Committee for Entrepreneurship in Healthcare and Medical Industry of the Russian Chamber of Commerce and Industry on February 3, 2010 had a joint meeting with the Healthcare Industry Committee of the Russian Union of Industrialists and Entrepreneurs to discuss the law bill “On Medicines.” Those participating in the discussion were Viktor Dmitriyev, Head of Association of Russian Drug Manufacturers, and delegates of member companies in ARPM.
ARPF plays an active role in discussing the law bill “On Medicines.” “It is only through systemic opposing and expert advise from the industry insiders that we can come up with truly effective solutions on evolutionary development of the medicine provision system in this country as a whole and drug industry as part of it. This period between the first and second readings of the law bill in the State Duma is when amendments and proposals are welcome and it is a good time for consolidation of public associations representing business and medical community, first of all, patients. Only in this case will the legislative activity be conceptual and integral, not fragmentary,” observed Victor Dmitriyev, Director General of ARPM.
All participants of the meeting wholeheartedly supported the need of enhancement and follow-up on the finalization of conceptual framework of the law bill. For instance, the procedure for calculating the ultimate factory price for manufacturers of medicines of the essential drug list mentions such a term as “innovative drug”, while it is not on the law bill. Participants of the meeting have a number of times spoken of the need for bringing together the powers and responsibility in regulatory practice in the field of medicine provision under a single state authority. The law bill as it is now refers to seven or more state authorities of all levels.
Innovative Russian drug manufacturers strongly believe that lack of compulsory international quality standards GMP is what keeps Russian drug industry from growth and development. The law bill does not provide for bringing drug manufacturing in line with the production and quality control regulations responding to international requirements. “In this situation that we have today when there are Russian drugs of unconfirmed quality in the market, consumers opt for imported drugs, and that’s partly the reason why we cede the domestic market to foreign suppliers. But we must also remember that we are risking losing our positions in the international market including the CIS countries, where these standards are an absolute requirement,” said V. Dmitriyev. The law bill provisions must be articulated more clearly in what concerns the creation of system of state supervision of imported drugs.
In his speech, V.Dmitriyev emphasized that the current law bill does not provide for any norm or regulation that would prescribe the procedure of manufacturing and exporting drugs produced specifically for export. The law bill implies that drugs for export are also subject to compulsory registration. That being said, the provision on the one hand reduces investment attractiveness of the industry for foreign investors and does not promote contract manufacturing in Russia, and on the other hand it considerably limits export potential of Russian drug manufacturers.
V. Dmitriyev also mentioned that the law bill contains a progressive norm on revocation of registration of drug ingredients to be replaced by quality control of drug ingredients within the drug registration procedure. However, the new system of introducing drug ingredients needs to be much more specific.
The law bill “On Medicines” is one of the key issues to be discussed at the conference “State Regulation and Russian Drug Industry 2010: The Follow Up,” jointly organized by ARPM, AIPM, and SPFO.
The Chairman of Committee for Entrepreneurship in Healthcare and Medical Industry of Russian Chamber of Commerce and Industry, Academician of RAMN (Russian Academy of Medical Sciences) V. I. Sergiyenko said, “Attention to the drug industry from the top state authorities in the last year has reflected in a considerably tighter state regulation of the drug market, which makes promoting the dialog between the executive power and the industry players important as never before. I am confident that the conference “State Regulation and Russian Drug Industry 2010: The Follow Up” will serve a good discussion ground for active exchange of opinions on all key issues of Russian drug industry.”
Association of the Russian pharmaceutical manufactures (ARPM) was established in 2002 as a non-commercial partnership bringing together leading Russian pharmaceutical companies. Currently the ARPM unites about 20 pharmaceutical plants which are situated in all Russian regions. Their share in the market of domestic medical forms in Russia makes more than 55%, around 40% of export and more than 70% of domestic medical forms for «DLO-program»
The priority tasks of the ARPM are to increase competitiveness domestic pharmasutical industry and to promote it to be involved to the World farmasutical market keeping grouth of industry and finance.
The ARPM actively cooperates with Russian Ministry of Health and social development, Federal service of control of public health and social development. The ARPM is the member of Russian Chamber of Commerce and Industry.
In 2007 The ARPM took first place in nominatioin «public organization» of experts pharmacutical industry «Platinovay Unciya»
Representatives of ARPM are members of Council for Development of Drug and Medical Industry of the Russian Government.
