The politics behind the implementation of the WTO Paragraph 6 Decision in Canada to increase global drug access

Globalization and Health

Jillian Clare Kohler¹  Laura C Esmail¹ 

[1] Leslie Dan Faculty of Pharmacy, 144 College St., Toronto, ON, Canada

关键词: Canada's access to medicines regime;    Human rights;    Paragraph 6;    TRIPS;    Compulsory licensing;    Patents;    Intellectual property rights;    HIV/AIDS;    Pharmaceuticals;    Drug access;    Access to medicines;   

Others  :  819538
DOI  :  10.1186/1744-8603-8-7

 received in 2011-08-27, accepted in 2012-04-03,  发布年份 2012

【 摘 要 】

Background

The reform of pharmaceutical policy can often involve trade-offs between competing social and commercial goals. Canada's Access to Medicines Regime (CAMR), a legislative amendment that permits compulsory licensing for the production and export of medicines to developing countries, aimed to reconcile these goals. Since it was passed in 2004, only two orders of antiretroviral drugs, enough for 21,000 HIV/AIDS patients in Rwanda have been exported. Future use of the regime appears unlikely. This research aimed to examine the politics of CAMR.

Methods

Parliamentary Committee hearing transcripts from CAMR's legislative development (2004) and legislative review (2007) were analysed using a content analysis technique to identify how stakeholders who participated in the debates framed the issues. These findings were subsequently analysed using a framework of framing, institutions and interests to determine how these three dimensions shaped CAMR.

Results

In 2004, policy debates in Canada were dominated by two themes: intellectual property rights and the TRIPS Agreement. The right to medicines as a basic human right and CAMR's potential impact on innovation were hardly discussed. With the Departments of Industry Canada and International Trade as the lead institutions, the goals of protecting intellectual property and ensuring good trade relations with the United States appear to have taken priority over encouraging generic competition to achieve drug affordability. The result was a more limited interpretation of patent flexibilities under the WTO Paragraph 6 Decision. The most striking finding is the minimal discussion over the potential barriers developing country beneficiaries might face when attempting to use compulsory licensing, including their reluctance to use TRIPS flexibilities, their desire to pursue technological development and the constraints inherent in the WTO Paragraph 6 Decision. Instead, these issues were raised in 2007, which can be partly accounted for by experience in implementing the legislation and hence a greater representation of the interests of potential beneficiary country governments.

Conclusions

The Canadian Government designed CAMR as a last resort measure. Increased input from the developing country beneficiaries and shifting to institutions where the right to health gets prioritized may lead to policies that better achieves affordable drug access.

