Multinational drug corporations, intellectual property rights and the Canadian state : a historical and critical analysis

This study critically analyzes the historical role and influence of multinational drug cotpOrations and multinational corporations in general; the u.s. government and the Canadian state in negotiating the global recognition ofIntellectual Property Rights (IPR) under GATT/NAFTA. This process began in 1969 when the Liberal government, in response to high prices for brand-name drugs amended the Patent Act to introduce compulsory licensing by reducing monopoly protection from 20 to seven years. Although the financial position ofthe multinational drug industry was not affected, it campaigned vigorously to change the 1969 legislation. In 1987, the Patent Act was amended to extend protection to 10 years as a condition for free trade talks with the u.s. Nonetheless, the drug industry was not satisfied and accused Canada of providing a bad example to other nations. Therefore, it continued to campaign for global recognition ofIPR laws under GATT. Following the conclusion of the GATTI Trade-Related aspects of Intellectual Property Rights agreement (TRIPS) in 1991, the multinational drug industry and the American government, to the surprise of many, were still not satisfied and sought to implement harsher conditions under NAFTA. The Progressive Conservative government readily agreed without any objections or consideration for the social consequences. As a result, Bill C-91 was introduced. It abandoned compulsory licenses and was made retroactive from December 21, 1991. It is the contention of this thesis that the economic survival of multinational corporations on a global scale depends on the role and functions of the modem state. Similarly, the existence of the state depends on the ideological-political and socioeconomic assistance it gives to multinational corporations on a national and international scale. This dialectical relation of the state and multinational corporations is explored in our theoretical and historical analysis of their role in public policy.

Accès aux médicaments : comment expliquer et améliorer la situation au Brésil

Le Brésil figure parmi les plus grands marchés consommateurs de médicaments. Cependant, le droit à l'accès aux médicaments, prévu dans sa Constitution Fédérale, ne fait pas partie de sa réalité. Cette situation est attribuable à plusieurs facteurs: le Brésil n'est pas capable de répondre à ses besoins internes et la consommation de médicaments n'est pas équilibrée. En réaction à cette constatation, nous analyserons la situation juridique actuelle du Brésil, afin d'indiquer les lacunes et barrières au plein accès aux médicaments et, surtout, de trouver une solution qui pourrait améliorer cette situation. Les organismes gouvernementaux brésiliens jouant un rôle important dans le développement des nouveaux médicaments sont présentés et, ensuite, l'encadrement juridique applicable à la recherche clinique et à l'autorisation de mise en marché des nouveaux médicaments est analysé; un bref survol de la législation applicable aux médicaments génériques est fait. Dans un deuxième moment de l'étude, la question d'accès aux nouveaux médicaments est mise en lumière: la législation brésilienne relative aux brevets, ainsi que le régime de licence obligatoire sont abordés; de plus, nous évaluons la compatibilité de ce régime avec l'Accord sur les ADPIC et nous évoquons les conflits internationaux qu'il a suscités. En vue de trouver des solutions aux difficultés brésiliennes identifiées, nous concluons notre étude avec l'examen de l'initiative canadienne pour favoriser l'accès aux médicaments aux pays du Sud (RCAN). Nous constatons que l'utilisation du RCAM pourrait, à court terme, favoriser l'accès aux médicaments au Brésil et, à moyen terme, aider à réduire les conflits internationaux. Finalement, à long terme, nous croyons que le Brésil pourrait jouer un rôle de leader international en adoptant une loi semblable à celle du Canada et, ainsi, il serait capable d'aider d'autres pays dans le besoin, qui n'ont aucune capacité de production locale, comme par exemple, plusieurs pays en Afrique.

Licença compulsória para medicamentos como política pública: o caso do anti-retroviral efavirenz

