Letter to ask World Health Organization to Evaluate New Treaty Framework for Medical Research and Development

The following is a letter to the World Health Organization (WHO) commission on Intellectual Property, Innovation and Health (CIPIH). This body is asked to evaluate a new treaty framework for medical R&D. (http://www.cptech.org/workingdrafts/rndtreaty4.pdf) This is essentially a substitute for existing or planned trade agreements that focus on patents or drug prices. The proposed Medical R&D Treaty (MRDT) is a 12 page work in progress that has been discussed for more than 2 years by a large number of public heath experts, economists, lawyers and others who are seeking to create a new paradigm for financing medical R&D. It features a number of new ideas for dealing with global R&D issues, including for example minimum obligations for supporting R&D, priority setting mechanisms, and a system of tradable credits for investments in particular projects that promote social or public interest objectives. (Creating markets for public goods.)

If you would like to add your name to the letter, send your name and preferred identification, including country of residence to rnd-signon@cptech.org.

(delivered to WHO on February 24, 2005)

Open Letter asking the WHO Executive Board and the WHO Commission on Intellectual Property, Innovation and Health (CIPIH) to Evaluate a Proposal for New Global Medical R&D Treaty

Dear Members of the WHO Executive Board and the WHO CIPIH:

The current global framework for supporting medical R&D suffers from profound flaws. A growing web of multilateral, regional, bilateral and unilateral trade agreements and policies focus nearly exclusively on measures that expand the scope and power of intellectual property rights, or reduce the effectiveness of price negotiations or controls.

These mechanisms are plainly designed to increase drug prices, as the sole mechanism to increase investments in R&D. Stronger intellectual property rights and high drug prices do create incentives to invest in medical innovation, but also impose costs, including:

  1. problems of rationing and access to medicine,
  2. costly, misleading and excessive marketing of products,
  3. barriers to follow-on research,
  4. skewing of investment toward products that offer little or no therapeutic advance over existing treatments, and
  5. scant investment in treatments for the poor, basic research or public goods.

A trade framework that only relies upon high prices to bolster medical R&D investments anticipates and accepts the rationing of new medical innovations, does nothing to address the global need for public sector R&D investments, is ineffective at driving investments into important priority research projects, and when taken to extremes, is subject to a number of well-known anticompetitive practices and abuses. Policy makers need a new framework that has the flexibility to promote both innovation and access, and which is consistent with efforts to protect consumers and control costs.

To this end, a number of experts and stakeholders have proposed a new global treaty to support medical R&D. This effort has produced a working draft (http://www.cptech.org/workingdrafts/rndtreaty4.pdf) that illustrates a particular approach for such a treaty -- one that seeks to provide the flexibility to reconcile different policy objectives, including the promotion of both innovation and access, consistent with human rights and the promotion of science in the public interest. The draft treaty provides new obligations and economic incentives to invest in priority research projects, and addresses several other important topics.

1 The World is Changing

The global trade framework for pharmaceuticals is changing. The pace of change is accelerating; the direction is toward higher prices and rationing of access, and the target of policy is often the elimination of basic government interventions to protect consumers. Most important, the world is increasingly locked-in to a rigid and increasingly controversial approach to financing R&D. It is thus urgent to propose and evaluate alternative trade frameworks.

2 The Draft R&D Treaty Project

The current draft R&D treaty seeks to stimulate discussion, noting of course that the development of a treaty is a democratic process involving negotiations between member states with input from civil society. The draft treaty text is a work in progress, representing a collaborative effort with contributions from many persons over the past two years.

The discussion below concerns draft 4, and some provisions will change in later drafts. The objective of the project is to propose an international system that (1) ensures sustainable investments in medical innovation, (2) provides a fair allocation of the cost burdens of such innovation, (3) creates mechanisms to drive R&D investment into the areas of the greatest need, and (4) provides the flexibility to utilize diverse and innovative methods of financing innovation while protecting consumers and ensuring access.

3 Obligations to finance R&D

At the core of the proposed treaty is an obligation to finance Qualified Medical Research and Development (QMRD). This obligation is tied to country GDP. In Draft 4, two different methods of determining the fraction of GDP for QMRD are presented. Alternative 1 uses different rates for each of four income groups (high, high medium, low medium, and low). Alternative 2 is a graduated rate.

