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Compulsory patent licensing and access to essential medicines in developing countries after the Doha DeclarationAdesola, Eniola Olufemi 09 July 2015 (has links)
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.
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Compulsory patent licensing and access to essential medicines in developing countries after the Doha DeclarationAdesola, Eniola Olufemi 09 July 2015 (has links)
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.
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Bioprospecting and intellectual property rights on African plant commons and knowledge: a new form of colonization viewed from an ethical perspectiveLenkabula, Puleng 09 1900 (has links)
This study engages in an ethical examination of contemporary socio-ecological and economic issues which takes seriously the plight of Africa, African communities, indigenous knowledge and biodiversity. It studies the impact of bioprospecting, biopiracy and intellectual property rights regimes on the protection, use, access to, and conservation of biodiversity and indigenous knowledge in Africa. The study also examines the ways in which northern multinational pharmaceutical and biotechnology companies and their agents prospect and convert African resources (biological commons and indigenous knowledge) into their intellectual property as well as private property. It argues that the transfer of African biological commons and indigenous knowledge is exacerbated by economic globalisation and the neo-colonial mentality of conquest concealed under the guise of commerce.
The study demonstrates through concrete case studies the tactics used by northern multinational corporations to claim these resources as their intellectual property rights and private property. It observes that the privatisation of biological commons and indigenous knowledge only brings about nominal or no benefits to African communities who have nurtured and continue to nurture them. It also observes that this privatisation results in fewer benefits for biodiversity as they lead to the promotion of monoculture, i.e. commercialisation of all things. To address the injustice and exploitative implications of bioprospecting, biopiracy and intellectual property rights, the study recommends the adoption and implementation of the African model law, the establishment of defensive intellectual property rights mechanisms, and the strategy of resistance and advocacy. It suggests that these measures ought to be grounded on the African normative principle of botho and the Christian ethical principle of justice. / Systematic Theology and Theological Ethics / D.Th.(Theological Ethics)
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Opening Pandora's Box : Exploring Flexibilities and Alternatives for Protecting Traditional Knowledge and Genetic Resources under the Intellectual Property FrameworkPapadopoulou, Frantzeska January 2014 (has links)
What happens when resources get valuable and scarce? How is Intellectual Property dealing with market failures related to sub-patentable innovation or purely traditional knowledge with interesting applications? The protection of traditional knowledge and genetic resources (TKGR) has been one of the major modern challenges in international IP law. The entry into force of the Convention on Biological Diversity (CBD) and its implementation in national legislation has created more questions than the ones it answered. The objective of this dissertation is to assist in the evaluation of current national and regional implementation initiatives as well in the presentation and evaluation of different forms of entitlements that could be applicable in the case of TKGR. The dissertation has employed a theoretical framework for this evaluation, by combining the Coase Theorem and Rawls' theory of justice. The choice of these two theoretical models is not a random one. In order for the entitlement covering TKGR to be successful, it has to be efficient. It has to offer a stable and efficient marketplace where access to TKGR is possible without unnecessary frictions. However, efficiency could not be the only objective. An entitlement focusing solely on efficiency would fall short of the needs and special considerations of TKGR trade. It would above all be counter to the objectives and major principles of the CBD, the “fair and equitable sharing of the benefits” and would certainly fail to address the very important North-South perspective. Fairness is thus a necessary complement to the efficiency of the proposed entitlement. This dissertation proposes a thorough investigation of the special characteristics, of right-holders, subject-matter, market place as well as of the general expectations that an entitlement is supposed to fulfill. In parallel to that, it looks into the meaning and scope of alternative entitlements in order to be able to propose the best alternative.
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Patents versus patients : global governance and the role of civil society in South Africa's quest for affordable drugsKarlsbakk, A. 12 1900 (has links)
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.
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Drempellewens : die uitbeelding van bewussyn in vyf debuutromans (tesis) en Hanna in die park (roman)Carstens, Hester 03 1900 (has links)
Thesis (MA (Afrikaans and Dutch))—University of Stellenbosch, 2007. / Two separate texts are submitted towards the degree MA in Kreatiewe Afrikaanse Skryfkunde. Firstly, a thesis with the title ‘Drempellewens: die uitbeelding van bewussyn in vyf debuutromans’, and secondly a novel called Hanna in die park. The novel and the thesis are thematically related.
