The Federal Government has proposed amendments to the Assisted Human Reproduction Act, the legislation that governs embryo research, including many aspects of stem cell research. The amendments, which are contained in an omnibus budget implementation bill tabled before Parliament on April 26, seeks primarily to implement the 2010 Supreme Court of Canada ruling that invalidated several provisions of the law on the basis that the power to enact those provisions belonged to the provinces. The bill also seeks to abolish Assisted Human Reproduction Canada, the beleaguered federal agency charged with the responsibility of enforcing the legislation. Other proposed changes include:
- The licensing regime for research activities permitted by the legislation will cease to exist. This means that scientists will no longer require a license to conduct research on supernumerary IVF embryos, for keeping and handling gametes and embryos, or for transgenics. These activities are, in fact, no longer regulated under the statute. However, they would still be subject to other research regulations, such as the Tri-Council Policy Statement and the CIHR Guidelines for Human Pluripotent Stem Cell Research, or to future provincial regulations.
- The revised statute will maintain the prohibitions on research involving embryos and gametes. This includes bans on creating embryos for research purposes, somatic cell nuclear transfer, buying and selling of human gametes, and possibly, the derivation of gametes from induced pluripotent stem cells. This, in my opinion, is a missed opportunity to revise aspects of the law that are out of touch with scientific realities and public opinion.
- The provision that bars many experts (persons who are, have applied to be or are affiliated with others licensed to carry out research activities permitted by the Act) from sitting on the Board of Directors of Assisted Human Reproduction Canada will be repealed. Prior to September 2009, such experts were also barred from sitting on the Stem Cell Oversight Committee, the national research ethics board established to monitor and approve human pluripotent stem cell research protocols. The practice of excluding experts from oversight boards is unique to Canada and to human pluripotent stem cell research, and is primarily aimed at addressing issues arising from conflicts of interest in research ethics oversight. The rule has attracted some criticism, with some commentators (including myself) noting that it is an example of cutting off the nose to spite the face. To exclude experts from oversight activities that sometimes require intimate knowledge of the field seems a bit heavy-handed and ill-informed. A better strategy would be to create comprehensive and stringent rules for managing conflicts of interest. This is the approach taken in most other jurisdictions, including the UK, whose stem cell research regulator is generally regarded as a model of good governance and oversight. One hopes that with the repeal of this provision, CIHR would also amend its rules to address the exclusion of experts from SCOC.
For those interested in seeing what the legislation would look like if the amendments are passed into law, I have prepared a draft revised version which you can download here.
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