i The Collected Courses of the Academy of European Law Series Editors: Professor Loïc Azoulai Professor Nehal Bhuta Professor Marise Cremona European University Institute, Florence Assistant Editor: Anny Bremner European University Institute, Florence VOLUME XXIV/ 2 New Technologies and EU Law ii The Collected Courses of the Academy of European Law Edited by Professor Loïc Azoulai, Professor Nehal Bhuta, and Professor Marise Cremona Assistant Editor: Anny Bremner Each year the Academy of European Law in Florence, Italy, invites a group of outstanding lecturers to teach at its summer courses on Human Rights law and European Union law. A ‘general course’ is given in each of the two fields by a distinguished scholar or practitioner, who examines the field as a whole through a particular thematic, conceptual, or philosophical lens, or looks at a theme in the context of the overall body of law. In addition, a series of ‘specialized courses’ brings together a group of highly qualified scholars to explore and analyse a specific theme in relation to Human Rights law and EU law. The Academy’s mission, to produce scholarly analyses which are at the cutting edge of the two fields, is achieved through publication of this series, the Collected Courses of the Academy of European Law. iii New Technologies and EU Law Edited by MARISE CREMONA 1 iv 1 Great Clarendon Street, Oxford, OX2 6DP, United Kingdom Oxford University Press is a department of the University of Oxford. It furthers the University’s objective of excellence in research, scholarship, and education by publishing worldwide. Oxford is a registered trade mark of Oxford University Press in the UK and in certain other countries © The several contributors 2017 The moral rights of the authors have been asserted First Edition published in 2017 Impression: 1 All rights reserved. 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Oxford disclaims any responsibility for the materials contained in any third party website referenced in this work. v Contents Table of Cases vii Table of Legislation xiii List of Abbreviations xxv Notes on Contributors xxix 1. Introduction 1 Marise Cremona I. THE EU, SCIENTIFIC RISK, AND REGULATORY DESIGN 2. Medical Technologies and EU Law: The Evolution of Regulatory Approaches and Governance 9 Mariachiara Tallacchini 3. EU Law and Bioethics 38 Stéphanie Hennette Vauchez 4. Regulating New Technologies: EU Internal Market Law, Risk, and Socio- Technical Order 74 Mark L. Flear II. EU LAW AND NEW TECHNOLOGIES— CHALLENGE AND RESPONSE 5. EU Data Protection Law: The Review of Directive 95/ 46/ EC and the General Data Protection Regulation 123 Peter Hustinx 6. Liabilities of Internet Users and Providers 174 Giovanni Sartor 7. Brave New Borders: The EU’s Use of New Technologies for the Management of Migration and Asylum 197 Jorrit J. Rijpma Index 243 vi vii Table of Cases n = footnote. EU CASES CJEU Cases (in number order) 26/ 62, Van Gend & Loos v. Nederlandse Administratie der Belastingen, [1963] ECR 1 (ECLI:EU:C:1963:1) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .77n 7/ 68, Commission v. Italy (Art Treasures case), [1968] ECR 423 (ECLI:EU:C:1968:51) . . . . . .80n 11/ 70, Internationale Handelsgesellschaft mbH v. Einfuhr- und Vorratsstelle für Getreide und Futtermittel, [1970] ECR 1125 (ECLI:EU:C:1970:114) . . . . . . . . . . . . . . . . . . . . . . . .77n 39/ 72, Commission v. Italy, [1973] ECR 101 (ECLI:EU:C:1973:13) . . . . . . . . . . . . . . . . . . . .106n 2/ 73, Geddo v. Ente Nazionale Rizi, [1973] ECR 865 (ECLI:EU:C:1973:89) . . . . . . . . . . . . . . .84 8/ 74, Procureur de Roi v. Dassonville, [1974] ECR 837 (ECLI:EU:C:1974:82) . . . . . . . . . . . . . .84 71/ 74, Van Duyn v. Home Office, [1974] ECR 1337 (ECLI:EU:C:1974:133) . . . . . . . . . . . . .106n 36/ 75, Rutili v. Ministre de l’intérieur, [1975] ECR 1219 (ECLI:EU:C:1975:137) . . . . . . . . . .212n 118/ 75, Watson and Belmann, [1976] ECR 1185 (ECLI:EU:C:1976:106) . . . . . . . . . . . . .220–2 21 106/ 77, Italian Minister of Finance v. Simmenthal SpA, [1978] ECR 629 (ECLI:EU:C:1978:49) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .77n 7/ 78, R v. Thompson and others, [1978] ECR 2247 (ECLI:EU:C:1978:209) . . . . . . . . . . . . . . . .88 120/ 78, Rewe- Zentrale AG v. Bundesmonopolverwaltung für Branntwein (Cassis de Dijon), [1979] ECR 649 (ECLI:EU:C:1979:42) . . . . . . . . . . . . . . . . . . . 