Research on early embryos and cell structures generated in laboratories offer new perspectives for health research and medicine. Meanwhile ethical questions arise. A conference provides the opportunity for critical reflection and discussion.
9.-10. October 2023, bcc Berlin Congress Center, Alexanderstraße 11, 10178 Berlin
The conference take place on October 9th – 10th 2023 at bcc Berlin Congress Center, Berlin. It invites to reflect anew on the perspectives of modern medicine with regards to research on and with early human embryos in vitro and other novel cell structures in scientific, ethical and legal terms. It is intended to highlight the scientific possibilities and perspectives for the various fields of medical research, to present international approaches, different points of view as well as framework conditions and thus to give new impulses for the discussion of ethical and legal questions.
International participants from science, society and politics are expected to attend the conference. There are no participation fees. The venue is the Berlin Congress Center (bcc), Alexanderstraße 11 in 10178 Berlin.
ELSA Research
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 addressed in a societal discourse. 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 modern life sciences. The aim of ELSA research is to identify and evaluate the chances and risks associated with findings in 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.
Should the potential of this research be tapped and utilised in Germany?
The use of human embryos, human embryonic or induced pluripotent stem cells, as well as a range of cell entities, such as organoids, or embryoids, enables to investigate many open questions in the fields of basic medical-biological research, applied medical research, personalized and regenerative medicine, as well as reproductive medicine.
This results in challenges for the ethical discourse and the existing legal framework in Germany, which is currently determined primarily by the Embryo Protection Act and the Stem Cell Act: How can the potential of research be tapped and utilised while simultaneously addressing ethical and legal concerns?
Many methods of modern life sciences (such as genome editing, high-throughput methods and single cell analysis) enable completely new dimensions of knowledge in embryo research. This is particularly important for regenerative and personalized medicine as well as for the treatment of hereditary diseases and common diseases such as diabetes, arthrosis, heart attack or stroke, and cancer. At the same time, early human embryonic development is still partly unclear, especially with regard to the emergence of developmental disorders and their origins. Due to the regulations of the German Embryo Protection Act (ESchG), research on and with human embryos is generally prohibited in Germany, as is participation in corresponding projects abroad..
Significant insights into common diseases can be generated by research with and utilization of human embryonic stem cells (hES cells). Additionally, this research offers the possibility of developing therapeutic approaches.
Stem cell researchers in Germany are increasingly critical that only those cell lines are available for research that were generated abroad before May 2007. They are only suitable for research to a limited extent, since the cell lines have accumulated different genetic and epigenetic deviations, have been cultivated in outdated media and may in part be contaminated with pathogens. Thus, they are not suitable for clinical studies. Furthermore, the prohibition of the use of hES cells outside the research context (research proviso contained in the Stem Cell Act) was repeatedly critized by researchers with regard to its negative effects on the development of advanced therapies in the Germany.
Research with pluripotent stem cells also includes 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). The existing regulations do not take these cell structures into account.
Statements from the scientific community as well as from ethical or expert bodies (in particular the National Academy of Sciences Leopoldina, the German Medical Association, the German Ethics Council and the Berlin-Brandenburg Academy of Sciences, BBAW) have lately highlighted the potentials and challenges with regard to stem cell and embryo research, and in particular point out the research possibilities existing in many other countries and their further development.
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 in developmental biology and reproductive medicine to regenerative and personalized medicine. It also defines the conditions under which "surplus" embryos that are no longer used elsewhere could also be used in Germany for high-level research objectives within a clear and transparent legal framework.
The conference, hosted by the BMBF, takes up the Leopoldina's statement and invites scientists to reflect perspectives of modern medicine with regard to stem cell and embryo research from a scientific, ethical and legal perspective, and to discuss potential amendments of the legal framework.
Existing legal framework imposes strict limits on research
According to the Embryo Protection Act (ESchG) and the Stem Cell Act (StZG) research on and with human embryos and a number of procedures, used in international medical research using human embryonic stem cells, are fundamentally prohibited in Germany. Some procedures are not clearly addressed by the existing legal standards - which were developed decades ago. Therefore, research and development of new treatments and therapeutics in Germany is more difficult, flawed 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 losing touch with international research in this specific field.
Impetus for research and a broad societal debate
There is broad consensus that findings from international research should be utilised for medical research and treatment in Germany even if some procedures may be legally not permitted in Germany.
Thus, methods and improvements in reproductive medicine based on embryo research that are permitted abroad may 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 2007.
With a view to 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.
