In the Swedish framework, biobanking has as its main legislative reference the law on biobanking in the healthcare sector of 2002. At the beginning of 2018, a governmental committee launched a proposal for a new law on biobanks. The new law on biobanks will come into force in 2023. When the biobank is used for research or clinical trial, that decision must be approved by a research ethics committee. There is a special law on the ethical assessment of all research projects.
As to the use/reuse of historical archives of health data, patient’s records must be kept for 30 or 50 years, depending on the circumstances. Secrecy should always prevail unless it is clear that such information may be disclosed or disclosed without any harm to the persons concerned. In relation to medical research, absolute secrecy will prevail for 70 years without any risk assessment in the specific case. The collection of human samples requires the consent of the person involved. Those samples can only be used for the purpose for which the consent was given. The time of preservation shall be stated and clarified in the statutes of the Biobank.