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Iceland's Health Sector Database: A Significant Head Start in the Search for the Biological Grail or an Irreversible Error?

Published online by Cambridge University Press:  24 February 2021

Hróbjartur Jónatansson
Hróbjartur Jónatansson*
Affiliation:
A M Law Firm, Sveinsson, Jonatansson & Karlsson, Reykjavik, Iceland; University of Iceland; University of Iceland; University of Virgina School of Law
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Extract

In December 1998, Iceland's Parliament, the Althing, passed the Act on a Health Sector Database (the Database Act or Act), a highly controversial law authorizing the development of a Health Sector Database (the Database) to collect genetic and medical information already contained in various locations around Iceland as part of Iceland's national health system. As a result of the Database Act, Iceland is the only country in the world with laws authorizing collection and storage of the genetic heritage of an entire population by a private biotechnology corporation with rights to exploit the data as a commercial commodity. Many databases now exist in Iceland as individual and segregated entities that contain detailed medical information about every Icelandic person, both living and dead, dating back to 1915 when the recording commenced.

Type
Articles
Information
American Journal of Law & Medicine , Volume 26 , Issue 1 , 2000 , pp. 31 - 67
Copyright
Copyright © American Society of Law, Medicine and Ethics and Boston University 2000

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References

1 Althing is the name for the Parliament of Iceland and is also the Icelandic word for “general assembly.” It is the oldest functioning legislature in the world. It was established in A.D. 930 and met yearly in the summer at Thingvellir, northeast of Reykjavik. The supreme governing body of Iceland during the old commonwealth (930-1262), the Althing served as both legislature and court. After Iceland lost its independence to Norway in 1262, the Althing's powers were gradually dissipated as royal authority grew more assertive. By the end of the 17th century, when absolutism had become the norm, the Althing was shorn of its judicial powers and was reduced to token existence. Suspended in 1800, it was reconvened in 1843 and has since met in Reykjavik. For more information on the history of the Althing, visit the Althing's website at http://www.althingi.is/∽wwwadm/upplens.shtml.

2 Act on a Health Sector Database No. 139/1998 [hereinafter Database Act], available at http://http://brunnur.stjr.is/interpro/htr/htr.nsf/pages/gagngr-log-ensk.

3 DeCODE Genetics, Inc., is registered in Delaware, U.S.A. For more information, visit the company's website at http://www.decode.is/company.

4 DeCODE Genetics has a special genealogy department with 10 employees. For further information see the deCODE website, id.

5 The Database Act states that the entry of data into the bank shall not commence until six months after its enactment. See Database Act, supra note 2, at Provisional Clause II. The rationale behind this provision is that people should have a six month grace period to consider whether to be included in the databank or opt out.

6 See Michael Specter, Decoding Iceland, THE NEW YORKER, Jan. 18, 1999, at 40, 46.

7 Scholars and scientists in this group are: Henry T. Greely, Professor of Law and Co-Director of the Program on Genomics, Ethics, and Society, Stanford University; Mary-Claire King, American Cancer Society, Professor, Departments of Medicine and Genetics, University of Washington; A.B. Miller, Professor Emeritus, Department of Public Health Sciences, University of Toronto, 1997, Special Expert, Early Detection Branch, Division of Cancer Prevention and Control, National Cancer Institute, 1997, Senior Epidemiologist, International Agency for Research on Cancer, Lyon, France, 1998 Acting Chief, Unit of Chemoprevention, International Agency for Research on Cancer, Lyon, 1998; and Montgomery Slatkin, Gompertz Professor of Integrative Biology, University of California, Berkeley, Department of Integrative Biology.

8 See, e.g., Sarah Lyall, A Country Unveils its Gene Pool and Debate Flares, N.Y. TIMES, Feb. 16, 1999, at D1, D1; see also Mannvernd, Association for Ethics in Science and Medicine in Iceland (last modified Jan. 28, 2000) http://mannvernd.is/english/index.html. Mannvernd is “the organized opposition to the Icelandic Government's Act on a Health Sector Database.” Id.

9 For more information see the National Human Genome Research Institute's website at http://www.nhgri.nih.gov/Policy_and_public_affairs/Communications/Publications/Maps_to_medicine/.

10 See Caskey, C. Thomas, DNA-Based Medicine; Prevention and Therapy, in THE CODE OF CODES 112, 112-13 (Kevles, Daniel J. & Hood, Leroy eds., 1993)Google Scholar.

11 See Romeo-Casabona, Carlos Maria, Genetics and the Law, in LAW IN MOTION 959, 978 (Blanpain, Roger ed., 1997)Google Scholar.

