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Are UK genetic databases governed adequately? A comparative legal analysis

Published online by Cambridge University Press:  02 January 2018

Susan MC Gibbons
Susan MC Gibbons*
Affiliation:
University of Oxford
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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.

Type
Research Article
Information
Legal Studies , Volume 27 , Issue 2 , June 2007 , pp. 312 - 342
Copyright
Copyright © Society of Legal Scholars 2007

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References

1. See, eg, A Cambon-Thomsen et al ‘An empirical survey on biobanking of human genetic material and data in six EU countries’ in Knoppers, BM (ed) Populations and Genetics: Legal and Socio-Ethical Perspectives (Lieden: Martinus Nijhoff Publishers, 2003) p 141.Google Scholar See also N Palmour ‘A survey of the variability of DNA banks worldwide’, ibid, p 123.

2. Human Genome Epidemiology Network, available at http://www.hugenet.org.uk; Public Population Project in Genomics, available at http://www.p3gconsortium.org/.

3. See, eg, genetic databases established by the Home Office Joint Entry Clearance Unit (for familial immigration checks) and the Child Support Agency (for resolving disputed paternity claims).

4. See, eg, Nuffield Council on Bioethics consultation paper Forensic Use of Bioinformation: Ethical Issues (November 2006). On the issues around forensic databases, see, eg, Noble, AA Introduction: Dna fingerprinting and civil liberties’ and other articles in ‘Forensic and police Dna databases’ (2006) 34(2) Journal of Law, Medicine and Ethics Google Scholar (special issue); R Brownsword ‘Genetic databases: one for all and all for one?’ (2007) 18(2) King’s College Law Journal (forthcoming); R Williams and P Johnson Forensic DNA Databasing: A European Perspective (Interim report, June 2005), available at http://www.dur.ac.uk/resources/sass/Williams%20and%20Johnson%20Interim%20Report%202005-1.pdf.

5. Especially the Police and Criminal Evidence Act 1984, s 64 (as amended).

6. Nuffield Council on Bioethics, above n 4, p 11.

7. Notably, forensic uses of non-forensic databases, potentially including medical research databases such as UK Biobank: ibid, p 19.

8. Better Regulation Task Force Regulation – Less is More: Reducing Burdens, Improving Outcomes: A BRTF Report to the Prime Minister (London, March 2005) Annex B, available at http://www.brc.gov.uk/downloads/pdf/lessismore.pdf.

9. See especially ss 2 and 21.

10. For clarity and simplicity, this paper concentrates on the legal and regulatory position in England and Wales.

11. Parry, B The Fate of Collections: Exploring the Dynamics of Trade in Bio-Information (New York: Columbia University Press, 2004).CrossRefGoogle Scholar

12. On these and other countries, see Austin, MA, Harding, S and McElroy, C Genebanks: a comparison of eight proposed international genetic databases’ (2003) 6 Community Genetics 37 Google ScholarPubMed; G Cardinal and M Deschênes ‘Surveying the population biobankers’ in Knoppers, above n 1, p 37;

13. For more detailed descriptions, see Cambon-Thomsen et al, above n 1; Austin, Harding and McElroy, above n 12; Chadwick, R et al (eds) The Ethics and Governance of Human Genetic Databases – A European Perspective (Cambridge: Cambridge University Press Google Scholar, forthcoming);

14. Brownsword, R ’Regulating human genetics: new dilemmas for a new millennium’ (2004) 12 Med LR 14 at 15.Google Scholar

15. See, eg, Kaye, J et al Population genetic databases: a comparative analysis of the law in Iceland, Sweden, Estonia and the Uk’ (2004) 8 TRAMES 15;Google Scholar

16. See further Sutrop, M Human genetic databases: ethical, legal and social issues’ and other articles in ‘Human genetic databases: ethical, legal and social issues’ (2004) 8 TRAMES Google Scholar (special issue); Knoppers, above n 1; Chadwick, above n 13;

17. Nuffield Council on Bioethics, above n 4, p 19.

18. D Price ‘The Human Tissue Act 2004’ (2005) 68 MLR 798 at 798–799 and references cited therein.

19. See, eg, House of Lords’ Science and Technology Committee, Fourth Report Report on Human Genetic Databases: Challenges and Opportunities (London: TSO, 2001), available at http://www.publications.parliament.uk/pa/ld200001/ldselect/ldsctech/57/5701.htm; Human Genetics Commission Inside Information: Balancing Interests in the Use of Personal Genetic Data (London: Department of Health, May 2002), available at http://www.hgc.gov.uk/UploadDocs/DocPub/Document/insideinformation_summary.pdf.

