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Cell-based regenerative medicine: new challenges for EU legislation and governance

Objective

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.

Field of science

  • /social sciences/economics and business/business and management/commerce
  • /social sciences/sociology/governance
  • /social sciences/law

Call for proposal

FP7-HEALTH-2013-INNOVATION-1
See other projects for this call

Funding Scheme

CSA-SA - Support actions

Coordinator

INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE
Address
Rue De Tolbiac 101
75654 Paris
France
Activity type
Research Organisations
EU contribution
€ 108 739
Administrative Contact
Muriel Bouas (Ms.)

Participants (8)

GOTTFRIED WILHELM LEIBNIZ UNIVERSITAET HANNOVER
Germany
EU contribution
€ 42 217
Address
Welfengarten 1
30167 Hannover
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Nils Hoppe (Prof.)
KOZEP-EUROPAI EGYETEM
Hungary
EU contribution
€ 53 029
Address
Nador Utca 9
1051 Budapest
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Eva Vas (Ms.)
LEGAL PATHWAYS BV
Netherlands
EU contribution
€ 41 944
Address
Klapheklaan 8
2111 XS Aerdenhout
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Jasper Bovenberg (Dr.)
THE CHANCELLOR, MASTERS AND SCHOLARS OF THE UNIVERSITY OF OXFORD
United Kingdom
EU contribution
€ 52 984
Address
Wellington Square University Offices
OX1 2JD Oxford
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Stephen Conway (Dr.)
MEDIZINISCHE UNIVERSITAT GRAZ
Austria
EU contribution
€ 52 822
Address
Auenbruggerplatz 2
8036 Graz
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Kurt Zatloukal (Prof.)
FONDATION NATIONALE DES SCIENCES POLITIQUES
France
EU contribution
€ 53 004
Address
Rue Saint Guillaume 27
75337 Paris
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Gina Sandanassamy (Mrs.)
KATHOLIEKE UNIVERSITEIT LEUVEN
Belgium
EU contribution
€ 52 911
Address
Oude Markt 13
3000 Leuven
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Karolien Mariën (Ms.)
ROYAL INSTITUTION FOR THE ADVANCEMENT OF LEARNING MCGILL UNIVERSITY
Canada
EU contribution
€ 42 350
Address
845 Sherbrooke Street West
H3A0G4 Montreal
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Bartha-Maria Knoppers (Prof.)