84– 85, 88 148/ 78, Pubblico Ministero v. Tullio Ratti, [1979] ECR 1629 (ECLI:EU:C:1979:110) . . . . . .106n 34/ 79, R v. Henn and Darby, [1979] ECR 3795 (ECLI:EU:C:1979:295) . . . . . . . . . . . . . . .86, 90n 272/ 80, Frans- Nederlandse Maatschappij voor Biologische Producten, [1981] ECR 3277 (ECLI:EU:C:1981:312) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .90, 91 40/ 82, Commission v. United Kingdom (Turkeys), [1984] ECR 0283 (ECLI:EU:C:1984:33) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .90n 174/ 82, Sandoz, [1983] ECR 2445 (ECLI:EU:C:1983:213) . . . . . . . . . . . . . . . . . . . . . . . . . .90– 91 C- 286/ 82 and 26/ 83, Luisi and Carbone v. Ministero del Tesoro, [1984] ECR 377 (ECLI:EU:C:1984:35) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .44 177/ 83, Theodor Kohl KG v. Ringelhan & Rennett SA and Ringelhan Einrichtungs GmbH [1984] ECR 3651 (ECLI:EU:C:1984:334) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .88 178/ 84, Commission v. Germany (Beer Purity), [1987] ECR 1227 (ECLI:EU:C:1987:126) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 88– 89n 121/ 85, Conegate v. HM Customs and Excise, [1986] ECR 1007 (ECLI:EU:C:1986:114) . . . . .86 C- 300/ 89, Commission v. Council (Titanium Dioxide), [1991] ECR I- 2867 (ECLI:EU:C:1991:244) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .93n C- 367/ 89, Richardt and others, [1991] ECR I- 4621 (ECLI:EU:C:1991:376) . . . . . . . . . . . . 86–8 7 C- 59/ 90, Society for the Protection of Unborn Children Ireland Ltd v. Stephen Grogan and Others, [1991] ECR I- 04685 (ECLI:EU:C:1991:378) . . . . . . . . . . . . .44 C- 155/ 91, Commission v. Council (Waste Directive), [1993] ECR I- 939 (ECLI:EU:C:1993:98) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .93n C- 267/ 91 and 268/ 91, Keck and Mithouard, [1993] ECR I- 6097 (ECLI:EU:C:1993:905) . . . . .84 C- 275/ 92, Customs Excise v. Schindler, [1994] ECR I- 1039 (ECLI:EU:C:1994:119) . . . . .80n, 87n C- 292/ 92, Hünermundand others v. Landesapothekerkammer Baden- Württemberg, [1993] ECR I- 6787 (ECLI:EU:C:1993:932) . . . . . . . . . . . . . . . . . . .84n C- 315/ 92, Verband Sozialer Wettbewerb e.V. v. Clinique Laboratoires SNC and Estée Lauder Cosmetics GmbH, [1994] ECR I- 317 (ECLI:EU:C:1994:34) . . . . . . . . . . . . . 88– 89n C- 401/ 92 and C- 402/ 92, Tankstation, [1994] ECR I- 2199 (ECLI:EU:C:1994:220) . . . . . . . . .84n viii viii Table of Cases C- 69/ 93 and 258/ 93, Punto Casa SpA v. Sindaco del Comune di Capena et Comune di Capena i Promozioni, [1994] ECR I- 2355 (ECLI:EU:C:1994:226) . . . . . . . . . . . . . . . . . .84n C- 412/ 93, Société d’Importation Edouard Leclerc- Siplec v. TF1 Publicité SA and M6 Publicité SA, [1995] ECR I- 179 (ECLI:EU:C:1995:26) . . . . . . . . . . . . . . . . . . . . . . . . . . .84n C- 470/ 93, Verein gegen Unwesen in Handel und Gewerbe Köln e.V. v. Mars GmbH, [1995] ECR I- 1923 (ECLI:EU:C:1995:224) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 88– 89n C- 418/ 93 to 421/ 93, 460/ 93 to 462/ 93, 464/ 93, 9/ 94 to 11/ 94 and 14/ 94 to 15/ 94, Semeraro Casa Uno v. Sindaco del Comune di Erbusco, [1996] ECR I- 2975 (ECLI:EU:C:1996:242) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .84n C- 70/ 94, Fritz Werner Industrie- Ausrüstungen GmbH v. Federal Republic of Germany, [1995] ECR I- 3189 (ECLI:EU:C:1995:328) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .86 C- 34/ 95 to 36/ 95, Konsumentombudsmannen (KO) v. De Agostini (Svenska) Förlag AB, [1997] ECR I- 