20. For notable exceptions, see Kaye, J Do we need a uniform regulatory system for biobanks across Europe?’ (2006) 14 European Journal of Human Genetics 245;CrossRefGoogle Scholar and other essays in that special issue; Brownsword, above n 14 and other articles in that special issue.

21. Inimgeeniuuringute seadus, RT I 2000, 104, 685, together with its implementing regulations.

22. Isikuandmete kaitse seadus, RT I 2003, 26, 158.

23. Andmekogude seadus, RT I 1997, 28, 423.

24. Council of Europe, Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine (Oviedo, 4 April 1997, ETS 164) (Convention on Human Rights and Biomedicine).

25. See the websites available at http://www.geenivaramu.ee/ (Estonian Genome Project); http://www.genomics.ee/ (Estonian Genome Project Foundation).

26. See further OM Adnardóttir et al ‘The Icelandic Health Sector Database’ (1999) 6 EJHL 307; HT Greely ‘Iceland’s plan for genomics research: facts and implications’ (2000) 40 Jurimetrics 153; R Aðalsteinsson ‘The constitutionality of the Icelandic Act on a Health Sector Database’ in J Sándor (ed) Society and Genetic Information: Codes and Laws in the Genetic Era (Budapest: CEU Press, 2003); the website available at http://www.decode.com/.

27. Lög um gagnagrunn á heilbrigðissviði.

28. Rose, above n 12, at 186.

29. See generally Office of Science Policy and Planning, National Institutes of Health Iceland’s Research Resources: The Health Sector Database, Genealogy Databases, and Biobanks (June 2004), available at http://grants.nih.gov/grants/icelandic_research.pdf/; Trouet, C and Sprumont, D Biobanks: investigating in regulation’ (2002) 2 Baltic Yearbook of International Law 3.Google Scholar

30. Lög um lífsýnasöfn. While generally applicable, the deCODE project was its catalyst.

31. See especially Act on the Rights of Patients, No 74/1997 (Lög um réttindi sjúklinga); Regulation on Scientific Research in the Health Sector, No 552/1999 (Reglugerð um vísindarannsóknir á heilbrigðissviði); Regulation on a Health Sector Database, No 32/2000 (Reglugerð um gagnagrunn á heilbrigðissviði); Act on Protection and Processing of Personal Data, No 77/2000 (Lög um persónuvernd og meðferð persónuupplýsinga) as amended; Regulation on the Keeping and Utilisation of Biological Samples in Biobanks, No 134/2001 (Reglugerð um vörslu og nýtingu lífsýna í lífsýnasöfnum); Rules on the Security of Personal Data in Biobanks, No 918/2001 (Reglur um öryggi persónuupplýsinga í lífsýnasöfnum). See also the Operating Licence for the Creation and Operation of a Health Sector Database, issued to deCODE by the Minister of Heath and Social Security, State Regulation No 691295-3549.

32. Lag om biobanker i hälso- och sjukvården mm (2002:297). See also the Biobanks in Medical Care Ordinance (2002:746) (Förordning (2002:746) om biobanker inom hälso- och sjukvården mm) and Administrative Guidelines concerning Biobanks in Health Care (2002:11) (Socialstyrelsens föreskrifter och allmänna råd (2002:11) om biobanker i hälso- och sjukvården mm).

33. Personuppgiftslag (1998:204). See also the Personal Data Ordinance (1998:1191) (Personuppgiftskungörelsen (1998:1191)).

34. Lag om forskningsetisk prövning (2003:460) and its supporting ordinances.

35. See further the website available at http://www.biobanks.se/medicalbiobank.htm/.

36. Rose, above n 12, at 186.

37. Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells [2004] OJ L102/48. Two technical annexes (Commission Directives 2006/17/EC and 2006/86/EC) provide detailed rules.

38. Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data [1995] OJ L281/31. Additional EU and Council of Europe instruments pertain to clinical trials, biomedicine, genetics, databases and intellectual property rights.

39. Relevant common law rulings cover negligence, battery, consent, capacity, the duty of confidence, privacy, property rights and intellectual property.

40. See the website available at http://www.ukbiobank.ac.uk/.

41. Above n 38. See Personal Data Protection Act 2003 (Estonia); Act on Protection and Processing of Personal Data, No 77/2000 (Iceland); Personal Data Act (1998:204) (Sweden); Data Protection Act 1998 (UK).

42. In particular, Health and Social Care Act 2001, s 60; Health Service (Control of Patient Information) Regulations 2002, SI 2002/1438.

43. Schedule 1, para 6.

44. Hansard HL Deb, vol 664, col 371, 22 July 2004 (Lord Warner); Hansard HL Deb, vol 664, cols GC503–GC504, 16 September 2004 (Lord Warner); Hansard HL Deb, vol 664, col GC504, 16 September 2004 (Lord Clement-Jones).

45. The Human Tissue Act 2004 (Ethical Approval, Exceptions from Licensing and Supply of Information about Transplants) Regulations 2006, SI 2006/1260. ‘Qualifying research’ means research that is ethically approved in accordance with the Regulations.

46. Liddell, K and Hall, A Beyond Bristol and Alder Hey: the future regulation of human tissue’ (2005) 13 Med LR 170 Google Scholar at 214.

47. Email advice from Human Tissue Authority Regulatory Officer, 1 March 2006.

48. Act on a Health Sector Database, No 139/1998 and associated regulations.

49. Act on Biobanks, No 110/2000 (Iceland); Biobanks in Medical Care Act (2002:297) (Sweden).

50. UK Biobank Ethics and Governance Framework: Version 2.0 (May 2006), available at http://www.ukbiobank.ac.uk/docs/EGF_Version2_July%202006.pdf.

51. UK Biobank Ethics and Governance Council Annual Report 2004–2005 p 2, available at http://www.egcukbiobank.org.uk/assets/wtx032076.pdf.

52. UK Biobank Ethics and Governance Framework, above n 50, para I.B.3. By contrast, participants in an equivalent project planned by the USA National Human Genome Research Institute will be given the option to be told about such findings: A Coglan ‘One million people, one medical gamble’ New Scientist 19 January 2006.

53. HGRA, ss 11 and 16(2).

54. UK Biobank Ethics and Governance Framework, above n 50, para I.B.3. Under the HGRA, gene donors also have a (theoretical) right to genetic counselling: see further text to n 145 below.

55. Professor John Newton The UK Biobank: Opportunity or Threat? Oxford Medical Seminar (University of Oxford, 21 April 2004).

56. See, eg, World Medical Association Declaration of Helsinki (1964, 2000 as amended) para 5; Department of Health Research Governance Framework for Health and Social Care (London, 2nd edn, 2005) paras 2.2.1 and 3.6.3; UNESCO Universal Declaration on Bioethics and Human Rights (33rd session, 19 October 2005), art 3(2); Recommendation Rec(90)3 of the Committee of Ministers to Member States concerning Medical Research on Human Beings, Principle 2(1).

57. For debates around a possible duty of care to alert participants to personally meaningful research results, see, eg, Johnston, C and Kaye, J Does the Uk Biobank have a legal obligation to feedback individual findings to participants?’ (2004) 12 Med LR 239.Google Scholar

58. UK Biobank Ethics and Governance Framework, above n 50, para III.A.3.

59. House of Lords’ Science and Technology Committee, above n 19, para 7.34.

60. Kaye, above n 20, at 245.

61. See, eg, S Pincock ‘Human Tissue Bill could jeopardise research, scientists warn’ (2004) 328 BMJ 1034; Liddell and Hall, above n 46, at 172–173 and references cited therein; Hansard HC Standing Committee G, cols 82, 131–132, 29 January 2004 (Dr Murrison); Hansard HL Deb, vol 664, cols 384–387, 22 July 2004 (Lord Winston), Hansard HL Deb, vol 664, cols 395–395, 22 July 2004 (Baroness O’Neill).

