The East African Community (EAC) states recently adopted a policy on utilising the WTO-TRIPS flexibilities on public health. The policy spells out a number of flexibilities and the minimum standards thereof to be enacted in domestic legislation. This study critically reviews this policy. In doing this, the study notes that the EAC member states, like most developing states, have very low per capita income levels. The people are too poor to afford expensive medicines. At the same time, these countries are faced with peculiar, region-specific diseases, the so-called ‘African diseases.’ Already, these diseases have been neglected by foreign pharmaceuticals reluctant to invest in developing medicines for poor markets. There are no established pharmaceuticals in the EAC states. It is against this background that this research makes an argument against the aforementioned policy. It will be demonstrated that the policy is biased towards ensuring access to medicines through price-reduction, at the expense of patent protection. This approach is inappropriate because: first, given the absence of market incentives to invest in developing medicines for African diseases, the policy will only worsen the already bad situation since it undermines the strongest alternative incentive (patent protection); and second, such a policy will not only discourage foreign pharmaceuticals further but also suppress domestic pharmaceutical activity, which is undoubtedly necessary in view of the growing neglect of African diseases by foreign pharmaceuticals. / Dissertation (LLM)--University of Pretoria, 2014 / gm2015 / Centre for Human Rights / LLM / Unrestricted

Magister Legum - LLM / Access to medicines is an essential component of the basic human right to health and a key determinant of the importance attached to the health care system of a country. It essentially entails the availability and acceptability of the essential medicines on the market and the ability of patients to afford such medicines when needed. Globally, countries face access to medicine challenges partly because of patents which undoubtedly accounts for excessive pricing of medicine. As such, efforts have been made to ensure the accessibility of medicines through the Trade-Related Aspect of Intellectual Property Rights (TRIPS) flexibilities of the World Trade Organisation (WTO). Beyond these interventions, it is incumbent on Members of the WTO to domesticate the flexibilities of the TRIPS Agreement before their utilisation because by their very nature, they cannot be self-executed. With an estimated population of 29.6 million, about 310 000 people in Ghana are living with HIV. The country’s health facilities record 40 per cent of outpatient visits each year and about 14 550 per 100 000 of the population are infected with tuberculosis with cancer on the rise. These diseases require medicines which are mostly patented yet Ghana has access to medicine problems despite the existence of a national health insurance system. Ghana has however not fully incorporated the TRIPS flexibilities in its national legislations and therefore unable to fully utilise the flexibilities as an option to access essential medicines. Questions therefore remain as to why and how Ghana can utilise the flexibilities to improve access to medicines. Based on an examination of the WTO’s patent system and legislations of Ghana, this mini- thesis contends that, the extent of incorporation of the flexibilities are inadequate due to the existence of lacunas in the Ghanaian legislations. Furthermore, a comparative assessment with South Africa supports an understanding that conditions are not ripe for full utilisation of all the flexibilities. It further argues that the utilisation of the TRIPS flexibilities by Ghana has been rendered ineffective due to administrative, political, economic and social challenges which adversely affects the full utilisation of the flexibilities incorporated and those yet to be incorporated. It is therefore important that Ghana adopts holistic approaches taking into consideration best practices if the TRIPS flexibilities must be effectively utilised. This mini-thesis concludes that, the TRIPS flexibilities are necessary for accessing essential medicines in Ghana to promote the right to health and that a review of Ghana’s current legislations to fully incorporate the TRIPS flexibilities and addressing other non-legal challenges are the required linchpin for effective utilisation of the TRIPS flexibilities.

Despite the adoption of the Doha Declaration on the TRIPS Agreement and Public Health in 2001, which unequivocally affirmed WTO members’ rights to use compulsory licences and other TRIPS flexibilities to access medicines, thirteen years on, developing countries and least developed countries are still grappling with access to medicines issues and a high disease burden. Despite some well researched and eloquent arguments to the contrary, it is a trite fact that patents remain an impediment to access to medicines by encouraging monopoly prices. The WTO TRIPS Agreement gives members room to legislate in a manner that is sympathetic to access to affordable medicines by providing for exceptions to patentability and the use of patents without the authorisation of the patent holder (TRIPS flexibilities). This study focuses on access to medicines under the TRIPS Agreement from a SADC comparative perspective by interrogating the extent of the domestication of TRIPS provisions promoting access to medicines in the SADC region with specific reference to Botswana, South Africa and Zimbabwe. After establishing that all SADC members, including Seychelles which is yet to be a WTO member have intellectual property (IP) laws in their statute books, this study confirms that while most of the IP provisions may be used to override patents, they are currently not being used by SADC members due to non-IP reasons such as lack of knowledge and political will. The study also engages in comparative discussions of topical occurrences in the context of access to medicines litigation in India, Thailand and Kenya and extracts useful thematic lessons for the SADC region. The study’s overall approach is to extract useful lessons for regional access to medicines from the good experiences of SADC members and other developing country jurisdictions in the context of a south-south bias. The study draws conclusions and recommendations which if implemented will in all likelihood lead to improved access to medicines for SADC citizens, while at the same time respecting the sanctity of patent rights. The study recommends the adoption of a rights-based approach, which will ultimately elevate patient rights over patent rights and urges the region to consider using its LDCs status to issue compulsory licences in the context of TRIPS Article 31 bis while exploring the possibility of local pharmaceutical manufacturing to produce generics, inspired by the experiences of Zimbabwe and current goings on in Mozambique and the use of pooled procurement for the region. The study embraces the rewards theory of patents which should be used to spur innovation and research into diseases of the poor in the SADC region. Civil society activity in the region is also identified as a potential vehicle to drive the move towards access to affordable medicines for all in the SADC region. / Mercantile Law / LL.D.

