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Paul McHugh, M.D.
CHAIRMAN KASS: Good morning, and welcome to the
second day of the 7th meeting of the President's Council on
Bioethics, and welcome especially to our fellow citizens, and members
of the public.
I would like to introduce first a
new member of our staff, Carter Snead, whom I mentioned yesterday.
Carter will be joining us in a couple of weeks. He is a lawyer, who
has been liberated from Ropes and Gray to come spend some time with us,
and we will be working on the things that we are speaking about this
morning.
After yesterday's discussion
of topics that have to do with extra therapeutic -- possible extra
therapeutic uses of biomedical technology, we return this morning to
another subject that has occupied us really for -- since the beginning,
namely the question of the regulation of biomedical technologies.
And we are very fortunate this
morning to have not just one, but two distinguished visitors from the
mother country, the nation that has in fact taken the lead in the
regulation of biomedical technology, and we stand to learn a great deal
from their contributions.
I would like to welcome Baroness
Helena Kennedy, who is the Chair of the Human Genetics Commission, and
Ms. Suzi Leather, who is the Chair of the Human Fertilization and
Embryology Authority.
And we will have presentations in
that order, with a break in between. And without further adieu, let me
simply ask Baroness Kennedy to begin. Thank you very much both for
being here.
BARONESS KENNEDY: Well, can I
say immediately on behalf of Suzi Leather and myself that we are
enormously privileged to be invited to join you this morning. And we
know of your work, and we are very thrilled that you want to know
something of ours.
I am also flattered on behalf of
Britain that we are seen as being leaders in this field. Usually we
look to the United States and follow, and we are usually about 10
years behind on most things.
And so it is rather nice for
there to be an area in which we many have some experience from which
you could draw. But I think it is difficult. I always feel that law
is cultural, and the ways in which we deal with issues inevitably are
going to be very different,
But it is useful to hear from
others about how they are addressing the many challenges that there are
as a result of the developments in human genetics. There is no doubt
that with those developments come new ethical, social, and legal
challenges.
And our experience is that there
is amongst the public concern, and they express it in terms of
eugenics, of course, and concerns about human cloning, but they also
express it in relation to privacy, their fears about the invasion of
privacy, and they do want to have control over their own genetic
information, and fears about others having their hands on that genetic
information.
And they also feel that in many
ways the development of science in this area is moving at such a pace
that they really are worried that somehow as a nation we are not
keeping up with the speed of progress.
The Human Genetics Commission,
therefore, was set up three years ago. And I think it is important to
look at the context in which that happened. We have had a very big
backlash against genetic modification of food when the public became
aware that there were many research programs in operation already using
genetically modified processes in food production.
The public felt that they had not
had enough consultation and that they had not been aware of those
developments, and that in some ways there was almost a conspiracy of
silence amongst scientists, government officials, and corporate
interests.
And it became we felt somewhat
inflamed partly because there had not been enough public debate. So I
think that government is very conscious of that, and that dissents,
that way in which progress was taking place without sufficient
consultation and connection with the public interests, that when it
came to human genetics that we shouldn't fall afoul of the same
problems.
And this was particularly
important because on the whole it was recognized that the public felt
benefits in this area, but their apprehensiveness may become somewhat
inflamed, particularly in the way in which our tabloid press often had
headlines describing Frankenstein science and so on.
So the commission was set up
three years ago and as I said, it was set up as really to look at the
ethical, social, and legal implications of the new science, and the
That it would really be giving
advice to government on the issues as they were coming at us. And one
of the reasons that the Commission was established was because there
were already a number of different bodies, there were a number of different committees which were dealing with
these issues, but it was felt that there were gaps between them and
that some issues were falling between those gaps, and that there should
be an umbrella over a number of the committees, and the
Commissioner's role was to provide that umbrella.
The Commission has a wide range
of experiences, rather like your own committee. It has on it really
people who are drawn from ethics, law, industry, patient groups,
consumers, social scientists, geneticists, and other health care
professionals.
And that really was to reflect
what we saw as being the central issues. I was appointed as the Chair,
and the way that appointments took place was that there was an
advertisement in national newspapers and through journals inviting
application to join the Commission, and people did in quite significant
numbers apply to be on the Commission.
And I was publicly, or not
publicly, but privately, but I certainly responded to the invitation to
apply for this role, as did a number of people. And we were
interviewed, and there was an interviewing process, and I was
eventually appointed.
I would like to think that's because, as a lawyer, I might ask difficult questions. But also it
is fair to say that I have a background in human rights, and it is felt
that at the heart of this there are many human rights issues.
So the Human Genetics Commission
was established, and we have two ministries to whom we answer; the
Ministry of Health, and the Department of Trade and Industry, which has
within it the responsibility for science.
And so I have two specific
ministers to whom I relate, and with whom I meet on a regular basis.
The Commission, although established by government, and although
responsive to those two ministries,and indeed receiving our funding
from those ministries, is seen as being at arms-length from government.
And the idea is that there may be
times when we will give advice and we will give it publicly, but advice
which would be uncomfortable to government. And again I like to think
that one of the reasons for my appointment is that I am seen as being
someone who is prepared to sometimes say some of the things that might
be uncomfortable for government to hear.
There has been at the heart, if
you like, our mission -- and it was very clear to us when we were first
established -- that it was important for the Commission to engage the
public in debate, and it was felt that there was insufficient quality
debate on these subjects.
And the way in which debate had
been conducted was really at a very sort of slight level, often rather
hysterical. So the challenge to us was to have a public debate, and
the difficulty then of course is all of the difficulties that you
yourselves know about,which is that in order to do that
it is very time consuming, and it can be very demanding on the
Commissioner. But we are anxious to take up the challenge.
It is often the case that those
who will participate are people who already have a degree of knowledge
and learning on the subject, or whose families have already got a
reason to be interested in genetic issues, because there might be
persons with genetic traits in the family.
But we were trying to get the
debate beyond interest groups, and to reach a wider public, and I think
to some extent that we are having some success on that.
What we do is that we now hold
our meetings rather as you do, and we learn -- here we have certainly
learned from the United States in that, as you know, we did not have a
Freedom of Information Act like you have until very recently, and all the debate about the
creation of a Freedom of Information Act meant discussion about how
much more public government meetings and so on should be. So we
decided to hold all of our meetings as you do in public, to have
available the minutes of the meeting on the website, and to have the
agenda on the website, and to as much as possible do everything in the
open.
And that has been an experiment
in Britain, and it is not how things normally are conducted in
Britain. We have a culture of secrecy about most things, and so this
has been an almost revolutionary process in the public domain.
We take the meetings all around
the country, and that is much easier in Britain than it is here in the
United States, but we have held our meetings in Scotland, and in
Northern Ireland, in Manchester, in Bristol.
We have taken the meetings up
around the country, and the idea is that people have the opportunity of
coming, of listening, of seeing what the issues are, and watching the
nature of the debate, and how it is conducted.
We also have opportunities of
particular events happening, where we invite, for example, younger
people, people who are students, and high school people, to meetings so
that their views are also part of our consultations.
We have recently established
something that we call a consultative panel, and the reason for this
was that we felt that we wanted to draw in the interest groups in a
much more productive dialogue with the Commission.
