November 28, 2011
This post was co-authored by Wannes Van Hoof* and Stijn Smet.
Recently, the European Court of Justice (ECJ) was asked to deliver a preliminary ruling on the use of human embryos for scientific research. The case concerned an application by Greenpeace, seeking annulment from the German courts of a patent held by Mr. Brüstle. The patent had been obtained by Mr. Brüstle in 1997 and relates to the isolation and purification of neural precursor cells, processes for their production from embryonic stem cells and their use for the treatment of neural defects. The patent had already led to the development of clinical applications, in particular for patients suffering from Parkinson’s disease. Greenpeace took issue with the patent and demanded its annulment in court, because the process involves the use and destruction of human embryos.
In this post, Wannes Van Hoof, a colleague from the Bioethics Institute Ghent, and Stijn Smet will take a look at the ruling of the ECJ, both from an ethical and a legal perspective. In doing so, we will address issues that also confront the European Court of Human Rights in cases involving ethical and moral dilemmas, such as the question on the role of subsidiarity and deference on the one hand and a need for more substantive guidance by international courts in these matters on the other.
The Judgment of the ECJ (by Stijn Smet)
In Brüstle the German Bundesgerichtshof (Federal Court of Justice) posed three preliminary questions to the ECJ regarding the interpretation of the applicable EU Directive. Article 3 of the Directive 98/44/EC on the legal protection of biotechnical inventions principally allows patentability of inventions that concern biological material, but the Directive excludes such patentability on the human body in its article 5. When a patentable invention makes use of elements isolated from the human body, the Directive is less clear. In those cases, its article 6 becomes particularly relevant. This article prevents the patentability of inventions where their commercial application would be contrary to ordre public or morality and specifies in its second paragraph that, among others, inventions that involve the use of human embryos for industrial or commercial purposes shall be unpatentable. Since application of art. 6 (2) was not clear cut in the case of Greenpeace v. Brüstle, the ECJ was asked by the German court to offer an interpretation of the term “human embryo” in art. 6 (2), as well as to rule on whether scientific research fell within the expression “for industrial or commercial purposes”. The ECJ was also asked to determine whether art. 6 (2) excluded patentability in cases where production required the prior destruction of human embryos, as was the case with Mr. Brüstle’s patented process.
In its ruling, the ECJ first determined that the term human embryo should be considered as an autonomous concept of EU law and thus required a uniform interpretation that would apply in the entire territory of the Union. In the eyes of the ECJ it followed clearly from the Directive that it was geared towards the smooth functioning of the internal EU market and that the lack of a uniform definition of the term “human embryo” would adversely affect the internal market. In order to deliver a uniform interpretation, the ECJ determined that it should take the context of the entire Directive into account, including its preamble, which refers explicitly to fundamental rights and the dignity of the person. On that basis, the Court ruled that “[t]he context and aim of the Directive … show that the European Union legislature intended to exclude any possibility of patentability where respect for human dignity could thereby be affected.” Without further elaboration, the ECJ continued: “[i]t follows that the concept of ‘human embryo’ … must be understood in a wide sense.” The Court subsequently ruled that basically all processes that lead to the commencement of a process of development of a human being should be regarded as creation of a human embryo, regardless of whether the process involves fertilisation. The Court only left open the question as to whether obtaining stem cells from a human embryo at the blastocyst stage would fall under “commencing development of a human being”, leaving the German courts to decide that question. However, regarding the third question the ECJ did rule that patentability is excluded as soon as the process of obtaining stem cells requires the destruction of human embryos, as was the case for Mr. Brüstle’s patented invention. The ECJ ruled that, in all cases and all stadia of development, destruction of human embryos falls under the term “use of human embryos” in art. 6 (2) of the Directive and leads to unpatentability of any invention based thereon. Regarding the second question, related to scientific research, the Court held that “the use of human embryos for the purposes of research which constitutes the subject-matter of a patent application cannot be separated from the patent itself and the [commercial and industrial] rights attached to it.” Consequently, the Court ruled that art. 6 (2) also covers the use of human embryos for scientific research, only leaving room for patentability in case of use of human embryos for therapeutic or diagnostic purposes which are useful for the human embryo itself.
