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Effects of TRIPS Plus Provisions in International Trade Agreements upon Access to Medicines in Developing Countries


Affiliations
1 LNJN National Institute of Criminology and Forensic Science, Delhi-110 085, India
 

Though the UN has envisaged that accessibility to essential medicines is a basic human right, a large number of people in developing countries are denied access to essential medicines. MNCs having the branded medicines have a tendency to choke the supply chain of cheaper generic medicines using the weapon of intellectual property rights. The TRIPS Agreement has set the minimum standard of protection of Intellectual Property but it has provisions of flexibilities such as compulsory licenses, parallel imports limitations to patent rights, etc., which can be used by member states to provide access to these essential medicines to their people. However, countries like US are using provisions which are over and above the flexibilities incorporated in TRIPS to deny access to essential medicines to people in developing countries. The accessibility of essential medicines to the population in developing countries as affected by these FTAs, ACTA, TPP and TTIP agreements have been examined in this paper and a case has been made out for the unity of the developing and least developed countries to deter US from choking the supply lines of the essential medicines to poor and needy.

Keywords

Doha Declaration, TRIPS, Free Trade Agreements, ACTA, TPP, TTIP, intellectual Property Rights, TRIPS Plus, TRIPS Flexibilities.
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  • Universal Declaration of Human Rights, ed. United Nations (United Nations, 1948), Article 30.
  • International Covenant on Economic, Social and Cultural Rights, in Treaty Series, 993, p.3, ed. United Nations (UN General Assembly, 1966), Article 12.
  • International Covenant on Economic, Social and Cultural Rights, in Treaty Series, 993, p.3, ed. United Nations (UN General Assembly, 1966), Article 5.
  • The World Health Report 2008: Primary Health Care Now More Than Ever, World Health Organization, 2008.
  • World Health Statistics 2015, in Geneva: WHO, ed. World Health Organization (Geneva: World Health Organization, 2015), fig. 7,3rd graph.
  • World Health Statistics 2015, in Geneva: WHO, ed. World Health Organization (Geneva: World Health Organization, 2015), fig. 5.
  • Ellen FM’tHoen, TRIPS, pharmaceutical patents and access to essential medicines: A long way from Seattle to Doha, Chicago Journal of International Law, 3 (1) 2002.
  • Alexandra Cameron et al., Medicine prices, availability, and affordability in 36 developing and middle-income countries: A secondary analysis, The Lancet, 373 (9659) 2009.
  • Alexandra Cameron et al., Switching from originator brand medicines to generic equivalents in selected developing countries: How much could be saved?, Value in Health, 15 (5) 2012.
  • Agreement on Trade-Related Aspects of Intellectual Property Rights, ed. World Trade Organization, 1869 UNTS 299; 33 ILM 1197 (1994), World Trade Organization, 1994.
  • Free Trade Agreements signed by US with several countries under Trade Promotion Authority Act, 2002, which mandates IP protection in bilateral and multilateral agreements similar to US Domestic Law.
  • Anti- Counterfeiting Trade Agreement, 2010, 10 of the 11 negotiating parties [Australia, Canada, EU (+22 members), Japan, Mexico, Morocco, New Zealand, Singapore, South Korea, Switzerland, United States] signed by 2012, except Switzerland. The 22 EU Member countries also signed. So far only Japan has ratified. European Parliament rejected ACTA on 4 July 2012 on grounds of potential threat to civil liberties.
  • Trans-Pacific Partnership Agreement, 2016 (signed but not in force). An attempt by US to unite 12 countries in Pacific Rim.
  • Transatlantic Trade and Investment Partnership, ed. US and EU (Under Negotiation).
  • Cameron et al., Switching from Originator Brand Medicines to Generic Equivalents in Selected Developing Countries: How Much Could Be Saved?, Table 5, Value in Health, 15(5) (2012) 664 -73.The Graph in this paper is drawn by using this secondary data.
  • Cameron et al., Switching from Originator Brand Medicines to Generic Equivalents in Selected Developing Countries: How Much Could Be Saved?, Table 5, Value in Health, 15(5) (2012) 664 -73. Consolidated Table is original to this paper.
  • Declaration on the TRIPS Agreement and Public Health adopted on 14 November 2001, Doha WTO Ministerial 2001: TRIPS, ed. DOHA WTO MINISTERIAL 2001:TRIPS, WT/MIN(01)/DEC/2, and 20 November 2001 (Doha 2001).
