CE26 - Innovation, travail 2020

Fragmentation and defragmentation of the law on biomedical innovations – I-BioLex

Fragmentation and defragmentation of the law on biomedical innovations

European law on Biomedical innovations (BI), in areas such as gene therapy, regenerative medicine, or nanomedicine, involves two contrasting processes: fragmentation (division or segmentation), and defragmentation (gathering together, connecting or ‘harmonising’). Instead of regarding them 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.

Genealogies and roles of legal processes in the co-construction of law and biomedical innovations

The project’s objectives are to explore and explain these legal processes of fragmentation and defragmentation of the law on biomedical innovations and provide ‘genealogies’- here understood as histories of successive developments- in order to highlight their complementary roles in the co-construction of law and biomedical innovations (i.e. the influence of biomedical innovations on law and that of law on the development of biomedical innovations) and to provide answers to the societal issues raised by these innovations.

I-BioLex uses comparative (European Union, Council of Europe, French and English law) and interdisciplinary (Law, STS, Sociology, Pharmaceutical Sciences, Molecular Biology and Biotechnology) approaches and combines theoretical and empirical elements to test the research hypothesis, and find out how the law can serve various societal objectives.

Ongoing publications

The project's productions are available at the following link: elsibi.hypotheses.org/i-biolex/productions-5

European law on Biomedical innovations (BI), in areas such as gene therapy, regenerative medicine, or nanomedicine, involves two contrasting processes: fragmentation (division or segmentation), and defragmentation (gathering together, connecting or ‘harmonising’). Instead of regarding them 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.

Project coordination

Aurélie Mahalatchimy (Droits international, comparé et européen)

The author of this summary is the project coordinator, who is responsible for the content of this summary. The ANR declines any responsibility as for its contents.

Partnership

DICE Droits international, comparé et européen

Help of the ANR 321,881 euros
Beginning and duration of the scientific project: December 2020 - 48 Months

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