The legal situation in questions of stem cell research is very complex. This is partly due to the fact that,in Germany (as in other countries), the issues are not centrally regulated, but many different laws, ordinances, and other regulations from public law, criminal law and, in parts, also civil law (e.g. in questions of unproven therapies) play a role in stem cell research. Administrative competence is also highly heterogeneous. In addition, there are no uniform international laws or at least regulatory models for stem cell research. Each country has its own approaches in legislation and administration and, even at the level of the European Union, there are only a few common regulations. At the same time, modern research is hard to imagine without international cooperation. This poses a great challenge for the actors in stem cell research if they want to be legally secure with their research and its exploitation. Below you will find the most important laws with brief explanations.
The Act on the Protection of Embryos(Embryo Protection Act; ESchG) was enacted in 1990 and entered into force in 1991. It aims to regulate the handling of human embryos and gametes in connection with the fertility treatment that was emerging at the time (in vitro fertilization; IVF). Although stem cell research was not yet the subject of legislative scrutiny at the time (the first human embryonic stem cells were only cultivated for the first time in the USA and Israel in 1998), the law still has a decisive influence on the legal situation regarding stem cell research, especially as it has remained largely unchanged since it came into force. The law prohibits (at least in the predominant opinion of the jurists) therapeutic as well as reproductive cloning and punishes any misuse of IVF techniques, including the use of embryos for research purposes. According to ESchG, a fertilized, developable egg cell, as well as any totipotent cell removed from it, is already considered an embryo. On the basis of this broad concept of embryos, ESchG prohibits any use of an embryo defined in this way, with the exception of inducing pregnancy in the egg donor. This means that the derivation of embryonic stem cells from human embryos is prohibited in Germany. This also applies to what areknown as surplus embryos, which are no longer needed to induce pregnancy in an IVF procedure and may be used for the derivation of human embryonic stem cells in other legal systems. In fact, ESchG aims to prevent the development of surplus embryosby stipulating that only a maximum of three eggs may be fertilized per IVF cycle and that all fertilized eggs must be transferred to the mother. Since ESchG came into force, it has only undergone significant changes with regard to preimplantation diagnostics (with the inclusion of Section 3a). The complete text of the law can be found here (in German).
While the Embryo Protection Act prohibits the derivation of human embryonic stem cellsin Germany, it leaves open the question of whether German scientists may conduct research on human embryonic stem cells obtained abroad. This area of legal uncertainty triggered a broad discussion after the German Research Foundation (DFG) received an application for funding concerning research on human stem cells that were to be imported from abroad. Due to the unclear legal situation, the DFG approached the German Bundestag with the question. After a long and controversial debate, the Law to Ensure Embryo Protection in Connection with the Import and Use of Human Embryonic Stem Cells(Stem Cell Act; StZG) was passed on June 28, 2002. The Stem Cell Act represents a compromise between freedom of research and patients’ rights on the one hand and the protection of early human life on the other. It prohibits the import and use of embryonic stem cells. However, there are exceptions to this ban under certain conditions. Initially, stem cell imports are only permitted for high-ranking research purposes (which undisputedly include basic research and research into therapies for serious, so far incurable diseases). The current legal situation does not permit the import of embryonic stem cells for use in therapies that have already been developed. The imported stem cells must have been obtained from surplus embryos in the country of origin in accordance with the legal situation there and before the deadline on May 1, 2007. This deadline regulation is intended to prevent embryos from being destroyed abroad specifically for the production of stem cells for German use in order to counter the accusation of double standards. The deadline was originally January 1, 2002, (i.e. before the law came into force). However, this deadline was postponed in the course of an amendment to the law in 2008 in order to give German researchers access to new stem cell lines that were produced without the aid of animal feeder cells, for example.
The Robert Koch Institute (RKI), advised by the Central Ethics Committee for Stem Cell Research, is the competent authority for approving applications for the import of human embryonic stem cells. The complete text of StZG can be found here (in German).
The patent situation for human embryonic stem cells poses a major difficulty for this field of research. After many years of litigation between Greenpeace and the holder of several patents relating to embryonic stem cells, the European Court of Justice (ECJ) ruled in 2011 that procedures for the development of which human embryonic stem cells were used are inadmissible under the European Biopatents Directive (and thus also under German patent law based on it). This also applies if the embryonic stem cells are no longer required for the resulting process, but have been used in its development.
However, patents based on embryonic stem cells are possible if the cell lines used were obtained without the destruction of embryos. In addition, methods involving the use of cell lines derived from embryos that are no longer capable of development are patentable. However, since these explanations still allowed room for interpretation, the ECJ specified its case law in 2014 by clarifying that methods based on the use of human embryonic stem cells generated by parthenogenesis are, in principle, patentable.
There are already very large differences in the extent to which research on embryonic stem cells is permitted in Europe. While in Belgium or England, for example, scientists are given a relatively large number of research opportunities, in Italy and Austria, for instance, there are strict regulations concerning when embryonic stem cells may be used for research purposes. This map gives an initial overview. In addition to further information on the European countries, the website also offers a worldwide overview.
A more detailed, but not exhaustive, description of the legal situation in Germany and selected other countries can be found here.