Hostname: page-component-cd9895bd7-jkksz Total loading time: 0 Render date: 2024-12-21T16:53:40.590Z Has data issue: false hasContentIssue false

Addressing legal and political barriers to global pharmaceutical access: Options for remedying the impact of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) and the imposition of TRIPS-plus standards

Published online by Cambridge University Press:  01 July 2008

JILLIAN CLARE COHEN-KOHLER*
Affiliation:
Assistant Professor, Leslie Dan Faculty of Pharmacy, University of Toronto, Canada
LISA FORMAN
Affiliation:
Post-Doctoral Fellow, Canadian Institutes of Health Research & Comparative Program in Health and Society, Munk Centre for International Studies, Toronto, Canada
NATHANIEL LIPKUS
Affiliation:
Gilbert’s LLP, Toronto, Canada
*
* Corresponding author: Jillian Clare Cohen-Kohler, Assistant Professor, Leslie Dan Faculty of Pharmacy, University of Toronto, 144 College Street, Toronto, Ontario M5S 3M2, Canada. Email: jillian.kohler@utoronto.ca

Abstract

Despite myriad programs aimed at increasing access to essential medicines in the developing world, the global drug gap persists. This paper focuses on the major legal and political constraints preventing implementation of coordinated global policy solutions – particularly, the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) and bilateral and regional free trade agreements. We argue that several policy and research routes should be taken to mitigate the restrictive impact of TRIPS and TRIPS-plus rules, including greater use of TRIPS flexibilities, advancement of human rights, and an ethical framework for essential medicines distribution, and a broader campaign that debates the legitimacy of TRIPS and TRIPS-plus standards themselves.

Type
Articles
Copyright
Copyright © Cambridge University Press 2008

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

Abbott, F.M. (2002), ‘Study paper for the British Commission on Intellectual Property Rights on the WTO TRIPS Agreement and its implications for access to medicines in developing countries’, Commission on Intellectual Property Rights [Online]. Available: www.iprcommission.org/papers/word/study_papers/sp2a_abbott_study.docGoogle Scholar
Attaran, A. and Gillespie-White, L. (2001), ‘Do patents for antiretroviral drugs constrain access to AIDS treatment in Africa?’, Journal of American Medical Association, 286(15):18861892.CrossRefGoogle ScholarPubMed
Borrell, J.R. and Watal, J.(2002), ‘Impact of patents on access to HIV/AIDS drugs in developing countries’, Working paper 92, May 2002, Centre for International Development, Harvard University [Online]. Available: <www2.cid.harvard.edu/cidwp/092.pdf>..>Google Scholar
Bloche, G.M. (2002), ‘WTO deference to national health policy: toward an interpretive principle’, Journal of International Economic Law, 5(4): 825848.CrossRefGoogle Scholar
Caves, R.E., Whinston, M.D.and Hurwitz, M.A.(1991), ‘Patent expiration, entry and competition in the US pharmaceutical industry’, Brookings Papers on Economic Activity: Microeconomics, 162.Google Scholar
Chaudhuri, S., Goldberg, P.K.and Jia, P.(2003), ‘The effects of extending intellectual property rights protection to developing countries: a case study of the Indian pharmaceutical market’, Working Paper 10159, National Bureau of Economic Research Working Paper Series, Cambridge [Online]. Available: www.nber.org/papers/W10159.Google Scholar
Cohen, J.C., Gyansa-Ludderodt, M.and Torpey, K.(2003), ‘Increasing access to medicines: policy options for Ghana: access to medicines advisory group consultative draft’, December 2003.Google Scholar
Commission on Human Rights, resolutions 2001/33, 2002/32 and 2003/29, Access to medication in the context of pandemics such as HIV/AIDS. E/CN.4/2002/2000; E/CN.4/RES/2001/33, E/CN.4/2003/L33.Google Scholar
