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.
|Title of host publication||Legal and Forensic Medicine|
|Editors||Prof Roy G. Beran|
|Publisher||Springer Berlin Heidelberg|
|Number of pages||37|
|Publication status||Published - 1 Jul 2013|