Denmark

Legislation

• Act on Processing of Personal Data (APPD)(No. 429 of 31 May 2000 with later amendments).
• Act on a Biomedical Research Ethics Committee System (Act No. 402 of 28 May 2003 with later amendments)(circular outlining amendments through Act No. 272 of 1 April 2006), supported by:
  • Ministerial Order No 806 of 12 July 2004 on Information and Consent at Inclusion of Trial Subjects in Biomedical Research Projects  (pdf: In English)
• Act on Health (Consolidation Act No. 95 of 7 February 2008 with later amendments). The Act is supplemented by administrative regulations including ministerial orders and guidelines concerned with patients rights in regards to tissue samples, specifically:
  • Ministerial Order No. 966 of 22 September 2004 on the ‘Use of Tissue Register’ and
  • Guideline No. 83 of 22 September 2004 on Biobanks in the Health Care Services – Patients Rights and Duties of the Authorities.
• Act on Patients’ Rights No. 482 of 01 July 1998 (In Danish)
• Other Legislation including:
  • The Act on Quality and Safety in Regards to Human Tissue and Cells (The Tissue Act) (Law No. 273 of 1 April 2006)[In Danish], which implements EU Directive 2004/23/EC. Many orders and guidelines relating to this Act have been issued by the National Board of Health.
  • There are also special regulations in Danish law regarding the use of genetic information in insurance- and employment relations.

Guidance

• No ‘official’ practical guidance or codes of good practices specifically regulating research using BBGDs.
• The Danish Medical Association has issued ethical guidelines regarding genetic testing and counselling.
• The National Committee on Biomedical Research Ethics has issued Guidelines about Notification etc. of a Biomedical Research Project to the Committee System on Biomedical Research Ethics (May 2008) which include extensive information regarding research on tissue samples.

Biobanks/Genetic Databases

• Biobanks must register with the Danish Data Protection Agency, the website shows 135 biobanks registered.
• Harmonisation of all Danish biobanks to be used for research purposes through “Biobank Denmark” who have counted approximately 15 million samples.
• Dual or multi-use biobanks (e.g. for diagnosis and scientific purposes) are common, examples include the Danish PKU (Phenylketonuria) Biobank and those on hospital pathological wards.

Other References

• Danish Government white paper on biobanks in the health care services.
• Statens Sundhedsvidenskabelige Forskningsråd (Danish Medical Research Council) (1996). Health Science Information Banks – Biobanks.
• Ministry of Science Technology and Innovation Press Release “Denmark To Set Up World-Class National Biobank“  Feb 24, 2009.