Commission on Intellectual Property Rights (CIPR) (2002), ‘Integrating intellectual property rights and development policy’, Report of the Commission on Intellectual Property Rights. [Online]. Available:www.iprcommission.org/papers/pdfs/final_report/CIPRfullfinal.pdf [Accessed February 19, 2004]Google Scholar
Commission on Intellectual Property Rights, Innovation, and Public Health (CIPIH) (2006), ‘Public health: innovation and intellectual property rights’, World Health Organisation, Geneva. [Online]. Available:www.who.int/intellectualproperty/documents/thereport/en/index.html [accessed April 4, 2006]Google Scholar
Committee on Economic, Social, and Cultural Rights (2000), ‘The right to the highest attainable standard of health’, General Comment 14, UN Document E/C.12/2000/4.Google Scholar
Cook, A. (1998), ‘How increased competition from generic drugs has affected prices and returns in the pharmaceutical industry’, Congressional Budget Office Study.Google Scholar
Correa, C.M. (2002), ‘Public health and intellectual property rights’, Global Social Policy, 2(3): 261278.CrossRefGoogle Scholar
Cptech (2006), ‘Recent health related compulsory licenses and disputes’ [Online]. Available: www.cptech.org/ip/health/cl/recent-examples.html.Google Scholar
Declaration ministérielle, adopted 14 November 2001. Doha, 2001. (WT/MIN(01)/DEC/1, 20 November 2001 (01-5859)) [Doha]Google Scholar
Drahos, P. (2002), ‘Developing countries and international intellectual property standard-setting’, Study Paper 8, Commission on Intellectual Property Rights [Online]. Available: www.iprcommission.org/papers/pdfs/study_papers/sp8_drahos_study.pdf.CrossRefGoogle Scholar
The Economist(2004), ‘South African pharmaceuticals: me too – welcome new investment in the generic drug industry’, 25 March 2004: 62.Google Scholar
Engdahl, E. (2005), ‘India alters patent views’, Legal Times, 11 July 2005.Google Scholar
Federal Register (2000), ‘Access to HIV/AIDS pharmaceuticals and medical technologies’, Executive Order 13155, Presedential Documents, Federal Register 65(93) 30521, 12 May 2000.Google Scholar
Forman, F. (2006), ‘Trading health for profit: bilateral and regional free trade agreements affecting domestic property rules on intellectual property rules on pharmaceuticals’, in Cohen, J.C.Schuklenk, U. and Illingsworth (eds), P.The Power of Pills: Social, Ethical, and Legal Issues in Drug Development, Marketing, and Pricing, London: Pluto Press.Google Scholar
Forman, L. (2007), ‘Trade rules, intellectual property and the right to health’, Ethics and International Affairs, 337(21): 3.Google Scholar
Gambardella, A., Orsenigo, L. and Pammoli, F.(2000), ‘Global competitiveness in pharmaceuticals, a European perspective’, Report prepared for the Directorate General Enterprise of the European Commission, November 2000.Google Scholar
Gervais, D. (1998), The TRIPS Agreement: Drafting History and Analysis, London: Sweet & Maxwell.Google Scholar
Goemaere, E., Kaninda, A.V.Ciaffi, L.Mulemba, M.Hoen, E.and Pecould, B. (2002), Letter to the Editor, Journal of American Medical Association, 287(7): 841.Google Scholar
Govindaraj, R., Reich, M.and Cohen, J.C.(2000), World Bank Pharmaceutical Discussion Paper, World Bank Publications.Google Scholar
Groombridge, M.A. (1999), ‘The TRIPS trade-off: reconciling competing interests in the millennium round’, Journal of World Intellectual Property, 2(6): 9911013.CrossRefGoogle Scholar
Helfer, L.R. (2004), ‘Regime shifting: the TRIPS Agreement and new dynamics of international intellectual property lawmaking’, Yale Journal of International Law, 29: 1.Google Scholar
Henry, D. and Lexchin, J.(2002), ‘The pharmaceutical industry as a medicines provider’, The Lancet, 360(9345): 15901595.CrossRefGoogle ScholarPubMed
