APPENDIX 85
Memorandum from Professor Donna L Dickenson,
Birkbeck College, University of London
I have been asked to make a written submission
of evidence, based on my recent research on the French national
bioethics committee, my current membership of the Royal College
of Obstetricians and Gynaecologists Ethics Committee, and my past
membership of several clinical ethics committees in Oxford and
London. I am also the author of some 60 articles and seven books
concerning reproductive ethics and other issues in medical law.
In addition I have led six European Commission projects in medical
ethics and law, including the current EC-funded project PropEur:
Property Regulation in European Science, Ethics and Law, which
examines and compares regimes of property in human tissue across
Eastern and Western Europe. I was asked by the Retained Organs
Commission to submit an expert opinion on personal and property
rights in tissue and have submitted consultation opinions to the
Human Fertilisation and Embryology Authority, the Law Commission
and other policy-making bodies.
Whilst I have sometimes disagreed with individual
Human Fertilisation and Embryology Authority decisions, I am strongly
opposed to proposals to replace the statutory regulatory powers
of the HFEA with a national ethics committee having merely consultative
powers. The HFEA is widely respected throughout Europe and greatly
envied in the United States. It is a valuable counterweight to
a system of research governance which is regarded in the rest
of Europe as quite permissive enough, indeed possibly too lax.
I therefore disagree with the recent claims by Robert Winston
and the submission of the British Fertility Society, both of whom
assert that the HFEA has inhibited research progress. In point
of fact, in such areas as stem cell technologies the UK is a research
leader, with a far more liberal and market-oriented regime than
its competitors within Europe and indeed than the United States.
There is no need to move further down that road, and many reasons
to think that an updated regulatory authority, accompanied by
a national bioethics committee but not replaced by it, is absolutely
essential to deal with the rapid evolution of new reproductive
technologies. Even with the advent of the Human Tissue Authority,
and the ethics governance framework of UK Biobank, the HFEA's
statutory authority will still remain necessary, and its 15 years
of decision-making experience will help to guide the new bodies.
While the UK debates setting up a national ethics
committee to replace the Human Fertilisation and Embryology Authority,
France is doing the reverse: creating a new statutory national
biomedicine regulatory authority, in addition to the 20-year-old
national ethics committee. After January 2005 the CCNE (Comite
Consultatif National d'Ethique) will be joined, or perhaps
outranked, by a new agency, L'Agence de la Biomedicine,
created by legislation passed this past summer. To date the CCNE
has delivered 85 opinions; since 1997 it has had the power to
select its own topics, but contrary to the stereotypical view
of French thought as deductive, most represent current practical
dilemmas and are heavily weighted towards clinical relevance.
Established in 1983 by the decree of 23 February,
and given a formal statutory basis by the "lois bioethiques"
of 1994[306]
and 2004,[307]
the French CCNE has a total membership of 39 persons, plus a chairman
appointed by the President of the Republic. Within the full group,
there are three separate methods of appointment. The first "college"
consists of five members likewise appointed by the President,
"belonging to the principal philosophical and spiritual families";[308]
the second of 19 persons with particular competence in ethics,
appointed by the National Assembly, the Senate, the Conseil
d'Etat, the Cour de Cassation, and the ministries of
Justice, Health, Research and Communication. The final "college"
of 15 members is selected from nominations by the major professional
and research bodies, such as the national academies of medicine
and science, the Institut Pasteur, the College de France,
and the nationally funded research bodies INSERM and CNRS. Although
this third group is meant to be particularly expert in research,
it is not necessarily limited to scientists and physicians; nor
is the second group heavily weighted to philosophers. Jurists
carry considerable authority and are well represented in most
working groups, with a tendency to conflate ethical and legal
thinking by referring to existing law in order to derive ethical
principles.[309]
The 2004 law sets up a new "Agence de
la Biomedicine"[310]
with functions similar to (but wider than) those of the Human
Fertilisation and Embryology Authority. Much of the 2004 legislation
seems at first glance to rely on this agency to ensure that no
ill is done by the numerous relaxations of principle elsewhere
in the statute, such as the greatly expanded list of purposes
for which tissue can be taken as a gift from a living person.
(For example, no tissues or cells can be transferred to any other
establishment without authorisation from the new agency, which
may help to inhibit totally free global markets in biomaterial.)
This is a good measure, in my view, because the new French agency
will encounter a much more commodified situation at its inception
in 2005 than the HFEA did when it began operations 15 years ago.
