Submission form the Human Fertilisation
& Embryology Authority (HFEA)
1. The HFEA is pleased to submit evidence
in support of the Select Committee's inquiry. This focuses on
the position adopted by the Authority to date, including interpretation
of the requirements of the Human Fertilisation and Embryology
Act 1990 and the Authority's plans to conduct a public consultation
on the desirability of permitting the creation of hybrid and chimera
embryos for research purposes.
2. Relevant copies of papers presented to
the Authority and its sub committees, together with minutes of
those meetings, are attached.
Independent legal advice obtained by the Authority in relation
to this issue has been withheld for the usual reasons of legal
privilege. Specific references to Counsel's advice in the paper
presented to the Authority on 10 January 2007 have also been removed.
The legal issues considered by the Authority are however summarised
in this paper.
THE 1990 ACT
3. In 2005, the Government's public consultation
on the Review of the Human Fertilisation & Embryology Act
sought views on whether the law should permit the creation of
human-animal hybrid or chimera embryos for research purposes only
(subject to the limit of 14 days culture in vitro, after which
the embryos would have to be destroyed). The HFEA's response to
this (November 2005) was that:
The creation of human-animal hybrids is permitted
until the two cell stage under the current Act and the HFEA considers
that research within the constraints outlined by the Government
should be permitted.
As long as it can be ensured that such entities
would never be implanted into a woman or allowed to develop beyond
the 14 day stage, and as long as the research would fall under
current research purposes, it could be argued that the ethical
justification for the creation of such entities is consistent
with research as it is currently allowed.
Nevertheless, we recommend that the Government
has proper consideration to the diversity of views on this issue.
The HFEA would recommend that hybrids and chimeras are defined
in the new Act.
4. This remains the HFEA's formal position.
5. Early in 2006, UK scientists stated publicly
that they might wish to create hybrid embryos by fusing human
cells with rabbit eggs. The Authority therefore began to address
this issue in anticipation of receiving an application for a licence
to undertake this research.
6. A key question for the Authority at this
point was whether hybrid embryos fall within it's jurisdiction
under the 1990 Act. As it is the nature of the embryo, and not
the process by which it is created, that is critical to the question
of whether it falls within the scope of the Act, it was important
to understand whether hybrid embryos could properly be categorised
as "live human embryos". If there was scientific agreement
that a hybrid embryo contained a full human genome, a reasonable
interpretation of the Act would be that such embryos should be
treated as live human embryos unless it could be clearly proved
that the embryo could never be viable. The implication of a judgement
that hybrid embryos are not live human embryos is that such research
involving the creation of hybrid embryos could be undertaken free
7. In April and May 2006 respectively, the
Authority's Scientific and Clinical Advances Group (SCAG) and
Ethics and Law Committee (ELC) were asked to consider this and
related issues. SCAG's general opinion was that this type of hybrid
embryo should be classed as human. ELC agreed that an embryo containing
human nuclear DNA and mitochondria of animal origin should be
regarded as an "embryo" for the purposes of the 1990
Act. ELC also took the view that the creation, keeping or use
of such an embryo was capable of being regarded as necessary or
desirable for one of the purposes set out in Schedule 2 of the
8. Subsequently, in November 2006, the Authority
sought further expert scientific opinion from relevant members
of the HFEA Horizon Scanning Expert Panel. Those who responded
agreed that this type of hybrid embryo would contain a complete
human genome. However, there was no consensus on whether a hybrid
embryo would be capable of implantation (ie whether it would potentially
be viable and therefore afforded the protection of the Act). There
was also a lack of consensus on whether the embryo would be human
from day one.
9. This advice and opinion, together with
a summary of the ethical issues, was presented to the Authority
at its meeting on 10 January 2007 (by which time two research
licence applications had been received). The Authority's conclusionthat,
under current legislation, this sort of research potentially falls
within the remit of the HFEA to regulate and licencereflects
the remaining scientific uncertainties particularly on the potential
viability of hybrid embryos and the fact that this conclusion
has not been tested by the courts.
10. Two applications for research licenses
for derivation of embryonic stem cells from hybrid embryos were
received by the Authority on 7 November. The paper presented to
the Authority on 10 January 2007, makes clear that acceptance
that hybrids fall within its remit requires these applications
to be referred on to a licence committee of the Authority for
consideration. The Authority was invited to consider developing
a policy statement which a licence committee could take into account
in reaching a decision. However, advice given to the Authority
on the day of the meeting provided a further optionto delay
reaching a policy position and consideration by licence committee
pending a full public consultation.
11. The decision to undertake a full and
detailed consultation was taken by the Authority on the grounds
that it would be wrong to make an immediate judgement on these
complex and controversial matters before a proper body of evidence
had been built up. Although the Government's consultation on the
review of the 1990 Act detected public disquiet in this area,
it addressed it in limited detail and in the context of a large
number of other questions.
12. Although the Authority's consideration
of hybrids to date has been prompted by two particular licence
applications, its scope will be much wider. The consultation will
address all types of chimera and hybrid embryos, ie embryos which
contain some elements of animal DNA.
13. The consultation exercise is currently
being planned, but we expect the consultation to run from late
April to late July and for the Authority to use the results to
arrive at a policy position at its meeting on 5 September. The
Authority is currently exploring the option of using a number
of methods for gathering public views, including a formal written
consultation, a public opinion poll, a large scale public debate,
focus groups, small scale meetings with individuals or stakeholder
groups and briefing to Parliamentarians. Throughout this process,
the Authority will work closely with the scientific community,
the various interest groups and the public to develop a proper
understanding of the different types of science and outcomes that
hybrid and chimera research would involve.
14. The Authority's chief concern in addressing
the issue of hybrids and chimera is to exercise its responsibilities
as a regulator in a way that is fair to all interests whilst meeting
its responsibilities under the 1990 Act. We also hope that the
information gained during our consultation will help to inform
Ministers and Parliament in reviewing the 1990 Act. We are pleased
that the Select Committee is also actively engaged in considering
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