What is a Biobank?

The Swedish Act on Biobanks (SF 2002:297) defines the concept "Biobank"
as "biological material from one or several human beings collected and stored indefinitely or for a specified time and whose origin can be traced to the human or humans from whom it originates"

The definition of the concept biobank in the Swedish Act on Biobanks differs from Previous medical usage, In which "biobank" denotes a large collection of samples brought together for use in research.

According to the Swedish Act on Biobanks,

• the size of the sample collection has no significance; a single human sample may be a biobank.
   
• there is no difference between samples collected for research or during routine medical care.
   
• human biological material where it is NOT possible to identify the person from whom the material originates, by any means, is not biobank material. (i.e., unidentified human biological material).
   
• coded human biological material, for which there exists any kind of a translation key or sequence of translation keys between the code and a personal identifier, is regarded as biobank material.

The Swedish Act on Biobanks covers the handling of biological samples. The information that is gained during analysis of a sample is, however, governed by other regulations, such as Patientjournallagen (the Swedish Act of Medical Records), Personuppgiftslagen (the Swedish Act of Personal Information), Sekretesslagen (the Swedish Official Secrets Act) and Etiklagen (the Swedish Act on Ethics).

The largest existing biobanks in Sweden consists of samples collected during routine medical care that are stored after analysis. These biobanks belongs to the counties of Sweden responsible for the provision of medical care.