12 See ARTHUR ROGERS & DENNIS DURAND DE BOUSINGEN, BIOETHICS IN EUROPE 11-14 (1995).

13 See 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: Convention on Human Rights and Biomedicine, E.T.S. No. 164, 36 I.L.M. 817, at art. 32, available at http://www.coe.fr/eng/legaltxt/164e.htm [hereinafter Convention on Bioethics].

14 See Council of Europe, Recommendation (98) 2 on the Provision of Haematopoietic Progenitor Cells (last visited Jan. 25, 2000) http://www.coe.fr/cm/ta/rec/1998/98r2.htm; Council of Europe, Recommendation (97) 15 on Xenotransplantation (visited Jan. 25, 2000) http://www.coe.fr/cm/ta/rec/1997/97rl5.htm; Council of Europe, Recommendation 1240 (1994) on Protection and Patentability of Material of Human Origin (visited Jan. 25, 2000) http://stars.coe.fr/ta/ta94/erecl240.htm; Council of Europe, Recommendation (94) 11 on Screening as a Tool of Preventive Medicine (visited Jan. 25, 2000) http://www.coe.fr/cm/ta/rec/1994/94r11.htm; Council of Europe, Recommendation (92) 3 on Genetic Testing and Screening for Health Care Purposes (visited Jan. 25, 2000); http://www.coe.fr/cm/ta/rec/1992/92r3.htm; Council of Europe, Recommendation (92) 1 on the Use of Analysis of Deoxyribonucleic Acid (DNA) within the Framework of the Criminal Justice System (visited Jan. 25, 2000) http://www.coe.fr/cm/ta/rec/1992/92r1.htm; Council of Europe, Recommendation 90 (13) on Prenatal Genetic Screening, Prenatal Genetic Diagnosis and Associated Genetic Counseling (visited Jan. 25, 2000) http://www.coe.fr/cm/ta/rec/1990/90r13/htm; Council of Europe, Recommendation 1046 (1986) on the use of Human Embryos and Fetuses for Diagnostic, Therapeutic, Scientific, Industrial, and Commercial Purposes (visited Jan. 25, 2000) http://stars.coe.fr/ta/ta86/erecl046.htm; Council of Europe, Recommendation 934 (1982) on Genetic Engineering, 2 HUMAN GENE THERAPY 327, 327-28 (Mary Ann Liebert, Inc. 1999).

15 Convention on Bioethics, supra note 13.

16 See id. at preamble; see also Riedel, Eibe, Global Responsibilities and Bioethics: Reflections on the Council of Europe's Bioethics Convention, 5 IND. J. GLOBAL LEGAL STUD. 179, 179-89 (1997)Google Scholar.

17 Article 15a of the Statute of the Council of Europe provides the legal significance with regard to Council members. See Council of Europe, Statute of the Council of Europe, E.T.S. No. 1, at art. 15, available at http://www.coe.fr/eng/legaltxt/le.htm. Within the Council of Europe, international treaties are drafted by a committee of governmental experts and adopted by the Committee of Ministers. Then they are opened for signature. All Member States can become a Party to any treaty. Each treaty has its own provisions called “final clauses,” concerning the modalities of its entry into force. As a rule, the accession of non-member States requires an invitation by the Committee of Ministers. There are some treaties to which the European Community can become a Party. See Council of Europe - Treaty Office, About Treaties (visited Feb. 9, 2000) http://conventions.coe.int/treaty/en/intro.htm.

18 See Convention on Bioethics, supra note 13, at arts. 11-14.

19 See id. at art. 34.

20 See Convention on Bioethics, supra note 13, at art. 2.

21 See id. at arts. 5-10, 15-20, 28.

22 See id. at arts. 11-12.

23 See id. at art. 13.

24 See id. at arts. 15-18.

25 See id. at art. 5; see also id. at art. 19(2).

26 See id. at art. 6.

27 See id. at art. 10.

28 See id. at art. 15.

29 See id. at art 26.

30 See Riedel, supra note 16, at 180.

31 See id.

32 See id.

33 The German philosopher Hans Jonas argued that:

Modern technology has produced new capabilities of such magnitude, with such novel objects and novel consequences, that the framework of earlier ethics no longer fits. The Antigone Choir about the horrific, about the stupendous might of humankind today would have to be reformulated … we will have to re-learn reverence and shuddering, to protect us from the aberrations of our own might, such as from experiments with the human constitution. The paradox of our situation consists in that we will have to regain lost reverence from shuddering, the positive from the imagined; reverence for human beings were and are, and shuddering from what they might turn into and might stare at us from an anticipated future.

Id. (quoting HANS JONAS, THE IMPERATIVE OF RESPONSIBILITY 11 (12th ed. 1995)).

