Cover Page The handle http://hdl.handle.net/1887/25174 holds various files of this Leiden University dissertation. Author: Hellemondt, Rachèl Evelien van Title: Genomics and the Law Issue Date: 2014-04-10 GENOMICS AND THE LAW ISBN: 978-94-90858-24-7 Author: Rachèl van Hellemondt Lay out and printing: Drukkerij Mostert, Leiden, the Netherlands Cover: D. Ketting This thesis is the result of the research project: ‘Large scale applications of genomics in the field of predictive medicine in the Netherlands: ‘the role of the law’ of the Centre for Society and the Life Sciences in The Netherlands, funded by the Netherlands Genomics Initiative and The Centre for Medical Systems Biology © R.E. van Hellemondt, The Netherlands All rights reserved. No part of this publication may be reproduced in any form or by any means without written prior permission of the author. GENOMICS AND THE LAW Proefschrift ter verkrijging van de graad van Doctor aan de Universiteit Leiden, op gezag van Rector Magnificus prof. mr. C.J.J.M. Stolker, volgens besluit van het College voor Promoties te verdedigen op donderdag 10 april 2014 klokke 15.00 uur door Rachèl Evelien van Hellemondt geboren te Voorburg in 1971 PROMOTIECOMMISSIE Promotores: Prof. dr. A.C. Hendriks Prof. dr. M.H. Breuning Overige leden: Prof. dr. R.C. Tobler Prof. dr. M.C. Cornel (Vrije Universiteit, Amsterdam) Dr. E.C.A. Asscher (Erasmus MC, Rotterdam) Voor Joas en Freeke CONTENTS Chapter 1 Introduction 9 PART A PROTECTION VERSUS SELF-DETERMINATION Chapter 2 Freedom, equals happiness? The regulation of DNA diagnostics in health care from a human rights perspective Chapter 3 Prenatal screening in the light of self-determination Chapter 4 The restriction of freedom of expression for health service from EU and constitutional perspective PART B 19 39 53 EUROPEAN LEGAL FRAMEWORK Chapter 5 Legislation on direct-to-consumer genetic testing in seven European countries Chapter 6 Dutch Act on population screening is at odds with EU law 75 93 Chapter 7 Regulating the use of genetic tests: Is the Dutch law an example for other countries with regard to DTC genetic testing? 105 Chapter 8 Which lessons can we learn for the European Union legal framework of medicines for the regulation of direct-to-consumer tests? 119 Chapter 9 Concluding remarks 137 Chapter 10 Summary 151 Addendum References Abbreviations Samenvatting Curriculum Vitae Publications 158 182 183 188 190
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