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Biobank Regulation in Finland and the Nordic Countries

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Biobank Regulation in Finland and the Nordic Countries Biobank Regulation in Finland and the Nordic Countries By Dr. Salla Silvola, University of Helsinki l 1 The biobank as a concept The term biobank, or biopankki, in Finnish, is not used in everyday life in Finland. Neither does the concept of the biobank appear in the existing legislation in Fin- land.2 The word itself refers to the storing of biological material. As it does not di- rectly refer to any research activities, the average layman could easily mistake its purposej guesses can range from collections of rare plants to human organ banks. However, the word is commonly used amongst Nordic biomedical researchers, and has been in use in the ethico-Iegal debate since the mid-1990S, although there is no Single universal definition for it even in this forum} Biobanks may be established not only for research, but also, for example, for patient safety, quality assurance, trans- plantation, assisted procreation, or for manufacturing medicinal products. Many biobanks have been set up for a combination of purposes.4 For present purposes, I will refer to a biobank as a collection of human biological samples combined with health and lifestyle information on the provider of the sam- ple.S The information mayor may not be linked to an identifiable person (personal data), and the information mayor may not contain genetic information. 1 Dr. Salla Silvola (fonnerly Salla L6tjonen) works as Senior Advisor in Legislative Affairs in the Ministry ofJustice, Finland. She is also a Docent in Medical and Bio Law and teaches part-time at the Faculty of Law at the University of Helsinki. She is a former member of the board of the Nordic Committee on Bioethics (2002-2007) and a former member of the board of directors of the European Association of Health Law (2008-2009). 2 Whereas the terms tissue bank and cell bank appear in Finland's Act on the Medical Vse of Human Organs and Tissues (§§ 1, la). 3 See, for instance, L. Nielsen et al., Health Science Information Banks: Biobanks (Danish Central Scientific-Ethical Committee, Danish Council of Ethics, Danish Medical Research Council, Copenhagen, 1996) and G. Hermeren, Protecting Human Integrity, in M. Sorsa & J. Eyrfjoro (eds.), Human Biobanks (Nordic Committee on Bioethics, Copenhagen, 1997). 4 See, for instance, E. Rynning, Legal Challenges and Strategies in the Regulation of Research Biobanking, in J.H. Solbakk et al. (eds), The Ethics of Research Biobanking (Springer, New York, 2009) pp. 280-281. 5 A rather similar definition was used by a group of experts working for the European Commission. They considered biobank collections to mean "the biolOgical samples themselves, plus the related databases, allowing a certain level of acceSSibility, availability and exchange for scientific studies". European Commission, 25 Recommendations on the ethical} legal and social implications of genetic testing by Eryl McNally, Anne Cambon-Thomsen, Celia Brazell, Jean-Jacques Cassiman, Alastair Kent, Klaus Lindpaintner, Paula Lobato de Faria, Detlef Niese, Henriette Roscam Abbing, Jan Helge Solbakk, Helene Tack, Erik Tambuyzer, Thomas R. Weihrauch, Erik Wendel (Brussels 2004). Salla Silvola - 9789004223813 Downloaded from Brill.com09/28/2021 09:03:38AM via free access 278 • SALLA SILVOLA The collection and use of biological samples is regulated in several legal instru- ments in Finland, depending on the purpose for which the sample has been col- lected.6 The research community has repeatedly criticised the scattered legislation in this area. In an attempt to clarify the situation, a Bill was put before Parliament specifically aimed at regulating biobanks on 30 December 2010.7 However, due to the Parliamentary elections in April 2011, the particular Parliament that the Bill was put before was unable to finalise the processing of this Bill before it was dissolved. Hence the Bill lapsed. The new government has decided to continue with this legiS- lative project, but whether or not the principles of the lapsed Bill will be followed, is not yet confirmed. Regarding the use of the concept of the biobank in the legal arena, it is interest- ing to note the different approaches taken in the Nordic countries. According to the legislations of Iceland, Norway, and Sweden, biobank regulation does not apply to the temporary keeping of samples. However, there are duties that fall on the owner of the biobank after a certain period of time without regard to the action (or non-ac- tion) of the biobank owner.8 According to the (now defunct) Finnish Biobank Bill, a collection of samples would not qualify as a biobank until it had fulfilled the rather extensive requirements needed for national registration. If a collection of samples does not seek the status of a biobank, it could remain outside the proposed legisla- tion independent of the time period that the samples are retained. 