Guidance and supervision of biobanks at Fimea

Guidance and supervision of biobanks at Fimea

Fimea's task is to steer and supervise biobanks. As part of this supervision, Fimea regularly inspects biobanks. For implementing biobank regulation, Fimea has the right to inspect the premises and operations of biobanks as well as any relevant documents. As part of biobank inspections, assessment is also made of the implementation of the right to self-determination, protection of privacy, and transparency in the use of biobank samples.

An inspection record is drawn up for each inspection, and a copy of this is sent to the biobank owner and the person responsible for the biobank within 30 days of the inspection. The custodian of the biobank must immediately initiate any measures needed to address identified deficiencies and inform Fimea of the measures to be taken and of the timetable for their implementation within 30 days of receiving the inspection report.

Reform of the Biobank Act

The Biobank Act (688/2012) entered into force on 1 September 2013. A project aiming at a comprehensive reform of the Biobank Act is currently being carried out within the Ministry of Social Affairs and Health. The aim of the reform is to implement, for both the Biobank Act and to other laws relating to biobank activities, the needed amendments that have come to light following the introduction of the EU General Data Protection Regulation and various problems of legal interpretation that have arisen in the application of the Biobank Act. The reform of biobank legislation is also linked to the Act on the Secondary Use of Social and Health Data (the ‘Secondary Use Act’), which entered into force on 1 May 2019, and to the Genome Act, which is being currently in preparation.