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Snakes and ladders –some stem cell players win, other lose

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The decision by the US Court of Appeals for the District of Columbia, effectively dismisses an earlier ruling of district court judge Royce Lamberth that prohibited the use of public funds to support research using embryonic stem cells following his opinion that to do so would violate a 1996 law preventing the use of taxpayer dollars in research that harms a human embryo. Although no federal law has ever banned embryonic stem cell research in the United States, the funding restrictions imposed by the Lamberth decision and the small number of permitted stem cell lines approved by the Bush administration have not favored American progress in this valuable field of enquiry. Removing the Lamberth ruling may pave the way for greater success if more federal funds can be accessed by embryonic stem cell researchers and we at the Stem Cell Portal, as representatives of a community of active stem cell scientists, applaud the decision with the greatest enthusiasm.

The state of affairs in Europe is not so encouraging. On March 10th, the European Court of Justice issued a preliminary opinion that procedures involving established human embryonic stem cell lines are not patentable. While this has yet to become law within the European Union, it does nothing to encourage industrial investment in translational research that may arise from embryonic stem cell projects since commercial organisation will perceive the field to be too risky if the considerable financial input required to take a potential therapy from “bench to bedside” cannot be protected. This decision seems to have surprised many leading European researchers. As it stands, the opinion is unlikely to bring about immediate changes in the way academic research is conducted in individual member states of the European Union even if it does eventually become law. In any case, intra-European national laws governing stem cell research are as varied as those between individual states of the USA ranging from relatively liberal (such as the UK and Sweden) to the more restrictive rules of Germany so the immediate problem has more to do with the future development of stem cell therapies which cannot progress without industrial involvement. That notwithstanding we cannot rule out future developments that may restrict academic research.

The preliminary opinion originates from Judge Yves Bot and its primary argument seems to be that although embryonic stem cell lines can no longer be considered to be bona fide embryos, because they are incapable of developing into a whole organism, their embryonic origin cannot be disregarded. According to Bot patenting of embryonic stem cell technologies equates to the industrial use of Human embryos which in his view is “contrary to ethics and public opinion”. The opinion must now be considered by thirteen additional judges of the European Court of Justice’s “grand chamber” however few preliminary opinions have been reversed in the past so it is likely that this restriction will become enshrined in European law. Some academic researchers feel that the patent restriction will not be the only negative outcome of such legislation. Hans Scholer, a leading figure in German stem cell research and director of the Max Planck Institute for Molecular Biomedicine in Münster, points out in Nature news (http://www.nature.com/news/2011/110310/full/news.2011.152.html) that states who are currently undecided about the future of stem cell research will quite obviously refer to the decisions of the European court when formulating their regulatory frameworks. Given the nature of the decision, any conclusions they make are unlikely to favour the use of embryonic stem cells.

It would be a most disturbing development if pluripotent stem cell research were to suffer more setbacks in Europe particularly since it is uncertain how the new law would relate to induced pluripotent stem cells (iPSC). It is quite clear that iPSC circumvent most if not all the objections raised by the European court but if the possible restrictions alluded to in this article and other become reality, what guarantees do we have that iPSC will be exempt? In any case, iPSC cannot yet replace embryonic stem cells in the primary research needed to develop therapies. As underlined by Professor Austin Smith, director of the Cambridge stem cell institute in a letter to Nature (http://www.nature.com/nature/journal/v472/n7344/full/472418a.html?WT.ec_id=NATURE-20110428), iPSC offer many possibilities for disease modelling but they are not ready to replace embryonic stem cells because the reprogramming process needed to make them is imperfect. These problems will undoubtedly be solved and perhaps therapies based on patient specific iPSC will become reality but the permissive regulatory environment that allowed embryonic stem cells to progress in the first place is prerequisite to this development. As advocates of stem cell research of all types in any part of the world, we at the Stem Cell Portal hope that the European Court of Justice will consider the great social and commercial benefits that may accrue to the European Union from the successful development of treatments for many serious diseases that could be developed in its member states as a direct benefit of a benign regulatory environment.