A new Biobank Act

On this page, you can find information in English regarding the new Swedish Biobank act, effective July 1, 2023.

The Swedish Biobanks in Medical Care Act (SFS 2002:297) allows human biological material that have been collected and/or stored for healthcare purposes to be used in research and clinical trials if the patient/donor has given consent. However, on July 1, 2023, Sweden will have a new Biobank Act, effective from that day.

Biobank Sweden have created an unofficial English translation of the Biobank Act (2023:38), as well as summarized some of the main changes of the new act compared to the current one in a separate document. Among the key changes are:

• Expanded scope.
• The purposes determine the legal requirements
• New exceptions are imposed
• Removal of secondary biobanks
• New rules for access to samples
• Removal of general subsidiarity
• Samples may be stored abroad
• More explicit rules on de-identification
• New rules on penalties, damages, and supervision
• Simplified definitions and clarified responsibilities

For more information and specifics regarding the changes that comes with the new Biobank Act, see our documents below.

Documents

A New Biobank Act – a summary (updated on 2023-02-16)

English translation of the Biobank Act (2023:38) (2023-04-05)

Biobank Sweden is not responsible for any errors in this material or for any damage that may be caused by such errors. If you find inaccuracies in the material, please report these to info@biobanksverige.se.

Link to the upcoming legislation:

Biobankslag (2023:38) Svensk författningssamling 2023:2023:38 – Riksdagen (Swedish only)