Negotiations on R&D funding agreements


1994: Pharmaceutical Drugs, Intellectual Property Rights and Public Health: A Consumer Perspective from the United States, May 12. A discussion of how R&D mandates can ensure innovation does not suffer when prices lowering policies are embraced.


1996: Comments on Trade and Pharmaceutical Policies: A Perspective from the U.S. Consumer Movement, HAI Seminar: World Trade Organization/GATT, Pharmaceutical Policies and Essential Drugs, October 4, 1996, Bielefeld, Germany.

Our proposal for a new framework for trade agreements on pharmaceuticals focuses on international efforts to share the costs of R&D, while leaving each country the flexibility to choose the particular mechanisms to promote R&D. Any combinations of the options described above would be acceptable. The level of expected effort should depend upon measures of ability to pay, such as per-capita income.

Finally, I would like to encourage this audience to consider the importance of better collection of economic data on pharmaceutical development costs. The industry has far too tight a control over statistics on drug development costs, and they use this control to deter independent research on pharmaceutical policies. The Sanders proposal (HR 4270, 104th Congress) outlines many of the statistics that should be collected, and we hope that organizations such as Health Care International will support such data collection efforts.


Comments for the Working Group On Intellectual Property Rights, Third Trade Ministerial and Americas Business Forum, Belo Horizonte, Brazil, May 13-16, 1997. In the context of the Free Trade of the Americas Negotiations, CPTech proposed:

1. Intellectual property regimes for healthcare should seek to achieve public health goals. It is not appropriate to treat healthcare is a matter of commerce only.

2. In the area of healthcare, the focus of trade agreements on intellectual property should be the equitable and reasonable sharing of the costs of research and development, rather than the particular mechanisms for R&D support, such as patent or other exclusive rights.

3. Equitable sharing should be based upon per capita expenditures on healthcare R&D. Countries with higher per capita incomes should assume higher burdens for R&D expenditures.

4. Countries should have discretion to chose the mechanisms for achieving per capita healthcare expenditures. Expenditures by governments, commercial or non-profit entities would satisfy targets, as would payments to royalty owners, or profits from unlicensed inventions (subject to corrections for double counting).

5. Qualifying R&D expenditures would include research on the development of new pharmaceuticals and other therapies and devices, as well as other items that are less likely to attract private investment. For example, research on adverse reactions to pharmaceuticals, dietary practices, appropriate technologies for rural healthcare, or epidemiology research would satisfy effort targets. It should be recognized that public health goals will reflect research priorities which differ in important respects from investor priorities.


1999: Preliminary thoughts on a program for Essential Health Research. January 6.

1999: Amsterdam Statement to WTO Member States on Access to Medicine, November 26. This joint NGO declaration called upon the World Trade Organization to examine “new paradigms for intellectual property rights and health care, including “burden sharing” approaches for R&D that permit countries to consider a wider range of policy instruments to promote R&D.”


2000: How Much does it cost to develop a new drug, April 2. Paper for Geneva meeting of the MSF Working Group on R&D.

2000: James Love. “Paying for health care R&D: Carrots and Sticks,”paper presented to the MSF working group on R&D, Geneva. October 23-24.


2001: TACD resolution on global access to health care DOC NO. TRADE-10-01 DATE ISSUED: MAY, 2001.

2001 October 12. Intellectual Property, innovation and international trade agreements. Wizards of OS. Discussion of R&D Treaty.

2001 December 20. Can we create a global trade framework for health care R&D that puts patients first? Presented at the Fifth International Conference on Home and Community Care for Persons Living with HIV/AIDS. Chaing Mai, Thailand.


2002 February 11. Can we create a global trade framework for health care R&D that puts patients first?

2002 March 10. Can we create a global trade framework for health care R&D that puts patients first? Madison Wisconsin.

2002 September 18. Ottrott-le-Haut, France, Hubbard and Love present Radical IP scenarios to Aventis meeting on pharamceutical scenarios.

2002 November 1. How to frame a global trade agreement that promotes R&D and does not undermine lower prices in countries with less ability to pay. The Trans Atlantic Consumer Dialogue (TACD) Committee on Intellectual Property public conference on the Impact of Intellectual Property Rules on Consumers of Health Care Services.

