Are UK genetic databases governed adequately? A comparative legal analysis

Abstract

Given the burgeoning of genetic research and proliferation of human genetic databases, especially in the biomedical sphere, this paper explores whether the existing laws and regulatory structures for governing genetic databases in England and Wales are adequate. Through a critical survey of relevant rules, bodies and practices, it argues that the current UK framework is far from ideal in at least five major areas: (1) forms and styles of law used, especially the separate legislative regimes for physical biomaterial and data; (2) core definitions; (3) formal regulatory bodies, licensing and notification requirements; (4) ethics committees and other advisory panels; and (5) enforcement powers and sanctions. Such shortcomings could have major implications for stakeholders, hamper efforts to achieve European or international harmonisation of genetic database principles and practices, and undermine the UK’s standing as a world leader in genetics and biotechnology. Drawing on comparative analysis of governance strategies adopted in Estonia, Iceland and Sweden, the paper identifies alternative options and lessons from experiences abroad, suggesting possible avenues for reform that may warrant serious consideration in the UK.

Reflexive governance in biobanking: on the value of policy led approaches and the need to recognise the limits of law

“…Much has been written about the so-called unique and challenging features of biobanks, including issues relating to the nature, scope and adequacy of consent (Otlowski 2009); the importance of protecting privacy (Taylor and Townend 2010;Schröder et al 2010); the impossibility of guaranteeing anonymity (Lowrance and Collins 2007); the eternal quest to establish and maintain trust (Sutrop 2007); and the inadequacy of existing legal mechanisms to accommodate some or any of these features (Gibbons 2007). This article does not seek to repeat any of these discussions.…”

Definitions of genetic testing in European legal documents

“…One study has pointed out some controversial definitions related to genetics, such as biological material or DNA, in legal documents (Gibbons 2007). That study examined how adequate the existing laws were, and how governance structures were applicable to genetic databases in England and Wales, and found significant differences between core concepts of genetic terms within four European countries (UK was compared with Estonia, Iceland and Sweden); the study identified different approaches to define genetic databases and their contents, e.g.…”

Population Biobanking and International Collaboration

“…This proposed legislation seeking to establish the countrywide health record database was in fact ruled unconstitutional by the Icelandic Supreme Court [24]. On the other hand, UK Biobank, which is to a large extent self-regulating, has been identified as a leader in ‘promoting trust, confidence, credibility and participation' even in the absence of direct legal regulation [22]. …”

“…Separate legal regimes may also apply to samples as physical specimens and data as purely informational [22]. Not only that, but regulation may differ according to the purpose for which physical specimens are used or the type of physical specimens.…”

“…Not only that, but regulation may differ according to the purpose for which physical specimens are used or the type of physical specimens. In the UK, for example, licenses are required to store tissues or cells, but not DNA [22]. Estonia's legal regime is relatively unique in that the Human Genes Act does away with the distinction between the two, referring to ‘biosamples and personal data' in combination.…”