The focus of the thesis is the portrayal of the consciousness of protagonists who, because of their age and situation, may be considered ‘threshold characters’. The question that is posed is the following: what kind of narrator and what narratological strategies can best express the unfixed nature of the protagonist in a so-called ‘coming of age’-novel? To examine this issue, theoretical tools are taken from mainly two sources: the work of anthropologists Arnold van Gennep and Victor W. Turner about the liminal phase in rites of passage, and Dorrit Cohn’s theories about the depiction of consciousness, as set out in her book, Transparent Minds (1983). Five debut novels are discussed using these concepts. They are Die Ryk van die Rawe (Jaco Fouché), Annerkant die Longdrop (Anoeschka von Meck), trips (Manie de Waal), Less than Zero (Bret Easton Ellis) and You Shall Know Our Velocity! (Dave Eggers). The liminal characteristics of the protagonists and their situations are discussed. Using Cohn’s three modes of narration, namely psychonarration, narrated monologue and quoted monologue, a discussion follows of what effect the kind of narrator and narratological modes has on the convincing and striking portrayal of a liminal character’s consciousness. The conclusion is reached that a narrator who is also in some kind of liminal position, or who experiences a threshold-consciousness, is most effective in the portrayal of the nature of liminality.
The novel is about a young woman, Hanna Moolman, who is having trouble with the requirements of becoming adult. She works as a waitress in Stellenbosch and leads a somewhat lonely, frustrated life. Her relationship with especially her mother and her younger sister is strained. When her sister, a beautician in training, becomes pregnant, old sibling rivalries and family secrets are brought to the fore. During the crisis of her sister’s pregnancy, there are also various other influences on Hanna’s state of mind; among others, her part-time job as a researcher for an old lady who is writing about the domestic history of the Afrikaner woman, an impudent graffiti artist who seems to be watching Hanna, and a client at the restaurant where she works who leaves her mysterious notes.
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Improvement of global access to life-saving medicines : facing the futureVersteynen, Leo January 2010 (has links)
This research, with the main focus on HIV/AIDS, tuberculosis and malaria, was based on data from the literature, and on questionnaire and interview surveys with the main stakeholders: authorities, drug-developers and NGOs/foundations. It revealed the following determinants, which contributed to the occurrence of drug pricing conflicts in Brazil, Thailand and South Africa: governmental constitutional commitments to supply medicines to poor people, the existence of a local pharmaceutical industry capable of producing generic versions of patented medicines and long histories of disease treatment programmes. The research documented the preferred approaches to increase global access to life-saving medicines for the next decade, which were found to be: public-private-partnerships, prevention measures, dedication of >0.5% of GNP to poor countries, and improvement of national healthcare/insurance systems. Those approaches were integrated into a conceptual framework, which could enable country-level organizations to move beyond the conflict mentality via a 'Public-Private-Partnership for gradual Self-Sufficiency and Sustainability Model,' (P3S3). Within this framework, rich countries should invest >0.5% of their GNP to help to alleviate poverty in poor countries. With these funds, national governments should implement programmes to expand implementation of disease prevention measures and improve national - 4 - healthcare/insurance systems and the quality of the medicines involved. Public-private-partnerships should act as 'steering-and-controlling' organizations to guide the process and to minimise corruption. As a positive message to all who currently lack access to these medicines, the thesis author's conclusion is that the use of this model could help to turn the current unsustainable development policies into sustainable ones, and as a consequence, it would contribute to improvements in the quality of life of millions of people in poor countries.
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Valorisation économique de la propriété industrielle : cas de l'industrie pharmaceutique en tunisie / Economic valuation of industrial property : tunisian pharmaceutical caseBen gamra, Seima 14 January 2011 (has links)
La présente recherche vise à comprendre le processus ou le mécanisme de valorisation de la propriété industrielle aussi bien dans les pays développés que dans les pays en développement suite à la conclusion de l’accord historique ADPIC.L’analyse de données factuelles se rapportant à la protection de la propriété industrielle pharmaceutique en Tunisie nous oriente vers une modélisation possible de l’industrie pharmaceutique tunisienne.La recherche identifie deux voies ou stratégies d’exploitation des brevets : « license in » ou « license out ». Cependant, c’est le dépôt de brevet par les nationaux résidents qui fait défaut en Tunisie dans le domaine pharmaceutique, dominé par les biotechnologies à l’échelle mondiale.Le rapprochement des industries locales avec des partenaires scientifiques internationaux pourrait être une voie possible de valorisation. / We aim in this research to study how to assess the value of a patent in developed countries as well as in emerging ones, mainly according to the TRIPS.Modelization of the pharmaceutical industry in Tunisia has been possible when analyzing data evidence from pharmaceuticals patents in Tunisia.This research identify two strategies to capitalize on patents: « license in » ou « license out ».However, only few local industries in Tunisia are willing to file patents, even ifbiotechnologies dominate global pharmaceutical market.Being in touch with international scientific partners, signing contracts could help to valorize industrial property in Tunisia.
