On 23 October, 2006, the Chair of the Board, the Executive Director and partners of Drugs for Neglected Diseases initiative (DNDi), sent an open letter, which relates to the landmark World Health Organization (WHO) R&D Resolution 59.24, to all candidates for the WHO Director-General position.
Geneva, 23 October 2006
As co-promoters of the R&D Appeal launched in 2005 by Drugs for Neglected Diseases initiative and its partners, 19 Nobel Laureates and now supported by over 7500 scientists and academics worldwide, we firmly believe that governments should play a pivotal leadership role in needs-driven R&D for neglected diseases.
The landmark R&D Resolution 59.24 was approved by the member states of the World Health Assembly one week after the late WHO Director General, Dr. Lee, received the R&D Appeal in May 2006. The R&D Appeal urges global public responsibility in:
- Setting global health R&D priorities according to patient needs
- Establishing better strategies to stimulate essential health R&D (for diagnostics, vaccines, and drugs)
- Providing sustained financial support to essential health R&D
We wish to remind the 13 WHO Director General candidates that the WHO, in living up to its institutional mandate, now has the imperative to play a leading role in prioritizing and creating an environment more conducive to innovative medical research that addresses the essential needs of the poor.
Found in the WHA Resolution, this spirit remains true to the main recommendations of the Report of the Commission on Intellectual Property Rights, Innovation and Public Health (CIPIH) released on 3rd April 2006.
In response to a growing concern over the inadequacy of the current global system to support innovation in new medicines and essential health tools for neglected diseases, the WHA Resolution seeks to ensure that R&D efforts address the priority needs of patients living in resource-poor settings and often without access to essential medicines.
To achieve these objectives, the resolution aims to harness collaborative R&D initiatives involving governments and to ensure that progress in basic science and biomedicine is translated into improved, safe, and affordable health products – drugs, vaccines, and diagnostics.
The WHO has been given a two-year time frame in which to create a more favourable environment for needs-driven R&D. We firmly believe that, by displaying the same boldness it showed in adopting the Essential Drugs policies in the 1970s, the WHO can impose its will and influence by swiftly acting on the tenets set by the WHA Resolution.
Through philanthropic commitments made in recent years, many initiatives have been established to accelerate innovation for neglected diseases that respond to patients needs. But to ensure a long-term and sustainable response, the WHO needs to recapture its central institutional role on health and to exercise that role fully by defining needs, assessing priorities, and ensuring that other institutions and actors are held accountable in terms of their health policies and programs.
We sincerely hope the next leader of WHO will have the strength and clarity of purpose to undertake his role as director of the organization responsible for global public health.
Yves Champey Bernard Pecoul
President of the board, DNDi Executive Director, DNDi
Call to Governments
Call to governments to provide significant and sustained support to bring essential new drugs, vaccines, and diagnostics to people suffering and dying from neglected diseases
- Every day over 35,000 people die from infectious diseases such as AIDS, malaria, tuberculosis, and most neglected diseases such as leishmaniasis, Chagas disease and sleeping sickness.
- These diseases affect hundreds of millions, yet we lack safe, affordable, effective, field-adapted vaccines, diagnostics, and drugs to tackle them.
- Between 1986 and 2001, global funding for health research rose from $30 billion to US$106 billion, but progress towards new health tools for the poor remains insignificant.
- Of 1,393 new medicines approved between 1975 and 1999, only 1% was developed for tropical diseases and tuberculosis.
- Basic science about infectious diseases exists and biomedicine is developing extremely fast, but without political determination this progress cannot be used to develop essential products.
- The profit-driven model of drug development is not suited to developing essential health tools for neglected diseases.
- Current regulatory practices are poorly adapted to assessing the therapeutic advances of new drugs, vaccines and diagnostics for neglected diseases.
- Higher levels of intellectual property protection have not resulted in increased drug R&D for global health needs.
