Wednesday, June 20, 2012

Waiting for November 2012 and the Final Verdict on Brüstle v. Greenpeace e.V.

The German Federal Court of Justice (“BGH”) finally announced that it will decide in the case Brüstle v. Greenpeace e.V. on November 27, 2012.

The case was described and discussed here at PredictER News, December 13, 2012 and June 11, 2012. The court will adjudicate more than two years after it requested preliminary ruling from the European Court of Justice (ECJ) on December 17, 2009 (Case Xa ZR 58/07, now changed to X ZR 58/07), and a year after the ECJ’s decision in Case C-34/10 regarding the interpretation of Art. 6 of the Directive 98/44/EC on October 18, 2011.

The BGH’s decision will not only influence the question of whether or not patents can be gained on inventions which are based on embryonic stem cells, but it will also impact embryonic stem cell research in general. In addition to the German Patent Protection Act, the German Embryonic Protection Act (“ESchG”) is also based on Directive 98/44/EC.

The ESchG prohibits research with embryos, see Paragraph 2 ESchG, but not research with embryonic stem cells. However, Paragraph 2 ESchG has to be interpreted in the terms of the ECJ decision now. As a result, and with ECJ's broad interpretation of the Directive and definition of embryos research with human embryonic stem cells might be prohibited in Germany. In other words, embryonic stem cells would have to be treated as embryos and, as such, research would be prohibited. This prohibition would include even basic research on embryonic stem cells.

Therefore, the German jurisdiction as well as the legislature should examine how the ESchG should be interpreted in future. A change or amendment to the ESchG's definition of embryos should also be deliberated, because under German law, the use of the term "embryo" and its impact on stem cell research needs clarification. Because the ECJ has not directly prohibited embryonic stem cell research, but has persisted in broadly defining "embryo," other than the ECJ the BGH has to take the consequences of its verdict for embryonic stem cell research into consideration.

It still remains to be seen what will happen on November 27, 2012 and what consequences the decision will have on embryonic stem cell research.

-- Bianca Buechner, Ph.D., LL.M. Candidate
Indiana University Robert H. McKinney School of Law

Monday, June 11, 2012

What happened after the European Courts of Justice decision Brüstle v. Greenpeace e.V.?

More than six months after the European Court of Justice (ECJ) decided Brüstle v. Greenpeace e.V. (Case C-34/10) on October 18, 2011 (which was described and discussed here at PredictER News, December 13, 2012), the German Federal Court of Justice (BGH) has still not made its decision. What happened after the October decision?

Only a couple days after the decision had been made, several representatives of the European Parliament filed a request to the EU Commission to stop the funding of embryonic stem cell research in the EU program, Horizon 2020 (EPP Group in the European Parliament). In their point of view, the ECJ decision indicated that embryonic stem cell research shall cease.

Horizon 2020 is the main EU financial instrument to support research and innovation in the Member States. The research funding budget will cover an amount of about 80 Billion Euro to be used from 2014 to 2020. Horizon 2020 was drafted on the basis of Decision No 1982/2006/EC of the European Parliament and of the Council of 18 December 2006 concerning the Seventh Framework Program of the European (FP7) Community for research, technological development and demonstration activities (2007-2013). Art. 6 Subsec. 2 of the Decision No 1982/2006/EC regulates that research on human stem cells, both adult and embryonic, may be financed, depending both on the contents of the scientific proposal and the legal framework of the Member State(s) involved. However, Decision No 1982/2006/EC was made before the European Court of Justice held in Brüstle v. Greenpeace e.V. that human embryonic stem cell lines have to be seen as embryos.

On May 31, 2012 the 3169th Competitiveness Council meeting was held. Inter alia, the Proposal for a Regulation establishing Horizon 2020, as well as the rules for participation and dissemination, were discussed in the form of a Progress Report. It has been announced that the EU Science Minister finally reached an agreement on the overall structure of the Horizon 2020 research funding program. The proposal of the Committee on Industry, Research and Energy to amend the Horizon 2020 proposal (COM(2011) 811) from November 30, 2011 does not suggest any changes to the Horizon 2020 proposal of the European Commission related to stem cell research. Even though, requests have been filed to stop or lower the funding of embryonic stem cell research the proposal for Horizon 2020 did not change the wording of section 2.1, that “Supporting a large set of embryonic, high risk visionary science and technology collaborative research projects is necessary for the successful exploration of new foundations for radically new future technologies” (COM(2011) 811, Sec. 2.1 of the Council Decision).

The Competitiveness Council agreed that stem cell research will be treated under Horizon 2020 the same as under the 7th Framework Program. The following “Triple-Lock-System” which was established under FP7 will be continued for the funding of stem cell research:

  1. National Legislation must be respected and EU projects must follow the laws of the Member States in which the research is conducted; and
  2. all projects have to be scientifically peer reviewed and must undergo rigorous ethical review; and
  3. EU funding cannot be used for derivation of new stem cell lines or for research that destroys embryos (3169th Competitiveness Council meeting).
The German Federal Court of Justice decision is still outstanding. The final decision on Horizon 2020 (“FP8”) has not been made yet either. It still remains to be seen how the German Federal Court of Justice will decide and which influence the decision will have not only on the German legislation but also on Horizon 2020.

-- Bianca Buechner, Ph.D., LL.M. Candidate
Indiana University Robert H. McKinney School of Law