Final Report (all chapters)

credentialing, requirements for DEA registration on the part of doctors and hospitals,
enforcement of informed consent rules, establishment of requirements for malpractice insurance
coverage, and other requirements. In theory, states could use these powers to revoke the licenses
of physicians that practice unsafe procedures like reproductive cloning, though it is not clear how
well any state agencies are set up to make rules in this area and to enforce them.
Several states have enacted legislation in the area of reproductive medicine, but state-level
legislations are generally limited to very specific aspects of reproductive medicine. Recent state
laws either attempt to ban any kind of cloning or limit the ban to reproductive human cloning.
Among the states that have banned both reproductive and research cloning are Arkansas, Iowa,
North Dakota, South Dakota, and Michigan. New Jersey and California, both home to large
biotech sectors, have passed legislation banning reproductive cloning but legalizing research
cloning. In our view, these state measures have failed to provide sufficient regulatory oversight.
California is notable insofar as it drafted model legislation in 2003 to provide for state regulatory
oversight of embryo research, legislation that was then superseded by Proposition 71. The latter,
which passed in November of 2004, removed most prior institutional safeguards, and is in our
view totally inadequate as a regulatory model.
3.4 Self-Regulation
Both foes and advocates of regulation often see industry self-regulation as quite distinct
from government oversight, but in fact the line between the two is often blurred. The government
often relies on private sector groups to achieve public goals (for example, the Underwriters
Laboratories’ role in consumer safety), or else backs up private enforcement through an implicit
threat of formal sanctions (for example, the Securities and Exchange Commission).
Over the last 25 years, the American Society for Reproductive Medicine has developed most
of the currently existing medical and ethical guidelines in the area of reproductive medicine. The
Society for Assisted Reproductive Technologies (SART), which comprises most of the nation’s
ART programs, has a well-established though narrow history of self-regulation that gathers data
about ART success rates.
In our view, these programs rarely meet the standards of legal precision expected by legal
scholars and policy-makers. Often, they come dangerously close to being simple exhortatory.
Nevertheless, this admittedly incomplete system of private governance provides an important
basis for incrementally and selectively strengthening the oversight of the ART industry.
4 Recent Regulatory Initiatives in Other Countries
4.1 The British HFEA
The British Human Fertilisation and Embryology Authority (HFEA) was established in 1990
on the basis of the Human Fertilisation and Embryology Act, which in turn sprang out of the
earlier Warnock Commission. The act established the HFEA as a new regulatory body to oversee
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