Understanding the Legal Framework for Stem Cell Regulation within Europe

Biological samples and resources derived from the human body are regarded as the essential raw material for the continued advancement of life science and health-related biotechnology (OECD, 2001). Analysis of human biological material will increase understanding of the physio-pathological factors underlying disease and lead to better clinical outcomes.  However, although there are European directives to govern tissue and cell banks, they are applied very differently from one country to another. The EUCelLEX project aims to address this as this area of research rapidly develops and expands.

The main objective of EUCelLEX is to assess how current European legislation is applied in different countries in the light of scientific, legal and institutional developments. The project aims to provide the European Commission with recommendations that will facilitate the use of stem cells in all areas from research to clinical application.

HeLEX is working with other partners in the consortium to look at the impact of European regulation on stem cell science.