Iceland

Legislation

  • Icelandic Data Protection Act (Act on the Protection of Privacy as regards the Processing of Personal Data, No. 77/2000)
  • Act on a Health Sector Database no. 139/1998 Governing the creation and operation of a centralised database of non-personally identifiable health data (including genetic data)  in order to increase knowledge to improve health and health services (Article 1), and includes the right to opt-out (Article 8). This Act does not apply to biological samples.
  • Act on Biobanks No. 110/2000 - applies to the collection of biological samples, and their keeping, handling, utilisation and storage in biobanks - “a collection of biological samples which are permanently preserved” (Arts 2 & 3). The Act does not cover samples which are temporarily stored for up to five years, which may include samples used for research. The Act does not cover the storage of gametes and embryos.
  • Regulations including Regulations on the keeping and utilisation of biological samples in biobanks No 134/2001 apply to the collection of biological samples, their storage, handling, utilisation and preservation in biobanks and complement Act 110/2000.
  • Clinical Trials Legislation.
  • Court Cases including:
    • The Icelandic Supreme Court Case Gudmundsdottir, R. vs. The State of Iceland 27 November 2003, Information about the case, verdict. In the court case a young woman requested that health information in the medical records of her deceased father should not be transferred to the Icelandic Health Sector Data Base. The Supreme court accepted the request on the grounds that she had her own interest in preventing the transfer of her father’s health data – as “information could be inferred from such data relating to the hereditary characteristics of her father which might also apply to herself” (Verdict, page 1). The Health Sector Database Act was in effect shown to be unconstitutional, as it did not protect privacy sufficiently considering the privacy provisions in the Icelandic Constitution.
    • Another court case dealt with the issue of medical privacy and ended with the sentencing of a doctor who had taken information on a patient from medical records, and given an insurance company some information about the health condition of the patient without his explicit consent Information about case (in Icelandic)

Biobanks/Genetic Databases

  • deCODE Genetics - a bio-pharmaceutical company developing products to improve the treatment, diagnosis and prevention of common diseases [For Biobank information see P3G Catalogue]. The company uses medical records for specific research projects, and has genetic samples from over a third of the population. It has also created a database with the genealogies of the population from the settlement in the 9th century to the present day that has been made open to the public (“Íslendingabók”).
  • Reykjavik Heart Study - investigation of the interaction between age, genes and environment [P3G Catalogue][Icelandic Heart Association]

Useful References

  • Kaye. J, Helgason HH, Nomper A et al “Population genetic databases: a comparative analysis of the law in Iceland, Sweden, Estonia and the UK.” TRAMES 2004; 8: 15 – 34.
  • Gibbons, S. et al ‘Lessons from European population genetic databases: comparing the law in Estonia, Iceland, Sweden and the United Kingdom’ (2005) 12 EJHL 103.
  • Kaye. J “Do we need a uniform regulatory system for biobanks across Europe?” European Journal of Human Genetics (2006) 14, 245 – 248.
  • Gibbons, S., “Are UK genetic databases governed adequately? A comparative legal analysis” [with Estonia, Iceland and Sweden] Legal Studies, Vol. 27 No. 2, June 2007, pp. 312–342.
  • Gertz, R. “An Analysis of the Icelandic Supreme Court Judgement on the Health Sector Database Act“(2004) 1:2 SCRIPT-ed.
  • Arnason, V. “Coding and Consent: Moral Challenges of the Database Project in Iceland” (2004) Vol. 18 No. 1 Bioethics.
  • Greely, H. T. “Iceland’s Plan for Genomics Research: Facts and Implications”. Jurimetrics (2000) 40: 153–191.
  • Rose, H “The Commodification of Bioinformation: The Icelandic Health Sector Database (IHSD)” Published by The Wellcome Trust, London (2001).
  • Winickoff, D.E. “Genome and Nation. Iceland’s Health Sector Database and its Legacy“. Innovations, MIT Press (2006).