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Fragmentation and defragmentation of the law on biomedical innovations

PI : Aurélie Mahalatchimy

ANR-20-CE26-0007-01

A team of researchers in Social and Human Sciences as well as in Biomedical and Pharmaceutical Sciences have obtained a four-years funding from the French National Agency for Research to analyse two contrasting processes: fragmentation (division or segmentation), and defragmentation (gathering together, connecting or ‘harmonising’) of the European law on Biomedical innovations (BI), mainly in gene therapy, regenerative medicine, and nanomedicine areas. Instead of regarding these processes as oppositional forces, the research hypothesis is that they can jointly contribute to and express the adaptability and coherence of the law as it pertains to BI. The project’s objectives are to explore and explain these legal processes and provide ‘genealogies’- here understood as histories of successive developments- of both processes in European law on BI. Building on the works linked to legal oversight of complex BI, law temporality and law fragmentation phenomenon, I-BioLex uses comparative and interdisciplinary approaches and combines theoretical and empirical elements to test this hypothesis while helping to determine how the law on BI can serve diverse societal objectives.

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