O presente trabalho objetivou a formataÃÃo de uma metodologia de elaboraÃÃo de base de informaÃÃes para alocaÃÃo negociada de Ãgua visando subsidiar as decisÃes dos comitÃs de bacias e das comissÃes gestoras nas operaÃÃes dos reservatÃrios monitorados pela Companhia de GestÃo dos Recursos HÃdricos â COGERH. O AÃude Arneiroz II, localizado na bacia hidrogrÃfica do Alto Jaguaribe, no municÃpio de Arneiroz, estado do CearÃ, responsÃvel por perenizar 113 km do rio Jaguaribe, atà a sede da cidade de JucÃs, foi o reservatÃrio identificado para realizaÃÃo da supracitada pesquisa, por possuir uma complexa dinÃmica de perenizaÃÃo. A metodologia para elaboraÃÃo da base de informaÃÃes iniciou-se da validaÃÃo das informaÃÃes de oferta e demanda do sistema que compreende o AÃude Arneiroz II, dados do manancial e dos estudos de perda em transito ao longo do percurso perenizado. Assim, concluiu-se que, para este estudo de caso, o cenÃrio para o transporte de Ãgua que atende as demandas existentes de forma satisfatÃria e eficiente, se dà por meio de dutos abertos ou fechados, e nÃo pela perenizaÃÃo direta do rio Jaguaribe atà a cidade de JucÃs. O cenÃrio de perenizaÃÃo apresenta como prejuÃzo a diminuiÃÃo da garantia da oferta de Ãgua em pelo menos trÃs anos de seca extrema, enquanto que as perdas em trÃnsito representam 79% da vazÃo mÃdia liberada pela vÃlvula do AÃude Arneiroz II numa operaÃÃo anual de perenizaÃÃo. / This study aimed to formatting a methodology for development of information base for negotiated allocation of water in order to support the decisions of watershed committees and management committees in the operations of reservoirs monitored by the Company Management of Water Resources - COGERH. The weir Arneiroz II, located in the basin of Alto Jaguaribe in Arneiroz municipality, state of CearÃ, responsible for evergreening 113 km Jaguaribe river to the headquarters city JucÃs, the reservoir was identified for conducting the above research, by have a complex dynamic of evergreening. The methodology for compiling the information base began validation of information supply and demand system comprising Weir Arneiroz II, data source and loss studies in perennial traffic along the route. Thus, it was concluded that, for this case study, the scenario for the transport of water that meets existing demands satisfactorily and efficiently, is by means of open or closed ducts, and not by direct perpetuation Jaguaribe river to the city of JucÃs. The scenario presents evergreening as losses decreased guarantee the supply of water for at least three years of extreme drought, while the losses in transit represent 79 % of the average flow rate released by the weir Arneiroz II valve on an annual operation evergreening.

This paper attempts to estimate the change in sales associated with pharmaceutical patent expiration. Using data from the Medical Expenditure Panel Survey and patent expiration information from historical Orange Book publications, I estimated monthly sales associated with choice pharmaceutical patents. I then used a fixed-effects model to estimate the average change in sales before and after initial patent expiration, controlling for patent extension factors. My findings support that pharmaceutical patent expiration results in a statistically significant drop in sales by 38% on average within this sample, and further, that patent extensions had a negligible effect on this relationship. The question of patent expiration’s effect on sale is economically important for the sake of evaluating the efficacy of pharmaceutical patent law in protecting the interests of brand-name and generic drug manufacturers as well as paying consumers.

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.