Pharma 2020: results and prospects
During the implementation of the state program "Pharma-2020", more than 30 domestic companies have been modernized
Pharmaceutical Bulletin
On June 17, a meeting of the Board of the Ministry of Industry and Trade was held in Moscow, dedicated to the results of work in 2014 and the main activities of the department in 2015 and subsequent years. Minister Denis Manturov reported on the activities implemented over the past year, and also outlined the main directions of industrial development, specifying the priority goals and objectives of the department for the near future.
In his report, the head of the Ministry of Industry and Trade dwelt in more detail on the measures for the development of priority industries that were implemented by the department in 2014.
In 2014, the scientific and educational center for the development of innovative and import-substituting medicines and technology transfer was put into operation on the basis of the Ural Federal University named after the first President of Russia B.N. Yeltsin.
In May 2014, a new production of full-cycle influenza vaccines was opened on the basis of the St. Petersburg Research Institute of Vaccines and Serums of the FMBA of Russia in St. Petersburg. The project was implemented in strategic cooperation with FSUE NPO Microgen.
In April 2014, the drug rituximab of domestic production was registered in the Russian Federation, developed with the support of the Ministry of Industry and Trade of Russia in 2010-2012. Within the framework of the event "Organization of pilot production of substances and medicines based on monoclonal antibodies necessary for the production of expensive import-substituting drugs of JSC "BIOCAD" State Program". State investments in the development of technology and the organization of production amounted to 285 million rubles. In total, since the state registration of the drug, about 130 thousand packages of the developed drug have been sold for a total amount of 5.5 billion rubles, the main part is public procurement, budget savings from the purchase of a domestic drug only in 2014 exceeded the volume of public investment in the development of the drug.
In October 2014, the drug nonacog alpha (recombinant blood clotting factor IX) was registered, developed within the framework of the event "Creation of a modern biotechnological center "Generium" of the State Program. As a result of the implementation of the event, Generium CJSC became a full-cycle manufacturer of three main drugs for the treatment of various forms of hemophilia: recombinant blood clotting factors VII, VIII and IX.
The state program "Development of the pharmaceutical and medical industry" for 2013-2020 made it possible to create competitive and more affordable analogues of foreign drugs in such areas as oncology, immunology and neurology.
New production and technological competencies have appeared: monoclonal antibodies (CJSC "BIOCAD"), insulins and their analogues (LLC "Geropharm-bio"), cytokines and growth factors (CJSC "BIOCAD"), recombinant blood clotting factors (CJSC "Generium"), recombinant enzymes (CJSC "Generium"), recombinant vaccines (FSUE NPO "Microgen", FSUE "St. Petersburg Scientific Research Institute of Vaccines and Serums and the Enterprise for the Production of bacterial Preparations" FMBA of Russia, FSUE "Enterprise for the production of bacterial and Viral preparations of the Institute of Poliomyelitis and Viral Encephalitis named after M.P.Chumakov RAMS"), recombinant proteins obtained in E. Coli (competencies since Soviet times – CJSC "BIOCAD", CJSC "Generium" and other companies).
According to analytical agencies, the total volume of private investments in the pharmaceutical industry during the implementation of the Program exceeded 120 billion rubles. For comparison, the volume of public investments amounted to 39 billion rubles. During the implementation of the state program, more than 30 domestic companies have been modernized, more than 50 billion rubles have been attracted to create new production facilities.