In the last few years, this health challenge has spurred global awareness and some commitment from the international community. A number of developing countries have been strengthening their capacity for new health technologies, and their role will be increasingly critical. Not-for-profit entities have been established to accelerate innovation for neglected diseases. They are beginning to build a pipeline of projects in response to the real needs of neglected patients. These product development partnerships act as ÒvirtualÓ laboratories, working collaboratively with public research institutes, universities, and pharmaceutical and biotechnology industries. However, the majority of these entities are mainly funded by philanthropic organizations and individual donors. The response remains insufficient with only marginal involvement by wealthier governments.
There is an urgent need to correct the fatal imbalance of the current drug development model. Governments must take responsibility for global public health.
New models and financial mechanisms must be pursued. Determined policy action is needed to direct health-needs driven R&D and harness collaborative R&D initiatives. This will ensure that initial progress is translated into improved, affordable and field-adapted drugs and diagnostics that can reach patients most in need.
We urge governments to provide
- Political leadership - Make global health and medicines a strategic sector and set R&D priorities according to the needs of patients. Only then can the world achieve the Millennium Development Goals that envision - among other things - significant progress in combating HIV/AIDS, tuberculosis, malaria and other neglected diseases.
- Sustained financial support - Governments, rich and poor, as well as inter-governmental organisations should provide, on a sustainable basis, US$ 3 billion a year needed to reach an appropriate level of health research for diseases of the poor. To secure long-term success, funding mechanisms should be designed.
- New rules to stimulate essential health R&D - Redirecting today's knowledge and scientific expertise to neglected needs will mean a substantial shift in the way essential health products are valued, financed and made available. A new enabling framework should include access to knowledge, chemical compounds, and research tools protected by intellectual property rights. Technology transfer and research capacity strengthening in disease-endemic countries should be at the heart of the endeavour. In addition, regulatory approval processes must be streamlined in order to rapidly deliver essential medicines to patients. The risks and benefits of each drug or vaccine must be assessed in relation to the needs of patients, the severity of the disease, and available treatments and vaccines.
Without bold, new steps, disease will continue to ravage the developing world, with global consequences. Governments should act NOW.
- Paulo Buss (President, Oswaldo Cruz Foundation , Brazil)
- Nirmal K. Ganguly ( Indian Council of Medical Research, India);
- Rowan Gillies (President, Médecins Sans Frontières International);
- Richard Jefferson (Director, BIOS Initiative , Australia);
- Davy Koech (Director, Kenya Medical Research Institute , Kenya);
- Philippe Kourilsky (Director General, Institut Pasteur , France);
- Ismail Merican (Director General, Ministry of Health, Malaysia );
- Barbara Stocking (Director, Oxfam GB)
Nobel Prize Laureates
- Pierre-Gilles de Gennes ( Physics 1991);
- Shirin Ebadi ( Peace 2003);
- Adolfo Perez Esquivel ( Peace 1980);
- Dario Fo ( Literature 1997);
- Nadine Gordimer ( Literature 1991);
- Roger Guillemin (Physiology or Medicine 1977);
- José Ramos Horta ( Peace 1996);
- Mairead Corrigan Maguire ( Peace 1976);
- Médecins sans Frontières ( Peace 1999);
- Rigoberta Menchú Tum ( Peace 1992);
- Sir Paul M. Nurse (Physiology or Medicine 2001);
- Sir John E. Sulston ( Physiology or Medicine 2002);
- Desmond Tutu ( Peace 1984);
- Betty Williams ( Peace 1976);
- Jody Williams ( Peace 1997)
