Legal and political discrepancies between member states are creating significant barriers to progress in collaborative research on stem cells, warn two consortia funded under the European Union’s 6th Framework Programme.
The directors of EuroStemCell, the European Consortium for Stem Cell Research, and ESTOOLS, the largest grouping of human embryonic stem cell researchers in Europe, have sent a joint statement to members of the European Parliament calling on legislators and administrators to “act to enable all European scientists to work freely together in the pursuit of knowledge without fear of legal action or loss of research funding”.
There is particular concern about restrictive conditions for stem cell research in Germany and Italy. Projects that are perfect legal in Sweden and the UK could lead to a three-year prison sentence in Germany, the consortia claim. Researchers from countries with stringent legislation may also expose themselves to liability by taking on co-ordinating roles in European networks that include institutions generating their own human embryonic stem cell (hESC) lines, they add.
One example given is that German scientists feel unable to take up the opportunities for exchange visits between partner laboratories funded under the ESTOOLS project. A key element of the project is comparing different hESC lines and establishing standard conditions for their culture and differentiation.
However, most non-German partners are working with hESCs derived after the cut-off date of 31 December 2001 imposed under German law. As a result, the joint statement notes, German scientists are “unclear whether they could be subject to some penalty if they are involved in comparative research with such cells”.
“Despite common funding through the 6th and 7th framework of the European Commission, current legislation means that scientists within Europe cannot freely exchange personnel and cell lines,” commented Professor Peter Andrews, co-ordinator of the ESTOOLS consortium. “This has huge consequences for stem cell research in Europe, limiting the ability of researchers with different expertise in different countries to work together for the common good.”
Italy and Germany
A particular bugbear in Italy is that public funding for stem cell research is directed exclusively at projects using adult stem cells. The country’s law on assisted conception does not allow new stem cells to be derived from human embryos, the joint statement notes. However, researchers are permitted to work on already established hESC lines from frozen discarded embryos, no matter when these were isolated.
In Germany, the Stem Cell Act of July 2002 imposes a general ban on research with human embryonic stem cells. If hESC lines are imported, they need to have been derived from ‘surplus’ embryos prior to 1 January 2002, EuroStemCell and ESTOOLS point out.
In November 2006 the German Research Foundation called for urgent amendments to the Act that would abolish this cut-off date, permit imports of stem cells for diagnostic, preventative and therapeutic purposes (the current legislation allows imports for research purposes only), and lift the threat of prosecution hanging over German scientists involved in stem cell research either abroad or through international collaborations.
Recently Germany’s National Ethics Council also called for the legal restrictions on stem cell research to be relaxed. Politicians are expected to raise the issue in the Bundestag, the lower house of the German Parliament, this autumn.