34 See id.

35 See id. at 181. According to Eibe Riedel:

[m]ost Western European states have fairly liberal laws on human gene technology; only in Germany and in some southern European countries do the laws reflect a more rigorous ethical position. The German national position induced German pharmaceutical and biochemical firms to invest in countries with more favorable climates for human technology.

Id.

36 See id.

37 See id.

38 See id.

39 This view is implicit in the creation of the Database Act. Ragnheidur Haraldsdottir, deputy permanent secretary of Iceland's Ministry of Health says: “We feel that we might be able to contribute something to the world … [s]ome people would maintain that it would be unethical not to try to use the unique resources that we have in Iceland to try to improve the health of Icelanders, and hopefully of others.” Lyall, supra note 8, at D4. In the author's view, these words definitely constitute a proscience position on behalf of the Icelandic government.

40 See id. at 182.

41 See generally Schwartz, Paul M., European Data Protection Law and Medical Privacy, in GENETIC SECRETS—PROTECTING PRIVACY AND CONFIDENTIALITY IN THE GENETIC ERA 392 (Rothstein, Mark A. ed., 1997)Google Scholar [hereinafter GENETIC SECRETS] (giving an overview of data protection laws in Europe).

42 See Gesetz Zum Schutz von Embryonen, v. 13.12.1990 (BGBI. I 1990 S. 2746).

43 See Gentechnik Gesetz BGBI 510/1994.

44 See 34 Gazz. Uff. 78 (Apr. 3, 1993), Decree-Law No. 92, Mar. 3, 1993.

45 See, e.g., Law No. 35/1988 on Assisted Reproductive Procedures 6119 (B.O.E. 1988, 282).

46 See Law No. 94-653 of July 29, 1994, J.O., July 30, 1994, p. 11056, reprinted in 45 INT'L DIG. HEALTH LEGIS. 498 (1994); Law No. 94-654 of July 29, 1994, J.O., July 30, 1994, p. 11060, reprinted in 45 INT'L DIG. HEALTH LEGIS. 473 (1994).

47 See Human Fertilisation and Embryology Act, 1990, ch. 37 (Eng.).

48 See The Act Relating to the Application of Biotechnology and Medicine, Law No. 56, Aug. 5, 1994.

49 See Act No. 356, June 6, 1991, on Environment and Genetic Engineering, available at http://www.oecd.org/ehs/den356.htm.

50 See ALBERT P. BLAUSTEIN & GISBERT H. FLANTZ, CONSTITUTIONS OF THE COUNTRIES OF THE WORLD 6 (Supp. 1994) (translating the 1992 amendment to Article 24 of the Swiss Constitution).

51 See supra notes 42-49.

52 See Schwartz, supra note 41, at 405.

53 See Riedel, supra note 16, at 182.

54 Act on the Rights of Patients No. 74/1997 [hereinafter Patient Act], available at http://brunnur.stjr.is/interpro/htr/htr/nsf/pages/act-rightspatients.

55 The Bill on Human Tissue Samples was first submitted to the Althing in its 123rd session in 1998-1999. See Althing Doc. No. 121-Case No. 121.

56 According to the Bill on Human Tissue Samples, the objective of the law is to ensure the protection of personal privacy with regard to the gathering, storage, appropriation and utilization of human tissue samples and that such use serves scientific and medical purposes and is conducive to the public good. See id., at art. 1 (translation by author).

57 See generally id.

58 See Bill on a Health Sector Database, Notes to the Bill (visited Feb. 7, 2000) http://brunnur.stjr.is/interpro/htr/htr.nsf/pages/gagnagr-ensk [hereinafter Notes to the Database Bill]. Kari Stefansson is an M.D., D.Med., and received his degrees from the University of Iceland. He has held faculty positions in neurology, neuropathology and neuroscience at Harvard Medical School and the University of Chicago. He is one of the founders of deCODE Genetics and is the company's President and CEO. See deCODE Genetics Board of Directors (last modified Jan. 27, 2000) http://www.decode.is/company/index.html.

59 See Notes to the Database Bill, supra note 58.

60 See id.

61 See id.

62 See id.

63 See Lyall, supra note 8, at D1.

64 See ICELAND 874-1974, HANDBOOK PUBLISHED BY THE CENTRAL BANK OF ICELAND ON THE OCCASION OF THE ELEVENTH CENTENARY OF THE SETTLEMENT OF ICELAND 33 (1975) [hereinafter ICELAND 874-1974].

65 See id.

66 See id.

67 See Stefansson, Kári & Gulcher, J., Population Genomics: Laying the Groundwork for Genetic Disease Modeling and Targeting, 36 CLIN. CHEM. LAB. MED. 523, 523 (1998)Google Scholar.

68 See id.; see also Michael Binyon, An Icelandic Saga Unveils Life's Secrets, THE TIMES OF LONDON, Feb. 13, 1999, at 17; Lyall, supra note 8, at D1.