There had been an original
complaint when the Commission was established that interest groups were
not represented sufficiently on the Commission. There are a number of
people on the Commission who, in fact, in their families do have genetic
traits by the way, and there is one member of the group who is on the
Council of the Genetic Interest Group.
But it was felt that that was
insufficient by many of the groups. And even within the Genetic
Interest Group in Britain there are, if you like, dissenters, and
disagreements on some of these matters.
And it was felt that those
disagreements and different views should be represented. Well, we felt
that to turn the Commission into an organization or into a committee
which was representative rather than in which you drew together
expertise was not going to be very useful, and could become impossible
because it would have to become so large.
The Commission at the moment is
16 strong, and the only representation as such that we have on it is
from the involved nations, so that we have a member of the Scottish
Health Ministry, the Welsh, and the Irish, and so there we do require
representation.
But apart from that we have
sought to retain as a body of expertise and of interest, but not
representational. And so the consultative panel draws in, and we
invited people to apply to come on to, and there are 110 people on this
consultative panel.
They interact with us by way of
e-mail, and also we have just recently had a big meeting to which they
were all invited, and which their expenses were paid for. So it is a
way of engaging a bigger group.
But again not as a part of the
internal commission, but to draw on their interests and concerns, and
to make sure that we are really tapping into those who have a knowledge
somewhat and what their concerns are.
I think the setting up of the
Commission was in many ways quite a courageous move by government, and
I think that they do feel that it has been very positive, which
isn't to say that there have not been areas where they have been
sensitive to the ways in which we would want government to proceed.
The first issue that affected us
was an issue concerning insurance, and this was or this related to
whether or not there should be a moratorium in relation to the use of
genetic tests by insurance companies.
Previous committees had looked at
this, and sort of in some ways we felt had perhaps dodged the ultimate
issue, and sought to find other ways of dealing with it, saying that
perhaps they could only use tests which had been passed by a particular
committee.
And so by the time that we were
established only one test had been passed, and that was the test in
relation to Huntington's Disease. But there was a great deal of
public distrust about that formulation.
There was a sense in which they
felt that although this had been agreed by the insurance industry, that
there certainly was evidence to suggest that it was not being followed
by all parties of the industry.
It became known that a particular
large insurance company was indeed using the BRCA-1 test in relation
to breast cancer, and we were very concerned that if something was not
done very quickly on the area of insurance that public distrust was
going to grow.
And so in an initial polling, we
found that this was one of the things that was spoken of, and almost at
the time of the list by members of the public, and worry that insurance
companies were stacking premiums against members of the public when
using genetic tests.
And this was somehow an area out
of -- that was going to be out of control. So, I had meetings, and the
Commission had meetings with the Association of British Insurers, and I
think that was with a great deal of encouragement and a report which
indicated that we would in the end have to be minded to ask government
to legislate for a moratorium. And insurance industry agreed on a
voluntary moratorium for five years.
And the moratorium is that they
will not use genetic tests, saving policies over a certain limit, and
that is set high, at half-a-million pounds life insurance. They can
use genetic tests then.
Critical illness insurance, over
300,000 pounds. But apart from that, genetic tests can't be used
and will not be used on a voluntary and agreed moratorium for five
years.
And the preface of that was to
give time to look at the implications of this in terms of social
policy, and public policy. And to look at whether, for example, would
premiums increase the board if it were not possible for insurance
companies to use such information.
And to look at the arguments,
which are that in any event genetic information is used by insurance
companies already, and given that family histories are taken. But for
Britain there are special questions, and perhaps rather different from
those affecting you here.
But they relate to the reforming
of the welfare state, because given the way in which our societies are
changing, and with the age frame changing, and with people living
longer lives, and there being more older people and fewer babies being
born, and so on, there are real issues for the British welfare state.
And there is a ruling back of the
welfare state and we are seeing it on a number of different fronts.
And what is anticipated is that people will be making more and more,
and taking control of their arrangements for their old age.
And in doing so the insurance
world will have a much greater role to play. And so in those
circumstances, should or should not genetic tests be used by the
insurance industry.
So those are matters which we
really have to engage with the Treasury that was going to be involved,
and the whole question of our economic arrangements, financial
industries, and so on. And so there are serious big picture issues
here which we felt that we needed time to look at, rather than rushing
to either abandoning, or, if you like, a permission.
And so we want to properly debate
about it, so that the public are well aware of what the long term
consequences of any decision might be. So the moratorium was one of
the first things that we were involved with.
The other issue that we took on
immediately was as a result of consultation and it was about privacy.
And we published in May of this year a report called Inside
Information, which I hope that you received. And this is
a report on personal genetic information, and we put a lot of time into
this report because the public had expressed their fears that genetic
information could go into the hands of people that they wouldn't
want their genetic information to be received by.
And we felt that this was very
important, because it was interesting, and that in consulting with the
public, we had a big consultation exercise at the beginning of this
work on privacy.
And the public on the one hand
are very excited by the possibilities of genetic finds providing
perhaps wonderful cures for disease, and therapies which will alleviate
or ameliorate disease.
They see the benefits in a very
real way, but as against that they are very fearful of what the
consequences would be of their information, as I said, getting in the wrong
hands.
They are very suspicious of
government, and of the corporate world. They are very worried about
the ways in which they feel they would be disadvantaged or
discriminated against if information were to reach into areas where
they would not want it to reach.
So it was actually showed that on
the one hand
-- I mean, it was very interesting and somewhat contradictory. On the
one hand, 9 out of 10 people were saying, "wonderful," that genetic science
is making these great developments, and that we want cures for disease,
and we want all the good stuff.
And at the same time, and in
amongst those same people, there were a third who said that in fact
human genetics was tampering with nature, and that it was unethical,
and that they felt that it really in some ways affronted some of their
deepest beliefs.
Three-quarters of people, of the people that were consulted, felt that
they had too little information or controls were in existence, and that
they had little or no confidence that the rules and regulations which
did exist were keeping pace with developments.
So it was on that basis that we
really did have a look at how we would deal with the issues of privacy,
and how we would create much harder -- you know, much more solid walls
around medical information.
The other issue for us was that
in Britain that we are embarking on a very important research project
called BioBank. It is a project combining the Medical Research Council
and the Wellcome Foundation. And the idea is that some half-a-million
people across the country and around the country will be invited to
take part in this research project, and to give samples, which will be
anonymized.
And it is a very important
research project because of course it is about the epidemiology of
disease, and to combine it with genetic knowledge.
And in order to encourage people to participate in that, we have to
make sure that we address their concerns about privacy.
And at the very same time, and
within the National Health Service, we have and we are embarking on an
upping of the use of technology, and there are going to be much more,
if you like, developed systems for retaining information on patients,
and on the patient's body.
And indeed the National Health
Service's medical records are of great use to people all over the
world. I mean, many researchers here in the United States go to
Britain to do epidemiological research because we have got it over
there very nicely, neatly, and tidily in our medical records.
And these will be more easily
accessible once they are computerized in a very coherent way. So the
fear is that that sensible use of technology and the keeping of medical
records in many ways makes the individual or the citizen more
vulnerable.
