© ifpma 2009wipo open-ended forum on proposed development agenda projects - 13/10/2009 ifpma views...

© IFPMA 2009WIPO Open-ended Forum on Proposed Development Agenda Projects - 13/10/2009

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

Guilherme Cintra, Policy AnalystGuilherme Cintra, Policy AnalystIntellectual Property and Trade, IFPMAIntellectual Property and Trade, IFPMA

2 © IFPMA 2009WIPO Open-ended Forum on Proposed Development Agenda Projects - 13/10/2009

Non-profit NGO founded in 1968Non-profit NGO founded in 1968

Represents R&D-based pharmaceutical industry worldwideRepresents R&D-based pharmaceutical industry worldwide

Based in Geneva, official observer status with UN, including the Based in Geneva, official observer status with UN, including the World Health Organization, also WIPO, WTO, etc.World Health Organization, also WIPO, WTO, etc.

AIM: global policy environment favoring innovation in medicine,AIM: global policy environment favoring innovation in medicine,for the benefit of patients around the worldfor the benefit of patients around the world

IFPMA Membership: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 ForceIFPMA 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 briefThe IFPMA in brief


The pharmaceutical industry and policymakers in both The pharmaceutical industry and policymakers in both developed and developing countries share the same objective: developed and developing countries share the same objective: the development and then the widest possible access to new the development and then the widest possible access to new drugsdrugs

Patent Landscaping Project will help policymakers in obtaining Patent Landscaping Project will help policymakers in obtaining solid information on IP practices in health areasolid information on IP practices in health area

But to maximize their innovation and access strategies, But to maximize their innovation and access strategies, policymakers should be aware of the special characteristics of policymakers should be aware of the special characteristics of the pharmaceutical industrythe pharmaceutical industry

• Current global IP system makes possible the constant discovery of new Current global IP system makes possible the constant discovery of new drugs, which after a period of exclusivity will become off-patent and drugs, which after a period of exclusivity will become off-patent and open to generic competition. open to generic competition.

• Nevertheless, there is room for strategic partnerships to address Nevertheless, there is room for strategic partnerships to address specific health needs of developing countriesspecific health needs of developing countries

R&D and Access: common goalsR&D and Access: common goals


The patent is just the beginningThe 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?

Challenge: development of economically-feasible

manufacturing capacity that meets the required safety criteria

yesno

Production and distribution of quality pharmaceutical products

Challenge: research, development and obtain market approval of the product

Product gets market approval


The long R&D process (1)The long R&D process (1)


The long R&D process (2)The long R&D process (2) R&D requires skilled workforce, good infrastructure, legal R&D requires skilled workforce, good infrastructure, legal

framework, etc. framework, etc. Modern pharmaceutical R&D requires a large network of Modern pharmaceutical R&D requires a large network of

collaborators in different countries. Only large private collaborators in different countries. Only large private sector companies manage to do in-house all the different sector companies manage to do in-house all the different phases of the R&D process.phases of the R&D process.

The R&D of a single drug can cost from US$800mi to The R&D of a single drug can cost from US$800mi to US$1.3bi. US$1.3bi.

Research institutions and companies in developing Research institutions and companies in developing countries should try to participate in collaborative R&D countries should try to participate in collaborative R&D networks in order to get the best synergy possible.networks in order to get the best synergy possible.


Finding the best synergiesFinding the best synergies


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*1 project = 1 compound in development *1 project = 1 compound in development or 1 screening program for 1 diseaseor 1 screening program for 1 disease

MedicineMedicineR&D projectsR&D projects

VaccineVaccineR&D projectsR&D projects

Source: IFPMASource: IFPMA

IFPMA Status Report on DDW R&D - 2009IFPMA Status Report on DDW R&D - 2009

R&D for TDR 10 Priority Diseases:R&D for TDR 10 Priority Diseases:

- Chagas- Chagas

- Dengue- Dengue

- Human African Trypanosomiasis- Human African Trypanosomiasis

- Leishmaniasis- Leishmaniasis

- Leprosy- Leprosy

- Lymphatic Filariasis- Lymphatic Filariasis

- Malaria- Malaria

- Onchocerciasis- Onchocerciasis

- Schistosomiasis- Schistosomiasis

- Tuberculosis- Tuberculosis


The long way to accessThe 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


Some ARVs licensing examplesSome ARVs licensing examples

Staduvine and Didadosine

Aspen (South Africa) and Emcure (India)

Viread® and Truvada® Aspen (South Africa)

Tenofovir10 Indian companies to distribute in 95 developing countries

Epivir® and Combivir® Africa

Efavirenz 5 South African generic manufacturers

Second line ARVs

10 companies in Bangladesh, Ethiopia, Kenya, South Africa, Tanzania and Zimbabwe


Patents are not a barrier to accessPatents are not a barrier to access

A patent landscape will show that most companies do not A patent landscape will show that most companies do not file for patents on pharmaceuticals in LDCs and/or have file for patents on pharmaceuticals in LDCs and/or have committed not to enforce those rights in those countries.committed not to enforce those rights in those countries.

95 % of the drugs on the WHO essential list are not 95 % of the drugs on the WHO essential list are not patentedpatented

There are many company access programs that sell There are many company access programs that sell pharmaceuticals at cost or donate them to a large pharmaceuticals at cost or donate them to a large number of developing countries (for a list of some of number of developing countries (for a list of some of these programs see these programs see http://www.ifpma.org/healthpartnerships)http://www.ifpma.org/healthpartnerships)


Information for good policiesInformation for good policies

More than just “what, where and by whom,” the critical More than just “what, where and by whom,” the critical information needed for sound health and innovation information needed for sound health and innovation policies in developing countries is:policies in developing countries is:• What is the scientific capacity of the country; what kind of What is the scientific capacity of the country; what kind of

technology transfer would be more effective and how to attract it 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 How to benefit from the existing industry access programs and

other funding mechanisms (e.g. Global Fund).other funding mechanisms (e.g. Global Fund).

© IFPMA 2009WIPO Open-ended Forum on Proposed Development Agenda Projects - 13/10/2009

Thank You!Thank You!Guilherme CintraGuilherme Cintra

[email protected]@ifpma.org

Ch. Louis-Dunant 15Ch. Louis-Dunant 15P.O. Box 195P.O. Box 195112211211 Geneva 20211 Geneva 20SwitzerlandSwitzerland

Tel: Tel: +41-22-338 32 00+41-22-338 32 00Fax:Fax: +41-22-338 32 99+41-22-338 32 99Email: Email: [email protected]@ifpma.orgWeb:Web: www.ifpma.orgwww.ifpma.org

© ifpma 2009wipo open-ended forum on proposed development agenda projects - 13/10/2009 ifpma views...

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