O objetivo deste estudo é avaliar o processo de implementação da Licença Compulsória no caso do anti-retroviral efavirenz. Esta pesquisa é de caráter descritivo, o meio de investigação foi o estudo de caso e foi conduzido com entrevistas semi-estruturadas contendo questões abertas para um conjunto de atores representativos da área da Saúde Pública que participaram do processo da licença compulsória residentes nos estados do Rio de Janeiro e São Paulo e no Distrito Federal durante os meses de outubro a dezembro de 2009. Permitiu-se que esses indivíduos se expressassem mais ou menos livremente de forma que eles produzissem discursos. Para a análise dos discursos, utilizou-se a técnica do Discurso do Sujeito Coletivo (DSC). Os resultados demonstraram que o Brasil possui capacitação tecnológica para desenvolver e produzir anti-retrovirais em um prazo relativamente curto. Os resultados mostram ainda que a Licença Compulsória ajudou a refrear os gastos com anti-retrovirais e que o instrumento pode ser utilizado para garantir o acesso da população a medicamentos anti-retrovirais de alto custo e estratégicos para o Sistema Único de Saúde em um ambiente de recursos limitados sempre que se chegar a um impasse na negociação para redução de preços com os laboratórios farmacêuticos transnacionais.

Patentes e licenciamentos compulsórios de medicamentos: o marco regulatório internacional e a ação dos países em desenvolvimento

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES)

Licenciamento provisório da patente: inibidores de protease no tratamento da Hepatite C crônica

Pós-graduação em Pesquisa e Desenvolvimento (Biotecnologia Médica) - FMB

An economic analysis of unilateral refusals to license intellectual property

The intellectual property laws in the United States provide the owners of intellectual property with discretion to license the right to use that property or to make or sell products that embody the intellectual property. However, the antitrust laws constrain the use of property, including intellectual property, by a firm with market power and may place limitations on the licensing of intellectual property. This paper focuses on one aspect of antitrust law, the so-called “essential facilities doctrine,” which may impose a duty upon firms controlling an “essential facility” to make that facility available to their rivals. In the intellectual property context, an obligation to make property available is equivalent to a requirement for compulsory licensing. Compulsory licensing may embrace the requirement that the owner of software permit access to the underlying code so that others can develop compatible application programs. Compulsory licensing may undermine incentives for research and development by reducing the value of an innovation to the inventor. This paper shows that compulsory licensing also may reduce economic efficiency in the short run by facilitating the entry of inefficient producers and by promoting licensing arrangements that result in higher prices.

Commentary on Foreign Reprints Act 1847

Legislation enabling colonial territories to import unauthorised foreign reprints subject to the payment of an import duty, to be collected for the benefit of British publishers.
The commentary explores the background to the Foreign Reprints Act 1847, and in particular, the differences between the British and colonial markets for literary works, and the introduction of 'responsible government' in the colonies. It also considers the movement in the late 1860s and early 1870s, on the part of the British book trade, to have the legislation repealed, as well as the efforts of the Canadian legislature to replace the import scheme with a system of compulsory licensing, set against the backdrop of increasingly fractious Anglo-Canadian copyright relations. The Canadian demands for compulsory licensing scheme were by and large abandoned, and the 1847 Act remained on the statute books until the passing of the Copyright Act 1911.

Article 27(3)(b) TRIPS and plant variety protection in developing countries

In comparison with industrialised countries, agriculture in developing countries accounts for a substantial share of GDP and involves a substantial sector of small-holders and traditional agriculturalists. In view of these differences, the biotechnology clause of Article 27.3.b TRIPS with its requirement of plant variety protection either by patents or an effective sui generis system or a combination of the two has been controversial. However, developing countries have made surprisingly little use of the freedom to design their own systems in this field. Instead, there has been a surge in UPOV membership among developing countries and some have gone as far as introducing patent protection for plant varieties. Such countries now have to consider the same exclusions and exceptions to patenting that are normally discussed in countries with much more advanced biotechnology industries. The chapter examines the scope for the use of orde public considerations under Article 27.2 TRIPS, of exclusions for research and experimental purposes under Article 30 TRIPS, compulsory licensing under Article 31 TRIPS as well as the advantages of a specific breeding exemption and it briefly comments on the various sui generis options. While liberal interpretations of the TRIPS exceptions remain possible, the chapter concludes that the majority of developing countries will be better off in more creatively using the freedom to develop sui generis systems suitable for their local conditions rather than struggling to introduce TRIPS conform ‘limited exceptions’ to patent protection for plant varieties.

