Ethical issues and new legal regulations

The legal protection that embryos should enjoy has been highly controversial in Germany for many years. This is inextricably linked to the question of the moral status of an embryo discussed in ethics. A maximalist position ascribes full moral status to the embryo from the moment the egg is fertilised. According to this view, the early human embryo already has the same human dignity and right to life as a born human being. More liberal protection positions either assume a gradual increase in the embryo's entitlement to protection as development progresses or assess various caesuras in its development as morally important or decisive.

In the context of graduated embryo protection, protection claims must be weighed against freedom of research, the gain of knowledge and the interests of parents or future patients. For a long time, the issues to be weighed up related solely to contraception, abortion and birth complications. Since the 1970s, however, the spectrum of such issues has expanded considerably. It now also concerns the area of reproduction, for which new technical procedures have been developed in order to realise a desire to have children in the case of existing infertility or to promote the health of the future child. It is no longer just a question of whether an embryo or foetus growing in a woman's uterus has the same right to protection of life as a born human being, but of how a fertilised egg in a petri dish should be handled appropriately. It is not only the embryo's right to life that is up for debate, but also the question of how and with what aims human life may be created and how it may be handled.

The question arises as to what a scientifically sound, constitutionally and ethically acceptable path can look like today that takes into account the pluralism in questions of the worthiness of protecting embryos on the one hand, the protection of freedom of research and the rights of potential parents as well as the protection of the interests of future children and patients on the other. Weighing up these different interests, the German National Academy of Sciences Leopoldina and the Union of the German Academies of Sciences and Humanities argue in their joint statement "Reassessment of the protection of in vitro embryos in Germany" from 2021 in favour of allowing embryo research for high-level research objectives in accordance with international ethical standards in the future.

At the same time, the statement points to an ethical problem: If an area of research in Germany is rejected as ethically controversial, but the results of foreign research groups are utilised, this is to a certain extent ethically inconsistent. In the field of biomedicine, this currently applies to all IVF procedures, including pre-implantation genetic diagnosis, which has been authorised in Germany since 2011, and research on human embryonic stem cells. Although the latter is permitted in Germany within narrow limits, the derivation of stem cells from embryos is prohibited, meaning that these are imported from abroad.

According to international scientific opinion, there are a number of important questions that can only be answered with the help of embryo research. Scientists working in Germany are currently only allowed to contribute very little to their clarification because research with early human embryos is prohibited by the Embryo Protection Act (ESchG) of 1990. Leopoldina and the Academies' Union are in favour of a new debate on the permissibility of research on embryos for high-level research objectives in Germany. In a pluralistic democracy, the most restrictive position should not be the standard for legal regulations, according to the academies.

There are also a large number of embryos in Germany that are created as part of reproductive medical treatments and are no longer used for this purpose, for example because family planning has been completed. The current IVF register shows that around 20,000 embryos were cryopreserved in Germany in 2019 and almost 10,000 embryos were thawed and transferred to induce pregnancy. So far, surplus embryos can only be donated to other couples who wish to have children or must be discarded. The third option of making embryos available for high-level research purposes is currently not available to couples. Surveys in many countries show that the majority of couples surveyed are willing to donate embryos for research once family planning is complete. This willingness is also becoming apparent in Germany.

In their statement, the Leopoldina and the Academies' Union are in favour of research on early supernumerary embryos, i.e. embryos that were created in vitro for reproductive purposes and are no longer used for this purpose. The decision as to whether surplus embryos are made available for research should lie with the couple from which they originate. With the help of independent counselling in advance, those affected could make informed decisions.

Authorisation for research should only apply to high-priority research objectives that serve to gain scientific knowledge in the context of basic research and the expansion of medical knowledge. A federal authority could, for example, work together with an ethics committee to check whether a research project fulfils the criterion of high priority. According to the academies of science, the derivation of human embryonic stem cells from surplus embryos could also be assessed and authorised within this framework.

The Leopoldina and the Academies' Union recommend a new legal framework for the use of surplus early embryos for research. The new regulatory framework should take into account both current and emerging scientific developments, such as embryo-like structures and artificially created embryos derived from germ cells produced in vitro.

Published: May 2021