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."