Research in Germany: ECJ ruling on embryos must not be interpreted to the detriment of research

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ECJ ruling on embryos must not be interpreted to the detriment of research

12/21/11

Source: Alexander von Humboldt Foundation

Joint Press Release from the Alliance of German Science Organisations

The Alliance of German Science Organisations has expressed concern about possible negative implications for research resulting from the ruling of the European Court of Justice (ECJ) on the interpretation of the term “embryo". The Alliance criticises that the ECJ ruling fails to give due consideration to the current status of public debate in Germany, and fears that research using human embryonic stem cells could be discredited in its entirety. The ruling must not be accorded further significance beyond matters of patent law, for example in relation to the issue of research funding, the Alliance demands in its following statement, which is largely based on a paper published by the German Research Association’s Senate Commission on Genetic Research:

In its ruling of 18 October 2011 in “Brüstle vs. Greenpeace" (C-34/10), the European Court of Justice (ECJ) has undertaken an extensive interpretation of the term “embryo", with significant implications for the stem cell debate.

Regardless of the fact that the ruling itself pertains exclusively to issues of patent law, various parties have meanwhile attributed meanings to the statements made by the Court that go far beyond questions of patentability. The Alliance of German Science Organisations is aware of the manifold ethical, legal, societal and political challenges associated with the protection of embryos. The science organisations constituting the Alliance have therefore always advocated a responsible approach to the use of embryos, and support the high standards of protection developed in Germany through broad public and parliamentary discourse and codified in the Embryo Protection Act and the Stem Cell Act.

There is cause for concern that beyond its immediate scope the ruling may present research using human embryonic stem cells (hESCs) in its entirety in a negative light and morally discredit those conducting research in this field. Even if the ruling does not directly touch on research into induced pluripotent stem cells (iPS), which is ethically unobjectionable, it may also have indirect and unintentional implications for further research into these stem cells, as hESCs serve as an important reference against which to measure possible therapies based on iPS cells.

Even before the Stem Cell Act came into effect in 2002, hESC research, which is still seen as controversial by the public, has always been conducted with the greatest responsibility in Germany. In its ruling however the ECJ attempts to create an unambiguousness that fails to give appropriate consideration to the current status of public debate in Germany and its European neighbours. The adoption of the EU directive on the legal protection of biotechnological inventions (98/44/EC) was preceded by ten years of controversial discussion because no European definition of the term “embryo" existed that was supported by all the member states. This situation has not changed, as evidenced by the latest rulings of the European Court of Human Rights (ECHR) on the protection of prenatal life and the Austrian Reproductive Medicine Act. The ECJ however fails to preserve the latitude that European law previously afforded the member states in defining how they uphold public order and public decency. Moreover, the ECJ ruling constitutes a departure from central principles of intellectual property law that are also enshrined in international trade law, in particular insofar as it is no longer the possible commercial applications of an invention, but the factual conditions that precede any invention that have become the focus of patent application review. The conditions under which an invention is made must of course comply with the general principles of (criminal) law, but they have no immediate effect on the question of its possible (non-) patentability. This applies all the more considering that a patent does not confer permission for the research activities of the patent holder; nor does a patent represent a state permit for production or sale. A patent merely protects the intellectual achievement of the inventor. Patent law is thus also in doctrinal terms not the appropriate place to establish a common European “ordre public", whatever form it might take.

Against this background, attempts to accord the ECJ ruling a significance beyond the already complex issues of patent law, for example with regard to research funding, cannot go unchallenged. Efforts to construe it in such a way are neither normatively nor methodically tenable, and go far beyond the limits of a supportable interpretation.

The Alliance of German Science Organisations is an association of the most important German research associations. Members of the Alliance are the Alexander von Humboldt Foundation, the German Academic Exchange Service, the German National Academy of Sciences Leopoldina, the German Research Foundation, the Fraunhofer Gesellschaft, the Helmholtz Association of German Research Centres, the German Rectors’ Conference, the Leibniz Association, the Max Planck Society and the German Council of Science and Humanities.

The Alexander von Humboldt Foundation
Every year, the Alexander von Humboldt Foundation enables more than 2,000 researchers from all over the world to spend time researching in Germany. The Foundation maintains a network of well over 25,000 Humboldtians from all disciplines in more than 130 countries worldwide - including 48 Nobel Prize winners.

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