In Oliver Brüstle v Greenpeace e.V (Case C‑34/10) the Grand Chamber was faced with the question as to whether EU law permitted the patenting of a process allowing for the production, from stem cells extracted from human embryos, of an almost unlimited quantity of isolated and purified precursor cells having neural or glial properties. The claim was made in the patent application that these neural precursor cells had a direct clinical application for individuals suffering from a variety of neurological diseases, such as Parkinson’s disease. These immature precursor cells were, by definition, still capable of developing and so might be transplanted into the nervous system of sufferers with the hope of there regenerating and repairing neurological damage sustained by the patient.
The problem from the perspective of EU law is that Article 6 of Directive 98/44/EC on the legal protection of biotechnological inventions which, so far as relevant states as follows:
1. Inventions shall be considered unpatentable where their commercial exploitation would be contrary to ordre public or morality; however, exploitation shall not be deemed to be so contrary merely because it is prohibited by law or regulation.
2. On the basis of paragraph 1, the following, in particular, shall be considered unpatentable:… (c) uses of human embryos for industrial or commercial purposes.”
A legal challenge to Dr. Brüstle’s patent was brought in Germany by Greenpeace who argued that the patent involved the use of human embryos for industrial or commercial purposes. Deciding that the issue required the guidance of the CJEU, the German Federal Court of Justice (the) referred the following knotty questions to Luxembourg:
“1. What is meant by the term “human embryos” in Article 6(2)(c) [of Directive 98/44/EC]?
(a) Does it include all stages of the development of human life, beginning with the fertilisation of the ovum, or must further requirements, such as the attainment of a certain stage of development, be satisfied?
(b) Are the following organisms also included:
– unfertilised human ova into which a cell nucleus from a mature human cell has been transplanted;
– unfertilised human ova whose division and further development have been stimulated by parthenogenesis?
(c) Are stem cells obtained from human embryos at the blastocyst stage also included?
2. What is meant by the expression “uses of human embryos for industrial or commercial purposes”? Does it include any commercial exploitation within the meaning of Article 6(1) of [of Directive 98/44/EC], especially use for the purposes of scientific research?
3. Is technical teaching to be considered unpatentable pursuant to Article 6(2)(c) of the Directive even if the use of human embryos does not form part of the technical teaching claimed with the patent, but is a necessary precondition for the application of that teaching:
- because the patent concerns a product whose production necessitates the prior destruction of human embryos,
- or because the patent concerns a process for which such a product is needed as base material?”
The CJEU held that the term “human embryo” should, for the purposes of application of the Directive, designate an autonomous concept of EU law which must be interpreted in a uniform manner throughout the EU. Otherwise said the CJEU there would be:
“a risk of the authors of certain biotechnological inventions being tempted to seek their patentability in the Member States which have the narrowest concept of human embryo and are accordingly the most liberal as regards possible patentability, because those inventions would not be patentable in the other Member States. Such a situation would adversely affect the smooth functioning of the internal market which is the aim of the Directive.”
The Court observed that while one of the purposes of the Directive was to promote investment in the field of biotechnology, the Directive also required that the use of biological material originating from humans must be consistent with regard for fundamental rights and, in particular, the dignity of the person. Against that background the CJEU considered the concept of ‘human embryo’ within the meaning of Article 6(2)(c) of the Directive must be understood in a wide sense and accordingly ruled as follows:
“[i] any human ovum must, as soon as fertilised, be regarded as a ‘human embryo’ within the meaning and for the purposes of the application of Article 6(2)(c) of the Directive, if that fertilisation is such as to commence the process of development of a human being.
[ii] That classification must also apply to a non-fertilised human ovum into which the cell nucleus from a mature human cell has been transplanted [cloning] and
[iii] a non-fertilised human ovum whose division and further development have been stimulated by parthenogenesis.”
The court noted in relation to the second and third categories that “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.”
The CJEU left it open to the Member State court to determine, in the light of scientific developments, whether or not stem cells obtained from a human embryo at the blastocyst stage were capable of commencing the process of development of a human being. If they were then such stem cells would also fall within the concept of ‘human embryo’ within the meaning and for the purposes of the application of Article 6(2)(c) of the Directive.
