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

Objectif

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.

Appel à propositions

FP7-HEALTH-2013-INNOVATION-1
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Régime de financement

CSA-SA - Support actions

Coordinateur

INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE
Adresse
Rue De Tolbiac 101
75654 Paris
France
Type d’activité
Research Organisations
Contribution de l’UE
€ 108 739
Contact administratif
Muriel Bouas (Ms.)

Participants (8)

GOTTFRIED WILHELM LEIBNIZ UNIVERSITAET HANNOVER
Allemagne
Contribution de l’UE
€ 42 217
Adresse
Welfengarten 1
30167 Hannover
Type d’activité
Higher or Secondary Education Establishments
Contact administratif
Nils Hoppe (Prof.)
KOZEP-EUROPAI EGYETEM
Hongrie
Contribution de l’UE
€ 53 029
Adresse
Nador Utca 9
1051 Budapest
Type d’activité
Higher or Secondary Education Establishments
Contact administratif
Eva Vas (Ms.)
LEGAL PATHWAYS BV
Pays-Bas
Contribution de l’UE
€ 41 944
Adresse
Klapheklaan 8
2111 XS Aerdenhout
Type d’activité
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Contact administratif
Jasper Bovenberg (Dr.)
THE CHANCELLOR, MASTERS AND SCHOLARS OF THE UNIVERSITY OF OXFORD
United Kingdom
Contribution de l’UE
€ 52 984
Adresse
Wellington Square University Offices
OX1 2JD Oxford
Type d’activité
Higher or Secondary Education Establishments
Contact administratif
Stephen Conway (Dr.)
MEDIZINISCHE UNIVERSITAT GRAZ
Autriche
Contribution de l’UE
€ 52 822
Adresse
Auenbruggerplatz 2
8036 Graz
Type d’activité
Higher or Secondary Education Establishments
Contact administratif
Kurt Zatloukal (Prof.)
FONDATION NATIONALE DES SCIENCES POLITIQUES
France
Contribution de l’UE
€ 53 004
Adresse
Rue Saint Guillaume 27
75341 Paris Cedex 07
Type d’activité
Higher or Secondary Education Establishments
Contact administratif
Gina Sandanassamy (Mrs.)
KATHOLIEKE UNIVERSITEIT LEUVEN
Belgique
Contribution de l’UE
€ 52 911
Adresse
Oude Markt 13
3000 Leuven
Type d’activité
Higher or Secondary Education Establishments
Contact administratif
Karolien Mariën (Ms.)
ROYAL INSTITUTION FOR THE ADVANCEMENT OF LEARNING MCGILL UNIVERSITY
Canada
Contribution de l’UE
€ 42 350
Adresse
845 Sherbrooke Street West
H3A0G4 Montreal
Type d’activité
Higher or Secondary Education Establishments
Contact administratif
Bartha-Maria Knoppers (Prof.)