Regulation of Human Embryonic Stem Cells in Europe
The benefit of developing new health technologies cannot be doubted, but divorcing this benefit from the moral controversies which surround innovations, such as stem cell therapies, is far from easy. This chapter considers how permissive and cohesive the regulatory landscape, applicable to human stem cells (particularly embryonic stem cells), in Europe is by focusing in detail upon the most controversial areas of patenting and licensing, broadly compared to research funding and specific European Union (EU) regulation. The analysis begins by gently introducing the science behind current innovations. Adopting a legal analysis, the current situation in Europe is identified in terms of patenting: pluripotent stem cells, totipotent cells, induced pluripotent and protein-induced pluripotent stem cells (and for completeness multipotent stem cells), their derivative products, and the processes which create them. This enables the impacts of patenting to be assessed, which identifies that the European patent system and EU approaches are far less restrictive than they appear. This creates a risk of patenting law being misinterpreted as conveying a restrictive moral approach to the technology, rather than the permissive legal approach to patenting innovation that it is. Comparison with the overarching regulation identifies that, despite the broad definition of human embryos adopted by the EU in determining patenting, there is a cohesive approach to regulating human embryonic stem cells. This is structured to maximize the choice of individual Member States in determining how permissively or restrictively they wish to regulate stem cell technology.
KeywordsStem Cell European Union Pluripotent Stem Cell Human Embryo Preimplantation Genetic Diagnosis
- 2.Boseley S. Geron abandons stem cell therapy as treatment for paralysis. The Guardian (15 November 2011) [accessed December 2011]. Available from: http://www.guardian.co.uk/science/2011/nov/15/geron-abandons-stem-cell-therapy
- 7.Dressel R. Multipotent adult germ-line stem cells, like other pluripotent stem cells, can be killed by cytotoxic T lymphocytes despite low expression of major histocompatability complex class I molecules. Biology Direct. 2009. Available from: http://www.biology-direct.com/content/4/1/31. Accessed Dec 2011.
- 8.Pincock S. Adult stem cell report questioned. The Scientist. 26 February 2007. Available from: http://www.the-scientist.com/news/home/52892/. Accessed Aug 2011.
- 9.Akst J. Skipping Pluripotency. The Scientist. 14 September 2011. Available from: http://the-scientist.com/2011/09/14/skipping-pluripotency/. Accessed Dec 2011.
- 10.Zhao T, et al. Immunogenicity of induced pluripotent stem cells. Nature. 2011. Available from: http://www.nature.com/nature/journal/ v474/n7350/full/nature10135.html. Accessed December 2011.
- 11.Tsuji O, et al. Therapeutic potential of appropriately evaluated safe-induced pluripotent stem cells for spinal cord injury. PNAS. 2010: 107; 12704-09. Available from: www.pnas.org/cgi/doi/ 10/1073/pnas.0910106107. Accessed November 2011.
- 14.Akst J. First hESC Trial Kaput. The Scientist. 2011. Available from: http://the-scientist.com/2011/11/15/first-hesc-trial-kaput/. Accessed Dec 2011.
- 15.Van S. Stem cells from whole adult bone marrow specialized into central nervous system cells. 20 December 2002. Available from: http://www.innovations-report.de/html/berichte/ biowissenschaften_chemie/ bericht-15394.html. Accessed Aug 2011.
- 17.Sample I. Scientists make human stem cells without destroying the embryo. The Guardian. 2006; 3.Google Scholar
- 19.Human Fertilisation and Embryology Authority (HFEA) website. Available from: http://www.hfea.gov.uk/6252.html. Accessed Dec 2011.
- 20.The Human Fertilisation & Embryology Authority (HFEA) in the UK granted two CNR licenses in november 2006 and currently has 21 active embryonic research licenses. Available from: http://www.hfea.gov.uk/. Accessed Nov 2006.
- 21.Grund M, Farmer SJ, Huster S. The German Federal Patent Court confronts the patentability of human embryonic stem c. Bio-science law review. 2007;8(4). Available from: http://www.grundipg.com/files/Stem _Cells_in_Germany__2007_.pdf. Accessed Dec 2011.
- 22.Dennehey S, Director of patents (UKIPO). Practice notice (Inventions involving human embryonic cells). Business Law Review 2009; 627.Google Scholar
- 23.Brüstle v Greenpeace C-34/10. 2011. Available from: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri= CELEX:62010CJ0034:EN:HTML ; point 29, G2/06 opinion of the President of the EPO on the WARF case ; p51-55, G2/06 Warf  EPOR 15;point 28-31; T356/93 Plant Cells/PLANT GENETIC SYSTEMS (PGS) 8 OJ EPO 545 (1995);p561. Accessed Dec 2011.
- 25.Warren-Jones A. Finding a ‘common morality codex’ for biotech: a question of substance. IIC. 2008;6(39):638–61.Google Scholar
- 26.Brüstle v Greenpeace C-34/10. 2011. Available from: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri= CELEX:62010CJ0034:EN:HTML; points 44-46, Accessed Dec 2011.
- 27.Cohn A. Wisconsin Alumni Research Foundation Changes Stem Cell Policies to Encourage Greater Academic-Industry Collaboration. WARF News. 2007. Available from: http://www.warf.org/news/news.jsp?news_id=209. Accessed June 2010.
- 28.Joliff-Botrel G, Perrin P editors. Stem cells: European research projects involving stem cells in the 6th Framework Programme. European Commission. Available from: http://ec.europa.eu/research/fp6/p1/stemcells/pdf/stemcell_eu_research_fp6_en.pdf. Accessed Dec 2011.
- Laurie G. Patenting stem cells of human origin. European Intellectual Property Review. 2004;26(2):59–66.Google Scholar
- Sterckx S, Cockbain J Assessing the morality of the commercial exploitation of inventions concerning uses of human embryos and the relevance of moral complicity: comments on the EPO’s WARF decision. 2010; 7:1 SCRIPTed 83, http://www.law.ed.ac.uk/ahrc/script-ed/vol7-1/sterckx.asp.