This work develops a means to encourage states to take advantage of the flexibilities of compulsory licensing in the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) which promotes access to medicines in a public health emergency. In pursuing this solution, the precautionary approach (PA) and the structure of risk analysis have been adopted as a means to build a workable reading of TRIPS and to help states embody the flexibilities of intellectual property (IP). This work argues for a PA reading of TRIPS and that states have the precautionary entitlements to determine an appropriate level of health protection from the perspective of “State responsibility” in international law. A philosophical review is conducted followed by the examination of existing international legal instruments including the WTO Agreement on the Application of Sanitary and Phytosanitary Measures, the WHO International Health Regulations, the Codex Alimentarius, and the Cartagena Protocol on Biosafety. The PA has been found to have a pervasive influence on risk regulation in international law, yet the application is fraught with fragmentations in different legal regimes. In order to reach a harmonious interpretation and application of the PA in the WTO, the legal status of PAs of different WTO instruments have been analysed. Further, a comparative study on PAs in terms of legal status in the exemptions of the WTO and TRIPS obligations has been proposed. The political and moral basis for compulsory licencing in a public health emergency has been bolstered through the interpretation and the creation of legal status of the PA in WTO/TRIPS law.

Es ist kein Geheimnis, dass die Welt ein COVID-19-Impfstoffproblem hat. Die meisten Impfdosen wurden in Europa und Nordamerika verabreicht, während viele ärmere Landkreise weniger als 1 % ihrer Gesamtbevölkerung geimpft haben. Angesichts der neuen Varianten mit Gesundheitsrisiken haben Länder wie Südafrika und Indien vorgeschlagen, dass die Welthandelsorganisation vorübergehend auf geistige Eigentumsrechte für COVID-19-Impfstoffe verzichtet, um die Produktion von Impfstoffen zu steigern. Die Wirtschaftsmächte der Welt wie die USA, Großbritannien und die Europäische Union legten ihr Veto gegen die Idee ein und machten geltend, dass Rechte an geistigem Eigentum wichtig seien, um kontinuierliche Innovation zu gewährleisten. Sie sind der Meinung, dass ein Verzicht auf solche Rechte nicht zu einer Produktionssteigerung führen würde. Es stellt sich daher die Frage, ob dies nur zwei Möglichkeiten sind: Entweder bleiben Patente unverändert oder Patente werden nicht berücksichtigt. Eine Alternative und vielleicht ein Mittelweg ist die Zwangslizenzierung. Obwohl es eine scheinbar gute Option ist, bringt es seine eigenen Probleme mit sich. Patente sind beispielsweise territorial und gewähren dem Patentinhaber ein Monopol für eine begrenzte Zeit von 20 Jahren. Auf der Grundlage öffentlicher Bedürfnisse – einschließlich gesundheitlicher Notfälle – kann eine Regierung jedoch anderen erlauben, das Produkt herzustellen, normalerweise gegen eine angemessene Lizenzgebühr oder Gebühr, die an den Patentinhaber gezahlt wird. Dieser endet jedoch an der Grenze. Artikel 31 des WTO-Übereinkommens über handelsbezogene Aspekte des Rechts des geistigen Eigentums (TRIPS) beschränkt Zwangslizenzen hauptsächlich auf die inländische Produktion und Verwendung. Dies ist auch auf Unternehmen innerhalb des Territoriums beschränkt, die hauptsächlich Produkte für den Export herstellen. Dies würde natürlich den Sinn solcher Zwangslizenzen überflüssig machen, da die Länder, die solche Impfstoffe herstellen, nicht die Länder sind, die keinen Zugang dazu haben. Das andere Problem beim COVID-19-Impfstoff besteht darin, dass die zur Herstellung solcher Impfstoffe verwendeten Technologien komplex sind und zahlreiche Patente, Geschäftsgeheimnisse und Know-how beinhalten. Ein Zwangslizenzsystem müsste sich nicht nur auf Patente, sondern auch auf das entsprechende geistige Eigentum beziehen. Um die Impfstoffproduktion erfolgreich auszubauen, benötigen Länder eine mäßig reibungslose Struktur, die es einem Land wie Indien ermöglicht, eine einzige, pauschale Lizenz zu erteilen, die es Unternehmen ermöglicht, Impfstoffe herzustellen, die von US-amerikanischen oder europäischen Unternehmen für den Export in alle Länder ohne eigene Produktionskapazitäten entwickelt wurden . Die vorgeschlagene WTO-Aufhebung der Rechte an geistigem Eigentum soll die Notwendigkeit einer verbesserten Impfstoffproduktion ansprechen, aber sie wird vielleicht ein wenig zu stark betont. Eine Zwangslizenzierung würde den Weg für den Ausbau der Impfstoffherstellung ebnen und gleichzeitig die Rechteinhaber entschädigen. / It is no secret that the world has a COVID-19 vaccine problem. The majority of vaccination doses have been administered in Europe and North America, whilst many poorer counties have vaccinated less than 1% of their entire population. In light of the new variants presenting health risks, countries such as South Africa and India have proposed that the World Trade Organisation temporarily waive intellectual property rights for COVID-19 vaccines to help increase the production of vaccines. The world’s economic powerhouses such as U.S., Britain and the European Union vetoed the idea, submitting that intellectual property rights are important for ensuring continued innovation. They are of the opinion that waiving such rights would not result in increased production. The question therefore stands if these are only two options: either patents remain unchanged, or patents are disregarded. An alternative, and perhaps a middle ground is that of compulsory licensing. Although a seemingly good option, it presents its own problems. For instance, patents are territorial and grant the patent holder a monopoly for a limited time of 20 years. However, based on public needs – including health emergencies, a government can allow others to make the product, usually with a fair royalty, or fee, paid to the patent owner. However, this ends at the border. Article 31 of the WTO’s Agreement on Trade-Related Aspects of Intellectual Property Law, or TRIPS, limit compulsory licenses primarily to domestic production and use. This is also limited to companies within the territory, producing products primarily for export. This of course would make the whole point of such compulsory licenses redundant, since the countries producing such vaccines are not the countries that do not have access to them. The other problem with the COVID-19 vaccine is that the technologies used in producing such vaccines are complex and involve numerous patents, trade secrets and know-how. A compulsory licensing system would need to address not just patents but also the related intellectual property in question. To successfully expand vaccine production, countries need a moderately smooth structure to allow a country such as India, to grant a single, blanket license allowing companies to produce vaccines develop by the U.S. or European companies for export to all countries that lack their own manufacturing capacity. The proposed WTO waiver of intellectual property rights seeks to address the need of improved vaccine production, but it may be little too far stressed. Compulsory licensing would smooth the way for the expansion of vaccine manufacturing whilst at the same time still compensating the right holders.

