Transcript Radical IP scenarios

Stimulating medical R&D when
inventions enter the public domain
James Packard Love
CPTech
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CIPP Workshop on Intellectual Property, Biotechnology
Capacity and Development
Buenos Aires
25 September 2006
Basic ideas
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Separate markets for innovation from markets for
products
Allow generic competition for products, driving prices
closer to marginal costs of manufacture and distribution
Create new systems of finance for innovation, including
(1) rewards for successful product development that are
not tied to product prices, and (2) new methods of
financing open collaborative science projects
Create new global trade framework to address free rider
problems, and to raising funding for global health care
priorities
Current focus
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Promote use of prizes to reward innovations that improve
health care outcomes
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The United States market for prescription medicines
Rewarding inventions for health care problems of patients and
communities with low incomes
Countries with large internal markets: India or Brazil
Investigate possible role of competitive intermediaries to
support open collaborative research projects
Change focus of trade agreements from specifying IPR
regimes to addressing minimum levels of support for R&D
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Inclusive in terms of mechanisms. All systems to support R&D
addressed, including traditional public sector funding, rewards for
success innovations, competitive intermediaries, etc.
Some key dates
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September 18, 2002, Ottrott-le-Haut, France. Aventis
Radical IP scenarios
January 26, 2005, Rep. Sanders introduces HR 417
February 24, 2005, Request to Evaluate Proposal for New
Global Medical R&D Treaty
May 27, 2006. WHA resolution: Public health, innovation,
essential health research and intellectual property rights:
towards a global strategy and plan of action
December 4-8, 2006, 1st meeting of WHO Intergovernmental
working group (IGWG)
May 2008, WHA considers global strategy and plan of action
Medical Innovation Prize Fund
HR 417 - 109th Congress
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Annual funding of .5 percent of US GDP -- approximately
$60 billion per year
Developers of medicines are rewarded for impact of
invention on health care outcomes
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10 year participation in rewards
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All products are open to generic competition
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Set-asides
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4 percent (2.4b) for global neglected diseases;
10 (6b) percent for orphan drugs; and
4 (2.4b) percent global infectious diseases and other global public
health priorities, including research on AIDS, AIDS vaccines, and
medicines for responding to bio-terrorism
Relationship between Medical Innovation
Prize Fund and Patent System
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Patent owners would not have rights to prohibit
or authorize use and sale of products
However,
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Patents would be factor in establishing ownership of
inventions.
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Ownership of invention would create claims against
Prize Fund (Prize fund payments are far higher than
current royalty payments)
Supply of QALYs
Size of prize fund
more elastic supply
less elastic supply
.75% of GDP
.50 % of GDP
QALYs_50
QALYs_75
QALYs
supplied
Next steps on US prize fund
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New bill introduced in 2007. Some technical issues will
be addressed, such as treatment of inventions that are
developed at roughly the same time, or treatment of
rewards for new uses of older medicines.
Emphasis on expanding community of technical experts
working on the proposal (economists, lawyers, research
community, various stakeholders, etc).
Fall of 2007. Begin serious effort to promote public
debate on proposal.
Essential Patent Pool Proposal
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Create pool for downstream use of patents on
essential medical technologies.
Create fund to provide rewards for inventions
licensed to pool that improve health care
outcomes.
Possible extensions
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Agreement that developing countries that support
reward fund can seek more liberal exceptions to IPR
rules
2005 Medical R&D Treaty proposal
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New paradigm for trade negotiations -- focuses on R&D
rather than mechanisms to raise prices.
Inclusive: Recognizes the importance of public and private
sector R&D funding, and different mechanisms to stimulate
R&D
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For example
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Strong IP, high prices
Weak IP, low prices, public sector funding
Alternative incentives systems
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Focuses on capacity of country to support R&D costs
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Flexibility in terms of mechanisms
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Creates global system of tradable credits as incentives to
fund R&D in areas of priority.