3843 (ECLI:EU:C:1997:344) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .84n C- 378/ 96, Rijksdienst voor Pensioenen v. René van Looveren (Aher- Waggon), [1998] ECR I-4 473 (ECLI:EU:C:1998:357) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .89n C- 269/ 97, Commission and Parliament v. Council (Beef Labelling), [2000] ECR I- 2257 (ECLI:EU:C:2000:183) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .93n C- 97/ 98, Jägerskiöld v. Gustafsson, [1999] ECR I- 7319 (ECLI:EU:C:1999:515) . . . . . . . . . . . .80n C- 209/ 98, Entreprenørforeningens Affalds/ Miljøsektion (FFAD) v. Københavns Kommune, [2000] ECR I- 3743 (ECLI:EU:C:2000:279) . . . . . . . . . . . . . . . . . . . . . . . . . .89n C- 254/ 98, Schutzverband gegen unlauteren Wettbewerb v. TK-H eimdienst Sass GmbH, [2000] ECR I- 151 (ECLI:EU:C:2000:12) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .84n C- 376/ 98, Germany v. European Parliament and Council (Tobacco Advertising I), [2000] ECR I- 8419 (ECLI:EU:C:2000:544) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .93– 94 C- 377/ 98, Netherlands v. Parliament and Council (Biotechnology), [2001] ECR I- 7079 (ECLI:EU:C:2001:523) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4– 5, 66, 99– 100 C- 379/ 98, PreussenElektra AG v. Schleswag AG, [2001] ECR I- 2099 (ECLI:EU:C:2001:160) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .89n C- 405/ 98, Konsumentombudsmannen (KO) v. Gourmet International Products AB (GIP), [2001] ECR I- 1795 (ECLI:EU:C:2001:135) . . . . . . . . . . . . . . . . . . . . . . . . . . . .84n C- 112/ 00, Schmidberger v. Austria, [2003] ECR I- 05659 (ECLI:EU:C:2003:333) . . . . . . . . . . .71 C- 465/ 00, 138/ 01, and 139/ 01, Rechnungshof v. Österreichischer Rundfunk and others, [2003] ECR I- 04989 (ECLI:EU:C:2003:294) . . . . . . 134– 135, 144, 152, 218– 219, 221– 222 C- 101/ 01, Bodil Lindqvist, [2003] ECR I- 12971 (ECLI:EU:C:2003:596) . . . . . . . . .134– 135, 136 C- 192/ 01, Commission v. Denmark, [2003] ECR I- 9693 (ECLI:EU:C:2003:492) . . . . . . . . . . .91 C- 322/ 01, Deutscher Apothekerverband e.V. v. 0800 DocMorris NV and Jacques Waterval, [2003] ECR I- 14887 (ECLI:EU:C:2003:664) . . . . . . . . . . . . . . . . .84n, 88, 89, 95 C- 491/ 01, British American Tobacco (Investments) Ltd and Imperial Tobacco Ltd, [2002] ECR I- 11453 (ECLI:EU:C:2002:741) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .93 C- 36/ 02, Omega Spielhallen- und Automatenaufstellungs- GmbH v. Oberbürgermeisterin der Bundesstadt Bonn, [2004] ECR I- 09609 (ECLI:EU:C:2004:614) . . . . . . . . . . . . . . . . .71 C- 434/ 02, Arnold André GmbH & Co. KG v. Landrat des Kreises Herford, [2004] ECR I-1 1825 (ECLI:EU:C:2004:800) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .93n C- 20/ 03, Burmanjer and others, [2005] ECR I- 4133 (ECLI:EU:C:2005:307) . . . . . . . . . . . . .85n C- 210/ 03, R (on the application of Swedish Match AB and Swedish Match UK Ltd) v. Secretary of State for Health, [2004] ECR I- 11893 (ECLI:EU:C:2004:802) . . . . . . . . . . .93n C- 380/ 03, Germany v. European Parliament and Council (Tobacco Advertising II), [2006] ECR I- 11573 (ECLI:EU:C:2006:772) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43– 44, 93– 94 C- 317/ 04 and 318/ 04, European Parliament v. Council and Commission, [2006] ECR I-9 171 (ECLI:EU:C:2006:609) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .88, 210 C- 366/ 04, Schwarz v. Bürgermeister der Landeshauptstadt Salzburg, [2005] I- 10139 (ECLI:EU:C:2005:719) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .95– 96 C- 434/ 04, Ahokainen and Leppik, [2006] ECR I- 9171 (ECLI:EU:C:2006:609) . . . . . . . . . . . .88 ix Table of Cases ix C- 441/ 04, A- Punkt Schmuckhandels GmbH v. Claudia Schmidt, [2006] ECR I- 2093 (ECLI:EU:C:2006:141) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .84n C- 77/ 05, United Kingdom v. Council, [2007] ECR I- 1145 (ECLI:EU:C:2007:803) . . . . . . . . .200 C- 110/ 05, Commission