Laws and regulation
The biobank law
The Finnish Parliament approved the Biobank Law on October 2, 2012 (law 688/2012). The law entered into force on September 1, 2013. This law will improve opportunities for citizens to obtain information about ongoing research projects that use their samples. The sample donors can also prohibit the use of their samples, at any stage of the research project. The Biobank Law requires technical solutions that will allow donors to monitor the usage of their samples. From 2020, Finnish Medicines Agency Fimea directs and supervises the activities of Finnish biobanks. Until that, Valvira had the same role. Additionally, the establishment of a new biobank requires a supportive statement by the National Committee on Medical Research Ethics.
In addition to ensuring donors’ sovereignty and the protection of privacy, the Biobank Law also includes many provisions relating to the organization and operation of a biobank. It authorises the transfer to the biobank of samples collected in the past, as well as future collecting of samples.