EUROPEAN JOURNAL OF HEALTH LAW最新文献

This study examines the decisions of the German and Austrian constitutional courts on the subject of assisted suicide in a comparative legal framework. Both judgments are based on human dignity and the right to self-determination, but differ in their definition of the limits of the state's obligation to protect life. The German Federal Constitutional Court interprets the right to self-determination in the broadest sense: It states that the motives for a decision to end one's life cannot be subject to external evaluation, as they fall exclusively within the sphere of the individual's inner convictions. The Austrian Constitutional Court, on the other hand, merely declared that a total ban was unconstitutional and left it to the legislature to lay down detailed rules. As a social and political consensus in favour of stricter regulation has emerged in Austria, the legislature limits the circle of eligible persons in the Sterbeverfügungsgesetz (Living Will Act) to those who are terminally ill or suffering from a life-threatening illness and layed down detailed procedural safeguards. The fundamental difference between the two models can thus be summarised as follows: Germany recognises personal autonomy under all circumstances without any restrictions, while Austria restricts access to assisted suicide more strictly and limits it to the seriously ill in order to prevent abuse.

Regulation of Substances of Human Origin (SoHO) is an important topic of Union health law both in the context of research and in the context of healthcare services and treatment of patients. When we observe Union SoHO law, we do not only observe a linear movement towards greater harmonisation and less differentiation between national laws. At the same time as the 'expected' harmonisation processes of an inexorable process of greater Union law coverage of a field, and less space for national difference, we also observe counter-processes in the opposite direction. Focusing on the role of the Court of Justice of the Union to understand the dynamics of Union regulation of the sector through the analysis of 19 SoHO cases, this article proposes two new legal analytical concepts to explain these processes: 'defragmentation' and 'fragmentation' which provide an explanatory model as a tool of legal science to use to promote greater understanding of Union law.

The governance of pharmaceutical expenditure is a crucial issue in ensuring access to pharmaceutical care, especially in countries with universal healthcare systems where both the pricing and reimbursement of medicines are managed by public authorities. Through a comparative analysis of the challenges and policy solutions adopted by the United Kingdom and Italy, this article focuses on key issues related to the management of reimbursed medicine costs: the allocation of competences among public authorities, cost-effectiveness assessment, expenditure control, and price transparency. It highlights critical issues and outlines future research perspectives.

This article analyses how the notion of health data under the GDPR has evolved through the legal instruments and provisions on health data sharing in the Data Governance Act (DGA) and the European Health Data Space (EHDS), aiming both legal sources to facilitate data access and governance, including electronic health data for its primary and secondary use, by establishing harmonised rules. These regulations open opportunities to enhance cross-border data access, the promotion of data altruism, and the development of data governance models facilitating biomedical research. In the specific context of rare diseases, however, significant challenges remain emerging from variations between EU Member States implementation of the EHDS. In particular, the EHDS's secondary use framework, the genomic and biobank data exception, and the coexistence with the DGA's consent‑based data altruism model create a complex legal landscape for rare disease research. This contribution intends to clarify the legal bases for secondary use to improve the capacity to protect data subjects' right to data protection, while preserving data value and utility in biomedical research within the context of rare diseases.

While digital health technologies have rendered national borders technically obsolete, the European Union's (EU) legal framework for cross-border telemedicine remains fragmented. This paper examines the tension between the EU's internal market logic - favouring the free movement of services - and the Member States' protected competence over health system organisation under Article 168(7) TFEU. By analysing the limitations of the 2011 Patients' Rights Directive, the study evaluates whether the recent European Health Data Space (EHDS) Regulation and the broader European Health Union can provide a coherent regulatory foundation for digital mobility in the context of cross-border telemedicine. This will be done by relying on two primary legal frictions: professional licensing and reimbursement mechanisms. The paper argues that for the EHDS Regulation to succeed, it must move beyond technical interoperability to address the underlying legal-ethical conflicts of digital sovereignty.