Revisions to the stem cell act would improve framework conditions for German researchers. International stem cell research has yielded important new findings in recent years, especially in research on human embryonic stem cells. It has extended and enhanced our knowledge of the properties of stem cells, for example in connection with regenerative cell treatment or the investigation of genetic diseases.
However, as a result of the legal framework conditions, science in Germany can only make a limited contribution to this field. Due to the key date regulation and the penalties established in the Stem Cell Act of 2002, German researchers are denied access to new cell lines and, to a large extent, prevented from working in international projects. These new cell lines, which are available as standard in the stem cell banks in other countries, enable research on an international level and, in the long term, circumvent the production of further stem cell lines. For German researchers, however, access to these stem cell banks is currently prohibited. The Deutsche Forschungsgemeinschaft (DFG, German Research Foundation) therefore argues that the 2002 Stem Cell Act stands in urgent need of revision and now, in its third statement on stem cell research, makes the following recommendations:
The key date regulation should be revoked. German research should be given access to new stem cell lines that are produced and used abroad, so long as these originate from “surplus” embryos.The introduction of cell lines should also be permitted, if these are to be used for diagnostic, preventative or therapeutic purposes.The threat of penalty for German scientists should be removed and the scope of the law should be limited unambiguously to the national territory.
The DFG is and remains against reproductive cloning. The DFG still condemns “research cloning” (somatic nuclear transfer,) as the basic cytobiological processes of early cell development have not yet been adequately explained. For the time being, alternative methods should be researched. 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.
Commentary on the recommendations:
On 1): The cells available in Germany are contaminated with animal cell products or viruses and have not been extracted or cultivated under standardised conditions. In recent years, new stem cell lines have been established that are free from contamination and that can be licensed in the EU. These cell lines have been partly acquired by the “International Stem Cell Forum,” which releases them for research. In the view of the DFG, it is urgent that scientists in Germany be granted access to cell lines that have been established since 1 January 2002 and thereby meet the current standards in science and technology. At the same time, it should be ensured that the cell lines are acquired exclusively from surplus embryos. The revocation of the key date regulation would significantly improve the competitiveness of German scientists in the field of stem cell research.
On 2): The Stem Cell Act states that cell lines may only be imported into Germany from abroad for purposes of research. As the development of new application-oriented procedures is slowly becoming a reality, importation for diagnostic, preventative and therapeutic purposes should also be allowed.
On 3): The current stem cell law, and the penalty threat implied by it, poses a significant legal risk for German researchers, for example when they are 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 situation has led to the increasing isolation of German researchers, especially considering the fact that more and more European countries are removing legal restrictions in the field of stem cell research. In order to avoid the criminalisation of German researchers and to achieve legal security, the DFG proposes the removal of the threat of penalty and the explicit restriction of the scope of application of the Stem Cell Act to the home country.
The DFG’s previous statements, from 1999 and 2001, generated lively political, scientific and public debate about the possibilities and limits of this field of research. Scientifically promising findings, ethical reservations and legal considerations were key in this discussion. In January 2002, following this discussion process, the Stem Cell Act was adopted by the German Federal Parliament. This move met with general approval as a political compromise. With this third statement, formulated by the DFG Senate Commission on Genetic Research, the DFG is continuing this discussion process against the background of current scientific developments, especially in the international arena.