European Court of Justice Considers Embryonic Stem Cell Ban

    By Kevin E. Noonan --

The European Court of Justice (ECJ) is poised to make a decision regarding the patent-eligibility of human embryonic stem cells (hESCs) in Europe, and that decision will be "no" if the court follows the recommendation of the court's advocate general.

The case began in 2004, when Greenpeace sued in German federal court over a German patent to the University of Bonn involving methods for deriving neural cells from hESCs (DE 197568664 C1).  While German laws regarding stem cell research have been characterized as the "most restrictive in Europe," such research is permitted provided that it is performed with pluripotent (rather than totipotent) cells, using cell lines imported from abroad and only cell lines that were made prior to May, 2007.  Nevertheless, Greenpeace argued that claims to methods for using hESCs were "immoral and against public order," provisions of European law generally that define subject matter not eligible for patent (there is no corresponding provision under U.S. law).

The German federal court ruled for Greenpeace in 2006, and the university appealed to the German supreme court.  That court decided that it needed to refer the question to the ECJ, since German law was closely patterned on European Union guidelines for biotechnology patenting.

On March 17, 2011, the ECJ advocate-general, Judge Yves Bot, rendered an opinion that stem cell patents were "contrary to ethics and public policy" because they required "industrial use" of human embryos.  This is not a final decision of the ECJ, which will now consider the matter before the entire 13 judges of the court and render an opinion in the next several months.  However, it is expected that the court will agree with the advocate-general, since it is rare that such preliminary opinions are overruled, according to a court spokesman.

This possibility prompted several stem cell scientists in Europe to send a letter to the court, published in Nature on April 28th, setting forth the case for stem cell patenting.  In the letter, the scientists expressed their "profound concern" in the capacities as "coordinators of multinational European stem-cell projects."  They contend that stem cells are cell lines, not embryos, and that they were derived from "surplus in vitro fertilized eggs donated after fertility treatments" that could not be maintained "indefinitely."  The existence of "more than 100" established stem cell likes make concerns about embryos "misplaced," they assert, and warn that it may be "premature to suggest that human embryonic stem cells can be replaced" (by iPS cells, for example) in developing stem cell therapies.  A stem cell ban in Europe will prevent scientists from "deliver[ing] clinical benefits without the involvement of biological industry," and such companies "must have patent protection as an incentive" to do their work in Europe.  This will result, these scientists predict, in "European discoveries [being] translated into applications elsewhere, at a potential cost to the European citizen."

This action is the latest in a series of initiatives by individuals and groups with philosophical objections to patents involving biological materials, particularly material derived from human beings.  These include the Public Patent (PubPat) Foundation's attempts to invalidate the Thomson hESC patents in the U.S. (unsuccessful with regard to U.S. Patent Nos. 5,843,780 and 6,200,806 and currently pending against U.S. Patent No. 7,029,913) as well as PubPat and the ACLU's challenge to human gene patenting in the AMP v. USPTO (Myriad) case.  Opponents of such patents voice various arguments and rationales against patenting products of human biology, but ultimately the argument is the one raised in Europe, that there are moral objections to the practice.  Such objections are sincerely held by many and it is neither possible nor productive to make arguments on these grounds:  as it is in many public policy debates, these positions tend to be absolutes for some, not subject to merely reasoned argument.  Perhaps the best rejoinder of the argument is to posit the situation if patent opponents prevail (which also comprises a part of the scientists' argument in their letter).  Lack of patent protection will have two concrete and predictable consequences:  lack of financial investment to translate basic scientific discoveries to useful commercial products, and (where possible) reducing or eliminating public disclosure of inventions (and where not possible, investment in other technologies).  Neither outcome is conducive to reducing human morbidity or mortality or improving the human condition.  It is hard to understand how advocating such an outcome can be considered the more moral position.