Hogerzeil, H.V., Samson, M.Casanovas, J.V.and Rahmani-Ocora, L.(2006), ‘Is access to essential medicines as part of the fulfilment of the right to health enforceable through the courts?’, The Lancet, 368(9532): 305311.CrossRefGoogle ScholarPubMed
Hollis, A. (2002), ‘The link between publicly funded health care and compulsory licensing’, Canadian Medical Association Journal, 167(7): 756766.Google ScholarPubMed
International Federation of Pharmaceutical Manufacturers Association (2000), ‘TRIPS, pharmaceutical and developing countries: implications for health care access, drug quality and drug development’, International Federation of Pharmaceutical Manufacturer’s Association, Geneva.Google Scholar
Kimani, D. (2002), ‘New law blocks import of HIV/Aids generics into Nairobi’, The East African (Nairobi), 1 July 2002. Available: IP Health List http://lists.essential.org/pipermail/ip-health/2002-July/003230.html.Google Scholar
Lazzarini, Z. (2003), ‘Making access to pharmaceuticals a reality: legal options under TRIPS and the case of Brazil’, Yale Human Rights Journal, 6:103138.Google Scholar
Levison, L. and Laing, R.(2003), ‘The hidden costs of essential medicines’, WHO Essential Drugs Monitor, 33:20.Google Scholar
Loewenson, R. (2000), ‘Essential drugs in Southern Africa need protection from public health safeguards under TRIPS’, Bridges, Comment 3.Google Scholar
Love, J. (2007), ‘Recent examples of the movements on the use of compulsory licenses around the world’, in theMinistry of Public Health and the National Health Security Office Thailand, Facts and Evidences on the 10 Burning Issues Related to the Government Use of Patents on Three Patented Essential Drugs in Thailand, February 2007. Available : www.moph.go.th/hot/White%20Paper%20CL-EN.pdfGoogle Scholar
Mandavilli, A. (2007), ‘Reinventing an industry’, Nature, 445(7124): 138139.Google ScholarPubMed
Mannan, A. and Story, A.(2006), ‘Abolishing the product patent: a step forward to global access to drugs’, in Cohen, J.C.Illingworth, P. and Schuklenk, U.The Power of Pills: Social, Ethical and Legal Issues in Drug Development, Marketing and Pricing, London: Pluto Press.Google Scholar
Maskus, K.E. (2000), Intellectual Property Rights in the Global Economy, Washington, DC: Institute for International Economics.Google Scholar
Maskus, K.E. (2006), Reforming US Policy: Getting the Incentives Right, CSR No. 19, Council on Foreign Relations, November 2006.Google Scholar
Maskus, K.E. and Lahouel, M.(1999), ‘Competition policy and intellectual property rights in developing countries: interests in unilateral initiatives and a WTO Agreement’, in the World Bank Global Conference on Developing Countries and the Millennium Round, Geneva, 20–21 September 1999, revision December 1999. Available: http://orion.forumone.com/ABCDE/files.fcgi/186_maskus.pdf.Google Scholar
McCalman, P. (1999), ‘Reaping what you sow: an empirical analysis of international patent harmonisation’. Available: www.innovations.harvard.edu/showdoc.html?id=5075Google Scholar
Médecins Sans Frontières (2001), ‘Fatal imbalance: the crisis in research and development for drugs for neglected diseases’ [Online]. Available:www.msf.org/source/access/2001/fatal/fatal.pdf [Accessed: 9 April 2004]Google Scholar
Médecins Sans Frontières (2003a), ‘Doha derailed: a progress report on TRIPS and access to medicines’ [Online]. Available:www.accessmed-msf.org/documents/cancunbriefing.pdf [Accessed 19 February 2004]Google Scholar
Médecins Sans Frontières (2003b), ‘Procurement of antiretroviral medicines in low- and middle-income countries: the experience of MSF’. Available: www.accessmed-msf.org/documents/procurementreport.pdfGoogle Scholar
Médecins Sans Frontières (2005), ‘Will the lifeline of affordable medicines for poor countries be cut? Consequences of Medicines Patenting in India’, Briefing document, February 2005.Google Scholar