<p>For many years pharmaceutical patents and their impact on prices have been at the centre of the international debate over insufficient access to lifesaving HIV/AIDS medicines in developing countries. The conflict has largely revolved around the implementation of an intellectual property system in the developing world, subsequent the adaptation of the TRIPS Agreement, which has made a 20 year pharmaceutical patent protection mandatory for these countries and consequently contributed to high drug prices for patented medicines as well as limited the use of generic drugs.</p><p>Developing countries, where patents are already in place, have sought to reduce high drug prices by making use of compulsory licensing, a safeguarding practice allowing the production or importation of a generic medicine without the consent of the patent holder. Compulsory licences are allowed under the TRIPS Agreement, but disagreements about the conditions, under which compulsory licences are available for ‘essential medicines’, have restricted their use. A definition of the extent to which compulsory licensees can export generic drugs to developing countries unable to manufacture their own has been missing, but on 30 August 2003 the WTO announced that it had resolved this problem by lifting the TRIPS Agreement’s restrictions on exports and permitting exports of drugs produced under a compulsory license as an exception to a patent right. The main question is whether the compulsory licensing system as prescribed in the recent Decision is an ample means of improving access to patented AIDS medicines in the developing world.</p><p>By means of legal and economic reasoning this master thesis argues that the 30 August Decision on lifting TRIPS’ restrictions on exports of patented pharmaceuticals produced under compulsory licences provides complex and uncertain rules, rendering an unreliable employment of compulsory licensing. It is desirable that further recommendations are given on which generic producing companies should be awarded compulsory licences and also on which premises. In reality, the debate about compulsory licensing is part of a much wider structural problem in development policy. The solution to the inaccessibility problem requires a mix of courses of action with a functioning compulsory licensing system included. However, disagreements such as how necessary funding should be divided equitably between developed countries could protract the reaching of a pragmatic solution.</p>

