Thérèse Murphy

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?

IS HUMAN RIGHTS PREPARED? RISK, RIGHTS AND PUBLIC HEALTH EMERGENCIES

A new force seems to be at work in public health law and practice. Consider, for example, the proliferation of references to ‘preparedness’; specifically, ‘public health emergency preparedness’ and its more specialised variants such as ‘public health emergency legal preparedness’ and ‘international legal preparedness’. There is also increasing use of related phrases such as ‘global public health security’ and ‘international health security’. Of course, a proliferation of terms is not enough to prove that a new force is in play: language shifts all the time in all sorts of areas, and although such changes may reflect and contribute to deep social transformation, they can also be nothing more than passing fashions with little or no impact. But public health emergency preparedness does not feel like a superficial, short-lived trend: in fact, it seems almost the exact opposite. Indeed, as David Fidler and Laurence Gostin emphasise in their recent book, Biosecurity in the Global Age, a ‘policy revolution’ seems to have taken place – a revolution brought about by a ‘collision’ of public health and security.1 The collision of security and public health is our focus in this article. But before explaining why, we need to define ‘public health emergency preparedness’, in particular its impressive–sounding correlate, ‘global public health security’, and its less readily comprehensible subset, ‘public health emergency legal preparedness’. In the World Health Report 2007, Dr Margaret Chan, Director-General of the World Health Organization (WHO), described ‘global public health security’ as ‘the reduced vulnerability of populations to acute threats to health’.2 Later in the same report, more detailed definitions were provided: Public health security is … the activities required, both proactive and reactive, to minimize vulnerability to acute public health events that endanger the collective health of national populations. Global public health security widens this definition to include acute public health events that endanger the collective health of populations living across geographical regions and international boundaries … .[G]lobal health security, or lack of it, may also have an impact on economic or political stability, trade, tourism, access to goods and services and, if they occur repeatedly, on demographic stability.3 The other term that requires some explanation is ‘public health emergency legal preparedness’. Stated shortly, this is all about having the right laws in place and then using them in the right way in a time of public health emergency.4 In other words, it is about both legal preparedness for, and response to, public health emergencies – it is both proactive and reactive. More generally, it can be said to be an essential part of both public and global public health security, and a subset of public health emergency preparedness.

What is a Fair Trial? Rape Prosecutions, Disclosure and the Human Rights Act

This article engages with the vogue for predicting the effects of the Human Rights Act 1998 by focusing on the rape prosecution and trial. The specific interest is feminist scrutiny of the right to a fair trial, particularly the concept of ‘fairness’, in light of the increasing use of disclosure rules (in Canada and England) to gain access to medical and counseling records. Transcending the two contemporary narratives of ‘victims’/women’s rights and defendants’ rights in the criminal justice system, the authors argue for the infusion of the legal debate on disclosure with feminist understandings of wider cultural debates. They suggest that an increased reflexivity about intimacy, publicity and power, leading perhaps to the development of a concept of ‘democratic publicity’ (Fraser, 1997, p. 100), might help to revision the meaning of ‘relevant’ evidence in the rape trial. They also suggest that the wide-ranging cultural debate about memory, truth and history, and the emerging commitment to experimentation in responding to massive, institutionalised human rights violations (including apartheid, war crimes and child abuse) might be of use in deepening current thinking about the rape trial and listening to the ‘voice’ of the complainant.

KINSHIP: BORN AND BRED (BUT ALSO FACILITATED)? A COMMENTARY ON ‘DONOR CONCEPTION: ETHICAL ASPECTS OF INFORMATION SHARING’ (NUFFIELD COUNCIL ON BIOETHICS, LONDON 2013)

INTRODUCTION Some questions seem to need no thought at all. Secrecy or openness? Lies or truth? In each instance, one answer seems obvious, the other repellent. More than this, a straight, to-the-point answer seems the only sensible choice. Why complicate the questions? To do so would raise the spectre of the Secret State; it might also stymie moves towards ‘open’ science and give succour to practices of commercial confidentiality that harm life and health. Other questions, by contrast, seem to need far too much thought. Most of us duck and dodge these, but some cleave to certainties even in the face of paradox, a plurality of views, and potentially profound consequences. Family life, as many have pointed out, often throws up questions of this second sort. Take the duo with which we started: ‘secrecy or openness?’ and ‘lies or truth?’ They seemed straightforward

Technology, Tools and Toxic Expectations: Post-Publication Notes on 'New Technologies and Human Rights'

New Technologies and Human Rights arrived in my postbox at the start of the year.1 I had edited this book and written a couple of its chapters, so its appearance in print and, more so, my first flip through its pages brought relief, delight and worry in about equal measure. The cover looked great, I thought, and the crisp, new pages seemed to be free of typos. It seemed, too, that readers would find that the collection did what it promised to do. The overall aim was to review and develop the role of human rights in the regulation of new technologies. Three questions were given particular attention. First, are human rights a threat? Are human rights, in other words, helping to create a brave new world of choice, wherein human dignity is fundamentally compromised and discrimination is widespread as a result of decisions by individuals and families (by and large from the affluent North) to use technology to render themselves ‘better by design’? Second, are new technologies a threat to human rights? For instance, if we embrace these technologies as regulatory tools in the field of criminal justice on the grounds that they offer efficient and effective ways of managing crime and criminals, do we risk corroding dignity, human rights and fundamental freedoms?2 And third, in light of the above, isn’t the case that we need better

Crowning Glory: Public Law, Power and the Monarchy:

‘New public law’ has a keen interest in the deployment of power and the shifting nature of the public and private. In this article, we argue that the historical legacy of the Crown has hindered the ability of public lawyers to respond to changes in modes of governance in the UK. The constitutional law textbook tradition has played a key role in limiting critiques of the Crown because of the obfuscation that surrounds the legal and political status of the Monarch. However, instead of discounting the significance of the monarchy, we use it as a resource for exploring governing power, the blurring of boundaries and constitutional renewal. Our starting point is the life, death and, most importantly, the funeral of Diana, Princess of Wales. The latter event exposed the political relevance of the ‘personal’ in a most dramatic way, generating claims about the ‘feminisation of the government’ and ‘emotions augmenting democracy’. We follow through on these claims in order to focus on the effects of adopting private, intimate-sphere norms in the public sphere, in particular public-sphere decision making. While aware of the risks associated with this ‘transformation’ of democracy, we conclude that the increasing centrality of the intimate merits consideration in new public law’s search for progressive tools of modern governance.

REGULATORY ‘DESIRABLES’ FOR NEW HEALTH TECHNOLOGIES

This paper examines the relationship between health, technology and regulation, focusing in particular on what happens in the context of innovation. Key elements identified that inform (or should inform) the regulation of new health technologies include the following: (1) hybridity, (2) regulatory certainty and stability; (3) a move away from risk-based regulation alone; and (4) regulatory legitimacy through participation and information.

Contextualising the Regulation of Health Technologies

Explores key themes in journal special issue on Contextualising the Regulation of Health Technologies