STEM CELL RESEARCH LEGISLATION

Stem Cell Research Legislation



Stem Cell Research Legislation

Introduction

Stem cell research is a phrase that stirs controversy, engages imaginations, raises hopes and expectations and targets deeply held moral and religious convictions.  As such, it has provided fertile ground for scientific, medical, ethical, philosophical and political debates.While stem cell research may not always be considered, strictly speaking, a legal issue, it necessarily exists within the boundaries established by law and policy in individual jurisdictions.  As is true of every emerging technology that has the potential to significantly affect key societal structures such as our healthcare systems, it requires (and deserves) well-thought-out policy responses that are appropriately grounded in clear and consistent principles.  Whether stem cell research has traditionally enjoyed this type of response is an open question. 

Discussion

While the phrase “stem cell research” is often and perhaps unconsciously linked with “human embryonic stem cell research,” there are a number of types of stem cell research.  The use of adult stem cells and umbilical cord blood stem cells in bone marrow treatments for cancer and other blood disorders are two familiar examples.  More recently, induced pluripotent stem cells derived from adult somatic cells, somatic cell nuclear transfer (SCNT) or “therapeutic cloning” and interspecies somatic cell nuclear transfer (iSCNT) have emerged as scientifically promising techniques. Nonetheless, human embryonic stem cell (hESC) research has largely dominated public discourse and been the focus of most legislative initiatives(Mulkay 1997).  

Regulations governing stem cell research vary widely around the world.  The legality of the various technologies is an excellent example of this variance. Some policy positions appear to have clear religious groundings, such as predominantly Catholic nations' (for example, Ireland and Italy) prohibitions on the derivation of hESC lines within their borders.  However, where countries with relatively similar cultural, political and religious positions have taken starkly different approaches, the links are less clear. For instance, the U.K. permits both SCNT and iSCNT; Australia permits SCNT but prohibits iSCNT; and Canada explicitly prohibits SCNT but likely implicitly allows iSCNT.  Other jurisdictions function in the absence of regulation(Vogelstein 2000). 

Regulatory framework

UK legislation allows work with both adult and embryonic stem cells, and is considered to be among the most clear, comprehensive and responsible in the world. The position was reached after a period of lengthy debate, begun in 1990 with the Warnock committee. The system of effective regulation, described as pragmatic rather than permissive, has been adopted as a model in other countries.As outlined earlier, the HFE Act 1990 was recently amended by the HFE (Research Purposes) Regulations, which introduced additional purposes for which research on human embryos can be licensed. The drafting of the Regulations leaves scope for uncertainty in two main areas. Firstly, two of the additional purposes allowed by the regulations refer to 'serious disease'; this is not a term that is clearly defined in the HFE Act or in other statutes.

As the House of Lords Stem Cell Research Committee has pointed out, it is not clear whether 'serious' refers to the consequences of a disease for the individual or for society, nor whether 'serious disease' encompasses serious injury ...