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IFPMA views on the strategic use of information for sustainable innovation and health policies

IFPMA views on the strategic use of information for sustainable innovation and health policies. Guilherme Cintra, Policy Analyst Intellectual Property and Trade, IFPMA. The IFPMA in brief. Non-profit NGO founded in 1968 Represents R&D-based pharmaceutical industry worldwide

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IFPMA views on the strategic use of information for sustainable innovation and health policies

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  1. IFPMA views on the strategic use of information for sustainable innovation and health policies Guilherme Cintra, Policy AnalystIntellectual Property and Trade, IFPMA

  2. The IFPMA in brief • Non-profit NGO founded in 1968 • Represents R&D-based pharmaceutical industry worldwide • Based in Geneva, official observer status with UN, including the World Health Organization, also WIPO, WTO, etc. • AIM: global policy environment favoring innovation in medicine,for the benefit of patients around the world • IFPMA Membership: • 27 R&D-based biopharmaceutical companies (Europe, India, Japan & USA) • 44 national Industry Associations, from all 5 continents • IFPMA Influenza Vaccine Supply International Task Force • 16 R&D influenza vaccine companies (Australia, China, Europe, Japan, USA)

  3. R&D and Access: common goals • The pharmaceutical industry and policymakers in both developed and developing countries share the same objective: the development and then the widest possible access to new drugs • Patent Landscaping Project will help policymakers in obtaining solid information on IP practices in health area • But to maximize their innovation and access strategies, policymakers should be aware of the special characteristics of the pharmaceutical industry • Current global IP system makes possible the constant discovery of new drugs, which after a period of exclusivity will become off-patent and open to generic competition. • Nevertheless, there is room for strategic partnerships to address specific health needs of developing countries

  4. The patent is just the beginning Information on a chemical compound disclosed in a patent application 1st question to ask: is the product approved for marketing? yes no Challenge: development of economically-feasible manufacturing capacity that meets the required safety criteria Challenge: research, development and obtain market approval of the product Production and distribution of quality pharmaceutical products Product gets market approval

  5. The long R&D process (1)

  6. The long R&D process (2) • R&D requires skilled workforce, good infrastructure, legal framework, etc. • Modern pharmaceutical R&D requires a large network of collaborators in different countries. Only large private sector companies manage to do in-house all the different phases of the R&D process. • The R&D of a single drug can cost from US$800mi to US$1.3bi. • Research institutions and companies in developing countries should try to participate in collaborative R&D networks in order to get the best synergy possible.

  7. Finding the best synergies

  8. IFPMA Status Report on DDW R&D - 2009 MedicineR&D projects VaccineR&D projects R&D for TDR 10 Priority Diseases: - Chagas- Dengue- Human African Trypanosomiasis- Leishmaniasis- Leprosy- Lymphatic Filariasis- Malaria- Onchocerciasis- Schistosomiasis- Tuberculosis Number of Active Research and Development Projects* *1 project = 1 compound in development or 1 screening program for 1 disease Source: IFPMA

  9. The long way to access If product is authorized for marketing: Technology transfer Voluntary Licensing Reverse engineering using info disclosed on patent application for the production of generics (if patent is expired) • More likely to happen in countries with strong IP protection • Other know how (e.g. trade secrets, manufacture techniques) are also transferred Pharmaceuticals produced in a cost-effective and safe way Performance of the healthcare system Patients

  10. Some ARVs licensing examples

  11. Patents are not a barrier to access • A patent landscape will show that most companies do not file for patents on pharmaceuticals in LDCs and/or have committed not to enforce those rights in those countries. • 95 % of the drugs on the WHO essential list are not patented • There are many company access programs that sell pharmaceuticals at cost or donate them to a large number of developing countries (for a list of some of these programs see http://www.ifpma.org/healthpartnerships)

  12. Information for good policies • More than just “what, where and by whom,” the critical information needed for sound health and innovation policies in developing countries is: • What is the scientific capacity of the country; what kind of technology transfer would be more effective and how to attract it • How to plug-into collaborative R&D networks • Examples of R&D partnerships that could be emulated • How to improve procurement practices • How to benefit from the existing industry access programs and other funding mechanisms (e.g. Global Fund).

  13. Thank You! Guilherme Cintra g.cintra@ifpma.org Tel: +41-22-338 32 00Fax: +41-22-338 32 99Email: info@ifpma.orgWeb: www.ifpma.org Ch. Louis-Dunant 15P.O. Box 195121211 Geneva 20Switzerland

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