uman tissue and biobank research is of increasing importance for Katharina Beier, Hunderstanding the causes of widespread diseases and developing Silvia Schnorrer, effective therapies. However, while the success of biobank research depends Nils Hoppe, on the availability of a large number of samples and the consolidation of collections across country borders is very desirable from the perspective Christian Lenk (eds.) of researchers, the legal and ethical requirements for the procurement, storage and use of human tissue samples are rather heterogeneous across The Ethical and different countries. Moreover, the lack of comprehensive supranational Legal Regulation of regulation on human tissue and biobanking can be seen as posing a serious threat to transnational biomedical research. Against this background, it was Human Tissue and one of the aims of the EU-funded Tiss.EU project (“Evaluation of Legislation Biobank Research and Related Guidelines on the Procurement, Storage and Transfer of Human Tissues and Cells in the European Union – an Evidence-Based Impact Analysis”) in Europe to analyse the ethical and legal regulation of human tissue and biobank research across the 27 European Member States plus Switzerland. The Proceedings of the results of nine international workshops and three conferences are gathered in this volume. While the country reports evaluate the implementation of Tiss.EU Project ethical and legal guidelines at a national level, point out their strengths and deficits, and, where required, create an evidence base for the revision of said legislation, the conference reports address more general ethical and legal issues in this field. The volume is completed by a final presentation of project’s results. U4 Sichtbare Fläche 167 x 246 mm U1 Sichtbare Fläche 167 x 246 mm Bei Randabfallenden Farbflächen oder Bildern Bei Randabfallenden Farbflächen oder Bildern muss die Farbfläche oder die Bild Datei in den muss die Farbfläche oder die Bild Datei in den iobank Research in Europe in Research iobank Überklebungsbereich gehen. B Überklebungsbereich gehen. Bitte auch für den Buchrücken beachten. Bitte auch für den Buchrücken beachten. Buchrücken Muster Breite 10 x 246 mm Beier/Schnorrer/Hoppe/Lenk (eds.) The Ethical and Legal Regulation of Human Tissue and Tissue Human of Regulation Legal and Ethical The (eds.) Beier/Schnorrer/Hoppe/Lenk ISBN: 978-3-86395-031-6 Universitätsverlag Göttingen Universitätsverlag Göttingen Katharina Beier, Silvia Schnorrer, Nils Hoppe, Christian Lenk (eds.) The Ethical and Legal Regulation of Human Tissue and Biobank Research in Europe This work is licensed under the Creative Commons License 3.0 “by-nd”, allowing you to download, distribute and print the document in a few copies for private or educational use, given that the document stays unchanged and the creator is mentioned. You are not allowed to sell copies of the free version. erschienen im Universitätsverlag Göttingen 2011 Katharina Beier, Silvia Schnorrer, Nils Hoppe, Christian Lenk (eds.) The Ethical and Legal Regulation of Human Tissue and Biobank Research in Europe Proceedings of the Tiss.EU Project Universitätsverlag Göttingen 2011 Bibliographische Information der Deutschen Nationalbibliothek Die Deutsche Nationalbibliothek verzeichnet diese Publikation in der Deutschen Nationalbibliographie; detaillierte bibliographische Daten sind im Internet über <http://dnb.ddb.de> abrufbar. Address of the Editor Katharina Beier E-mail: [email protected] This work is protected by German Intellectual Property Right Law. It is also available as an Open Access version through the publisher’s homepage and the Online Catalogue of the State and University Library of Goettingen (http://www.sub.uni-goettingen.de). Users of the free online version are invited to read, download and distribute it. Users may also print a small number for educational or private use. However they may not sell print versions of the online book. Satz und Layout: Katharina Beier Umschlaggestaltung: Franziska Lorenz © 2011 Universitätsverlag Göttingen http://univerlag.uni-goettingen.de ISBN: 978-3-86395-031-6 Contents Introduction 1 Ethical and Legal Aspects of Research with Human Tissue in Europe 7 (First International Conference, Göttingen) Katharina Beier Rights and Entitlements in Human Tissue and Cells 19 (First International Workshop, Hannover) Katharina Beier Anonymisation and Pseudonymisation as Means of Privacy Protection 25 (Second International Workshop, Budapest) Petra Bárd, Judit Sándor Biobanks for Research Purposes 35 (Third International Workshop, Paris) Christine Noiville, Florence Bellivier, Virginie Commin Privacy, Confidentiality and Personality Rights in Biobanking and 51 Genetic Research with Human Tissue (Second International