QMRD would include (1) basic biomedical research, development of biomedical databases and research tools, (2) development of pharmaceutical drugs, vaccines, medical diagnostic tools, (3) medical evaluations of these products, and (4) preservation and dissemination of traditional medical knowledge,

There is a separate obligation to finance Priority Medical Research and Development (PMRD), and two alternative methods of setting benchmarks for PMRD. In the current draft at least half of PMRD investments must be targeted for neglected diseases.

4 Methods of financing R&D

While virtually all of today's trade agreements focus exclusively upon purchase of medicines at high prices as the sole method of financing R&D, the Draft R&D Treaty takes a much broader view. Acceptable methods of finance include such items as direct public funding, tax credits or other expenditures, philanthropic spending, research funding obligations imposed on sellers of medicines, purchases of relevant medical products (to the degree that such expenditures induce investments in medical R&D), and innovation prizes (to the degree that such prizes induce investments in medical R&D).

5 Benefits of Meeting Obligations to Finance R&D

The proposed treaty would require member states to forgo dispute resolution over intellectual property or pricing issues relating to the products covered by the agreement. This would include all multilateral, regional, bilateral and unilateral intellectual property and trade agreements.

6 Tradable Credits for Investments in Certain Public Goods

In addition to the basic obligations outlined above, the draft treaty proposes a system for assigning credits for projects that are considered socially important. Member countries could use these credits to satisfy treaty obligations. Similar to the Kyoto climate treaty, credits would be traded across borders -- and countries that exceed the benchmark obligations can sell excess credits. The credits will be given for a variety of projects including:

7 Promotion of Open Access Research

The draft treaty proposes adoption of a best practices model for the support of open access biomedical research, and obligations that research supported by public funds enter open access archives.

8 Equitable Access to Publicly Funded Inventions

Member countries would be obligated to provide equitable access to publicly funded inventions.

9 Changes in laws for patents, copyright and related rights.

The draft treaty text provides for minimum exceptions to patent rights for research, and a novel agreement to not accept patent applications for inventions that are based upon data from certain open public databases (like the HapMap Project), as well as a best practice for practices model for exceptions in laws on copyright and related rights, including laws on databases.

10 Global Norms / Decentralized Control of R&D Spending

While the draft treaty proposes global norms regarding obligations to invest in R&D, and tradable credits as incentives to invest in certain types of R&D projects, the management of specific R&D outlays would be decentralized, and controlled by Member countries.

Members would be free to embrace a diversity of management approaches to support R&D, including the direct funding of profit or non-profit research projects, market transactions such as purchases of medicine that provide incentives for research and development, payment of royalties to patent owners, tax credits, innovation prizes, investments in competitive research intermediators, mandated research and development obligations on sellers of medicines or other alternatives that have the practical effect of either directly or indirectly financing medical R&D.

11 Transparency and Measurement

Members would agree to adopt consistent approaches to measuring R&D flows and outcomes. The measurement of investment flows will follow three principles.

(1) No double counting (mechanisms to finance R&D are complex, involving mixed sources of finance and transnational flows of products and investments, but each investment will only be counted once).

(2). Source of finance rather than location of investment. For example, if products are purchased in one country but R&D is performed in another, the country that paid for the products would receive credit for funding the R&D. The county that performed the R&D would not.

(3) Evidence based estimates. In cases where measured investments are based upon estimates of the relationship between outlays on products (or other incentives) and actual R&D investments, the estimates are based upon the best empirical evidence of such relationships.

12 Evaluate Proposals for New Global Frameworks to Support Medical R&D

We call upon the WHO CIPIH to engage in debates over the appropriate global framework to support medical R&D, and to evaluate the Draft R&D Treaty proposal. This initiative seeks to refashion global policy to better fulfill the objective of providing "access to medicine for all."

The treaty proposal recognizes the importance of ensuring sustainable sources of finance for innovation, including R&D for neglected diseases and other public health priorities, and it provides opportunities to experiment with new and promising mechanisms to finance R&D, such as prize funds, competitive intermediators, compensatory liability regimes, or open collaborative projects such as the Human Genome Project. We are at a key moment in history, as we rapidly create new rules that will long determine the nature, costs and distribution of benefits of medical knowledge goods. In order to create the best possible systems, policy makers should consider the fullest range of options, including this innovative, flexible and choice preserving idea.