69 See ICELAND 874-1974, supra, note 64, at 33.

70 The Icelandic Immigration Act is from 1965 whereas the Danish Immigration Act is from 1983 (Undlændingeloven, No. 226, June 8th, 1983). The Icelandic legislation has therefore not been revised in accordance with legal developments in Denmark. Iceland's decision not to follow its Nordic neighbors in this area can be regarded as a sign of unwillingness or hesitation to liberalize the immigration legislation.

71 According to Volume 37 of the NORDIC STATISTICAL YEARBOOK 1999 (Klaus Munch Haagensen ed., 1999), the number of non-national citizens as a percentage of the total population in 1999 was 3.71% in Norway, 4.82% in Denmark and 5.65% in Sweden.

72 A comprehensive information source concerning Icelandic genealogy can be found at http://nordicnotes.com/Iceland/Genealogy_iceland/Genealogy_iceland.html.

73 See 23 Feb ‘98 Daily News from Iceland (visited Feb. 23, 2000) http://www.icenews.is/23feb98.html.

74 See id.

75 In 1996, Iceland's public expenditure on health was 6.8% of its gross domestic product (GDP). See Organization for Economic Co-operation and Development (OECD), Frequently Asked Data— Health Expenditure (visited Jan. 26, 2000) http://www.oecd.org/els/health/fad_l.htm. According to OECD, only four nations of twenty-nine member nations spent a higher percentage of GDP on health care. See id.

76 For more information see the Icelandic National Economic Institute's website at http://www.stjr.is/frr/thst/eng/stat/statist.htm.

77 See Notes to the Database Bill, supra note 58.

78 See id.

79 See id.

80 See Information Report No. 1, The Ministry of Health and Social Security, Reykjavik (1997).

81 See id.

82 See id.

83 See id.

84 See Notes to the Database Bill, supra note 58.

85 See id.

86 A good example is Dr. Kári Stefansson. See supra note 58.

87 See deCODE's web site, supra note 3.

88 See Notes to the Database Bill, supra note 58.

89 See id.

90 See Database Act, supra note 2, at art. 4.

91 See Database Act, supra note 2, at art. 5.

92 A committee established by the enactment of the Act Concerning the Registration and Handling of Personal Data No. 121/1989, reprinted in BUSINESS GUIDE TO PRIVACY AND DATA COLLECTION LEGISLATION 264-65 (Charles E.H. Franklink ed., 1996).

93 See Database Act, supra note 2, at art. 5.

94 See id. at art. 9.

95 See id. at art. 6.

96 See id. at art. 7.

97 See id.

98 See id. at art. 3.

99 See id. at art. 7.

100 Id. at art. 3.

101 Id.

102 Id.

103 COMMITTEE OF MINISTERS, COUNCIL OF EUROPE, THE PROTECTION OF MEDICAL DATA: RECOMMENDATION (97) 5 ADOPTED BY THE COMMITTEE OF MINISTERS OF THE COUNCIL OF EUROPE ON 13 FEBRUARY 1997 AND EXPLANATORY MEMORANDUM (1997) [hereinafter Recommendation (97) 5].

104 Database Act, supra note 2, at art. 3.

105 Id.

106 Id.; see also discussion, infra Part III.A.5.a.

107 See 8 ENCYCLOPEDIA AMERICANA LIBRARY EDITION 594 (1994).

108 See Warren, Samuel D. & Brandeis, Louis D., The Right to Privacy, 4 HARV. L. REV. 193, 193 (1890)Google Scholar.

109 See id.

110 See id.

111 See id.

112 See id.

113 See Convention for the Protection of Human Rights and Fundamental Freedoms, E.T.S. No. 5 (visited Feb. 28, 2000) http://www.coe.fr/eng/legaltxt/5e.htm [hereinafter Convention for the Protection of Human Rights]

114 See id.; Universal Declaration of Human Rights, G.A. Res. 217 III(A), U.N. GAOR, 3d Sess., at 71, U.N. Doc. A/810 (1948).

115 See Warren & Brandeis, supra note 108, at 193.

116 See id.

117 See Recommendation (97)5, supra note 103, at 7.

118 See, e.g., the landmark decision in the case of Pavesich v. New England Life Insurance Co., 50 S.E. 68, 68-69 (Ga. 1905), where Judge Cobb examines the question to what extent an individual has a right of privacy which he can enforce.

119 See id. at 69.

120 See id.

121 See id.

122 See generally PHILIP KlTCHER, THE LIVES TO COME: THE GENETIC REVOLUTION AND HUMAN POSSIBILITIES (1996) (examining developing genetic technology); see also U.S. Congress, Office of Technology Assessment, New Developments in Biotechnology: Patenting Life—Special Report, OTABA- 370 (Washington, D.C.: U.S. Government Printing Office, Apr. 1989).