So how do we deal with that
issue? And we really have tried to formulate some sensible proposals to
government about the tightening of those restrictions, and we have made
recommendations about the creation of a criminal offense for anybody
who would make sure of genetic information with either obtaining
genetic medical information by deception, or without proper consents.
Now, I want to deal with some of
our reasoning for that, and that I think that we were very conscious of
a case that had taken place in Scotland, which is where I hail from,
and there had been a case involving a man who had AIDS, and
transmitting the disease to a woman through sexual intercourse.
And having been asked by her on
what his position was on basically not revealing the fact that he was a
sufferer. And he was prosecuted criminally, criminal prosecution. And
the way that he was establishing that he was someone who had been HIV
positive was through an anonymized research project which had taken
place in prison, while he had been in prison for another offense.
And he had taken part in the
research program on the understanding that it was going to be
anonymized. His anonymity was decoded and it was by that process that
it was possible to bring the prosecution against him.
That case was Regina versus
Kelly, which was not appealed, and so it is still the first
instance of a High Court case in Scotland. It did, though, set up alarm
bells about the way in which in certain circumstances though could be a
decoding, a de-encripting of even anonymized research.
And so different interest groups
expressed concern that anyone taking part in research might actually
make themselves vulnerable to all sorts of other possibilities.
So we then looked at that issue
of wrongfully, and without proper consent, making use of genetic
information. We also looked at what we saw as being real risks that
people might want to access the genetic information of public figures.
Politicians, and people in the
public limelight, wanting to show whether they had indeed fathered a
child or not fathered a child, and whether in fact they may be people
who were carrying a particular genetic trait.
And if someone thought that a
senior politician was someone who carried a trait for some sort of
something, like Huntington's, that maybe people when that person
was still 30 might want to preclude them from taking part in public
life. I mean, one can imagine different circumstances.
Now, those are the ones that are
rare and unusual, but a much more obvious one is one that I think you
are familiar with here in the United States, which is that people would
take a sample from a child in order to prove that the assumed father is
not indeed the father.
And what concerns us in Britain
is that that can be hugely damaging to the child, and we are looking at
this from the point of view of the well-being and the welfare of the
child.
That while it is right that a
father should be able to establish whether indeed he is the father or
not of a child, that should be done through the proper processes,
through legal processes through either agreements through lawyers,
obtaining proper consents, and applying through the courts.
But not in ways which could be
inimical to the interests of a child, especially if it was thrown into
the child's face or the mother's face in the presence of a
child, and the long term consequences of that for a family.
Because one has to remember that
it isn't just a father who might do that. It could be an
interested mother-in-law, or a relative who has suspicions about a
child, and whether indeed the person who claims to be the father is the
father.
And I think that our concerns
were that this has to be managed properly and that it may be that one
would have to look at the creation of a criminal offense for obtaining
genetic information by deception, or without proper consents.
The other thing that we felt may
be required would be to create even greater obligations on medical
practitioner and those associated with medical care, and their
responsibilities and duties may have to also be regulated in some
stricter way.
Now, the question that you may
all ask is, "well, is genetic information really so different from other
medical information?" And I think that we could probably answer the
question by saying that it is not considerably different, but there is
something different about it, in that it does have a much
greater impact, and a clearer impact on others within the family or
others that are related. The other thing is that the perception of the
public isn't as different, and I do think that we can not be dismissive
of public perceptions.
So we have been involved, and
have completed that report, and we have established a number of
principles around the privacy of individuals, and I think it is all
there in the report which I sent through to you.
The issue that we are now dealing
with is the one of -- and we have been asked to do this by government,
is to look at over-the-counter testing. And one of the reasons for
looking at this is because it already is beginning to happen in
Britain.
I know that it is probably much
more familiar to all of you, and what we have been having a public
consultation on, and at the moment being assessed, and the issue here
is again around whether or not there should be a difference between
some tests being available over the counter, as distinct from perhaps
more serious tests.
Where we would really go would be
counseling, and we would want, if you like, a medical intermediation so
that people can really understand what a test is telling them.
Our fear is that some people will
be overly concerned by results from a test, and read them in a much
more worrying way. Or in fact they have been given a clean bill of
health, when in fact there are matters which should be understood and
be more concerning than what might first appear.
And so we feel that there are
different kinds of information and what we are looking at is whether
some of them should be only available through medical practitioners and
not just available over the counter. But again it is an issue of the
market, and a sense in which why should members of the public, and not
themselves, be the determinants of what tests they want to take part
in.
And they are well-enough
informed, and surely they should be the people making decisions. So
those are the issues affecting us just now in relation to this current
issue, and we will be advising government by the end of the year.
The piece of work that we are
then looking at is a very major area, and it is about reproductive
choice in genetics, and Suzi Leather will go on to deal with this under
the banner of her own committee's work.
We are really looking at the
ethical issues connected with ways in which people could make use of
genetic testing to enhance their children, or making choices as to
gender, for example.
And those are the ones where we
really do feel that there should be real public debate, and a sense of
the public's concerns. We do think that there is a shift taking
place.
A number of years ago, I think
some research -- and Ms. Leather will deal with this -- that there was
some research that the public, that there was a real unwillingness
for people to be able to make choices even on gender.
However, that somehow has been
ameliorated over a number of cases recently, where people who already
have a family of say, sons, might want to have a daughter, and in small
polling, it seems that there has been something of a shift in that
area.
But this is the big one that we
will be looking at over the next 12 months. So that really is the work
of our Commission. I am very happy to answer questions from your
Committee on our work, and I hope that this might be the beginning of a
greater collaboration between our two countries on these very important
issues.
CHAIRMAN KASS: Thank you very
much. Why don't I simply open the floor for discussion and hold my
own questions back. Frank, Frank Fukuyama.
PROF. FUKUYAMA: Well, Baroness
Kennedy, thank you very much. We really appreciate your coming
to speak to us. You know, I teach a course, and it is a basic graduate
-- introductory graduate level course-- in comparative politics, a lot of which is why the
United States is so different from Europe.
And it seems to me that this is a
perfect illustration. And one of the areas in which there is a
consistent difference is in interest groups, or the nature of interest
groups, so that you tend to have peak
associations in Europe, and interest groups are organized, much more
organized than they are here. And I was thinking about that insurance
case that you were talking about, and whether it would be even
conceivable to do something like that in this country, where you could
get a voluntary agreement on the part of a large sector on the basis --
I mean, I am trying to imagine.
Let's say that our council
decided that you needed similar rules or restraint on the part of the
American insurance industry, and Leon was to pick up the phone.
Who would he call, and what would
be the interlocutor on the other side that will allow you to suggest
that in lieu of actual regulation, or legislation, that they consider
adopting this kind of a voluntary ban.
And I think that if you try to
imagine that as an American happening, you just realize why our system
is so completely different. But I just wanted to ask you a little bit
more about that particular case.
You don't have any regulatory
power to enforce a ban. So, first of all, who do you talk -- who is
your interlocutor on the side of the insurance industry, and did this
depend on a kind of implicit threat of regulation by Parliament if they
didn't, and if so, how explicit was that?
Or was this just one of these things that can happen in Europe, and in
Japan, where there is enough deference to the authority of government
that this comes about?
BARONESS KENNEDY: It is almost
like giving away one's advocacy secrets if you are a barrister in
the courts, and you are always somewhat unwilling to do that.
