Policy history
6. It is nearly thirty years since the birth
of the first child conceived using in vitro fertilisation
(IVF). In light of scientific developments in the fertilisation
and embryology field, a Committee of Inquiry was appointed in
1982, chaired by Baroness Warnock. The Committee's Report (the
Warnock Report) published in 1984 concluded that there was an
urgent need for a scheme of active monitoring and regulation in
this area.[5] Following
a process of public consultation through Green and White Papers,
Parliament passed the Human Fertilisation and Embryology Act 1990
(the 1990 Act) which implemented many of the recommendations of
the Warnock Report and in particular provided a legislative framework
for:
- The creation of human embryos
outside the body and their use in treatment
- Use of human embryos in research
- Use of donated gametes and embryos
- The establishment of the Human Fertilisation
and Embryology Authority (HFEA) with responsibility for licensing,
monitoring, information and advice on human embryo research and
assisted reproduction treatment.
7. The 1990 Act has since undergone a series
of modifications. In 1992, some of the information disclosure
restrictions in the original Act were revised after they were
found to be overly restrictive.[6]
In 2001, the purposes for which embryo research could be licensed
were extended to include "increasing knowledge about the
development of embryos", "increasing knowledge about
serious disease", and "enabling any such knowledge to
be applied in developing treatments for serious disease",
thus paving the way for embryonic stem cell research.[7]
Meanwhile, in 2001 the Human Reproductive Cloning Act was passed
outlawing any attempt to create a child through a process other
than fertilisation using sperm and egg. In 2004, Parliament agreed
that donor-conceived children would be able to access the identity
of their sperm, egg or embryo donor on reaching the age of 18.[8]
8. There have also been developments in the law
on human tissue. Following a 2002 Department of Health review
of the law on human organs and tissues, the Human Tissue Act 2004
established the Human Tissue Authority (HTA). Also in 2004, the
European Union Tissue Directive set EU-wide standards of quality
and safety for the donation, procurement, testing, processing,
preservation, storage and distribution of human tissue and cells.[9]
The Scottish Parliament passed the Human Tissue (Scotland) Act
in 2006.
9. Separate from this legislative process, the
Department of Health undertook a review of its 'arm's length bodies'
in an effort to improve efficiency and cut bureaucracy.[10]
One of the conclusions of this review was a proposal to replace,
by April 2008, the HFEA and the HTA with a single body with responsibilities
across the range of human tissue and cells, to be known as the
Regulatory Authority for Tissue and Embryos (RATE). Proposals
for RATE form Part 1 of the draft Bill.
10. In 2005 the House of Commons Science and
Technology Select Committee published a report on Human Reproductive
Technologies and the Law.[11]
The preceding inquiry investigated the legislative framework provided
by the 1990 Act and challenges presented by technological advance
and "recent changes in ethical and societal attitudes."
In light of the Committee's Report, and legislative changes that
had already been made, the Department of Health undertook a review
of the 1990 Act.
11. The Government's rationale for this review
was that:
"The [1990] Act has stood the test of time well,
and is a tribute to the foresight of its creators … The Act
and the regulatory system it established have instilled public
confidence in the safe and ethical use of assisted reproduction
technology subject to appropriate safeguards. However, it was
never expected that the Act would remain forever unchanged in
this area of fast-moving science." [12]
12. The Government conducted a public consultation
exercise in 2005 and received 535 formal responses from around
100 stakeholder groups and organisations and a wide range of individual
professionals, patients and members of the public. An independently
commissioned summary of responses was published in March 2006.[13]
In December 2006, the Department of Health responded with its
proposals for revised legislation in a White Paper.[14]
In 2006, the House of Commons Science and Technology Select Committee
began an inquiry into the proposals in the White Paper for the
regulation of hybrid and chimera embryos reporting in March 2007.
Table 1 provides a chronology of relevant legislation, reviews,
reports and events.
TABLE 1
Chronology of relevant legislation, review
and reports
