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EUCelLEX Project: Assessment of the social issues raised by the use of regenerative medicine in Euro
Date:12/9/2013

nts in the use of human cells centre around new legal and institutional issues. More particularly, the development of research infrastructures at European level (BBMRI-ERIC, FCrin ) means re-examining the relevance of all this in the light of rapidly expanding clinical practice which also has to take public health issues into account. Thus today, the areas of examination can be seen to be expanding, and hence the inadequacy of European legislation regarding cell research. It should added that certain parts of the process of translating basic knowledge, up to and including the marketing of new products, are unequally regulated, either by the national laws of the member states or by Europe.

The EUCelLEX Project objectives

It is within this context that the EUCelLEX Project's chief objective is to examine current legislation concerning the therapeutic use of somatic cells, in both the public and private sectors and in a number of European countries.

To this end, the project aims to assess the relevance of current European legislation in order to provide the data needed to establish a European framework for the use of stem cells of every type (embryo, adult and IPS cells from cord blood) in the light of recent scientific, legal and institutional developments in Europe. To obtain a complete picture of the European situation, the legal study will be complemented by an examination of current clinical practices together with the many ethical recommendations throughout Europe. Starting with the observation that the entire translational process, from research to the marketing of a product, is only partially covered by the EU rules, the teams will need to examine the heterogeneous nature of the legislation due to the freedom of action allowed to the member states.

Initially, each of the partners in the project will need to examine the legislation and the policies in their respective countries governing the use of stem cells at both national and E
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Contact: Emmanuelle Rial-Sebbag
rialseb@cict.fr
33-056-114-5616
INSERM (Institut national de la sant et de la recherche mdicale)
Source:Eurekalert

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