Press Release 08/2007
Berlin, 16 July 2007

The National Ethics Council issues its Opinion on the Stem Cell Law

The German National Ethics Council (NER) is today (Monday) presenting its position statements on the possible amendment of the Stem Cell Law.

In this Opinion the NER discusses whether the emerging international trends in stem cell research, coupled with the experience so far gained with the Stem Cell Law, indicate a need for the provisions in force since 2002 to be amended.

On the basis of the compromise arrived at in 2002, 14 of the 24 members of the NER consider that the Stem Cell Law should be amended. In their view:

The protective aim set out in Section 1 No. 2 of the Law - namely, that of preventing actions in Germany from giving rise to the derivation of embryonic stem cells - should in future be achieved by a practicable and reliable case-by-case consideration as a part of the approval procedure for the import and use of embryonic stem cells. For this purpose, the central approval authority established under the Stem Cell Law must be satisfied that the production of the relevant cell lines was neither instigated by the applicant itself nor otherwise effected by virtue of actions in Germany. The case-by-case consideration should replace the cut-off date criterion.

To preclude even the prospect that possible demand in Germany might constitute an incentive for the production of embryonic stem cells in other countries, it should be permissible to import and use only embryonic stem cells obtained from universally accessible stem cell banks on a non-profit basis. The use of embryonic stem cells produced for commercial purposes should be prohibited.

The criminal provisions of the Stem Cell Law should be repealed. Any German involvement in the consumption of extracorporeally derived embryos is in any case punishable under the Embryo Protection Law. The Stem Cell Law should merely determine the action to be taken in the event of infringements of the approval requirements; the appropriate instrument for such matters is the law governing regulatory offences.

The import and use of embryonic stem cells should be permissible not only for research but also for the diagnosis and treatment of diseases.

In the view of nine members of the NER, an amendment of the Stem Cell Law would constitute not a continuation of the existing compromise but a substantial modification and abandonment of it:

The erosion of the ethical and moral foundations of the Stem Cell Law resulting from the dropping of the cut-off date criterion and the addition of new permitted uses would, if the Embryo Protection Law remained in force, be ethically contradictory and not readily defensible to the public.

Again, it is still unclear whether, and if so when, effective therapies can be developed from embryonic or pluripotent stem cells. A review of the ethical considerations is not therefore justified on these grounds.

In this situation, the members concerned hold that two alternative options would be compatible with this second position: (a) leaving the cut-off date system unchanged; or (b) reopening the debate on the normative fundamentals and hence on the Embryo Protection Law itself. In this case, another point to be considered is whether it would not after all be preferable for the embryos and fertilized pronuclei available in Germany to be used for research rather than for new HES cells to be constantly imported from other countries. The signatories of the second position have contrasting views with regard to the above alternatives. However, for different reasons they all consider the extension or abandonment of the cut-off date and the resulting possibility of additional uses to be so problematic that they are unable to associate themselves with the proposals contained in the position statement in favour of an amendment of the Stem Cell Law.

Another member of the NER favours the retention of the compromise underlying the Stem Cell Law but considers that, while there should still be a cut-off date in the past, this date should be made more recent.

The German text of the Opinion can be accessed online at:
http://www.ethikrat.org/stellungnahmen/stellungnahmen.html.
An English version will be available in due course.

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