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The Need for a Legitimate Regulatory Regime in Bioethics: A Global and European Perspective
Uppsala University, Disciplinary Domain of Humanities and Social Sciences, Faculty of Law. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics.
2013 (English)In: Missouri law review, Vol. 78, no 1, 465-488 p.Article, review/survey (Other academic) Published
Abstract [en]

Bioethics in global biobanking touches upon several internationally acceptedfundamental rights and values, namely the sample donor's right ofprivacy, the patient's right to health, and - at least implicitly - scientific freedom.From the perspective of fundamental rights, however, there are veryfew internationally applicable rules as to the enforcement of these rights atthe administrative level. Instead, the combination of the practical need forcommon rules and the lack of political will and/or legislative competencewithin the international community or the European Union (EU) seems tohave paved the way for soft law. Further, the role of courts in the area ofbioethics and biobanking, nationally as well as internationally, is limited.The implementation of administrative rules at the national or regional levelsis carried out by research committees and research funding institutions, usuallywith limited or no right to appeal to the general court system. Consequently,the traditional mechanisms of political and judicial control to a largeextent are unavailable. The question raised here is whether the theories connectedto global administrative law can be of any guidance in developing alegitimate regulatory regime for international biobanking. Can principles ofparticipation, transparency, and reasoned decisions be of relevance in this area of law?

Place, publisher, year, edition, pages
School of Law University of Missouri, 2013. Vol. 78, no 1, 465-488 p.
National Category
Research subject
Administrative Law
URN: urn:nbn:se:uu:diva-218131OAI: oai:DiVA.org:uu-218131DiVA: diva2:694932
Swedish Research Council
Available from: 2014-02-08 Created: 2014-02-08 Last updated: 2016-04-07

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Reichel, Jane
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