[To sign, send an email to rnd-signon@cptech.org, with your name and the way you would like to be identified, including country of residence.]

Initial Signatures include:

James Love, Director, CPTech, Washington, DC, USA

Tim Hubbard, Head of Human Genome Research, Wellcome Trust Sanger Institute, Cambridge, UK

Martin Khor, Third World Network, Malaysia

Sir John Sulston, Winner of 2002 Nobel Prize for Physiology or Medicine, Former Director of the Wellcome Trust Sanger Institute, Cambridge, UK

Dominique Stoppa-Lyonnet, Head of the Genetics Department of the Medical Division of the Institut Curie, Paris, France

Dr. Massimo Barra, Vice President, International Federation of the Red Cross

Ellen 't Hoen, Director of Policy Advocacy and Research, Access to Essential Medicines Campaign, Médecins sans Frontières

Oxfam International

Spring Gombe, Health Action International (HAI)

Anna Fielder, Director, Consumers International, Office for Developed and Transition Economies, London, USA

Bernard Sanders, Member, United States House of Representatives, USA

Ian Gibson MP, Chair, House of Commons Select Committee on Science and Technology, UK

Alain Claeys, Député de la Vienne, France

Claude Huriet, Ancien sénateur de la Meurthe-et-Moselle, France

David Hammerstein, Member of European Parliament, Spain

Jean-Luc Bennahmias, Member of European Parliament, France

Daniel Cohn-Bendit, Member of the European Parliament

Luisa Morgantini, Member of the European Parliament, Italy

Monica Frassoni, Member of the European Parliament, Co-President of the Green/Efa Group, Italy

Glenys Kinnock, Member of the European Parliament, Co-President of the ACP-EU Joint Parliamentary Assembly, UK

Vittorio Agnoletto, Member of the European Parliament, former president of LILA - Italian League for the fight against AIDS, group GUE/NGL, Italy

Dr. Dorette Corbey, Member of European Parliament, The Netherlands

Dr. Rodrigo Salinas, Director, Instituto de Salud Publica de Chile, Santiago de Chile

Cristina de Albuquerque Possas, Head of Research and Technological Development Unit National STD-Aids Program, Ministry of Health, Brazil

Dr. Benjamin Gilbert, Institute for Pharmaceutical Technology, Fundação Oswaldo Cruz, Ministry of Health, Brazil

William W. Fisher III, Hale and Dorr Professor of Intellectual Property Law, Harvard Law School, USA

Peter Suber, Open Access Project Director, Public Knowledge, Research Professor of Philosophy, Earlham College, USA

HeeSeob Nam, Intellectual Property Left, Patent Attorney, Korea

Dr. Christian Wagner, BUKO Pharma-Kampagne, Bielefeld, Germany

Ruth Mayne, Oxford Brookes University, UK

James Boyle, William Neal Reynolds Professor of Law, Duke University, USA

Peter Drahos, Professor and Head of Progam, Regulatory Institutions Network, Research School of Social Sciences, Canberra, Australia

Jonathan Berger, AIDS Law Project, South Africa

Nathan Geffen, Treatment Access Campaign, South Africa

Lawrence Lessig, Professor of Law at Stanford Law School, Chairman of the Creative Commons, USA

Nicoletta Dentico, President, Global Health Watch in Rome, Italy

Jiraporn Limpananont, Ph.D., Chair of Social Pharmacy Research Unit, Faculty of Pharmaceutical Sciences, Chulalongkorn University, Bangkok, Thailand

Andy Gray, Senior Lecturer, Dept of Therapeutics and Medicines Management, Nelson R Mandela School of Medicine, Durban, South Africa

Joel Lexchin MD, School of Health Policy and Management, York University, Toronto, Ontario, Canada

Joan Rovira, Director of Research for SOIKOS (Centro de Estudios en Economia de la Salud y de la Politica Social) Barcelona, Spain

Frederick M. Abbott, Edward Ball Eminent Scholar, Professor of International Law, Florida State University College of Law, USA

