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A Unified European Approach on Tissue Research and Biobanking? A Comparison

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Book cover Biobanks and Tissue Research

Part of the book series: The International Library of Ethics, Law and Technology ((ELTE,volume 8))

Abstract

As is by now a well-investigated fact that human tissue research and biobanking is not regulated by a common legal framework in Europe so far, this article aims to step beyond this rather descriptive finding. By focussing on central issues of biobank research, the authors do not only highlight common trends and perspectives in the regulation of human tissue research across the countries of the European Union and Switzerland but also identify the ethical and legal foundations for some of the persisting differences in this field. Their analysis bears on the premise that certain countries hold similar research traditions and are united by common ethical and legal pathways for regulating research. Based on their distinction of seven country groups and their respective regulatory frameworks, the authors finally draw some overall conclusions regarding the future regulation and potential legal harmonization of this field within the European Union.

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Notes

  1. 1.

    This article is based on findings of the EU-funded Tiss.EU project “Evaluation of Legislation and Related Guidelines in the Procurement, Storage and Transfer of Human Tissues and Cells in the European Union – an Evidence-Based Impact Analysis” that is coordinated by the Department for Ethics and History of Medicine at the University of Goettingen, Germany (http://www.tisseu.org).

  2. 2.

    Whilst the Convention is not ratified by all Member States of the European Union so far, the CoE has adopted it.

  3. 3.

    See also the UNESCO International Declaration on Human Genetic Data (2003, art. 8a).

  4. 4.

    See also the Convention on Human Rights and Biomedicine (1997, art. 22).

  5. 5.

    It is important to note that the Tissue Directive 2004/23/EC merely covers therapeutic applications of human biological samples.

  6. 6.

    See also the Oviedo Convention or the CoE’s Recommendation 2006(4), art. 21.

  7. 7.

    This classification resembles the structure of the Tiss.EU project. For more information on its research methodology, see http://www.tisseu.org (accessed 4 March 2011).

  8. 8.

    Biobanks for research (2004); Human tissue biobanks for research (2010).

  9. 9.

    Biobanks for medical research (2007).

  10. 10.

    Biobanks: obtainment, preservation and use of human biological material. Medico-ethical guidelines and recommendations (2006).

  11. 11.

    This is also required by the guidelines of the SAMS (see 2006, 4.7).

  12. 12.

    As an additional precaution it is required that the key-code is kept separately from the coded data.

  13. 13.

    Jonathan Yearworth & ors v Bristol NHS Trust [2009] EWCA Civ 37 (4 February 2009).

  14. 14.

    Cited after the presentation and translation from Sigrid Sterckx (see Tiss.EU Report Birmingham 2010).

  15. 15.

    According to figures from the Public Population Project in Genomics (P3G), out of 82 national research cohort studies (comprising 7.8 million subjects), 2 million come from the Scandinavian countries. This matches 25% of the subjects currently enrolled worldwide (see Nobel 2008, 13).

  16. 16.

    See the report of a Ministry task group (Betaenkning no. 1414, May 2002). Amendments have been carried out on the Act on the Legal Status of Patients (482/1998), the Act on Processing Personal Data (429/2000) and the Act on Ethics Review of Scientific Research (69/1999). The new regulations on biobanks were published as Ministerial Order No. 966 of 22 September 2004 (Use of Tissue Register) by the Ministry of Health.

  17. 17.

    See for example the Finish Act on the Status and Rights of Patients (785/1992) and the Act on Medical Research (488/1999). However, like Denmark also Finland revised its existing legislation, e.g. the Act on the use of Human Organs and Tissues for Medical Purposes was supplemented with provisions on the collection and usage of human tissues (see Rynning 2009, 297).

  18. 18.

    A proposition for a Tissue Act has been submitted to the Parliament in spring 2010 and is expected to come into force in 2011.

  19. 19.

    This is a unique feature of the Swedish Data Protection Law which derives support from the EC Data Protection Directive’s provision that “member states may, for reasons of substantial public interest, lay down exemptions” regarding the protection of personal data (art. 8, para. 4).

  20. 20.

    In Sweden a revision of the BMCA is ongoing. In November 2010 the Swedish government released a report “A new Biobanks Act” (SOU 2010: 81) that formulates proposals for an amendment of the present law. For example, it suggests the introduction of an opt-out system for the procurement and storage of samples.

  21. 21.

    For further information on the Estonian framework, see also Sándor and Bárd (2009c).

  22. 22.

    See Gene Donor Consent Form, available at: http://www.geenivaramu.ee/index.php?id=100 (accessed 4 March 2011).

  23. 23.

    The chief processor of the Estonian Genome Project is the University of Tartu.

  24. 24.

    See Paula Lobato de Faria’s analysis presented at the Tiss.EU workshop in Paris, June 2009.

  25. 25.

    Recommendation no. 77: ethical issues raised by collections of biological material and related data: “biobanks”, “biolibraries” (2005).

  26. 26.

    Recommendation on Banks of Biological Material of Human Origin (Biobanks) in Biomedicine Research (2006).

  27. 27.

    Act 2472/97 on the Protection of Individuals with Regard to the Processing of Personal Data implementing the European Directive 95/46/EC.

  28. 28.

    Opinion on the Establishment and Use of Biobanks and Registries of Human Biological Samples for Research Purposes (2009).

  29. 29.

    Biobanks and research on human biological material (2006).

  30. 30.

    This is irrespective of Malta, Greece and Italy where the existent frameworks remain silent on this issue.

  31. 31.

    Protection of Individuals, Law 138 (I) 2001, amended 2003.

  32. 32.

    See Act 67/98 which transposes the European Data Protection Directive 95/46/EC into Portuguese law.

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Author information

Authors and Affiliations

  1. Department of Ethics and History of Medicine, University of Göttingen, Göttingen, Germany

    Katharina Beier

  2. Department of Ethics and History of Medicine, University of Göttingen, 37073, Göttingen, Germany

    Christian Lenk

Authors
  1. Katharina Beier
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  2. Christian Lenk
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Correspondence to Katharina Beier .

Editor information

Editors and Affiliations

  1. Humboldtallee 36, Göttingen, 37073, Germany

    Christian Lenk

  2. Central European University, Nádor utca 9, Budapest, 1051, Hungary

    Judit Sándor

  3. Dublin City University, Residences Campus, Glasnevin, Dublin 9, Ireland

    Bert Gordijn

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Beier, K., Lenk, C. (2011). A Unified European Approach on Tissue Research and Biobanking? A Comparison. In: Lenk, C., Sándor, J., Gordijn, B. (eds) Biobanks and Tissue Research. The International Library of Ethics, Law and Technology, vol 8. Springer, Dordrecht. https://doi.org/10.1007/978-94-007-1673-5_10

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