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.
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References
1.
M.Kattelus, “Implementation of the Directive on the Application on Patient’s Rights in Cross-Border Healthcare (2011/24/EU) in Finland,”European Journal of Health Law21, no. 1 (2014): 23–32.
2.
M.Hartlev, “The raison d’être of Nordic Health Law,” in E.Rynning and M.Hartlev, eds., Nordic Health Law in a European Context (Brill, Leiden: Martinus Nijhoff Publishers, 2011): at 54–55.
Ministry of Social Affairs and Health, “Improving Health by Using Genomic Data, Finland’s Genome Strategy, Working Group Proposal,”available athttp://issuu.com/sitrafund/docs/finland_genomestrategy (last visited February 1, 2016).
10.
Id., at 20–25.
11.
G.-J.van Ommen, “BBMRI-ERIC as a Resource for Pharmaceutical and Life Science Industries: The Development of Biobank-Based Expert Centres,”European Journal of Human Genetics23, no. 7 (2015): 893–900.
Council of Europe, “Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine,”1997, available at <http://conventions.coe.int/Treaty/en/Treaties/Html/164.htm> (last visited February 1, 2016).
See D.Townend, “EU Laws on Privacy in Genomic Databases and Biobanking.”Journal of Law, Medicine & Ethics44, no. 1 (2016) 128–142.
31.
See webpage of TUKIJA, available at <www.tukija.fi/en> (last visited February 1, 2016).
32.
Supranote 26, Recital 26: whereas to determine whether a person is identifiable account should be taken of all the means likely reasonably to be used either by the controller or by any other person to identify the said person.”
Supra note 12; see also S.Pathmasiri, “Intellectual Property Rights in Publicly Funded Biobanks: Much Ado about Nothing?”Nature Biotechnology29, no. 4 (2011): 319–323.
Regulation (EU) No 536/2014 of the European Parliment and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (Text with EEA relevance), now in Recital 80, available at <http://ec.europa.eu/health/files/eudralex/vol-1/reg_2014_536/reg_2014_536_en.pdf> (last visited February 1, 2016).
41.
World Medical Association (WMA), “On Ethical Considerations Regarding Health Databases and Biobanks,” 2015-03-18, A draft from the Work Group intended for open consultation after acceptance of the Executive Committee of the WMA”, avaialable at <http://www.wma.net/en/20activities/10ethics/15hdpublicconsult/2015-Draft-policy-HDB_BB.pdf> (last visited February 1, 2016).
