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European Law and New Health Technologies

Project team
Dr Mark L. Flear (QUB) (Principal Investigator)
Dr Anne-Maree Farrell (Manchester)
Professor Tamara K. Hervey (Sheffield)
Professor Therese Murphy (Nottingham)

Project events

Seminar 1: Introduction the Core Research Questions and Developing Research Capacity, Sheffield Law School, Friday 13 November 2009
Programme and Registration form
Reading list

Seminar 2: Legitimating Techniques, School of Law, University of Nottingham, Friday 19 March 2010
Programme and Registration form
Reading list

Seminar 3: European Law and New Health Technologies, Institute of Governance, Queen's University Belfast, Friday 5 November 2010
Programme and Registration form

Seminar 4: Challenges and Opportunities, Chancellors Hotel and Conference Centre, Manchester, Friday 25 March 2011
Programme and Registration form

Overview
This seminar series is sponsored by the Economic and Social Research Council. The series looks at questions pertaining to the specific substantive area of new technologies applied in health fields, within the specific regional jurisdiction of the law of the European Union (EU) and Council of Europe (CoE) (‘European Law’).

Background
Health is a matter of fundamental importance in European societies, both as a human right in itself, and as a factor in a productive workforce and therefore healthy economy. New health technologies promise improved quality of life for patients suffering from a range of diseases, and perhaps prevention of incidence of disease in the future. At the same time, new health technologies pose significant challenges for governments. How can we be sure that new health technologies are safe, effective, and provide appropriate value for (public) money? To guard against the possible dangers arising from new health technologies, all European governments regulate their development, marketing, and public financing.

The health technology industry is a global industry. Because of this, it is not always feasible for national governments to regulate health technologies entirely within their borders. (Wealthy) patients can always seek innovative treatments elsewhere in the world. There is little to be done about this at a global level. From the point of view of European societies, however, both the EU and the CoE offer a more immediate focus or prospect for regulatory control. Both of these legal systems are already being used to regulate new health technologies. The fact that the EU involves a ‘single market’, with rights to move within it, means that patients have already sought innovative medical treatment in another European country, where that treatment is not available at home, and have used the courts to have that treatment paid for by public funds. While the development of European law in the area of new technologies offers significant commercial and innovation opportunities in the European context, the use of certain types of human material, such as human embryos, raises risk, ethics, and rights-based concerns.

The engagement of European law with new health technologies – where health is a matter primarily of national concern, paid for by national health care systems – also raises questions of the legitimacy of that regulation, in particular citizenship involvement and democracy.

Objectives
In having regard to this background the series seeks to answer the following research questions:

1. What are the defining features of the European law approach to new health technologies and what is the significance of European law to such technologies?

2. How is European law or governance to be legitimated?  In particular, what are – and what should be – the roles of risk, ethics, rights and markets in the European law approach?

3. What are the implications of European level governance of new health technologies for citizenship?

4. If traditional legal strategies of ‘command and control’ – legally binding or so-called ‘old’ governance – are ineffective at national level, how do they fare at European level?  What ‘new’ legal or governance – not legally binding – strategies need to be developed, if any?  How do risk, ethics and rights-based approaches relate to ‘old’ and ‘new’ governance strategies?

These research questions will be examined through case studies in individual seminars, including the following: the relationship between rights and risk in the regulation of new health technologies; ethical and legal governance of human material and associated technologies; the role of expert committees and new governance mechanisms in the assessment and management of new health technologies at European, rather than national, level; patient rights and redress; and a focus on particular health problems, of topical concern in European societies, such as AIDS, cancer and obesity.

Relevant legal and policy documents

Links to international, supranational and civil society organisations

Linked events
 ‘A Symposium with Professor Roger Brownsword:  Super-stewardship in the Context of Public Health’, School of Law, University of Sheffield
 

Annual Student Human Rights Conference, convened by the Human Rights Law Centre, University of Nottingham, ‘New Technologies: Your Life? Your Health? Your Privacy? Our Human Rights'

 

Bibliography

Publications

Journal Special Issues

O. Bekou and T. Murphy (eds.), 'Special Issue: Human Rights and New Technologies', (2010) 10(4) HRLR

Articles

R. E. Ashcroft, 'Could Human Rights Supersede Bioethics?', (2010) 10(4) HRLR 639
A.-M. Farrell, 'Adding Value? EU Governance of Organ Donation and Transplantation', (2010) 17 EJHL 51
M. Flear and A. Vakulenko, ‘A Human Rights Perspective on Citizen Participation in the EU's Governance of New Technologies’, (2010) 10(4) HRLR 661
M. Fox, S. Franklin, M.-A. Jacob, T. Murphy and B. Prainsack, 'Embryonic Hopes: Controversy, Alliance, and Reproductive Entities in Law and the Social Sciences', (2010) 19 Social & Legal Studies 497
T. Murphy and G. Ó Cuinn, 'Works in Progress: New Technologies and the European Court of Human Rights', (2010) 10(4) HRLR 601

Chapters

T. Hervey, 'Adjudicating in the Shadow of the Informal Settlement?: The Court of Justice of the European Union, 'New Governance' and Social Welfare' in G. Letsas and C. O'Cinneide (eds.), Current Legal Problems 2010: Volume 63 (Oxford: OUP, 2010)
A.M. Farrell, 'Addressing organ shortage in the European Union: getting the balance right', in A.-M. Farrell, D. Price and M. Quigley, Organ Shortage: Ethics Law and Pragmatism, Cambridge University Press, 2011, p. 227