Prof Udo Schuklenk, Chair in Ethics and Public Policy, Glasgow Caledonian University, UK

Suntaree Vitayanatpaisan, Chairperson, Drug Study Group (DSG), Bangkok, Thailand

Charles Medawar, Director, Social Audit Ltd, London, UK

Dr. Shyama V. Ramani, Department of Economics, INRA (Institut National de la Recherche Agronomique) - Universite Pierre Mendes, France

Donald Light, Professor of Comparative Health Care Systems, University of Medicine and Dentistry of New Jersey, USA

Talha Syed, Doctoral Candidate, Harvard Law School, USA

Dr. Alexander C. Tsai, Case Western Reserve University School of Medicine, USA

Mei-ling Wang, Ph.D, Associate Professor of Social Sciences and Health Policy, University of the Sciences in Philadelphia, USA

Carolyn Deere, Global Economic Governance Programme, Oxford University, UK

Warren Kaplan, Center for International Health and Development, Boston University School of Public Health, USA

Leonard Rodberg, Associate Professor and Chair, Urban Studies Department Queens College/CUNY, NY, USA

Terence H. Young, Chair, Drug Safety Canada, Ontario, Canada

Madeline Boscoe, R.N, Advocacy Coordinator, Women's Health Clinic, Winnipeg, Canada

Harriet G. Rosenberg, Ph.D., Health and Society Programme, York University, Toronto, Canada

Richard J. Brown, MD, Board, Physicians for a National Health Program, NY Metro Chapter, USA

Dr. Andrew Herxheimer, Emeritus Fellow, Cochrane Centre, UK

Dr. Jillian Clare Cohen, Assistant Professor, Leslie Dan Faculty of Pharmacy, University of Toronto, Canada

Richard Stallman, Founder, Free Software Foundation, USA

Elia Abi-Jaoude, Psychiatry Resident, University of Toronto, Canada

Institute for Agriculture and Trade Policy, USA

Barbara Mintzes, Centre for Health Services & Policy Research, University of British Columbia, Canada

Alan Cassels, Drug policy researcher, School of Health Information Science, University of Victoria, Victoria, BC Canada

John Howkins, Director, IP Charter, London, UK

David Dudley, Attorney, USA

Kevin Outterson, Associate Professor of Law, West Virginia University, USA

Professor Anil K. Gupta, Kasturbhai Lalbhai Chair in Entrepreneurship, Indian Institute of Management, India

Dr. Ikrame MOUCHARIK, membre d'ATTAC Maroc, Morocco

Gazanfer Aksakoglu, Professor and Head, Department of Community Medicine, Dokuz Eylul University, Izmir, Turkey

Robert Weissman, Director, Essential Action, Washington, DC, USA

David M. Olson, M.D., Medical Advisor, Medecins Sans Frontieres-USA

Michael Geist, Canada Research Chair in Internet and E-commerce Law, University of Ottawa, Canada

Aidan Hollis, Associate Professor, Department of Economics, University of Calgary, Canada

Bob Huff, Editor, GMHC Treatment Issues, New York, USA

George M. Carter, Director, Foundation for Integrated AIDS Research (FIAR), Brooklyn, NY, USA

Dr.B.Ekbal, National Convenor Peoples Health Movement (Jan Swasthaya Abhiyan), India

Dr. Valeria Frighi, Oxford Centre for Diabetes, Endocrinology and Metabolism, Churchill Hospital, Oxford, UK

Pierre Druilhe, Head BioMedical Parasitology Unit, Pasteur Institute, Paris, France

Dr. Anthony Bryceson, Emeritus Professor of Tropical Medicine, London School of Hygiene and Tropical Medicine, London

Prof. Dr. F. Cankat Tulunay, President of Turkish Clinical Pharmacological Society, Medical School of Ankara University, Department of Clinical Pharmacology, Turkey

Gaëlle Krikorian, France

Robin Gross, Executive Director, IP Justice, San Francisco, USA

Nathan Ford, Head of Medical Unit, Médecins sans Frontières-UK

David Scondras, Search for a Cure, Cambridge, USA

Beth Burrows, Director, Edmonds Institute, USA

Joan-Ramon Laporte, Professor of Clinical Pharmacology, Universitat Autonoma de Barcelona, Institut, Catala de la Salut, Barcelona, Spain

