Mark Flear

European Law and New Health Technologies

1. European Law and New Health Technologies: The Research Agenda PART I: SETTING THE SCENE 2. The Defining Features of the European Unions Approach to Regulating New Health Technologies 3. Fixed Points in a Changing Age? The Council of Europe, Human Rights, and the Regulation of New Health Technologies 4. Mapping Science and New Health Technologies: In Search of a Definition A Regulators Perspective PART II: LEGAL APPROACHES TO EUROPEAN LAW AND NEW HEALTH TECHNOLOGIES 5. Innovative Tissue Engineering and Its Regulation: The Serach for Flexible Rules for Emerging Health Technologies 6. Looking After the Orphans? Treatments for Rare Diseases, EU Law, and the Ethics of Costly Healthcare 7. Exclusions in Patent Law as an Indirect Form of Regulation For New Health Technologies in Europe 8. New Health Technologies and their Impact on EU Product Liability Regulations A Regulators Perspective A Regulators Perspective PART III: REGULATORY THEORY, REGULATORY INNOVATION, EUROPEAN LAW AND NEW HEALTH TECHNOLOGIES 9. Risk, Legitimacy, and EU Regulation of Health Technologies 10. Something Old, Something New, Something Borrowed: Emerging Health Technologies and the Continuing Role of Existing Regulations 11. Science, Law, and the Medico-Industrial Complex in EU Pharmaceutical Regulation: The Deferiprone Controversy 12. The Governance of Therapeutic Nanoproducts in the European Union: A Model for New Health Technology Regulation? A Regulators Perspective PART IV: NEW TECHNIQUES FOR RESEARCHING EUROPEAN LAW AND NEW HEALTH TECHNOLOGIES 13. Taking Technology Seriously: STS as Human Rights Method 14. Novel Rights Approaches to Health Technologies 15. Sociotechnical Innovation in Mental Health: Articulating Complexity 16. Where the Wild Things Are: Xenotechnologies and European Hybrid Regulation 17. When Sperm Cannot Travel: Experiences of UK Fertility Patients Seeking Treatment Abroad A Regulators Perspective PART V: BRINGING IT ALL TOGETHER Conclusion: A European Law of New Health Technologies?

Regulatory or Regulating Publics? The European Union’s Regulation of Emerging Health Technologies and Citizen Participation

‘Citizen participation’ includes various participatory techniques and is frequently viewed as an unproblematic and important social good when used as part of the regulation of the innovation and implementation of science and technology. This is perhaps especially evident in debates around ‘anticipatory governance’ or ‘upstream engagement’. Here, we interrogate this thesis using the example of the European Unions regulation of emerging health technologies (such as nanotechnology). In this case, citizen participation in regulatory debate is concerned with innovative objects for medical application that are considered to be emergent or not yet concrete. Through synthesising insights from law, regulatory studies, critical theory, and science and technology studies, we seek to cast new light on the promises, paradoxes, and pitfalls of citizen participation as a tool or technology of regulation in itself. As such we aim to generate a new vantage point from which to view the values and sociotechnical imaginaries that are both ‘designed-in’ and ‘designed-out’ of citizen participation. In so doing, we show not only how publics (do not) regulate technologies, but also how citizens themselves are regulated through the techniques of participation.

The Open Method of Coordination on Health Care after the Lisbon Strategy II: Towards a Neoliberal Framing?

This paper undertakes a content analysis of the discourse on the Open Method of Coordination on health care (OMC/HC) in order to show how equity and solidarity are increasingly linked to optimisation and, as such, how neoliberalism increasingly frames health care. Some of the side-effects of this reframing for politics are highlighted: legitimating and extending European Union governance, reducing the space for oppositional formations and limited citizenship. The analysis begins by interrogating the broader context of the Lisbon Strategy II, after which the techniques of the OMC/HC and its substantive outputs are analysed.

Developing Euro-biocitizens through Migration for Healthcare Services

The effects of the Community right to migrate for healthcare services on patients have yet to be studied extensively. This paper uses a sociological institutionalist perspective to show how such migration might cause change in patients, especially their motivations, agency, self-understanding, identity and citizenship. This suggests the development of Euro-biocitizenship and patients as Euro-biocitizens, as well as providing a rejoinder to critiques of the right, and calls for new governance to address its effects.

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 EUs 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.

