More on Purpose and Scope of The Swedish Biobanks Act

Biological samples are routinely collected in hospitals and clinics. Many of these samples are stored for longer periods of time, for instance samples collected in general medical examinations for diagnostic purposes or for later use in research projects. Tissue is sometimes removed from patients as part of a treatment regiment, or are donated for transplantation or other medical purposes. Biobanks may thus contain samples from both living and deceased persons, as well as from foetuses.

The Biobanks Act regulates the use of these biological materials from humans. The Act has been in force since January 1, 2003. The explicit purpose of the biobank regulation is to safeguard access to stored material for researchers and clinicians, while protecting the integrity of the individual sample provider.

The Biobanks Act only regulates the use of the biological material itself. The use of any information concerning the patients (sample providers) – case records, health registers, code keys, etcetera – is regulated elsewhere, mainly in the Medical Records Act, the Secrecy Act, the Personal Data Act, and the so-called data file statutes.

The Biobanks Act does not regulate samples collected in biobanks outside the health care domain.

The Act regulates materials that are stored for longer periods of time. In the preparatory work, it is suggested that the period intended for the scope of the act is storage exceeding two months.
As for the kinds of materials that fall under the regulation, the Biobanks Act only regulates the use of materials that can be traced to the individual persons from whom it has been collected.

The Biobanks Act is subsidiary in relation to other statutes, which means that if there are divergent provisions in other statutes, then these will override the Biobanks Act. Such provisions are found in the Transplant Act, the Autopsy Act, and in the Act on Research or Treatment Activities involving Fertilised Human Ova. However, there are special regulations concerning the so-called PKU registry (a screening program on all new-born babies that has been going on since1974) and the PKU biobank in the Biobanks Act, chapter 5, and these override other regulations.