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Author: Zamira Xhaferri
This book examines the law and practice of the delegation of rulemaking powers to the European Commission. It combines legal doctrine with empirical research methods to bridge the gap between “law on the books” and “law in action” to fully appreciate the meaning and the impact of the changes post-Lisbon. The results of the empirical case study provide food for thought on how the current legal framework regime for delegated rulemaking by the European Commission could be improved. The findings seek to contribute to the academic and policy debates on this research topic that is likely to continue in forthcoming years.

Abstract

The protection of whistleblowers in healthcare is necessary to ensure quality of care by raising concerns about suspected breaches of human rights and Union law. This protection has evolved over the years through initiatives from the European Council, which were also taken into account in two rulings of the European Court of Human Rights, and the European Parliament. However, these initiatives implement a general framework rather than focussing directly on healthcare. This article therefore starts from analysing the general protection. Hereinafter, the relevance for the healthcare sector will be examined for each of the involved initiatives.

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In: European Journal of Health Law
In: European Journal of Health Law
In: European Journal of Health Law

Abstract

In this paper I have tried to identify and analyse some critical points that Regulation No. 526 of 2014 on clinical trials still presents. I have seen that in the face of a long gestation, the criticisms that have been made of the regulation have been various. If we think of the first criticism identified in the regulation, the so-called law shopping, we must affirm that the subject of experimentation is a very delicate matter since it has a direct and frontal impact on the guarantee of the right to health of European citizens and the use of law shopping does not provide adequate guarantees for the protection of the rights of those participating in a trial. Secondly, the marginalisation of the Ethics Committees whose role is decided at the level of the single national legal system does not ensure that components of independence and representation of the point of view of patients and their associations are guaranteed. This aspect is undoubtedly an important criticism of the regulation as the importance of the role played by the Ethics Committees in the assessment procedures for authorisation applications is not taken into fully consideration. Also, in this case, the economic need for simplification and speed of the evaluation procedure seem to prevail over the need to ensure a thorough and independent scientific and ethical review of authorisation applications. We believe that in the case of Regulation No. 536 of 2014, greater awareness of risks and opportunities will be achieved only by verifying in practice the possible distortions to which this legislation can lead. Only through serious monitoring and reporting of the effects of the regulation on the protection of patients’ rights will it be possible to identify and indicate targeted changes to the rules contained therein and, of course, to adopt the consequent measures to reduce possible damages. In this sense, also on the basis of a possible and foreseeable future phase of gestation of Regulation No. 534 of 2014, we believe that in the European area, in the field of clinical trials but not exclusively, that trend, developed above all in the French context, of the “experimentation of laws” should be further cultivated.

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In: European Journal of Health Law

Abstract

This paper deals with a series of legal cases in Italy, Germany, and Austria, between September 2019 and December 2020, which ruled that laws prohibiting or restricting assistance in suicide were unconstitutional. There are similarities between these three cases, all of which are influenced by the practice of assisted suicide in Switzerland, but also differences, not least because of the antecedent legal contexts. Each case is based on flawed reasoning. They have in common an exaggerated account of autonomy or self-determination, insufficiently qualified by the duty to protect human life or by other ethical constraints. The Italian and Austrian Courts also appeal to the principle of equality and to a supposed analogy with refusal of life-sustaining treatments, both of which raise concerns in relation to further expansion of the provisions. In responding to these flawed judgements, legislators should favour proposals that prevent the normalisation of assisted and non-assisted suicide.

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In: European Journal of Health Law

Abstract

Informed consent has been inconsistently conceptualised as a right, an immunity or even a power in the hands of the patient, which leaves its legal definition as partially indefinite.

From the norms of the CHRB, a legal theory stance and the proposals of celebrated authors — namely, W.N. Hohfeld, H. Kelsen and R. Alexy, I will provide a steady conceptual structure for the subjective legal positions of the parties involved in the healthcare relationship regarding informed consent.

Full Access
In: European Journal of Health Law
In: European Journal of Health Law
In: European Journal of Health Law