Skip to main content

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

Cel

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.

Zaproszenie do składania wniosków

FP7-HEALTH-2013-INNOVATION-1
Zobacz inne projekty w ramach tego zaproszenia

System finansowania

CSA-SA - Support actions

Koordynator

INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE
Adres
Rue De Tolbiac 101
75654 Paris
Francja
Rodzaj działalności
Research Organisations
Wkład UE
€ 108 739
Kontakt administracyjny
Muriel Bouas (Ms.)

Uczestnicy (8)

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