M.A. / Any organization or structure over time has a historical background, a reason for existence, and an objective. In this sense PAGAD is no exception. The aim of the following discussion is to place the establishment of PAGAD within a broader historical and ideological context. This section will be discussed under the following headings: Broad historical context. The objective of this heading is to state clearly that the establishment of PAGAD was not an one time only decision taken by a few disillusioned members of the community in the Western Cape. Indications are that the establishment of anti-crime forums had been present since the 1950s, each with different members, but always with the same purpose and goals. The main objective of this section is to indicate to the reader that the establishment of PAGAD had had a historical development. Fight against crime as explanatory condition. On the basis of the above-mentioned historical development, this section will be focussing on the socio-economical conditions prevailing in the Western Cape, in order to explain the development of so-called popular justice organizations. Ideological context of the rise of People Against Gangsterism and Drugs. The name of the organization already puts it against the background of tenn "popular justice". This section will attempt to put PAGAD in the framework of Muslim politics in the Western Cape. Division in PAGAD. This section will be focussing on the split in PAGAD during September 1996, on the ground of the ideological divisions in the Muslim community in the Western Cape. Although the split in the ranks of PAGAD occurred very early in the existence of the organization, it is very important to take notice of it, as the split was a result of the manifestation of ideological differences. There will be continuous reference to the said split in the cause of this case study as it altered PAGAD's objectives as well as its modus operandi. Relationship between PAGAD and Qibla and the strategy and objectives of Qibla. The objective of this section is to look into Qibla as such and to study Qibla's alleged role in the actions of PAGAD. Discussion on the aforementioned should not be seen as isolated from each other, but that it should be interpreted as a totality.

This project will evaluate California's narcotic registration program to determine whether or not the intent and the purpose established in the legislation is being met.

Thesis (S.M.)--Harvard-MIT Division of Health Sciences and Technology; and, (S.M.)--Massachusetts Institute of Technology, Engineering Systems Division, Technology and Policy Program, 2004. / Includes bibliographical references (p. 59-61). / Published findings report that it takes approximately eight years to bring a novel drug to market at an average cost of $800 million. Over the last ten years, the Food and Drug Administration (FDA) has helped to reduce the time from filing a new drug application (NDA) to granting marketing approval (i.e. the approval phase). However, there has been no alteration in the time required to progress from an investigational new drug application (IND) to an NDA filing (i.e. the clinical phase) over this same period. Since approval times began to decrease upon the initiation of the Prescription Drug User Fee Act (PDUFA), in this thesis I analyze the impact of PDUFA and calculate its benefits to companies. Due to the importance of getting new drugs to the market faster, I also investigate why there has been no significant change in the time required to test a drug clinically, and attempt to identify steps that could be taken to improve the clinical trial process. To investigate this, I evaluated ways in which the FDA and industry can work together to reduce clinical development times, without compromising safety. The results from this study show that PDUFA has had a significant impact on reducing approval times. More importantly, I determined that the direct costs of PDUFA are small in irmlparison to its benefits. In addition, my analysis of the early clinical phases (pre-clinical to Phase II) of drug benefits. In addition, my analysis of the early clinical phases (pre-clinical to Phase II) of drug development has revealed potential steps both the FDA and industry can take to facilitate a more efficient process for assessing the safety and efficacy of drugs. Thus, this study represents an important step towards improving the development of medicines for the world. / by Matthew W. Strobeck. / S.M.

In 1994, the members of the World Trade Organisation (WTO) adopted the Agreement on Trade-Related Aspects of Intellectual Property (the "TRIPs Agreement") and thus committed themselves to respect certain standards for intellectual property protection. This thesis studies the scope of the standards for patent protection and their impact upon trade in medicines. The first part addresses the international dimension of the issue and explains how international trade in medicines can contribute to enhancing the level of global welfare. The first chapter argues that in order to fulfil this latter objective legislation relating to patents must be adapted to the economic and social situation of countries. The second chapter demonstrates that such adaptation is not only allowed, but is indeed encouraged by the provisions of the TRIPS Agreement. The second part of this thesis addresses the issue from a Canadian perspective, and discusses the way Canadian patent provisions applying to pharmaceuticals should be drafted so as to allow Canada to participate in---and to benefit from---international trade in medicines. Thus, I first analyse the factual, political, and legislative factors that influence the Canadian pharmaceutical industry. I then study the role of Canada as part of the integrated market for medicines, as well as the social, industrial and economic objectives underlying Canadian policies. I finally propose some modifications and adaptations to the Canadian Patent Act and suggest some orientations for future multilateral negotiations.

No description available.

Looking primarily at the social and political trends in South Africa over the course of the last century and a half, this thesis explores how these trends have contributed to the establishment of the southern Africa cannabis complex. Through an examination of the influence which the colonial paradigm based on Social Darwinian thinking had on the understanding of the cannabis plant in southern Africa, it is argued that cannabis prohibition and apartheid laws rested on the same ideological foundation. This thesis goes on to argue that the dynamics of cannabis production and trade can be understood in terms of the interplay between the two themes of ‘prohibition’ and ‘resistance’. Prohibition is not only understood to refer to cannabis laws, but also to the proscription of inter-racial contact and segregation dictated by the apartheid regime. Resistance, then, refers to both resistance to apartheid and resistance to cannabis laws in this thesis. Including discussions on the hippie movement and development of the world trade, the anti-apartheid movement, the successful implementation of import substitution strategies in Europe and North America from the 1980’s, and South Africa’s incorporation into the global trade, this thesis illustrates how the apartheid system (and its collapse) influenced the region’s cannabis trade.

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.