The EU Clinical Trials Regulation: Key Priorities, Purposes and Aims and the Implications for Public Health

The replacement of the European Union (EU) Clinical Trials Directive by the new Clinical Trials Regulation (CTR), which entered into force on 16 June 2014 but will not apply before 28 May 2016, provides an opportunity to review the legal and political context within which this important aspect of research law and policy sits and to reflect on the implications for public health. My aim in this article is to relate the context to the key purposes and aims of EU law and policy on clinical trials in order to explain and clarify its orientation. On that basis, I argue that the CTR and the changes it introduces to the law on clinical trials are part of the EU's continued focus on market optimisation. It is this focus that orients and directs the wider pharmaceutical development pipeline, but that undermines the achievement of key public health objectives.

Hydrodynamic and sediment fluxes through the inlets of the Ria Formosa

Tese de dout., Ciências do Mar, da Terra e do Ambiente (Ciências do Mar-Oceanografia Física), Faculdade de Ciências e Tecnologia, Univ. do Algarve, 2011

Achieving human security through UN human rights law: prospects and challenges

This paper explores the prospects and challenges of achieving human security through United Nations (UN) human rights law. The paper does not aim to pronounce definitively on the achievement of human security by way of UN human rights law that is, to assess the achievement of human security per se 'as a future end state'. Rather the focus of the paper is firmly placed on the capacity of UN human rights law to achieve human security. The paper departs from the premise that if human rights define human security, international human rights law and UN human rights law in particular should have something to say about the achievement of human security.

Securitisation law: EU and US disclosure regulations

Providing key guidance on the process of securitisation, this comprehensive title explains in detail exactly what practitioners need to know. Featuring the most up-to-date commentary, Securitisation Law and Practice cuts through this complicated process using practical aids such as flow charts and checklists. The book also contains discussion on the latest case law (including case studies) and critical legal issues. The book also features: (1) Analysis of the recent securities regulations regarding asset-backed securities disclosures in the US and EU, providing an understanding of the differences in regulatory reporting requirements between jurisdictions. (2) Discussion of the various types of asset-backed structures that have been created over the last 30 years. (3) Analysis of the major legal decisions in the US and EU regarding securitisation transactions, including such cases as Enron, Parmalat and the recent sub-prime problem.

Critical autopoiesis and the materiality of law

Autopoietic theory is increasingly seen as a candidate for a radical theory of law, both in relation to its theoretical credentials and its relevance in terms of new and emerging forms of law. An aspect of the theory that has remained less developed, however, is its material side, and more concretely the theory’s accommodation of bodies, space, objects and their claim to legal agency. The present article reads Luhmann’s theory of autopoietic systems in a radical and material manner, linking it on the one hand to current post-structural theorisations of law and society, and on the other hand extending its ambit to accommodate the influx of material considerations that have been working their way through various other disciplines. The latter comprises both a materialisation of the theory itself and ways of conceptualising the legal system as material through and through. This I do by further developing what I have called Critical Autopoiesis, namely an acentric, topological, post-ecological and posthuman understanding of Luhmann’s theory, that draws on Deleuzian thought, feminist theory, geography, non-representational theory, and new material and object-oriented ontologies. These are combined with some well-rehearsed autopoietic concepts, such as distinction, environment and boundaries; Luhmann’s earlier work on materiality continuum; more recent work on bodies and space; as well as his work on form and medium in relation to art. The article concludes with five suggestions for an understanding of what critical autopoietic materiality might mean for law.

Confronting law affectively: encounters of a Patpong sex tourist

When considering spaces of sex-work such as Patpong in Bangkok, Thailand, the inclination is to be drawn into habitual debates concerning the legitimacy of sex-work and the clear objectification of sex-workers. While these concerns are valid and real, there are significant absences in terms of the theoretical mapping of the space, such as the affect of the presence of law, bodies, space and the sexual encounter itself. Law emerges as the most significant presence, since it both forms the transactional surface of Patpong and produces the confusion and revilement that results from the confluence of cold legal exchange with the tactile intimacy of the sexual encounter. This text explores the ethnographic space of Patpong in order to understand ways in which law’s transactional, effective surface is both embodied through subjectivication and spatially emplaced, yet also disrupted through the affective agency of the bodies and spaces it enfolds in order to produce this surface. This exploration will point to the limitations of law’s effective surface and suggest ways in which law might be located within a regime of affect, which returns the law to the body it subjectivises.

