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. Valvira, the National Supervisory Authority for Welfare and Health, directs and supervises the activities of Finnish biobanks. 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.
From the point of view of the researcher, the most important change made by the Biobank Law is the authorisation to compile samples for research programs which are not yet fully formulated. Until now, the collection of samples for research has generally followed a process similar to, for example, that conducted in clinical drug trials, in which the rationale for the use of donors’ samples and data was explained to them in great detail. Therefore, novel usage of the samples considering any new research has not been possible without first obtaining a new consent of the donor.
Read more: Finland on a road towards a modern legal biobanking infrastructure by Sirpa Soini, Published at European Journal of Health Law 2013 (3) 289-94
In Finland, the biobanking activity is governed by the following laws:
- The Biobank Law (pdf)
- The Law on the medical use of human organs, tissues and cells (in Finnish)
- The Law on the status and rights of the patient (in Finnish)
- The Medical research law (in Finnish)
- The Personal data Act (in Finnish)
The following authorities guide and monitor the Finnish biobanks:
- The National Supervisory Authority for Welfare and Health (VALVIRA)
- The National Committee on Medical Research Ethics (TUKIJA)
- The applicable regional ethical committees
For a quick tour on aspects of the Biobank law, please see Soini Law Building Bridges 281013