The scientific community in Europe has reacted with disbelief and disappointment to the ruling of the ECJ, worrying that the ruling will cause European companies and scientists to miss out on commercial applications for embryonic-stem-cell research. There is a specific fear that the ruling could reduce the European companies’ willingness to invest in treatments based on stem cells, since it leaves all patents for processes that involve the destruction of human embryos vulnerable to challenge. Mr. Brüstle himself added “[t]he saddest part is the bad news it brings for young people in the field, because 90% of them went into this to make a difference in biomedicine and to develop therapies. What can we say to them? It will be difficult to persuade them to stay in Europe.”
Commentary (by Wannes Van Hoof)
Within Europe, more and more morally sensitive cases are brought before the ECJ and the European Court of Human Rights (ECtHR). These courts are faced with a constant struggle between very broad principles, conventions and human rights on the one hand, and very distinct religious, moral and cultural identities at national levels on the other. Especially the ECtHR tends to hide behind the concept of the margin of appreciation to avoid having to formulate any substantial moral position beyond the minimalistic principles and conventions. In ethical terms: the courts are generally morally relativist. There are indications that the Strasbourg Court is increasingly resorting to the margin of appreciation in ethically complex cases, as evidenced by the recent S.H. and others judgments of the Grand Chamber (see Alexandra Timmer’s post on this case here). Arguably, the Court is forcefully aware of the strong critique of judicial activism it has been receiving from national governments in recent times and is attempting to calm the storm by taking a more deferential approach in, inter alia, cases involving ethical dilemmas. Surprisingly, the Brüstle v. Greenpeace case demonstrates how another approach is possible: the other major European Court, the ECJ, hardly leaves any room for national appreciation. The court imposes a uniform approach throughout the EU.
In the case of Brüstle v. Greenpeace, the age-old problem of the moral status of the embryo is the central issue. This problem returns in different forms in discussions on abortion, pre implantation genetic diagnosis, stem cell research, … There is absolutely no European consensus on this matter. For example, Ireland prohibits abortion unless the pregnancy endangers the life of the woman and in Poland only in the case of severe medical reasons an abortion is warranted, but most European countries allow abortion on request until 10 or 12 weeks of gestation and accept medical or psychological reasons for abortion at a later stage. Should we interpret from this that the embryo or foetus deserves protection from 10 or 12 weeks of gestation? Or that any zygote should be attributed a high moral status? The ECJ specifically mentions that there should be a uniform meaning of human embryo to avoid what I call ‘patent-tourism’ where people request patents in the more liberal Member States to avoid strict regulations in others. Such a uniform definition will clearly result in moral conflict at national levels. In this case, every European country that supports embryonic stem cell research will experience serious problems for the cooperation between the public and private sector in stem cell research.
The court does not directly participate in the moral discussion, but limits itself to the interpretation of the law (as is its proper function). However, its judgment bears a heavy moral burden. In that regard, the judgment should be applauded. Instead of hiding behind different ‘national identities’, the court made a substantial point: there is no patentability on scientific research using embryonic stem cells. This confers a uniform point of view on a morally contested matter. Unlike the ECtHR, the ECJ was determined not to submit to moral relativism and came up with an actual judgment. At least partially, as the court still leaves up to the referring court to ascertain whether a stem cell obtained from a human embryo constitutes a ‘human embryo’ within the meaning of Article 6(2)(c) of Directive 98/44.
However, to abandon the position of moral relativism for an absolute rule requires particularly persuasive arguments. Nowhere in the judgment are such arguments to be found. The court dogmatically stuck to their interpretation of a 1998 Convention, which is ages ago when it comes to the ethics of stem cell research and scientific research in general. The court used a lexical definition of the embryo to justify their moral position. The role of the ECJ is mainly procedural as it serves to interpret EU legislation. In this case, however, the interpretation has practical consequences, which means the judgment is de facto substantial. I applaud that the court takes a position in certain moral matters, because moral relativism will only take you so far and may open pathways to morally questionable positions. However, it is not Europe’s role to prescribe absolute rules on moral matters based on mere dogmatic reasons. Especially in areas of contested morality within Europe, the court should justify its position explicitly, so that continuous discussion and revision may govern these issues which are subject to continuous changes both in light of scientific developments and dynamic moral convictions and beliefs.
*Wannes Van Hoof obtained a Master’s degree in Philosophy and a Master’s degree in Social and Cultural Anthropology (Catholic University of Leuven). He is currently completing a PhD at the Bioethics Institute Ghent (Ghent University) on cross-border reproductive care. He has a special interest in issues of legal diversity in assisted reproduction and health care in general.
 Add link to piece on Nature.com: http://www.nature.com/news/2011/111018/full/news.2011.597.html