Final Report (all chapters)

This argument is not likely to convince American commentators of administrative law who
may describe the HFEA as a classic example of an “unaccountable” regulatory institution.
Formally, the HFEA may be less accountable than other regulatory institutions, but in practice,
its policies can hardly be described as “arbitrary and capricious.” The HFEA, mindful of its
unique position, traditionally has taken accountability seriously. An extensive process of public
consultation always precedes the adoption of controversial new policies. Among the subjects
selected by the HFEA for consultation are sex-selection and screening technologies, gamete and
embryo donation, and pre-implantation genetic diagnosis. 75 Through the appointment process,
the government can affect, at least in general terms, the future direction of the agency. Moreover,
the HFE Act requires the HFEA to prepare an annual report for the minister of health. The
reports are submitted to both houses of the Parliament for review. 76 Finally, HFEA policies are
subject to judicial review. In sum, while the HFEA enjoys more regulatory discretion than other
administrative entities, it cannot be described as an unaccountable regulatory institution in the
sense attributed to this term by U.S. scholars of administrative law.
6.4.2 The HFE Act
Any human embryo created outside the human body falls under the jurisdiction of the HFE
Act. This means that certain types of ART treatments that do not require the creation of an in
vitro embryo are not subject to the act’s provisions. Artificial insemination is an example; the
sale of fresh sperm is another.
Like other statutes discussed in this chapter, the HFE Act distinguishes between prohibited
and regulated activities. Prohibitions contemplated by the act are broadly consistent with
activities banned by statutes passed in other countries. Section 3 identifies prohibited activities
pertaining to the use of embryos, and Section 4 does the same for gametes. More specifically,
Section 3(2)(a) and (b) prohibits transferring a non-human embryo or any non-human gametes to
a woman’s uterus. Section 3(3)(a) also prohibits storing or using an embryo after the appearance
of the primitive streak, but in any case no later than 14 days. Section 3(3)(b) prohibits
transferring a human embryo to an animal, and Section 3(3)(d) was intended to prohibit any form
of cloning, though at the time cloning technologies did not yet exist. Section 12 prohibits, with
some qualifications, the commercial trade of embryos and gametes. Finally, Schedule 2, Section
(1)(4) prohibits the genetic modification of embryos.
Activities not explicitly prohibited by the HFE Act are regulated. The act regulates the
artificial creation of embryos, the storage of gametes and embryos, and the use of embryos for
research purposes by requiring ART practitioners and researchers to obtain a license for each of
these three types of activities. 77 This means that research on human embryos, either privately or
publicly funded, it legal under the act. In addition to the donation of human gametes and
75
76
77
See http://www.hfea.gov.uk/AboutHFEA/Consultations.
See Sections 7(1), (2) and (3) of the Act.
See Sections 3(1)(a) and (b) and Section 11.
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