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The Legal Duel: The TRIPS Agreement and Drug Access Issues

Is the Agreement Actually the Cunning Manoeuvre it has been Dubbed?


Brenda Mey

This thesis discusses the flexibilities built into the Agreement on Trade Related Aspects of Intellectual Property Rights that are relevant for ensuring access to and availability of new medicines for the treatment of life-threatening diseases. Using Kenyan and Indian patent laws as case studies, the thesis examines the experience these countries have had in making use of the flexibilities. The thesis concludes that besides the TRIPS flexibilities, the resolution of the problem of access to medicines requires a concrete and a potent mix of country specific non-IP strategies. To test the hypotheses advanced in it, the thesis applies descriptive, qualitative and quantitative methodologies as well as interpretive analysis of court cases.


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Table of statutory instruments


Africa AU. 1998 African Model Legislation for the Protection of the Rights of Local Communities, Farmers, Breeders and for the Regulation of Access to Biological Resources’, adopted, 6 October, 1998. Available at: [accessed Fe- bruary 2011]. 2003 ‘African Charter on Human and Peoples’ Rights on the Rights of Women in Africa’, adopted by the Conference of Heads of State and Government Maputo, Mozambique Ju- ly. Available at: [accessed February 2010]. ARIPO Treaty. 1982 ‘Harare Protocol on Patents and Industrial Designs and the Regulations thereto’, adopted on 10 December, 1982, in force from 1 January, 2001. Available at: [accessed May 2007]. 1993 ‘The Banjul Protocol on Marks’, adopted by the Admin- istrative Council at Banjul, the Gambia on 19 Novem- ber, 1993, and as last amended on 13 August, 2004. Available at: [accessed May 2009]. Brazil WIPO (CLEA). 2001 ‘Brazil-Industrial Property, to Regulate Rights and Obli- gations Relating to Industrial Property’, Law No. 9.279 of May 14, 1996. Available at: [accessed May 2007]. xxviii Canada Canada Gazette. 2005 ‘Use of Patented Products for International Humanitarian Purposes Regulations’, SOR/2005-143, Patent Act, P.C. 2005-861 May 10, 2005, in force since 1 June, 2005. Available at: [accessed January 2011]. East African Community EAC. 1999 ‘The Treaty Establishing the East African Community’, in force since 7 July, 2000. Available at: [accessed November 2006]. 2009 ‘Protocol on the Establishment of the East African Community Common Market’, in force since 20 No- vember, 2009. Available at: [accessed November 2006]. 2004 ‘Protocol on the Establishment of the East...

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