EUCelLEX Project: Assessment of the social issues raised by the use of regenerative medicine in Euro

PUBLIC RELEASE DATE:

9-Dec-2013

Contact: Emmanuelle Rial-Sebbag rialseb@cict.fr 33-056-114-5616 INSERM (Institut national de la sant et de la recherche mdicale)

The purpose is to submit the data obtained to the European Commission for it to draw up legislative measures in line with medical advances in this field. On 4 December the nine research teams in Europe and Canada met at the Political Sciences Research Centre in Paris (CEVIPOF) for the launching of the project.

Biobanks: the future of regenerative medicine

Today, human biological specimens are seen as resources essential to advances in the life sciences and medicine. The analytical data obtained enable a better understanding of the various diseases and also make it possible to propose the appropriate treatment, notably in the field of regenerative medicine . Gathering, storing, processing and distributing them are all done by the biobanks - key players in the transfer of scientific knowledge to clinical practice. These biological databanks will enable researchers to identify new clinical biomarkers and develop new therapeutic approaches such as regenerative medicine. In this field, research into stem cells continues to be promising, stimulating as it does the body's self-healing ability.

Need for a legal definition of the use of human biological specimens at European level

From 2004 to 2006, the European Union adopted three directives governing cells and human tissues in order to standardise their acquisition, their storage and their use for therapeutic purposes. These directives apply specifically to tissue and cell banks, including cord blood strains and cells used for regenerative medicine. However, they were used in very different ways from one country to another. "At present, the European legal texts concerning the use of stem cells for research by the players in the public and private sectors are not such as to enable the efficient sharing of these resources in Europe, which may impede advances in research," explains Emmanuelle Rial-Sebbag, coordinator of the EUCelLEX Project.

Furthermore, scientific developments 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

View post:
EUCelLEX Project: Assessment of the social issues raised by the use of regenerative medicine in Euro