The aim of the conference on October 9th – 10th, 2023 is to reflect anew on research with surplus embryos and other novel cellular structures in scientific, ethical and legal terms. It will highlight scientific possibilities and perspectives for various research areas in medicine, show other international aspects and frameworks. Furthermore, it strives to improve the basis for the discussion of various ethical and legal questions.
Up to 400 international participants from science, society and politics are expected to attend the conference.
Preliminary program in English language
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The dynamic developments in modern life sciences lead to new opportunities and perspectives for research and for humans. However, they also raise new questions that need to be clarified in a social exchange. The German Federal Ministry of Education and Research (BMBF) supports this dialogue across disciplines through ELSA research, which deals with ethical, legal and social aspects of current advances in the modern life sciences. The aim of ELSA research is to identify and evaluate the chances and risks associated with findings in the modern life sciences. The BMBF recognized the importance of ELSA research at an early stage. Since 1997, the ministry has been providing programmatic funding for ELSA research, currently with around 4.5 million euros per year.
How can the potential of this research be tapped and utilised?
Research in the fields of basic medical-biological research, applied medical research, personalized and regenerative medicine, and reproductive medicine can profit from the use of human embryo and human embryonic stem cells. Moreover, a range of laboratory-generated cells and cellular entities, such as organoids, embryoids, or chimeras may be employed in the aforementioned research.
This poses challenges for the ethical discourse and the existing German legal framework, currently determined by the Embryo Protection Act and the Stem Cell Act: How can the potential of research be tapped and utilised, addressing ethical and legal concerns at the same time?
Many methods of modern life sciences (such as genome editing, -omics and single cell analysis) unveil completely new dimensions of knowledge for embryo research. This is particularly important for regenerative and personalized medicine as well as for the treatment of hereditary and common diseases like diabetes, osteoarthritis, heart attack or stroke, and cancer. At the same time, early human embryonic development remains partially unclear, especially with regard to the emergence of developmental disorders and their causes. Research on human embryos is generally prohibited in Germany due to the regulations of the German Embryo Protection Act (ESchG), as is participation in respective research abroad.
Significant insights into widespread diseases can be generated through research and use of human embryonic stem cells (hES cells).
Stem cell researchers working in Germany are increasingly critical of the limited suitability of the hES cell lines currently available in Germany under the Stem Cell Act (StZG) for state-of-the-art research. Only cell lines obtained abroad before the deadline of May 1, 2007 are permissible in Germany. Accordingly, most cell lines have accumulated different genetic and epigenetic deviations, were cultivated in outdated media, or could in part be contaminated with pathogens. This makes them essentially unsuitable for state-of-the-art research in clinical trials. Furthermore, under the Stem Cell Act it is prohibited to use hES cells outside the research context (“research proviso”). This has repeatedly been problematized by researchers in this context with regard to its negative effects on the development of advanced therapies in the German research area; the regulation should therefore be reviewed.
Research with pluripotent stem cells is also directed towards the development of laboratory-derived human cell entities that increasingly resemble their natural "models" in terms of developmental potential (organoids, artificial egg/ sperm cells, embryo-like structures). These cellular structures are not yet fully covered and regulated by the law. Under the guidelines and definitions of the Embryo Protection Act (ESchG) being in force for more than 30 years, this research can hardly be carried out in Germany according to the international state of the art.
The conference will address the according challenges for the ethical discourse and the legal framework and discuss possible perspectives for adaptations of the law on reproductive medicine, the Embryo Protection Act and the Stem Cell Act.
Statements from the scientific community as well as from ethical or expert bodies (including the National Academy of Sciences Leopoldina, the German Medical Association, the German Ethics Council and the Berlin-Brandenburg Academy of Sciences, BBAW) have in recent years highlighted the potentials and challenges with regard to stem cell and embryo research. In particular they also presented research possibilities existing in many other countries and their further development. At the same time, they outline under which conditions so-called "surplus" embryos that are no longer used for other purposes could be used in Germany, too, for high-level research objectives within the framework of systematic and transparent procedures. In particular, the Leopoldina statement "Re-evaluating the protection of in vitro embryos in Germany" (2021) illustrates the great importance for broad areas of medical-biological research, from basic research / developmental biology and reproductive medicine to regenerative and personalized medicine.
Existing legal framework imposes strict limits on research
In addition to research on and with human embryos, a number of methods used in international medical research using hES cells are generally prohibited in Germany and particularly covered by the Embryo Protection Act (ESchG) and the Stem Cell Act (StZG) Thus, research and development of new treatment methods and therapeutics in Germany is impeded, fraught with legal uncertainties or even impossible. In addition, the international cooperation of German researchers is legally and practically restricted. As a result, German scientists are prone to lagging behind international research in this specific field.
The German Embryo Protection Act (ESchG) regulates the in vitro creation and subsequent use of human embryos: This is to protect them from the risks associated with assisted reproductive techniques. In addition, the law is based on the idea of ensuring the social protection of the individual created by extracorporeal techniques from, for example, "split motherhood" in the case of surrogate mothers or egg donation, post-mortem fertilization or intentional alteration of the genome. Finally, the ESchG also contains other important protective regulations, in particular the prohibition of third-party embryo research, the production of embryos, and cloning.
With the act to ensure embryo protection in connection with the import and use of human embryonic stem cells (Stem Cell Act - StZG), the German legislature in 2002 regulated a subject area that had not been covered by the Embryo Protection Act (ESchG) until then: the import and use of human embryonic stem cells (hES cells) derived from surplus embryos abroad. The issue being regarded by many parliamentarians as an unintended regulatory gap was therefore placed on its own legal basis. The StZG enables scientists working in Germany to conduct research with human embryonic stem cells under restrictive conditions without restricting the protection of human embryos guaranteed by the Embryo Protection Act.
Impetus for research and a broad societal debate
There is broad consensus that findings from international research - albeit procedures may be not permitted in Germany according to the restrictions or prohibitions described above - should nevertheless be utilised for medical research and treatment.
Thus, methods and improvements in reproductive medicine based on embryo research abroad may - to the extent permitted - also be used in Germany. Moreover, human embryonic stem cells, for example, may not be obtained in Germany but researchers may use those obtained abroad before May 1, 2007.
In view of the dynamic scientific developments in this field, the BMBF organises this conference to develop the basis for a qualified bioethical discourse. Thereby, it aims to equally meet the needs of research and medical application, as well as the associated legal and ethical concerns.The BMBF conference shall contribute to gaining new insights into early forms of human life and to provide impetus for contemporary medical research and legal-ethical discourse. At the same time, it shall facilitate an informed and broad societal exchange.
The slider for “Speakers” below is yet under construction
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