This study evaluated the benefits and the problems of implementing the World Trade Organization's decision on the implementation of Paragraph 6 of the Doha Declaration by developing country members.

This study evaluated the benefits and the problems of implementing the World Trade Organization's decision on the implementation of Paragraph 6 of the Doha Declaration by developing country members.

Magister Legum - LLM / This study evaluated the benefits and the problems of implementing the World Trade Organization's decision on the implementation of Paragraph 6 of the Doha Declaration by developing country members. / South Africa

Thesis (MA)--Stellenbosch University, 2005. / ENGLISH ABSTRACT: This thesis is an explanatory study into civil society's increased influence in global governance. More specifically this situation is examined by looking at the generic medicine debate that came in the wake of the passing of the Medicines and Related Substances Act by the South African government in 1997. This debate gained worldwide attention and touched some of the prevailing inequalities between the developed world and the developing world in our globalised society. The research question that is addressed here is to what extent did civil society influence the signing of the Doha Declaration of the TRIPS Agreement and Public Health by the members of the World Trade Organisation (WTO) in 2001? In doing so, this thesis looks at the role of the US government, the South African government, the pharmaceutical industry, the WTO's TRIPS Agreement and civil society in the form of nongovernmental organisations like Treatment Action Campaign (TAC), Oxfam and Medecines Sans Frontieres (MSF). The study applies a constructivist approach in order to analyse how civil society used global advocacy networks to inform and communicate the normative concerns regarding South Africa and developing countries' lack of access to HIVand AIDS drugs. Moreover, it examines how civil society's use of moral authority challenged the regulative power of the WTO. The study concludes that civil society played a vital role in influencing the WTO member states' decision to sign the Doha Declaration on the TRIPS Agreement and Public Health. However, it was not only civil society's ability to set the agenda concerning the HIV/AIDS pandemic, but also the content of the normative concerns themselves that help explain its success. Consequently, the study further concludes that civil society's success in this specific case must be seen in light of its growing influence in challenging global governance. / AFRIKAANSE OPSOMMING: Hierdie tesis is 'n verduidelikende studie van die burgerlike samelewing se groeiende invloed in globale regering. Hierdie situasie word meer spesifiek ondersoek deur te kyk na die generiese medisyne debat wat gevoer is na die Suid-Afrikaanse Regering die Medisyne en Verwante Stowwe Wet van 1997 goedgekeur het. Hierdie debat het wêreldwye aandag geniet en het geraak aan sommige van die bestaande ongelykhede wat daar heers tussen die ontwikkelde en ontwikkelende wêreld in die geglobaliseerde samelewing. Die navorsingsvraag wat hier aangespreek word is tot watter mate die burgerlike samelewing die ondertekening van die Doha Verklaring van die TRIPS Ooreenkoms en Publieke Gesondheid deur lede van die Wêreld Handelsorganisasie (WHO) in 2001 beïnvloed het. Deur dit te doen, sal hierdie tesis kyk na die rol van die Amerikaanse regering, die Suid- Afrikaanse regering, die farmaseutiese bedryf, die WHO se TRIPS Ooreenkoms en die burgerlike samelewing in die vorm van nie-regerings organisasies soos die Treatment Action Campaign (TAC), Oxfam en Medecines Sans Frontieres (MSF). Die studie maak gebruik van 'n konstruktiwistiese benadering om 'n analise te doen van hoe die burgerlike samelewing globale ondersteunings netwerke gebruik het om die normatiewe besorgdhede wat heers oor die tekorte in Suid-Afrika en die ontwikkelende lande ten opsigte van toegang tot MIV en VIGS medisyne, toe te lig en te verkondig. Verder ondersoek die studie hoe die gebruik deur die burgerlike samelewing van morele gesag die regulerende mag van die WHO uitgedaag het. Die studie kom tot die gevolgtrekking dat die bugerlike samelewing 'n uiters belangrike rol gespeel het in die WHO lidlande se besluit om die Doha Verklaring van die TRIPS Ooreenkoms en Publieke Gesondheid te onderteken. Dit was egter nie net die burgerlike samelewing se vermoë om die agenda daar te stel ten opsigte van die MIV/VIGS pandemie nie, maar ook die inhoud van die normatiewe besorgdhede self wat bygedra het om hierdie sukses te verduidelik. Gevolglik kom die studie tot die verdere gevolgtrekking dat die burgerlike samelewing se sukses in hierdie spesifieke geval gesien kan word in die lig van sy groeiende invloed in die uitdaging van globale mag en gesag.

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.

