Aurélie Mahalatchimy, Marie Glinel, Tamara K Hervey
{"title":"Understanding European Union Substances of Human Origin Case Law through Defragmentation and Fragmentation.","authors":"Aurélie Mahalatchimy, Marie Glinel, Tamara K Hervey","doi":"10.1163/15718093-bja10166","DOIUrl":"https://doi.org/10.1163/15718093-bja10166","url":null,"abstract":"<p><p>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.</p>","PeriodicalId":43934,"journal":{"name":"EUROPEAN JOURNAL OF HEALTH LAW","volume":" ","pages":"1-23"},"PeriodicalIF":0.7,"publicationDate":"2026-05-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147844093","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"European Court of Human Rights.","authors":"Joseph Dute, Tom Goffin","doi":"10.1163/15718093-bja10172","DOIUrl":"https://doi.org/10.1163/15718093-bja10172","url":null,"abstract":"","PeriodicalId":43934,"journal":{"name":"EUROPEAN JOURNAL OF HEALTH LAW","volume":"33 2","pages":"223-240"},"PeriodicalIF":0.7,"publicationDate":"2026-04-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147844117","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Pharmaceutical Expenditure Governance in the UK and Italy.","authors":"Alice Cauduro","doi":"10.1163/15718093-bja10168","DOIUrl":"https://doi.org/10.1163/15718093-bja10168","url":null,"abstract":"<p><p>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.</p>","PeriodicalId":43934,"journal":{"name":"EUROPEAN JOURNAL OF HEALTH LAW","volume":" ","pages":"1-28"},"PeriodicalIF":0.7,"publicationDate":"2026-04-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147844133","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"The Dilemma between Data Protection and Data Altruism within the Context of Rare Diseases in the European Health Data Space.","authors":"Laura Centeno Casado","doi":"10.1163/15718093-bja10169","DOIUrl":"https://doi.org/10.1163/15718093-bja10169","url":null,"abstract":"<p><p>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.</p>","PeriodicalId":43934,"journal":{"name":"EUROPEAN JOURNAL OF HEALTH LAW","volume":"33 2","pages":"137-165"},"PeriodicalIF":0.7,"publicationDate":"2026-04-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147844236","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"The Telemedicine Paradox: Why Data Moves but Care Does Not.","authors":"Wendy Kwaku Yeboah","doi":"10.1163/15718093-bja10171","DOIUrl":"https://doi.org/10.1163/15718093-bja10171","url":null,"abstract":"<p><p>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.</p>","PeriodicalId":43934,"journal":{"name":"EUROPEAN JOURNAL OF HEALTH LAW","volume":"33 2","pages":"187-202"},"PeriodicalIF":0.7,"publicationDate":"2026-04-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147844191","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Addressing De Facto Discrimination through the European Health Data Space: Taking Obesity as a Case Study of Non-Immediate Primary Use.","authors":"Vincenzo Forte","doi":"10.1163/15718093-bja10170","DOIUrl":"https://doi.org/10.1163/15718093-bja10170","url":null,"abstract":"<p><p>This paper investigates the structural limitations of cross-border healthcare mobility under Directive 2011/24/EU, analysing whether the European Health Data Space (EHDS) could offer a constitutionally compatible solution to its limited practical effectiveness. Although the directive formally recognises patients' right to reimbursement for treatment abroad, organisational fragmentation and inadequate digital interoperability persistently constrain its effective exercise. Against this background, the article introduces the interpretative concept of 'non-immediate primary use' of electronic health data. This is defined as a professionally mediated and infrastructural process designed to identify appropriate cross-border treatment options when national systems are clearly inadequate. Using obesity as a case study of structural discrimination, the analysis argues that digital coordination under the EHDS could implement existing mobility rights without expanding the competences of the Union under Article 168(7) TFEU. The EHDS is therefore presented as an infrastructural instrument that can reinforce substantive equality within the current constitutional allocation of powers.</p>","PeriodicalId":43934,"journal":{"name":"EUROPEAN JOURNAL OF HEALTH LAW","volume":"33 2","pages":"166-186"},"PeriodicalIF":0.7,"publicationDate":"2026-04-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147844054","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Tamara K Hervey, Ollie Bartlett, Joaquín Cayón-De Las Cuevas, Vincent N Delhomme, André den Exter, Anniek de Ruijter, Mirko Ðuković, Mark L Flear, Markus Frischhut, Éloïse Gennet, Tom Goffin, Mary Guy, Pin Lean Lau, Aurélie Mahalatchimy, Marcin Michalak, Vera Lúcia Raposo, Santa Slokenberga, Annette Schrauwen
