The Brüstle case and the commercial exploitation of the human embryo
The positive effects of the decision on such a milestone ruling will certainly spill over to other policy fields, starting with EU research funding
The European Court of Justice (ECJ), on 18 October last, issued the final decision on the Brüstle case (Oliver Brüstle v Greenpeace e.V.), a milestone in the legal protection of the human embryo as well as a sign of hope for all European patients. What the Court did was nothing but uphold a prevailing interpretation which had already been supported, among others, in the Opinion of the Advocate General, Mr. Yves Bot, delivered earlier this year and analysed in the europeinfos issue no. 139 . The interpretation that inventions related to human embryonic stem cells (hESC) are not patentable challenges, however, powerful economic interests. The ECJ came to this conclusion after interpreting the expression “human embryo” as used in Directive 98/44/EC on the legal protection of biotechnological inventions. This legal instrument lays down, in Article 6/2/c), that: “shall be considered unpatentable: (...) uses of human embryos for industrial or commercial purposes”.
This lawsuit was lodged, according to the spokesperson of Greenpeace, in order to rule out that any creature be abused with the aim of profiting, be such creatures either plants or animals, or human beings. Patenting could lead to the creation of monopoly in the field of food production, in the former case; or to human body commercialisation, in the latter. Greenpeace repudiates both consequences.
The European Court set out the broadest definition possible of a human embryo, and the one that better fits the current scientific data. No stage of development of the human being is put aside, starting from the very beginning: “any human ovum after fertilisation” is already a human embryo, and also the product of cloning – “any non-fertilised human ovum into which the cell nucleus from a mature human cell has been transplanted” or “whose division and further development have been stimulated by parthenogenesis”. Therefore, it becomes meaningless to use expressions such as “pre-embryo”, “clonote”, “technical artifact” or any of the others so often used to discriminate against certain unborn human beings to whom recognition of human dignity and, thus, legal protection, is refused.
Furthermore, the ECJ held that, if one cannot obtain economic benefits from the destruction of human embryos, so it is equally inadmissible to economically benefit from the cells whose procurement entail such destruction. Indeed, during such a process, the embryo at the stage of blastocyst is destroyed and used as mere base material. And that is so, according to the ECJ, “whatever the stage at which that [destruction] takes place”, meaning that an invention using cell lines previously derived is still unpatentable.
It is noteworthy that research itself is not thereby prohibited, only its commercial exploitation. Nevertheless, the economic incentive having been withdrawn, research in this field will clearly be affected. That is not bad news for European patients, as research on alternative sources of stem cells – adult, umbilical cord blood or induced pluripotent – will likely be fostered with new resources being channelled to it. None of these alternative sources poses special ethical problems, and some have already produced proven clinical results.
Finally, it is likely that such a judicial decision will impact on other fields where protection of human dignity – of each and every human being, without any discrimination – is also at stake. Starting with the European funding of research and innovation, whose new Framework programme, Horizon 2020, covering the period 2014-2020, will start to be debated as from December. If the EU legal order is meant to be unitary and internally coherent, a criterion similar to the one adopted by the ECJ should prevail in this specific field as well. Meaning that projects covering either research activities which destroy human embryos – including for the procurement of hESC – or any subsequent steps involving hESC obtained in a previous derivation process that entails such destruction, should not be admitted for funding.
Last but not the least, one should reflect whether or not EU funding research whose possible results are legally prevented from being turned into actual innovation in the market and therefore will lack any concrete impact on society, would be inefficient from an economic point of view, a misuse of scarce resources –at a time of acute crisis – and, in short, a great nonsense.