On 25 May 2018, the EU General Data Protection Regulation (GDPR) will come into force. As with the Data Protection Directive (95/46/EC), the regulation of biobanks for scientific research will be profoundly affected by this reform. Accordingly, a comparative survey of some of the existing national regulatory frameworks is of value to aid understanding of whether and how EU Member States will need to realign their systems to ensure compliance with the new Regulation. This article provides a comparison of the positions of Member States in the Mediterranean and Eastern European area, focusing

This chapter seeks to provide insight into the ways in which Member States leveraged the regulatory discretion afforded to them by the GDPR. Specifically, it reviews the biobank regulatory environment; whether and how derogations under Article 89(2) GDPR are enabled; the legal basis for scientific research and the role of consent in biobanking post-GDPR; the balance between individual rights and public interest in national law; and finally, the GDPR’s impact and future possibilities for biobanking. In exercising self-determination, Member States can, to a certain extent, align data protection requirements with their values and aspirations. Such alignment, though, could jeopardize collaborative research. In light of the need to bridge divergent legal and ethical requirements at a national and supranational level, the role of Research Ethics Committees (RECs) might prove to be essential.

Introduction: the Implementation of the Principle of Solidarity as a 'Make-it or Break-it' Challenge for the EU1 1.1 Does the European Integration Process Postulate Solidarity? This special issue aims at addressing the crisis of solidarity which is hammering the governance of irregular migration and asylum policies within the EU.2 The Treaties expressly mention the pivotal role of the principle of solidarity in the EU integration process, as one finds in Articles 2 and 3 of the TEU, where solidarity is among the fundamental values of the EU. To be more precise, solidarity is also one of the founding principles of the internal market, which aims at achieving a social market economy, realizing solidarity between generations and among Member States.3 In the field of migration and asylum law, solidarity between Member States is a core element of the common policies on asylum, immigration and external border controls, together with fairness toward third-country nationals.4 For example, Article 80 TFEU mirrors the concern about solidarity by stating that migration policies shall be "governed by the principle of solidarity and fair sharing of responsibility".5 Moreover, in his Opinion in the case Slovakia and 1 Before the German Parliament, Angela Merkel stated: "Europe faces many challenges, but that of migration could become the make-or-break one for the EU.

Resumen: El presente artículo se propone desarrollar el tema de la regulación de la actividad médica y de investigación científica por parte de los legisladores nacionales, en el marco de un panorama normativo en donde la influencia de las fuentes internacionales resulta ser un elemento relevante que los legisladores deben considerar a la hora de intervenir en este ámbito.Abstract: This paper deals with the sometimes problematic regulation at national level of medical and scientific issues and defends the necessity for national legislator of taking into consideration the sources of international and comparative law at this regards.Palabras clave: Legislación sobre cuestiones científicas -Derecho comparadoBioética Key words: Legislation on scientific issues -Comparative Law -Bioethics 1. Derecho y Ciencia: ¿papel para el legislador?El presente artículo se propone desarrollar el tema de la regulación de la actividad médica y de investigación científica por parte de los legisladores nacionales, en el marco de un panorama normativo en donde la influencia de las fuentes internacionales resulta ser un elemento relevante que los legisladores deben considerar a la hora de intervenir en este ámbito 1 . * Profesor Ayudante Doctor. Universidad de Trento (Italia). Se agradece al doctor Juan Pablo Castillo Morales, doctorando en la Escuela de Doctorado en Estudios Jurídicos Comparados y Europeos de la Facultad de Jurisprudencia de la Universidad de Trento, para su fundamental ayuda en la revisión lingüística de este artículo. La responsabilidad de los contenidos pertenece, obviamente, al autor. La cuestión de quien es el sujeto institucional mayormente legitimado para regular esta actividad representa un elemento esencial y preliminar, puesto que -desde una perspectiva teórica -pueden ser múltiples las herramientas normativas aplicables en este ámbito. Además de la ley, una pluralidad de fuentes pueden concurrir a la regulación, de forma alternativa o complementaria 2 : entre otros, la jurisprudencia 3 , la actividad reguladora de autoridades técnicas, la autorregulación 4 de los sujetos médicocientíficos (o de sus instituciones exponenciales).De todas formas, parece no ser cuestionable que el legislador esté llamado a tener un papel central en la regulación de este ámbito, teniendo en cuenta la especial relevancia de las cuestiones suscitadas por actividades de este tipo, que llaman en causa derechos y principios constitucionales. En este sentido, la necesidad que sea en primer lugar el legislador el que introduzca una regulación ha sido expresada de manera reiterada a nivel internacional y nacional (constitucional). Oxford, 2006, p. 893, «as to regulation, one cannot only observe an increase in statutory legislation, but also in all kinds of voluntary regulation, supplementing statute law but sometimes also replacing it. While the emergence of this so called self-regulation is a general phenomenon, it seems to be especially prominent in the health field, where the power of the professions has always been substantial and ...

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