Stem cell research deemed "immoral" in the EU will nevertheless be funded by Brussels, possibly patented overseas and re-imported for sale, policymakers and experts said following the issuing of an opinion by an advocate-general of the European Court of Justice.
It is unethical and immoral to allow patents from research involving human embryonic stem cells, according to an opinion issued in March by Court of Justice Advocate-General Yves Bot, in response to the German Federal Court of Justice.
The German court asked its EU counterpart to define 'human embryo' and outline their practical uses as spelled out in the EU's Biotechnology Directive, in order to clarify the Brüstle vs. Greenpeace case (see 'Background').
The Court usually follows the recommendations of its advocates-general, but the prospect of a ban on patents in the sector leaves an awkward paradox for the future funding of such research.
Member states divided
Private companies and pharmaceutical giants are deterred from investing in such research if they cannot patent innovations. But since the regulation of embryonic stem cell research is a national competence, under the EU's research framework programme, funding may be given for research taking place in countries which allow embryonic stem cell-based research.
EU member states are sharply divided over the issue. Embryonic stem cell line production is forbidden in Austria, Denmark, France, Germany and Ireland, but permitted in Finland, Greece, the Netherlands, Sweden and the United Kingdom.
A spokesman for the Commission's Research Commissioner Maire-Geoghegan Quinn said that all funding projects are "subject to ethical review and EU funds may not be used for the derivation of new embryonic stem cell lines". However, that does not preclude the use of funds within member states on embryonic stem cell research, which could then be patented overseas.
EU-funded, patented elsewhere, then re-imported
If so, innovations using such patented embryonic stem cell research could be developed into products which could be re-imported into the EU, having been protected elsewhere.
The Commission never comments on advocate-general opinions, which are not binding on the Court, but a Commission official told EURACTIV he believed that the Advocate-General's opinion may not be followed by the Court on this occasion.
Several leading stem cell scientists — including 'Dolly the Sheep' creator Sir Ian Wilmut – wrote last month to Nature magazine expressing "profound concern" at the Advocate-General's opinion.
They claimed that companies must have patent protection as an incentive to invest in Europe. If a ban is implemented, they said: "European discoveries could be translated into applications elsewhere, at a potential cost to the European citizen."
Greenpeace's advisor on the case, Christop Then (executive director of Test Biotech), said that the EU-funded research could be patented overseas, but stressed that at least the patents would still largely be owned by EU companies.
Then noted that the "scenario [of foreign companies buying the research] might apply in some cases, but it is not very likely to become the most relevant. If the EU is funding research, why then should the European company sell its results on, rather than file a patent by themselves overseas?"
But the chair of the inter-party bioethics group in the European Parliament, centre-right MEP Miroslav Mikolášik (Slovakia), who warmly welcomed Bot's opinion, warned: "We must be very attentive and carefully consider all aspects of the EU funding of the research which could turn against our principles."
Yves Bot's opinion in the Court of Justice in the case Brüstle vs. Greenpeace "remarkably anticipates further legal developments related to the controversial area of the research," according to MEP Miroslav Mikolášik (European People's Party;Slovakia), the chair of the inter-party bioethics group in the European Parliament, who warmly welcomes the opinion.
He said that he would "strongly support other ethically unontroversial alternative methods, especially research on adult stem cells and umbilical cord blood stem cells, which have enormous healing potential not yet fully appreciated".
However, he insisted that "none of the parts of human embryo following the moment of conception can be patented - it would mean violation of the principle of non-commercialisation of human body anchored in our legislation. Therefore we must be very attentive and carefully consider all aspects of the EU funding of the research which could turn against our principles".
Research may well be patented overseas, but is at least likely to be EU-owned, according to Greenpeace's advisor on the case, Christop Then (executive director of Berlin-based Test Biotech).
He said: "The scenario [of foreign ownership] might apply in some cases, but it is not very likely to become the most relevant. If the EU is funding research, why then should the European company sell its results, rather than filing a patent by themselves overseas?"
"It is expected that the European Court of Justice for the first time will come up with a definition of 'human embryo' in the context of European patent law and in this regard the case might turn out as a milestone," Then added.
He said: "We do not think it is appropriate to put any pressure on the ECJ. But we all might agree that commercial use of human embryos should not be encouraged by patents. Patent law should not only be driven by the interest of patent holders but by seeking a balance with the overall interests of civil society. The case now pending will not solve the problems, but will give a signal to politicians and industry, no matter what its outcome finally will be."
"Beyond stem cell patents we see further need for discussion," according to Then. "Since patents on human gene sequences as well as patents on plants and animals are an issue of controversial debates not only in Europe but also in the US, Australia and other regions, we think it is time for a broader debate about future of 'life patents'."
"It is time for reasonable and progressive voices to speak out against this decision [of the Advocate-General]," according to George Schlich, the in-house patent counsel for Stem Cell Sciences Limited.
He said: "We should not be frightened in Europe of supporting this research."
The 1998's EU 'biotech directive' - formally known as the EU Directive on the legal protection of biotechnological inventions – aims to clearly distinguish what is patentable and what is not.
In order to protect biotechnological inventions, member states must ensure that their national patent laws conform to the provisions of the directive.
The EU court has been asked to define 'human embryo' and outline their practical uses as spelled out in the EU's Biotechnology Directive, which states that "the human body, at the various stages of its formation and development," cannot be considered a patentable invention.
The request for a preliminary ECJ ruling on the matter comes from the German Federal Court of Justice, which failed to decide whether to patent a method of converting embryonic stem cells (hESC) into nerve cells to treat neurological trauma and disease.
The method was introduced by German researcher Oliver Brüstle, who was originally granted a patent in 1999.
But following legal action by Greenpeace, the patent was deemed to be in violation of the EU biotech directive and was partially revoked.
After a renewed appeal by the patent holder and given the incapacity of the German court to decide, a number of questions are now being referred to the ECJ for a preliminary ruling. A request for a preliminary ruling enables national courts to ask the ECJ for its interpretation of EU law or enquire as to its validity.
The ECJ's response or interpretation is binding on the national court to which it is addressed, as well as on other national courts before which problems of the same nature are raised. Advocate-General Bot issued a preliminary decision on the matter on 10 March, and such decisions usually form the substantial basis of the European Court of Justice's ultimate judgment.
- The ECJ is expected to make its decision shortly, after which the German court is expected to make its final decision by the end of the year.
EU official documents
- European Court of JusticeOpinion of Advocate-General Yves Bot - 10 March 2011
- European Court of JusticeReference for a preliminary ruling from the Bundesgerichtshof (Germany) lodged on 21 January 2010 - Prof. Dr. Oliver Brüstle v Greenpeace e.V. (Case C-34/10)
EU Actors positions
NGOs and Think-Tanks
- GreenpeaceShould human embryos be patented?
- GreenpeacePatents on embryonic human stem cells – a chronology
Think tanks & Academia
- European Science Foundation (ESF)The reality of human stem cell research in Europe European Science Foundation reports on the scientific, ethical and legal issues in human stem cell research (24 June 2010)
- EURACTIV Slovakia:Výskum kme?ových buniek leží na stole Súdneho dvora EÚ