2002: James Love. The Benefits of a Treaty on R&D., Presentation given at the Drugs for Neglected Diseases (DND) Working Group, in Rio de Janerio, Brazil, December 3, 2002.


2003: Request for WIPO Meeting on Open and Collaborative Development Models

2003 February 28. How can we address access, and fund R&D? Next steps in the campaign for access to essential medicines. Mailman School of Public Health, Columbia University, New York, NY

2003: New Intellectual Property Regimes and New Business Models for Funding R&D, The Human Genome and Africa, Stellenbosch, South Africa. March 20.

2003: Basis for a treaty on R&D. CPTech, MSF, Oxfam Meeting on global framework for supporting health research and development (R&D) in areas of market and public policy failure. Geneva. April 29.

2003: From TRIPS to RIPS: A better Trade Framework to support Innovation in Medical Technologies, Agence nationale de recherches sur le sida/Institute d’ économie publique. Workshop on Economic issues related to access to HIV/AIDS care in developing countries Université de la Méditerranée, Marseille, France. May 27.

2003: Intellectual property rights, innovation and public health, WHA56.27. May 28. This resolution created the mandate for the WHO Commission on Intellectual Property Rights, Innovation and Public Health.

2003 June 14. Tim Hubbard and James Love in the New Scientist. Medicines without barriers.

2003 June 24. Tim Hubbard and James Love. Paper presented at the Meeting on The Role of Generics and Local Industry in Attaining the Millennium Development Goals (MDGs) in Pharmaceuticals and Vaccines held at the World Bank. An Agenda for Research and Development.

2003: Evidence Regarding Research and Development Investments in Innovative and Non-Innovative Medicines.September 22.

2003 September 24-29. Global Dialogues on IP: Public Health & IP/Collective Management of IP, Rockefeller Foundation Bellagio Study and Conference Center.

2003 November 12. Two Steps for Equitable Access to Intellectual Property.

2003 November 17. A better trade framework to support innovation in health care technologies, The Aventis/Marseille Proposal, James Love, APHA.

2003 December 4. Paper presentend by James Love at Columbia University’s Workshop on Access to Medicines and the Financing of Innovations in Heath Care. A New Trade Framework for Global Healthcare R&D.


2004 February 2. Essay by James Love and Tim Hubbard published in the PLoS Biology. A New Trade Framework for Global Healthcare R&D.

2004 March 4. Op-ed by James Love and Tim Hubbard published in the Guardian. We’re Patently Going Mad: Lifesaving drugs must be developed differently – for all our sakes. Here is James V. Delong’s rather rambling attack on the Guardian article, which links quite a few different issues, proposals and movements into one.


2005 January 26. Rep. Sanders introduced H.R. 417 – The Medical Innovation Prize Fund Act, in the 109th Congress.

2005: Letter of 162 experts asking World Health Organization to evaluate a proposed treaty framework for medical research and development. February 24.

2005: Understanding the Medical R&D Treaty Proposal. MSF meeting on ensuring innovation for neglected diseases, London. June 8.

2005: Australia presentation. New Paradigms in International Trade for Knowledge Goods. September 9.

2005: Determining the value of a pharmaceutical invention under HR 417, the Medical Innovation Prize Fund, International Seminar: Contributions to the Development Agenda on Intellectual Property Rights. UNU-INTECH, Maastricht, The Netherlands. September 24.

2005: Determining the value of a pharmaceutical invention under HR 417, the Medical Innovation Prize Fund. Montreal. October 1.

2005: On November 16, the Republic of Kenya submits a draft resolution to the 117th Session of the WHO Executive Board for the establishment of a working group to examine global health priorities for medical research and development.


2006: In January, Kenya submits a background document for its proposed resolution, and 285 scientists from 51 countries, including 5 Nobel Prize winners send a letter to the WHO Executive Board supporting the Kenyan resolution. On January 24, Brazil joins with Kenya in submitted a revised draft resolution proposed a WHO initiative to create a bold new global framework for essential health R&D. The United States and the European Commission oppose the proposal.

2006: Public health, innovation and intellectual property rights. Report of the World Health Organization Commission on Intellectual Property Rights, Innovation and Public Health. April 3.

2006″ Brazil proposes work on R&D Treaty at April 28 WHO EB meeting, April 30.

2006: James Love. “Drug development incentives to improve access to essential medicines.” Bulletin of the World Health Organization. 84 (5). May.

