Supplementary evidence from the Human
Fertilisation & Embryology Authority (HFEA)
SCIENCE AND TECHNOLOGY SELECT COMMITTEE INQUIRY
INTO THE APPROPRIATENESS OF CURRENT GOVERNMENT PROPOSALS FOR REGULATION
OF RESEARCH USING CHIMERA AND HYBRID EMBRYOS
Thank you for your letters of 7 and 9 February
asking follow up questions to the oral evidence session held with
Ms Shirley Harrison, Ms Angela McNab and Professor Neva Haites
on the 31 January 2007.
I have grouped your questions together where
relevant. Taking these in order, you asked for:
1) A statement on our reasons for not disclosing
the legal opinion the HFEA has obtained with respect to whether
or not research using human-animal chimera or hybrid embryos and
specifically, embryos created through somatic cell nuclear transfer
of human genetic material into enucleated animal ova, falls within
HFEA remit (as referred to in Q93-98 of the session transcript).
The Authority decided, for the usual reasons
of legal privilege, not to release the independent legal opinions
it had obtained. The issue of whether hybrid embryos fall within
the remit of the 1990 Act is open to interpretation, and whatever
decision the Authority eventually takes in this regard could in
future be subject to legal challenge. Our concern was that any
inadvertent disclosure of our legal advice could be damaging to
the Authority if a legal challenge were mounted on our interpretation
of the 1990 Act.
For that reason, we had hoped that we could
communicate the essential issues by providing the Committee with
a summary of the legal position in our written statement to the
Inquiry and by providing relevant Authority papers and minutes.
However, it became clear during our evidence session, and in considering
the issues raised in your subsequent letters, that this information
was not of itself sufficient to help the Committee address some
of its key questions.
Although our legal advice on the risks of disclosure
remains unchanged, we have decided to share with the Committee,
on a strictly confidential basis, opinions provided to the Authority
by Dinah Rose QC, on 6 July 2006 and 5 January 2007. These opinions
should be read in conjunction with each other. We hope that having
sight of these legal opinions will help the Committee to a better
understanding of the decisions taken by the Authority on 10 January,
and the points made in the Authority's subsequent statements,
and help to address the Committee's outstanding questions. We
are of course happy to answer any further questions that may arise
from consideration of these opinions.
Copies of the legal opinions are enclosed. As
mentioned, we are providing these on terms of strict confidentiality.
Members of the Committee are free to discuss the opinions amongst
themselves but the contents of the opinions, or any part of them,
must not be discussed outside of the Committee, or published,
without the prior consent of the HFEA. I would be grateful if
you could confirm that the Committee as a whole are happy to abide
by these terms.
I also enclose an unedited version of the paper
considered by the Authority on 10 January (the copy submitted
previously has some small sections removed that related directly
to Counsel's opinion). This version of the paper should be treated
on the same confidential basis as the two legal opinions.
The Committee should be aware of one slight
inaccuracy in the opinion dated 5 January 2007 which stems from
a lack of clarity in our original instructions to Ms Rose. At
paragraph 17, Ms Rose quotes the instructions as stating that
"the Department of Health has indicated to the Authority
that it considers that the 1990 Act does not empower the Authority
to grant a licence authorising the creation of a hybrid embryo".
This is an accurate rendition of our instructions. However, the
point being made by the Department was that the Government White
Paper which preceded the 1990 Act indicated an intention to prohibit
the creation of hybrid embryos. This of course is not the same
as the Department offering an opinion on the legal interpretation
of the Act as it stands. The same point about the historical context
of the Act was picked up in Ms Rose's opinion of 26 July 2006
(see paragraphs 20-27) and mentioned in the paper presented to
the Authority on 10 January 2007 (see paragraph 10).
2) Legal advice the HFEA has obtained with
respect to embryo viability (Q84 of the transcript refers).
This is contained in the two legal opinions
enclosed with this letter. In particular, we would like to draw
the Committee's attention to paragraphs 32-39 of the legal opinion
dated 6 July 2006 and paragraphs 22-24 of the opinion of 5 January
In discussing viability, Ms Rose refers in her
first opinion to the decision of the House of Lords in Quintavalle
(R (on the application of Quintavalle) v Secretary of State for
Health  UKHL 13). Lord Millett states at paragraph 40(c)
of the judgement that a human embryo is a live human organism
containing within its cells a full set of 46 chromosomes with
the normal potential to develop and, if implanted in a woman,
to become a fetus and eventually a human being. He then goes on
to look at the words of the Act in Section 1 (1) which states
In this Act, except where otherwise stated- (a)
embryo means a live human embryo where fertilisation is complete,
and (b) references to an embryo include an egg in the process
of fertilisation, and, for this purpose, fertilisation is not
complete until the appearance of a two cell zygote.
