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.

Bernard Mandeville and the doctrine of laissez-faire

The view of Mandeville as a pioneer of laissez-faire is difficultto reconcile with his repeated insistence that private vices were turnedinto public benefits by the ‘dexterous management of the skilfulpolitician’. Even if references to the skilful politician are regarded asshorthand for a legal and institutional framework, there remains thequestion of whether such a framework is a spontaneous order or theproduct of purposeful experiment as Mandeville thought? Mandevillewarned about the harmful effects of meddling but his complaint wasabout the actions of fashionable do-gooders rather than government. Heunderstood that the voluntariness of a transaction could be regarded asa defence against complaints of unfairness but he was quick to pointout the limitations of voluntariness especially in the market for labour.Mandeville’s objective was to teach people what they are not what theyshould be. He pointed to the strengths of the emerging market systembut was not afraid to expose its faults.

Projective Identification and the Fear of Failing: Making Sense of Practice Educators' Experiences of Failing Social Work Students in Practice Learning Settings

The paper focuses on emotions and processes that may arise for practice educators when working with a struggling or failing student in a practice learning setting.1 The paper firstly documents a previously undertaken thematic review of the literature, which explored why practice educators appeared to find it difficult to fail students in practice learning settings. Secondly, the paper draws on two UK qualitative studies that highlighted the emotional distress experienced by practice educators when working with a marginal or failing student. The paper documents key findings using a case study approach from both studies. We argue that the concept of projective identification offers a plausible and illuminating account of the states of mind experienced by practice educators and in making explicit, unconscious states of mind, our aim is that practice educators will feel confident to make appropriate assessment decisions when required.

Spacing abstraction: capitalism, law and the metropolis

In considering contemporary accounts of the interrelations of economic, legal and urban forms of social relations in the emergence of a global capitalist modernity, this paper argues that politico-juridical imaginaries of new forms of transnational universality have tended to be limited by virtue of both an anachronistic recourse to spatial models of the polis and a failure to confront the ineliminability of abstraction to any idea of global social interconnectivity. In such terms, it argues, Lefebvre’s famous call for a ‘right to the city’ needs to be reinscribed as a properly modern right to the metropolis; one that would allow us to conceive of the possibility of new kinds of relation between individual and collective subjectivity and the development of abstract social forms.

Spatial justice: law and the geography of withdrawal

While spatial justice could be the most radical offspring of law’s recent spatial turn, it remains instead a geographically informed version of social justice. The majority of the existing literature on the subject has made some politically facile assumptions about space, justice and law, thereby subsuming the potentially radical into the banal. In this article, I suggest that the concept of spatial justice is the most promising platform on which to redefine, not only the connection between law and geography, but more importantly, the conceptual foundations of both law and space. More concretely, the article attempts two things: first, a radical understanding of legal spatiality. Space is not just another parameter for law, a background against which law takes place, or a process that the law needs to take into consideration. Space is intertwined with normative production in ways that law often fails to acknowledge, and part of this article is a re-articulation of the connection. Second, to suggest a conception of spatial justice that derives from a spatial law. Such a conception cannot rely on given concepts of distributive or social justice. Instead, the concept of spatial justice put forth here is informed by post-structural, feminist, post-ecological and other radical understandings of emplacement and justice, as well as arguably the most spatial of philosophical discourses, that of Deleuze–Guattari and the prescribed possibilities of space as manifold.

The metamorphosis of authority: a case study of the Aga Khan Development Network and the Ismaili Imamate

This research is a study of modern developments of the institutions of the Nizārī Ismaili imamate during the time of the present Ismaili Imam, Shāh Karīm al-Ḥusaynī, Aga Khan IV, as the 49th hereditary living Imam of Shiʿi Nizārī Ismaili Muslims, particularly addressing the formation of the Aga Khan Development Network (AKDN) and the functions of the Community institutions. Using the case study of the Aga Khan Development Network and the Nizārī Ismaili imamate, this research demonstrates that the three ideal types of authority as proposed by Weber, namely the traditional, charismatic and legal-bureaucratic types, are not sufficient to explain the dynamics of authority among Muslims. This is partly due to Weber’s belief in the uniqueness of Western civilisation, which is a product of his thesis on Protestant Ethics and partly because his ideal typical system does not work in the case of the Muslim societies. The Ismaili imamate with its multifarious institutions in contemporary times is the most suitable counter-example by which to powerfully demonstrate that Weberian models of authority fail to explain this phenomenon and it would indeed appear as a paradoxical institution if viewed with Weberian theses. The Ismaili imamate in contemporary times represents a paradigm shift and a transmutation not only as regards the Weberian models but also when viewed from inside the tradition of Shiʿi Muslim history. This evolutionary leap forward, which has been crystallised over the course of the past half a century, in the Ismaili imamate suggests the development of a new form of authority which is unprecedented. There are clearly various elements in this form of authority which could be discerned as rooted in tradition and history; however the distinctive elements of this new form of authority give it a defining and exciting dimension. There are several qualities which are peculiar to the contemporary condition of the Ismaili imamate and its style of leadership which are distinctive. Most importantly, while some central features, like succession by way of designation (naṣṣ) has not changed, there is one overarching quality which can best capture all these elements and that is the transmutation of the Ismaili imamate from the person of the Imam into the office of imamate and thus we are now facing the institutionalisation of the imamate and the office being the embodiment of the authority of the Imam. I have described this new development as a metamorphosis of the authority because it gives an entirely new form and content to the previously familiar concept of authority in the Shiʿi Ismaili Muslim tradition.