  • Declaration on the TRIPS Agreement and Public Health adopted on 14 November 2001, Doha WTO Ministerial 2001: TRIPS, ed. DOHA WTO MINISTERIAL 2001:TRIPS, WT/MIN(01)/DEC/2, and 20 November 2001 (Doha 2001), para 4.
  • Declaration on the TRIPS Agreement and Public Health adopted on 14 November 2001, Doha WTO Ministerial 2001: TRIPS, ed. DOHA WTO MINISTERIAL 2001:TRIPS, WT/MIN(01)/DEC/2, and 20 November 2001 (Doha 2001), para 5.
  • UNHRC, Draft Resolution on Access to medicines in the context of the right of everyone to the enjoyment of the highest attainable standard of physical and mental health,32nd Session, Agenda No. 3 (2016).
  • Patrick B, Globalization, Pharmaceutical pricing, and South African health policy: Managing confrontation with US firms and politicians, International Journal of Health Services, 29 (4) 1999.
  • Mohara A et al., Impact of the introduction of Government use licenses on the drug expenditure on seven medicines in Thailand, Value in Health, 15 (1) 2012.
  • Akaleephan C et al., Extension of market exclusivity and its impact on the accessibility to essential medicines, and drug expense in Thailand: Analysis of the effect of TRIPS-Plus proposal, Health Policy, 91 (2) 2009.
  • Kapczynski A, Harmonization and its discontents: A case study of TRIPS implementation in India's pharmaceutical sector, California Law Review, 97 (6) 2009.
  • Lee Linda L, Trials and TRIPS-ulations: Indian Patent Law and Novartis Ag v Union of India, Berkeley Technology Law Journal, 23 (1) 2008.
  • Ghanotakis E, How the US interpretation of flexibilities inherent in TRIPS affects access to medicines for developing countries, The Journal of World Intellectual Property, 7 (4) 2004.
  • David Vivas-Eugui, Regional and Bilateral Agreements and a TRIPS-Plus World: The Free Trade Area of the Americas (FTAA), Quaker United Nations Office (QUNO), 2003.
  • Grover A, Report of the Special Rapporteur on the Right of Everyone to the Enjoyment of the Highest Attainable Standard of Physical and Mental Health, UN General Assembly, Human Rights Council, 2009.
  • Deere C, The implementation game: The TRIPS Agreement and the global politics of intellectual property reform in developing countries, OUP Oxford, 2008.
  • Indian Patents Act, 1970, Section 3(d).
  • Abbott Frederick M & Reichman Jerome H, The Doha Round's public health legacy: Strategies for the production and diffusion of patented medicines under the amended TRIPS provisions, Journal of International Economic Law, 10 (4) 2007.
  • Cecilia Oh, Compulsory licences: Recent experiences in developing countries, International Journal of Intellectual Property Management, 1 (1-2) 2006.
  • Musungu Sisule F & Cecilia Oh, The Use of Flexibilities in TRIPS by Developing Countries: Can They Promote Access to Medicines? World Health Organization, South Centre Geneva, 2006.
  • Nathan Ford et al., The role of civil society in protecting public health over commercial interests: Lessons from Thailand, The Lancet, 363 (9408) 2004.
  • Developing countries can take lesson from European Union in detailing anti-competitive practices in pharmaceutical sector, Domanico Fabio & Kamilarova Elena, Final results of the commission pharmaceutical sector inquiry: Competition and regulatory concerns to address, Antitrust, 2009.
  • Susan K Sell, TRIPS-Plus free trade agreements and access to medicines, Liverpool Law Review, 28 (1) 2007.
  • Abbott Frederick M, Intellectual property provisions of bilateral and regional trade agreements in light of US Federal Law, UNCTAD-ICTSD Project on IPRs and Sustainable Development, Issue Paper, no. 12, 2006.
  • Jorge María Fabiana, TRIPS-Plus provisions in trade agreements and their potential adverse effects on public health, Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector, 1 (3) 2004.
  • Correa Carlos María, Implications of bilateral free trade agreements on access to medicines, Bulletin of the World Health Organization, 84 (5) 2006.
  • Fink C & Reichenmiller P, Tightening TRIPS: Intellectual property provisions of US Free Trade Agreements, Trade, The World Bank Group Trade Note, 7 February 2005.
  • Fink C, Entering the jungle of intellectual property rights exhaustion and parallel importation, Intellectual Property and Development: Lessons from Recent Economic Research, Oxford, UK: Oxford University Press/Washington, DC: World Bank, 2005.
  • Krikorian Gaëlle P & Szymkowiak Dorota M, Intellectual property rights in the making: The evolution of intellectual property provisions in US Free Trade Agreements and access to medicine, The Journal of World Intellectual Property, 10 (5) (2007).
