EUROPEAN JOURNAL OF HEALTH LAW最新文献

Over the past few years, some parents and clinicians in the UK have argued about decisions on the fate of critically-ill children, with the cases ending in protracted and emotionally-sapping legal disputes. The long-running legal conflicts have played out in the public eye, eliciting conflicting opinions. At the core of the disputes is whether parents or clinicians should determine the appropriate course of action. In the event of the disagreements, the domestic court intervenes guided by the ‘best interests’ principle. A corpus of scholarship, falling on either side of the debate, has captured the contradictions. Until recently, the discourse had focused on the common recourses to domestic courts and the European Court of Human Rights. However, in the recent case of incapacitated 12-year-old Archie Battersbee, his parents sought redress from the international human rights system through the Committee on the Rights of People with Disabilities to stop termination of his life support. The courts barred the involvement of the Committee on the basis that the UK had not incorporated the treaty which birthed the Committee. The case brought into sharp focus the relationship between international law and domestic law. First, this paper asserts that the weight (not) given to international law by the domestic courts was inconsistent with its treatment of international obligations in other cases. Secondly, the position that unincorporated treaties do not have legal effect in domestic proceedings is ambiguous. Finally, the treaty body appeared ill-suited to handle a case of a critically-ill child in the face of the impatient demands of local justice.

At the end of 2022, the European Commission published a proposal for a directive to revise the strict liability regime introduced in 1985. Although the main goal of this new proposal is to adapt the regulations to information technologies such as artificial intelligence, it has multiple impacts on other economic sectors, including the pharmaceutical market. Therefore, this proposal could change the deal in terms of liability in this specific market. Indeed, the proposal modifies the burden of proof, which can be quite challenging to establish in the case of adverse effects of medicinal products. It introduces a possible presumption of liability for a manufacturer who fails to communicate, to a court, the information they required, which might jeopardise the protection of trade secrets and commercial confidentiality. In addition, the proposal also extends the limitation period, and more importantly, it mandates the application of the ‘development risk defence.’

In many European legal systems, the provisions of medical legislative acts impose directly on healthcare professionals an obligation to act with due care. This imperative may be considered a basic principle of practising all medical professions, and even a generally accepted principle of medical law. Due care is the manner of conduct by medical professionals that meets the requirements contained in an objective and external standard of conduct created for each specific obligational relationship. Despite the differences between European legal systems, from a comparative perspective it is possible to notice similar factors taken into account when determining the standards of due care in medicine. This is because the conduct of medical professionals is largely determined by actual state of medical knowledge, medical standards and deontological codes relating to all medical professional activities. The aim of the article is to discuss in detail these issues in comparative perspective.

Due to the war against Ukraine, the European Union Temporary Protection Directive, establishing a new migration status of temporary protection, was activated for the first time. The substance of the minimum requirement for providing healthcare services in the Directive appears unclear but is supposed to correspond to human rights standards. This article analyses the standards established in the European Social Charter (revised), recognising several health-related rights. The paper clarifies the material scope of health-related rights and analyses to what extent the Charter applies to persons enjoying temporary protection. The application of health-related rights in the Charter varies depending on citizenship, whether refugee status was additionally sought, and whether a person is seen as a resident or regular worker. The study indicates ambiguity in the position of this group and how the European Social Rights Committee may include it in the scope of protection.

Against the backdrop of interconnected devices, people, and processes in the Internet of Everything (IoE) an examination of the MDR (Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EE), data protection and cybersecurity rules are carried out with respect to medical devices' privacy and security. The legal analysis therefore investigates how and to what extent the MDR could cope with the copious challenges of cybersecurity and data protection in the IoE of medical devices. The article sheds light on how the MDR sets a minimal standard of requirements for medical device safety and security. In this respect, an unexpected and complicated regulatory interplay is discussed providing for a well-coordinated approach for digital health technologies. Finally, the article discusses several key points of the proposed EU AI Regulation considering digital health technologies.