v. Italy (Trailers), [2009] ECR I- 519 (ECLI:EU:C:2009:66) . . . . . . . . .85n C- 137/ 05, United Kingdom v. Council, [2007] ECR I- 11593 (ECLI:EU:C:2007:805) . . . . . . .200 C- 142/ 05, Åklagaren v. Mickelsson and Roos, [2009] ECR I- 4273 (ECLI:EU:C:2009:336) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .85n, 89n C- 150/ 05, Van Straaten v. Staat der Nederlanden and Republiek Italië, [2006] ECR I- 9327 (ECLI:EU:C:2006:614) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .217n C- 301/ 06, Ireland v. European Parliament and Council, [2009] ECR I- 593 (ECLI:EU:C:2009:68) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .223n C- 524/ 06, Huber v. Bundesrepublik Deutschland, [2008] ECR I- 9705 (ECLI:EU:C:2008:724) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .152n, 220–2 21 C- 73/ 07, Tietosuojavaltuutettu v. Satakunnan Markkinapörssi Oy and Satamedia Oy, [2008] ECR I- 09831 (ECLI:EU:C:2008:727) . . . . . . . . . . . . . . . . . . . . . .135 C- 88/ 07, Commission v. Spain (Medicinal Herbs), [2009] ECR I- 1353 (ECLI:EU:C:2008:567) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .90 C- 518/ 07, Commission v. Germany, [2010] ECR I- 01885 (ECLI:EU:C:2010:125) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .134, 137n, 142 C- 553/ 07, College van burgemeester en wethouders van Rotterdam v. M. E. E. Rijkeboer, [2009] ECR I- 03889 (ECLI:EU:C:2009:293). . . . . . . . . . . . . . . . . . .136 C- 482/ 08, United Kingdom v. Council, [2010] ECR I- 10413 (ECLI:EU:C:2010:631) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .200, 216n C- 92/ 09 and 93/ 09, Volker und Markus Schecke GbR and Hartmut Eifert, [2010] ECR I- 11063 (ECLI:EU:C:2010:662) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .143–1 45, 220 C- 108/ 09, Ker- Optika bt v. ÀNTSZ Dél- dunántúli Regionális Intézete, [2010] ECR I- 12213 (ECLI:EU:C:2010:725) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 84– 85n C- 439/ 09, Pierre Fabre Dermo- Cosmétique SAS v. Président de l´Autorité de la Concurrence, [2011] ECR I- 9419 (ECLI:EU:C:2011:649) . . . . . . . . . . . . . . . . . . . . . 84– 85n C- 543/ 09, Deutsche Telekom AG v. Bundesrepublik Deutschland, [2011] ECR I- 3441 (ECLI:EU:C:2011:279) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .220 C- 34/ 10, Brüstle v. Greenpeace e.V., [2011] ECR I- 09821 (ECLI:EU:C:2011:669) . . . . . . 4– 5, 41, 62– 68, 100, 100– 101n C- 188/ 10 and 189/ 10, Melki and Abdeli, [2010] ECR I- 05667 (ECLI:EU:C:2010:363) . . . . . .206 C- 355/ 10, European Parliament v. Council, 5 September 2012, not yet published (ECLI:EU:C:2012:516) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 206, 206n C- 468/ 10 and 469/ 10, Asociación Nacional de Establecimientos Financieros de Crédito (ASNEF) and Federación de Comercio Electrónico y Marketing Directo (FECEMD) v. Administración del Estado, [2011] ECR I- 12181 (ECLI:EU:C:2011:777) . . . . . . . . . . . .4– 5 C- 614/ 10, Commission v. Austria, 16 October 2012, not yet published (ECLI:EU:C:2012:631) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .134, 142– 143, 146n, 167n C- 617/ 10, Åkerberg Fransson, 26 February 2013, not yet published (ECLI:EU:C:2013:280) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .142 C- 399/ 11, Melloni v. Ministerio Fiscal, 26 February 2013, not yet published (ECLI:EU:C:2013:107) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .142 C- 131/ 12, Google Spain SL and Google Inc v. Agencia Española de Protección de Datos and González, judgment of 13 May 2014, not yet published (ECLI:EU:C:2014:317) . . . . . . . . 5, 133, 134n, 136, 153, 155n, 159n, 163n, 193– 195 C- 288/ 12, Commission v. Hungary, 8 April 2014, not yet published (ECLI:EU:C:2014:237) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .134, 142– 143, 146n, 167n C- 291/ 12, Michael Schwarz v. Stadt Bochum, 17 October 2013, not yet published (ECLI:EU:C:2013:670) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .143, 220–2 22