【 授权许可】

   
2012 Esmail and Kohler; licensee BioMed Central Ltd.

【 参考文献 】

• [1]World Health Organization: The World Medicines Situation. Geneva: World Health Organization; 2004.
• [2]Frost LJ, Reich MR: Access: how do good health technologies get to poor people in poor countries. Cambridge, MA: Harvard University Press; 2008.
• [3]World Health Organization: How to develop and implement a national drug policy. Volume 6. Geneva. WHO; 2003.
• [4]UNAIDS: UNAIDS Report on the Global AIDS Epidemic. Geneva: Joint United Nations Programme on HIV/AIDS (UNAIDS); 2010.
• [5]Mendis S, Fukino K, Cameron A, Laing R, Filipe A Jr, Khatib O, et al.: The availability and affordability of selected essential medicines for chronic diseases in six low-and middle-income countries. Bulletin of the World Health Organization 2007, 85:279-288.
• [6]Kohler JC: Reflections on pills and poverty. CPJ 2007, 140:379.
• [7]World Trade Organization: Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health: Decision of the General Council of 30 August 2003. [http://www.wto.org/english/tratop_e/trips_e/implem_para6_e.htm] webcite
• [8]Canada's Access to Medicines Regime [http://www.camr-rcam.gc.ca/index_e.html] webcite
• [9]Attaran A: A tragically naive Canadian law for tragically neglected global health. Canadian Medical Association Journal 2007, 176:1726-1727.
• [10]Cohen-Kohler JC, Esmail LC, Cosio AP: Canada's implementation of the Paragraph 6 Decision: Is it sustainable public policy? Globalization and Health 2007, 3:12. BioMed Central Full Text
• [11]Elliott R: Delivery past due: global precedent set under Canada's Access to Medicines Regime. HIV/AIDS Policy & Law Review/Canadian HIV/AIDS Legal Network 2008, 13:1-5.
• [12]Schön DA, Rein M: Frame reflection: Toward the resolution of intractable policy controversies. New York: Basic Books; 1994.
• [13]Stone DA: Policy paradox: The art of political decision making. 2nd edition. New York: Norton; 2002.
• [14]Krasner SD: International regimes. Ithaca: Cornell University Press; 1983.
• [15]Schattschneider EE: The semisovereign people: a realist's view of democracy in America. New York: Holt, Rinehart and Winston; 1964.
• [16]Baumgartner FR, Jones BD: Agendas and instability in American politics. Chicago: University of Chicago Press; 1993.
• [17]World Trade Organization: Fact sheet: TRIPS and pharmaceutical patents. obligations and exceptions. [http://www.wto.org/english/tratop_E/trips_e/factsheet_pharm02_e.htm] webcite
• [18]Correa CM: Implications of the Doha Declaration on the TRIPS Agreement and public health. Geneva: World Health Organization, Essential Drugs and Medicine Policy; 2002.
• [19]Médecins sans Frontières: Examples of the importance of India as the "pharmacy for the developing world". Geneva: Médecins sans Frontières; 2007.
• [20]Outterson K: Should access to medicines and TRIPS flexibilities be limited to specific diseases? American Journal of Law and Medicine 2008, 34:279-301.
• [21]World Trade Organization: Doha WTO Ministerial 2001: Declaration on the TRIPS agreement and public health, adopted on 14 November 2001. [http://www.wto.org/english/thewto_e/minist_e/min01_e/mindecl_trips_e.htm] webcite
• [22]Lexchin J: After compulsory licensing: coming issues in Canadian pharmaceutical policy and politics. Health Policy 1997, 40:69-80.
• [23]Jenish D: Trials and triumphs: The remarkable story of Canada's generic pharmaceutical industry. Canada: Canadian Generic Pharmaceutical Association; 2003.
• [24]Reichman J, Hasenzahl C: Non-voluntary licensing of patented inventions. City: Geneva, ICTSD and UNCTAD; 2003. Issue Paper, 5
• [25]Doern GB, Sharaput M: Canadian intellectual property: The politics of innovating institutions and interests. Toronto: University of Toronto Press; 2000.
• [26]Lexchin J: Pharmaceuticals, patents, and politics: Canada and Bill C-22. International Journal of Health Services 1993, 23:147-160.
• [27]Scoffield H, Chase S: Ottawa heeds call on AIDS. Toronto: Globe and Mail; 2003:A1.
• [28]Elliott R: Pledges and pitfalls: Canada's legislation on compulsory licensing of pharmaceuticals for export. International Journal of Intellectual Property Management 2006, 1:94-112.
• [29]Ng E, Kohler JC: Finding Flaws: The Limitations of Compulsory Licensing for Improving Access to Medicines-An International Comparison. Health LJ 2008, 16:143.
• [30]Goodwin P: Right idea, wrong result - Canada's Access to Medicines Regime. American Journal of Law and Medicine 2008, 34:563-580.
• [31]Canadian-made life saving HIV/AIDS drug heading to Africa under Canada's Access to Medicines Regime (CAMR) [http://www.apotex.com/nl/en/aboutapotex/sept23.asp] webcite
• [32]Government of Canada: Report on the statutory review of sections 21.01 to 21.19 of the Patent Act. Ottawa: Government of Canada; 2007.
• [33]Krippendorff K: Content analysis: An introduction to its methodology. Thousand Oaks, CA: Sage Publications, Inc; 2004.
• [34]Blackburn S: The Oxford dictionary of philosophy. 2nd edition. Oxford: Oxford University Press; 2005.
• [35]Huberman AM, Miles MB: Qualitative data analysis: An expanded sourcebook. 2nd edition. Thousand Oaks, CA: Sage Publications; 1994.
• [36]Howlett M, Perl A, Ramesh M: Studying public policy: Policy cycles & policy subsystems. 3rd edition. Don Mills, Ont: Oxford University Press; 2009.
• [37]Abbott FM: The WTO Medicines Decision: World pharmaceutical trade and the protection of public health. American Journal of International Law 2005, 99:317-358.
• [38]Sell SK, Prakash A: Using ideas strategically: The contest between business and NGO networks in intellectual property rights. International Studies Quarterly 2004, 48:143-175.
• [39]t'Hoen EFM: The global politics of pharmaceutical monopoly power. drugs patents, access, innovation and the application of the WTO Doha Declaration on TRIPS and Public Health. Diemen, The Netherlands: AMB Publishers; 2009.
• [40]Kellow A: Promoting elegance in policy theory: Simplifying Lowi's arenas of power. Policy Studies Journal 1988, 16:713-724.
• [41]Elliott R: Canada can carry much more. Toronto: Globe and Mail; 2003:A23.
• [42]Elliott R: Fixing Access To Medicines Regime Essential. [http://www.countercurrents.org/elliott261010.htm] webcite 2010.
• [43]Graham B: Canada leading the way. Toronto: The Toronto Star; 2003:A21.
• [44]Martin P: Speech from the throne to open the third session of the thirty-seventh Parliament of Canada. Government of Canada; 2004.
• [45]Commission on Intellectual Property Rights: Public health, innovation and intellectual property rights: Report of the Commission on Intellectual Property Rights, Innovation and Public Health. Geneva: World Health Organization; 2006.
• [46]Orsi F, d'Almeida C: Soaring antiretroviral prices, TRIPS and TRIPS flexibilities: a burning issue for antiretroviral treatment scale-up in developing countries. Current Opinion in HIV and AIDS 2010, 5:237.
• [47]Intervention of India at the WTO TRIPS Council on "Effective operation of Para 6 system" [http://lists.essential.org/pipermail/ip-health/2009-March/013533.html] webcite