1. © IFPMA 2009WIPO Open-ended Forum on Proposed Development Agenda Projects - 13/10/2009 IFPMA views on the strategic use of information for sustainable innovation and health policies Guilherme Cintra, Policy Analyst Intellectual Property and Trade, IFPMA

2. © IFPMA 2009WIPO Open-ended Forum on Proposed Development Agenda Projects - 13/10/2009 2  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)27 R&D-based biopharmaceutical companies (Europe, India, Japan & USA) 44 national Industry Associations, from all 5 continents44 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)16 R&D influenza vaccine companies (Australia, China, Europe, Japan, USA) The IFPMA in brief

3. © IFPMA 2009WIPO Open-ended Forum on Proposed Development Agenda Projects - 13/10/2009 3  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.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 countriesNevertheless, there is room for strategic partnerships to address specific health needs of developing countries R&D and Access: common goals

4. © IFPMA 2009WIPO Open-ended Forum on Proposed Development Agenda Projects - 13/10/2009 4 The patent is just the beginning Information on a chemical compound disclosed in a patent application 1 st question to ask: is the product approved for marketing? Challenge: development of economically-feasible manufacturing capacity that meets the required safety criteria yes no Production and distribution of quality pharmaceutical products Challenge: research, development and obtain market approval of the product Product gets market approval

5. © IFPMA 2009WIPO Open-ended Forum on Proposed Development Agenda Projects - 13/10/2009 5 The long R&D process (1)

6. © IFPMA 2009WIPO Open-ended Forum on Proposed Development Agenda Projects - 13/10/2009 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. © IFPMA 2009WIPO Open-ended Forum on Proposed Development Agenda Projects - 13/10/2009 7 Finding the best synergies

8. © IFPMA 2009WIPO Open-ended Forum on Proposed Development Agenda Projects - 13/10/2009 8 Number of Active Research and Development Projects* *1 project = 1 compound in development or 1 screening program for 1 disease Medicine R&D projects Vaccine R&D projects Source: IFPMA IFPMA Status Report on DDW R&D - 2009 R&D for TDR 10 Priority Diseases: - Chagas - Dengue - Human African Trypanosomiasis - Leishmaniasis - Leprosy - Lymphatic Filariasis - Malaria - Onchocerciasis - Schistosomiasis - Tuberculosis

9. © IFPMA 2009WIPO Open-ended Forum on Proposed Development Agenda Projects - 13/10/2009 9 The long way to access If product is authorized for marketing: Reverse engineering using info disclosed on patent application for the production of generics (if patent is expired) Technology transfer Voluntary Licensing 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. © IFPMA 2009WIPO Open-ended Forum on Proposed Development Agenda Projects - 13/10/2009 10 Some ARVs licensing examples Staduvine and Didadosine Aspen (South Africa) and Emcure (India) Viread® and Truvada®Aspen (South Africa) Tenofovir 10 Indian companies to distribute in 95 developing countries Epivir® and Combivir®Africa Efavirenz5 South African generic manufacturers Second line ARVs 10 companies in Bangladesh, Ethiopia, Kenya, South Africa, Tanzania and Zimbabwe

11. © IFPMA 2009WIPO Open-ended Forum on Proposed Development Agenda Projects - 13/10/2009 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. © IFPMA 2009WIPO Open-ended Forum on Proposed Development Agenda Projects - 13/10/2009 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 itWhat 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 networksHow to plug-into collaborative R&D networks Examples of R&D partnerships that could be emulatedExamples of R&D partnerships that could be emulated How to improve procurement practicesHow to improve procurement practices How to benefit from the existing industry access programs and other funding mechanisms (e.g. Global Fund).How to benefit from the existing industry access programs and other funding mechanisms (e.g. Global Fund).

13. © IFPMA 2009WIPO Open-ended Forum on Proposed Development Agenda Projects - 13/10/2009 Thank You! Guilherme Cintra g.cintra@ifpma.org Ch. Louis-Dunant 15 P.O. Box 195 121211 Geneva 20 Switzerland Tel: +41-22-338 32 00 Fax:+41-22-338 32 99 Email: info@ifpma.org Web:www.ifpma.org