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C. Concerns regarding the implementation of TRIPS flexibilities
56. Developing countries, while attempting to implement TRIPS flexibilities in order to
address public health concerns, have experienced pressures from developed countries and
multinational pharmaceutical corporations. In this respect, the cases of South Africa, Thailand
and India are particularly illustrative.
57. In 1996, South Africa adopted a new National Drugs Policy with the goal of “ensuring an
adequate and reliable supply of safe, cost-effective drugs of acceptable quality to all citizens of
South Africa”.53 Following the principles of the Policy, the South African Government amended
its existing Medicines Act to improve access to medicines.54 In response, South Africa was
placed on the United States Special 301 Watch List55 and 39 pharmaceutical companies filed a
suit, challenging the amendments, contending that they would destroy patent protections by
giving the Health Minister overly broad powers to produce or import cheaper versions of drugs
still under patent.56 Worldwide public outrage eventually led to a change in the US position57 and
to the withdrawal of the lawsuit by the pharmaceutical companies in 2001.
58. Thailand also faced pressure following its attempts to lower prices of medicines through
compulsory licensing. Between 2006 and 2007, Thailand issued compulsory licences for HIV
and heart disease medicines in order to meet its obligations to provide universal access to
medicines.58 In 2007, Thailand was placed on the Special 301 Priority Watch List.59 The
position of the European Commission was also unwelcoming of the measures taken by
53
National Drug Policy for South Africa, 1996, p. 3.
54
Medicines and Related Substances Control Amendment Act No. 90 of 1997.
55
See Special 301 Report 1999. This list is maintained under the United States Trade Act, 1974,
in respect of each country. It is a precursor to trade sanctions that the United States may impose
on any country unilaterally.
56
Essential Drugs in Brief, issue No. 04, April 2001, Department of Essential Drugs and
Medicines Policy, WHO.
57
See Executive Order 13155, “Access to HIV/AIDS Pharmaceuticals and Medical
Technologies” (10 May 2000).
58
Compulsory licences were issued for clopidogrel for heart disease, and lopinavir/ritonavir and
Efavirenz for HIV.
59
Office of the United States Trade Representative (USTR), Special 301 Report, 2007.
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