But the truth is that I met with
the Association of British Industry, which has a body representing by
and large the whole of industry. I mean, there are pockets of the
industry which don't belong, and they were or would be described as
carpetbaggers. But by and large the industry does join together under
the banner of the association.
And I think that our insurance
industry is feeling a little bit beleaguered at the moment, with a
number of scandals on life insurance and so on. So I think that there
is a willingness to have -- you know, there is a real feel that they
have to win back public confidence.
So that was one of the good bits
of the picture which I was able to, if you like, draw on, is that here
was a way of the insurance industry showing that actually it was more
concerned with the public good.
But I can't pretend that I
didn't hold toes to the fire, and the way of doing that was to say
in the end that I will be advising legislation, because if you
don't do it on a voluntary basis, time has to be bought because we
are in the process of reforming the welfare state, and until we have a sight of just
what is on the horizon, you may find that legislation is could be much
worse and more much detrimental to you. So this is the best way of at
least holding, or not to say in the past, but holding on to some
possibilities for you.
So at the moment we have -- we
have persuaded them that it was in their own interests to do this. So
rather than a deference to government, you know, passively, it was
really because it was seen that government just now needed time in its
development of its reform agenda.
CHAIRMAN KASS: Paul McHugh
and then Michael.
DR. MCHUGH: I also want to thank
you very much for coming and telling us about your enterprises and your
travails and I wanted to pick up an issue that you mentioned, and would
like to hear you develop it. You said that the issue of genetic
information, particularly in the insurance arena, was seen by the
public as different than the ordinary information that the insurance
companies do take.
I presume in Britain that they
measure people's blood pressure and they take a urine sample, and
things of that sort, and if the urine has sugar in it, and the blood
pressure is about 140. they alter their plans. Is that correct, first
of all?
BARONESS KENNEDY: Well, that is
correct, but more. The insurance industry in Britain, and I am sure or
I am assuming that it is the same here, but it may not be, will also
ask what did your father die of, and what did your grandfather die of,
and what did your mother die of.
And is there any illness in the
family, and has anybody had cancer and so on, and the profile that is
created is really giving genetic information in any event.
DR. MCHUGH: Yes, that's
right, and so this issue of public perception about genetic information
is the crucial matter, and through your wonderful means of persuasion
and pressure, you have produced a period of voluntary moratorium, and
you chose five years.
I wanted to know two questions.
Why five years, and what is actually happening during this moratorium
to either enlarge the public's understanding of this issue, the
place of genetic information and how it can be perceived inaccurately
by the measures that are now being used, and more accurately, and
perhaps more benignly, and in more direct ways, and also in the opposite
direction. Why five years, and what is going on during the
moratorium?
And also because we felt that
within five years that we may have a better sense of the tests which
are really going to make a difference, because as you would all know,
the majority of genetic tests are multifactorial, and therefore to read
anything very predictive from them is going to be difficult in any
event.
So we felt that within five years
that we should have a fairly good idea of whether this effort was going
to be solid, as distinct from a bit more amorphous.
We felt that gave some time for
the insurance industry, along with us, to have much more public debate
about those very things that you are talking about. The public at the
moment seemed to feel that genetic tests are very different.
And what one wanted to do was to
have more discussion about that and more debate, and to some extent I
have been encouraging the insurance industry itself to take a lead on
this.
I have been saying to them that
you, too, should be doing research, and it should not all be left to
government. And I am afraid that has been more of a tendency in
Britain.
That when it comes to research
and things like that, that it is then government, and government
bodies, and academic bodies that should do it. So I have been saying
to the insurance industry that you must conduct your own research and
so why it is in fact in the public's interest for this, and that it
will be more expensive to the public as a whole.
That there are other ways in
which you could meet if you like the needs of this small number
comparatively of people who may have single cell diseases and so on.
And that there are devices and
ways that you could deal with that, but you have to be creative, and
you must come up with some ideas, and don't leave it all to us.
And so the five years is not seen
as just being a sort of time for government to think. It is also a
time for the insurance industry to get its act together, and to learn
advocacy skills itself about what its purpose is.
DR. MCHUGH: I think that is
wonderful, but how are they doing it? Are they waking up to their
responsibilities even if driven by corporate interests?
BARONESS KENNEDY: Well, it is
interesting that I have met with -- you know, we have a body of
actuaries and they, for example, are doing a great deal of work that
they think will support and help the insurance industry in this.
Also, people are coming up with
schemes which are to prevent discrimination, and to help if you like
either by having -- I mean, to have the government create a safety net
for the few, or the insurance industry itself creating if you like a
safety net for those who would be in that small category of single cell
diseases.
And it is also a question of
whether genetic tests might not be, or even genetic histories, might
not be used in some areas at all. And so they are looking at the
products that they could create which could deal with some of these
issues.
And at the moment, I think that there has been a lot of anxiety that
there might be a complete ban, as there is in some parts of Europe. So
I think there is some creative thinking going on.
CHAIRMAN KASS: Michael Sandel
and then Dan.
DR. FOSTER: As you have
hinted, there are or is genetic information just from history about the
genetic type of the family that may give you some hint about the genotype there, and that is always going to be available.
But if one looks to the future --
I mean, that seems very reasonable for the insurance companies to have,
but if in fact genetic testing moves much further along, and I
don't know whether this is going to ever happen or not, but at
least in principle -- people are talking about because of the availability
of DNA arrays and so forth, that might one in some sense develop a
whole genetic history of an individual person.
And in a small country, you can
get extremely valuable information. The question I want to ask is if
you have given any thought to the encryption problem, in terms of
hiding genetic information. As far as I can tell from reading, the
Icelandic experience is the prototype here.
And everyone who has looked at
this thinks that it is really as secure as anything could be. And
there is powerful new information coming about. For example -- and I
don't know whether it is true or not -- but I mean there are ideas
that you have the suspect genes for schizophrenia and so forth that
vary a little bit from workers in this country that I know.
I mean, most gains in Iceland
seem to be a little different from the schizophrenic or depressant
genes that are being isolated here. So I guess the question is that it
seems to me that that sort of pervasive genetic information, if it ever
comes about, would be much more critical to protect than measuring a
Breast Cancer-1 gene or something like that or a Huntington gene.
Because it would have potential
implications even for polygenic illnesses if you looked at that. Now,
I don't know if there are going to be enough computational
biologists to ever do this.
I mean, the greatest shortage in
science right now is computational biologists that know how to assess
all the genetic changes, and it is a specialty that is very narrow, and
very sophisticated, and it may not be available.
But the bottom line question is,
is your Commission beginning to think about how this genetic
information might be encrypted, and would you in your own mind consider
the Icelandic model as something that you might follow?
I realize that in a large country
like your own, compared to Iceland, that may not be applicable.
BARONESS KENNEDY: Certainly that
is one of the things that we have put on a list as being an area that
we would like to look at, and we are very conscious of the problems
surrounding encryption, and at the moment we certainly have not
embarked on any work. The resourcing of our Commission makes that
difficult.
