Hostname: page-component-586b7cd67f-t8hqh Total loading time: 0 Render date: 2024-11-26T01:04:00.008Z Has data issue: false hasContentIssue false
  • English
  • Français

Biobanks as a Central Part of the Finnish Growth and Genomic Strategies: How to Balance Privacy in an Innovation Ecosystem?

Published online by Cambridge University Press:  01 January 2021

Sirpa Soini
Get access Rights & Permissions [Opens in a new window]

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.

Type
Symposium Articles
Information
Journal of Law, Medicine & Ethics , Volume 44 , Issue 1: Part II: Harmonizing Privacy Laws to Enable International Biobank Research , Spring 2016 , pp. 24 - 34
Copyright
Copyright © American Society of Law, Medicine & Ethics 2016

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

Kattelus, M., “Implementation of the Directive on the Application on Patient’s Rights in Cross-Border Healthcare (2011/24/EU) in Finland,” European Journal of Health Law 21, no. 1 (2014): 23–32.CrossRefGoogle Scholar
Hartlev, M., “The raison d’être of Nordic Health Law,” in Rynning, E. and Hartlev, M., eds., Nordic Health Law in a European Context (Brill, Leiden: Martinus Nijhoff Publishers, 2011): at 54–55.Google Scholar
Act on the Status and Rights of the Patients 785/1992 (also called Patient Rights Act), available at <https://www.finlex.fi/fi/laki/kaannokset/1992/en19920785.pdf> (last visited February 1, 2016).+(last+visited+February+1,+2016).>Google Scholar
Hartlev, , Supra note 2, at 54–55.Google Scholar
Peltonen, L., Jalanko, A. and Varilo, T., “Molecular Genetics of the Finnish Disease Heritage,” Human Molecular Genetics 8, no. 10 (1999): 1913–1923.CrossRefGoogle Scholar
Gissler, M. and Haukka, J., “Finnish Health and Social Welfare Registers in Epidemiological Research,” Norsk Epidemiologi 14, no. 1 (2004): 113–120.Google Scholar
FIHTA Healthtech Finland, “Industry overview,” available at <http://www.finnishhealthtech.fi/industry-overview> (last visited February 1, 2016).+(last+visited+February+1,+2016).>Google Scholar
Health Sector Growth Strategy for Research and Innovation Activities 16, 2014, available at <http://www.tem.fi/files/40138/TEMrap_16_2014_web_26052014.pdf> (last visited February 1, 2016).+(last+visited+February+1,+2016).>Google Scholar
Ministry of Social Affairs and Health, “Improving Health by Using Genomic Data, Finland’s Genome Strategy, Working Group Proposal,” available at http://issuu.com/sitrafund/docs/finland_genomestrategy (last visited February 1, 2016).Google Scholar
Id., at 20–25.Google Scholar
van Ommen, G.-J. et al., “BBMRI-ERIC as a Resource for Pharmaceutical and Life Science Industries: The Development of Biobank-Based Expert Centres,” European Journal of Human Genetics 23, no. 7 (2015): 893–900.CrossRefGoogle Scholar
Biobank Act (688/2012), English translation, available at <https://www.finlex.fi/fi/laki/kaannokset/2012/en20120688.pdf> (last visited February 1, 2016).+(last+visited+February+1,+2016).>Google Scholar
Stjernschantz-Forsberg, J. and Soini, S., “A Big Step for Finnish Biobanking,” Nature Reviews Genetics 15, no. 1 (2014): 6.CrossRefGoogle Scholar
Personal Data Act, available at <https://www.finlex.fi/fi/laki/kaannokset/1999/en19990523.pdf> (last visited February 1, 2016).+(last+visited+February+1,+2016).>Google Scholar
Governmental Proposal 86/2011 for a Biobank Act, available only in Finnish and Swedish.Google Scholar
The Constitution of Finland 731/1999, available at <https://www.finlex.fi/fi/laki/kaannokset/1999/en19990731.pdf> (last visited February 1, 2016).+(last+visited+February+1,+2016).>Google Scholar
Council of Europe, “Convention for the Protection on Human Rights and Fundamental Freedoms,” 1949, available at <http://conventions.coe.int/Treaty/en/Treaties/Html/005.htm> (last visited February 1, 2016).+(last+visited+February+1,+2016).>Google Scholar
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).+(last+visited+February+1,+2016).>Google Scholar
Act on the Openness of Government Activities 621/1999, available at <https://www.finlex.fi/fi/laki/kaannokset/1999/en19990621.pdf> (last visited February 1, 2016).+(last+visited+February+1,+2016).>Google Scholar