Treaty mechanisms overview
Treaty parties
Assembly for Medical Innovation (AMI)
Council Medical Innovation (CMI)
Treaty Secretariat
Committee on Traditional
Knowledge (CTK)
Another
country’s
project
Prize
Fund
Buy out
Approved
drugs
Committee on Exceptionally
Useful Projects (COEPUP)
Committee on Technology,
Transfer and Capacity (CTEC)
Country A
Purchase of
patented drugs
Committee on Open
Public Goods (COPG)
Committee on open
Access publishing (COAP)
Report of treaty
Qualifying projects
13%
Committee on Priority
Medical Research (CPMRD)
International
Projects
e.g. PPPs
Directed
research
Country B
Treaty Supporters
Tim Hubbard, Head of Human Genome Research, Wellcome Trust Sanger Institute, Cambridge,
UK. James Lov e, Director, CPTech, Washington, DC, USA * Martin Khor, Third World Network,
Malay sia * Sir John Suls ton, Winner of 2002 Nobel Prize f or Phy siology or Medicine, Former
Director of the Wellcome Trust Sanger Institute, Cambridge, UK * Dominique Stoppa-Ly onnet,
Head of the Genetics Department of the Medical Div ision of the Institut Curie, Paris, France * Dr.
Massimo Barra, Vice President, International Federation of the Red Cross * Ellen 't Hoen,
Director of Policy Adv ocac
y and Research, Access toEssential Medicines Campaign, MŽ
dec ins
sans FrontiŽ
re s * Oxfam International * Spring Gombe, Health Action International (HAI) * Anna
Fielder, Director, Consumers International, Off ice for Dev eloped and Transition Economies,
London, USA * Bernard Sanders, Member, United States House of Representativ es, USA * Ian
Gibson MP, Chair, House of Commons Select Committee on Science and Technology, UK * Alain
Claey s, DŽ
p utŽde la Vienne, France *Claude Huriet, Ancien sŽ
n ateur 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/Ef a Group, Italy * Gleny s
Kinnock, Member of the European Parliament, Co-President of the ACP-EU Joint Parliamentary
Assembly, UK * Vittorio Agnoletto, Member of the European Parliament, f ormer president of LILA
- Italian League for the fght
i 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 Dev elopment Unit National STD-Aids Program, Ministry of Health, Brazil * Dr.
Benjamin Gilbert, Institute f or Pharmaceutical Technology, FundaŽ
‹ o Oswaldo Cruz, Ministry of
Health, Brazil *
W illiam W. Fisher III, Hale and Dorr Pro f essorof Intellectual Property Law, Harv ard Law School,
USA * Peter Suber, Open Access Project Director, Public Knowledge, Research Prof essor of
Philosophy, Earlham College, US * HeeSeob Nam, Intellectual Property Left, Patent Attorney,
Korea * Dr. Christian W agner, BUKO Pharma-Kampagne, Bielef eld, German * Ruth May ne,
Oxf ord Brookes Univ ersity , UK * James Boy le, William Neal Rey nolds Prof essor of Law, Duke
Univ ersity, USA * Peter Drahos, Prof essor and Head of Program, Regulatory Institutions Network,
Research School of Social Sciences, Canberra, Australia * Jonathan Berger, AIDS Law Project,
South Af rica * Nathan Geff en, Treatment Access Campaign, South Af rica *Lawrence Lessig,
Professor of Law at Stanf ord Law School, Chairman of the Creativ e 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 Univ ersity ,
Bangkok, Thailand * Andy Gray, Senior Lecturer, Dept of Therapeutics and Medicines
Management, Nelson R Mandela School of Medicine, Durban, South Af rica *Joel Lexchin MD,
School of Health Policy and Management, Y ork Univ ersity, Toronto, Ontario, Canada * Joan
Rov ira, Director of Research f orSOIKOS (Centro de Estudios en Economia de la Salud y de la
Politica Social) Barcelona, Spain * Frederick M. Abbott, Edward Ball Eminent Scholar, Prof essor
of International Law, Florida State Univ ersity College of Law, USA * Prof Udo Schuklenk, Chair in
Ethics and Public Policy , Glasg
ow Caledonian Univ ersity, UK * Suntaree Vitay anatpaisan,
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) - Univ ersite Pierre Mendes, France * Donald Light,
Professor of Comparative Health Care Sy ste ms, Univ ersity of Medicine and Dentistry of New
Jersey ,USA * Talha Syed, Doctoral Candidate, Harv ard Law School, USA * Dr. Alexander C.