It is an area of concern for us
though when we actually look at and consider what we think are ethical
issues on the horizon. We certainly think that those are the ones that
are going to be particularly difficult, the ones around things like
mental illness or the trait or potential for mental illness, and
behavioral traits from what has just been done by
the Nuffield Foundation on Bioethics, which is a very good piece of
work which I would recommend to you, and which I am sure other people
have done work on in this country. And it is a matter of
concern to us also in the area of crime detection, because we perceive
a possibility that it could be, for example, made use of in that area,
too.
So it is certainly something that
we have on the horizon as an issue that we would want to engage with,
but at the moment, we have done no work on it at all, and the only
people that have been the Nuffield Foundation.
But I didn't mention, and let
me do so before I forget, but one of the areas that does concern us is
the use of DNA in crime prevention. This is an area where the general
public are very enthusiastic about genetic purposes and uses.
They feel that if it can be used
to catch criminals, then terrific. Given the enthusiasm, our
government has gone much further than any other government, in that we
passed legislation a year ago which allows for the retention of DNA
samples, even of those who are acquitted of crimes, so that it remains on the
databases, and in the databank, even when someone is acquitted. But
even more interesting, is that we in Britain conduct intelligence
screens, where, for example, if a child were killed in a village, all the
men in the village might be invited to give a genetic sample so that
they can be eliminated from investigations.
And in Britain, and I know that
it doesn't happen in the same way here, but in Britain people will
all step forward and participate voluntarily. And now under the new
legislation, they will sign a consent form.
And their genetic tests will be
kept forever on the database, too. So we have, and we are expecting,
that before long 1 in 15 people will be on the database, and most of
them of course will be men. So a high proportion of British men will
be on the police database.
It has raised a very interesting
debate in Britain, which is that if you are doing that, and a lot of
people who are not convicted of crimes are on that database -- and many
of them because of their good will in volunteering samples for
elimination purposes -- there are two issues.
One is whether there is an
informed consent, and if somebody actually volunteers and says, "take my
sample, because I want to help the police, and I certainly don't
want to be looked at suspiciously by refusing," is it an informed
consent if it is given in the heat of an investigation.
The second thing is that people
have been saying, "well, look, if you are taking all these samples in
this way of anybody who is suspected or in any way is in the purview of
a criminal investigation, why don't you just have a sample taken
from everybody in the nation?"
That is fairer than having only a
percentage of people, some of whom have not committed a crime at all.
Otherwise, you create if you like an unevenness and the sense of an
injustice on those who are in there, and their brother isn't, and
yet they have never committed a crime.
And we are a rather passive,
gentle nation it seems, because nobody has become particularly alarmed
enough to make enough of an issue of this. But it is very interesting,
because as you know what happens with genetic samples taken for
criminal investigation is that a bar code is created.
And the bar code is made or is
created in what I would call as being described as junk DNA, DNA that
would not tell you anything about a medical history. But the bar code
is kept on a computer, and of course a bar code is taken for any sample
found at the scene of a crime.
But when they take a sample from
a suspect, or from anyone who takes part in an intelligence screen, the
sample is also kept. And the sample is kept in the freezer somewhere.
I argued, because I am involved
in Parliament, and that I am a member of the House of Lords, and I
argued at the time that this really had serious risks, and I didn't
think that people were debating it enough. That if you are keeping the
samples, then what is the rationale for that?
The rationale given by government
was that the samples are kept in case the computer goes down, and your
bar codes is somehow messed up. And the answer given was that you
sometimes on the bar code, you are getting -- that it is not being made
clear enough and you might want to go back and see the sample to make
sure that the bar code has the clarity that is required.
Well, I think that it was
disingenuous, and I think that the real reason is that they want to
keep the samples because as science is developing in the way that as
Dr. Foster was saying, is that, there may be uses to which the samples
could be put.
If at the scene of a crime you
find a sample, and you think that sample is suggesting that the person
who committed the crime carries a trait for a Tay – Sachs, and is
somebody with red hair, then you want to be able to go to your bank,
your police bank, and look through it and see if there is anybody on
the bank that fits that description.
The other risks, of course, that
the public is going to see before very long is that if they have access
to medical records, then any of us can then be looked at.
Now, the answer that is given by
lots of people in the public is, "well, so what? If you have got
nothing to hide, why should you worry." But of course any of us
concerned with civil liberties know that there are risks in all of
that.
But at the moment in Britain, I
think we probably have a much more liberal regime than anywhere else in
the world, in that we keep the samples and we keep the bar codes of not
just convicted people, but people who have in any way been investigated or
voluntarily participated, which is quite an extraordinary development, and one that I would be
interested in hearing your views on, but I suspect that I can imagine
them. And I did come into it with the FBI here in the United States at
one stage, and they thought this was extraordinary that this was
happening in Britain, and they were in fact quite jealous, and said that in fact that they
had had an experience once of a murder taking place in a hospital, and
they had hoped to do an intelligence screen of all of the people who
worked in the hospital, and they refused to take part.
And it is very interesting, and I
think it is divided into a different cultural experience, and that
people in the United States are much more conscious of the potential
for the invasion of privacy; whereas, people are much more I think
accepting in Britain.
CHAIRMAN KASS: Thank you.
Michael Sandel.
PROF. SANDEL: Well, I would like
to make an observation drawing on the comments and questions about your
project on the use of genetic information by insurance companies, and
then ask a question on a different topic.
We have not put on our agenda the
question of the use of genetic information by industry or by insurance
companies, though we have had some discussion, and our colleague, Mary
Ann Glendon, who isn't here, has been a big advocate of including
as a project the questions about the commercialization of the body and
of genetic information, under which this topic would fall.
And I think the interest that you
have sparked around the table in this question suggests that it may be
something that we should discuss as a possible topic, and Paul McHugh
suggests that maybe the public perception is inaccurate and should be
dispelled.
But there is or there may be
something to it worth investigating, because there is a very
interesting philosophical question about the extent to which insurance
as a social practice should pool risk, or individuate risk.
And obviously the companies have
in their interests to use whatever device that they can to individuate
and specify risk. But there may be social interests in resisting
certain extensions of the individuation of risk in the provision of
insurance.
And that raises all sorts of
interesting and important ethical and social questions that I think
might make a worthwhile project for us to take up.
So I think that you have prompted
us or certainly me to think more about that, and I think based on the
reaction around the table that others might find this of interest as
well.
I have a question on a different
topic. In the packet of information that was provided in connection
with this session was the Human Reproductive Cloning Act of 2001,
adopted in the U.K.
And this was the law that banned
reproductive cloning in the U.K., and I was struck by the simplicity of
the legislation, which says very simply that, "A person who places in a
woman a human embryo which has been created otherwise than by
fertilisation is guilty of an offense."
So in one sentence, the law. And
the reason that it struck me is that here we have had endless, endless
debates because there is widespread consensus in this Council and in
the U.S. Congress to ban reproductive cloning, just as you have done.
But what has prevented its
happening is a concern, is an objection, that to ban reproductive
cloning by law would somehow implicitly permit or endorse a much more
controversial practice, namely the use of cloning techniques for
biomedical research.
And the argument has been raised
in this country that we couldn't possibly ban reproductive cloning
simply as you have done with this one sentence law, because that would --
to pass such a law would implicitly sanction, or permit, or endorse,
cloning for biomedical research. Was that objection raised in Britain?
