Mary Donnelly and Maeve McDonagh

Abstract

This article analyses the balance which the GDPR strikes between two important social values: protecting personal health data and facilitating health research through the lens of the consent requirement and the research exemption. The article shows that the normative weight of the consent requirement differs depending on the context for the health research in question. This more substantive approach to consent is reflected in the research exemption which allows for a more nuanced balancing of interests. However, because the GDPR articulates the exemption at an abstract and principled level, in practice the balance is struck at Member State level. Thus, the GDPR increases difficulties for EU cross-border health projects and impedes the policy goal of creating a harmonised regulatory framework for health research. The article argues that in order to address this problem, the European Data Protection Board should provide specific guidance on the operation of consent in health research.

Catherine Le Bris

Abstract

The harmful consequences of female circumcision for women’s health have been demonstrated and are regularly recalled by the World Health Organisation. Whereas in the past, the cultural dimension of the practice was emphasised, which result in impunity or absence of guilt, it is now considered by the United Nations as a violation of human rights, especially of the right to health. In 2012, the General Assembly asked States for a total ban on the practice. Despite the consensus on the punishability of female circumcision, its enforcement diverges, in particular in Western Europe. France is considered as a model in this area, that’s why this study focuses on it. Yet, under French law, there is no special legislation criminalising the practice: female circumcision is punishable on grounds of mutilation. However, the French success is not complete: the prevention of such acts could be improved.

Gisela Ernst

Abstract

As a result of the constantly increasing number of innovative but exceedingly high priced medicines, many Member States have implemented price-regulating mechanisms to ensure the financial viability of their healthcare systems. However, the European Court of Justice applies strict criteria to these measures – some of them have already been suspended for the purposes of the free movement of goods. The European Union (EU) allowed the development of an ever-stricter case law on one hand, without changing the legal frame on the other hand. Considering the importance and the binding nature of the Court’s judgements, this leaves great uncertainty for national legislators about which measures to remedy the pricing problem are legally possible and which are not. In order to provide clarity, this article seeks to analyse the development of the case law and to define the legal scope for pharmaceutical pricing mechanisms in the EU.