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.

Transgender Freedom and the Law: A Liberal-Poststructural Discussion on McNally

In R v McNally, gender deception is found capable of leading to the vitiation of consent to sexual intercourse and, in so doing, places restriction on the freedom of transgendered individuals in favour of cisgendered freedom. This paper seeks to challenge the standing of this decision by adopting a combined methodological approach between Deleuzian post-structuralism and Gewirthian legal idealism. In so doing, we attempt to show that the combination offers a novel and productive approach to contentious decisions, such as that in McNally. Our approach brings together post-structuralist corporeality which conceives of the body as material and productive, and Gewirth’s ‘agent’ to conceptualise the legal body as an entity which can, and should, shape judicial reasoning. It does this by employing the criterion of categorically necessary freedom on institutionalised practical reasoning. These ‘bodies of agents’ can be conceived as the underpinning and justificatory basis for the authority of the law subject to the morally rational Principle of Generic Consistency. This egalitarian condition precedent requires individualisation and the ability to accept self-differentiation in order to return to a status, which can be validly described as “law”. Ultimately, we argue that this theoretical combination responds to a call to problematise the connection made between gender discourse and judicial reasoning, whilst offering the opportunity to further our conceptions of law and broaden the theoretical armoury with which to challenge judicial reasoning in McNally. That is, a ‘good faith’ attempt to further and guarantee transgender freedoms.

Embracing difference and the deferral of self-government: a critical analysis of the framing and practice of contemporary peace building

This thesis analyses how dominant policy approaches to peacebuilding have moved away from a single and universalised understanding of peace to be achieved through a top-down strategy of democratisation and economic liberalisation, prevalent at the beginning of 1990s. Instead, throughout the 2000s, peacebuilders have increasingly adopted a commitment to cultivating a bottom-up and hybrid peace building process that is context-sensitive and intended to be more respectful of the needs and values of post-war societies. The projects of statebuilding in Kosovo and, to a lesser extent, in Bosnia are examined to illustrate the shift. By capturing this shift, I seek to argue that contemporary practitioners of peace are sharing the sensibility of the theoretical critics of liberalism. These critics have long contended that post-war societies cannot be governed from ‘above’ and have advocated the adoption of a bottom-up approach to peacebuilding. Now, both peace practitioners and their critics share the tendency to embrace difference in peacebuilding operations, but this shift has failed to address meaningfully the problems and concerns of post-conflict societies. The conclusion of this research is that, drawing on the assumption that these societies are not capable of undertaking sovereign acts because of their problematic inter-subjective frames, the discourses of peacebuilding (in policy-making and academic critique) have increasingly legitimised an open-ended role of interference by external agencies, which now operate from ‘below’. Peacebuilding has turned into a long-term process, in which international and local actors engage relationally in the search for ever-more emancipatory hybrid outcomes, but in which self-government and self-determination are constantly deferred. Processes of emphasising difference have thus denied the political autonomy of post-war societies and have continuously questioned the political and human equality of these populations in a hierarchically divided world.

Public Interests, Private Disputes: Investment Arbitration and the Public Good

This paper seeks to investigate the bases for resistance to arbitration in general -and investor arbitration in particular- focusing on the way in which arbitral tribunals deal with notions of public interest and the public good. The paper hypothesises that while courts have within their terms of reference the capacity to consider notions of public interest, arbitral tribunals do not. It is this core difference in the scope of decision making between the two bodies that could render privately organised dispute resolution unsuitable for disputes that have public aspects, like investor-state disputes. The paper discusses the meaning of public interest and the public good as found in the literature. It then proceeds to consider how tribunals in the investment field have dealt with these concepts. This leads to a conclusion urging not abandonment of arbitration as a component of dispute resolution, but caution. It is argued that unchecked growth in private dispute resolution can threaten perceptions of legitimacy and democratic accountability. The paper adopts a socio-legal methodology in considering the effect of legal mechanisms on social and political phenomena. It is also informed by a law and economics methodology in addressing impacts of dispute resolution mechanisms on economic efficiency. The contribution of the paper rests on theorising motivations for resistance to private dispute resolution, a topical issue in light of the TTIP debate.

Task Competency in the Rights Analytic: Mental Health and the Justification for Rights and Duties

The paper concerns the moral status of persons for the purposes of rights-holding and duty-bearing. Developing from Gewirth’s argument to the Principle of Generic Consistency (PGC) and Beyleveld et al.’s Principle of Precautionary Reasoning, I argue in favour of a capacity-based assessment of the task competencies required for choice-rights and certain duties (within the Hohfeldian analytic). Unlike other, traditional, theories of rights, I claim that precautionary reasoning as to agentic status holds the base justification for rights-holding. If this is the basis for generic legal rights, then the contingent argument must be used to explain communities of rights. Much in the same way as two ‘normal’ adult agents may not have equal rights to be an aeroplane pilot, not all adults hold the same task competencies in relation to the exercise of the generic rights to freedom derived from the PGC. In this paper, I set out to consider the rights held by children, persons suffering from mental illness and generic ‘full’ agents. In mapping the developing ‘portfolio’ of rights and duties that a person carries during their life we might better understand the legal relations of those who do not ostensibly fulfil the criteria of ‘full’ agent.

Market expansion and the co-opetition of criminal organizations in Italy

A Work Project, presented as part of the requirements for the Award of a Masters Degree in Management from the NOVA – School of Business and Economics