Sweden

Legislation

Freedom of Information/Access to Official Documents

Some of this legislation forms a part of the Swedish Constitution and the provisions primarily focus on the requirements and limits of lawful disclosure and dissemination of information and documents held by public agencies, including publicly run health care institutions and universities etc. There is also general legislation on requirements for the preservation of official documents. Furthermore, there are certain legal rules overriding the ordinary provisions in extraordinary situations, for example in relation to investigation of serious crimes (or perhaps not so serious).

  • Instrument of Government (1974:152) webpage
  • Freedom of the Press Act (1949:105) webpage
  • Act (1980:100) on Secrecy
  • Archives Act (1990:782)
  • Penal Code (1962:700) webpage
  • Code of Judicial Procedure
  • Act (2004:168) on Transmittable Diseases

Processing of Personal Data

The second category contains a number of statutes and ordinances enacted at least partly for the implementation of the Data Protection Directive, thus explicitly addressing different areas of processing of personal data, as defined in the Personal Data Act. It is important to note that in the data processing performed by public agencies, this legislation is subsidiary to the traditional set of rules mentioned above, which governs access to official documents.

  • Personal Data Act (1998:204) webpage
  • Police Data Act (1998:622)
  • Act (1998:543) on Health Data Registers
  • Act (1999:353) on Research Registers for Forensic Psychiatry
  • Patient Data Act (2008:355)

Other Applicable Legislation

Then there is also complementing legislation addressing privacy issues not covered by the two sets of rules mentioned above, dealing e.g. with genetic integrity, donor autonomy and various measures aimed at reducing the risk of privacy infringements in relation to the taking, collection, storage and use of human biological material, as well as the use of genetic information.

  • Act (2006:351) on Genetic Integrity webpage
  • Act (2003:460) on Ethics Review of Research Involving Humans webpage
  • Biobanks in Medical Care Act (2002:297) link to pdf
  • Act (1998:531) on Professional Activities in Health and Medical Services
  • Transplant Act (1995:832)
  • Autopsy Act (1995:832)
  • Medicinal Products Act (1992:859)
  • Health and Medical Services Act (1982:763)link to pdf

Certain relevant provisions can also be found in for example the more recent

  • Act (2006:496) on blood safety
  • Act (2008:286) on standards of quality and safety in use of human tissues and cells

In addition to this, there are numerous ordinances passed by the Government in relation to the different Acts above, also ones specifically regulating the prerequisites for various automated registries under the Act on Health Data Registers. Finally, there are numerous relevant regulations, issued primarily by the National Board on Health and Welfare.

Guidance

  • The Swedish Association of Local Authorities and Regions (SALAR), runs the National Biobank Council, which contains guidelines on research access to biobanks in Swedish. SALAR also negotiated access agreements between Universities and county councils.
  • The Data Protection Board has issued practical guidance on the processing of sensitive personal data in research (2003:1), processing of genetic data for research (2002:4) and data processing in relation to biobanking (2001:2 and 2004:2). It also issued guidance on consent requirements, and processing personal data in research.
  • The Swedish Research Council adopted ethical guidelines on biobank research in 2003, and more general guidance on the use of sensitive data in 2007.

Biobanks/Genetic Databases

  • The National Board of Health and Welfare keeps a register of  biobanks falling under the Biobanks in Medical Care Act (2002), which is not easily accessible and does not cover all biobanks. A response to a request for registered biobanks established for research purposes mentioned approx. 25 research biobanks containing 0-30000 samples.
    • The Swedish Research Council (2008) report does list some of the largest research biobanks, including the Medical biobank in Umeå (265 000 blood samples, previously commercialised by UmanGenomics); The Karolinska Institutet (KI) Biobank (40 000 subjects from different projects); Cohort of Swedish Men (46 000 participants); and All Babies in Southeast Sweden (ABIS) (17 000 subjects).
    • Lifegene - prospective cohort study studying half a million Swedes (using samples, questionnaires and follow-up) with the aim of creating new tools to prevent, diagnose and treat common diseases.
  • Dual or multi-use biobanks (e.g. for health care/research purposes) are very common, with each of the 20 County Councils storing samples. There are efforts to coordinate these to develop regional/e-biobanks by SALAR.
    • The Swedish National Biobank Program estimate the health care system contains 50-100 million samples in departments such as Clinical pathology and cytology (e.g. Cervical cytology) departments; Clinical Microbiology ; Maternity Welfare ; Newborn screening (including the PKU  biobank). Examples of these types of biobanks are listed on the website.

References

  • Codex contains both international and domestic research related legislation, regulations and guidelines.
  • Hoeyer, K (2006) ‘The Power of Ethics: A case study from Sweden on the social life of moral concerns in policy processes‘ Sociology of Health and Illness 28:6, 785 - 801.
  • Swedish Research Council (2008) Biobanks - Integration of Human Information to Improve Health (English).
  • 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.