The goal of obtaining a greater access to medicines in South Africa is challenging and demands a wide variety of actions to be put into practice, involving a legislative intervention as well as strict jurisprudential interpretations.
The experience of foreign developing economies, which had fully or partly implemented the TRIPS flexibilities, can offer a concrete appraisal of the short and long-term implications that an appropriate use of the TRIPS flexibilities could have upon public health in South Africa, and especially access to medicines.
In Thailand, the mortality rate caused by malaria dropped from 10.9 per 100,000 persons in 1977 to 0.1 per 100,000 persons in 2009, after the policy in favor of the public health sector was
398 For further discussion about Kenyan parallel importation policy, see P. Munyi, R. Lewis-Lettington, Willingness and Ability to Use TRIPs Flexibilities: Kenya case study (2004) in DFID Health Systems Research Centre, Issue Paper
– Access to Medicines accessible online at
http://www.who.int/hiv/amds/countries/ken_UseTRIPsFlexibilitiesDFID.pdf, accessed in June 2015.
implemented by the Thai government.399 Particularly, in 2007, the first compulsory licence for non-communicable diseases (NCD) was issued for the drug Plavix, which treats cardiovascular diseases. It helped reduce the price of Plavix from US$ 2.75 per tablet to US$ 0.03 per tablet.400 Subsequently, other four compulsory licences were issued on drugs to treat cancer. This led the United States Trade Representative to include Thailand on the “Special 301” Watch List, since, according to the US, Thailand’s actions lacked transparency in the granting of compulsory licences.401
As critically discussed, India is one of the largest producers of generic medicines in the world, whose generic pharmaceutical industry satisfies 95% of the national health needs.402 Since the TRIPS Agreement came into force, India attempted to maximize the use of its flexibilities, in particular its patentability standards and the issuance of compulsory licences for pharmaceuticals.
Recently, a compulsory licence for the anti-cancer drug, Nexavar, was granted in March 2012,403 allowing the generic drug manufacturer, Natco, to put sorafenib tosylate into the market at US$ 162 per patient per month instead of the original price of US$ 5162.51.404
In 2003, Malaysia issued a government-use licence, during a period of two years, for importing generic ARVs from the Indian company, Cipla. This induced the patent owners, Bristol-Myers Squibb and GlaxoSmithKline, to drastically reduce the prices for the stavudine + didanosine + nevirapine from US$ 261.44 to US$197.10 (per patient per month) and the combination of zidovudine and lamivudine + efavirenz from US$ 362.63 to US$ 136.34 (per patient per month).
Furthermore, after the import of generic ARVs under a government-use licence, the percentage of cost reduction in 2004 was of 83% for stavudine + didanosine + nevirapine (per patient per month)
399 See S. Wibulpolprasert, “Thailand Health Profile 2008-2010”, Printing Press, The War Veteran Organization of Thailand (2010).
400 See S. Danawala & Z. Zhang, “Implications of TRIPS Flexibilities for Access to Non-communicable Disease Medicines in Lower and Middle Income Countries” in International Journal of Nursing and Health Care, (2013) Volume 1 Number 1, 6.
401 J. Wetzler, M. Mankad & A. Burrowbridge, Timeline for US- Thailand Compulsory Licence Dispute, Version 3.
Program on Information Justice and Intellectual Property. (2009) Available online at: http://infojustice.org/wp- content/uploads/2012/11/pijip-thailand-timeline.pdf, accessed in June 2015.
402 See S. Danawala and Z. Zhang, (note above) 7.
403 See Controller General of Patents, Designs and Trade Marks, Compulsory Licence Application No.1 of 2011.
Available online at: www.ipindia.nic.in/iponew/compulsory_licence_12032012.pdf, accessed in June 2015.
404 See S. Danawala and Z. Zhang, (note above) 7.
and of 68% for the combination of zidovudine and lamivudine + efavirenz.405
As already seen, in July 2005, after long negotiations between the pharmaceutical company Abbott and the Government of Brazil regarding the granting of a compulsory licence for the drug Kaletra,406 Abbott agreed to decrease the price of the drug from US$ 1.17 to US$ 0.63 (unit price per Kaletra capsule).407
The above are only a few examples of the results achieved by low-income countries, which have successfully reduced drug prices, as a result of a better use of the flexibilities granted by the TRIPS Agreement. Therefore, in applying a patent policy, which is more favorable to public health, South Africa can also obtain the same positive outcomes resulting in greater price reductions for medicines, which will lead to increased access to medicines.
Importantly, the positive effects experienced by some of these mentioned emerging economies can be fully experienced if a revision of the national policies which introduced TRIPS-plus provisions is also carried out. As discussed,408 TRIPS-plus are provisions whose scope goes beyond the original intention of the TRIPS Agreement’s standards.409 These provisions are often implemented through FTAs and they aim at increasing IP protection, but they can concurrently obstruct the full use of the flexibilities available in the TRIPS Agreement.410 In particular, a special report of the UN High Commission for Human Rights stressed the negative impacts that FTAs can have upon access to medicines, stating that: “these agreements are usually negotiated with little transparency or participation from the public, and often establish TRIPS-plus provisions. These provisions undermine the safeguards and flexibilities that developing countries sought to preserve under
405 See M. Khor, “Patents, compulsory licences and access to medicines: some recent experiences” in World Health Organization, Intellectual Property and access to medicines, (2010) 93.
406 For further details, see Chapter IV, 3) d) of this study.
407 See M. Khor (note above) 99.
408 See Chapter II, 3) c) iii) of this study for further discussion.
409 S. Musungu & G. Dutfield, Multilateral Agreements and a TRIPS-Plus World: The World Intellectual Property Organisation, TRIPS Issues Papers No. 3, (2003) QUNO, Geneva, and Quaker International Affairs Programme, Ottawa, Canada. In particular, the authors highlighted that: “ […] the adoption of multilateral, plurilateral, regional and/or national intellectual property rules and practices which have the effect of reducing the ability of developing countries to protect the public interest aims to increase the level of protection for right holders beyond that which is given in the TRIPS Agreement [...]”.
410 See S. Danawala and Z. Zhang, (note above) 4.
TRIPS”.411 As a result, there is a “need to revisit trade-related agreements in light of their impact on the right to health and in particular on access to medicines” 412, but particularly, “developing countries and LDCs should not introduce TRIPS-plus standards in their national laws. Developed countries should not encourage developing countries and LDCs to enter into TRIPS-plus FTAs and should be mindful of actions which may infringe upon the right to health”. 413
Consequently, the positive implications resulting from implementation of the TRIPS flexibilities, as experienced by the discussed emerging economies, can succeed through an effective strategy of complete use of the flexibilities available in the TRIPS, and especially refraining from entering into new TRIPS-plus FTAs.414
4. COMPETING INTERESTS: THE HUMAN RIGHT TO HEALTH VERSUS