Researchers in Germany have to comply with two pieces of legislation, the Embryo Protection Act, which prohibits the generation of any embryonic stem cell lines, and the Stem Cell Act, which bans the import of any stem cell lines apart from the so called Presidential lines.
Taken together, this means Germany has the strictest of laws of any country worldwide, a fact that has prompted many researchers to move overseas. Furthermore, although untested, there is an ambiguity that implies these scientists could be charged with offences under the German law for carrying out stem cell research abroad.
Internationally, stem cell research has yielded important findings in recent years, extending and enhancing knowledge of the properties of these cells and beginning to hone them for use in cell therapy.
But, says the DFG, science in Germany can make only a limited contribution to this important field. Due to the date regulations and the penalties in the Stem Cell Act, German researchers are denied access to new cell lines and, to a large extent, prevented from working in international projects.
Contaminated cells
The cut-off point in the Stem Cell Act means that the only cells available in Germany are contaminated with animal cell products or viruses, and have not been extracted or cultured under standardised conditions.
DFG is calling for the date regulation to be revoked, allowing access to newer stem cell lines that are produced and used abroad, so long as these originate from embryos left over from in vitro fertilisation treatment.
The foundation also called for German scientists to be allowed to develop their own cell lines – if these are to be used for diagnostic, preventative or therapeutic purposes – and said the threat of penalties for German scientists doing stem cell research abroad should be removed, with the scope of the law limited unambiguously to Germany alone.
However, the DFG still condemns therapeutic cloning (somatic nuclear transfer), saying the basic cytobiological processes of early cell development have not yet been adequately explained.
“For the time being, alternative methods should be researched,” says the Foundation, adding that research into adult stem cells must also be further promoted, “As it represents a meaningful supplement to, though not a substitute for, embryonic stem cell research.”
Newer stem cell lines that are free from contamination can be licensed in the EU or acquired for research purposes from the International Stem Cell Forum.
The current stem cell law, and the penalty threat implied by it, poses a significant legal risk for German researchers involved in international cooperative projects (including EU-financed projects); when they conduct research in foreign laboratories on cells that would be forbidden in Germany; and when they publish papers based on such research. This has led to the increasing isolation of German researchers.