APPENDIX 21
Memorandum from Comment on Reproductive
Ethics
SUMMARY
Comment on Reproductive Ethics (CORE) was established
in 1994 as a public interest group focusing on the ethical problems
raised by human reproduction, particularly the new technologies
of assisted conception. The first public meeting of CORE that
year addressed the role of the Human Fertilisation & Embryology
Authority (HFEA or Authority) and questioned their authority to
make ethical decisions in this field. This has been a key concern
of CORE throughout the past decade, and will be the major focus
of our submission to your committee.
ARGUMENTS
The HFEA has extended its role beyond its statutory
remit
1. Colleagues from the Lawyers' Christian
Fellowship will be dealing in greater detail with this aspect
of the HFEA in relationship to the HFE Act 1990, but there are
some general points CORE would like to make insofar as this argument
dovetails into the major thrust of our submission, namely that
the HFEA is neither a democratic nor representative body.
2. As very clearly reiterated on their own
website, when the HFEA was established in 1991 its role was almost
exclusively a regulatory one. CORE has no difficulty in accepting
the necessity of robust regulation in the field of assisted reproduction,
including such aspects as licensing, monitoring and the supervision
of good technical practice. Data collection is also a significant
and necessary part of regulation.
3. CORE is, however, concerned with ethical
decisions made by the HFEA without any clear justification, statutory
or otherwise. There is no historical indication that the HFEA
was ever intended to take on the role of ethical policy maker,
and even in the HFEA's current statement of their duties such
an assumed role is nowhere justified. The nearest one gets to
any explicitly declared stance which goes beyond the strictly
regulatory and into ethical policy making is where it is stated
that the HFEA "where appropriate" will "advise
the Secretary of State for Health on developments in these fields".
(HFEA website) That the HFEA passes on advice to the Secretary
of State has an inevitable logic and is again not a major problem
for CORE, but this in no way gives automatic authority to the
HFEA to make decisions in relationship to the legality or ethical
acceptability of new developments or applications in assisted
reproduction.
4. The HFEA clarifies on its website what
it does not do. These include:
— It is not a pressure group.
— It is not involved in funding for
treatment.
— It is not a research body.
CORE suggests that the HFEA be invited to defend
such claims in the light of the following sample of recent activities:
— The HFEA is currently involved, together
with the Department of Health, in overt promotion of gamete donation.
At an HFEA meeting in October 2003 it was minuted that "The
HFEA could make a significant contribution to changing the climate
around sperm donations and encouraging different groups to donate".
— The Chair of the HFEA has made widely
publicised public announcements that the clause from the Act that
refers to the child's need for a father should be removed from
the Act.
— A payment of £15,000 was made
in 2002-03 for survey and research by the HFEA to the National
Infertility Support Network CHILD, whose Executive Director, Clare
Brown, is a member of the HFEA.
— It developed together with the MRC
a pilot scheme to target IVF clinics for embryos for research,
minuted in September 2003. "MRC is keen to use one consent
form covering research and treatment, and not enable patients
to opt out of one for the purpose of the pilot", does not
make comfortable reading.
The process of public consultation in this field
is in urgent need of review
5. We welcome the lead taken by the Science
& Technology Select Committee (Committee) in consulting with
the public and are very much in favour of public consultation
in this highly sensitive field. We do not consider it appropriate,
however, for a regulatory body such as the HFEA to supervise consultation
exercises on wide reaching and controversial ethical issues. CORE
was founded in response to serious dissatisfaction with a 1994
HFEA consultation on donated ovarian tissue, which having recorded
public opinion then virtually ignored it. Our dissatisfaction
has increased over the years and was reinforced following the
recent consultation on "Sex Selection". CORE's response
to that consultation included a general criticique of the HFEA
process which we attach as (Annexe A not printed).
The HFEA is neither democratic nor representative
6. Were it possible to contain the activities
of the HFEA within their actual Parliamentary remit, the membership
of the HFEA would be of little interest to CORE. It is because
the HFEA has assumed such an overt policy-making role that we
raise concerns in this area.
7. The Committee in 2002 highlighted the
non-democratic character of the HFEA, during a questioning session
with the then Chair of the HFEA, Ruth Deech. She was asked why
the Authority had taken an ethical decision in relationship to
tissue-typing without any external consultation, let alone Government
involvement. Ms Deech asserted that the HFEA was protecting "Members
of Parliament from direct involvement in that sort of thing".
You will remember your Committee's robust reply that "Parliament
does not need protecting and democracy is not served by unelected
quangos taking decisions on behalf of Parliament".
8. It will be known to the Committee that
CORE felt obliged to challenge the HFEA's tissue-typing policy
decision, not because of the specific ethical dilemmas involved,
but because it believed that public interest and the democratic
process had been seriously abused.
9. Because the HFEA has increasingly assumed
a role which extends far beyond its original Parliamentary remit,
and over the years has been making major ethical decisions of
significance for society as a whole, it is of great concern to
CORE that the appointment system to the HFEA effectively excludes
from policy decisions any organisations or sections of the public
with a similar perspective to our own.