2 Structure and nature of regulation More interesting Nordic variation can be found in the different approaches taken in the structures regulating biobanks. The Icelandic Biobanks Act is the oldest in the Nordic countries, adopted in 2000.9 It covers all collections of biological samples irrespective of whether these have been collected in connection with health care or research. Sweden's biobank legislation currently contains specific provisions only as re- gards biobanks connected with health care (I will subsequently refer to these as diagnostic biobanks).lO Research on humans is covered by the Act on Ethical Re- 6 The samples collected for diagnostic use are governed by the Act on the Status and Rights of Patients, no. 785 from 1992, samples collected for research use are governed by the Medical Research Act, no. 488 from 1999, and samples collected from the deceased, as well as the secondary use of biological samples, are governed by the Act on the Medical Use of Human Organs and Tissues, no. 101 from 2001. 7 Bill on the Biobank Act and the Act amending the Act on the Medical Use of Human Organs and Tissues and the Act on the Status and Rights of Patients, no. 325 from 2010. 8 This period of time varies. In Iceland, keeping temporarily means storage up to 5 years. In Norway and Sweden, the time period for keeping temporarily has not been stated on a legal level. In practice, however, it has been set at a maximum of 2·4 months. 9 No. 110 from 2000. 10 Biobanks in Health Care Act, no. 297 from 2002. Salla Silvola - 9789004223813 Downloaded from Brill.com09/28/2021 09:03:38AM via free access BIOBANK REGULATION IN FINLAND AND THE NORDIC COUNTRIES • 279 view of Research on Humans (the Ethics Review Act) 11 and the Medicines Act12• However, as neither of these Acts contains any specific provisions on biobanks used in research, a committee report has been published which proposes to expand the scope of the current Biobanks in Health Care Act to include biological samples col- lected and used for research. 13 In Norway, the regulation ofbiobanks also began with biobanks connected with medical care.l4 However, in 2009, the new Medical and Health Research Act1S came into force, which not only contains provisions on medical research on humans in general, but also provisions on biobanks collected and used for research purposes. Denmark has the most centralised health legislation of all the Nordic countries; here, the main principles of nearly all health-related regulation have been gathered under one Health Act.l6 In addition, the Act on Research Ethics Committees and Biomedical Research Projects (the Committee Act) 17 applies. Danish provisions re- garding the collection of biological samples are concise and very liberal vis-a.-vis the needs of biomedical research. The current Finnish regulation of biobanks is, as previously said, spread across different laws, depending on the original purpose of the sample for which it was col- lected. The provisions regarding the secondary use of biological samples are, how- ever, enshrined in the Act on the Medical Use of Human Organs and Tissues (the Tissue Act).l8 These provisions are almost as concise and liberal as in the Danish regulation. However, if the Biobank Bill is passed unchanged by the next Parliament, the Finnish regulation will not be the strictest, but the most extensive and detailed amongst the Nordic countries. 3 Preconditions for setting up a biobank Based on the currently existing Nordic legislation, only the Danish and Finnish biobanks need no separate approval, besides ethical approval, in order for each re- search project to proceed.l9 At the other extreme, only the Icelandic biobanks re- quire actual licensing. The Icelandic licence is provided by the Ministry of Welfare 11 No. 460 from 2003. 12 No. 859 from 1992. 13 En ny biobankslag, Betankande av Biobanksutredningen, Statens Offentliga Utredningar [A new Biobanks Act, Report by the Biobank Inquiry, Swedish Official Reports) SOU 2010:81, Stockholm 2010. 14 Health Care Biobanks Act, no. 12 from 2003. 15 No. 44 from 2008. 16 No. 95 from 2008, latest consolidated version no. 913 from 2010. 17 No. 402 from 2003. 18 Act no. 10 1 from 2001. 19 However, if the cells or tissue that are processed in the biobank are transferred to another human, the provisions of the EC Directive on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells (2004/23/EC, Tissue Directive) will apply. All 'tissue establishments' falling under the scope of the application of the Tissue Directive require a tissue licence. Salla Silvola - 9789004223813 Downloaded from Brill.com09/28/2021 09:03:38AM via free access 280 • SALLA SILVOLA following recommendations from both the Medical Director of Health and the Na- tional Bioethics Committee.20 In Sweden and Norway, no licence or previous ethical evaluation is required from biobanks connected with health care.21 In Norway, founding a research biobank re- quires the approval of a regional research ethics committee.22 According to the Swedish committee report, ethical approval would also be required before samples could be collected for a research biobank in Sweden.23 In addition, the supervisory authority should be notified of both types ofbiobanks.
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