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Cell-based regenerative medicine: new challenges for EU legislation and governance
- Abstract
- This proposal aims at collecting and analysing facts and figures in order to assess the current legislation on
the therapeutic use of somatic cells, and to bridge it with the research infrastructure capacity building. Although
EU has adopted 3 Directives on Tissues and cells between 2004 and 2006 to harmonise the procurement,
storage and use of cells for therapeutic use in Europe, countries have implemented these directives in very
different ways. Furthermore, research has been partially covered by the initial regulation, calling into question the
match between regulation and practices that will develop in the near future, in particular with the emergence of
European research infrastructures. Finally many changes have occurred in the scientific, legal and institutional
environment of cell use, leading to a necessary update of this regulation with regards to its implementation in
national legislation and its impact on research practice and innovation. Two domains are at stake: research
(infrastructures) and medical practice/public health measures (cells). The therapeutic use of cells is regulated by
EU law whereas its research counterpart is mainly depending on national laws and regulations. This gap calls for
a coordinated action in order to optimize the translational process, since the full pipeline is not coherently taken
into account in current legislations. To achieve these objectives, our project relies on a coherent consortium
of experts in the fields of cells therapies, cells banks and translational biomedicine, having strong expertise
in law and/ or in governance issues. After 36 months the project will deliver evidence about the contemporary
practices around cells and will design a picture of the market and its distribution between the public and private
sector. The project will thus help the Commission in the regulatory choices covering the use of human cells for
therapeutic purposes and to foster the innovation potential of related research activities.
- Keywords
- Stem cell research
- european law
- Local Subprojectlead:
- Zatloukal Kurt
- Duration:
- 01.10.2013-30.09.2016
- Programme:
- EU (FP-7)
- Subprogramme
- Health FP7-HEALTH-2013-INNOVATION-1
- EU-Project Instruments
- Coordination and Support Action (Support)
- Type of Research
- other
- MUG Research Units
- Diagnostic and Research Institute of Pathology
- Project partners
- Fondation Nationale des Sciences Politiques, France
- Gottfried Wilhelm Leibniz Universität Hannover, Germany
- Institut de la Sante de la Recherche Medicale (INSERM), France
- Katholieke Universiteit Leuven, Netherlands
- KOZEP-EUROPAI EGYETEM, Hungary
- Legal Pathways BV, Netherlands
- McGill University- Royal Institution for the advancement of learning, Canada
- The Chancellor, Masters and Scholars of the University of Oxford, United Kingdom