Final Report (all chapters)

ureaucratic. As we discuss in more detail in chapter 6.4, reproductive cloning in Britain is
prohibited, but research cloning is legal. Any research protocol involving nuclear transplantation
must obtain a license from the Human Fertilization and Embryology Authority, which closely
scrutinizes the rationale for conducting research on human embryos in general, and for research
cloning in particular. This provision alone is likely to make the HFEA unacceptable to the
American scientific community. Yet ironically, in October of 2004, the HFEA approved the first
research protocol involving nuclear transplantation. The decision was far from uncontroversial.
Pro-life groups vocally denounced it, but were eventually forced to recognize that the HFEA had
acted according to the laws of the country. As a result, a research group in Britain is now moving
forward with a cloning protocol backed by the full force of the law – despite, or perhaps thanks
to, a regulatory system considered by American observers to be too intrusive.
5.2.3 Legislative Initiatives at the State Level
Our discussion of state-level initiatives is not meant to be exhaustive. After examining
various state-level legislative initiatives, we have come to the conclusion that there is little to be
learned from the states either in the area of reproductive medicine or biomedical research. As
several commentators have recognized, few states have passed legislation concerning
reproductive technologies, and even fewer cases are relevant to the present discussion.
Of some interest is the approach taken by Louisiana to regulating reproductive medicine.
Louisiana, certainly, is the state that has passed the most comprehensive legislation in this area,
and also the most restrictive. Noteworthy in particular is the extensive legal protection afforded
to the embryo, defined as a “juridical person” enjoying most of the legal rights and protections
afforded to children. 39 More pertinent to the discussion is Louisiana reliance on the American
Society for Reproductive Medicine and the American College of Obstetricians and
Gynecologists (ACOG) to ensure that reproductive laboratories and facilities meet suitable
standards of quality and consistency. This is an important precedent: It demonstrates that, as for
other policy domains, it is both possible and sensible for regulators to rely on private standarddeveloping
organizations to achieve public goals. 40 The case of Pennsylvania is also worth
mentioning in this context, because it is to our knowledge the only state that has adopted
extensive record-keeping requirements. Both Louisiana’s and Pennsylvania’s experience in
regulating reproductive medicine could prove very valuable to federal regulators tasked with
implementing similar schemes at the federal level.
When it comes to the regulation of biomedical research, recent state-level initiatives closely
follow federal patterns. They are narrowly focused on cloning and stem cell research, and just
like the numerous federal bills introduced over the last few years, they either attempt to ban any
39
40
President's Council on Bioethics, Reproduction and Responsibility: The Regulation of New Biotechnologies,
p.52-53.
As we show in more detail in chapter 13.6, there are some good prima facie reasons for delegating certain
functions to the private sector, including economic efficiency, flexibility, and access to technical and medical
expertise.
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