EUROPEAN JOURNAL OF HEALTH LAW最新文献

The European healthcare sector is transforming toward patient-centred and value-based healthcare delivery. The European Health Data Space (EHDS) Regulation aims to unlock the potential of health data by establishing a single market for its primary and secondary use. This paper examines the legal challenges associated with the secondary use of health data within the EHDS and offers recommendations for improvement. Key issues include the compatibility between the EHDS and the General Data Protection Regulation (GDPR), barriers to cross-border data sharing, and intellectual property concerns. Resolving these challenges is essential for realising the full potential of health data and advancing healthcare research and innovation within the EU.

The creation of the European Health Data Space is a milestone. It establishes something new and makes it possible to have faster and more efficient health treatment, but also to untap the potential of unused data for policy-making and development of new technologies. However, for the EHDS to be functional, it is imperative that a balance it struck between the aim of having useful data to achieve important public objectives on one side and the goal of enabling patients to have control over their health data. The original Draft Report of the European Parliament came closest to achieving these objectives and should have represented the blueprint for the final compromise. Having a harmonised opt-out for secondary use is crucial for striking the right balance between the mentioned objectives. The end result is far from perfect regarding primary use, but represents a good balance in the area of secondary use concerning the opt-out.

Uterus transplantation (UT) is a surgical procedure that seeks to correct absolute uterine infertility. As such, it is coupled with assisted reproductive technologies (ART). Currently performed as an investigational procedure in France, this technique could be subject to a legal framework in the future. Given its specificities, the French legislator will need to state their position on several matters. Regarding the donor, they will need to determine whether the benefits for the infertile woman justify exposure of a living person to the risks of the removal procedure. If necessary, they will have full freedom to set the criteria for selecting the living donor based on age, the existence or not of past pregnancies or the nature of the donor-recipient relationship. On the other side, the conditions for becoming a recipient should be consistent with the existing rules for ART. Other considerations could include age and past pregnancies again. Lastly, the legislator will also need to address the possible desire for UT without the endpoint of pregnancy.

Anonymous gamete donation creates a specific conflict between human rights and public interests under Article 8 of the ECHR. This was first assessed in the ECtHR's landmark decision in Gauvin-Fournis and Silliau v. France of 7 September 2023. This article critically analyses this judgment, taking into account the European legal framework for anonymous gamete donation, the recommendations of the competent authorities and the previous case law of the ECtHR on the right to know one's biological origin as an integral part of one's identity that is protected under the right to private and family life.

Legislation produced under the EU Commission's Better Regulation Agenda sometimes fails to achieve the Treaty obligation to ensure a high level of health protection in all EU policies and activities. Public health advocates have raised the question of whether EU law can be employed to challenge this apparent breach of Treaty obligations at the proposal preparation stage, compelling the Commission to amend prospective EU legislation so that it better protects health. This article will demonstrate that unfortunately this is not possible due to the justiciability of both Article 168 TFEU and the Better Regulation Agenda. However, this awareness can help public health advocates to re-focus their efforts on strategies that will likely have a greater impact in swaying the direction of EU health policy.