Report on Embryo Terminology in German and European law

Since the establishment of the first human embryonic stem cell line in 1998, a great deal has been achieved in the field of stem cell research. However, the debate around the use of early-stage human embryos remains controversial. This controversy is also reflected in the terminology. The German legal system alone contains at least three different definitions of the term 'embryo': one in the Embryo Protection Act, one in the Stem Cell Act and yet another embryo definition in patent law. The question of the interplay between these different terms and what the practical impact of this lack of regulatory homogeneity has on researchers is now being reviewed by a report commissioned by the Ethical, Legal and Social Working Group of the Stem Cell Network NRW and being undertaken by law professor Ralf Müller-Terpitz at the University of Mannheim.

The human embryo has long been at the center of the diverse range of debates around stem cell research. Although, since its beginnings, social discourse about stem cell research has broadened  and at times shifted emphasis, in particular as stem-cell based treatments approach market maturity, human embryonic stem cells and the associated ethical and legal issues still play an important role. When assessing the question of how to handle early-stage human embryos, a wide range of ethical, social and economic and also religious and cultural factors enter the equation. The complexity of the original question has led to a highly heterogeneous and differentiated range of answers being produced internationally, which have not exactly made the practical handling of research projects any easier. Part of the existing problem is due to the terminology. For example, the question of defining what actually this embryo that needs protecting is has been answered differently in UK law to the solution found in the German legal system.

Yet even within the German legal system, the term 'embryo' is not used consistently. Section 8 para. 1 of the Embryo Protection Act (ESchG), which came into force in 1991 and has remained broadly unchanged since, defines it as " … an embryo already means the human egg cell, fertilized and capable of developing, from the time of fusion of the nuclei, and further, each totipotent cell removed from an embryo that is assumed to be able to divide and to develop into an individual under the appropriate conditions for that." Many of the technological courses of action which have been developed or at least kick started since the law was passed were unthinkable at the time when the law was first enacted (e.g. the production of nuclear transfer entities, tetraploid complementation or the production of CDX2-deficient and thus 'depotentized' embryos). And so it is not surprising that there is considerable disagreement in jurisprudence about how applicable the term 'embryo', as laid down in the Embryo Protection Act, really is to the different embryo-like entities. Thus, for example, there is controversy among legal experts over whether the nuclear transfer clone is an embryo in the sense of the Embryo Protection Act and thus whether according to the Embryo Protection Act a ban could follow on research cloning using cell nuclear transfer.

The 2002 Stem Cell Act, which came into force in 2002 and was revised in 2008, does not exactly contribute to the legal clarification of the term 'embryo' either. The Act states under Section 3 para. 4 that the embryo is defined as "... any human totipotent cell that is assumed to be able to divide and to develop into an individual under the appropriate conditions for that." Unlike the Embryo Protection Act, which only includes totipotent cells under the term 'embryo' if they were taken from a fertilized ovum, under the Stem Cell Act any totipotent human cell is considered to be an embryo. Therefore, with respect to clones which have been produced using cell nuclear transfer, the conclusions one must draw regarding the embryo characteristics of clones according to the terms of the Stem Cell Act may be different to those based on the Embryo Protection Act. 

The more recent legislation from the European Court of Justice (ECJ) on patent issues supplies a further definition of the embryo. In a landmark decision on the interpretation of the European Biotech Directive, the ECJ clarified the following on 18 October 2011: "Any human ovum after fertilization, any non-fertilized human ovum into which the cell nucleus from a mature human cell has been transplanted, and any non-fertilized human ovum whose division and further development has been stimulated by parthenogenesis constitutes a 'human embryo'." This very broad definition has for the first time laid down an embryo term which is effective over and above the national legal systems of each of the European member states, even if it is initially only in the narrow field of patent law. In a later ruling in 2014, the ECJ partially corrected this definition and, in view of more recent findings, excluded parthenotes from the domain of the Biotech Directive embryo definition because they do not have the inherent ability to develop into a human being.

In Germany too, this thus more precisely defined patent law embryo definition is taking legal effect, via the roundabout way of German patent law. Thus, in German law alone, there are now at least three different definitions of the term 'embryo'. Up until now, the interplay between these laws and any potential areas of tension arising have not been thoroughly and systemically examined, in particular with a view to the potential practical impact for stem cell researchers. In view of these facts, the Ethical, Legal and Social Working Group of the Stem Cell Network North Rhine-Westphalia have commissioned a legal opinion. Holder of the Chair for Public Law, Economic Regulation and Media Law at the University of Mannheim and an acknowledged expert in the field of life sciences law, Professor Dr Ralf Müller-Terpitz, has now submitted a thorough report on this issue. In the report, the varying embryo definitions in German and European law have been examined, the scope of each has been defined and clearly distinguished from one another, potential areas of conflict have been mapped out and their legal implications made explicit. To meet the information needs of scientists, scientific and research organizations, research managers and other parties, the report contains a practice-oriented summary (Practical Guide). The report will shortly be published through the appropriate channels. Until then, those interested may request a copy from the office of the Stem Cell Network NRW.