2006. WHA59.24 Public health, innovation, essential health research and intellectual property rights: towards a global strategy and plan of action May 27.

2006 September 25. Stimulating medical R&D when inventions enter the public domain, CIPP Workshop on Intellectual Property, Biotechnology Capacity and Development. Buenos Aires.


2007: Tom Giovanetti on the R&D Treaty, and political science, November 10.



2009: Submissions of Member States and Stakeholders to WHO Expert Working Group on R&D Financing, May 11.

2009: WHA to take up IGWG resolution 9am Friday, May 21.

2009: WHO at a crossroads on a mandate for an R&D Treaty, May 21.

2009: The World Health Assembly takes step back, but leaves door open, for medical R&D Treaty. May 22.

2009: Civil Society letter to Members of the WHO Expert Working Group on R&D Financing, July 1.

2009: WHO Expert Working Group on R&D Financing (EWG), September 2.


2010: The WHO EWG’s proposals for taxes to fund medical R&D, January 14.

2010: World Health Organization (WHO) to hold consultation on report of Expert Working Group on R&D financing, January 19.

2010: Briefing on the Report of the WHO Expert Working Group on R&D Financing, April 19.

2010: Launch of 2.3(c) Committee: Salle XXV (Palais des Nations): May 19, 13:00 to 14:30, May 17.

2010: KEI Statement on WHA 63 Establishment of Consultative Expert Working Group on Research and Development: Finance and Coordination, May 21.

2010: On the topic of Transparency, cost benefit analysis and de-linkage of cost of R&D from price of the products. August 4. Written submission U.S. Senate Committee on Health, Education, Labor, and Pensions (HELP) Hearing on Treating Rare and Neglected Pediatric Diseases: Promoting the Development of New Treatments and Cures

2010: Notes from EU Parliament meeting on innovation+access for medical technologies, November 18.


2011: World Health Organization Executive Board to create new consultative expert working group on R&D Financing, January 17.

2011: The WHO EB debate over membership of the new R&D Financing consultative expert working group (CEWG), January 18.

2011: WHO to tackle pandemic influenza, de-linkage, prizes, R&D financing and non-communicable diseases, March 18.

2011: WHO Consultative Expert Working Group on R&D Financing holds open briefing on 18 November 2011 @ 5 PM in Salle C, WHO, November 9.

2011: TACD Resolution on Innovation and Access to Medical Technologies June.

2011: 21 submissions to the WHO Consultative Expert Working Group on R&D Financing. June 27.

2011: 2nd meeting of WHO Consultative Working Group on R&D Financing (CEWG): Summary of proceedings by Chair (John Arne Røttingen), July 13.

2011: WHO CEWG to pave the way for binding global convention on biomedical R&D, November 19.


2012: World Health Organization’s Consultative Expert Working Group on R&D Financing releases its Report. April 5.

2012: Views on the Report of the WHO Consultative Expert Working Group on Research and Development (CEWG), April 12.

2012: Is the WHO CEWG proposal for the R&D treaty “too small”? May 4.

2012. Obligations to fund R&D, under CEWG recommendation, May 23.

2012: US intervention at World Health Assembly on the CEWG on R&D financing and coordination, May 24.

2012: The WHA negotiations so far, on R&D financing, May 24.

2012: KEI Statement on WHA resolution on Consultative Expert Working Group on Research and Development: Financing and Coordination, May 26.

2012: Wellcome Trust tells WHO it opposes R&D Treaty and the de-linkage of R&D costs from drug prices. November 26.

2012: WHO negotiators propose putting off R&D treaty discussions until 2016, November 29.


2013: WHO Director-General Chan throws down the gauntlet on the CEWG process: “Let’s fight this out at the Assembly!”, January 26.

2013: WHO/WIPO/WTO trilateral report: Human rights, de-linkage and the R&D Treaty

2013: The IPR chapter of the 1998 US/EU treaty on scientific and technological cooperation. Time for an update? October 11.



2015: KEI comments to DHHS on WHA agenda 17.4, the Consultative Expert Working Group on Research and Development, May 8.

2015: USTR releases documents from 2012 R&D treaty negotiations, September 21.What’s wrong with current system of funding R&D, and what are ideas for reforms?, October 21.