title: Biobanks as a Central Part of the Finnish Growth and Genomic Strategies: How to Balance Privacy in an Innovation Ecosystem?
abstract: Finland has aimed to make itself an international leader in genomic research and related business and, in working towards that goal, has enacted biobank legislation. The Biobank Act requires biobanks to gain approval, be supervised, and register at the national level. Numerous other laws may also apply in any given research setting, such as the Personal Data Act, the Medical Research Act, and the Act on Medical Use of Human Organs and Tissues.In terms of privacy protection, anonymization is generally not permitted under Finnish law and therefore most biobanks pseudonomize data and samples. However, the broad understanding of what is identifiable data in Finland has created difficulties in sharing with non-EU countries. Furthermore, consent to biobank research is only applicable to the sample and related data, not to data stored in other health-related registries, and consent is only to the field of research for that particular biobank. These restrictions impede the sharing of samples and data for research.
authors.affiliation: Sirpa Soini, LL.M. works as senior legal adviser in Helsinki, and specializes in biomedical law and regulation. Alongside legal practice, she is engaged in various research and collaboration projects. She is a member of the National Medical Research Ethics Committee of Finland (TUKIJA), Senior legal adviser Academic Medical Center of Helsinki Biobank, and National Biobanking Steering Group (Ministry of Health and Social Affairs). Her pending doctoral dissertation at the Faculty of Law, Helsinki, studies legal pluralism in biomedical regulation.
authors.forename: Sirpa
authors.initials: S
authors.lastname: Soini
mesh_terms: D018070:Biological Specimen Banks; D017753:Ecosystem; D005387:Finland; D023281:Genomics; D006801:Humans; D018907:Privacy