  • Jorge M F, TRIPS-plus provisionsin trade agreements and their potential adverse effects on public health, Journal of Generic Medicines, 1 (2004) 199–211.
  • Kantor M, US Free Trade Agreements and the Public Health, Submission to the WHO’s Commission on Intellectual Property Rights, Innovation, and Public Health, http://www.who.int/intellectualproperty/submissions/US%20FTAs%20 and%20the%20Public%20Health.pdf, 2005.
  • Kantor M, US Free Trade Agreements and the Public Health, Submission to the WHO’s Commission on Intellectual Property Rights, Innovation, and Public Health, http://www.who.int/intellectualproperty/submissions/US%20FTAs%20a nd%20the%20Public%20Health.pdf, 2005, p. 3.
  • Kantor M, US Free Trade Agreements and the Public Health, Submission to the WHO’s Commission on Intellectual Property Rights, Innovation, and Public Health, http://www.who.int/intellectualproperty/submissions/US%20FTAs%20a nd%20the%20Public%20Health.pdf, 2005, p. 9.
  • Fink C, Entering the jungle of intellectual property rights exhaustion and parallel importation, Intellectual Property and Development: Lessons from Recent Economic Research, Oxford, UK: Oxford University Press/Washington, DC: World Bank, 2005; Fink C & Reichenmiller P, Tightening TRIPS: Intellectual property provisions of US Free Trade Agreements, Trade, The World Bank Group Trade Note, 7 February 2005.
  • Drahos P, Bits and Bips, The Journal of World Intellectual Property, 4 (6) 2001.
  • Statement by the President on Senate Passage of Trade Promotion Authority and Trade Adjustment Assistance, News Release, 2015, https://www.whitehouse.gov/the-pressoffice/ 2015/05/22/statement-president-senate-passage-tradepromotionauthority-and-trade-a.
  • Krikorian G P & Szymkowiak D M, Intellectual property rights in the making: The evolution of intellectual property provisions in US Free Trade Agreements and access to medicine, Journal of World Intellectual Property, 10 (5) (2007) 388–418, at 393.
  • Flynn Sean M & Madhani B, Acta and access to medicines, The Greens, European Free Alliance, 2011.
  • Weatherall K, Politics, compromise, text and the failures of the Anti-Counterfeiting Trade Agreement, Sydney Law Review, 33, 2011.
  • Baker B K, Acta-Risks of third-party enforcement for access to medicines, American University International Law Review, 26 2010.
  • Jaeger T, Merging Acta into TRIPS: Does TRIPS-Based IP Enforcement Need Reform?, in TRIPS Plus 20, From Trade Rules to Market Principles, ed. Hens Ulrich, Reto M, Hilty, Matthaias Lamping & Joseph Drexl, Heidelberg: Springer, 2016.
  • Morin Jean‐Frédéric, Multilateralizing Trips‐Plus Agreements: Is the US strategy a failure?, The Journal of World Intellectual Property, 12 (3) 2009.
  • Peter K Yu, The rise and decline of the intellectual property powers, Campbell Law Review, 34 2012.
  • TRIPS Wars: Developing Countries Strike Back, 2016, http://goo.gl/irhKcQ.
  • Perez-Rocha, The Transatlantic Trade and Investment Partnership (TTIP): Why Should the World Beware, Brussels, Rosa-Luxemburg-Stiftung, 2015.

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  • Effects of TRIPS Plus Provisions in International Trade Agreements upon Access to Medicines in Developing Countries

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Authors

Sandeep Mittal
LNJN National Institute of Criminology and Forensic Science, Delhi-110 085, India

Abstract


Though the UN has envisaged that accessibility to essential medicines is a basic human right, a large number of people in developing countries are denied access to essential medicines. MNCs having the branded medicines have a tendency to choke the supply chain of cheaper generic medicines using the weapon of intellectual property rights. The TRIPS Agreement has set the minimum standard of protection of Intellectual Property but it has provisions of flexibilities such as compulsory licenses, parallel imports limitations to patent rights, etc., which can be used by member states to provide access to these essential medicines to their people. However, countries like US are using provisions which are over and above the flexibilities incorporated in TRIPS to deny access to essential medicines to people in developing countries. The accessibility of essential medicines to the population in developing countries as affected by these FTAs, ACTA, TPP and TTIP agreements have been examined in this paper and a case has been made out for the unity of the developing and least developed countries to deter US from choking the supply lines of the essential medicines to poor and needy.

Keywords


Doha Declaration, TRIPS, Free Trade Agreements, ACTA, TPP, TTIP, intellectual Property Rights, TRIPS Plus, TRIPS Flexibilities.

References