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4 Pillar Three: The Promise of Biotechnology
Pages 47-58

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From page 47...
... Nevertheless the committee has observed encouraging signs of new entrepreneurship and believes that during the next decade, Russia will begin to emerge as a significant contributor in this field, probably relying heavily on joint ventures with international companies. While imported products will continue to have a major presence in the Russian pharmaceutical/biotechnology market, a stronger domestic presence should improve the overall infrastructure for more effectively combating infectious diseases in the country.
From page 48...
... Reddy's, Pfizer, Janssen-Cilag, Egis, Akrikhin, Balkanpharma, and Boehringer Ingelheim (TEMPO Noncommercial Partnership Center of Modern Medical Technology, 2003)
From page 49...
... 5.7 12 Anti-rabies 2.6 5 Tick-borne encephalitis, cultured, cleaned, concentrated, 2.5 5 inactivated, dry Mumps, cultured, live, dry 2.3 5 Influenza, allantois, live, intranasal, for children 1.9 4 Poliomyelitis, peroral 1, 2, and 3 types 1.7 4 Mumps-measles, cell-cultured 1.7 3 Measles, cell-cultured 1.6 3 Viral hepatitis A 1.3 2 SOURCE: TEMPO Noncommercial Partnership Center of Modern Medical Technology, 2003. Also, www.gsen.ru lists all vaccines licensed in Russia, both domestic and imported.
From page 50...
... Petersburg's Scientific Research Institute 0.19 2.2 of Vaccines and Serums Institute Merieux 0.11 1.3 Chumakov Institute of Poliomyelitis and 0.06 0.7 Viral Encephalitis Chiron Behring GmbH and Co. 0.04 0.5 SOURCE: TEMPO Noncommercial Partnership Center of Modern Medical Technology, 2003: 21.
From page 51...
... Of immediate concern to domestic producers of vaccines, drugs, and other medical products is the new Russian legal requirement that by 2005 all production facilities must comply with the regulations calling for Good Manufacturing Practices (GMP)
From page 52...
... The bulk of agrodrugs are purchased by privately owned agricultural enterprises or by joint stock companies. While privatization of agricultural land has fallen behind other privatization efforts, practically all businesses engaged in animal husbandry are non-state organizations, specifically private enterprises and joint stock companies privatized in the early 1990s.
From page 53...
... : · registration of foreign and domestic drugs and annual certification of conformity to reference specimens · licensing of trade in pharmaceutical products and associated quality control measures · coordination of retail prices with government ministries · import and export of drugs and precursors · lists of vitally needed drugs that receive tax and other special considerations · insurance policies for drug coverage · clinical tests of drugs, including preliminary studies of properties, preclinical investigations, and clinical trials · value-added taxes and exemptions for pharmacies and other organizations · requirements for good manufacturing practices at production facilities · advertising limitations · intellectual property rights · efficacy requirements THE GAP BETWEEN RESEARCH AND PRODUCTION As noted in this and previous chapters, many research institutes have been working on the development of new vaccines, drugs, diagnostic test kits, and other items. But a large gap exists between most research endeavors and successful commercial marketing of research products.
From page 54...
... veterinary medicines. During the Soviet era, Biokhimmash designed specialty production equipment for biodefense facilities.
From page 55...
... . A second example of institute scientists finding a market niche is the production of insulin by the firm Natsionalnie Biotekhnologii.
From page 56...
... They include difficulties in finding secure facilities, the large number of repetitive inspections of premises and their contents, and the need for entrepreneurs to constantly search for financing in a country where commercial banks are accustomed to repayments of loans within six months. Inconsistent tax policies, intellectual property rights that do not reward scientific success and are rarely enforced, and complicated procedures for licensing facilities and approving products also inhibit commercial activity in Russia (see Appendix P for a key regulation concerning licensing)
From page 57...
... A complementary approach is to support Russian manufacturers who are targeting markets in the countries of the former Soviet Union where longtime connections give Russian firms a considerable advantage over foreign firms trying to penetrate these markets. An obvious product for targeted marketing has been diagnostic test kits.
From page 58...
... 58 BIOLOGICAL SCIENCE AND BIOTECHNOLOGY IN RUSSIA BOX 4.3 Developing the Animal Biotechnology Sector "The optimal direction to advance the biotechnology industry is to prioritize the development of those aspects that are able to quickly become profitable and there by attractive for private investors. Examples are cattle feeds and pet foods.


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