For many years pharmaceutical patents and their impact on prices have been at the centre of the international debate over insufficient access to lifesaving HIV/AIDS medicines in developing countries. The conflict has largely revolved around the implementation of an intellectual property system in the developing world, subsequent the adaptation of the TRIPS Agreement, which has made a 20 year pharmaceutical patent protection mandatory for these countries and consequently contributed to high drug prices for patented medicines as well as limited the use of generic drugs. Developing countries, where patents are already in place, have sought to reduce high drug prices by making use of compulsory licensing, a safeguarding practice allowing the production or importation of a generic medicine without the consent of the patent holder. Compulsory licences are allowed under the TRIPS Agreement, but disagreements about the conditions, under which compulsory licences are available for ‘essential medicines’, have restricted their use. A definition of the extent to which compulsory licensees can export generic drugs to developing countries unable to manufacture their own has been missing, but on 30 August 2003 the WTO announced that it had resolved this problem by lifting the TRIPS Agreement’s restrictions on exports and permitting exports of drugs produced under a compulsory license as an exception to a patent right. The main question is whether the compulsory licensing system as prescribed in the recent Decision is an ample means of improving access to patented AIDS medicines in the developing world. By means of legal and economic reasoning this master thesis argues that the 30 August Decision on lifting TRIPS’ restrictions on exports of patented pharmaceuticals produced under compulsory licences provides complex and uncertain rules, rendering an unreliable employment of compulsory licensing. It is desirable that further recommendations are given on which generic producing companies should be awarded compulsory licences and also on which premises. In reality, the debate about compulsory licensing is part of a much wider structural problem in development policy. The solution to the inaccessibility problem requires a mix of courses of action with a functioning compulsory licensing system included. However, disagreements such as how necessary funding should be divided equitably between developed countries could protract the reaching of a pragmatic solution.

Made available in DSpace on 2016-08-10T10:47:13Z (GMT). No. of bitstreams: 1 MARINA ZAVA DE FARIA NUNES.pdf: 891847 bytes, checksum: 721e7bfd66a50cac76da0f8e9086c684 (MD5) Previous issue date: 2014-06-30 / This work is linked to the research line "socio-economic relations", the Graduate Program in Law, International Relations and Development at the Catholic University of Goiás and analyzes the institution of compulsory licensing for drugs as a public health policy in the optics of the case analysis of "antiretroviral" Efavirenz. The dissertation discusses how problematic the apparent conflict between two fundamental rights when access to medicines through public health policies: the right to health and right to intellectual property. It points out, however, the relevance of the legal institution of compulsory or compulsory licensing as an instrument to achieve harmonization between the mentioned example of rights. Como defended, will be conducting a case study, aiming to demonstrate the consequence of compulsory licensing for the compound Efavirez Program against AIDS held in Brazil. As a theoretical framework dissertation includes a discussion of the social function of property, sung by Marques Medicine, collision and weighting of fundamental rights applied to the case in the teachings of Alexy, and finally the theory of fundamental rights Canotilho. / Este trabalho vincula-se à linha de pesquisa &#8213;Relações sócio-economicas&#8214;, do Programa de Pós-Graduação em Direito, Relações Internacionais e Desenvolvimento da Pontifícia Universidade Católica de Goiás e analisa o instituto de licença compulsória para medicamentos como política pública de saúde sob a ótica da análise de caso do &#8213;anti-retroviral&#8214; Efavirenz. A dissertação aborda como problemática a aparente colisão entre dois direitos fundamentais quando do acesso a medicamentos através de políticas públicas de saúde: o direito à saúde e o direito à propriedade intelectual. Aponta-se, portanto, a relevância do instituto jurídico do licenciamento compulsório ou obrigatório como instrumento capaz de realizar a harmonização entre os mencionados direitos. Como exemplo do defendido, realizaremos um estudo de caso, buscando demonstrar as consequênicas do licenciamento obrigatório do composto Efavirez para o Programa de combate à AIDS realizado no Brasil. Como referencial teórico a dissertação abarca a discussão da função social da propriedade, entoada por Remédio Marques, a colisão e a ponderação de direitos fundamentais aplicados ao caso concreto nos ensinamentos de Alexy, e por fim a teoria dos direitos fundamentais de Canotilho.

