22.11.2019
The Forum organizer is The Unit “Medical-Pharmaceutical projects the XXI century” with support of the government of Saint Petersburg, the Committee for Industrial Policy, Innovations and Trade of Saint Petersburg and the Ministry of Industry and Trade of the Russian Federation. The program of the 9th “LIFE SCIENCE INVEST” forum was traditionally focused on the trends in the development of pharmaceutical sphere, but at the same time there were comprehensively discussed the key topics of the development of entire range of spheres in the “life sciences” and human prosperity segment.
The Forum held a thematic session "Biomedical cell products in healthcare - current state, barriers for the industry, development prospects". The session was moderated by Igor Korobko, Director of the Department of Science, Innovation Development and Management of Biomedical Health Risks of the Ministry of Health of the Russian Federation, and by Alexey Martynov, President of the Association of Biomedical Cell Products (BMCP) Manufacturers.
The session was opened by Igor Korobko, who briefly described the recently created legal and regulatory framework for the BMCP in Russia, its shortcomings identified in the course of their implementation (which was quite expected, given the huge volume of regulatory documentation). Igor Korobko emphasized that the regulation in the BMCP field is primarily aimed to ensure that only the high quality, safe and effective BMCP are allowed into circulation on the market, this is a priority for the Ministry of Health of the Russian Federation in a function of a regulatory authority.
Svetlana Solovyova, Director of the Legal Department of the Ministry of Health of the Russian Federation, gave her explanation on an extremely acute question for the developers of the BMCP: does the biomedical cell products produced at a licensed manufacturing site require to be used during pre-clinical trials of the BMCP? The Legal Department of the Ministry of Health of the Russian Federation gave a positive answer to this question. According to the Government Decree of the Russian Federation “On the approval of the Provision on licensing of the production of biomedical cell products activities”, the BMCP for pre-clinical trials should be manufactured exclusively on production sites that have received license to produce BMCP in compliance with the established procedure.
The heads of the leading federal scientific medical research centers, Academician of the Russian Academy of Sciences, Honored Scientist of the Russian Federation Gennady Sukhih (Federal State Budgetary Institution “National Medical Research Center for Obstetrics, Gynecology and Perinatal Medicine n.a. academician V.I. Kulakov” by the Ministry of Health of the Russian Federation) and Professor, Chief outside oncologist of the Northwestern Federal District Alexey Belyaev (Federal State Budgetary Institution “National Medical Research Center for Oncology n.a. N.N. Petrov” by the Ministry of Health of the Russian Federation) came up with the proposal to re-establish the possibility of using cellular products that they had and used in frames of their pre-2012 permits for the use of new medical technologies and licenses for medical activities in the implementation of high-tech medical care for the use of cellular technologies. Since the issuance of the Federal Law No.180 “On Biomedical Cell Products” and implementing regulations, the effective medicines, used by these Centers, should be tested through pre-clinical and clinical trials. According to the heads of these Centers, such situation makes it very difficult and hinders from using of well-in-place and streamlined treatment processes.
Alexey Martynov, President of the Association of Biomedical Cell Products Manufacturers, talked about the situation concerning the assistance of the Federal Executive Authorities, various funds and other institutions in the field of the biomedical cell products industry development. All types if financial support that the above-mentioned structure can offer for projects development assume that developers or industrial partners should provide at least 30% of the funding.
However, at the current moment it is impossible to find that industrial partner, who would agree to freeze their finances for at least 7 years – according to the Federal Law No.180, registration of BMCP is possible only after the creation of a licensed production site, where BMCP will be produced for pre-clinical and clinical trials. According to the Association, it is necessary to take some steps in order the state to be able to provide real assistance in the BMCP industry development in the Russian Federation.
In conclusion of the session Olga Vostrikova, Chairlady of the International Union for Patients Care and Support, stood with a request to all the key structures that can influence on solution of the problems that were identified during the session, to resolve it in the shortest period. It will allow the Russian patients to use such effective and innovative medicines as biomedical cell products.
The participants of the session expressed the hope that all the issues and seemingly unresolvable problems raised by specialists during the session will be considered by the relevant structures. Moreover, the decision, made as a result, will allow to speed up the BMCP industry development in the Russian Federation and to reduce the period of launch of the highly effective medicines for treatment of the socially significant and difficult-to-treat diseases on the Russian market.
There is another good news that showed the deep interest of the Russian institutions and organization in Biomedicine sphere development, namely: in development and implementation of the projects in the field of genetics and biomedical cell products in the Russian Federation. Autonomous Non-Commercial Organization on Health Promotion “Health Leader” (Executive Director Mr. Martynov A.D.) signed the collaboration agreement with Association of pharmaceutical manufacturers of the Eurasian Economic Union (Chairman of the Executive Board, Mr. Chagin D.A.). Furthermore, Autonomous Non-Commercial Organization on Health Promotion “Health Leader” and Federal State Budgetary Institution “National Medical Research Center for Oncology n.a. N.N. Petrov” by the Ministry of Health of the Russian Federation (Director, Mr. Belyaev F.M.) signed the memorandum of cooperation.
Both documents confirm the readiness to support and develop comprehensive cooperation in the field of genetics and cell technologies in every possible way.
"Today, the problem of developing biomedical cell products and evaluating their safety is coming to the force all over the world, and it is very important to maintain this trend in our country. We are very pleased with the fact that such discussions have been organized on the most important platforms for the industry, such as LSI, and the agreements have been signed with the leading market players. In our turn, we express a serious interest in the development of this sphere and encourage the Association of Biomedical Cell Products Manufacturers initiatives”, - Maxim Ivanov, Director of Federal State Budgetary Science Institution “Institute of Toxicology of Federal Biomedical Agency” of Russia stated.
By Alexey Martynov
Source: Medline.ru