10. There is no more apposite defence of
our argument that the HFEA is deliberately unrepresentative than
the exchange which follows.
On 18 October 2002, Ms Suzi Leather, Chair of
the HFEA, gave evidence to US President's Council on Bioethics
in Washington D.C. She was questioned by Prof Gilbert C. Meilaender,
as to whether there were any members of the HFEA who were opposed
to embryo research.
Ms Leather's replied: "Your question (is)
about should we have people who are opposed to it."
Prof Meilaender: "The question is do you?"
Ms Leather: "No, we don't. This does come
up as an issue, and I think that the government has felt in a
sense of what would be the purpose of having somebody there. It
is not as if we are not continually reminded that there are many
people who hold very firm views against what we do.
And I believe that those views should be respected,
but they are out with the moral consensus in the UK at the moment,
and I don't think we need them continually on the committee saying
that I am opposed to all of this . . . because I think that would
stop the decision making that we have to do." (Transcript
USA Govt website www.bioethics.gov)
11. It is extremely difficult to obtain
clear information as to how appointments are made to the HFEA.
The paper answer is that these appointments are made by the Minister
of Health, following response to public advertisements. One would
have to be incredibly naïve to believe that the Department
of Health is making these choices, except at the level of Chair,
and not simply rubber-stamping recommendations put forward by
senior committee members.
12. It is fortunately not at all difficult
to obtain information about the appointment process from existing
or former committee members, which is how CORE learned that the
process is even less democratic than thought. It is common HFEA
practice to approach people directly and invite them to apply.
13. Nobody from a pro-life perspective who
has applied to join the HFEA over the last 13 years has even been
called for interview. The job description for membership openly
stipulates that those who apply must subscribe to the objectives
of the HFEA, so possibly the more conservative applicants were
wasting their time anyway, particularly in light of Ms Leather's
extraordinary admission quoted above.
14. And what exactly are the HFEA's objectives?
Are these so pre-determined that they exclude a priori
any opposing views, even in advance of new technologies such as
tissue-typing, cell nuclear transfer, or whatever lies around
the corner?
15. The HFEA would do well to study carefully
to what extent their appointment system respects the Code of Practice
of The Commissioner for Public Appointments.
We draw attention to the following points:
— Merit (and diversity): 2.04 departments
must guard against positive discrimination.
— Equal opportunities: 2.08 . . . Care
must be taken, at every stage, not to discriminate on the grounds
of gender, race, age, disability, religious belief or similar
philosophical belief . . .
— Probity—The problem most likely
to arise is that of actual or perceived conflict of interest:
2.09.1 In relation to conflict of interests, there are five issues
most frequently encountered which could lead to real, or apparent,
conflicts of interest: financial interests or share ownership,
candidates who are actively sought from within a field of expertise
in which the public body works. Such a connection does not
preclude an appointment, but it might well be perceived by the
public as a conflict of interest and will need to be handled sensitively.
— Role description and person specification:
3.10 . . . the person specification does not contain unnecessary
requirements that will rule out applications from a particular
group within society
16. According to the HFEA website, the Authority
encourages variety in its membership. "To ensure that the
HFEA has an objective and independent view, the HFE Act requires
that the Chair, Deputy Chair and at least half of the HFEA Members
are neither doctors nor scientists involved in human embryo research
or providing infertility treatment. HFEA Members bring to the
HFEA a broad range of expertise from medicine to law and religion
to philosophy."
17. There have been only 65 members of the
HFEA since its establishment in 1991 so it has not been difficult
to analyse the profile of the committee and the general ethos
of the members over the years, but we will restrict ourselves
to an overview of the current committee, to explore briefly the
concepts of objectivity and independence.
18. There are currently 18 HFEA members,
including the Chair, who is a declared member of the Labour Party
and by necessity in agreement with Government policy on cloning,
stem cell research and so on. The Deputy Chair is a pro-choice
philosopher/bioethicist, and a member of The Stem Cell Steering
Committee.
19. Of the remaining 16 members, seven are
directly involved in IVF treatment. Four of the seven are also
involved in stem cell research and a list of their involvement
with pharmaceutical companies through share-holdings, consultancies
or departmental research grants includes Astra Zeneca, Eli Lilly,
Merck, Pharmacia, Servier, Takeda, Serono Pharmaceuticals, Ares
Serono, Organon, Schering and others. One of the four was the
lucky recipient of the first embryonic stem cell licence to be
issued by the HFEA.
20. There are three members of patient infertility
groups, understandably self-interested, a liberal Anglican Bishop
who is a major proponent of embryonic stem cell research, and
an academic lawyer who has argued publicly in favour of maximum
reproductive freedom including the right to social sex selection
and human cloning. Her presence adds the first touch of genuine
independence to the Authority's profile, but one wonders how such
a polarised position can be justified at the same time as applicants
from the opposite spectrum are categorically excluded.