Flesh of the Law: Material Metaphors

Existing legal metaphors, even the predominantly spatial and corporeal ones, paradoxically perpetuate a dematerialized impression of the law. This is because they depict the law as universal, adversarial, and court-based, thus ignoring alternative legalities. Instead, there is a need to employ more radically material metaphors, in line with the material turn in law and other disciplines, in order to allow law's materiality to come forth. I explore the connection between language and matter (the ‘flesh’ of the law) through legal, linguistic, and art theory, and conclude by suggesting four characteristics of material legal metaphors.

The law of the sea: the United States, Canada and the deep seabed

The Falkland Islands War of 1982 was fought over competing claims to sovereignty over a group of islands off the east coast of South America. The dispute was between Argentina and the United Kingdom. Argentina claims the islands under rights to Spanish succession, the fact that they lie off the Argentine coast line and that in 1833 Great Britain took the islands illegally and by force. The United Kingdom claims the islands primarily through prescription--the fact that they have governed the islands in a peaceful, continuous and public manner since 1833. The British also hold that the population living on the islands, roughly eighteen hundred British descendants, should be able to decide their own future. The United Kingdom also lays claim to the islands through rights of discovery and settlement, although this claim has always been challenged by Spain who until 1811 governed the islands. Both claims have legal support, and the final decision if there will ever be one is difficult to predict. Sadly today the ultimate test of sovereignty does not come through international law but remains in the idea that "He is sovereign who can defend his sovereignty." The years preceding the Argentine invasion of 1982 witnessed many diplomatic exchanges between The United Kingdom and Argentina over the future of the islands. During this time the British sent signals to Argentina that ii implied a decline in British resolve to hold the islands and demonstrated that military action did more to further the talks along than did actual negotiations. The Argentine military junta read these signals and decided that they could take the islands in a quick military invasion and that the United Kingdom would consider the act as a fait accompli and would not protest the invasion. The British in response to this claimed that they never signaled to Argentina that a military solution was acceptable to them and launched a Royal Navy task force to liberate the islands. Both governments responded to an international crisis with means that were designed both to resolve the international crisis and increase the domestic popularity of the government. British Prime Minister Margaret Thatcher was facing an all-time low in popularity for post-War Prime Ministers while Argentine President General Galtieri needed to gain mass popular support so he could remain a viable President after he was scheduled to lose command of the army and a seat on the military junta that ran the country. The military war for the Falklands is indicative of the nature of modern warfare between Third World countries. It shows that the gap in military capabilities between Third and First World countries is narrowing significantly. Modern warfare between a First and Third World country is no longer a 'walk over' for the First World country.

The Ontario Municipal Freedom of Information and Protection of Individual Privacy Act: an analysis of its application to school boards

In Canada freedom of information must be viewed in the context of governing -- how do you deal with an abundance of information while balancing a diversity of competing interests? How can you ensure people are informed enough to participate in crucial decision-making, yet willing enough to let some administrative matters be dealt with in camera without their involvement in every detail. In an age when taxpayers' coalition groups are on the rise, and the government is encouraging the establishment of Parent Council groups for schools, the issues and challenges presented by access to information and protection of privacy legislation are real ones. The province of Ontario's decision to extend freedom of information legislation to local governments does not ensure, or equate to, full public disclosure of all facts or necessarily guarantee complete public comprehension of an issue. The mere fact that local governments, like school boards, decide to collect, assemble or record some information and not to collect other information implies that a prior decision was made by "someone" on what was important to record or keep. That in itself means that not all the facts are going to be disclosed, regardless of the presence of legislation. The resulting lack of information can lead to public mistrust and lack of confidence in those who govern. This is completely contrary to the spirit of the legislation which was to provide interested members of the community with facts so that values like political accountability and trust could be ensured and meaningful criticism and input obtained on matters affecting the whole community. This thesis first reviews the historical reasons for adopting freedom of information legislation, reasons which are rooted in our parliamentary system of government. However, the same reasoning for enacting such legislation cannot be applied carte blanche to the municipal level of government in Ontario, or - ii - more specifially to the programs, policies or operations of a school board. The purpose of this thesis is to examine whether the Municipal Freedom of Information and Protection of Privacy Act, 1989 (MFIPPA) was a neccessary step to ensure greater openness from school boards. Based on a review of the Orders made by the Office of the Information and Privacy Commissioner/Ontario, it also assesses how successfully freedom of information legislation has been implemented at the municipal level of government. The Orders provide an opportunity to review what problems school boards have encountered, and what guidance the Commissioner has offered. Reference is made to a value framework as an administrative tool in critically analyzing the suitability of MFIPPA to school boards. The conclusion is drawn that MFIPPA appears to have inhibited rather than facilitated openness in local government. This may be attributed to several factors inclusive of the general uncertainty, confusion and discretion in interpreting various provisions and exemptions in the Act. Some of the uncertainty is due to the fact that an insufficient number of school board staff are familiar with the Act. The complexity of the Act and its legalistic procedures have over-formalized the processes of exchanging information. In addition there appears to be a concern among municipal officials that granting any access to information may be violating personal privacy rights of others. These concerns translate into indecision and extreme caution in responding to inquiries. The result is delay in responding to information requests and lack of uniformity in the responses given. However, the mandatory review of the legislation does afford an opportunity to address some of these problems and to make this complex Act more suitable for application to school boards. In order for the Act to function more efficiently and effectively legislative changes must be made to MFIPPA. It is important that the recommendations for improving the Act be adopted before the government extends this legislation to any other public entities.

