How should we understand the European Union’s Court’s decisions about ‘substances of human origin’?

The EU’s Court is usually thought of as driving ‘Europeanisation’. Its rulings make EU law more ‘harmonised’ and reduce differences between Member States. It is also – like all courts – supposed to make sure that law is consistent. The same concepts in different areas should have the same meanings – a basic concept of legality. We call these ideas ‘defragmentation’. We examine the EU Court’s decisions on substances of human origin (blood, tissues, cells etc). We show that – instead of only being about ‘harmonisation’ and consistency – the Court’s decisions also include ones that allow less harmonisation and more differentiation between EU Member States, and ones that allow for different meanings of concepts in different contexts. We call these ‘fragmentation’. We conclude that the fragmentation and defragmentation model we propose allows a better analytical frame than ‘harmonisation’ to promote greater understanding of EU law.

The paper’s scope is the law of the European Union, and specifically the 19 decisions of the European Court of Justice, on the topic of substances of human origin.

• The paper covers 19 decisions of the Court of Justice of the European Union. Four are on patentability of substances of human origin. Five are about the framing, safety and quality of substances of human origin. Five are on tax exemptions and economic incentives. Six are about blood: its designation as a non-commodity and the significance of its donation.
• We show both ‘defragmentation’ and ‘fragmentation’ across these decisions.
• Defragmentation is found in making sure Member States comply in time with their EU law obligations, by adopting national law with binding force. National circumstances, whether linked to domestic difficulties or national ethical positions, are not an acceptable reason for non-compliance. Compliance includes providing the Commission with mandatory information. 
• Defragmentation is also found where the Court reduces or removes national discretion by the way it interprets EU law. The Court rejects differences in languages as a reason for having different interpretations of EU law. The Court creates common EU concepts, like a Value Added Tax exemption, and says how they are to be used. The Court’s reasoning – while acknowledging the possibility of national differences – does not permit them.
• Fragmentation is found where the Court does not ‘read across’ definitions from one piece of EU legislation to another, but has different definitions of the same concept in different contexts. For example, ‘blood’ in the Value Added Tax directive is not interpreted in the same way as ‘blood’ in the Blood Safety Directive. Human organs and samples are also interpreted differently in different contexts.
• Fragmentation is also found where the Court’s reasoning – if not the result of a decision – allows in principle for different national approaches. For example, the Court allows for Member States to have different approaches to the qualifications required for a person responsible for a blood establishment.
• Overall we offer an analytical frame for lawyers, policy-makers, healthcare professionals and providers, and patients to understand the complexities of EU law on substances of human origin. This frame could be applied also to other areas of EU law.

• Introduction
• Context: SoHO Litigation To Date
• Normative Defragmentation
• Normative Fragmentation
• Material Defragmentation
• Material fragmentation
• Conclusions

Full reference of the paper: 

A. MAHALATCHIMY, M. GLINEL, T.K. HERVEY, Understanding European Union SoHO caselaw through defragmentation and fragmentation, (2026). European Journal of Health Law (5 May 2026, published online ahead of print 2026) : https://doi.org/10.1163/15718093-bja10166

Open Access link to the paper:

https://brill.com/view/journals/ejhl/aop/article-10.1163-15718093-bja10166/article-10.1163-15718093-bja10166.xml

This lay summary is written by the authors of the article Tamara K Hervey (The City Law School, University of London, UK) and  Aurélie Mahalatchimy (Aix-Marseille University, CNRS, DICE, CERIC, Aix-en-Provence, France).