62. For example, the Medicines and Healthcare Products Regulatory Agency Trading Fund Order 2003, SI 2003/1076 defines ‘tissue bank’ as ‘any place where human tissue or cells are stored or processed’. The glossary to the Medical Research Council guidelines Human Tissue and Biological Samples for Use in Research (2001) defines ‘human tissue or sample collection’ as ‘any samples of human biological material to be kept for reference, teaching or future research use’. During parliamentary debates over the Human Tissue Bill, ‘tissue bank’ was the term most frequently used.

63. House of Lords’ Science and Technology Committee, above n 19, paras 3.3–3.4.

64. Above n 16, p 2.

65. Ibid.

66. ‘Population genetic database’ is relatively well understood. For a definition of ‘population biobank’, see, eg, Council of Europe Recommendation Rec(2006)4 of the Committee of Ministers to Member States on Research on Biological Materials of Human Origin (adopted 15 March 2006) art 17. Amongst commentators, the term ‘human genetic database’ seems widely accepted. See, eg, Árnason, Nordal and Árnason, above n 16, p 14.

67. See further SMC Gibbons et al Governing genetic databases: challenges facing research regulation and practice’ (2007) 34(2) JLS (forthcoming).Google Scholar

68. J Kaye ‘Regulating human genetic databases in Europe’ in Chadwick et al, above n 13; Kaye, above n 20, at 246.

69. Chapter 1, s 3. Care providers include providers of professional medical care, and laboratories that receive biosamples from such persons or entities and preserve them in biobanks: Ch 1, s 2.

70. Árnason, Nordal and Árnason, above n 16, p 13.

71. Also genetic material stored in DNA pellets or other extra-cellular media: Liddell and Hall, above n 46, at 204 (discussing the largely identical definition of ‘bodily material’ in HTA, s 45(5)).

72. Gametic materials and embryos created ex vivo are regulated separately under the Human Fertilisation and Embryology Act 1990.

73. ‘Acellular materials are not themselves within the scope of the Bill, but the control of cells from which they come is within the scope of consent’: Hansard HC Standing Committee G, cols 58–59, 27 January 2004 (Dr Ladyman). See also Price, above n 18, at 800; email advice, above n 47.

74. Chapter 1, s 2.

75. See text to n 41 above.

76. Definitions of ‘genetic data’ feature only in Estonia (HGRA, s 2(9)) and Iceland (Act on a Health Sector Database, No 139/1998, art 3(7); Act on Protection and Processing of Personal Data, No 77/2000, s 2(8)(c), defining ‘health data’ as including ‘genetic data’).

77. Article 2(a) of the Directive deems ‘personal data’ to mean ‘any information relating to an identified or identifiable natural person’ (emphasis added).

78. Liddell and Hall, above n 46, at 175.

79. HTA, s 53(1); DPA, s 1(1).

80. Above n 41.

81. This body replaced the former Data Protection Commission.

82. Act on Protection and Processing of Personal Data, No 77/2000, s 38.

83. DPA, Sch 9.

84. To the extent that the Personal Data Protection Act 2003 and its associated regulations apply under the HGRA.

85. The Personal Data Protection Act 2003 provisions do not apply where coded tissue samples or coded data are processed as part of a dataset that includes five or more gene donors: HGRA, s 7(2).

86. Personal Data Protection Act 2003, s 36(2).

87. Opinions differ. Some commentators argue that dual systems simply produce complexity, regulatory redundancy and arbitrary inconsistency: Liddell and Hall, above n 46, at 212 and 223; McHale, above n 16, at 94. Conversely, the House of Lords’ Science and Technology Committee, in its Fourth Report (above n 19), rejected a unified regulatory regime as being ‘impossibly cumbersome’ (para 3.16). Others point to qualitative differences between tissues and data, arguing that the two are not legally synonymous vis-à-vis their nature or implications: Price, above n 18, at 820.

88. HTA, s 39, s 45, Sch 1 and Sch 4, Pt 2.

89. Nuffield Council on Bioethics, above n 4, p 17.

90. House of Lords’ Science and Technology Committee, above n 19, para 7.66.

91. Nuffield Council on Bioethics, above n 4, pp 17–18.

92. Especially the Medical Research Council, General Medical Council and Human Genetics Commission.

93. HTA, ss 14–15.

94. Above n 37. The Directive requires accreditation of tissue banks, and sets minimum standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissue and cells intended for human application.

