Campana Salud para el Desarrollo Barcelona – Diciembre 2008 Judit Rius Sanjuan Knowledge Ecology International (KEI) Perspectivas futuras en la OMS

Que es la resolucion WHA 61.21? Estrategia Mundial y Plan de Accion de la OMS sobre salud publica, innovacion y propiedad intelectual (Mayo 2008) “The most important document on public health and intellectual property since the 2001 WTO Doha Declaration” “A mind shift in the perception of the complex relation of public health and intellectual property” “The World Health Assembly has reached consensus on a plethora of difficult and important topics on topics that were considered controversial only a short time ago”

Origenes

Long story short More than 250 scientists, economists and other experts (including 5 Nobel Prize winners) sent letters to the WHO requesting a new global framework for essential health R&D CIPIH Report ( ) Resolution WHA IGWG negotiations ( ) Regional and sub-regional meetings and contributions Civil society participation Web-based public hearings

Resultados

Doha Declaration PLUS Strong recognition of the importance of generic competition and transfer of technology:  Compulsory licensing and other TRIPS flexibilities  Patent Pools and collective management of Intellectual Property  “Encourage the further development and dissemination of publicly or donor-funded medical inventions and know-how through appropriate licensing policies, including but not limited to open licensing, that enhance access to innovations for development of products of relevance to the public health needs of developing countries on reasonable, affordable and non- discriminatory terms”

Open Science Promote public access to the results of government funded research by encouraging that investigators submit their final manuscripts to an open access database (e.g US NIH publication policy) Support the creation of voluntary open databases and compound libraries Support open-source methods for discovery science in order to develop a sustainable portfolio of new products

Re-think the basis for innovation Recognition that the IP regime is limited in its scope to deliver products that are crucial for developing countries (CIPIH Report) The urgent need to rethink: the way we prioritize R&D to ensure that it responds to real needs + the amount dedicated to R&D + the way it is financed so that products that are developed are made accessible to those who need them.  A biomedical R&D treaty  New innovation inducement mechanisms, like prizes, to provide innovative incentives that are not linked to product prices  Separate the market from the product from market from innovation

Reform R&D incentive mechanisms

Current Pull system: MONOPOLIES = High Prices

Resolution WHA REQUESTS the WHO Director-General: (4) to encourage the development of proposals for health- needs driven research and development for discussion at the Intergovernmental Working Group that includes a range of incentive mechanisms including also addressing the linkage between the cost of research and development and the price of medicines, vaccines, diagnostic kits and other health-care products and a method for tailoring the optimal mix of incentives to a particular condition or product, with the objective of addressing diseases that disproportionately affect developing countries;

Main idea: Separate market for innovation from market for products R&D Cost/ Drug developers Product Cost/ Consumers

PRIZES instead of MONOPOLIES

Proposal: Prizes to reward drug development Monetary rewards for successful investment on medical innovations A more rational and fair system to pay for innovation, while … Ensuring access = generic competition from regulatory approval Prizes & patents: Obligation to open license to a Pool. Re- defining the patent as a claim against a monetary prize (right to be remunerated), rather than an exclusive right to exclude competition Open source divident: new incentives for sharing access to knowledge and technology + set-asides to encourage greater collaborations/contributions from southern R&D institutions

Advantages of Prizes to reward drug development Lower prices make inventions freely available to competitive suppliers from day 1 Society pays only successful and needs-driven innovation Prizes linked to objective impact of invention on improvement in health care outcome Reduce incentives for me too products and marketing practices

Bolivia & Barbados proposals Prize Fund for Development of Low-Cost Rapid Diagnostic Test Prize Fund for the Development of New Treatments for Chagas Disease Priority Medicines and Vaccines Prize Fund (PMV/pf) Prizes as a Reward Mechanism for New Cancer Treatments Licensed Products Prize Fund (LP/pf) for Donors

El Futuro

Expert Working Group “To establish urgently a results-oriented and time- limited expert working group to examine current financing and coordination of research and development, as well as proposals for new and innovative sources of funding to stimulate research and development related to Type II and Type III diseases and the specific research and development needs of developing countries in relation to Type I diseases, and open to consideration of proposals from Member States..”

This is just the beginning Next round of negotiations: Implementation (globally, regionally, nationally)  Transform this document full of action points into reality. E.g. Prizes for Chagas and TB  Civil society and governments should continue to be active, creative and action-oriented  The WHO has yet to address the estimation of funding needs for priority R&D and to created a framework for sustainable sources of funding = Biomedical R&D Treaty

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