Alterations of legal status in Germany unnecessary
On March 18th the executive board of the Deutsche Forschungsgemeinschaft (DFG) has discussed and passed a statement concerning issues of human embryonic stem cells. In the last weeks this paper had been compiled by a group of experts and the senate committee for fundamental questions of genetic engineering called together by the president of the DFG. Publication of this statement is in compliance with the statutory tasks of the DFG to advise legislative and executive in scientific matters.
In November 1998 two groups in the US and Israel reported that they had been successful for the first time to keep human pluripotent stem cells in permanent tissue culture. Pluripotent stem cells are prepared either from supernumerary embryos obtained in the course of artificial fertilisation (ES cells), or from tissues of aborted fetuses (EG cells). Such cells are immortalised, they can be propagated indefinitely, and, theoretically, can develop into any of the approximately 210 cell types of the human body. These capacities promise a number of revolutionary scientific and medical novelties affecting, for example, treatment of cancer, Parkinson's disease, Alzheimer's disease, or diabetes. Such cells might also render themselves suitable for producing human tissues or organs in the laboratory, for testing drugs on human cells rather than on animals, and for the development of novel drugs due to a better understanding of cellular specialisation and differentiation processes.
The DFG realises that research on and with human stem cells would allow the pursuance of fundamental diagnostic and therapeutical goals, the great potential of which for medicine cannot be assessed yet precisely in its entirety. The DFG is aware of the fact also that for various motives legal and ethical reservations exist against currently known methods of preparing pluripotent stem cells.
The embryo protection law prohibits any research on and with embryos if the embryo is not the immediate beneficiary. Accordingly, removal of pluripotent cells from an embryo is prohibited in Germany. The preparation of embryonic stem cells (ES cells) from blastocysts is carried out for reasons other than those aimed at preserving the embryo. Thus it is not compatible with the provisions of the embryo protection law. This is true also if the development of the embryo will not be impaired by the removal of some cells.
Nuclear transfer into enucleated oocytes aimed at generating pluripotent stem cells is prohibited also because this technique might be employed to clone human beings.
Preparation of pluripotent stem cells from tissues of prematurely aborted dead foetuses or aborted foetuses can be carried out legitimately in Germany. This type of cell or tissue preparation is subject to regulation by the General Medical Council Guidelines for Usage of Foetal Cells and Foetal Tissues. The DFG concludes that currently there is no need to alter the German legal status concerning research with human pluripotent stem cells.
It is the view of the DFG that the process of shaping opinions concerning ethical and embryological questions in relationship with research on stem cells has only just begun in Germany and abroad. The DFG suggests that this opinion-shaping process should take place on a broad basis and will take part in it. At the same time the DFG will make efforts to work towards the development of uniform European standards in this matter which will include also a due assessment of existential values such as human dignity and health which are fundamental and guaranteed by the constitutional law.
With respect to future research on and with human stem cells the DFG believes that under all circumstances measures must be taken to rule out that embryos, sperm cells or oocytes will be allowed to develop from human pluripotent stem cells. In addition, effective measures will have to be taken to prevent cloning of human beings or generation of human beings with artificially altered genetic information. As an appropriate way the DFG suggests the establishment of a central commission assessing research projects with stem cells on the basis of ethical, legal, and scientific point of views, and fulfilling the role also of a supervisory attendant body.
The DFG statement and a graphic explaining technical terms can be downloaded from the DFG homepage at http://www.dfg.de/english/press/spec_inform.html