Decree 298/2009 on patient records, § 4, para. 3, not available in English. See <https://www.finlex.fi/fi/laki/smur/2009/2090298> (last visited February 28, 2016).+(last+visited+February+28,+2016).>Google Scholar
Act on the Protection of Privacy in Working Life 759/2004, § 15, available at <https://www.finlex.fi/fi/laki/kaannokset/2004/en20040759.pdf> (last visited February 1, 2016).+(last+visited+February+1,+2016).>Google Scholar
Act on electronic processing of personal data in social and health care 159/2007, not available in English.Google Scholar
Act on National registries on health care 556/1989, not available in English.Google Scholar
Medical Research Act 488/1999, available at <https://www.finlex.fi/fi/laki/kaannokset/1999/en19990488.pdf> (last visited February 1, 2016).+(last+visited+February+1,+2016).>Google Scholar
Act on the Medical Use of Human Organs and Tissues 101/2001, available at <https://www.finlex.fi/fi/laki/kaannokset/2001/en20010101.pdf> (last visited February 1, 2016).+(last+visited+February+1,+2016).>Google Scholar
EU Data Protection Directive, available at <http://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:31995L0046&from=EN> (last visited February 1, 2016).+(last+visited+February+1,+2016).>Google Scholar
Health Care Professionals’ Act 559/1994, available at <http://www.finlex.fi/fi/laki/kaannokset/1994/en19940559.pdf> (last visited February 1, 2016).+(last+visited+February+1,+2016).>Google Scholar
Health Care Act 1326/2010 available at <https://www.finlex.fi/fi/laki/kaannokset/2010/en20101326.pdf> (last visited February 1, 2016).+(last+visited+February+1,+2016).>Google Scholar
Finland Penal Code 39/1889, available at <https://www.finlex.fi/fi/laki/kaannokset/1889/en18890039.pdf> (last visited February 1, 2016).+(last+visited+February+1,+2016).>Google Scholar
See Townend, D., “EU Laws on Privacy in Genomic Databases and Biobanking.” Journal of Law, Medicine & Ethics 44, no. 1 (2016) 128–142.CrossRefGoogle Scholar
See webpage of TUKIJA, available at <www.tukija.fi/en> (last visited February 1, 2016).+(last+visited+February+1,+2016).>Google Scholar
Supra note 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.”Google Scholar
Article 29 Data Protection Working Party, “Opinion 4/2007 on the concept of personal data,” at 15-16, example No. 13 and at 18, available at <http://ec.europa.eu/justice/policies/privacy/docs/wpdocs/2007/wp136_en.pdf> (last visited February 1, 2016).+(last+visited+February+1,+2016).>Google Scholar
Kaye, J. et al., “Dynamic Consent: A Patient Interface for Twenty-First Century Research Network,” European Journal of Human Genetics 23, no. 2 (2015): 141–146.CrossRefGoogle Scholar
Committee on a Framework for Development a New Taxonomy of Disease; National Research Council, “Toward Precision Medicine: Building a Knowledge Network for Biomedical Research and a New Taxonomy of Disease,” 2011, available at <http://www.nap.edu/catalog/13284/toward-precision-medicine-building-a-knowledge-network-for-biomedical-research> (last visited February 1, 2016).+(last+visited+February+1,+2016).>Google Scholar
Supra note 12; see also Pathmasiri, S. et al., “Intellectual Property Rights in Publicly Funded Biobanks: Much Ado about Nothing?” Nature Biotechnology 29, no. 4 (2011): 319–323.CrossRefGoogle Scholar
See THL Biobank’s Access policy, available at <https://www.thl.fi/documents/10531/689268/2015+THL+Biobank+General+Terms+of+Access.pdf/0fa83ca9-6ac7-4a4f-95e2-6bb8999539b7> (last visited February 1, 2016).+(last+visited+February+1,+2016).>Google Scholar
Supra note 30.Google Scholar
Supra note 9, Objective 3.5, at 26–28.Google Scholar
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).+(last+visited+February+1,+2016).>Google Scholar
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).+(last+visited+February+1,+2016).>Google Scholar
Global Alliance for Genomics and Health, “Framework for Responsible Sharing of Genomic and Health-Related Data,” available at <http://genomicsandhealth.org/about-the-global-alliance/key-documents/framework-responsible-sharing-genomic-and-health-related-data> (last visited February 1, 2016).+(last+visited+February+1,+2016).>Google Scholar