinical trials , regardless of the risk class and availability for the analogues , long registration , the inability to challenge the decision of experts (except judicial procedure ) in cases of refusal to register is reflected on the timing of introduction of modern development and can affect the performance of the Federal Program " Development of the pharmaceutical and medical industry until 2020 and Beyond"

In order to eliminate the problems encountered when accessing health care products , and enhance the competitiveness on this basis the production of medical products , the meeting decided to entrust the Union associations and enterprises of the medical industry to compile expressed at the meeting proposals on improving the circulation of medical products and submit them to the Coordinating Council of the Ministry of Health in Russia for discussion and amending the relevant legal acts.

According to the results of the joint meeting, the resolution of the meeting is to be sent to the Government of the Russian Federation. 

 

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