In Germany, the Embryo Protection Act and the Stem Cell Act govern the derivation of human embryonic stem cells (ES cells) and scientific work on and with them. The Embryo Protection Act (Embryonenschutzgesetz 1991) prohibits the production or use of embryos for any purpose other than to initiate pregnancy. What is more, all forms of manipulation performed on an embryo created outside the body that do not serve its preservation are prohibited. This means that all creation of and research involving embryos that does not serve the preservation of the embryo is banned. In addition, Section 6 (1) of the Act states: “Anyone who causes artificially a human embryo to develop with the same genetic information as another embryo, foetus, human being or deceased person will be punished with imprisonment up to five years or a fine.” Thus, the procedure of research cloning or therapeutic cloning using cell nuclear transfer is fundamentally prohibited by law.

However, there is dispute amongst lawyers over how to interpret the term ‘same’ in the wording “with the same genetic information”. Depending on how the term is interpreted, the cloning ban laid down in Section 6 of the Embryo Protection Act might not encompass all types of cloning techniques and would thus permit certain cloning procedures. If the term ‘same’ in this legal wording is understood in the sense of ‘identical’, then an embryo cloned using cell nuclear transfer would not fall under Section 6 (1) of the Act. The genetic information of an embryo cloned in this manner is not completely identical to the genetic information of the nuclear donor as a minimal amount of foreign mitochondrial DNA from the donor egg cell is also passed on to the embryo. However, since the mitochondrial DNA only makes up around 0.01 to 0.02 percent of the whole genome, for quantitative reasons many authors advocate referring to ‘the same genetic information’, i.e. interpreting ‘same’ in the sense of ‘comparable’.

In legal terms, the actual validity of the Stem Cell Act is undisputed. However, whether the Act is compatible with other laws and constitutional provisions has been the subject of controversial debate for some time now. Among other issues, the interpretation of the Federal Republic of Germany's Basic Law is controversial, namely: the constitutional issue of whether the full worthiness-of-protection status should apply to the human embryo from the moment of pronuclear fusion. 

The Federal Constitutional Court (Bundesverfassungsgericht) has hitherto expressed an opinion on the question of how far human dignity and the protection of life extend with respect to unborn life on two occasions in connection with court practice on abortion. In its first decision on abortion of 25 February 1975, the Federal Constitutional Court determined that the basic right to life defined in Article 2, paragraph 2 of the Basic Law also extends to unborn life and life “at least from the fourteenth day after conception (nidation, individuation)”. This formulation leaves open the question as to whether the basic right to life is also afforded to an embryo before the fourteenth day after conception. While the second decision of 28 May 1993, affirms that human dignity is “already [due] to the unborn human life”, the court expressly left unresolved the question of “whether, as insights of medical anthropology would suggest, human life arises prior to the fusion of egg and sperm cell”. Regulations governing abortion formed the subject matter of the proceedings. Consequently, only the term of the pregnancy, which “according to the [...] provisions of the Criminal Code [extends] from completion of the fertilised egg becoming implanted in the uterus [...] until the commencement of birth”, had a bearing on the decision.

Whether a human embryo should be protected from the “point of pronuclear fusion” or not until a later point in its development is considered to be insufficiently clarified at present due to differing protective regulations for an embryo depending on whether it is in vitro or in vivo. For some time now, the possibility of amending the Embryo Protection Act has been discussed among scientists and in the public realm.

The 1991 Embryo Protection Act has no provision for research carried out on those embryonic stem cells which have become available abroad under different statutory requirements. Since 2002, the import and use of human embryonic stem cells for research purposes has been regulated by the Stem Cell Act.

In accordance with the Stem Cell Act (introduced in 2002 and partially revised in 2008), the import and use of embryonic stem cells is generally prohibited and only permissible in certain circumstances. Excepted from the general import and research bans are, among others, those stem cells obtained before the cut-off date of 1 May 2007 (in the original version, the cut-off date was 1 January 2002) and derived from embryos surplus to IVF treatments. Even the passing of the Stem Cell Act has not ended debate on the issue in Germany. 

Further information on present regulations of stem cell research in Germany can be found here: In Focus „Research with Human Embryonic Stem Cells“.