95. Liddell and Hall, above n 46, at 214.

96. Price, above n 18, at 811.

97. British Medical Association BMA Response to the Queen’s Speech (15 November 2006), available at http://www.bma.org.uk/pressrel.nsf/wlu/SGOY-6VKGC5?OpenDocument&vw=wfmms.

98. For example, to contact gene donors, or renew, supplement or verify their descriptions of state of health: HGRA, ss 24(2)(4) and 29(1).

99. Formally, the Committee on the Creation and Operation of a Health Sector Database. See Act on a Health Sector Database, No 139/1998, art 6; Regulation on a Health Sector Database, No 32/2000, arts 15–17.

100. Chapter 6, s 3.

101. Central Office for Research Ethics Committees, discussed further below.

102. Articles 18–21.

103. Above n 37.

104. Like the HTA, the Directive’s Art 3 definitions of ‘tissue’ and ‘cells’ do not descend to a sub-cellular level, and so apparently exclude extracted genetic material – although, genetic testing of tissue and cells subject to the Directive is covered. See text to n 71 above.

105. Article 6(1).

106. The Human Fertilisation and Embryology Act 1990 lays down a licensing and inspection scheme. Following the organ retention scandals, the Chief Medical Officer conducted a limited census of organs, body parts, still-births and fetuses held by NHS pathology services: Department of Health, Department of Education and Employment and the Home Office Report of a Census of Organs and Tissues Retained by Pathology Services in England (January 2001).

107. Liddell and Hall, above n 46, at 213.

108. Act on Biobanks, No 110/2000, art 2.

109. Ibid, arts 4–6.

110. Ibid, art 6.

111. The Icelandic Data Protection Authority uses independent contractors to conduct annual security reviews of the handling and storage of biosamples in specific biobanks.

112. Other statutes also provide for registers for health and research purposes. See, eg, the Medical Care Registers Act (1998:544) (Lag (1998:544) om vårdregister); Health Data Registers Act (1998:543) (Lag (1998:543) om hälsodataregister).

113. Chapter 2, s 5.

114. See text to nn 49 and 69 above.

115. From 1989 in Estonia: T Veidebaum ‘Research ethics in Estonia’ in D Beyleveld, D Townend and J Wright (eds) Research Ethics Committees, Data Protection and Medical Research in European Countries (Aldershot: Ashgate, 2005) p 245.

116. National Patient Safety Agency/COREC Building on Improvement: Implementing the Recommendations of the Report of the Ad Hoc Advisory Group on the Operation of NHS Research Ethics Committees (August 2006), available at http://www.corec.org.uk/consultation/ImplementationPlan.pdf. That document outlines the plan for implementing nine recommendations.

117. Medicines for Human Use (Clinical Trials) Regulations 2004, SI 2004/1031, Pt 2. See, generally, Hedgecoe, A et al Research ethics committees in Europe: implementing the directive, respecting diversity’ (2006) 32 J Med Ethics 483CrossRefGoogle ScholarPubMed at 484–485; s 11.4.3.

118. The Human Tissue Act 2004 (Ethical Approval, Exceptions from Licensing and Supply of Information about Transplants) Regulations 2006, SI 2006/1260. Other necessary conditions are that the material came from a living person and that the researcher will not be able to identify the source.

119. Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use [2001] OJ L121/34.

120. See, eg, Department of Health Research Governance Framework for Health and Social Care (2nd edn, 24 April 2005), available at http://www.dh.gov.uk/assetRoot/04/12/24/27/04122427.pdf. Note that COREC’s policy under the Standard Operating Procedures for Research Ethics Committees in the United Kingdom: Version 3.1 (October 2006) p 10, available at http://www.corec.org.uk/applicants/help/docs/SOPs.pdf, is to apply the Clinical Trials Regulations standards generally to all NHS REC reviews of research involving human participants.

121. COREC Governance Arrangements for NHS Research Ethics Committees (July 2001) para 3.1, available at http://www.dh.gov.uk/assetRoot/04/05/86/09/04058609.pdf.