Tsai, Case W estern Reserv eUniv ersity School of Medicine, USA * Mei-ling Wang, Ph.D,
Associate Prof essorof Social Sciences and Health Policy ,Univ ersity of the Sciences in
Philadelphia, USA * Caroly n Deere, Global Economic Gov ernanc
e Programme, Oxf ord
Univ ersity, UK * W arren Kaplan, Center f or International Health and Dev elopment, Boston
Univ ersitySchool of Public Health, USA * Leonard Rodberg, Associate Prof essor and Chair ,
Urban Studies Department Queens College/CUNY, NY, USA
Terence H. Young, Chair, Drug Safety Canada, Ontario, Canada * Madeline Boscoe, R.N,
Adv ocacy C
oordinator, Women's Health Clinic, Winnipeg, Canada * Harrie t G. Rosenberg, Ph.D.,
Health and Socie ty Progra mme, Y orkUniv ersity , Toronto, Canada * Richard J. Brown, MD,
Board, Phy sici
ans f ora National Health Program, NY Metro Chapter, USA * Dr. Andrew
Herxheimer, Emeritus Fellow, Cochrane Centre, UK * Dr. Jillian Clare Cohen, Assistant
Professor, Leslie Dan F aculty of Pharmacy, Univ ersity of Toro
n to, Canada * Richard Stallman,
Founder, F ree Software F oundation, USA * Elia Abi-Jaoude, Psy chiatry Resident, Univ ersity of
Toronto, Canada * Institute f or Agriculture and Trade Policy, USA * Barbara Mintzes, Centre f or
Health Serv ices& Policy Research
, Univ ersity of British Colu m bia, Canada * Alan Cassels , Drug
policy researche
r , School of Health Inf orm ation Science, Univ ersity of Vic toria, Vic toria, BC
Canada * John Howkins, Director, IP Charter, London, UK * David Dudley, Attorney, USA * Kevin
Outterson, Associate Prof essorof Law, West Virginia Univ ersity, USA * Professor Anil K. Gupta,
Kasturbhai Lalbhai Chair in Entrepreneurship , Indian Institute of Management, India * Dr. Ikrame
MOUCHARIK, membre d'ATTAC Maroc, Morocco * Gazanf er Aksakoglu, Prof essor and Head,
Departm ent of Com munity Medicine, Dokuz Eyul
l University, Izm ir, Turkey * Robert W eissman,
Director, Essential Action, W ashin gton, DC, USA * David M. Olson, M.D., Medical Adv isor,
Medecins Sans F rontieres-USA * Michael Geist, Canada Research Chair in Internet and Ecommerce Law, Univ ersity of Ottawa, Canada * Aidan Hollis, Associate Prof essor, Department of
Economics, Univ ersity of Calg ary , C anada * Bob Huff, Editor, GMHC Treatm ent Issues, New
Y ork, USA * George M. Carter, Director, F oundation f or Integrated AIDS Research(FIAR),
Brooklyn, NY, USA * Dr.B.Ekbal, National Convenor Peoples Health Movem ent (Jan Swasthay a
Abhiyan), India * Dr. Valeria F rig hi, Oxf ord Centre f orDiabetes, Endocrinology and Metabolism,
Churchill Hospital, Oxf ord , UK * Pierre Druilhe, Head BioMedical Parasitology Unit, Pasteur
Institute, Paris, F rance *Dr. Anthony Bry ceson, Emeritus Prof essor 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 Univ ersity, Departm ent of
Clinical Pharmacology, Turkey * Ga‘ll e Krikorian, F rance * Robin Gross, Executiv e Director, IP
Justice, San F rancisco, USA * Nathan Ford, Head of Medical Unit, MŽ
d ecin s sans FrontiŽ
res -UK
* Dav di Scondras, Search f or a Cure, Cambridge, USA * Beth Burrows, Director, Edmonds
Institute, USA * Joan-Ramon Laporte, Prof essor of Clinical Pharmacolo gy, Univ ersitat Autonoma
de Barcelona, Institut, Catala de la Salut, Barcelona, Spain * Pro f essor Brook K. Baker,
Northeastern Univ ersity School of Law, Health Global Access Project, USA
Dav id Henry , Pro f essorof Clinical Pharmacology, Consultant Phy sician, Univ ersity of Newcastle,
New South Wales, Australia * Paul Dav is, Health GAP (Global Access Project), USA * Carles
Roersch,Director, Instituto de Medicina Dominicana, Santo Domingo, Dominican Republic *
Pierre Chirac, Access to Esse
ntial Medicines Campaign, MŽdecins sans FrontiŽ
re s, Paris, France
* Mr. Nikolaos Tsemperlidis, President, and Mrs. Ev angelia Kekeleki, General Secretary, KEPKAConsumers Protection Centre, Thessaloniki, Greece * Pedro Rof fe , Senior Fellow ICTSD,
Director, UNCTAD-ICTSD Project on Intellectual Property and Sustainable Dev elopment,
International Centre f or Trade and Sustainable Dev elopment (ICTSD), Geneva, Switzerland * Dr.
