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Biobank activities will be harmonised

Biobanks are part of the research infrastructure. In biobanks, samples of human origin and related data are stored for supporting research.

Biobanks operate in Finland in connection with hospital districts, universities, the National Institute for Health and Welfare (THL), the Finnish Red Cross Blood Service, the Finnish Hematological Registry and healthcare service company Terveystalo.

The establishment and operation of biobanks in Finland are regulated and supervised. The National Supervisory Authority for Welfare and Health to the Finnish Medicines Agency (FIMEA) directs and monitors biobank activities and maintains a national biobank register, which was established to provide information and increase transparency with regard to biobank activities. Until the end of 2019, the direction and monitoring tasks belonged to the National Supervisory Authority for Welfare and Health (Valvira).

There are currently eleven registered biobanks in Finland.

In 2017, the hospital districts and universities founded a joint service unit called the Finnish Biobank Cooperative, FINBB. All hospital biobanks and THL Biobank are members of the cooperative. In addition, the cooperative has a cooperation agreement with, for example, the Teveystalo biopankki.

The role of the cooperative is to support the activities of biobanks by harmonising operating practices, developing tools and simplifying processes. Biobanks will continue their core activities, i.e. the processing of samples and related data in order to support research, but with the help of the cooperative, biobank data can be accessed centrally through, for example, the Fingenious service.

Comprehensive reform of the Biobank Act

A comprehensive reform of the Biobank Act (688/2012) continues. In the further preparation of the bill on reforming the act, the opinions submitted to the Ministry of Social Affairs and Health during the consultation round from 28 March 2018 to 11 May 2018 have been taken into account, and the proposal has been further developed based on expert views.

The reform of the Biobank Act is a legally challenging task as it reconciles many needs:

  • the needs identified by the biobank legislation steering group,
  • the clarifications and amendments required by the Regulation of the European Parliament and of the Council on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation),
  • and the harmonisation of the Biobank Act and other legislation, such as the Act on Secondary Use of Social and Health Data (552/2019), the Act on the Electronic Processing of Client Data in Healthcare and Social Welfare (159/2007), and the bill on a Genome Center and on processing of genomic data (Genome Act).

Background material

Further information:

Petra Nikkanen, Legal Adviser 
Ministry of Social Affairs and Health, Turvallisuus ja terveys -osasto / TUTO, Bioteknologia ja lääkkeet -yksikkö / BILA 
Telephone: 0295163293, email address: [email protected]

Kristiina Kaski, Specialist 
Ministry of Social Affairs and Health, Turvallisuus ja terveys -osasto / TUTO, Bioteknologia ja lääkkeet -yksikkö / BILA
Telephone: 0295163320, email address: [email protected]
 

Further information