21. The final four members come from a business
or media background, and attendance by CORE at open meetings of
the HFEA has not shown any of them to have reservations about
activities of the Authority. To consider such a committee independent
and objective is untenable.
22. One does not wish to suggest that no
member since 1991 has ever expressed any conservative opinions
about HFEA activities. The philosopher, Professor Brenda Almond,
for example, recorded her opposition to the designing of tissue-matching
embryos in a letter to The Times, (26 July 2002). As she
was on the HFEA Ethics Committee at the time the controversial
policy decision was taken, her opposition provided CORE with some
small solace. It is unfortunate that Professor Almond's membership
was terminated after only three years, as her academic background
seriously enriched the composition of the Authority.
The HFEA, established as a fertility watchdog,
does not have the scientific background or organisational resources
to become involved in the complex issues of embryonic stem cell
research
23. The HFEA is already seriously over-stretched
in maintaining existing standards in the growing infertility industry,
and should not extend itself any further, and certainly not into
embryonic stem cell research. It is bad business practice to have
too diverse a portfolio.
24. The HFE Act was established to provide
at least some respect and protection to the human embryo. This
simply cannot be ensured under the present situation, particularly
in relationship to embryonic stem cell research, the justification
for which embraces nearly every field of disease or accident known
to man.
25. The Authority is placed inevitably in
a position of conflict of interest when it becomes involved in
negotiating embryo donation or specific embryo creation for stem
cell purposes. CORE is concerned that a growing number of members
of the Authority, as well as subsidiary group members, are now
involved in stem cell research. It is absolutely impossible for
the public to feel comfortable when the HFEA awards members of
the HFEA or peer reviewers or inspectors licences to conduct embryonic
stem cell research, as is increasingly happening.
26. Parliament endorsed embryo research
in 1990 and extended it in 2002, but always under the strictest
conditions. The only way the public can be reassured that there
are no abuses in this area is if there is maximum transparency
in relationship to all those involved in research, and if we can
be reassured that the HFEA has a restrictive or at the very least
a neutral position on this matter.
27. One of the safeguards we would like
to see upheld is that embryos are never used for research purposes
unless it is impossible to do the research in any other way, and
that the use of the human embryo is the only legitimate way forward.
This restriction can be implemented only if there are sufficient
peer reviewers and experts involved in the process of licence
applications who have real experience in animal or adult stem
cells or other alternatives, as well as expertise in diabetes,
Parkinson's, Alzheimer's, heart disease, spinal cord injuries,
blood disorders and the myriad other diseases which it is claimed
will benefit from embryonic stem cell research. Such a Herculean
task is beyond the capabilities of any one organisation, let alone
an HFEA whose principal role is the regulation of the infertility
network.
The HFEA is not professionally qualified to make
ethical decisions
28. We have argued that the HFEA does not
have Parliamentary authority to make ethical decisions, and that
its undemocratic and unrepresentative nature is unlikely to inspire
public confidence on those occasions when it does assume such
a role, but we also argue that the HFEA simply does not have the
academic expertise to make such decisions anyway.
29. Obviously they are well qualified to
deal with matters of health and safety, laboratory standards,
and the various protocols surrounding embryo creation, culture
and cryopreservation, data storage and so on, but ethical dilemmas
of wide and significant social import require a different approach
altogether and should be deliberated by specifically qualified
academics, as distanced as possible from any potential beneficiaries
of the proposed innovations.
30. How such a group might be established
and its ideal composition needs to be fleshed out, but we suggest
that the President's Council on Bioethics would be an excellent
model to look at. It is of high and balanced academic calibre
with an appropriate range of interests represented. It has no
legislative power but functions in a high-level advisory capacity.
31. The French National Consultative Bioethics
Committee is another suggested model. While preparing research
for CORE's Judicial Review of the HFEA's decision on tissue typing,
we found a superb and considered opinion on new developments in
pre-implantation genetic diagnosis prepared by this committee,
in which they addressed the ethical dilemmas of creating tissue-matching
siblings. No such documents have ever been created by the HFEA.
We attach the French Opinion as Annexe B (not printed), as a pdf
file with our covering letter.
32. The United Kingdom Parliament should
set up such a think-tank, with focus on philosophers, theologians
and qualified ethicists rather than scientists. Such a group,
far removed from any possible accusations of conflict of interest,
would address the ever-increasing ethical issues arising in the
field of reproductive technology and stem cell research, and report
its conclusions for the benefit of Westminster and the country
at large.
RECOMMENDATIONS
We repeat CORE'S recommendations as set out
in the executive summary, calling for:
1. A re-statement of the role of the HFEA
exclusively as a regulatory body.
2. A review of the process of public consultation
in the field of assisted reproduction.
3. A thorough inquiry into, and reform of,
the process of appointments to the HFEA.
4. The establishment of a new body, independent
of the HFEA, to regulate and licence embryo research for stem
cell purposes.
5. The establishment of an independent bioethics
think tank to address ethical issues in this field.
May 2004
| 
