Legal framework of biobanking

THL's official duties include following up and studying population health and welfare, according to the Act on the National Institute for Health and Welfare (668/2008). For this purpose THL collects samples and information.
Act on the National Institute for Health and Welfare (Finlex 668/2008) in FinnishLink to an external websiteOpens in a new tab
Act on the National Institute for Health and Welfare (Finlex 668/2008) in English, unofficial translation (pdf 29 kb)Link to an external websiteOpens in a new tab

The Biobank Act (688/2012), which took effect on 1 September 2013, aims to specify the practices and principles governing the use of human biological samples in different kinds of medical research projects that are not necessarily known at the time of the donation.
The Biobank Act (Finlex 688/2012) in FinnishLink to an external websiteOpens in a new tab
The Biobank Act (Finlex 688/2012) in English, unofficial translation (pdf 96 kb)Link to an external websiteOpens in a new tab

There are also several other acts and ethical guidelines that complement and specify the practices and principles governing biobanking activities. The Act on the Medical Use of Human Organs, Tissues and Cells (101/2001), for example, regulates the use of human organs, tissues and cells, removed as part of health care activities, for the purposes of medical research. The Act also regulates the transfer of such organs, tissues and cells to biobanks. The Medical Research Act (488/1999) defines the general practices concerning medical research as well as the rules governing the regional ethics committees.

EU General Data Protection Regulation (GDPR), Finnish Data Protection Act (1050/2018) and the Act on the Openness of Government Activities (621/1999) include further provisions governing the processing of and access to personal information for research purposes.

The use of national health care and patient registers is governed by the following acts:

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