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

Guilherme Cintra, Policy AnalystIntellectual Property and Trade, IFPMA


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)


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


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


The long R&D process (1)


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.


Finding the best synergies


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


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


Some ARVs licensing examples


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)


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).


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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