Ethics in Biotechnology
Human beings in the early stages of their development must not be objects of commercial interests
The Advocate-General of the European Court of Justice in Luxembourg has pleaded to generally exclude human embryos from patentability. Since in most cases the Court follows the Advocate-General in its ruling, the Court will probably decide likewise.
“I am very glad that we can now expect a decision that human beings in the early stage of their development are not made an object of commercial interests. If the decision was different, human embryos would become the object of exclusive marketing rights of individuals. This would lead to another overstepping of a threshold in the protection of human life”, said Peter Liese MEP, EPP Group Co-coordinator in the Environment, Public Health and Food Safety Committee of the European Parliament.
The German scientist, Professor Oliver Brüstle, whose patent application is the reason for the court case, and whose lawyers have even called for making cloned human embryos (created by the transplantation of genetic information from a body cell into an egg cell) the subject of patents, is also against the Advocate-General’s wishes.
Back in the late 90s, Brüstle had already applied for the patent. It is about the patenting of so-called neural precursor cells. One of the methods for obtaining these cells, the cloning of embryos (Cell Nuclear Transfer), is described in the patent specification. For the production of these cells, embryos have to be destroyed. Thus, for ethical reasons, Greenpeace had raised an objection against the patent. “The underlying 1998 EU Directive contains numerous restrictions on patentability for ethical reasons. This was a sine qua non condition of the European Parliament for the approval of the Directive”, said Peter Liese, who wrote his dissertation at the Institute of Human Genetics at the University of Bonn. The Federal Patent Court essentially decided in favour of Greenpeace; Brüstle then went to the Federal Court of Justice in Germany in order to object to the decision.
The Federal Court of Justice has now referred to the European Court of Justice not the question of how to deal with the patent, but the fundamental question of the patentability of human embryos and the patentability of cells derived from them. The Advocate-General has given the following recommendations: Similarly, the blastocyst stage of development, reached around five days after fertilisation, must also be classified as an embryo, since, according to the Advocate-General, the principle of human dignity, to which the Directive refers, 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.
In the Advocate-General’s opinion, it must therefore be agreed that inventions relating to pluripotent stem cells can be patentable only if they are not obtained to the detriment of an embryo, be it its destruction or modification.
To make an industrial application of an invention using embryonic stem cells would amount to using human embryos as simple base material, which would be contrary to ethics and public policy. “The Advocate-General’s decision is a major success for all who fight for ethics in modern biotechnology. I hope very much that the ECJ will follow this position. Developments over the last 10 years have shown that the hopes which have been put in embryonic stem cells are far from being realised. Patients benefit much more from alternative branches of research”, Peter Liese said. The final verdict is expected for the summer or autumn of 2011.