Lord Millett states that the definition in paragraph
(a) is in part circular since it contains the very term to be
defined. It assumes that the reader knows what an embryo is. The
purpose of the opening words of the paragraph, he states, is not
to define the word "embryo" but rather to limit it to
an embryo which is (i) live and (ii) human. He states that these
are the essential characteristics which an embryo must possess
if it is to be given statutory protection. When looking at embryos
created by CNR he states that such embryos are in all respects,
save the method of their creation, indistinguishable from other
embryos. They are alive and human, and accordingly possess all
the features which Parliament evidently considered makes it desirable
to regulate their use in treatment or research.
To the best of our knowledge, this is the only
interpretation of the Act where the issue of being "live"
has been discussed. The crucial concept, insofar as it was explored
by Lord Millett seems to be that the human embryo must have normal
potential to develop and if transferred into a woman, to become
a fetus and eventually a human being. Ms Rose's assessment of
how a court in future might treat this issue is at paragraph 34
of her opinion of 6 July 2006.
3) With relevance to the work proposed by
researchers at Newcastle University and King's College London,
a statement on what is meant by the phrase "it probably falls
within our remit". In particular, the Committee requests
your reasoning for using the term "probably" (as referred
to in Q80 of the session transcript)
Again, we would draw the Committee's attention
to the conclusions reached by Ms Rose in her opinions of 6 July
2006 and 5 January 2007 (paragraphs 40 & 41 and 22-24 respectively).
This makes clear the level of uncertainty remaining on this issue.
The Authority's statement that "these sorts
of research would potentially fall within the remit of the HFEA
to regulate and licence and would not be prohibited by the legislation"
takes account of this advice as well as the conclusions reached
by the Authority's Scientific and Clinical Advances Group and
the Ethics & Law Committee (papers from these meetings have
already been sent to the Committee).
4) Evidence to support the claim that there
is scientific opposition to work using human-animal chimera or
hybrid embryos and specifically, to create embryonic stem cell
lines through somatic cell nuclear transfer of human genetic material
into enucleated animal ova. In particular, the Committee requests
information on where this scientific opposition stems from, with
the opportunity to contact such scientists directly if this is
deemed necessary (as referred to in Q139 of the session transcript)
In the press statement that we published following
the Authority decision to carry out a policy review on hybrids
and chimera, we said that "There is not clear agreement within
the scientific community about the need for and benefits of this
science." It was from this statement that the Committee inferred
that there was opposition to this research. We are aware that
there is a lack of agreement within the scientific community around
specific issues relating to this research, for example on research
priorities and also the viability of entities created following
interspecies somatic cell nuclear transfer (iSCNT). However we
should make clear that we have not spoken to any scientists who
are in outright opposition to this research. Further differences
of opinion and other issues may however emerge as we consult a
wider range of scientific opinion over the coming months.
Some members of the scientific community consulted
by us felt that there was still much to learn about the process
of SCNT and that it would be more appropriate for this research
to be carried out in animal models without using human material.
Others thought it was too early to be doing SCNT research using
human eggs (but that the use of animal eggs was acceptable).
Some scientist took the view that questions
relating to iSCNT could be answered using animal models, and therefore
questioned the need for this research. This of course contrasted
with the views of those who think that there is great value in
iSCNT work at this time.
Much of this discussion took place at a scientific
meeting linked to the Authority's consultation on Donating Eggs
for Research. We reassured those researchers and scientists present
that the meeting would not be minuted to enable a full and open
debate. A summary of the meeting was produced but the comments
were not attributed to any of the people present. A copy of this
summary is enlcosed.
The HFEA Scientific and Clinical Advances Group
were also largely supportive of the use of iSCNT embryos, noting
that such entities would be human and that the Group could see
how creating such embryos could be necessary for research. Minutes
of this meeting have already been provided to the Authority.