BARONESS KENNEDY: Yes. But
really you have got to remember that this is set against a history, and
that one sentence bill was the culmination of many debates, and we had
already agreed in Britain -- I mean, it goes all the way back to the
Warnock Report which I thought one of your colleagues had.
And when we had originally
decided to legislate for in vitro fertilization, we started a process,
and in that process we created the authority which Suzi had, which is a
regulation authority.
So we have already gone down the
road of regulation, and we are well down it. I mean, you know, we are
over 10 years now there. And having done that, we have had many
debates along that road.
And we have a big set of debates
about, should the authority be able to allow for research in the area of
therapeutic cloning, and we had that debate that you are talking about
in relation to that.
So that before we ever got to the
creating of that act of Parliament which you have just read out, which
banned human cloning, we already had had a huge debate in Parliament
over whether the Human Fertilization and Embryology Authority should be
allowed to authorize this kind of research, because it is the
regulatory body which has that within it some control.
And there were many people who
felt that this was a step too far, and others who took a different
view. And of course you have got to remember that in our Upper House
you even have the Church represented, in that you have the Bishops
there, and it was very interesting hearing the arguments placed by, for
example, the Anglican church.
But there were great reservations
by many people, but at the end it was felt that in the -- if you like,
that in the balance of benefits and losses, of rights and wrongs, that
society -- that the benefit that could come to society, in terms of
ameliorating disease, and the pain and wretchedness of that, that if
the research was restricted only to research which was directed towards
serious disease, then it would be allowed.
But only in those very strict
circumstances, and so that debate had taken place, and really this bill
was because some people said, "Okay, we have given that, but we
haven't anywhere ever said that as a people we are abhorred by the
idea of cloning, of human cloning, and we want that declaratory
function of legislation to be present somewhere."
And that's why that bill came
into being. It was really a declaration to the world that we are
against human cloning, rather than really starting an approach as an
engagement on the issue of cloning.
We had been through all of those
debates, and we had allowed for very restricted research to take place,
and that had all been passed through Parliament.
And so then the final question
was, "Don't we need to have something that says in a declaratory
fashion that human cloning is abhorrent?"
PROF. SANDEL: So that what
happened was that there was a separate debate, if I understand you, a
separate debate on the highly contested issue of cloning for biomedical
research, which ended in permitting it under some very special
circumstances, subject to regulation and so on.
But having had that debate as a
separate debate enabled you to pass this law.
BARONESS KENNEDY: Yes.
PROF. SANDEL: And when this law
came up in Parliament were there those who opposed it because they
disagreed with the outcome of the other?
BARONESS KENNEDY: No.
CHAIRMAN KASS: I have --
BARONESS KENNEDY: It passed
through Parliament with great ease, because there was a general
consensus that human cloning was unacceptable.
PROF. SANDEL: And everyone
accepted the distinction between these two separate issues?
BARONESS KENNEDY: Absolutely.
PROF. SANDEL: Thank you.
DR. GÓMEZ-LOBO: Can I raise a
question? But the other one is human cloning as well. So what you are
really talking about are the intentions of the researchers when they
clone, right?
BARONESS KENNEDY: Yes, but I
would like for you to address those questions to Suzi Leather, because
I think that she would -- and not because the Commission shirks them, but because we actually do see a
very clear distinction between the creation of embryos in those lay
moments of creation, which we feel as being different from the
situation of implanting them into a woman so that they actually do grow
into human form, and that is the difference.
There is no way that we feel that
you can ever meet the profound beliefs of those that feel that at the
point of conception life is created, and that is sacrosanct.
And I think it is wrong to try to
persuade people that they are wrong. People believe that and should be
allowed to believe that, and respected for their belief system.
Then you have to say, you know,
that there are also people who believe that that life does not have
potential because it has not yet been implanted into the womb of a
woman, because it is that process of growing in the womb of a woman
that is going to determine this potential life into a real life.
Now, you can't meet those
two, and we are talking about theology, and you can't marry up
those two arguments. And we can sit and debate them forever.
You have to at the end of the day
see whether you think that those are -- you have to make an argument
about your morality, and at the end in Britain, the general feeling was
that the morality that says alleviating the pain and misery of so many
people who have disease is such an important good for society that in
very restricted circumstances, if you like, the thing that people might
see as not so good, of having research on cloned embryos is if you like,
a wrong that somehow has less moral horror because of the good that
will come of it.
And that is a balancing act and a
decision that people have to make, and some people will never find it
as being something that can be reconciled for them. And our society
has chosen a particular way and your society may choose in another way.
And there really seems to me to
be -- there has to be a recognition that at some point that you make
your choice.
DR. GÓMEZ-LOBO: Of course, this
is a very big debate and I have always been very happy to embark on it,
but let me make just one little point. I don't --
BARONESS KENNEDY: We could talk
about it forever, and so -- I mean --
DR. GÓMEZ-LOBO: Well, I
don't know about forever. One little point I want to make at this
time is that that is not what I make or what I hold, or as people hold –
not a theological statement.
The debate in my opinion should
be conducted on the basis of embryology. I think the 14 days is a much
more magical and theological date than anything else. But we will
proceed.
CHAIRMAN KASS: Actually, I
put myself on the queue and it follows up on this discussion, and I
want to abstract from the question about the embryo, and to make the
more general question about -- I mean, the commission is more than an
ethics commission and has other responsibilities.
But insofar as you do advise on
ethical grounds, on which moral considerations play a part, how do you
actually go about that? And in particular in this regard: in passing you said there seems
to be a shift in where the public is, for example, on the use of new
technologies for sex selection. And that led me to wonder whether or
not the Commission regards itself as finding out where public opinion
is on the ethical questions, and enshrining it.
Or does the Commission -- and I
will just sort of make the extreme opposite – that the Commission
regards itself as the teacher of the public on these matters, after
having listened to the various kinds of arguments?
In other words, is the answer to
the ethical question, to put it in a vulgar way, with apologies, to do
focus groups, and to do polling, or is there deliberation amongst
yourselves on the basis of them?
And then the second question would be on the basis of what kinds of principles or notions.
Would you then make
recommendations to the public and to the Ministry, that the public
feels strongly about this in this way, or they are divided, but we
think that the wisest course, or the most ethical course, the prudent
course, is this?
It's meant to be a general
question to just sort of flesh out the kind of ethical deliberation.
PROF. MEILAENDER: Leon, before
she answers, may I just tag on to your question, and come off the
queue, because this is what I was going to ask about, and I just wanted
to add one thing to your question.
CHAIRMAN KASS: Please.
PROF. MEILAENDER: He had -- and
I had noted also what you had said on the sex selection thing about
changing public opinion, and raised the question he had, but you seemed
to take sort of a different angle on the information you gave us about
the use of genetic information in criminal investigations, and the
storing of it and so forth.
And at least when I listened to
you the tone seemed to be that the public might be a little too
accepting of this, and somebody needed to buck them up a bit to be less
accepting.
So in the one case, it seemed a
little more as if you were going to kind of learn from the public, in
the case that Leon mentioned, and in the other case, it appeared more
as if you wanted to, as it were, to shape the public.
And so it is just another part of what you said that would relate to his question about how you
understand your relation to that larger public opinion.