The Nature letter was signed by the following scientists:

• Austin Smith EuroSyStem Project, Wellcome Trust Centre for Stem Cell Research, Cambridge, UK
• Peter Andrews ESTOOLS Project, Centre for Stem Cell Biology, University of Sheffield, UK
• Clare Blackburn EuroStemCell Project, MRC Centre for Regenerative Medicine, University of Edinburgh, UK
• Anders Björklund NeuroStemcell Project, Wallenberg Neuroscience Center, Lund University, Sweden
• Elena Cattaneo NeuroStemcell Project, University of Milan, Italy
• Giulio Cossu OptiStem Project, Stem Cell Research Institute, San Rafaelle Institute of Milan, University of Milan, Italy
• Juergen Hescheler ESNATS Project, Institute of Neurophysiology, University Hospital of Cologne, Germany
• Olle Lindvall NeuroStemcell Project, Lund Stem Cell Center, Lund University, Sweden
• Marc Peschanski STEM-HD, Institute for Stem Cell Therapy and Exploration of Monogenic Diseases, INSERM, Evry, France
• Daniel Pipeleers BetaCellTherapy Project, Diabetes Research Centre, Free University of Brussels, Belgium
• David Sassoon EndoStem Project, University of Paris VI/INSERM, Pitié Salpêtrière Medical School, Paris, France
• Anna Veiga hESCreg Project, Centre of Regenerative Medicine, Barcelona, Spain
• Catherine Verfaille HemiBio Project, Stem Cell Institute, K. U. Leuven, Belgium

Comments

[You Break It]

"It is hard to understand how advocating such an outcome can be considered the more moral position."

It's not hard unless you are a moral relativist.

[David Koepsell]

You Break It is partly correct. One could also make the same decision as a utilitarian or other sort of consequentialist. But there are strong deontological ethical roots in Europe and even elsewhere. Kantian ethics would oppose means-to-ends arguments completely, especially where there are implications for human dignity, or other non-defeasible duties involved. Not everyone believes that the ends justify every means, Kevin, and there are good historical reasons to reject consequentialism in general.

[Kevin E. Noonan]

Dear Break:

Not really. For example, I can put on the one hand the unused embryos that will be flushed down the toilet against all the (admittedly, potential) treatments and cures that can come from stem cell research (spinal cord injuries being one example relevant to the patent at issue). I have no difficulty saying without any relativism or reservation whatsoever that the moral position is advocating what will get such cures to people, as opposed to your conception (or anyone else's) of what is "moral." What's the problem with that?

[Kevin E. Noonan]

Dear Break:

Unless, of course, your position is that stem cell research is itself immoral (rather than the position taken by the advocate general, that it is only patenting stem cells and methods of using them that offends public morality). The former position would (at least) be a consistent moral one. If on the other hand the idea is that destroying embryos and using stem cells for research is fine as long as no one has a patent on the cells or the process, then I think the scientists addressed that argument eloquently and succinctly.

[Kevin E. Noonan]

All that's fine, David, but there are consequences to such positions, and the scientists laid out those consequences pretty well. When the "ends" are alleviation of human suffering, and the "means" are getting some usefulness from human material that would otherwise be discarded, I don't think that's "consequentialist" or "utilitarian", I think doing what we can to facilitate that outcome is the human, moral position to take. IF, as I said upthread, the position is that stem cell research is wrong per se as an assault on human dignity, and IF the possibility that human embryos will be discarded informs the position that in vitro fertilization is immoral, then I think there is a consistent ethical stand that can be taken. Frankly, I don't have a problem with moral positions taken on those grounds, but that isn't what's happening. Greenpeace isn't opposing stem cell research; this isn't PETA raiding biology labs and liberating the animals. The objection is patenting, not the research, and the basis for this isn't "human dignity" - where's the dignity in discarding a human embryo?

The objection is that someone may actually make money using this technology, and if that's the objection it is frankly naive. The "altruistic" impulse as the basis for economic behavior was tried ("from each according to his abilities, to each according to his needs"), famously, and didn't work out too well.

Using dead philosophers to support inconsistent positions may be fun, but until the ultimate question - should we permit stem cell research on moral grounds - is addressed, all the rest is politics. And politics, whatever its philosophy, has consequences (which Europeans may soon once again recognize, if the scientists' predictions are accurate).

