One more possible scenario which may or may not have some bearing on the EU Orphan approval for hESC.
"In Europe, regulations regarding embryonic stem-cell research differ from country to country. However, a ruling on Mar. 10, 2011, by the European Court of Justice of the European Communities denied patents on ES cells to Oliver Brüstle of the University of Bonn on ethical grounds. The court found that even if cell lines could be established without the destruction of embryos, the commercialization of human embryos was unacceptable, and contrary to public policy. This ruling may push European countries to adopt restrictive policies regarding embryonic stem cells and inhibit the development of ES-based therapies." http://investorshub.advfn.com/boards/read_msg.aspx?message_id=61552950
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