123 See Wilford, Benjamin S. & Nolan, Kathleen, National Policy Development for the Clinical Application of Genetic Diagnostic Technologies: Lessons from Cystic Fibrosis, 270 JAMA 2948, 2948-54(1993)Google Scholar.

124 “Genomic data are qualitatively different from other health data because they are inherently linked to one person. While non-genetic descriptions of any given patient's disease and treatment could apply to many other individuals, genomic data are unique.” Gostin, Lawrence O., Genetic Privacy, 23 J.L. MED. & ETHICS 320, 322 (1995)Google Scholar.

125 Annas, George J. et al., Drafting the Genetic Privacy Act: Science, Policy and Practical Considerations, J.L. MED. & ETHICS, 360, 360 (1995)Google Scholar.

126 See Ellen Wright Clayton, Informed Consent and Genetic Research, in GENETIC SECRETS, supra note 41, at 126.

127 See Gostin, supra note 124, at 320.

128 See Anita L. Allen, Genetic Privacy: Emerging Concepts and Values, in GENETIC SECRETS, supra note 41, at 31, 33.

129 See Resnik, David B., Genetic Privacy in Employment, PUB. AFF. Q. 47, 47-48 (1993)Google Scholar; PROMOTING SAFE AND EFFECTIVE GENETIC TESTING IN THE UNITED STATES: FINAL REPORT OF THE TASK FORCE ON GENETIC TESTING 13-14 (Neil A. Holtzman & Michael S. Watson eds., 1997).

130 See Annas et al., supra note 125, at 361-62.

131 See Niels Clemmensen, Denmark's Constitution 150 Years—England and the Danish Constitution of June 5 1849 (visited Jan. 26, 2000) http://www.um.dk/international/english/denmark/constitution_hist; see generally GUNNAR THRODDSEN, THE CONSTITUTION OF ICELAND (1946) (giving an overview of the Constitution of Iceland).

132 See generally THRODDSEN, supra note 131.

133 See, e.g., Convention for the Protection of Human Rights and Fundamental Freedoms, supra note 113; Universal Declaration of Human Rights, supra note 114; International Covenant on Civil and Political Rights, G.A. Res. 2200 A (XXI), U.N. GAOR (1966).

134 See Art. 66 of the original Constitution enacted in 1944, Law No. 33/1944.

135 See. e.g., K. Asmundsson v. The General Audit Office, Case No. 28/1989 (S. Ct. of Iceland 1989).

136 Law No. 62/1994.

137 See id.

138 Art. 71 of the amended Constitution, Law. No. 97/1995, Art. 9.

139 Id.

140 See Note to the Bill to the Law No. 62/1994 (enacting the Convention on Bioethics, supra note 13).

141 See id.

142 Convention for the Protection of Human Rights, supra note 113, at art. 8.

143 While most European countries have not enacted broad genetic privacy laws, specific statutes targeting genetic privacy are widespread. Germany, Austria and Switzerland are among the leading nations in Europe in this respect. See, e.g., Schwartz, supra note 41, at 405-08; see also supra notes 42^9.

144 See Patient Act, supra note 54, at arts. 4, 7, 10.

145 Law No. 68/1984.

146 See id. at art. 13.

147 See d'Ancona, Hedy, Patients’ Rights: Our Common Concern, A Welcome Address, in PROMOTION OF THE RIGHTS OF PATIENTS IN EUROPE 1, 1-2 (World Health Organization ed., 1995)Google Scholar.

148 See Patient Act supra note 54, at art. 5.

149 See id. at art. 14.

150 See id. at art. 10.

151 See id. at art. 2.

152 See id.

153 See id. at arts. 5-10.

154 See id. at art. 10.

155 See id. at art. 15.

156 Act Concerning the Recording and Handling of Personal Data No. 121/1989.

157 See Patient Act, supra note 54, at art. 15.

158 See Notes to the Database Bill, supra note 58

159 See Patient Act, supra note 54, at art. 15.

160 See Notes to the Database Bill, supra note 58.

161 See id.

162 See Database Act, supra note 2, at art. 8.

163 See id. at arts. 1-2.

164 See id. at art. 8.

165 See id.

166 Id.

167 See id.

168 Id.

169 Id.

170 See Interview of G. borsteinsdottir, Office Manager, Icelandic Health Ministry, Chairman of the working group on preparation of the Bill on Health Sector Database, in the Icelandic newspaper DV, January 16, 1999.

