Dear E-druggers,
I would like to share with you the following open letter signed by >60 NGOs on the follow up of the report of the Consultative Expert Working Group (CEWG). A shortened version of this letter was delivered this morning by HAI and KEI at the WHO's open-ended Member States meeting: -- Open letter to WHO Member States on the occasion of the open-ended Member States meeting on the follow up of the report of the Consultative Expert Working Group (CEWG) on Research and Development Financing and Coordination, November 26-28th 2012
More than ten years of debate and discussion and the publication of three expert reports all have arrived at one conclusion: medical technologies, such as medicines, diagnostics and vaccines too often remain unaffordable, unavailable and unsuitable for the people who need them.[i] This failure is costing lives and must be addressed through concrete and meaningful measures. It is not a problem for one country or region; it is the responsibility of all governments to ensure the health needs of their populations are met. We call on Member States to address the weaknesses in the current innovation system by ensuring, simultaneously, needs-driven research and development (R&D) and access to the fruits of R&D.
The last decade has seen the creation of a number of important initiatives to fill innovation gaps but these are ad hoc, fragmented and are not sustainable without significantly strengthened public leadership.
A complementary R&D framework is needed to address market and/or public policy failures; to stimulate R&D for diseases or areas of technology wherever market incentives have failed to deliver, and to ensure access to the resulting products.
The WHO Consultative Expert Working Group on R&D Financing and Coordination (CEWG) provides a clear vision of some critical and concrete steps that are needed to respond to these challenges.[ii] This includes mechanisms to establish needs and priorities, monitor R&D flows, coordinate R&D efforts, secure sustainable financing, promote new incentives and manage research outputs in a way that ensures both innovation and access. The CEWG report was clear that these functions are interrelated and that individual elements cannot stand alone, but rather require a framework to support their integration into a coherent whole, such as through a convention for essential health R&D.
Several Member States seem to support the establishment of a WHO-hosted global health R&D observatory.[iii] Such an observatory would be a positive first step. However, given the extent of the challenge, efforts that solely aim to improve monitoring of global health R&D and assist with priority-setting, are not enough. An observatory will not provide adequate coordination, increase sustainable financing or result in new medical tools that are needed. If this is the only outcome to result from more than ten years of deliberations it would be woefully inadequate.
With the health of so many at stake, Member States must agree on a process to address these fundamental problems and must do so in a manner that is consistent with several key principles.
Key principles to guide further discussions towards an essential health R&D framework include the following:[iv]
1 Priority health needs should drive R&D funding.
2 Global health R&D funding is a public responsibility and should be both sufficient and sustainable through public investments based on fair sharing of R&D costs.
3 Affordable and equitable access to the final product of publicly and philanthropically funded R&D should be the end goal of all R&D efforts, and to ensure this, it is essential to de-link R&D costs from the price of products.
4 Public interest R&D should be carried out in a more transparent manner: a Transparent R&D funding flows are needed for effective coordination (to avoid duplication and enhance efficiency); b Transparency of clinical trial data should be promoted to ensure the greatest possible sharing of research knowledge and data; c Transparent R&D financing should be encouraged, including routine disclosure of the costs of clinical trials, public and private subsidies for R&D, and prices and revenues for new products; d Transparent management of intellectual property rights should be enhanced, including greater transparency of patent status and landscapes, and the disclosure of relevant terms of licenses.
5 Incentives and norms which govern publicly-funded R&D should acknowledge R&D outputs as global public goods and expand knowledge-sharing and open management of intellectual property rights as a way to reduce the cost of R&D and ensure access to innovation.
We call urgently on Member States to work towards a transformative global framework for needs-driven health R&D.
ACTION AIDS ACCESS Foundation Alianza LAC Global por el Acceso a Medicamentos All India Drug Action Network Alternative Agricultural Network Berne Declaration BUKO Pharma-Kampagne Diverse Women for Diversity Drug Study Group Drug System Monitoring and Development Program Drugs for Neglected Diseases initiative European Aids Treatment Group Farmamundi Foundation for AIDS Rights Foundation for Consumers Foundation for Research in Science Technology & Ecology FTA Watch GAT-Grupo Português de Activistas sobre Tratamento de VIH/SIDA-Pedro Santos Global Health Advocates Global Health Justice Partnership, Yale University Grupo de Trabalho sobre Propriedade Intelectual - GTPI/REBRIP (Brazilian Working group comprised by 15 NGOs and Social Movements) Associação Brasileira Interdisciplinar de AIDS - ABIA Grupo Pela Vidda São Paulo Health Action International Africa Health Action International Asia-Pacific Health Action International Europe Health Action International Global Health and Development Foundation Health Consumers Protection Program Health GAP Health Poverty Action IFARMA Initiative for Health & Equity in Society (India) Knowledge Ecology International LOCOST (India) Médecins Sans Frontières- Access Campaign Mission Salud National Working Group on Patent Laws (India) Optonet International/Afrihealth Optonet Association Oxfam International People's Health Movement Restless Development RESULTS UK Rural Doctor Society Rural Doctors Foundation Rural Pharmacists Foundation Salud y Farmacos - USA Social Pharmacy Research Unit, Chulalongkorn University Stop AIDS Campaign Tearfund Thai Holistic Health Foundation Thai NGO Coalition on AIDS The Thai Network of People living with HIV/AIDS (TNP+) Trans Atlantic Consumer Dialogue Universities Allied for Essential Medicines
Signatories as of 25 November 2012. Open for endorsement.
Endnotes _______________________________
[i]For example in: WHO (2006) 'WHO, Public Health, Innovation and Intellectual Property Rights: Report of the Commission on Intellectual Property Right, Innovation, and Public Health' (CIPIH Report). p. 171. Available at: http://www.who.int/intellectualproperty/documents/thereport/ENPublicHealthReport.pdf <http://www.who.int/intellectualproperty/documents/thereport/ENPublicHealthReport.pdf> ; WHO (2004). 'The Global Medicines Situation Report, 2004'.p 19. Available at: http://ebookbrowse.com/world-medicines-situation-2004-pdf-d50566214 <http://ebookbrowse.com/world-medicines-situation-2004-pdf-d50566214> ; WHO (2012) 'Research and Development to Meet Health Needs in Developing Countries: Strengthening Global Financing and Coordination'. Report of the CEWG on Research and Development: Financing and Coordination (CEWG Report). April 2012. Available at: http://www.who.int/phi/CEWG_Report_5_April_2012.pdf <http://www.who.int/phi/CEWG_Report_5_April_2012.pdf> .
[ii]CEWG report 2012.
[iii]CEWG report 2012 p. 96-98.
[iv]The resolution WHA 65.22 adopted at the WHA 2012 singles out three specific elements for Member States to develop proposals on: transparency, coordination and sustainable financing. We would like to emphasize the need to integrate these with the R&D proposals and key principles or norms as recommended by the CEWG.
Tessel Mellema
Project Officer - Trade, Innovation & Access to Medicines
Health Action International (HAI) Europe Overtoom 60 II, 1054 HK Amsterdam t. +31 20 683 3684 f. +31 20 685 5002 e. Tessel@haieurope.org w. www.haieurope.org <http://www.haieurope.org/>
Follow HAI Europe on Twitter <https://twitter.com/#!/HAIEurope> or Facebook <https://www.facebook.com/pages/Health-Action-International-HAI-Europe/102588189864739>
Health Action International (HAI) is an independent, global network working to increase access to essential medicines and improve their rational use through research excellence and evidence-based advocacy.
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