{"title":"Conceptualising European Union Health Law.","authors":"Tamara K Hervey, Ollie Bartlett, Joaquín Cayón-De Las Cuevas, Vincent N Delhomme, André den Exter, Anniek de Ruijter, Mirko Ðuković, Mark L Flear, Markus Frischhut, Éloïse Gennet, Tom Goffin, Mary Guy, Pin Lean Lau, Aurélie Mahalatchimy, Marcin Michalak, Vera Lúcia Raposo, Santa Slokenberga, Annette Schrauwen","doi":"10.1163/15718093-bja10167","DOIUrl":"https://doi.org/10.1163/15718093-bja10167","url":null,"abstract":"<p><p>A collectively authored article, which (unusually in legal scholarship) makes explicit the processes and methodologies by which 'European Union health law' is conceptualised; the implications; and the strengths and weaknesses of the approach taken. Strengths include implied structural and systemic coherence; and the breadth of analysis that having a large team of authors permits, through holding their positionalities in creative interplay with each other. The authors argue that European Union health law - defined as transversal and distinctively European Union law that either directly or indirectly affects human health, in a broad sense - should be understood through a metaphor of growth and connectedness, specifically a 'tree'. The article seeks to initiate a discussion not only about European Union health law, but also about European law and health law.</p>","PeriodicalId":43934,"journal":{"name":"EUROPEAN JOURNAL OF HEALTH LAW","volume":" ","pages":"1-33"},"PeriodicalIF":0.7,"publicationDate":"2026-04-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147844104","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"From Margins to Movement: Young Scholars, Digital Health, and the Future of EU Health Law.","authors":"Sofia Palmieri, Mirko Đuković","doi":"10.1163/15718093-12423586","DOIUrl":"https://doi.org/10.1163/15718093-12423586","url":null,"abstract":"","PeriodicalId":43934,"journal":{"name":"EUROPEAN JOURNAL OF HEALTH LAW","volume":"33 2","pages":"129-136"},"PeriodicalIF":0.7,"publicationDate":"2026-04-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147844078","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Balancing Care: Human Rights Perspectives on Family Caregivers in Long-Term Care.","authors":"Sarah Claes","doi":"10.1163/15718093-bja10163","DOIUrl":"https://doi.org/10.1163/15718093-bja10163","url":null,"abstract":"<p><p>As European care systems increasingly depend on informal support, family members often assume caregiving roles without clear legal recognition. This paper examines to what extent such caregivers qualify as rights-holders under international human rights law, focusing on their position vis-à-vis care recipients and professionals. Drawing on the European Convention on Human Rights (ECHR) and the Convention on the Rights of Persons with Disabilities (CRPD), it identifies three types of caregiver rights: (1) Derivative rights, when inadequate support for recipients imposes a disproportionate burden; (2) Autonomous parallel rights, when caregivers' own rights, such as privacy or moral integrity, are directly affected; and (3) Autonomous conflicting rights, when caregiver and recipient claims collide, requiring balancing. The CRPD promotes a relational but subordinate recognition of caregiver rights, whereas the ECtHR adopts a balancing approach that can afford greater weight. A coherent rights-based framework must recognize interdependence and ensure principled balancing where rights intersect.</p>","PeriodicalId":43934,"journal":{"name":"EUROPEAN JOURNAL OF HEALTH LAW","volume":" ","pages":"1-22"},"PeriodicalIF":0.7,"publicationDate":"2026-03-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147844146","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"The Individualistic Drift of French Law: Desire and Normative Claims for New Subjective Rights in the \"French Surrogacy Market\".","authors":"Gaëlle Deharo","doi":"10.1163/15718093-bja10156","DOIUrl":"https://doi.org/10.1163/15718093-bja10156","url":null,"abstract":"<p><p>Could the emergence of a surrogacy market in France, despite its prohibition by the French Civil Code, be the tip of a social iceberg? This article aims to analyse the individualization of Law and society. Through innovative legal constructs, the possessors of rights provided by national Law are demanding changes to the law to suit their individual interests. By anchoring their desire in an existing subjective right, legal subjects situate the fulfillment of this desire within the legal domain, while raising the question of its normative dimension. Beyond traditional questions of legal agility, optimization and discursive dimension of the use of available rights, the consequences are crucial: because individualization is growing, the law is no longer a collective and social phenomenon, but a tool that the judge adjusts according to the desired result. What is at stake here is the meaning of Law, Justice and, ultimately, society itself.</p>","PeriodicalId":43934,"journal":{"name":"EUROPEAN JOURNAL OF HEALTH LAW","volume":" ","pages":"1-17"},"PeriodicalIF":0.7,"publicationDate":"2026-03-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147481908","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}