Despite the adoption of the Doha Declaration on the TRIPS Agreement and Public Health in 2001, which unequivocally affirmed WTO members’ rights to use compulsory licences and other TRIPS flexibilities to access medicines, thirteen years on, developing countries and least developed countries are still grappling with access to medicines issues and a high disease burden. Despite some well researched and eloquent arguments to the contrary, it is a trite fact that patents remain an impediment to access to medicines by encouraging monopoly prices. The WTO TRIPS Agreement gives members room to legislate in a manner that is sympathetic to access to affordable medicines by providing for exceptions to patentability and the use of patents without the authorisation of the patent holder (TRIPS flexibilities). This study focuses on access to medicines under the TRIPS Agreement from a SADC comparative perspective by interrogating the extent of the domestication of TRIPS provisions promoting access to medicines in the SADC region with specific reference to Botswana, South Africa and Zimbabwe. After establishing that all SADC members, including Seychelles which is yet to be a WTO member have intellectual property (IP) laws in their statute books, this study confirms that while most of the IP provisions may be used to override patents, they are currently not being used by SADC members due to non-IP reasons such as lack of knowledge and political will. The study also engages in comparative discussions of topical occurrences in the context of access to medicines litigation in India, Thailand and Kenya and extracts useful thematic lessons for the SADC region. The study’s overall approach is to extract useful lessons for regional access to medicines from the good experiences of SADC members and other developing country jurisdictions in the context of a south-south bias. The study draws conclusions and recommendations which if implemented will in all likelihood lead to improved access to medicines for SADC citizens, while at the same time respecting the sanctity of patent rights. The study recommends the adoption of a rights-based approach, which will ultimately elevate patient rights over patent rights and urges the region to consider using its LDCs status to issue compulsory licences in the context of TRIPS Article 31 bis while exploring the possibility of local pharmaceutical manufacturing to produce generics, inspired by the experiences of Zimbabwe and current goings on in Mozambique and the use of pooled procurement for the region. The study embraces the rewards theory of patents which should be used to spur innovation and research into diseases of the poor in the SADC region. Civil society activity in the region is also identified as a potential vehicle to drive the move towards access to affordable medicines for all in the SADC region. / Mercantile Law / LL.D.

