Medical Law International - Mapping the Regulatory Space For Genetic Databases and Biobanks in England and Wales

MAPPING THE REGULATORY SPACE FOR GENETIC DATABASES AND BIOBANKS IN ENGLAND AND WALES
JANE KAYE (*) AND SUSAN M C GIBBONS(**)
University of Oxford

ABSTRACT
   The ‘regulatory space’ metaphor articulated by Hancher and Moran offers a useful framing device for mapping and understanding the complex dynamics and patterns of interaction between the actors who populate existing regulatory regimes. This paper applies the ‘regulatory space’ analytical approach to map out and, thereby, gain a deeper understanding of, the current governance of genetic databases and biobanks in England and Wales. The paper draws on legal research undertaken for an ongoing socio-legal project into genetic database governance. It demonstrates some benefits of using the regulatory space approach as a precursor to applying normative theories and principles to formulate specific recommendations for regulatory reform. It also identifies potential pitfalls. The findings and conclusions should assist in designing policy recommendations for regulating genetic databases and biobanks better in the future.

A INTRODUCTION
   This paper presents some findings from legal research conducted for an ongoing socio-legal project entitled ‘Governing Genetic Databases’.(1) Earlier research with geneticists revealed that new repositories or collections of biological samples linked to medical and other data on individuals (commonly termed ‘genetic databases’ or ‘biobanks’) are burgeoning in the UK; yet scientists must re-invent the wheel in terms of the procedures used to manage them, and there is considerable uncertainty over legal requirements. A central goal of our project is therefore to gain a better understanding of the legal framework and regulatory structure governing genetic databases in England and Wales,(2) to help to determine what changes (if any) are needed to govern them more effectively and appropriately.
   This has proven to be a Herculean task. We began by mapping the governance framework as evidenced through the plethora of legal, ethical and other formal and informal instruments that apply— or potentially could apply—to genetic databases.(3) However, merely identifying the ‘paper’ requirements and standards does not provide a comprehensive or true picture; nor does it show how the framework affects, constrains or promotes the establishment, management, use and organisation of biobanks. Such deeper understanding can be reached only by uncovering how relevant actors and stakeholders, through their complex interactions, powers and day-to-day practices, influence the operation and regulation of genetic databases and the behaviour, perceptions and attitudes of other stakeholders.
   Accordingly, we have adopted (in modified form) the ‘regulatory space’ metaphor, originally articulated by Hancher and Moran,(4) as a core analytical tool. This paper presents our principal findings from using this tool, together with some critical reflections on those findings and our methodology. It suggests that the ‘regulatory space’ concept offers a helpful framing device for capturing and mapping out the key actors that exercise formal or informal authority over genetic databases at the national, European and international levels, their interactions and interdependencies. This field has never been subjected to analysis in such a way before. Significantly, our research has identified an astonishing array of actors, with widely differing sources of authority and influence. It has also exposed the largely haphazard, highly complex character of the existing governance structure, and the interrelationships between the principal stakeholders.

NOTES
*Wellcome Trust Research Fellow, Ethox Centre, University of Oxford.
**Researcher in Law, Ethox Centre, University of Oxford.
1 Wellcome Trust Biomedical Ethics programme, award ref: 076070/Z/04/Z (2005–2008); http://www.ggd.org.uk (last accessed 11.02.08).
2 For convenience, ‘England’ and ‘English’ will be used to denote England and Wales.
3 For detailed discussion, see: S.M.C. Gibbons, ‘Are UK Genetic Databases Governed Adequately? A Comparative Legal Analysis’ (2007) 27(2) LS 312; S.M.C. Gibbons et al., ‘Governing Genetic Databases: Challenges Facing Research Regulation and Practice’ (2007) 34(2) JLS 163.
4 L. Hancher and M. Moran, ‘Organizing Regulatory Space’ in R. Baldwin, C. Scott and C. Hood, A Reader on Regulation (Oxford: OUP, 1998), especially 148–172.

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