Médecins Sans Frontières (2006), ‘Neither expeditious nor a solution: the WTO’, 30 August, Decision is unworkable. Available: http://msf.ch/fileadmin/user_upload/uploads/communiques/images_2006/pdf/came_Neither_expeditious_nor_a_solution_-_August_30_and_the_JCPA_single_page.pdfGoogle Scholar
Minister of Health and Another v. Treatment Action Campaign and Others (2002), 5 South African Law Report 721, Constitutional Court of South Africa.Google Scholar
Morgan, M.R. (2006), ‘Medicines for the developing world: promoting access and innovation in the post-TRIPS environment’, University of Toronto Faculty of Law Review, 64(1): 45.Google Scholar
Narrain, S. (2005), ‘Patents and public health concerns’, The Hindu, 15 November 2005.Google Scholar
Organisation for Economic Cooperation and Development, Directorate for Financial, Fiscal and Enterprise Affairs, Committee on Competition Law and Policy (2000), Competition and Regulation Issues in the Pharmaceutical Industry, DAFFE/CLP (2000)29, 6 February 2001.Google Scholar
Organisation for Economic Cooperation and Development (2007), ‘The economic impact of counterfeiting and piracy’. Available: www.oecd.org/document/40/0,3343,en_2649_34173_39542888_1_1_1_1,00.htmlGoogle Scholar
Outterson, K. (2005), ‘Pharmaceutical arbitrage: balancing access and innovation in international prescription drug markets’, Yale Journal of Health Policy, Law and Ethics, 5: 193.Google ScholarPubMed
Oxfam (2002a), ‘US Bullying on Drug Patents: one year after Doha’, Oxfam briefing paper 33. Available: www.oxfam.org.uk/what_we_do/issues/health/downloads/bp33_bullying.pdfGoogle Scholar
Penrose, E.T. (1951), The Economics of the International Patent System, Baltimore: Johns Hopkins Press, Chapter XI.Google Scholar
Prahalad, C.K. and Hammond, A.(2002), ‘Serving the world's poor, profitably’, Harvard Business Review, September 2002.Google ScholarPubMed
Reich, M. (2000), ‘The global drug gap’, Science, 287(5460): 19791981.CrossRefGoogle ScholarPubMed
Roche Products Inc. v. Bolar Pharmaceutical Co. (1984), 733F.2d 838. Fed. Cir. of the US. 23 April 1984.Google Scholar
Rosenberg, T. (2001), ‘Look at Brazil’, New York Times Magazine, 20 February 2001.Google Scholar
Rozek, R.P. and Berkowitz, R.(1998), ‘The effects of patent protection on the prices of pharmaceutical products: is intellectual property protection raising the drug bill in developing countries?’, The Journal of World Intellectual Property, 1: 179243.CrossRefGoogle Scholar
Scherer, F.M. (2000), ‘The pharmaceutical industry’, in Culyer, A.L.and Newhouse, J.P. (eds), Handbook of Health Economics, Vol. 1, New York: Elsevier Science B.V.Google Scholar
Scherer, F.M. and Watal, J.(2001), ‘Post-TRIPS options for access to patented medicines in developing countries’, Commission on Macroeconomics and Health working paper WG4: 1, June 2001.CrossRefGoogle Scholar
Singh, S. (2007), ‘Indian pharma enters the global arena’, Cell, 128(5): 811814.CrossRefGoogle ScholarPubMed
Thorsteinsdottir, H., Quach, U.Daar, A.S.and Singer, P.A.(2004), ‘Health biotechnology innovation in developing countries’, Nature Biotechnology, 22, Supplement December 2004.Google ScholarPubMed
Trebilcock, M.J. and Howse, R.(1999), The Regulation of International Trade, 2nd edn, New York: Routledge.Google Scholar
Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) (1994), ‘Marrakesh agreement establishing the World Trade Organisation’, Annex 1C, 1869 U.N.T.S. 299, 33 I.L.M. 1197 (15 April).Google Scholar
Trouiller, P., Olliaro, P., Torreele, E., Orbinski, J., Laing, R.and Ford, N.(2002), ‘Drug development for neglected diseases: a deficient market and a public-health policy failure’, The Lancet, 359(9324): 21882194.CrossRefGoogle Scholar