「被忽視」的熱帶疾病(NTDs)中的寄生蟲疾病(Parasitic Diseases; PDs)除對非洲人群健康之危害甚鉅外，並進而對非洲地區社經體系造成嚴重衝擊與造成巨大的「失能調整人年」損失。由於不易取得治療PDs傳統基本藥物的問題，許多非洲民眾便以其部落社區的傳統治療師所採用的傳統草藥來進行PDs的治療，雖然這些傳統草藥容易取得，但是成分的內容和藥效品質甚或產生嚴重的致命副作用。雖然TRIPS協定第31條和杜哈宣言的第五和第六段對於製藥能力不足或大部分皆無製藥能力的貧窮國家，可以基於「國家緊急危難或其它緊急狀況」的事由，以強制授權方式取得專利藥或較便宜的學名藥以解決造成國家危難的特定公共健康事件，但是國際大藥廠認為無利可圖，不願意花費資金投注於預防或治療此類疾病藥物的相關研發外，高收入的國家為保護其大藥廠的藥物專利，也往往使用一些經濟制裁手段逼迫上述國家就制定國內專利法以保護其藥物專利。雖然經杜哈宣言修正TRIPS協定第31(f)條有關強制授權對外出口的障礙，但是出口國對於強制授權程序與是否能取得政治上和藥廠業者的支持，仍充滿困難。應用「專利池」可以減少交易成本或法律爭議而可調和「強制授權」與解決「權利耗盡」的爭議，有助於解決非洲開發中國家取得專利藥物的困境。PDs造成非洲開發中國家民眾失能等長期痛苦與健康生活損失，類推適用SARS模式，可依TRIPS協定第31條(b)與杜哈宣言第五段(c)將之視為「造成國家緊急危難或其它緊急狀況」的重大公共健康的事由而可行使強制授權。雖然「生醫專利池BVGH」的「非獨家個別授權與免授權費」的操作模式與傳統電信技術專利池不盡相同，但因藥廠不願投入治療PDs的傳統基本藥物存在的副作用與抗藥性的新藥研發，為鼓勵對治療PDs的藥物進行創新研發， BVGH彈性的授權方式與免繳交授權費，將有利於解決開發中國家未來取得新專利藥的困境。除BVGH外，建議結合全球獎勵基金以「激勵拉拔」的方式獎助願意投入治療PDs新藥研發並將專利自願授權給BVGH的藥廠。鑒於全球暖化與最近中東難民潮大量湧進歐洲，罕見的PDs可預期會大量傳播開來，將嚴重衝擊歐洲等先進國家良好的公共衛生體系，而使得「NTDs尤其是PDs不再只是專屬於貧窮國家的疾病，亦將常現於富有的先進國家」。這些NTDs疾病將提供藥廠進行新藥研發的利基，然而在未來可能產生專利池的反競爭問題，導致支配市場獨占性的隱憂值得關注。 / Parasitic diseases (PDs) not only cause the huge health hazards to African populations, but also they further severely impact on African socio-economic system as resulting in huge economic and health losses as assessed by disability adjusted life-years. Since it is not easy for Africans to access the essential medicine to treat PDs, many of them will seek for the help of local healers in tribal communities to treat PDs. Although these traditional herbs are readily available, the content and quality of drug ingredients may even cause serious fatal side effects. Poor countries with insufficiencies or lacks of the pharmaceutical capacities may still access the patented medicines or cheaper generics to solve the national crisis caused by the specific public health events through compulsory licensing (CL) based on "national emergency or the other emergency situations" according to TRIPS Article 31 and Doha Declaration on the fifth and sixth paragraph due to that the large international pharmaceutical companies consider unprofitable, unwilling to spend money to invest on the research and development (R&D) of new drugs for prevention or treatment purpose. Moreover, the high-income countries also tend to exert some of the economic sanctions to force those poor countries to enact national patent law in order to protect drug patents. Furthermore, the mandatory obstacle of exportation authorized by CL from the amended TRIPS Agreement Article 31 (f) by the Doha Declaration has been improved; nevertheless, it is still fraught with difficulties in utilization of CL for the exporting countries because this should be dependent on whether they may actually get the supports from political and the pharmaceutical industry. Application of patent pools model may benefit to reduce transaction costs or legal dispute thus reconciling and resolving issues related to CL as well as doctrine of patent exhaustion and that it is beneficial to help solve dilemma for African countries to access patented drugs. Because Africans severely suffer from disabled caused by PDs thus leading to long-term pain and health life losses, African countries can grant CL as PDs may be regarded as national crisis like SARS causing "national emergency or the other emergency situations" as authorized from TRIPS Agreement Article 31 (f) and Doha Declaration paragraph 5 (c). Although the practice of individual licensing with royalty-free for BVGH is somewhat different from that of traditional patent pools, this licensing practice mode is beneficial to innovation in new drugs R&D to improve the side effects and drug-resistance of traditional essential medicines and help African countries to access patented new drugs in the future. Finally, it is recommended to cooperate with Award Foundation to encourage incentive for pharmaceutical companies which contribute most to new drugs R&D and voluntary licensing to BVGH. Owing to global warming and recent emergence of huge refugees into Europe rare PDs will be obviously spread out thus causing severe impacts on well-established public health system as leading to emergence of PDs in developed countries like Europe. Altogether, such situations definitely provide a good incentive in new drugs R&D for pharmaceutical companies; however, it guarantees concerns on anti-competitive and monopoly issues derived by biomedical pools in the future.

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.