171 See Database Act, supra note 2, at art. 7.

172 See Council Directive 95/46 on the Protection of Individuals with Regard to the Processing of Personal Data and on the Free Movement of Such Data, 1995 O.J. (L 281) 31 [hereinafter Council Directive 95/46]. The Recommendations are, as the name suggests, mere guidelines of the Committee of Ministers under the terms of Article 15b of the Statute of the Council of Europe to the Member States. See Statute of the Council of Europe, supra note 17.

173 According to the Notes to the Database Act, supra note 58, the Council Directive 95/46, supra note 172, on Protection of Personal Data shall be included in the European Environment Agency (EEA) agreement in accordance with the EEA joint council's decision in December 1998. The Icelandic Government intends to enact the directive accordingly in the near future in accordance with its obligations to enact the subject matter of the Directive. See Notes to the Database Bill, supra note 58.

174 See Database Act, supra note 2, at art. 3; Council Directive 95/46, supra note 172, at 38.

175 Council Directive 95/46, supra note 172, at 40.

176 Id.

177 Id.

178 See id. at 39.

179 Id. at 33.

180 See id. at 38.

181 Id.

182 See Database Act, supra note 2, at art. 3.

183 See Council Directive 95/46, supra note 172, at 38.

184 See Council Directive 95/46, supra note 172, at 33.

185 Id. The controller as defined in Council Directive 95/46:

shall mean the natural or legal person, public authority, agency or any other body which alone or jointly with others determines the purposes and means of the processing of personal data; where the purposes and means of processing are determined by national or Community laws or regulations, the controller or the specific criteria for his nomination may be designated by national or Community law.

Id. at 38.

186 See id.

187 Recommendation (97) 5, supra note 103, at 6.

188 Id.

189 See id.; Council Directive 95/46, supra note 172, at 38.

190 See Notes to the Database Bill, supra note 58.

191 See id.

192 See Database Act, supra note 2, at arts. 13-15, 17.

193 Council Directive 95/46, supra note 172, at 39.

194 The first bill presupposed that all data would be personally identifiable. See Althing Doc. No. 1134-CaseNo. 661.

195 See Council Directive 95/46, supra note 172, at 40-41.

196 See id. at 41.

197 Id.

198 See id. at 40.

199 Id. at 41.

200 See id. at 40-41.

201 See id.

202 See Notes to the Database Bill, supra note 58.

203 See BLAUSTEIN & FLANTZ, supra note 50, at 6.

204 Churchill, Larry R. et al., Genetic Research as Therapy: Implications of “Gene Therapy” for Informed Consent, 26 J.L. MED. & ETHICS 38, 38-39 (1998)Google Scholar.

205 See OFFICE FOR PROTECTION FROM RESEARCH RISK, U.S. DEPT. OF HEALTH, EDUC. & WELFARE, THE BELMONT REPORT (1979), available at The Belmont Report (visited Jan. 27, 2000) http://www.nih.gov/grants/oprr/humansubjects/guidance/belmont.htm [hereinafter THE BELMONT REPORT].

206 See id.

207 See Szczygiel, Anthony, Beyond Informed Consent, 21 OHIO N.U. L. REV. 171, 178-93 (1994)Google Scholar (discussing the development of the common law doctrine of informed consent within the clinical care setting).

208 See Clayton, supra note 126, at 127.

209 Id.

210 See N.J. STAT. ANN. 10:5-45 (West 1999).

Genetic information not to be obtained without prior informed consent; exceptions: No person shall obtain genetic information from an individual, or from an individual's DNA sample, without first obtaining informed consent from the individual or the individual's representative according to regulations promulgated by the Commissioner of Health and Senior Services, in consultation with the Commissioner of Banking and Insurance, pursuant to subsection b. of section 9 of P.L. 1996, c. 126 (C.10:5-48). a. The requirement of this section shall not apply to genetic information obtained: … (5) For anonymous research where the identity of the subject will not be released.

Id.; see also OR. REV. STAT. § 659.710 (1998).

Informed consent required for obtaining genetic information; exceptions: (I) No person shall obtain genetic information from an individual, or from an individual's DNA sample, without first obtaining informed consent of the individual or the individual's representative, except: … (b) For anonymous research where the identity of the subject will not be revealed.

Id.

211 See Martin Enserink, Opponents Criticize Iceland's Database, 282 SCIENCE 859,859(1998).

212 See Jonathan M. Sarret & Linda A. Bailey, Environmental Population Screening, in GENETIC SECRETS, supra note 41, at 197, 202.

213 See Capron, Alexander Morgan, Informed Consent in Catastrophic Disease Research and Treatment, 123 U. PA. L. REV. 340, 340 (1974)Google Scholar.