In relation to the issue of viability of interspecies
SCNT embryos, we contacted a group of scientists the majority
of whom are on our horizon scanning panel and asked for a view
on the viability of such entities. The responses we received to
this were varied and there was no consensus. As this issue was
relevant to the legal advice we obtained, this lack of consensus
was significant. A summary of the questions and the responses
received is enclosed. Individual opinions are anonymised, as we
do not have the permission of the experts concerned to quote them.
However, the experts consulted were as follows: Professor Peter
Andrews (University of Sheffield), Dr David Edgar (University
of Liverpool), Professor Henry Leese (University of York), Dr
Justin St John (University of Birmingham), Professor Alan Trounson
(Monash Immunology and Stem Cell Laboratories), Dr Maureen Wood
(University of Aberdeen). The planned consultation will give the
Authority an opportunity to broaden the range of experts consulted
(see response to questions 6 & 7 below).
5) A reference to demonstrate where and when
the HFEA first indicated that it felt this was a matter best dealt
with by Parliament (as referred to Q91 of the session transcript)
The point behind Ms McNab's comment that "we
thought this issue would be best dealt with in Parliament"
is that, in an ideal world, we would have preferred these issues
to have been debated by Parliament and set out explicitly in legislation,
to give greater clarity than at present, before the Authority
had to address these issues.
The Authority has been calling for some time
for the 1990 Act to be updated. In July 2002, the then Chief Executive
of the HFEA Maureen Dalziel said, in response to the Science and
Technology Committee report, developments in human genetics and
"New, clearer legislation is desperately
needed that takes into account the massive scientific advances
that have taken place since the last Act was drafted and is less
open to misinterpretation."
In May 2004, the Authority's written evidence
to the Committee's inquiry into reproductive technologies and
the law said:
"The regulatory framework created by the
1990 Act has in general terms responded well to new scientific
and medical practice and public concerns....but other parts of
the Act now seem to be in need of speedy revision, for example
the definition of an embryo".
This message was repeated to the Committee in
our oral evidence sessions.
And again, in response to the Department of
Health's 2005 consultation on the review of the 1990 Act, the
"The HFEA would recommend that hybrids and
chimeras are defined in the new Act".
This remains the Authority's position. In the
meantime, however, the Authority is under a legal duty to act
within the legal framework as it stands.
6) Information detailing whom the HFEA has
consulted in relation to drafting the expected public consultation
on whether the creation of human-animal chimera or hybrid embryos
should be allowed for research purposes. In particular, the Committee
is keen to establish which scientists have been consulted in the
drafting of the consultation
7) A statement detailing how the HFEA intends
to explore the issue of embryo viability with the scientific community
There will be two strands to the HFEA's consultation
discussion with researchers and the
scientific community on the question of whether hybrid and chimera
embryos should be regarded as "live human embryos" within
the meaning of the 1990 Act. This will include the question of
viability (see paragraph 28 of Ms Rose's opinion of 5 January
a public dialogue to help us understand
public attitudes and opinions on stem cell research involving
the creation of a range of hybrid and chimera embryos, including
embryos created through interspecies somatic cell nuclear transfer.
This will include a written consultation document, focus group
work and a public debate.
Detailed plans for the consultation are still
under development, but the consultation period will run from late
April to late July to enable the Authority to take a policy decision
at its meeting on 5 September.
We are currently in the process of drafting
the written document for the public consultation, given the long
lead-in time for such documents. The focus of our current round
of discussions with scientists is therefore to help inform the
contents of this document, which will begin with a lay friendly
explanation of the science, its purpose, likely outcomes etc.
The scientists we are consulting include:
|Dr Robin Lovell-Badge||1 Feb 2007
||Stem Cell Biology and Developmental Genetics|
National Institute of Medical Research (NIMR)
|Dr Stephen Minger||5 Feb 2007
||Centre for Age related disease|
King's College London
|Dr Hui Zhen Sheng with|
(Dr Robin Lovell-Badge)
|8 Feb 2007||Shanghai Jiao Tong University
|Professor John Gurdon||23 Feb 2007
||The Wellcome Trust/CR UK Gurdon Institute|
University of Cambridge
|Professor Chris Shaw||26 Feb 2007
King's College London
|Dr Justin St John||27 Feb 2007
||Reproductive Biology and Genetics|
University of Birmingham
|Professor Lorraine Young||6 March 2007
||School of Human Development|
University of Nottingham
|Professor Keith Campbell||6 March 2007
||Division of Animal Physiology|
University of Nottingham
|Dr Lyle Armstrong||7 March 2007
||Institute of Human Genetics|
University of Newcastle
|Professor Roger Pederson||TBC
||Institute for Stem Cell Biology|
University of Cambridge
|Austin Smith||TBC||Wellcome Trust centre for stem cell biology|
University of Cambridge
|Professor Henry Leese||TBC
||Department of Biology|
University of York
We have not yet finalised a list of the scientists and scientific
and research institutions who we will consult on the first strand
of the consultation exercise, including the viability question.