In a remarkably (for the CJEU at least) unequivocal ruling, the Grand Chamber therefore answered the question posed by Federal Court of Justice’s as follows
“1. Article 6(2)(c) of Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions must be interpreted as meaning that:
– any human ovum after fertilisation, any non-fertilised human ovum into which the cell nucleus from a mature human cell has been transplanted, and any non-fertilised human ovum whose division and further development have been stimulated by parthenogenesis constitute a ‘human embryo’;
– It is for the referring court to ascertain, in the light of scientific developments, whether a stem cell obtained from a human embryo at the blastocyst stage constitutes a ‘human embryo’ within the meaning of Article 6(2)(c) of Directive 98/44.
2. The exclusion from patentability concerning the use of human embryos for industrial or commercial purposes set out in Article 6(2)(c) of Directive 98/44 also covers the use of human embryos for purposes of scientific research, only use for therapeutic or diagnostic purposes which are applied to the human embryo and are useful to it being patentable.
3. Article 6(2)(c) of Directive 98/44 excludes an invention from patentability where the technical teaching which is the subject-matter of the patent application requires the prior destruction of human embryos or their use as base material, whatever the stage at which that takes place and even if the description of the technical teaching claimed does not refer to the use of human embryos.”
This decision will undoubtedly provoke discussion and dissension particularly within the UK with its flourishing biomedical industry and research centres, keen to discover and exploit, both commercially and scientifically, the potential of human embryo stem cells for various therapeutic treatments. One suspects, indeed, that the UK may well be regarded in the words of the CJEU, as one of “the Member States which have the narrowest concept of human embryo and are accordingly the most liberal as regards possible patentability”.
Whatever one thinks of the merits of the decision, the reasoning of the CJEU is of particular interest from a legal and ethical point of view in its reference to and reliance upon “fundamental rights and, in particular, the dignity of the person” as regards the treatment of the human embryo. The relevant background to this decision, and the specific reliance upon “the dignity of the person” is undoubtedly to be found in the terms of the EU Charter of Fundamental Rights, Title I of which is headed “Dignity” and contains five articles, which are in the following terms
“Article 1 – Human dignity
Human dignity is inviolable. It must be respected and protected.
Article 2 – Right to life
1. Everyone has the right to life.
2. No one shall be condemned to the death penalty, or executed.
Article 3- Right to the integrity of the person
1. Everyone has the right to respect for his or her physical and mental integrity.
2. In the fields of medicine and biology, the following must be respected in particular:
(a) the free and informed consent of the person concerned, according to the procedures laid down by law;
(b) the prohibition of eugenic practices, in particular those aiming at the selection of persons;
(c) the prohibition on making the human body and its parts as such a source of financial gain;
(d) the prohibition of the reproductive cloning of human beings.
Article 4 – Prohibition of torture and inhuman or degrading treatment or punishment
No one shall be subjected to torture or to inhuman or degrading treatment or punishment.
Article 5- Prohibition of slavery and forced labour
1. No one shall be held in slavery or servitude.
2. No one shall be required to perform forced or compulsory labour.
3. Trafficking in human beings is prohibited.”
The right to human dignity is one which has its roots in German constitutional law and jurisprudence. In Netherlands v Parliament and Council (Case C-377/98) AG Jacobs in his Opinion of 14 June 2001, at para 197, referred to Articles 1 and 3(2) of the Charter to found the right to human dignity and to respect for an individual’s free and informed consent in medical procedures as being principles of EU law. This reference was not taken up by the court in its decision. Instead the CJEU first made explicit reference to the German law derived concept of dignity as being an unwritten principle also of EU law in a judgment involving the lawfulness of a ban on paint-ball guns from the UK to Germany, it being considered that the use of fake guns as a means of commercial entertainment in a game which simulated the shooting by individuals of their fellows might not be compatible with post WWII German notions of the requirements to respect the dignity of others. In upholding the compatibility with EU law of a ban in Germany on these UK imported good, the CJEU stated in Omega Spielhallen- und Automatenaufstellungs-GmbH (Case C-36/02) at paras 34–35 as follows:
“[T]he Community legal order undeniably strives to ensure respect for human dignity as a general principle of law. There can therefore be no doubt that the objective of protecting human dignity is compatible with Community law, it being immaterial in that respect that, in Germany, the principle of respect for human dignity has a particular status as an independent fundamental right. Since both the Community and its Member States are required to respect fundamental rights, the protection of those rights is a legitimate interest which, in principle, justifies a restriction of the obligations imposed by Community law, even under a fundamental freedom guaranteed by the Treaty such as the freedom to provide services.”
