Submission from Comment on Reproductive
Comment on Reproductive Ethics (CORE) is a public
interest group involved since 1994 in the ethics of assisted reproduction,
cloning and stem cell technology. We have given oral and written
evidence to the Science and Technology Committee on reform of
the HFE Act, and have participated in relevant consultations called
by the Department of Health and the Human Fertilisation and Embryology
Authority. We have organised conferences on women's health issues
within the European Parliament, where concerns about egg donation
for research and the ethics of stem cell research have been addressed.
We welcome this opportunity to raise some of
our many concerns in relationship to the creation of animal/human
hybrid and chimera embryos.
The scientific and legal complexities surrounding
the creation of animal/human hybrids and chimeras are colossal,
with currently no consensus on definitions, no consensus on either
the feasibility or necessity of such creations, and no possibility
of any workable international accord. It must be noted, however,
that to date more countries are opposed to than in favour of such
In this climate of uncertainty and disagreement,
we can see no justification for the UK to rush into decisions,
and we recommend absolute caution. Furthermore, despite the claims
made by the HFEA, it is in no way certain who has authority in
this field. CORE is not convinced that the HFEA has jurisdiction.
This matter alone demands serious clarification.
We recommend that considerable time and discussion
be spent in thorough investigation of these issues, both nationally
and internationally, and taking proper notice of the position
of other countries. This must be done both at the highest academic
and scientific levels but also as broadly as possible so that
the public is properly and accurately informed. The economic implications
of international agreements on human tissue must not be underestimated.
Having looked at the current evidence, CORE's
position is that animal/human hybrids and chimeras are neither
necessary nor desirable.
1. Why such haste?
Given the serious implications and novelty of
the science in question, we welcome the initiative of the Science
and Technology Committee in inviting public commentary on the
Government's proposals for the regulation of animal/human hybrid
and chimera embryos for research purposes. We feel nevertheless
that it is unfortunate that this consultation is taking place
within such limited time constraints, as this will be the first
occasion when these controversial matters has been discussed in
any real depth.
Animal/human hybrids were considered during
the earlier Science and Technology Consultation on Reform of the
Act, but neither then nor during the Department of Health's subsequent
consultation was this proposal singled out for any specific consideration.
We also note that the current initiative of
the Science and Technology Committee has not been widely publicised
and inevitably only those closely involved with the issues in
question will participate.
Recent criticism of the Government White Paper's
recommendations dismissed the "partisan" nature of those
who had contributed to the consultation exercise, suggesting that
the opinions of religious and pro-life lobbies had predominated.
It would be equally possible to argue that the
pro-cloning scientific lobby in the UK has been allowed exaggerated
influence. Certainly the media coverage of animal/human hybrids
recently has been anything but impartial, giving the impression
that there are no scientific arguments against such research,
and that the only opposition comes from those opposed to destructive
embryo research. As we will elaborate later, the international
picture is much more complex, as is the science itself.
CORE encourages balanced and informed debate,
and urges the Government to ensure that this takes place.
2. Scientific considerations
Before establishing the legal status of animal/human
hybrids and chimeras, it is essential that we have agreement as
to the exact scientific nature of the proposed entities.
We suggest that nothing in this area of science
is currently very clear and to give you just a taste of the level
of uncertainty involved, we refer you to minutes of HFEA meetings
where these issues have been discussed. Please note the following
quotes as examples, taken from a paper prepared for the Scientific
& Clinics Advances Group (SCAG) of the HFEA (26 April 2006):
"Members discussed the fact that it is unknown
what the proportion of contribution from human and animal mitochondria
will be in these hybrid embryos."
"It is questionable whether this technique
can produce physiologically normal stem cells lines."
"One member suggested that for the first
5 or 6 days of development the entity would initially be predominantly
rabbit. It would then become gradually humanised. It will become
predominantly human by eight or nine days of development."
Contrast this last statement with a comment
made by renowned neurologist, Lord Walton of Detchant, during
a debate in the House of Lords on hybrids and chimeras (9 January
"Such cells produced by tissue culture would
be free of any significant component of animal mitochondrial DNA".
Given that such cells would be derived around days five or six
of embryo development it is hard to know what to make of either
Public Health Minister, Caroline Flint, in a
letter to The Observer, 21 January, 2007, remarks that
there is no firm consensus, "about precisely which human-animal
creations should be allowed, any immediate imperative for doing
so, or the availability and interpretation of supporting evidence."
CORE could produce pages of contradictory statements,
made at the highest level, re the significance or not of
maternal mitochondria and the risks or not of physiological abnormalities.
We draw the Committee's attention, for example, to a major European
research project, in which Newcastle University is participating,
focusing on abnormalities of mitochondrial origin (www.mitodata.org).
The point we wish to make, however, is simply
that nothing is currently at all clear about the science involved,
and it would be extremely unwise to rush into decisions without
a rigorous objective scientific basis to deliberations.
It is unthinkable that decisions as to the nature
of an animal/human hybrid should be left to the deliberations
of the HFEA, let alone their subcommittees on Ethics and Law,
or the aforementioned Scientific and Clinical Advances Group,
and we can see little purpose to the Authority conducting their
own consultation later this year. Such a consultation should be
undertaken by Parliament.
3. Legal considerations
With so much uncertainty relating to scientific
definitions of animal/human hybrids it is extraordinary that the
Chief Executive Officer of the HFEA, Angela McNab, has issued
a press statement claiming licensing authority in this field.