Clinical Trials Abroad: The Marketable Ethics, Weak Protections and Vulnerable Subjects of EU Law

This chapter explores how the EU is a largely overlooked exporter of normative power through its facilitation and use of clinical trials data produced abroad for the marketing of safe pharmaceuticals at home; a move that helps to foster the growing resort to the latter as a fix for public health problems. These are made possible by the EU’s (de)selection of international ethical frameworks in preference to the international technical standards it co-authors with other global regulators. Clinical trials abroad underscore how ethics are contingent and revisable in light of market needs, producing weak protections and the vulnerable subjects of EU law. I argue that these components and effects of the regime are ultimately about that which undergirds, shapes and directs regulatory design. That is, I point to the use, infiltration, perpetuation and extension of market-oriented ideas, values and rationalities into formally non-market domains like biomedical knowledge production and public health. I explain how these are central to efforts at producing and legitimating the EU, its related imagined socio-political order based on a more innovative, profitable and competitive pharmaceutical sector in order to foster economic growth, jobs and prosperity, and with them the project of European integration. ‘Bioethics as risk’ is highlighted as a way to reshape and redirect the regulatory regime in ways that are more consistent with the spirit and letter of the ethical standards (and through them the human rights) the EU claims to uphold.

Charting a roadmap towards membership and formal voice in global bioethics standard-setting: Health research and the case of the International Council on Harmonisation

The United Kingdom’s (UK’s) imminent departure from the European Union (EU) has a further but usually overlooked consequence: The UK will also be leaving the various global fora where it has been represented with other Member States of the EU. In many cases, the UK will still have to comply with the global regulatory tools, including norms and standards, made by these fora. The UK’s departure from the EU thus raises the more general question of how those formally outside the fora that set global norms and standards can navigate membership procedures in order to become involved in setting them. This article focuses on the example of the International Council on Harmonisation (ICH) and its work in harmonizing good clinical practice (GCP) in relation to clinical trials for pharmaceuticals. By reference to this example, the article underlines the importance of the ICH to global standard-setting for GCP and the importance of engagement in this forum by those that do not have a formal role in setting the standards, but that must abide by them nonetheless if they are to trade globally. Subsequently, the article explains the formal procedures for membership and involvement in standard-setting. In doing so, the article aims to provide a roadmap towards membership and a say in global standard-setting.

Reframing EU Public Health Governance: From Risk to Citizenship and Participation

Risk is the dominant frame for the European Union’s (EU’s) growing albeit often overlooked public health governance. The starting point for this chapter is the distortion of public health priorities by and within this frame. I argue that existing efforts to identify, underline and tackle the distortions can be strengthened by reframing governance as a matter of citizenship so as to develop citizen participation in decision making. The chapter therefore seeks to add to discussion on EU citizenship within this collection and beyond, which focuses on judicial discourse on inter alia rights, responsibilities, needs and entitlements. The chapter not only raises awareness of but also offers a novel proposal for mobilising the discursive potential of key elements of citizenship for participation.

European Union Biomedical Research Law and Policy and Citizen Science

In this chapter I focus on the EUs emerging biomedical research law and policy and examine the development of citizen science in this setting. The chapter argues that while what the analysis reveals might not be specific to the EU, attention to this organisation underlines important but often overlooked aspects of citizen science. That is, citizen science is (being) made less about promoting substantive involvement by citizens in the fashioning of biomedical trajectories and their empowerment as participants that pursue aims defined by themselves rather than others. Instead citizen science is underpinned by a more longstanding EU level approach to participation in science-based issues that sees it being harnessed, shaped and directed towards supporting the production and legitimation of organisational identity and sociotechnical order (in this case the EU’s). Within biomedical research law and policy citizen science might therefore be expected to support market-optimised biomedical futures and a dynamic internal market and economy. Citizen science is thereby implicated in the delineation of the boundaries of responsibility and accountability (and blame) for the (non-)realisation of public health priorities and objectives. In this way law and policy on participation and citizen science might support current research trajectories that do not serve all health needs.

An Introduction to ‘New Technologies, European Law and Citizens’

it is a truism that the public profile of new technologies grows apace. in 2008 claudia castillo became the first patient to receive a bio-engineered windpipe grown from her own stem cells. Just prior to the publication of this special issue the potential of gene therapy to successfully treat hiV was highlighted.1 Such examples demonstrate how new technologies are the subject of intense media and public attention. highly topical, yet intensely controversial, new technologies elicit different views, ranging from rapture to derision with much in between. They also raise many questions for legal scholarship.2 The contributions to this special issue, which i edited with Sara ramshaw, represent several of the papers at a workshop we organised together at the Queen’s university of Belfast on 9th September 2008 under the title ‘Biotechnology, European Law and Citizens’.3 clearly, the original title has been amended, the reason being that the papers