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 Finnish
Act on the National Institute for Health and Welfare (Finlex 668/2008) in English, unofficial translation (pdf 29 kb)
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 Finnish
The Biobank Act (Finlex 688/2012) in English, unofficial translation (pdf 96 kb)
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.
- The Act on the Medical Use of Human Organs, Tissues and Cells (Finlex 101/2001) in Finnish
The Act on the Medical Use of Human Organs, Tissues and Cells (Finlex 101/2001) in English, unofficial translation (pdf 109 kb) - The Medical Research Act (Finlex 488/1999) in Finnish
The Medical Research Act (Finlex 488/1999) in English, unofficial translation (pdf 39 kb)
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.
- EU General Data Protection Regulation (EUR-Lex 2016/679)
- Data protection Act (Finlex 1050/2018) in Finnish
Data protection Act (Finlex 1050/2018) in English, unofficial translation (pdf 351 kb) - The Act on the Openness of Government Activities (Finlex 621/1999) in Finnish
The Act on the Openness of Government Activities (Finlex 621/1999) in English, unofficial translation (pdf 191 kb)
The use of national health care and patient registers is governed by the following acts:
- Act on the Secondary Use of Health and Social Data (Finlex 552/2019) in Finnish
Act on the Secondary Use of Health and Social Data (Finlex 552/2019) in English, unofficial translation (pdf 5,4 Mb) - The Act on the Status and Rights of Patients (Finlex 785/1992) in Finnish
The Act on the Status and Rights of Patients (Finlex 785/1992) in English, unofficial translation (pdf 41 kb) - The Act on the Electronic Processing of Client Data within Social Welfare and Health Care (Finlex 159/2007) in Finnish
(not available in English)