- Gunter Grass (Literature 1999)
- Stanley B. Prusiner (Physiology or Medicine 1997)
- Prof. Rolf.M. Zinkernagel (Physiology or Medicine 1996)
Scientists and Physicians
- Kirana Bhatt (Department of Medicine, University of Nairobi, Kenya);
- Leigh Bissett (British Medical Association, UK);
- Pierre-Etienne Bost (Deputy Director, Institut Pasteur, France);
- Yves Champey (Chair, DNDi Board of Directors, France);
- Simon Croft (R&D Director, DNDi, Switzerland);
- Alan Fenwick OBE (Chair of Tropical Parasitology and Director Schistosomiasis Control Initiative, Imperial College London, UK);
- Peter Folb (Medical Research Council, South Africa);
- Silvio Garattini (Director, The Mario Negri Institute of Pharmacological Research, Italy);
- Lalit Kant (Deputy Director General, Indian Council of Medical Research, India);
- Helen Lee (Chief of the Diagnostic Development Unit, University of Cambridge, UK);
- Stephen Maurer (Goldman School of Public Policy, Berkeley University, USA – Tropical Disease Initiative);
- Carlos Morel ( Scientific Coordinator , Oswaldo Cruz Foundation, Brazil);
- Visweswaran Navaratnam (Clinical Pharmacologist, University of Science, Malaysia);
- James Orbinski (Munk Centre for International Studies, University of Toronto, Canada);
- Bernard Pécoul (Executive Director, DNDi, Switzerland);
- Bennett Shapiro (former EVP and Head of Research, Merck & Company, USA);
- Richard Smith (Board member, Public Library of Science and former editor BMJ, USA);
- C. P. Thakur (Former Union Minister, Ministry of Health and Family, India);
- Julio Urbina (IVIC - Venezuelan Institute for Scientific Research, Venezuela);
- Nick White (The Wellcome Trust Mahidol University Oxford Tropical Medicine Research Programme, Thailand);
- Dyann Wirth (Harvard School of Public Health, USA) ;
- Yongyuth Yuthavong (Senior Researcher, NSTDA-National Science & Technology Development Agency, Thailand)
- Nubia Boechat (Director of far Manguinhos, Brazil)
- Paul L Herrling (Head of Corporate Research, Novartis)
- Giovanni Berlinguer (Member of the European Parliament –MEP-, Committee on Public Health);
- John Bowis (MEP, Rapporteur on neglected diseases);
- Dorette Corbey (MEP));
- Eduardo Galeano ( Uruguayan journalist, essayist and writer);
- Thomas Gebauer (Executive Director, Medico International);
- Paul Hunt (UN Special Rapporteur on the Right to the highest attainable standard of health );
- Glenys Kinnock (MEP);
- Stephen Lewis (UN Secretary General's Special Envoy for HIV/AIDS in Africa );
- Ney Matogrosso ( Brazilian singer and songwriter);
- Luisa Morgantini (MEP, President of the Development Committee);
- Mary Robinson (former President of Ireland, former High Commissioner for Human Rights – Executive Director, The Ethical Globalisation Initiative ) ;
- Viviane Senna (President, Ayrton Senna Institute),
- Susannah Sirkin (Deputy Director, Physicians for Human Rights);
- Ismael Serageldin (President MURS International);
- Carl Schlyter (MEP, Co-chair of the Economic Committee of ACP-EU Parliamentary Assembly);
- Walter Veltroni (Mayor of Rome and 2004 World Mayors finalist for Europe)
DNDi in association with:
- Davy Koech, Director, Kenya Medical Research Institute, Kenya
- Paolo Buss, President, Oswaldo Cruz Foundation, Brazil
- Philippe Kourilsky, Director General, Institut Pasteur, France
- Ismail Merican, Director General, Ministry of Health, Malaysia
- Nirmal K. Ganguly, Director General, Indian Council of Medical Research, India
- Rowan Gillies, President Médecins Sans Frontières International
- Barbara Stocking, Director, Oxfam GB
- Richard Jefferson, Director BIOS Initiative, Australia
Created in May 2003 at the 56th World Health Assembly, the Commission on Intellectual Property Rights, Innovation and Public Health (CIPIH) aims to review the interfaces and linkages between intellectual property rights, innovation and public health in the light of current evidence and examine in depth how to stimulate the creation of new medicines and other products for diseases that mainly affect developing countries.