214 See id. at 364.

215 See U.S. GENERAL ACCOUNTING OFFICE, REPORT TO THE RANKING MINORITY MEMBER COMMITTEE ON GOVERNMENTAL AFFAIRS, U.S. SENATE, SCIENTIFIC RESEARCH: CONTINUED VIGILANCE CRITICAL TO PROTECTING HUMAN SUBJECTS, GAO/HEHS-96-72 23 (1996).

216 The revised Declaration of Helsinki is available online at The Declaration of Helsinki (visited Feb. 29, 2000) http://www.unmc.edu/irb/source_documents/helsinki.htm.

217 See id.

218 See Clayton, supra note 126, at 127-28.

219 See id. at 132-33.

220 See Database Act, supra note 2, at art. 8.

221 Council Directive 95/46, supra note 172.

222 See Notes to the Database Bill, supra note 58.

223 See Database Act, supra note 2, at art. 8.

224 In February of 2000, a total of 16,600 people had requested to be excluded from the Database (of a total current population of approximately 270,000). See Mannvernd, Association for Ethics in Science and Medicine in Iceland (last modified Jan. 28, 2000) http://mannvernd.is/english/index.html. The most logical inference to draw from this fact is that the Database Act is supported by the majority of the Icelandic nation or, at least, the majority is indifferent to its existence.

225 See, e.g., id.

226 See id.

227 See Notes to the Database Bill, supra note 58.

228 See id.

229 For a further discussion on this subject, see generally E. RICHARD GOLD, BODY PARTS: PROPERTY RIGHTS AND THE OWNERSHIP OF HUMAN BIOLOGICAL MATERIALS (1996).

230 See Marie Hirtle & Bartha Maria Knoppers, Banking of Human Materials, Intellectual Property Rights and Ownership Issues: International Policy Positions and Emerging Trends in the Literature, available at Industry Canada's Intellectual Property Policy Directorate (visited Feb. 26, 2000) http://strategis.ic.gc.ca/pics/ip/knoppeef.pdf; see also Convention on Bioethics, supra note 13, at arts. 1-2, 21; Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the Legal Protection of Biotechnological Inventions, 1998 O.J. (L 213) 14 [hereinafter Directive 98/44].

231 See Convention on Bioethics, supra note 13, at art. 21.

232 See Directive 98/44, supra note 230, at 13.

233 The Office of Technology Assessment defines human biological material in the following way:

What are human biological materials? Human bodies contain a number of parts that can be useful in biomedical research. Healthy individuals continually produce a number of replenishable substances, including blood, skin, bone marrow, hair, urine, perspiration, saliva, milk, semen and tears. Human bodies also contain nonreplenishing parts, such as oocytes or organs, which may either be vital (e.g., heart) or to some extent expendable (e.g., lymph nodes or a second kidney). Finally, diseased examples of these body parts also exist.

OFFICE OF TECHNOLOGY ASSESSMENT, U.S. CONGRESS, NEW DEVELOPMENTS IN BIOTECHNOLOGY: OWNERSHIP OF HUMAN TISSUES AND CELLS—SPECIAL REPORT 24 (1987).

234 Diamond v. Chakrabarty, 447 U.S. 303 (1980).

235 See id. at 316.

236 See id. at 303.

237 See Council Directive 98/44, supra note 230, at 13 (acknowledging that “research and development in the field of genetic engineering require a considerable amount of high-risk investment, and therefore only adequate legal protection can make them profitable“).

238 See id.

239 See id.

240 See Rathman, George B., Biotechnology Case Study, in GLOBAL DIMENSIONS OF INTELLECTUAL PROPERTY RIGHTS IN SCIENCE AND TECHNOLOGY 319, 321 (1993)Google Scholar.

241 See id. at 321.

242 See Notes to the Database Bill, supra note 58.

243 See id.

244 See id.

245 In Article 14 of the first bill to the Patient Act submitted before the Althing in its 121st session, the respective health institution, doctor or other health workers who recorded the medical data were supposed to be the owners of the data. In the Althing's health and insurance Committee's opinion dated May 9, 1997, the committee suggested that Article 14 should be amended and the data should be kept where it is recorded without stipulating about the ownership of the data.

246 See discussion in the Althing, in its 10th meeting, Oct. 14, 1998, where three Members of Parliament criticized the Minister of Health position to maintain that patients had no proprietary rights in their medical data.

247 The amended bill to the Patient Act presupposed that those who record the medical data should be deemed as mere custodians. See Patient Act, supra note 54, at art. 14.

248 This position was maintained by the government when the Bill to the Patient Act came under discussion in the Althing in its 123rd session 1998-1999. See Parliamentary Doc. No. 814-Case No. 502 and Doc. No. 1065-Case No. 502.

249 See Patient Act, supra note 54, at art. 14.

250 See Database Act, supra note 2, at art. 7.

251 The Minister was responding to written question from a Member of Parliament with regard to the Database Act and gave her answers orally in a session in the Athing. See Parliamentary Doc. No. 42-Case No. 502.