In 2001 the Declaration on the TRIPS Agreement and Public Health (‘Doha Declaration’), affirmed the right of member states of the World Trade Organisation (‘WTO’) to interpret and implement the TRIPS Agreement as supportive of the protection of public health and, in particular, access to medicines. While initially well-received, consternation soon arose over the interpretation of a specific paragraph in the Doha Declaration dealing with compulsory licensing. After a further two years of deliberation, the WTO Decision on the Interpretation of Paragraph 6 (‘Paragraph-6 Decision’) was announced in August 2003 specifying when countries can import drugs produced elsewhere under compulsory licence. With one third of the world's population is still denied access to essential medicines - a figure which rises to over 50 per cent in Asia and Africa - the problems facing the public health community are two-fold. The first is the capacity of developing countries (‘DCs’) actually to use the flexibilities afforded under the TRIPS Agreement, the Doha Declaration, and the Paragraph- 6 Decision amid stark inequalities in health resources and the world trading system as a whole. These include provisions for compulsory licensing, parallel importation, and addressing imbalances in research and development (‘R&D’). The pending ratification of the Paragraph-6 Decision, from an interim solution to a permanent amendment, is accompanied by considerable uncertainty: will the protections be accessible under the system currently proposed? The second problem concerns the undermining of the above hard-won flexibilities by provisions adopted under various bilateral and regional trade agreements. Known as ‘TRIPS-plus’- or ‘WTO-plus’- measures, the level of intellectual property rights (‘IPRs’) rights protection being negotiated and even adopted under other trade agreements are more restrictive as regards public health protection. These two sources of concern have led to an increase in rather than a lessening of tensions between the public health and trade policy communities. The thesis opens with a brief analysis of the interplay between patents and medicines. This includes an overview of the human rights framework and the right of access to medicines as a manifestation of human rights. The historical development of the TRIPS Agreement, its legitimacy, and the effect of the introduction of patents for pharmaceuticals are critically analysed. The terms of the Doha Declaration as it relates to public health, the Paragraph-6 Decision and its system, the December 2005 Amendment, and the progress made to date on the public health protections available under the TRIPS Agreement are reviewed and discussed in detail. The thesis describes how, despite these important clarifications, concerns as to the capacity of DCs to implement specific measures persist. This thesis further addresses the development of compulsory licensing in India and South Africa, and the legal framework for compulsory licensing in these countries. The role of competition law and constraints faced by DCs in implementing the flexibilities offered by the TRIPS Agreement and Doha Declaration are considered before turning to the threat posed by TRIPS-plus measures and calls for their critical reassessment. The thesis considers the role of the Intergovernmental Working Group on Public Health, Innovation and Intellectual Property (IGWG), the WHO Commission on IPRs, Innovation and Public Health (CIPIH), Patent Pools, and international and multilateral donors in access to medicines. The thesis concludes by reviewing potential ways forward to ensure that access to medicines by the poor living in DCs is secured in all trade agreements. / Mercantile Law / LL.D.

In 2001 the Declaration on the TRIPS Agreement and Public Health (‘Doha Declaration’), affirmed the right of member states of the World Trade Organisation (‘WTO’) to interpret and implement the TRIPS Agreement as supportive of the protection of public health and, in particular, access to medicines. While initially well-received, consternation soon arose over the interpretation of a specific paragraph in the Doha Declaration dealing with compulsory licensing. After a further two years of deliberation, the WTO Decision on the Interpretation of Paragraph 6 (‘Paragraph-6 Decision’) was announced in August 2003 specifying when countries can import drugs produced elsewhere under compulsory licence. With one third of the world's population is still denied access to essential medicines - a figure which rises to over 50 per cent in Asia and Africa - the problems facing the public health community are two-fold. The first is the capacity of developing countries (‘DCs’) actually to use the flexibilities afforded under the TRIPS Agreement, the Doha Declaration, and the Paragraph- 6 Decision amid stark inequalities in health resources and the world trading system as a whole. These include provisions for compulsory licensing, parallel importation, and addressing imbalances in research and development (‘R&D’). The pending ratification of the Paragraph-6 Decision, from an interim solution to a permanent amendment, is accompanied by considerable uncertainty: will the protections be accessible under the system currently proposed? The second problem concerns the undermining of the above hard-won flexibilities by provisions adopted under various bilateral and regional trade agreements. Known as ‘TRIPS-plus’- or ‘WTO-plus’- measures, the level of intellectual property rights (‘IPRs’) rights protection being negotiated and even adopted under other trade agreements are more restrictive as regards public health protection. These two sources of concern have led to an increase in rather than a lessening of tensions between the public health and trade policy communities. The thesis opens with a brief analysis of the interplay between patents and medicines. This includes an overview of the human rights framework and the right of access to medicines as a manifestation of human rights. The historical development of the TRIPS Agreement, its legitimacy, and the effect of the introduction of patents for pharmaceuticals are critically analysed. The terms of the Doha Declaration as it relates to public health, the Paragraph-6 Decision and its system, the December 2005 Amendment, and the progress made to date on the public health protections available under the TRIPS Agreement are reviewed and discussed in detail. The thesis describes how, despite these important clarifications, concerns as to the capacity of DCs to implement specific measures persist. This thesis further addresses the development of compulsory licensing in India and South Africa, and the legal framework for compulsory licensing in these countries. The role of competition law and constraints faced by DCs in implementing the flexibilities offered by the TRIPS Agreement and Doha Declaration are considered before turning to the threat posed by TRIPS-plus measures and calls for their critical reassessment. The thesis considers the role of the Intergovernmental Working Group on Public Health, Innovation and Intellectual Property (IGWG), the WHO Commission on IPRs, Innovation and Public Health (CIPIH), Patent Pools, and international and multilateral donors in access to medicines. The thesis concludes by reviewing potential ways forward to ensure that access to medicines by the poor living in DCs is secured in all trade agreements. / Mercantile Law / LL.D.