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European judges and embryonic stem cells

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Following the article by Alessandro Blasimme, Giovanni Boniolo picks up the discussion on the recently approved EU ruling on stem cell research, trying to define and clarify the situation.

In recent days the Court of Justice of the European Union issued a somewhat surprising ruling. It concerned the case ( Judgment in Case C-34/10) Oliver Brüstle against Greenpeace, the former being a German scientist who patented a process in which human embryonic stem cells were also used in a potential therapy for Parkinson's disease, the latter a well-known organization that wanted to oppose such a move. Well, the Court of Justice has decided that: “A process which involves removal of a stem cell from a human embryo at the blastocyst stage, entailing the destruction of that embryo, cannot be patented”, explaining that “The use of human embryos for therapeutic or diagnostic purposes which are applied to the human embryo and are useful to it is patentable, but their use for purposes of scientific research is not patentable”.

This ruling sparked emotions (rather than reasoning) for and against, especially grounded on the emotions (rather than reasoning) that each one had on the use of human embryonic stem cells. This question however should be examined by separating what needs to be separated so as to assess it better and learn something from it.

First of all, the ruling is clearly not intended to be an ethical judgment, but only a legal assessment. This, as is generally the case in the relationship between ethics and law, is an important point which is worth considering. We often ask judges or lawyers to give their opinions on ethical issues related to biomedicine and they respond in terms of laws. This, however, is a gross classification error. As it is well known, there are laws and judgments that are ethically sustainable and others that are ethically indefensible, while there are actions that we value as ethically sustainable and which are also legal, but there are others that are illegal (depending on different Courts views). In short, law and ethics are two things that should be kept separate. This means that the ruling of the Court of Justice can be evaluated (positively or negatively) both from the legal and the ethical point of view, but using different techniques, as required by the different approaches, and always avoiding any undue muddling between the two fields.

The second point concerns the fact that the discussion revolves around the patentability of human embryonic stem cells rather than just the possibility of using them. This means that there may be people who, though favorable to the possible use of human embryonic stem cells, are nevertheless opposed to patenting the process involving them, possibly because they are opposed to any form of patentability of processes having to do with some aspects of life (especially human life). Therefore in order for a proper debate (ethical and legal) on the ruling to take place, we must keep the issue of the human embryonic stem cells patentability separate from that of their use, and only after examining them separately one may ponder the former in relation to the latter.

The third point concerns some aspects of the ruling that are questionable not so much from an ethical or legal standpoint, as from the methodological and epistemological one. Let's have a look at them. One of this aspect is contained in a passage which I have already mentioned, namely: “The use of human embryos for therapeutic or diagnostic purposes which are applied to the human embryo and are useful to it is patentable, but their use for purposes of scientific research is not patentable”. In practice, it is argued that while research on human embryos and the results obtained therefrom may not be patentable, their therapeutic or diagnostic use (at least, it would seem, that which is applied to the benefit of the embryo itself) can instead be patented.This is interesting because it is argued that there is a difference between research and its application. However, it is obviously not always possible to draw a clear difference between the two and the generalization of this aspect of the decision becomes quite doubtful and difficult to justify (even a law or a decision should be justified, or at least we would hope so! In this case, unfortunately, the justification is so vague as to be embarrassing for any citizen who does not confuse an ethical stance with an ethical prejudice: “[we] intended to exclude any possibility of patentability where respect for human dignity could thereby be affected”). On the other hand, the non-patentability of research processes (specifically, research processes involving human embryos), as already mentioned above, is a very controversial topic for the negative and positive consequences (even for the research itself) that both patentability and non-patentability involve. These consequences should be evaluated and discussed with as little ideological bias as possible, taking into great account how modern science functions from an economic point of view and what the current state of the world economy is.

The second epistemological issue I would like to emphasize is the rather questionable use of the definition made by the ruling. As we all know, the definition of a term is an act of agreement carried out within a given community (unless someone thinks it's really possible to grasp what there is in "nature" through a term, but I hope in science there are less naive metaphysicians than there are in philosophy). Therefore, that the ruling broadens the definition of 'human embryo' as it does, should not be so surprising (“[It is] in the view of the Court, that the concept of ‘human embryo’ must be understood in a wide sense. Accordingly, the Court considers that any human ovum must, as soon as fertilised, be regarded as a ‘human embryo’ if that fertilisation is such as to commence the process of development of a human being. A non-fertilised human ovum into which the cell nucleus from a mature human cell has been transplanted and a non-fertilised human ovum whose division and further development have been stimulated by parthenogenesis must also be classified as a ‘human embryo’. Although those organisms have not, strictly speaking, been the object of fertilisation, due to the effect of the technique used to obtain them they are capable of commencing the process of development of a human being just as an embryo created by fertilisation of an ovum can do so.”). Within the community of those who drafted the ruling, it was decided to provide that definition, and so be it. So far nothing wrong (neither from the epistemological point of view, nor from an ethical or social one).What is really surprising, however, (and gets somewhat annoying and not only from the epistemological point of view) is that a really very small community as the one which wrote the judgment would arrogate to itself the right to impose its definition upon a much larger community (as that of the EU citizens), moreover in stark contrast to the definition of that term as it is accepted within the community that is probably the only one entitled to propose a definition, that is, the scientific community.In short, I do not think it is such a nice thing that a judge stands up and says:"I am the law, and the definition of this term is the one I decided."

As you can realize from the above, the ruling should be discussed and evaluated (and criticized), also with a view to learn from it; however, it would perhaps be advisable that in doing so, the different levels of discussion be kept separate, and that one refrained from resorting to dogmatic ideologies or religious beliefs as if they were the repository of absolute truth, that is that one avoided proposing his/her own moral prejudices presenting, instead, one's own moral positions.

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