122. Note that the Home Office is establishing an Ethics Committee to advise the NDNAD’s Strategy Board on new proposed uses of the NDNAD and research proposals, and to review its decisions: Nuffield Council on Bioethics, above n 4, p 17.

123. See COREC, above n 120, pp 39 and 205–212.

124. While the Research Governance Framework (above n 120) lacks legal force, it declares research governance in compliance with its principles and standards to be a ‘core standard’ expected of all public health organisations. Any failures will trigger normal accountability and performance management procedures: paras 5.6–5.7.

125. Regulations 12 and 49.

126. Pattinson, above n 117, p 364.

127. Principally, research involving the processing of such data without explicit consent.

128. Sections 3–4.

129. E Rynning ‘The Swedish system for ethics review of biomedical research and processing of sensitive personal data’ in Beyleveld, Townend and Wright, above n 115, pp 251–253.

130. See text to n 98 above.

131. Plus informed consent from participants: Regulation on Scientific Research in the Health Sector, No 552/1999, arts 4 and 5.

132. Established under the Regulation on Scientific Research in the Health Sector, No 552/1999, issued under the Act on the Rights of Patients, No 74/1997.

133. Regulation on a Health Sector Database, No 32/2000, arts 25–28.

134. Regulation on Scientific Research in the Health Sector, No 552/1999, art 6.

135. Universal Declaration on the Human Genome and Human Rights (29th session, 11 November 1997), art 16; International Declaration on Human Genetic Data (32nd Session, 16 October 2003), art 16(b); Universal Declaration on Bioethics and Human Rights (33rd session, 19 October 2005), arts 19 and 22(2).

136. E Angell et al ‘Consistency in decision making by research ethics committees: a controlled comparison’ (2006) 32(11) Journal of Medical Ethics 662 and references cited therein. See also Department of Health Report of the Ad Hoc Advisory Group on the Operation of NHS Research Ethics Committees (No 268110, 2005) (the Warner Report), paras 3.5 and 3.8, available at http://www.dh.gov.uk/assetRoot/04/11/24/17/04112417.pdf.

137. See, eg, Baldwin, R and Cave, M Understanding Regulation: Theory, Strategy and Practice (Oxford: Oxford University Press, 1999 Google Scholar) ch 4; ); 3rd edn, 1994).

138. A Ayres and J Braithwaite Responsive Regulation: Transcending the Deregulation Debate (Oxford: Oxford University Press, 1992).

139. Personal Data Protection Act 2003, s 42.

140. Ibid; DPA, s 60.

141. Sweden has a maximum of 2 years’ imprisonment, but only for ‘grave’ violations: Personal Data Act (1998:204), s 49(d). In Iceland, imprisonment may be for up to 3 years: Act on Protection and Processing of Personal Data, No 77/2000, art 42.

142. Ibid, arts 40–42.

143. Act on a Health Sector Database, No 139/1998, art 17.

144. See above n 39.

145. HGRA, ss 10–11.

146. The HGRA, s 31 amended the Estonian Criminal Code by adding offences relating to inducing people to become gene donors, non-consensual research and breaches of professional medical confidence. All are punishable by fines, detention or imprisonment for up to 1 year.

147. Act on a Health Sector Database, No 139/1998, art 13.

148. Ibid, arts 14–15; Act on Biobanks, No 110/2000, art 15.

149. Chapter 6, ss 1 and 3.

150. See, eg, A v B plc [2002] EWCA Civ 337, [2003] QB 195 at [4] and [6]; Campbell v MGN [2004] UKHL 22, [2004] 2 AC 457 at [17] and [50].

151. Sections 5, 45 and 25 respectively.

152. Ethical Review Act (2003:460), s 38.

153. Information Commissioner’s Office What Price Privacy? The Unlawful Trade in Confidential Personal Information (London: TSO, 2006 Google Scholar) Foreword and para 7.8.

154. See Price, above n 18.

155. Biobanks in Medical Care Act (2002:297), Ch 6, s 2.

156. See AB v Leeds Teaching Hospital NHS Trust [2004] EWHC 644 (QB), [2004] 2 FLR 365; Price, above n 18, at 809.