BARONESS KENNEDY: I think that
when you are involved in a process like this, it is a two-step. You
are having to listen to the public, but you are also having to lead,
and to deny the role of leading I think is really one of the things
that in society that we are too ready to do now, the absence of
leadership on these sorts of issues.
And so I don't think that
polling is a very acceptable way to test public opinion, because on the
whole the quality of the debate that is taking place is not likely to
give you very sensible answers.
Sometimes when people actually
hear the full argument, it is a bit like the business on insurance.
They realize that the thing is much more complicated and interesting
than they thought it was.
The first instance is to say that
we want a ban on genetic tests by insurers, but once you explain that
it is more complicated than that, then people start shifting their
position.
And I think when you are talking
about ethics, you need leadership, and I think that is what the role of
governments is. We can only advise government. We aren't the
deciders of ethics, and my Commission is not pretending to have the
wisdom that others who actually in the end should make the decisions in
this.
All we can do is advise, but we
do have proper and real debate. We have a number of ethicists. We
have our churchmen, and we have a sort of secular ethicist on the
Commission.
And we are very mindful of how
important these issues are to people. But it is Parliament. The
debate on this sort of thing has to take place in Parliament, and it is
one of the reasons why I feel very strongly that my Commission is an
advisory body only, and not a regulatory body.
We are not like Suzi's
authority, and we don't do that. We advise. Government can accept
or reject our advice. Government is answerable to the people. So
whenever they give a leadership steer, if the people in the end
don't like it, there is a route that people can take.
But I do think that governments
should lead when it comes to these difficult issues, because
governments have the opportunity of taking part in complex discussion,
and in a way perhaps that the ordinary citizen going about their daily
round doesn't have a lot of time for.
They have a gut response, but if
you give them more time and more information, maybe they can come to
good decisions, too. But you do need leadership. Now, let me just go
back to the two issues where you think there is an inconsistency.
One is on sex selection for
children. The public again -- and when I say there might be a slight
shift on that, it is only because the public will say, "well, surely if
two people are having a family, and they have a number of boys, and
they decide that they want to have a girl, why shouldn't they be
able to do that if there is a way you can do it."
But when you explain to them what
it would involve in vitro fertilization, and that it would involve PGD,
and the dangers and risks that are involved in all of that, the
majority of people would say, "Well, I mean, who could be bothered?" Who is going to take the risks
and who wants to do that? Aren't we happy to have children at
all? So the reality is that unless it is a simple process, people are
not going to do it.
And it is when you explain to
people what would be involved, suddenly people realize that in fact it
is not around the corner, and not something that they themselves would
be begging to do and that the old – fashioned business
of having sex is actually fun, and the way that most people would
prefer to go about their business. So I don't think that it is
about taking a temperature gauge in the first instance, and then having
a full and open discussion where people are given information.
Now, the temperature gauge is, at
the moment I think, that people are saying, "Well, why shouldn't that
be possible?" And once you give them more full information about what
is involved, they say, "Who wants to be doing that?" and, "Is this a proper
process?"
And I think they retreat from it
with more information, and so I don't see an inconsistency in my
position. I think that actually people come to these complex and
difficult areas usually with a gut response, which is not to be
ignored, but once they have more information, they often shift their
ground.
And I think that what happened in
Britain was because we had been having a long term debate over in vitro
fertilization, over how it should be used, over whether the
circumstances in which permissions might be given with each new advance
to clinics or research bodies for what they were doing, we became used
to that process.
And then when the very profound
challenge is made, do you allow research on an embryo that is not going
to be implanted into a womb, that was a very important moment for the
British public. And there was very considerable debate.
And church people, and people
with very real religious convictions made clear their position. Many
others -- and in fact I would say that the majority of church-going
people in Britain actually in the end came down saying that the
terrible horror of people suffering terrible diseases is something that
we should seek to find ways to alleviate.
And if some research can make
that possible, although we have inhibitions about it, and we don't
feel that it is just something that people should do in a cavalier way,
we think it should be allowed in very restricted circumstances because
of the good that could come from it.
And I think that was a very tough
debate, and it took place in a way that in the end the majority of
people in Britain feel comfortable with.
So a lead was given, and I think
there is no doubt that Tony Blair himself took a lead, and he is
recognized as someone with very real religious conviction, but he gave
a lead on it.
And I think that is what
political leaders should do, one way or the other.
CHAIRMAN KASS: Charles.
Charles Krauthammer.
DR. KRAUTHAMMER: Yes, I would
like to echo Michael Sandel's noting the interest that you have
sparked on the council by your discussion of the question of the use of
genetic information by insurance companies, which had not been raised
here, but has actually sparked a lot of interest because it raises a
lot of extremely interesting issues.
And so I wanted to just engage
you for a moment on the substance of it, as opposed to the mechanism
and the regulation. I can imagine that there would be two reasons to
want to ban the use of that information or that procedure on the grounds of
privacy, and the other on the grounds of fairness. Privacy obviously,
you don't want that information ever to get out, and so you may not
want to require it in the first place, because you may not be able to
have absolutely a hundred percent reliable safeguards.
That I think is an easy issue.
The other one I find a little more intriguing. Was the rationale
because of the privacy, or was it because of the equity or unfairness?
I could imagine that the argument
might be that people don't feel that they ought to be penalized by
being denied insurance, or subjected to exorbitant rates on the grounds
of having some kind of hidden illness discovered by genetics.
What I am curious about is why
you would say that you can't use that or you would be violating a
principle of equity. By using genetic information, and in a
circumstance where I suspect by giving an ordinary blood test, then you
could look, for example, in SGOD, SGTPSs, and discover hidden liver
disease.
And it also may not be obvious to
a patient. So on what grounds did your council decide that this
information ought to be not used in the moratorium being imposed?
Was it the privacy issue or the
equity issue, and if it was the equity issue, how did you distinguish
genetic information from otherwise obtainable medical information – older
medical information?
BARONESS KENNEDY: In truth, it
was about both. It was both privacy and equity, and in fact there was
a very strong argument that came across from some quarters, which was
that in fact an unfairness would take place for people -- and let's
take as an example people with the Huntington's situation, and who
may have a positive test that says that they do not carry
Huntington's.
But on the family history, they
would not have difficulty getting insurance at all, and those people
feel that they would be discriminated against, and that they
couldn't use the positive test to come to an insurer and say, "Look,
despite the history in my family, I am not a carrier and I want to have
insurance."
And not surprisingly the
insurance industry would say, "There is a moratorium as to work across
the board," although at the moment most big companies are saying, "If you
come to us and you show us that you have a test, we will work it in
your favor," again answering this thing of wanting to show the public
that they are interested in the public good.
But at the moment we felt that
there were a number of pressing enough issues that meant that the
moratorium would give time to explore them, and not because we felt
that we had answered the question of wasn't there a lack of equity
in the circumstance that you are describing.
But we decided that we wanted
some more time for people to have that debate rather than to
instinctively opt for a banning, or for a just across the board use of
tests.
So we really came at it very
quickly, and it was one of the first things that the Commission did.
We did it within a period of really five months of being in existence,
and we didn't go into a great deal of detail about the way in which
there could be inequities as you have described.