Minutes of the meetings of the Ethics and Law Committee (ELC)
of the HFEA themselves reiterate the uncertainties of the scientific
nature of animal/human hybrids. As a consequence therefore there
is even more uncertainty as to their legal status as this clearly
depends on a definitive agreement on the science.
The legal position remains unclear and this
opinion is being expressed from many varied quarters.
It must be remembered that, under the HFE Act
1990, the HFEA is only responsible for human gametes and human
embryos. In the instance of animal/human hybrid cloning, no human
gametes are involved, and it has yet to be established whether
any embryo that might develop from an animal egg is animal or
human, particularly in the early period when stem cells would
In the same Lords' Debate cited earlier, Government
Spokesperson for Health, Lord Hunt of Kings Heath, states "Our
understanding is that the law is unclear about the regulation
of human and animal embryos created by novel processes."
Lord Walton of Detchant has no such doubts and argues that cells
produced in this way cannot be construed as embryos under the
terms of the HFE Act.
The Health Minister, Ms Flint, again in her
letter to The Observer, 21 January 2007, speaks of the
need "to clarify the extent to which regulation will apply
to the creation and human-animal hybrids and chimeras for research".
4. Justifying the use of human embryos
Whilst it is important to contain the debate
on animal/human hybrids and chimeras within certain clear parameters,
we cannot completely ignore the history of research in this area
and the significant ethical issues associated with use of the
human embryo and human cloning.
The use of embryos was argued initially as being
indispensable to progress, and the law was developed as a balancing
exercise between respect for the embryo and the purported need
to do research on it. In the HFE Act this concept is contained
in the term "necessary and desirable", qualities which
have to be demonstrated before such research is permitted.
CORE reiterates its total opposition to destructive
embryo research, but feels that even within the model of the balancing
exercise, not enough rigorous assessment of the need for human
embryos for research has been undertaken.
We suggest that the time has come for a thorough
analysis of the history of embryo research. It is 17 years since
the 1990 Act was passed and we should be assessing honestly how
many embryos have been used in this time, and what real benefits
have derived from the experiments to date. This analysis should
cover both fertility treatment and stem cell research, and include
the most recent licenses issued for cloning using cell nuclear
transfer. Only in this way can an objective assessment be made
as to the real necessity of using human embryos in this way, irrespective
of how they have been obtained or created.
5. The international perspective
Without re-opening the debate on the use of
the human embryo per se it must nevertheless be noted that,
whilst there are varied positions taken on the use of embryo surplus
to IVF requirements, there are very few countries in the world
who permit the deliberate creation of embryos for research purposes.
It should be noted, too, that opposition to human cloning either
for reproduction or research purposes is the majority position
worldwide. It is untenable to polarise opposition as coming primarily
from religious quarters.
The UK, therefore, is already out on a limb
in relationship to world opinion, and current proposals to create
animal/human hybrids are distancing the UK ever further from world,
and particularly European, thinking. It is arrogant to suggest
that we know better than most other countries.
We recommend an objective assessment of the
rationale behind the position of these countries, and in particular
draw your attention to the deliberations of the Australian Senate,
which culminated in a unanimous rejection of animal/human hybrids
in December 2006. The rejection was based on a pragmatic scientific
basis of either poor or unnecessary science but also included
interestingly concerns for the welfare of animals.
6. Economic considerations
We are hearing too frequently these days that
scientists should be able to do whatever they like, providing
there are no tangible risks involved, a libertarian approach which
CORE certainly does not endorse. However, even if one does not
accept the justification for ethical limitations to research,
there are nevertheless serious economic implications which cannot
We cannot afford to fund every research project
that is proposed and so further balancing exercises must be performed
to assess how best to spend available resources. Public funding
must be directed towards research which is scientifically sound.
There is a duty, therefore, to analyse with proper scientific
rigour the claims made about embryonic stem cell research and
cloning, and even more urgently in relationship to the alleged
benefits of animal/human hybrid cloning. In particular the status
of adult stem cell research, and the use of post-natal stem cells
(amniotic, placental and umbilical cord) must be considered more
We have a continued duty to objectivity and
the proposed assessment of previous research involving the human
embryo will also be invaluable in following these economic considerations.
In the European context these considerations
are particularly important, as no therapy involving human tissue
is likely to be marketable if not developed in accordance with
EU regulations. We feel that any future Government initiative
should take this on board much more seriously than has been the
case to date.
7. Are there acceptable alternatives?
The most widely stated justification for going
ahead with animal/human hybrid and chimera research at the moment
is that it will provide an ethical source of mammalian eggs and
avoid putting human donors at risk. CORE is one of the first to
argue that egg donation for research is too risky and invasive
to be justified, but we are also the first to argue that combining
human and animal tissue in this way is not an appropriate or safe
Animal cross species work has not been perfected,
animal cloning processes are still light years from delivering
high success rates, and human cloning does not seem to be working
properly (if at all) in any country in the world. To argue that
we need to do animal/human hybrid and chimera research when the
results are so poor in similar fields which are nevertheless far
more straightforward, seems quite extraordinary.
There are already research projects investigating
the derivation of embryonic-like human stem cell tissue, bypassing
any creation of human embryos. Obviously such possibilities require
individual analysis, but are sufficiently numerous and interesting
that they should be taken into consideration. CORE recommends
that the Science and Technology Committee reads "Alternative
Sources of Human Pluripotent Stem Cells", A White Paper
from the US President's Council on Bioethics in this regard. (www.bioethics.gov)