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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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Part II Case studies


185 Chapter 4: Patent laws in Kenya and India 4.1 Introduction Having examined the safeguards under the TRIPS that the poor and near poor WTO member states can use to gain and improve access to lifesaving medicines, this chapter finds that the full utilisation of such safeguard/flexibilities is vital if developing countries such as Kenya and India are to fulfil the mandate outlined in articles 1, 7 and 8 of the TRIPS, the Doha Declaration and the August 2003 Decision. The flexibilities are requisite for increasing innovation and technology transfer in medicines and vaccines, eradicating poverty and reducing the vast dis- ease burden most developing countries face. In this regard, the chapter critically examines the drug access shields in the TRIPS that have been grafted into the IP laws of Kenya and India, and the extent to which the same have been exploited to secure access to vital medicines. As the discussion progresses, it will become evident from the experiences both countries have made that some gaps still exist in terms of usage of the flexibilities for public health purposes. The findings in this chapter are that both countries have to change their stances, especially re- garding use of the flexibilities if the same are to serve their intended purposes. 4.2 Sticky ground realities in Kenya and India 4.2.1 Kenya Though Kenya managed to reduce the number of its population living on US $1.25 a day from 38.4% in 1981 to 19.7% in 2005, a significant part of the country’s...

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