Indecopi has within its functions the defense of free competition and the protection of intellectual property. This institutional design has the advantage of being able to see more clearly what are the points of convergence between the two subject-matter, harmonize them and achieve the goals they have in common. Within this convergence, there are sensitive issues as the granting of compulsory licenses. In this work, we highlight that compulsory licenses are exceptional measures and, to consider its granting, the State must have a procedure that provides confidence and predictability to citizens and clear definitions of what is meant by public interest, emergency and national security. Finally, it is proposed that the granting of compulsory licenses should be justified by a cost benefit analysis showing that is the best choice. / El Instituto Nacional de Defensa de la Competencia y de la Protección de la Propiedad Intelectual (IndecopI) tiene entre sus funciones tanto la defensa de la libre competencia como la protección de la propiedad intelectual. Este diseño institucional tiene la ventaja de permitir apreciar con mayor claridad cuáles son los puntos de convergencia entre ambas materias, armonizarlos y conseguir los objetivos que tienen en común. Dentro de esta convergencia, existen temas sensibles, como el otorgamiento de licencias obligatorias, por lo que en el presente trabajo se destaca su carácter de medida excepcional y se plantea que, para considerar su otorgamiento, el Estado debe contar con un procedimiento que brinde confianza y predictibilidad a la ciudadanía y con definiciones claras sobre qué debemos entender por interés público, emergencia y seguridad nacional. Finalmente, se propone que su otorgamiento tenga justificación en un análisis costo beneficio que arroje como resultado que, en efecto, era la opción más adecuada.

Pharmaceutical drugs are often hailed as the poster child for the proposition that patents foster accelerated rates of innovation. This sentiment stems, in large part, from the significantly high research and development (R&D) costs endemic to the pharmaceutical sector. I argue that if the role of the patent regime is one of fostering higher amounts of investment in the R&D process, it is better served by a direct investment protection regime, where the protection does not depend upon whether or not the underlying idea behind the drug is 'new' and 'inventive', the two central tenets of patent law. Rather, any drug that successfully makes it past the regulatory filter ought to be entitled to protection, since its discovery and development entail significant investment and risk. Owing to the inadequacy of the current patent regime in appropriately protecting intensive pharmaceutical R&D investments from free-riders, I propose a comprehensive investment protection regime that protects all the investment costs incurred during the drug discovery and development process. Though similar to existing data protection regimes in some respects, it differs in others. Firstly, it enables a recovery of all R&D costs, and not only costs associated with clinical trials. Secondly, unlike patents and data exclusivity which offer uniform periods of protection, it rewards investments in a proportionate manner, wherein drug originators are entitled to protection against free-riders only until such time as they recoup their specific investments and earn a rate of return on investment that is dependent on the health value of the drug. Given that a pure market exclusivity based investment protection regime is likely to foster excessive pricing and subject the market to the dictates of a single firm, I advocate a compensatory liability model based on a novel cost sharing methodology, where follow-on entrants are free to manufacture the drug, but must pay a reasonable amount of compensation to the originator.

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.

Kenyan labour laws inadequately protect HIV positive worker. The Constitution of Kenya, 1963, does not prohibit stereotypical attitudes adverse to HIV positive workers and discrimination on the basis of health status. It does not provide for the right to employment, health and health care services, and fails to delimit privacy and dignity rights. Under the Industrial Property Act, 2001, the basis for Government exploitation of patent through compulsory licensing is whimsical and parallel importing is not envisaged. Employers unilaterally draft employment contracts notwithstanding their unequal power relations to employees. The HIV and AIDS Tribunal institutionalises discrimination against HIV positive workers on the basis of the ambiguous ‘inherent job requirements.’ Plausible international labour laws and practices have no place in Kenya unless they are domesticated. SUMMARY This thesis interrogates the Kenyan labour laws and policies to identify their inefficiencies and suggest recommendations for reform. It commences with an analysis of the topical issues associated with the HIV positive worker. It then examines the extent of prevalence and ramifications of HIV/AIDS in Kenya. Subsequently, it studies the efforts made at the international and domestic arena in protecting the HIV positive worker. A comparative analysis is made of the laws protecting the HIV positive worker in a number of countries, namely, South Africa, United States of America and Australia. The thesis draws conclusions and recommends measures on how best to protect the Kenyan HIV positive worker. The labour laws should be amended to prohibit discrimination on the basis of health status, provide for right to affordable medication and work, allow negotiation of employment contracts, list international laws that Kenya ratifies without reservation as a source of law and delimit the concept of ‘inherent requirements of a job.’ The public should be sensitised to embrace HIV positive workers. Once the new Constitution is enacted, it should list socio-economic rights as fundamental rights and reform the office of the ombudsman to deal with complaints against private employers. / (LL.D.)