Professor Brook K. Baker, Northeastern University School of Law, Health Global Access Project, USA

David Henry, Professor of Clinical Pharmacology, Consultant Physician, University of Newcastle, New South Wales, Australia

Paul Davis, Health GAP (Global Access Project), USA

Carles Roersch, Director, Instituto de Medicina Dominicana, Santo Domingo, Dominican Republic

Pierre Chirac, Access to Essential Medicines Campaign, Médecins sans Frontières, Paris, France

Mr. Nikolaos Tsemperlidis, President, and Mrs. Evangelia Kekeleki, General Secretary, KEPKA-Consumers Protection Centre, Thessaloniki, Greece

Pedro Roffe, Senior Fellow ICTSD, Director, UNCTAD-ICTSD Project on Intellectual Property and Sustainable Development, International Centre for Trade and Sustainable Development (ICTSD), Geneva, Switzerland

Dr. Angelo Stefanini, Department of Medicine and Public Health, University of Bologna, Italy, Osservatorio Italiano sulla salute Globale - OISG, Italy

Darius Cuplinskas, Director, Information Program, Open Society Institute

Hervé Le Crosnier, Université de Caen (France) et Vecam, France

Valérie Peugeot, Vecam, France

Amy Nunn, Harvard School of Public Health, Department of Population and International Health, Harvard University, USA

Carlos Passarelli, Project Advisor, Brazilian Interdisciplinary AIDS Association (ABIA), Coordinator of the Work Group on Intellectual Property of the Brazilian Network for the Integration of the Peoples (REBRIP), Brazil

Claude Henry, Professor, Ecole Polytechnique, Paris, France

Dorothée Benoit Browaeys et Jean Jacques Perrier, Science Journalists, Editors, electronic Magazine Vivantinfo.com, Paris, France

Dr. Patrice Trouiller, Neglected Diseases Group, Antananarivo, Madagascar

Peter Eckersley, Intellectual Property Research Institute of Australia, University of Melbourne, Australia

Shyam Sundar, Banaras Hindu University, India

Maristela Basso, International Trade Law and Development Institute, São Paulo, Brazil

Dr. K Balasubramaniam, Co-ordinator, Health Action International Asia - Pacific, Sri Lanka

Oscar Bruña-Romero, Professor at the Department of Microbiology/Federal University of Minas Gerais and Scientist at the Fundacao Oswaldo Cruz (FIOCRUZ), Belo Horizonte, Brazil

Ana Rabello, Centro de Pesquisas René Rachou/Fundação Oswaldo Cruz (FIOCRUZ), Belo Horizonte, Brasil

H. David Banta, MD, MPH, Professor Emeritus of Health Technology Assessment, University of Limburg, Maastricht, the Netherlands, and Mount Sinai School of Medicine, New York City, Staff member of the World Health Organization (retired)

Prof Tariq Iqbal Bhutta, Lahore, Pakistan

Staffan Svensson, MD, Dept of Clinical Pharmacology, Sahlgren's Univ Hospital, Gothenburg, Sweden

Wija J. Oortwijn, PhD, Senior Analyst, RAND Europe , The Netherlands

Ali Qadir, TheNetwork for Consumer Protection, Pakistan

Dr. Ken Harvey, School of Public Health, La Trobe University, Australia

Rufus Pollock, Director, Open Knowledge Foundation

Anwar Fazal, Chairperson Emeritus, World Alliance for Breastfeeding Action

Professor Martin Bobrow, FRS, University of Cambridge, Department of Medical Genetics, UK

Karen Seabrooke, Women's Health Interaction, Canada

Marie de Cenival, SIDACTION, Paris, France

Mauro Guarinieri, Chair, Board of Directors, European AIDS Treatment Group, Brussels, Belgium

Wim Vandevelde, President, GAT - Grupo Português de Activistas sobre Tratamentos de VIH/SIDA, Portugal

Scott Lee, Woodrow Wilson School of Public and International Affairs, Princeton University, USA

Muntaser Eltayeb Ibrahim, Institute of Endemic Diseases, University of Khartoum, Sudan