For example, the company Geropharm-bio LLC has implemented a project to build a full-cycle insulin production plant in the Moscow region. A biopharmaceutical plant of Fort LLC has been opened in the Ryazan Region (500 new jobs have been created, 4.5 billion rubles have been attracted). In the Kirov region at the end of 2014, the opening of the innovative production complex of the company Nanolek LLC took place. CJSC R-Pharm has implemented a project for the construction of a pharmaceutical production complex in Yaroslavl. LLC "Infamed" (Kaliningrad region) has invested more than 1 billion rubles in the production of antiseptics, including the unique domestic drug "Miramistin". In June 2014, the opening of a new production building of the St. Petersburg Research Institute of Vaccines and Serums of the Ministry of Health of Russia in the Leningrad region took place. The company "NTFF Polisan" LLC invested 2.5 billion rubles in the construction and launch of the second stage of infusion production in St. Petersburg. The MedSintez plant has opened a site for the production of insulin preparations. JSC "Rafarma" (Lipetsk region) has completed the construction of a production complex, including several lines for the production of various dosage forms with a total project cost of over 3 billion rubles. JSC "Biosynthesis" (Penza) is completing the reconstruction of the building with several ampoule and infusion lines. A pharmaceutical plant is being built in the Kaluga Region on the territory of the Grabtsevo technopark by NovaMedica LLC. The program contributed to an increase in investment in the industry from both domestic manufacturers and foreign companies.
Currently, companies such as Merck Serono, Johnson& Johnson, Boehringer Ingelheim, Pfizer, Abbvie, Amgen have announced cooperation with Russian companies in the field of localization of their own products on the site of domestic companies. Novartis, Teva, NovoNordisk, Sanofi, Nycomed, KRKA RUS LLC, Gedeon Richter, Servier, STADA CIS, Berlin-Pharma CJSC (a subsidiary of Menarini Group), Ferring Pharmaceuticals invested in the creation of their own production facilities in the Russian Federation. Abbott has acquired 100% of the shares of the Russian company Veropharm OJSC and is implementing a project to build a new production site in Pokrov (Vladimir region).
In terms of the medical industry, Nanotechmed Plus (Novgorod) has announced plans to invest 1 billion rubles in the creation of a medical research and production complex in the Vsevolozhsky district of the Leningrad Region. The production is focused on the production of medical products made of carbon; at the first stage it is planned to master the production of bone implants. The estimated production volume will be up to 60 thousand products per year.
In the future, it is planned to expand the range of production. The company is scheduled to open in the second half of 2015.
In June 2014, the grand opening of Russia's first production of micro sources for brachytherapy took place in Dubna. Brachytherapy is a modern high–tech type of radiotherapy aimed at the treatment of prostate cancer, which significantly minimizes the side effects of traditional radiotherapy. The RUSNANO project promotes import substitution in the field of high-tech medical products: brachytherapy has been actively used in medical practice in the USA and Europe for almost 15 years, but Russia has not yet had its own production of iodine-based micro sources necessary for such therapy.
The plans for 2015 include:
– increasing the share of medicines of domestic production in the nomenclature of the list of VED to 67% and strategically important medicines and the list of vital and essential medicines.
– ensuring the purchase of medicines according to the list of mainly Russian-made VED by adopting a draft decree of the Government of the Russian Federation "On the establishment of restrictions on the admission of medicines originating from foreign countries when making purchases to meet state and municipal needs."
– implementation of the Decree of the Government of the Russian Federation No. 102 dated February 5, 2015 "On the establishment of restrictions on the admission of certain types of medical devices originating from Foreign Countries for the Purposes of Procurement for State and municipal Needs".
– development of the procedure for determining the stage of the technological process of production of medicines, as well as the procedure for issuing conclusions on the degree of localization (Federal Law of December 22, 2014 No. 429-FZ "On Amendments to the Federal Law "On the Circulation of Medicines") in order to provide manufacturers with different degrees of technological process depth with a differentiated scale of preferences.
The board was attended by representatives of the Government of the Russian Federation, the Russian Union of Industrialists and Entrepreneurs, the Public Council under the Ministry of Industry and Trade, the State Duma Committee on Industry. Within the framework of the board, state awards and the first certificate of conformity of the lean production system at the enterprise were awarded.
The full texts of the reports, transcripts and all decisions taken within the framework of the board can be found on the official website of the Ministry of Industry and Trade in the Documents subsection of the Open Data section.
Portal "Eternal youth" http://vechnayamolodost.ru
18.06.2015