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. 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.2 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.3 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:4
- Priority health needs should drive R&D funding.
- 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.
- 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.
- Public interest R&D should be carried out in a more transparent manner
- Transparent R&D funding flows are needed for effective coordination (to avoid duplication and enhance efficiency);
- Transparency of clinical trial data should be promoted to ensure the greatest possible sharing of research knowledge and data;
- 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
- 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.
AIDS ACCESS Foundation
Alianza LAC Global por el Acceso a Medicamentos
All India Drug Action Network
Alternative Agricultural Network
Diverse Women for Diversity
Drug Study Group
Drug System Monitoring and Development Program
Drugs for Neglected Diseases initiative
European Aids Treatment Group
Foundation for AIDS Rights
Foundation for Consumers
Foundation for Research in Science Technology & Ecology
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 Poverty Action
Initiative for Health & Equity in Society (India)
Knowledge Ecology International
Médecins Sans Frontières- Access Campaign
National Working Group on Patent Laws (India)
Optonet International/Afrihealth Optonet Association
People’s Health Movement
Rural Doctor Society
Rural Doctors Foundation
Rural Pharmacists Foundation
Salud y Farmacos - USA
Social Pharmacy Research Unit, Chulalongkorn University
Stop AIDS Campaign
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.
1For 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; WHO (2004). ‘The Global Medicines Situation Report, 2004’.p 19. Available at: 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.
2CEWG report 2012.
3CEWG report 2012 p. 96-98.
4The 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.