For information on the legal situation see below.

The scientific examination of moral questions plays an important role in medicine. Research on new technologies, their application, and the framework conditions to be considered always go hand in hand with questions of normative classification. Stem cell research, in particular, has always been accompanied by complex and, in some cases, highly controversial ethical debates since the beginnings of this field of research. It is essential to conduct these debates transparently and to face them again and again, especially in societies with different worldviews and concepts of life. Only in this manner can ways be found for dealing with new technologies that will also be sustainably supported by society. 

Destruction of human embryos
Translation of new research findings
Expectation management / unproven therapies
Related topics

The question of the importance of early human life played particularly in the early debate on stem cell research an important role, but it is still being discussed today. Although reprogramming somatic cells (cf. induced pluripotent stem cells) is now a very good alternative to using embryonic stem cells, many research approaches still depend on the use of human embryonic stem cells, for the production of which human embryos were destroyed at the beginning (cf. embryonic stem cells). However, it is not necessary to obtain new embryonic stem cells for every research question; it is possible to fall back on already established stem cell lines as embryonic stem cells can be multiplied again and again in culture conditions.

Fig.1: When does the human embryo become a human being in the moral sense? The figure shows the developmental stages from the (fertilized) egg to its implantation in the uterus. The blastocyst stage, i.e. before implantation into the uterus, is required for the derivation of embryonic stem cells. The inner cell mass is the embryonic stem cells.

The question as to whether the human embryo is worthy of protection lies at the center of the ethical discussion. Does this allow embryos to be used to derive stem cells or even to be created only for this purpose? There is no global answer to this question. In some countries, such as Germany, the derivation of embryonic stem cells is prohibited; in other legal systems, only what areknown as surplus embryos from fertility treatments may be used for research. Other legal systems permit the creation and destruction of human embryos specifically for research purposes. Ultimately, these regulations always raise questions about the moral status of early human life. When does the human embryo become a human being in the moral sense? From fertilization, from implantation in the uterus, from a certain stage of development or, for example, only from birth? A proven method of ethically evaluating an action is to ask about the legitimacy of both the objectives pursued by the action and the means used. Since the justifiability of the means also depends on what other means are available, the question of possible alternatives plays an important role. 

You can find a more detailed description of many core questions relating to stem cell research here.

Stem cell research has since developed beyond the stage of pure basic research. The first clinically tested therapies with stem cells are approved and many other therapeutic approaches are under development. With the increase in clinical trials, the involvement of clinical ethics committees in the approval process for stem cell-based applications is becoming increasingly important. 

Tissue databases are being created for stem cell research, particularly for research on induced pluripotent stem cells. But what rights do the original tissue donors have to the processed cell cultures and how are they to be involved appropriately in the research results? Should tissue donors be informed when research reveals abnormalities in their tissue samples?

Non-therapeutic applications of stem cell research are also pursued, such as the production of meat from Petridishes or the testing of new drugs. Such developments always raise further ethically relevant questions. For example, cultures from human stem cells or iPS cells could be used to test drugs and active substances and thus contribute to reducing the number of animal experiments. 

The production of meat from animal muscle stem cells has been possible for some time. Research and industry worldwide are now working on the marketability of lab-grown meat. The normative effects, for example with regard to animal welfare and climate protection, are enormous. These and many other questions will have to be discussed in the coming years by normative scientists, political decision-makers, and the public.

The potential of stem cell research has also raised many expectations in society. Patients suffering from severe and previously incurable diseases, in particular, have high hopes of being cured by tissue replacement. Research results to date are very promising and it is assumed that treatment approaches can be developed for a variety of diseases, such as diabetes and Parkinson’s disease, in the medium to long term. At this point, however, it must be emphasized that clinically proven stem cell therapies have so far only been available in a small number of areas (cf. Which stem cell therapies are available?). 

Unfortunately, however, hundreds of commercial providers offering stem cell treatments that have notbeen clinically tested have now become established worldwide. Such services are often associated with high costs for the patients and a carefulevaluation and aftercare do not take place. Many providers of unproven stem cell treatments offer the same treatment approach for a variety of different indications. For example, abdominal fat is removed from the patient, the stem cells contained in it are isolated and then (depending on the disease) retransplanted into the affected tissue. These treatments are not based on reliable clinical data and have not passed the stringent safety and efficacy protocols that apply to the approval of new drugs and treatments. From a scientific point of view, too, the probability of achieving success with such a treatmentis very low. At the same time, such treatments are permissible in some jurisdictions or are at least in a legal gray area. In addition, the ability of physicians and patients to freely choose therapies is of great importance in most legal systems. Finding the right balance between patient autonomy and patient protection and developing functioning mechanisms to ensure treatment quality that leave room for therapeutic innovation area major ethical challenge. 

Stem cell research is just one of many fields of biomedical research and is crucially influenced by findings and developments in other research areas. For example, the development of the CRISPR/Cas method for genome editing represents a huge step forward for biomedical research and, at the same time, triggers controversial ethical and legal discussions. The first report from China about the birth of allegedly HIV-immune babies in which the germ cells had previously been genetically modified came at the end of 2018.

The possibility of producing functional germ cells from induced pluripotent stem cells could have a significant effect on reproductive medicine. This technology would make it possible to produce genetic offspring for same-sex couples or even children with only one genetic parent (who are not clones). The normative effects of such developments on the image of the family and the various legal areas cannot yet be foreseen.
The mixture of human and animal genetic material or tissue, which plays a role in some research approaches in the field of stem cell research (e.g. tetraploid complementation or production of organoids), is another field of research with a high need for ethical classification. 

In summary, it can be stated that the ethical and social debates in stem cell research are shifting in parallel to the further development of the field of research, but, at the same time, the original questions must not be overlooked. The normative evaluation requires constant readjustment and, simultaneously, a reconnection to fundamental questions. A constant dialogue between biomedical research and the ethical, legal, and social science aspects of stem cell research is essential.

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.

Embryo protection act
Stem cell act
Patent situation
International legal situation

Embryo protection act

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).

Stem cell act

While the Embryo Protection Act prohibits the derivation of human embryonic stem  cells in 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).

Patent situation

The patent situation for human embryonic stem cells poses a major di"culty 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. As these explanations still left room for interpretation, the European Court of Justice clarified its case law in 2014, stating that methods based on the use of human embryonic stem cells generated by parthenogenesis are, in principle, patentable.

International legal situation

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.