But these will include the recognised experts in the field, scientific
institutions and others.
The Authority has also ensured that the lead researchers
who have submitted licence applications to the Authority have
been kept appraised of developments throughout. After they submitted
their applications to the Authority in November, Professor Minger
and Dr Armstrong were informed in writing of the decision to defer
consideration of their applications until the Authority had taken
a policy decision at its meeting on 10 January. They also received
personal phone calls on 11 January to inform them of the outcome
of the Authority's meeting, including the decision to consult
(Ms Harrison spoke to Dr Minger and Ms McNab to Dr Armstrong).
8) A list of all public consultations held by the HFEA.
In particular, the Committee would be grateful for a list of any
public consultations, held by the HFEA, directly related to research
and applications for research relevant to HFEA remit
9) Criteria used by the HFEA in deciding on the appropriateness/
necessity for holding public consultation in areas in which it
has done so
A list of public consultation held by the HFEA is enclosed
showing those which have been directly related to research.
The HFEA follows the Cabinet Office Code of Practice on Consultation
which promotes "effective consultation as a key part of the
policy making process". There is an expectation that ggovernment
departments, and independent regulators such as the HFEA, should
carry out a full public consultation whenever options are being
considered for a new policy or if new regulation is planned. This
is the general approach taken by the Authority.
The scope of HFEA consultations, and the range of people
consulted, varies depending on the subject matter:
narrow consultations on practice in licensed clinics
(egg on laboratory witnessing procedures or Dewar safety) will
normally be limited to the clinics directly affected and the relevant
professional and patient bodies and other experts;
consultations on issues which have a more direct
impact on patients or donors (such as the SEED Review on donation
practice and the review of guidance to clinics on conducting Welfare
of the Child assessments) will be broader and involve a written
consultation document, public meetings etc; and
consultations on issues of broader public concern
where is the issue is of interest to society as a whole (egg the
consultations on social sex selection; the use of pre-implantation
genetic diagnosis to detect late onset diseases such as inherited
breast cancer (the Choices and Boundaries review) and the present
consultation on the creation of hybrids and chimera embryos).
These consultations inform and educate the public, give people
an opportunity to engage with the relevant experts and provide
an opportunity for the public to express their opinions to the
HFEA. These types of consultations may also involve the Authority
engaging with groups outside of its normal sphere of interest,
egg disease specific patient or lobby groups.
In addition to these ad hoc consultation exercises, the Authority
consults on an ongoing basis with its on-line Patients Panel,
"Fertility Views" and its Licensed Centres Panel. These
consultations enable the Authority to understand patient needs
and expectations, improve service delivery, check how things perform
at a local level, check that measures work etc.
10) Other Issues: "Fairness"
There is a further point that we would like to make that
may help the Committee. In advising the Authority on the appropriate
procedures to adopt in taking a policy decision on the creation
of hybrid embryos, Dinah Rose addresses the issue of procedural
fairness (see paragraphs 25-29 of her opinion of 6 January 2007).
The issue of "fairness" was also discussed during the
evidence session on 31 January (see Qs105-07).
The concept of fairness addressed by Dinah Rose relates to
an expectation which arises on the part of individuals that procedural
fairness will be adopted in the case of decisions affecting their
interests which are made by public bodies. For example, in this
case it could be argued that the law recognises the creation of
hybrids for research purposes on the part of both scientists and
the general public as "an interest". This interest cannot
be properly be withdrawn or denied without those interested in
it being given an opportunity to comment and without the Authority
communicating rational grounds for any adverse decision made.
The concept of fairness raised in the evidence given to the
Committee needs to be seen in the context of Ms Rose's opinion
regarding the Authority's obligations to have regard to the interests
of the scientists and the public in this particular research.
It would be wrong for example to refuse to allow the research
without the scientists being given an opportunity to comment and
wrong to go ahead with it without other interested parties, including
those opposed to the research, also being given an opportunity
I hope this information is of help to the Committee in furthering
its Inquiry. Please let me know if you have further questions.