A generation ago, Europe was slow in adopting patent protection for biotechnology, and suffered with being behind the U.S. and other countries until recently. If stem cell research will flourish in the U.S. and Asia to the detriment of Europe, it is decisions like this one that will be the cause.

Hope you are well. The pictures of your child are wonderful.

[GJ]

This sort of off-target nonsense is why I stopped sending my donations to Greenpeace and started sending it to real environmental action groups - like those irreverent outlaws Sea Shepherd. Greenpeace got all enviro-religious.

[David Koepsell]

Kevin, the Kantian response is simply that consequences don't matter - if one is using a person as a means to an end one is per se violating the duty of respecting equal dignity. I don't view the use of human stem cells as problematic because persons are not used, though I do oppose monopolizing them ( or any non-engineered products) on different grounds, also deontological, as you know. As for biotech in Europe, given longer life expectancies, lower costs for medical care, and relatively higher standards of living here than in the US, it is arguable that Europeans lost little to nothing in "falling behind."

All is well here, thanks for the good wishes and I hope you enjoyed your birthday!

Best,
David

[Kevin E. Noonan]

David: a good reason not to be a Kantian.

Thanks for the birthday wishes.

[David Koepsell]

Kevin: I'm not a Kantian, actually. But Utilitarianism is not better. The "hedonic calculus" of Utilitarianism justifies using a certain number of persons to improve general happiness. It justifies slavery of a sufficiently small population for the good of the whole. Unless you accept that there are certain inviolable rights, and have some basis for believing such rights exist, utilitarianism is simply inhumane. My deontological ethics is rights-based, and as I point out in my GeneWatch article, rights to monopolize "commons-by(logical)-necessity" (like abstract ideas, natural phenomena, etc.) can never be justly granted to anyone.

[Kevin E. Noonan]

Dear David:

I am not as theoretically pure as you seem to be. I don't think that it follows that granting rights to methods for using stem cells is the same as slavery - indeed, the stem cells at issue stem from embryos whose "owners" (which brings up a whole other set of philosophical arguments, don't you think?) have donated the embryos rather than have them destroyed. And remember, the patent at issue are not directed to the cells but to methods for making neural cells from stem cells - and wasn't it your position in the gene patenting debate that method claims would be patent-eligible?

Not something we are going to resolve, given our basic underlying differences, but hyperbole doesn't help.

Thanks as always for the discussion.

[GJ]

which phenomena aren't natural? Man is not somehow separate from the world, he comes from it and is part of it. Everything he does becomes part of that world. The technology he makes doesn't somehow opearte on laws outside of the world itself, it is part of them. Sounds like some artificial distinction left over from a western religious concept of man being separate from nature.

[David Koepsell]

Kevin: you misunderstood my point, I wasn't equating anything with slavery, just pointing out the dangers of utilitarian ethics, which can be used to justify slavery, among other undesirable things. I don't think I've taken a position on the stem cell issue at all in this thread, and would not oppose method claims (just product claims). I was trying above to point out why utilitarian reasoning of the sort you rely in is flawed from a deontological standpoint, as well as attemoting to lay a theoretical foundation for a sensible philosophical standpoint taken by some in the debate.

GJ: the law distinguishes man-made from natural. The Supreme Court bars patents for abstract ideas, natural laws, and natural phenomena. I do think that, for instance, laws of nature are clearly not man-made, while steam engines, while they depend upon natural laws, are the products of human intention and thus not "natural" as the courts reasonably draw the distinction.

[Kevin E. Noonan]

David:

Sorry for the misunderstanding. I am not making a purely teleological argument, however; I think the problem with deontological arguments is that they rely, to a greater or lesser extent, on moral judgments and that those judgments tend to be imposed politically - which is just what we are seeing in the stem cell debate as well as the gene patenting debate.

I mistrust morality arguments just as much as you mistruct teleological ones; after all, 200 years ago (and in some places, even more recently) slavery or at least racist practices were justified by moral arguments that seem repugnant to us today.

Better in my view to take the view espoused by the US Supreme Court that "anything under the sun made by man" should be patentable, and to find patent ineligibility rarely.

Thanks for the comment.