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Legal policies steer direction of stem cell research
By Amy Zarzeczny

May 01 2009 issue


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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. 

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.  

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. 

Such differences are important for a number of reasons, including the impact they have on international collaboration.  This is particularly relevant given the increasing tendency for technologies, scientists and, in the case of medical tourism, even patients, to cross national borders. 

Other areas of policy divergence are equally relevant, including patent laws, compensation rules for gamete donors and consent requirements for donors and research participants — which is particularly important as the field moves towards clinical translation.

Also of central importance are funding structures, and, in particular, rules and restrictions governing the use of public funds.  Funding is central to the success of scientific research, but its relationship with regulation can be complex.  By way of illustration, despite the fact that SCNT is now permitted in the U.K. following amendments to the Human Fertilisation and Embryology Act, this research now appears to be impeded by lack of funding. 

Recent changes in U.S. federal funding rules, namely President Obama’s lifting of the ban on federal funding being used to support research on hESC lines derived after Aug. 9, 2001, have received much attention. The response in some states has been the introduction of legislation to restrict the use of state funds or otherwise prevent hESC research (for example, Texas, Mississippi and Oklahoma), in much the same way other states (for example, California, New Jersey and Connecticut) responded to President Bush’s funding restrictions by making funds for hESC research available on a state level.

While many of the issues being discussed in these contexts are familiar, the global economic crisis raises new and significant implications.  On one hand, some jurisdictions have made investment in science a priority in their stimulus endeavors. 

Conversely, the trend in other jurisdictions appears to be a retraction of funding.  An emerging issue associated with these contrasting trends is the concern about “brain drain.”  This issue has traditionally been associated with the permissiveness or restrictiveness of jurisdictions’ regulatory positions.  Now the emerging concern is that talented scientists and their teams will migrate to jurisdictions that provide them with the resources they require to do their work.

All in all, we are witnessing exciting and challenging times for stem cell research, law and policy.  The variety and depth of the issues facing policy makers around the world today are remarkable.  It will be fascinating to see how matters unfold and how law will be used as a shaping tool, particularly given that the legal implications of stem cell research cannot be separated from the broader policy context. For instance, the legislated review period for Canada’s Assisted Human Reproduction Act has arrived.

Will Canada’s position shift?  Only time will tell.  As we move forward, we should avoid sensationalizing this area.  While stem cell research certainly raises various unique issues requiring novel consideration and innovative responses, we must also be cognizant of how existing principles and policies addressing analogous issues can guide our steps. 

Ideally, informed discussion and debate will encourage a thoughtful and principled approach to policy making in the days ahead.

Amy Zarzeczny is a research associate at the University of Alberta’s Health Law Institute and project manager for a large interdisciplinary research project funded by the Canadian Stem Cell Network.

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