In the AG Opinion of 10 March 2011 in Case C‑34/10 Oliver Brüstle v Greenpeace eV Advocate General Bot at para 96:
“[H]uman dignity is a principle which must be applied not only to an existing human person, to a child who has been born, but also to the human body from the first stage in its development, i.e. from fertilisation.”
This analysis of Advocate General Bot would seem to have been adopted by the CJEU in its judgment. It is also an analysis which is consistent with the 1997 Oviedo Convention on Human Rights and Biomedicine, Article 18 of which states:
“Research on embryos in vitro
1 Where the law allows research on embryos in vitro, it shall ensure adequate protection of the embryo.
2 The creation of human embryos for research purposes is prohibited.”
Although the Oviedo Convention was adopted under the auspices of the Council of Europe it has not been signed up by the UK. This notwithstanding, however, in its judgment in Glass v United Kingdom (2004) 39 EHRR 15, the European Court of Human Rights had regard to the standards enshrined in the Oviedo Convention in finding that there had been a breach of the requirements of Article 8 ECHR. The case concerned the treatment in hospital of David Glass, a severely mentally and physically disabled individual (born in 1986) who required twenty-four hour attention. He was admitted to hospital in 1998 for an operation to alleviate an upper respiratory tract obstruction. He suffered post-operative complications, including infections, and had to be put on a ventilator when he became critically ill. The medical staff expressed the view that he was dying and that further intensive care would be inappropriate. His family were dissatisfied with this advice. He eventually recovered sufficiently to return home but had to be readmitted to hospital on several occasions in the months thereafter. On his readmission with respiratory failure, the hospital insisted that David was dying and that diamorphine should be given to relieve his obvious distress. David’s mother disagreed and objected to the proposed treatment in the belief that it would harm his chances of recovery. Diamorphine was nonetheless administered and doctors in the hospital also unilaterally placed a do-not-resuscitate order (DNR) in David’s case notes, again without his mother’s consent and knowledge. Contrary to the medical prognosis David’s condition improved after his family took action to resuscitate and stimulate him and he returned home. The Court found that the treatment which he had been given contrary to his mother’s wishes breached his right to physical integrity under Article 8, noting (at para 77)
“that the decision to impose treatment on the first applicant in defiance of the second applicant’s objections gave rise to an interference with the first applicant’s right to respect for his private life, and in particular his right to physical integrity.”
The CJEU reference in Oliver Brüstle v Greenpeace e.V (Case C‑34/10) to the principle of respect for concept of human dignity as extending to the human embryo and the ECtHR reliance on the Oviedo Convention in Glass v. UK may be seen pointing to the beginnings of an general European consensus which would set a fundamental prohibition on the use of human embryonic material embryos in any commercial or scientific processes not aimed at the therapeutic treatment of the specific individual embryo. This is said to follow from the respect owed to the dignity and physical and moral integrity of the individuals concerned and, in the words of the Oviedo Convention, a society where “the interests and welfare of the human being shall prevail over the sole interest of society or science.”
The decision in Brüstle may be a development which would run counter to the scientific consensus in the UK but Section 18 of the European Union Act 2011 implicitly reaffirms the primacy of EU law in the UK. As the Explanatory notes to this provision state at para 123:
“This section  does not alter the existing relationship between EU law and UK domestic law; in particular, the principle of the primacy of EU law. The principle of the primacy of EU law was established in the jurisprudence of the European Court of Justice before the accession of the United Kingdom to the European Communities. This is made clear, for example, in the judgment of the European Court of Justice in Costa v ENEL  ECR 585 (6/64), and Parliament accepted this principle in approving the European Communities Act 1972.”
Where the EU leads, then the UK must follow ….