Risk, innovation and the regulation of health technologies: examining EU governance of blood and plasma products

Abstract

This paper examines the relationship between risk, innovation and the regulation of health technologies, drawing on a case study of EU governance of blood and plasma products. It is argued that the political context brings complexity to EU regulatory processes, which impacts upon the management of the relationship between risk and innovation. This may be particularly apparent in politically sensitive areas of EU governance where public trust may be at issue, such as those involving health technologies. If the right balance is to be struck between risk and innovation in regulatory governance in this field, then particular attention should be paid to how the political context impacts upon policy framing, the maintenance of regulatory connection in line with core policy objectives and the promotion of regulatory legitimacy.

Keywords:

• risk
• innovation
• regulation
• health technologies
• blood
• plasma products
• European Union

Acknowledgements

This paper draws on research done whilst in receipt of Economic and Social Research Council grants “Risk, Safety and Consent in Contemporary Blood Services in the United Kingdom: Perspectives from Sociology and Law” (RES-062-23-2751) and “European Law and New Health Technologies” (RES-451-26-0764). The support of the ESRC is gratefully acknowledged. I would also like to acknowledge the support of the Wellcome Strategic Programme “The Human Body, its Scope Limits and Future”, conducted under the auspices of the Institute for Science Ethics and Innovation, University of Manchester, UK. I would also like to thank the two anonymous reviewers, as well as Ron Peek, for their comments on earlier drafts of this paper. The usual disclaimer applies.

Notes

1. The use of the term “blood” in this paper includes both whole blood and blood components as set out in Art. 3(a) and (b) of the Blood Directive (2002/98/EC).

2. Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC. OJ L 33.

3. The more formal term used for voluntary, unpaid donation is voluntary, non-remunerated blood donation. A blood donation is considered voluntary and non-remunerated “if the person gives blood, plasma or cellular components of his/her own free will and receives no payment for it, either in the form of cash or in kind which could be considered a substitute for money. This would include time off work other than that reasonably needed for the donation and travel. Small tokens, refreshments and reimbursements of direct travel costs are compatible with voluntary, non-remunerated donations”, see paragraph 9 (d) of Council Recommendation 98/463/EC of 29 June 1998 on the Suitability of Blood and Plasma Donors and the Screening of Donated Blood in the European Community. OJ L 203, p. 14.

4. This was an estimate provided in the early 1990s. Accurate, up-to-date data on current levels relating to the shortfall in plasma are difficult to obtain, as is the extent of Member State dependency on US-sourced plasma products. Indeed, the last time the Commission published any data on the issue was in 1994; see Commission of the European Communities, Commission Communication on Blood Safety and Self-Sufficiency in the Community COM (94) 652 final (1994).

5. Commission Directive 2005/61/EC having regard to Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC. OJ L 256; Commission Directive 2005/62/EC of 30 September 2005 implementing Directive 2002/98/EC of the European Parliament and of the Council as regards Community standards and specifications relating to a quality system for blood establishments. OJ L 256.

6. Directive 2001/83 of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use. OJ L 311.

7. European Medicines Agency, European Public Assessment Reports. Available from: http://www.ema.europa.eu/ema/index.jsp?curl=/pages/medicines/landing/epar_search.jsp&murl=menus/medicines/medicines.jsp [Accessed 22 August 2012].