Angelo Stefanini, Department of Medic ine and Public Health, Univ ersity of Bologna, Italy,
Osserv atorio Italiano sulla salute Globale - OISG, Italy * Darius Cuplinskas, Director, Inf ormation
Program, Open Society Institute * HervŽ Le Crosnier, Univ ersitŽ de Caen (France) et Vecam,
France * ValŽrie Peugeot, Vecam, France * Amy Nunn, Harv ard Scho
ol of Public Health,
Department of Population and International Health, Harv ard Univ ersity, USA * Carlos Passarelli,
Project Adv isor, Brazilian Interdisciplinary AIDS Association (ABIA), Coordinator of the W ork
Group on Intellectual Property of the Brazilian Network f or the Integration of the Peoples
(REBRIP), Brazil * Claude Henry , Prof essor, Ecole Poly technique, Paris, France * DorothŽe
Benoit Browaey s et Jean Jacques Perrier, Scie nce Journalists, Editors, electronic Magazine
Viv antinfo.com, Paris, France * Dr. Patrice Trouiller, Neglected Diseases Group, Antananarivo,
Madagascar * Peter Eckersley, Intellectual Property Research Institute of Australia, Univ ersity of
Melbourne, Australia * Shyam Sundar, Banaras Hindu Univ ersity
, India * Maristela Basso,
International Trade Law and Dev elopment Institute, S‹ o Paulo, Brazil * Dr. K Balasubramaniam,
Co-ordinator, Health Action International Asia - Pacif ic, Sri Lanka * Oscar Bru–a-Romero,
Professor at the Department of Microbiology/Federal Univ ersity foMinas Gerais and Scientist at
the Fundacao Oswaldo Cruz (FIOCRUZ), Belo Horizonte, Brazil * Ana Rabello, Centro de
Pesquisas RenŽ Rachou/FundaŽ
‹ o Oswaldo Cruz (FIOCRUZ), Belo Horizonte, Brasil * H. Dav di
Banta, MD, MPH, Prof essor Emeritus of Health Technology Assessme
nt, Univ ersity of Limburg,
Maastricht, the Netherlands, and Mount Sinai School of Medicine, New Y ork City, Staff member
of the W orld Health Organization (retired) * Prof Tariq Iqbal Bhutta, Lahore, Pakistan * Staff an
Sv ensson, MD, Dept of Clinical Pharmacology, Sahlgren's Univ Hospital, Gothenburg, Sweden *
W ija J. Oortwijn, PhD, Senior Analy st, RAND Europe , The Netherlands * Ali Qadir, TheNetwork
f or Consumer Protectio n, Pakistan * Dr. Ken Harv ey, School of Public Health, La Trobe
Univ ersity, Australia * Rufus Pollock, Director, Open Knowledge Foundation * Anwar Fazal,
Chairperson Em eritus, World Alliance for Breastf eeding Action * Prof essor Martin Bobrow, FRS,
Univ ersityof Cam bridge, Departm ent of Medical Genetics, UK * Karen Seabrooke, Wom en's
Health Interactio n, Canada * Marie de Cenival, SIDACTION, Paris, F rance * Mauro Guarin ieri,
Chair, Board of Directors, European AIDS Treatm ent Group, Brussels , Belgium * Wim
Vandevelde, President, GAT - Grupo PortuguŽs de Activ istassobre Tratam entos de VIH/SIDA,
Portugal * Scott Lee, W oodrow Wilson School of Public and International Affairs, Princeton
Univ ersity, USA * Muntaser Eltay eb Ibrahim, Institute of Endem ic Diseases, Univ ersity of
Khartoum, Sudan * Peter Lockley, Open Knowledge Foundation, UK * Margaret Chon, Prof essor,
Seattle Univ ersity School of Law, USA * Tenu Avaf ia , Researcher, Trade Law Centre f or
Southern Af rica, Stellenbosch, South Af rica * Prof essor Renato Cutrera , Chie f,
Bronchopneum ology Departm ent, Bambin GesŽ Pediatric Hospital, Rome, Italy *Rhoda
Karpatkin , President Em eritus, Consumers Union, USA * Em anuele Nicastri, National Institute f or