Conference, Göttingen) Katharina Beier Procurement, Storage and Transfer of Tissues and Cells for 61 Non-Clinical Purposes in a Legal and Ethical Perspective (Fourth International Workshop, Padova) Alessandra Bernardi, Luciana Caenazzo, Renzo Pegoraro Rights and Entitlements in Human Tissue and Cells: 77 the BENELUX Countries (Fifth International Workshop, Leiden) Jasper A. Bovenberg Anonymisation and Pseudonymisation as Means of Privacy Protection 89 (Sixth International Workshop, Stockholm) Claudio Tamburrini The Transfer, Storage and Procurement of Human Cells and Tissues 105 (Seventh International Workshop, Dublin) Elizabeth Yuko, Bert Gordijn Biobanking: Ethics, Governance and Regulation 119 (Eighth International Workshop, Birmingham) Sean Cordell Procurement, Storage and Transfer of Tissues and Cells for 131 Non-Clinical Research Purposes (Ninth International Workshop, Vilnius) Vilius Dranseika, Eugenijus Gefenas The Future of Biobanking in Europe: Searching for Answers 139 to the Ethical and Legal Challenges of Human Tissue Research (Final International Conference, Göttingen) Katharina Beier, Silvia Schnorrer Conclusions 161 Katharina Beier Introduction The Tiss.EU project – with full title “Evaluation of Legislation and Related Guide- lines on the Procurement, Storage and Transfer of Human Tissues and Cells in the European Union - an Evidence-Based Impact Analysis” – was funded by the Eu- ropean Commission in the 7th Framework Programme from April 2008 until March 2011. Within this project researchers from ten different European countries addressed questions of ethical and legal regulation regarding human tissue research. For this purpose, they analysed the respective legislation and guidelines in and across Europe, evaluating their implementation at a national level, their strengths and deficits, and, where required, created an evidence base for the revision of said legislation. This was made necessary by the lack of a comprehensive EU regulation on human tissue and biobanking, which poses a serious threat to transnational biomedical research. The legislation that exists so far covers mainly clinical applica- tion. In order to achieve its goal, the Tiss.EU project organized nine international workshops and three International Status Conferences during its three year project period, providing a platform for leading experts in the field of human tissue and biobank research. This allowed for the gathering of information on the current legislation in the 27 EU member states plus Switzerland. The present volume col- lects the revised reports on these events. Besides this, the documents, in their orig- inal form, can also be found at the project’s website, www.tisseu.org. One of the aims of the Tiss.EU project was the establishment of an information portal freely accessible to interested scientists as well as the broader public. The website also hosts an extensive database of legal documents, ethical guidelines and scientific articles on human tissue and biobanking to facilitate further research in the field. It will be maintained beyond the project period. During its term, the Tiss.EU project also set up a network of experts in the field of human tissue research, which connects about 150 representatives from a 2 Introduction multitude of disciplines, including ethicists, lawyers, physicians, policy makers and non-governmental institutions, from the whole of the European Union and Swit- zerland. The organizational structure of the Tiss.EU project was two-layered: on the one hand, there was a consortium consisting of the coordinating institution in Goettingen (Germany) and the nine academic partners from different EU Member States, namely France, Germany, Hungary, Ireland, Italy, Lithuania, Sweden, The Netherlands and the United Kingdom. Each partner was assigned a country group of two to five EU countries, which reported on the current regulation on human tissue and biobank research in their respective countries.1 On the other hand, the partners were teamed up in groups of two to three to evaluate the leading ethical and legal issues for human tissue research that arose with regard to one of the project’s four focal themes. Identifica- Coordinator, Collection tion of partner and dissemi- external institutions nation at the experts for and country online data- all EU groups base and the Member project States plus website as a Recommenda- Switzerland comprehen- tions from the by the Analysis of sive infor- project project the four mation partners focal themes source (workshops & confer- ences) 1 The country reports refer to a range of legal documents and guidelines on human tissue and biobank research. Insofar an English translation is available, these documents are accessible via the Tiss.EU website www.tisseu.org (under the