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The liability of internet intermediariesRiordan, Jaani January 2013 (has links)
Internet intermediaries facilitate a wide range of conduct using services supplied over the layered architecture of modern communications networks. Members of this class include search engines, social networks, internet service providers, website operators, hosts, and payment gateways, which together exert a critical and growing influence upon national and global economies, governments and cultures. This research examines who should face legal responsibility when wrongdoers utilise these services tortiously to cause harm to others. It has three parts. Part 1 seeks to understand the nature of an intermediary and how its liability differs from the liability of primary defendants. It classifies intermediaries according to a new layered, functional taxonomy and argues that many instances of secondary liability in English private law reflect shared features and underlying policies, including optimal loss-avoidance and derivative liability premised on an assumption of responsibility. Part 2 analyses intermediaries’ monetary liability for secondary wrongdoing in two areas of English law: defamation and copyright. It traces the historical evolution of these doctrines at successive junctures in communications technology, before identifying and defending limits on that liability which derive from three main sources: (i) in-built limits contained in definitions of secondary wrongdoing; (ii) European safe harbours and general limits on remedies; and (iii) statutory defences and exceptions. Part 3 examines intermediaries’ non-monetary liability, in particular their obligations to disclose information about alleged primary wrongdoers and to cease facilitating wrongdoing where it is necessary and proportionate to do so. It proposes a new suite of non-facilitation remedies designed to restrict access to tortious internet materials, remove such materials from search engines, and reduce the profitability of wrongdoing. It concludes with several recommendations to improve the effectiveness and proportionality of remedies by reference to considerations of architecture, anonymity, efficient procedures, and fundamental rights.
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Environnement bâti et transport actif scolaire : le cas des écoles de proximité de la région de MontréalFortin-Lacasse, Katerine 12 1900 (has links)
But
La diminution du transport actif scolaire est une problématique préoccupante dont les déterminants sont encore mal connus. Nous nous sommes donc penchée sur la question suivante : Quelle est la contribution de l’environnement bâti pour le choix d’un mode de transport actif pour les déplacements scolaires des enfants demeurant à proximité de leur école ?
Méthodologie
Pour répondre à cette question, nous nous sommes basée sur le cadre conceptuel de Tracy McMillan. Nous avons caractérisé le voisinage de trois écoles en milieu urbain et de trois écoles en milieu suburbain de la région de Montréal. Également, nous avons analysé les données du Groupe de recherche Ville et mobilité concernant les comportements des enfants ainsi que les comportements et perceptions des parents.
Résultats
Quatre des cas à l’étude se démarquent en raison de leur forte proportion de transport actif scolaire, soit les trois milieux urbains et un milieu suburbain. Les points communs de ces quatre cas sont la perméabilité du réseau viaire pour les piétons et les cyclistes et la perception favorable des parents vis-à-vis le transport actif scolaire.
Conclusion
Les environnements suburbains génèrent des comportements de transport actif uniquement chez les enfants alors que les environnements urbains génèrent systématiquement des comportements de transport actif chez les adultes et les enfants. Ce faisant, nous pouvons penser que les caractéristiques de l’environnement bâti des milieux urbains influencent les perceptions et les comportements des parents en faveur du transport actif scolaire. / Purpose
The proportion of children actively commuting to school has decreased significantly but few studies have investigated factors that might affect school mobility. This research examines the influence of a wide range of factors (such as urban form characteristics, parent’s travel behaviours and parental perceptions) on school travel behaviour for children who live near school.
Methods
The Tracy McMillan’s conceptual framework of an elementary-aged child’s trip to school was used. We objectively measured environmental attributes of three urban neighbourhoods and three suburban neighbourhoods in Montreal metropolitan area. Data of the Groupe de recherche Ville et mobilité regarding children trips to school, parental perceptions and parents’ travel behaviours were analysed.
Results
A high proportion of children are actively commuting to school in the three urban neighbourhoods and in one suburban neighbourhood. Connectivity for pedestrians and cyclists and positive parental perception of school active transportation are positively associated with high proportion of walking and biking to school in these four neighbourhoods.
Conclusion
Suburban neighbourhoods support active transportation only for children whereas urban neighbourhoods support active transportation for children and parents. Attributes of built environment in urban neighbourhoods seem to have a positive effect on parental perceptions and behaviours regarding walking and biking for school trips.
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