We already face a situation in which a globalised
trade in oocytes is developing, their shortage for IVF purposes
being aggravated by their current indispensability in the stem
cell technologies.[311]
Amounts of up to $50,000 per cycle have been reported for oocyte
sale, with up to 70 ova being extracted in some cases.[312]
It seems highly likely that poor women in the Third World and
in Eastern Europe will be the targets of this globalised trade,[313]
which is not presently overseen by any international regulatory
agency. In that threatening and troublesome context, two regulatory
heads are probably better than one: both the CCNE and the new
Agence de la Biomedicine for France, and for the UK, both
the HFEA and a national bioethics committee with something more
than merely consultative powers. The HFEA has already taken some
steps towards attempting to regulate this international trade—for
example, by overseeing procedures under which ova are imported
from Romania.
Two questions arise about the remit and composition
of a possible national ethics committee. One concerns the recruitment
of interest groups. Here I would advise caution: the US replaced
its excellent and representative national bioethics advisory committee
with a panel deliberately chosen to be "pro-life", and
thereby lost all credibility in the medical and bioethics community.
We must also bear in mind that our legislation and case law takes
a very different position from the American one on such questions
as abortion and therapeutic cloning, and the members of the group
must presumably adhere to the spirit of our law. This caution
should not be confined to "pro-life" interest groups,
but as the pro-life issues are among the most intractable, their
representation does create the gravest problems in terms of consensus
and effectiveness. We risk creating a situation such as that in
Germany, where research is hampered much more seriously than in
the UK by the implacable strength of the pro-life lobby.
Here again the French experience is instructive,
since the debate over the start of life is if anything more bitter
there than in the UK, with the pronounced division between Catholic
and secular opinion. Each of the three CCNE presidents to date
has laid a different level of stress on attaining unanimity and
on presenting a definite opinion to the government, rather than
elucidating the pros and cons of the argument so that ministers
and legislators can then make up their own minds. Thus, for example,
the second president, Jean-Pierre Changeux, explicitly rejected
the view that the task of the committee was merely to state possible
arguments. That agreement was possible in the 29 opinions over
which he presided was due, he believes, to concentration on practical
regulation rather than foundational debate on concepts such as
the status of the embryo.[314]
Second, there is the question of a referral
function for difficult cases as being within the possible remit
of a national committee. I have served on several local clinical
ethics committees, in London and Oxford, and would say that the
difficulty is speed of response. Many cases require judgements
to be made quite quickly; having to wait for an opinion from a
national committee might be problematic. For example, when I was
on the clinical ethics committee at St Mary's Hospital, London,
we were asked to approve the application for the world's first
hand transplant to be done at the hospital. Having reviewed the
documentation, we had some doubts about the mental capacity of
the patient, and asked for a psychiatric referral before saying
yea or nay. The clinical team decided to bypass this requirement
by having the procedure done quickly in France. Six months later,
it transpired that the patient was indeed psychotic, believed
that the cadaveric hand that had been transplanted was his own
hand, and therefore saw no need to take his immunosuppressives.
The hand had to be amputated. I mention this story to show the
sorts of pressures to make quick decisions which clinical ethics
committees already face from clinicians.
Although the profession understandably and predictably
wishes to regulate itself on ethical matters, medical and scientific
competence is not the same as legal or ethical expertise. There
has always been a certain degree of conflict between the HFEA
and some of the IVF clinics—by no means all—and that
this is only to be expected if the regulator has any power. In
fact the HFEA does have a number of IVF professionals on its board,
and its expertise is further enhanced by the very systematic manner
of its consultations, which have earned it great respect among
most medical ethicists, lawyers, scientists and clinicians.
December 2004
306 (1) Loi no 94-548 du 1 juillet 1994 relative
au traitement de donnees nominatives ayant pour fin la recherche
dans le domaine de la sante; (2) Loi no 94-654 du 29 juillet 1994
relative au don et a l'utilisation des elements et produits du
corps humain, a l'assistance medicale a la procreation et au diagnostique
prenatal; (3) Loi no 94-653 du 29 juillet 1994 relative au respect
du corps humain. Back
307
Articles L 1412-1, -2, -3, -4, -5, -6. Back
308
Article L 1412-2. Back
309
I am grateful to Simone Bateman, member of the committee from
1992-96, for this insight. Back
310
Article L 1418-1. Back
311
Donna Dickenson, "The threatened trade in human ova,"
Nature Reviews Genetics, vol 5 (March 2004), p 167. Back
312
Susan Weidman Schneider (2001) "Jewish women's eggs: a hot
commodity in the IVF marketplace," Lllith, vol 26,
no 3, p 22; Allen Jacobs, James Dwyer and Peter Lee, "Seventy
ova," Hastings Center Report, vol 31, no 4 (2001),
pp 12-14. Back
313
Donna Dickenson, "Commodification of human tissue: implications
for feminist and development ethics," Developing World
Bioethics, vol 2, no 1 (2002), pp 55-63. Back
314
Introduction by Jean-Pierre Changeux, in Didier Sicard (ed),
Travaux du Comite Consultatif National d'Ethique (Paris:
Quadrige/PUF, 2003). Back
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