Security and Securities in English Commercial Law

Paul Latimer, Associate Professor, Department of Business Law and Taxation. Faculty of Business and Economics, Monash University. Présentation dans le cadre du cycle de conférences organisé par le CRDP intitulé « Le droit à la sécurité ... la sécurité par le droit ».

Management renewal? Consequences of the new conception of the “best interests of the corporation” in North American and French Corporate Law

Corporate law integrates a stakeholder conception through the comprehensive meaning of the best interests of the corporation. In this paper, I address criticisms about classical definition of the firm’s purpose. Even if American law is more discreet and uncertain, it is possible to defend a broad conception of the best interests of the corporation. The interests of Canadian and French firms include their partners. While the notion of intérêt social is debatable in France, Canada has recently modified its point of view regarding the purpose of the firm. Indeed, the decision of the Supreme Court of Canada Magasins à rayons Peoples Inc. (Syndic de) v. Wise in 2004 changed the concept of corporate law. With respect to fiduciary duties, the Supreme Court set aside the traditional interpretation of the “best interests of the corporation” which gave primacy to shareholders’ interests. The Court held that the expression “best interests of the corporation” refers to the maximization of the corporation’s value. This innovative vision of the best interest of the corporation introduces stakeholder theory and corporate social responsibility (CSR) into corporate law and provides a new field for the firm’s management to frame their responsibilities. This paper concludes with an extended discussion of the implications of stakeholder and CSR influence for the future of corporate law, economy and financial researches.

The Legal Implications of Internet Marketing : Exploiting the Digital Marketplace Within the Boundaries of the Law

Au cours des dernières années, le domaine de la consommation a grandement évolué. Les agents de marketing ont commencé à utiliser l’Internet pour influencer les consommateurs en employant des tactiques originales et imaginatives qui ont rendus possible l’atteinte d'un niveau de communication interpersonnelle qui avait précédemment été insondable. Leurs interactions avec les consommateurs, en utilisant la technologie moderne, se manifeste sous plusieurs formes différentes qui sont toutes accompagnés de leur propre assortiment de problèmes juridiques. D’abord, il n'est pas rare pour les agents de marketing d’utiliser des outils qui leur permettent de suivre les actions des consommateurs dans le monde virtuel ainsi que dans le monde physique. Les renseignements personnels recueillis d'une telle manière sont souvent utilisés à des fins de publicité comportementale en ligne – une utilisation qui ne respecte pas toujours les limites du droit à la vie privée. Il est également devenu assez commun pour les agents de marketing d’utiliser les médias sociaux afin de converser avec les consommateurs. Ces forums ont aussi servi à la commission d’actes anticoncurrentiels, ainsi qu’à la diffusion de publicités fausses et trompeuses – deux pratiques qui sont interdites tant par la loi sur la concurrence que la loi sur la protection des consommateurs. Enfin, les agents de marketing utilisent diverses tactiques afin de joindre les consommateurs plus efficacement en utilisant diverses tactiques qui les rendent plus visible dans les moteurs de recherche sur Internet, dont certaines sont considérés comme malhonnêtes et pourraient présenter des problèmes dans les domaines du droit de la concurrence et du droit des marques de commerce. Ce mémoire offre une description détaillée des outils utilisés à des fins de marketing sur Internet, ainsi que de la manière dont ils sont utilisés. Il illustre par ailleurs les problèmes juridiques qui peuvent survenir à la suite de leur utilisation et définit le cadre législatif régissant l’utilisation de ces outils par les agents de marketing, pour enfin démontrer que les lois qui entrent en jeu dans de telles circonstances peuvent, en effet, se révéler bénéfiques pour ces derniers d'un point de vue économique.