Memorandum by the Department of Health
1. The Department of Health welcomes this
opportunity to assist the Science and Technology Committee in
its consideration of therapeutic cloning.
2. The HFEA/HGAC report Cloning Issues
in Reproduction, Science and Medicine was published in December
1998. In making its recommendations the report distinguished between
human reproductive cloning (ie designed to lead to the implantation
of an embryo in a woman and the birth of a cloned human being)
and research involving cell nuclear replacement or "therapeutic
3. On therapeutic cloning the HFEA/HGAC
indicated that they saw potential benefits from research involving
cell nuclear replacement order to develop treatments for:
(i) mitochondrial disorders; and
(ii) diseased or damaged tissues or organs.
4. The purposes for which the HFEA may currently
authorise research involving human embryos are set out in the
Human Fertilisation and Embyology Act 1990 (see Annex A.) Further
purposes maybe specified in affirmative regulations. The HFEA/HGAC
report invited the Government to consider such regulations to
allow research on embryos for the two purposes they had identified.
5. The Government Response published in
June 1999 also indicated that before deciding whether to make
regulations to allow further research purposes the Government
wished to take additional views on the potential benefits of the
additional purposes suggested; whether there are alternative approaches
which might offer the same benefits and whether there are additional
or different research purposes which the technology might point
6. In making its response the Government
took account of the fact that Parliament, on a free vote, has
determined that research on embryos should be permitted under
carefully controlled circumstances. However it also recognised
that, as reflected in the HFEA/HGAC public consultation which
preceded their report, there are a number of people who are opposed
to such research under any circumstances. The Government therefore
felt it was important to investigate further the suggested potential
health benefits of research involving human nuclear replacement
before deciding whether expanding the research purposes for which
human embryos may be created or used is justified.
7. The HFEA/HGAC report notes that in the
weeks immediately before the report was issued there had been
reports of significnt developments in research in the US involving
stem cells, of which the HFEA/HGAC had not been able to take full
account. This research involved taking stem cells from early fetuses
as well as embryos and had succeeded in establishing stable cell
8. This research appears to open up the
possibility of therapeutic purposes beyond those specified by
the HFEA/HGAC (at paragraph 5.10 of their report) such as treatment
of leukaemia; use in gene therapy; and use as a tool in drug development
for new treatments in a wide range of inherited and somatic disorders.
In deciding whether or not to expand the permitted research uses
of embryos the Government would wish to take account of the implications
of this most recent research and the additional research and therapeutic
possibilities it might suggest, over and above those outlined
in the HFEA/HGAC report.
9. The research referred to at paragraph
seven also raises the question as to whether embryos createdin
vitro will or should be the main or preferred source of stem
cells. Significant research is underway in the UK and elsewhere
using stem cells and other pluripotent cells obtained from blood,
cord blood and fetal tissue. Both ethical and practical considerations
(including the scarcity of embryos and eggs for IVF treatment
or research purposes) suggest that these alternatives merit serious
CMO EXPERT GROUP
10. In the light of the considerations outlined
above, the Government Response announced the intention to establish
an ad hoc Expert Advisory Group, chaired by the Chief Medical
Officer on the need for, anticipated benefits and risks of, and
alternatives, to the use of human embryos in research for the
additional purposes suggested by the HFEA/HGAC Report. The membership
and terms of reference of this group were announced on 18 August
(press release at Annex B). At the same time, the CMO wrote to
those who responded to the HFEA/HGAC's consultation and a range
of additional experts working in relevant fields worldwide seeking
their views on the following questions:
what are the current areas of research
in therapeutic cloning including stem cell studies, and which
are the most important?
what are the areas of human health
in which the use of therapeutic cloning techniques is most likely
to provide benefits?
how close are we to being able to
replicate animal work in humans?
what are the technical problems which
are you aware of any safety issues?
are there alternatives to research
on human embryos, created in vitro, to achieve the same
ends? If so, is it likely that they will be available within the
next five years?
what are the ethical and social implications
of such research and its potential therapeutic application?
what would be the likely future consequences
of the development of therapeutic cloning technology for health
11. The responses, which have been requested
by the end of October, will help inform the Group's conclusions.
The Government expects to receive the Expert Advisory Group's
advice early in the New Year.