Peter Lockley, Open Knowledge Foundation, UK

Margaret Chon, Professor, Seattle University School of Law, USA

Tenu Avafia, Researcher, Trade Law Centre for Southern Africa, Stellenbosch, South Africa

Professor Renato Cutrera, Chief, Bronchopneumology Department, Bambin Gesù Pediatric Hospital, Rome, Italy

Rhoda Karpatkin, President Emeritus, Consumers Union, USA

Emanuele Nicastri, National Institute for Infectious Diseases, Rome, Italy

Jacques Juillard, President, Association Mieux Prescrire, publisher of la revue Prescrire and Prescrire International, France

Bruno Toussaint, Editor-in-chief, la revue Prescrire, France

Christophe Kopp, Managing Editor, Prescrire International, France

Adriano Cattaneo, Unit for Health Services Research and International Health, IRCCS Burlo Garofolo, Trieste, Italy

Philippa Saunders, Essential Drugs Project, UK

Fabrizio Tediosi, Swiss Tropical Institute, Swiss Centre for International Health, Basel, Switzerland

Dr. Francis DELPEYROUX, INSERM (French National Institute of Health and Medical Research), France

Dr. Sunil Deepak, Director, Medical Support Department, AIFO - Bologna, Italy

Joana Ramos, Cancer Resources & Advocacy, Seattle, USA

Julien Reinhard, The Berne Declaration, Switzerland

Sean Flynn, Esq., Director, Institute on Law and Development, Washington, DC, USA

Samantha Power, Lecture in Public Policy, Carr Center for Human Rights Policy, Harvard University, USA

Els Torreele, Drugs for Neglected Diseases initiative (DNDi), Switzerland

Gert Matthijs, Head of Molecular Diagnostics Laboratory and Professor of Human Genetics, University of Leuven, Belgium

Steve Cowper, Steve Cowper & Associates, former Governor of Alaska (1986-1990), Austin, Texas, USA

Dr. John Erickson, Director, Institute for Global Therapeutics, Gaithersburg, MD, USA

Mr. B.K. Keayla, Secretary General & Managing Trustee, Centre for Study of Global Trade, System and Development, New Delhi, India

Madeleine R. Valera, MD, MScCHHM, Vice President for Quality Assurance Research and Policy Developemt Group, Philippine Health Insurance Corporation, Philippines

Ambrocio C. Ramos, Quality Assurance Research and Policy Developemt Group, Philippine Health Insurance Corporation, Philippines

Ornella Abollino, Faculty of Pharmacy, University of Torino, Italy

Pierre-Henri Gouyon, Directeur du laboratoire UPS-CNRS d'Ecologie, Systématique et Evolution, ainsi que professeur à l´Université Paris-Sud, à l´Agro et à l´Ecole Polytechnique, France

Philippe Aigrain, Transversales Science-Culture, France

Professor Sir David Weatherall FRS, UK

Göran Tomson, Professor International Health Systems Research, IHCAR Div International Health, Dept Public Health Sciences and Director of Doctoral Programme, Medical Management Centre, Karolinska Institutet, Stockholm, Sweden

Ramadhan R. Madabida, Chief Executive Officer, Tanzania Pharmaceutical Industries Ltd. Dar es Salaam, Tanzania

Professor Gordon Dougan, Principal Research Scientist, Member of the Board of Management, The Wellcome Trust Sanger Institute, Wellcome Trust Genome Campus, Hinxton, Cambridge, UK

Dr. Laura Celesti-Grapow, Department of Plant Biology, University of Rome "La Sapienza," Italy

Dr. David McCoy, Specialist Public Health Registrar, North East London Health Protection Unit, UK

S. Srinivasan, Managing Trustee, Low Cost Standard Therapeutics (LOCOST), Baroda, India

Carlos Cajas, Agrocentro, Guatemala

Derek Yach, Head of the Global Health Division, Department of Epidemiology and Public Health, Yale University, USA

Dr. Michael C. Latham, Graduate School Professor, Division of Nutritional Sciences, Cornell University, New York, USA

Virginia Thorley, Lactation Consultant and Historian, Brisbane, Queensland, Australia

Additional endoresements