Inf ectious Diseases, Rome, Italy * Jacques Juillard, President, Association Mieux Prescrire,
publisher of la rev ue Prescrire and Prescrire n
I ternational, F rance * Bruno Toussain t, Editor-inchief, la rev ue Prescrire, F rance * Chris tophe Kopp, Managing Editor, Prescrire International,
France * Adriano Cattaneo, Unit f orHealth Serv ices Research and International Health, IRCCS
Burlo Garof olo, Trieste, Italy * Philippa Saunders, Essential Drugs Project, UK * Fabrizio Tediosi,
Swiss Tropical Institute, Swiss Centre f or nternational
I
Health, Basel, Switzerland * Dr. F rancis
DELPEYROUX, INSERM (F rench National Institute of Health and Medical Research), F rance *
Dr. Sunil Deepak, Director, Medical Support Departm ent, AIFO - Bologna, Ita ly * Joana Ram os,
Cancer Resource
s & Adv ocacy, Seattle, USA * Julien Reinhard, The Berne Declaration,
Switzerland * Sean F ly nn, Esq., Director, Institute on Law and Dev elopm ent, W ashington, DC,
USA * Sam antha Power, Lecture in Public Policy, Carr Center f or Hum an Rights Policy, Harv ard
Univ ersity, USA * Els Torreele, Drugs f or Neglected Dis eases initiative (DND),
i Switzerland * Gert
Matthijs, Head of Molecular Diagnostics Laboratory and Prof essor of Hum an Genetics, Univ ersity
of Leuv en, Belgium * Stev e Cowper, Steve Cowper & Associates, form er Gov ern or of Alaska
(1986-1990), Austin, Texas, USA * Dr. John Erickson, Director, Institute f or Global Therapeutics,
Gaithersburg, MD, USA * Mr. B.K. Keay a
l , Secretary General & Managing Trustee, Centre f or
Study of Global Trade, Sy stem and Developm ent, New Delh i, India
Madeleine R. Valera, MD, MScCHHM, Vice President for Quality AssuranceResearch and Policy
Dev elopemt Group, Philippine Health Insurance Corporation, Philippines * Ambrocio C. Ramos,
Quality Assurance Research and Policy Dev elopemt Group, Philippine Health Insurance
Corporation, Philippines * Ornella Abollino, Faculty of Pharmacy, Univ ersity of Torino, Italy *
Pierre-Henri Gouy on, Directeur du laboratoire UPS-CNRS d'Ecologie, SystŽmatique et Ev olution,
ainsi que prof esseur ˆ l«Univ ersitŽPa ris-Sud, ˆ l«Agro et ˆ l«Ecole Polytechniq ue, France *
Philippe Aigrain, Transv ersales Science-Culture, France * Prof essor Sir Dav di Weatherall FRS,
UK * Gšran Tomson, Prof essor 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, Chie f Executive
Off icer, Tanzania Pharmaceutical Industries Ltd. Dar es Salaam, Tanzania * Dr. Laura CelestiGrapow, Department of Plant Biology, Univ ersity of Rome "La Sapienza," Italy * Dr. Dav di
McCoy, Specialist Public Health Regis trar, North East London Health Protection Unit, UK * Dr.
Michael C. Latham, Graduate School Prof essor, Div ision of Nutritional Sciences, Cornell
Univ ersity, New Y ork, USA * Virginia Thorley, Lactation Consultant and Historian, Brisbane,
Queensla nd, Australia * S. Sriniv asan, Managing Trustee, Low Cost Standard Therapeutics
(LOCOST), Baroda, India * Carlos Cajas, Agrocentro, Guatemala * Derek Y ach, Head of the
Global Health Div sion,
i
Department of Epidemiology and Public Health, Yale Univ ersity , USA *
Professor Gordon Dougan, Principal Research Scientist, Member of the Board of Management,
The W ellcome Trust Sanger Institute, W ellcome Trust Genome Campus, Hinxton, Cambridge, UK