BioWorld International Correspondent
MUNICH, Germany - The German cabinet issued guidelines this week to implement the new national law on human stem cell research. The law, which passed both houses of Parliament earlier this summer, puts the import of stem cells for research purposes on firm legal ground for the first time.
"The biggest change is that before the new law's passage, importing stem cells for research had existed in a legal gray zone," said Boris Mannhardt, a biologist at Bio-M, a venture capital and biotechnology network based in Munich. "Now companies are on solid ground."
Germany has one of Europe's most stringent laws on the protection of embryos, and the cultivation of embryos for research purposes remains forbidden, as does taking stem cells from discarded embryos that result from other purposes, such as in vitro fertilization (IVF). "No new stem lines will be created in Germany; that remains unchanged," Mannhardt said.
The patchwork of laws reflects deep divisions in Germany, where memories of medical experiments, forced sterilizations, euthanasia programs and eugenics ideas under the Third Reich have produced strong social control of science. The law for the protection of embryos is based on the first article of the country's postwar constitution, which maintains that the value of the individual is inviolable. At the same time, abortion has long been legal, and IVF is a routine procedure. Germany also contends with Britain for the top ranking among European biotechnology industries.
The country has compromises, such as allowing IVF but prohibiting pre-implantation diagnostics, based on the law protecting embryos. The two approaches are also present in the current law, which attempts to strike a balance between the scientific and competitive advantages of stem cell research and the ethical concerns voiced by many legislators, both in the government and the opposition.
The regulations for implementing the new law name the Robert Koch Institute (RKI) as the administrative body responsible for approving applications to import stem cells. They also set up a Central Commission for Stem Cell Research Ethics.
The minister of health, Ulla Schmidt, and the minister for research, Edelgard Bulmahn, said in a prepared statement that the law sets clear rules for scientists in Germany. "Only stem cells that were created before Jan. 1, 2002, may be imported, and only for important research purposes," the ministers said. Project proposals must be approved by the RKI, as well as the Central Commission. "This law harmonizes the different legal positions and ethical values between protecting embryos and ensuring the freedom of research."
The law stipulates that the stem cells must come from embryos that were left over from fertility treatments, and that no monetary reward may have been given for donating the excess embryos to scientific research. It further requires not only that planned projects have important scientific value, but also that no alternative method is available.
The Robert Koch Institute will evaluate every project that proposes to import stem cells and will consult the Central Commission about the ethical acceptability of each project. The commission will have five representatives from faculties of biology and medicine, and four from theology and ethics. The national government also will report to Parliament every two years, starting at the end of 2003, about experiences with the import regulations and the results of the research with human stem cells.