UNAIDS and World Health Organisation (2006), ‘Progress on global access to HIV antiretroviral therapy’, Report on ‘3 by 5’ and beyond, March 2006, UNAIDS and WHO, Geneva.Google Scholar
United Nations Development Programme (2003), Making Global Trade Work for People, New York: United Nations Development Programme.Google Scholar
United Nations High Commissioner For Human Rights (2006), ‘Status of ratifications of the principal international human rights treaties as of 9 March 2006’, Available: www.ohchr.org/english/bodies/docs/status.pdfGoogle Scholar
US Code Congressional and Administrative News (USCCAN) (1984), H.R.Rep. No. 98-857, Part I and 17 2647.Google Scholar
US Generalised System of Preferences (1999), Revised. Available:www.ustr.gov/reports/gsp/intro.html. [Accessed: June 14, 2004]. [GSP]Google Scholar
Weissman, R. (1996), ‘A long, strange TRIPS: the pharmaceutical industry drive to harmonise global intellectual property rules, and the remaining WTO legal alternatives available to third world countries’, University of Pennsylvania Journal of International Economic Law, 17(4): 10691125.Google Scholar
World Bank (2002), ‘Global economic prospects and the developing countries 2002: making trade work for the world's poor’, Available: www.worldbank.org/prospects/gep2002.Google Scholar
World Bank (2003), ‘Implementing the Doha mandate on TRIPS and public health’, International Trade Department; May 2003. Available:www.developmentgateway.org/download/191422/TradeNote5.pdf (Accessed 18 February 2004)Google Scholar
World Generic Markets (2005), ‘India passes patent amendments’, 30 March 2005.Google Scholar
World Health Assembly Resolution (2006), ‘Public health, innovation, essential health research and intellectual property rights: towards a global strategy and plan of action’, World Health Assembly 59.24, 27 May 2006.Google Scholar
World Health Organization (1998), ‘Progress of WHO member states in developing national drug policies and in revising essential drugs lists’, WHO/DAP/98.7, World Health Organization, Geneva.Google Scholar
World Health Organization (2000), ‘WHO medicines strategy: framework for action in essential drugs and medicines policy 2002–2003’, The World Health Organisation, Geneva. Available:www.who.int/medicines/strategy/strategy.pdf (accessed 2 March 2004)Google Scholar
World Health Organization (2001), ‘Globalisation, TRIPS and access to pharmaceuticals’, Policy Perspectives on Medicines, No. 3, March 2001. Available: www.who.int/medicines/library/edm_general/6pagers/PPM03ENG.pdfGoogle Scholar
World Health Organization (2002), ‘Implications of the Doha Declaration on the TRIPS Agreement and public health’, Health Economics and Drugs Series No.12, WHO/EDM/PAR/2002.3.Google Scholar
World Health Organization (2004), ‘Prequalifying priority medicines: ensuring the quality, safety, and efficacy of HIV/AIDS, tuberculosis and malaria medicines and diagnostics’, WHO/EDM/QSM/2004.2, World Health Organisation, Geneva. Available: http://mednet3.who.int/prequal/documents/PrequalBrochure_English.pdfGoogle Scholar
World Health Organization (2004), WHO Medicines Strategy: Countries at the Core 2004–2007, Geneva: World Health Organization.Google Scholar
World Health Organization and UNAIDS (1998), ‘Guidance modules on antiretroviral treatments: module 9: ethical and societal issues relating to antiretroviral treatments’, WHO/ASD/98.1, UNAIDS/98.7.Google Scholar
World Health Organization, UNAIDS, and UNICEF (2007) ‘Towards universal access: scaling up priority HIV/AIDS interventions in the health sector’, Progress report, World Health Organization, UNAIDS, and UNICEF, Geneva.Google Scholar
World Health Organization Intergovernmental Working Group on Public Health, Innovation and Intellectual Property (2006), ‘Elements of a global strategy and plan of action’, A/PHI/IGWG/1/4, 2 November 2006.Google Scholar