Survey of novice motorcycle riders and their riding experience before licensing

Graduated licensing schemes have been found to reduce the crash risk of young novice drivers, but there is less evidence of their success with novice motorcycle riders. This study examined the riding experience of a sample of Australian learner-riders to establish the extent and variety of their riding practice during the learner stage. Riders completed an anonymous questionnaire at a compulsory rider-training course for the licensing test. The majority of participants were male (81%) with an average age of 33 years. They worked full time (81%), held an unrestricted driver's license (81%), and owned the motorcycle that they rode (79%). These riders had held their learner's license for an average of 6 months. On average, they rode 6.4 h/week. By the time they attempted the rider-licensing test, they had ridden a total of 101 h. Their total hours of on-road practice were comparable to those of learner-drivers at the same stage of licensing, but they had less experience in adverse or challenging road conditions. A substantial proportion had little or no experience of riding in the rain (57%), at night (36%), in heavy traffic (22%), on winding rural roads (52%), or on high-speed roads (51%). These findings highlight the differences in the learning processes between unsupervised novice motorcycle riders and supervised novice drivers. Further research is necessary to clarify whether specifying the conditions under which riders should practice during the graduated licensing process would likely reduce or increase their crash risk.

Rough Justice or Zero Tolerance? - Reassessing the Nature of Copyright in Light of Collective Licensing (Part I)

Starting point in the European individualistic copyright ideology is that an individual author creates a work and controls the use of it. However, this paper argues that it is (and has always been) impossible to control the use of works after their publication. This has also been acknowledged by the legislator, who has introduced collective licensing agreements because of this impossibility. Since it is impossible to rigorously control the use of works this writing "Rough Justice or Zero Tolerance - Reassessing the Nature of Copyright in Light of Collective Licensing" examines what reality of copyright is actually about. Finding alternative (and hopefully more "true") ways to understand copyright helps us to create alternative solutions in order to solve possible problems we have as it comes e.g. to use of content in online environment. The paper makes a claim that copyright is actually about defining negotiation points for different stakeholders and that nothing in the copyright reality prevents us from defining e.g. a new negotiation point where representatives of consumers would meet representatives of right holders in order to agree on the terms of use for certain content types in online environment.

Rethinking copyrights for the library through Creative Commons licensing

Two recent and related social developments of note for libraries are an upsurge in cultural participation enabled by Web 2.0 media and calls in government policy for enhanced innovation through education. Ironically, these have occurred at the same time that increasingly stringent copyright laws have restricted access to cultural content. Concepts of governmentality are used here to examine these tensions and contradictions. In particular, Foucault’s critique of the author figure and of freedom as part of the will to govern within liberal democratic societies is used to argue for better quality copyright education programs in school libraries and library information science education programs. For purposes of teaching and research, copyrights are defined as agglomerations of legal, economic, and educational discourses that enable and constrain what can and cannot be done with text in homes, schools, and library media centers. The article presents some possibilities for renewal of school libraries around copyright education and Creative Commons licensing.

Driving and licensing experiences of learner drivers in two Australian states prior to major changes in the licensing laws

The learner licence is an important component of the graduated driver licensing system. This research describes the driving and licensing experiences of learner drivers in Queensland and New South Wales licensed prior to the changes made to the system in mid-2007. The sample consisted of 392 participants who completed a telephone interview just after they obtained their provisional licence. The results suggest that learner drivers in the two states had many similar experiences when they were obtaining a learner licence. However, once a learner licence was obtained, there were differences in the amount of practice, the supervisor learners practised with, the type of vehicle they used and the amount of unlicensed driving. This paper provides important baseline descriptive data that can be used to measure the impact of the changes that were introduced to the learner licence phase in mid-2007 in both of these states.

Open access policies, practices and licensing : a review of the literature in Australia and selected jurisdictions

The full economic, cultural and environmental value of information produced or funded by the public sector can be realised through enabling greater access to and reuse of the information. To do this effectively it is necessary to describe and implement a policy framework that supports greater access and reuse among a distributed, online network of information suppliers and users. The objective of this study was to identify materials dealing with policies, principles and practices relating to information access and reuse in Australia and in other key jurisdictions internationally. Open Access Policies, Practices and Licensing: A review of the literature in Australia and selected jurisdictions sets out the findings of an extensive review of published materials dealing with policies, practices and legal issues relating to information access and reuse, with a particular focus on materials generated, held or funded by public sector bodies. The report was produced as part of the work program of the project “Enabling Real-Time Information Access in Both Urban and Regional Areas”, established within the Cooperative Research Centre for Spatial Information (CRCSI).