Latest developments in stem cell research – new challenges for the prohibition of reproductive cloning?

During a plenary session held on 8 May 2014, the German Ethics Council conducted a public hearing concerning research on human embryonic stem cells created by somatic cell nuclear transfer and on induced pluripotent stem cells, and discussed the legal challenges that might arise from it.

In view of the most recent research results pertaining to the production of human embryonic stem cells (hES cells) by somatic cell nuclear transfer and to induced pluripotent stem cells (iPS cells), the Gesundheitsministerkonferenz [Conference of Health Ministers] requested the German Ethics Council to evaluate developments in these sectors. The Health Ministers are concerned that the cloning of humans for reproductive purposes – which is rendered technically feasible by means of these methods – may not be unequivocally prohibited by German law, and in particular by the Embryonenschutzgesetz [Embryo Protection Act] and the Stammzellgesetz [Stem Cell Act].

In her opening speech, Christiane Woopen, Chairwoman of the German Ethics Council, emphasized that clear regulations in Germany would not be sufficient and pointed out the importance of working towards effective prohibition of reproductive cloning in an international context.

Hans Schöler, molecular biologist and Director of the Max Planck Institute for Molecular Biomedicine in Münster, informed the audience on the present situation regarding hES cells ) by somatic cell nuclear transfer and iPS cells. Schöler explained the current biological findings on the pluripotency and totipotency of cells and on tetraploid embryo complementation. He explained that, from the biological point of view, it is unlikely – but not impossible – that the new techniques could make reproductive cloning of humans technically possible.

The legal expert Ralf Müller-Terpitz from the University of Mannheim considered possible legislative needs. In Müller-Terpitz's opinion, the new research methods are covered by existing law. However, inconsistencies and a lack of clarity exist on account of differing legal definitions of central terms such as 'embryo' and 'totipotency' in the Embryo Protection Act and Stem Cell Act. There is no compelling need to achieve more exact legal definitions, but it would be sensible to do so. In the process, a transition should be made from regulation through the instrument of criminal law to regulation through the instrument of public law.

Klaus Tanner, a theologian from Heidelberg and Chairman of the Robert Koch Institute's Stem Cell Commission, presented ethical considerations regarding the possible legislative needs. The possibility of technically generating biological developmental paths that do not exist as natural phenomena leads to a loss of clarity surrounding terms such as 'potentiality'. Therefore the need arises to reconsider the norms that are associated with them in order to safeguard protected interests. He advocated focussing more on the contexts of responsibilities and actions and less on considerations of the status of early human life in vitro.

The subsequent discussion was centred mainly on the advantages and disadvantages of reworking the legal framework. There is no compelling need to do so with respect to reproductive cloning, but the wish to achieve more uniformity is clear, especially regarding the definition of terms. The question was also discussed as to the appropriateness of introducing regular revisions of the legal stipulations in order to take account of current scientific developments, as is already the case in France.

The contributions to the hearing and the discussion are available here (in German).