Which samples are covered by the Swedish Biobank Act

The Biobank Act applies to identifiable human biological samples collected in Sweden and stored or intended to be stored for more than 9 months after sampling* in a biobank and are used for the purpose of

  1. care, treatment, or other medical purposes within the provision of healthcare,
  2. research,
  3. product manufacturing, or 
  4. education, quality assurance or development work within the framework of any of the purposes stated in 1–3.

It is the purposes for which samples are collected, stored, or used that determine whether the Biobank Act is applicable or not.

It doesn’t matter where samples are collected. For example, samples taken outside the health care system are also covered if they are collected, stored, or used for the purposes mentioned above.

The Biobank Act will also apply to samples collected for a purpose not covered by the Act, if and when it becomes relevant for use for one of the purposes covered by the Act.

*Please note. The Act must be applied to samples even before nine months if

  • the intention from the outset is to store the sample for more than nine months, or
  • the sample is not destroyed immediately after it has been analysed.