252 793 P.2d 479 (Cal. 1990).

253 See id. at 480.

254 Id. at 481.

255 Id.

256 See id.

257 See id.

258 See id.

259 See id.

260 See id. at 482.

261 See Heyer, Christopher, Moore v. Regents of the University of California: The Right of Property in Human Tissues and its Effects on Medical Research, 16 RUTGERS COMPUTER & TECH. L.J. 629, 630 n.8 (1990)Google Scholar.

262 See Moore, 793 P.2d at 482.

263 See id.

264 See id. at 482.

265 See Moore v. Regents of the University of California, 249 Cal. Rptr. 494, 500-01 (1988).

266 See id.

267 See Moore, 793 P.2d at 482.

268 See id.

269 See id. at 480.

270 See id.

271 See id. at 489.

272 See id.

273 Id. at 493.

274 See id. at 495.

275 See id. at 493-95.

276 For a further discussion of Moore v. Regents of the University of California, see generally Hartman, Rhonda G., Beyond Moore: Issues of Law and Policy Impacting Human Cell and Genetic Research in the Age of Biotechnology, 14 J. LEGAL MED. 463 (1993)Google Scholar.

277 See RESTATEMENT (SECOND) OF TORTS §§ 652B-E (1976). Section 652B states that “one who intentionally intrudes, physically or otherwise, upon the solitude or seclusion of another or his private affairs or concerns, is subject to liability to the other for invasion of his privacy, if the intrusion would be highly offensive to a reasonable person.” Id. at § 652B. Section 652C states that “one who appropriates to his own use or benefit the name or likeness of another is subject to liability to the other for invasion of his privacy.” Id. at 652C.

278 See Zacchini v. Scripps-Howard Broadcasting, 433 U.S. 562, 576 (1977).

279 Carson v. Here's Johnny Portable Toilets Inc., 698 F.2d 831 (6th Cir. 1983).

280 See id. at 836.

281 See EDMUND W. KITCH & HARVEY PERLMAN, INTELLECTUAL PROPERTY & UNFAIR COMPETITION 599-603 (5th ed. 1998); see also 17 U.S.C. § 106 (1994).

282 See Moore v. Regents of the University of California, 793 P.2d 479,481 (Cal. 1990).

283 See Database Act, supra note 2, at art. 3.

284 See id. at art. 2.

285 See deCODE Genetics (visited Feb. 7, 2000) http://www.decode.is/newsroom/q_and_a/more_Q_and_A.htm.

286 See id.

287 See id.

288 See Mannvernd, Association for Ethics in Science and Medicine in Iceland (last modified Jan. 28, 2000) http://mannvernd.is/english/index.html.

289 See id.

290 See The Icelandic Medical Journal, June 1998, An Interview with Mr. Kari Stefansson, CEO of deCODE Genetics.

291 See id.

292 See Database Act, supra note 2, at art. 9.

293 See Notes to the Database Bill, supra note 58.

294 Id.

295 See id.

296 See id.

297 See id.

298 See id.

299 See Heald, Paul, Federal Intellectual Property Law and the Economics of Preemption, 76 IOWA L. REV. 959, 963-64 (1991)Google Scholar.

300 See RICHARD A. POSNER, ECONOMIC ANALYSIS OF LAW § 3.3 (4th ed. 1992).

301 See id.

302 See id.

303 See Armin Spura & Patrice Laget, Innovation in Biotechnology: A Comprehensive Analysis, Recent Trends in U.S. Biotechnology: A Comprehensive Analysis, available at The European Union (EU) in the US (visited Feb. 26, 2000) http://www.eurunion.org/search/query.asp (search for “Spura” using the search engine at this address).

304 Id.

305 Id.

306 See id.

307 See id.

308 See id.

309 See id.

310 See id.

311 Database, supra note 2, at art. 4.

312 See supra note 234 and accompanying text.

313 Diamond v. Chakrabarty, 447 U.S. 303, 316 (1980).

314 See id. at 317.

315 The Chakrabarty case was a significant component of the legal foundation behind the development of biotechnological startup companies who could raise capital from venture capitalists based upon the research expertise of their principals and the assurance of the Chakrabarty decision that the fruits of their research would be patentable. See KlTCH & PERLMAN, supra note 281, at 840.

316 According to an opinion survey in 1998 on behalf of deCODE Genetics, Inc., 58% of those surveyed supported the enactment of the Database Act. See Healthcare Database - deCODE genetics Inc. - News (visited Feb. 2, 2000) http://www.database.is/frettir/nr9.html.

317 See Donna E. Shalala, 8 Health Matrix 223 (1998).