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Understanding European Union Substances of Human Origin Case Law through Defragmentation and Fragmentation.
Aurélie Mahalatchimy1, Marie Glinel2, Tamara K Hervey3
1Faculty of Law, Aix-Marseille University 5 Avenue Robert Schuman, 13628 Aix-en-Provence France.
European Journal of Health Law
|May 7, 2026
Summary
Union health law for Substances of Human Origin (SoHO) shows complex dynamics. Analysis reveals both harmonisation and fragmentation, with new legal concepts explaining these trends in SoHO regulation.
Area of Science:
- Health Law
- European Union Law
- Legal Science
Background:
- Regulation of Substances of Human Origin (SoHO) is crucial for both research and patient healthcare within the European Union.
- Current Union SoHO law exhibits complex dynamics, not solely moving towards harmonisation but also experiencing counter-processes.
- Understanding these dynamics is essential for effective legal frameworks in the SoHO sector.
Purpose of the Study:
- To analyze the dynamics of Union regulation of Substances of Human Origin (SoHO).
- To introduce and define two new legal analytical concepts: 'defragmentation' and 'fragmentation'.
- To provide an explanatory model for understanding the complexities of Union law in the SoHO sector.
Main Methods:
- Analysis of 19 case law decisions from the Court of Justice of the European Union concerning SoHO.
- Application of legal analytical concepts to interpret regulatory trends.
- Development of a theoretical framework to explain regulatory dynamics.
Main Results:
- The study identified counter-processes to harmonisation within Union SoHO law.
- The concepts of 'defragmentation' and 'fragmentation' were proposed to explain these observed dynamics.
- The analysis highlights the significant role of the Court of Justice of the European Union in shaping SoHO regulation.
Conclusions:
- Union regulation of Substances of Human Origin is characterized by both harmonisation and fragmentation.
- The proposed concepts of 'defragmentation' and 'fragmentation' offer a novel explanatory model for legal science.
- This model enhances the understanding of the complex evolution of Union law in the SoHO field.
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