Access to affordable life-saving medicines : the South African response.

Abstract

Patent protection grants the patent holder with a market monopoly, free from market competition allowing the patentee to charge any price; therefore medicines are sold at prices much higher than the marginal cost of production and distribution. The connection between international trade and intellectual property has aggravated human rights and public health concerns surrounding the inaccessibility of essential medicines. The World Trade Organisation‘s Trade Related Aspects of Intellectual Property Rights (TRIPS) Agreement is an international instrument which has greatly impacted intellectual property rights protection and access to medicine. It has globalized intellectual property law by obliging all Members to subscribe to the minimum international standards of protection for intellectual property. South Africa is an example of the issues faced whilst attempting to bring their domestic laws into compliance with the Agreement. The government had to attempt to strike a balance between creating an effective intellectual property infrastructure whilst realizing the therapeutic needs of those affected by HIV/AIDS. The South African Patents Act 57 of 1978 did not comply with the Agreement and was subsequently amended in order to bring its patent legislation in full compliance with the Agreement. Currently, South Africa grants patents for new uses or formulations of existing medicines consequently lengthening the period of patent monopoly by allowing pharmaceutical companies to obtain new patents for slight modifications to existing medicines. It is submitted that South Africa‘s patent legislation is more extensive than is necessary under international law, examples of this being disclosure standards and the process for compulsory licensing. In addition, it has not made use of provisions in its existing law to take measures to improve access to essential medicines, nor has it implemented legislative amendments consequent to the flexibilities established in the Doha Declaration. This dissertation seeks to review the steps South Africa has taken in its compliance with the TRIPS Agreement with respect to the relevant intellectual property legislation that has been enacted, including its implications for access to essential medicines. The intention behind this dissertation is to assess the efficacy of the intellectual property legislation in South Africa and its impact on access to medicines.