DR. KRAUTHAMMER: But I am puzzled
as to why one would conclude that the use of genetic information to
discover a hidden condition is inequitable, but we accept the use of
other medical information, like liver function tests also to obtain
information of hidden conditions.
But obtaining that information
and using it in deciding to give or to deny insurance is acceptable.
How does the genetic information differ from the traditional other
medical information which is obtained from normal medical testing?
BARONESS KENNEDY: Well, I
thought that was the tests that I had made earlier on, which is that
there is no difference between some of the information you will get
from a genetic test, and from the information that you will get from
other tests or from a history.
The point was that in -- and it
is like all these things. There was a trade-off. We couldn't say
to the insurance industry that you are not allowed to use even history
or test at all during this period of the moratorium or we wouldn't
have gotten the voluntariness that we wanted.
And we ourselves wanted to have
more time to look at whether what the position of the Commission would
be on the taking of history, or the use of other tests.
And we wanted also the public to
become more aware of the ways in which all of that information would
have to be taken out of the frame potentially if they insisted on their
anxieties being privileged in relation to genetic information that you couldn't really draw
a firm line between genetic information and other kinds of
information. So it was a trade-off. We said, "Make your" -- I mean,
"Give your commitment that you will not use genetic tests, and we will
allow you to carry on doing what you do already, using tests already in
the public domain, and which are already part of your processing."
That in a way gives comfort to
the public because at the moment their lack of knowledge about the
differences. That also gives us time to look at where this is going.
So it wasn't a pretense of
being some kind of coherent position. It was a trade-off.
CHAIRMAN KASS: We are coming
up on the break. So, Bill Hurlbut, just briefly, and then we will
break.
DR. HURLBUT: My question relates
to the fact that your country has a national health organization. When
I look at the possibilities implied by genetic sequencing and
understanding each person having a profile and a database and so forth,
I see a mixed reality.
For one thing there is a large
misperception by the public concerning the determinism of genetics.
That obviously has to be ameliorated by education. Nonetheless, even
if it is just statistical probabilities, it seems like information
either in the hands of physicians, or in the hands of individual
patients, or in their minds, of course, could increase both -- well,
could decrease costs, and increase efficiency, and have overall
benefits.
What I want to ask you is that
there has been a long history of debate in this country and everywhere,
I guess, about how much imposition a general society has over the
individual.
When you have a national health
plan, you have a different situation, where you have a general interest
in the individual's situation, and therefore more argument for
imposing certain types of information on the individual.
To what extent are you debating
currently the degree to which individuals should be informed, be it
before marriage, or during some process before childbearing, concerning
their genetic situations?
To give you a historic example in
our country. Linus Pauling at one point suggested that everybody
carrying a recessive trait for a debilitating disease have tattooed his
or her body someplace an indicator of this so that two people
wouldn't fall in love.
And at one time in my class, we
had a long discussion about where on the body that tatoo ought to be.
So --
BARONESS KENNEDY: My
grandmother, you know, in private part might never have seen the light
of day, you know.
DR. HURLBUT: So you see the
drift of my question.
BARONESS KENNEDY: Yes. Well, we
haven't yet looked at in detail the way in which the National
Health Service is going to have to accommodate this huge area of
change. We see it as having an enormous impact.
One of the things that we feel is
a relief to us in Britain is that if you have a National Health
Service, in many ways the fears around insurance and unemployment, and
discrimination in those areas is greatly reduced, because people get
health care anyway.
And that is one of the wonderful
things, and that is one of the arguments is maintenance is better, and
that genetics can be accommodated within it. But we also feel very
conscious of the fact that people have the right not to know
information about their genetics if they choose.
We also think that increasingly
the relationship between patients and doctors in Britain is becoming
much more like the American model. I mean, I think previously
patients were much more passive in Britain, but now they are conscious
of themselves as being active decision makers in their health care.
And they are much more informed,
and they go to their doctors with demands in a way that perhaps in the
past they didn't. So in those circumstances, we do think that
patients will be probably driven to seeking information and wanting to
have genetic tests.
However, I can't imagine ever
any compulsion being something that people would see as desirable, the
idea that people should be required to disclose. I mean, those are
difficult issues that we are going to have to engage with, but at the
moment the idea requiring people to do it is something that we would
resist.
DR. HURLBUT: Have you
entertained the possibility that there might be some situations in
which you require people not to do it? In other words, where there is
such a mis-impression about the implications of findings? Do you see
what I am talking about?
BARONESS KENNEDY: No, I would
like for you to explain it better. An example. Can you just let me
have an example of what you mean?
DR. HURLBUT: Well, say for
example that with breast cancer genes. There is a widespread
misperception about that, and how probable your --
BARONESS KENNEDY: Yes, that was
one of the things that I was talking about in terms of over-the-counter
testing, is that the area in which we have engaged with that has been
about -- is in the current work that we are doing, which are there are
tests which usually need mediation.
They need explanation, because a
simple reading of the test is not going to be good enough. And
therefore if people start acquiring information, for example, using the
internet, and contacting laboratories privately because they don't
want their information to be in medical records, for example.
Then the fear that is being
expressed is that many of those people will receive information which
they themselves misinterpret, because it is not being done and loaded
for them in the right way.
And they are not having the sort
of medical assistance and counseling that is necessary, and that kind
of mediation is important, particularly with some of those tests which
are complex, and where things are multi-factorial and so on.
And the moment the general public
imagines this, and it is almost like a determinant where you will be
told the date on which you are going to die. They have a very
optimistic idea about exactly how predictive tests are.
And I think that with a process
of education that we have to go through in letting people know that it
is not quite like that. But the difficulty we think is that many
people, if they fear that information is not going to be protected it within
the National Health Service, may opt for private testing.
Then, of course, the doctors
wouldn't have the full picture and wouldn't be able to give
them the right kind of health care. But the other thing is that they
may not get the right kind of, if you like, support, and counseling, and
mediation in dealing with the information.
CHAIRMAN KASS: Thank you very
much. The member for Improved Social Insurance would like to ask you a
question, and I will indulge you if it is brief, and then we have to
take a break.
PROF. SANDEL: It is brief. It
is just to consider a note for a possible future project on genetics
and insurance, and it is provoked by Charles pressing for the
principle.
Here is the issue. Insurance is
a mechanism for pooling risk, and in the case of auto insurance -- oh,
and it is for sharing risk. But the reason for the sharing is not some
principle of social solidarity and equality.
The sharing is based on
ignorance, of not knowing in the case of life insurance of who will die
when. But the not knowing generates a social practice that involves
sharing or pooling the risk that I will die sooner than you.
And in the case of auto
insurance, for example, I don't want to be pooled with bad
drivers. If we could know who will have auto accidents and who
wouldn't, that would be a good thing, because we could make the
liability fall on the bad drivers.
But that in the case of life
insurance, suppose we could know through a new genetic technology when
every person would die, then there would be no reason for the sharing,
because the ignorance that underwrites the sharing would be dispelled,
and there would be no social practice of sharing the risk that someone
will die sooner rather than later.
And the question that that poses
ethically, and this isn't to answer it, but it is to suggest the
question, but the question is do we want to dispel all of the ignorance
that underwrites the practice of sharing risk that life insurance as a
social practice permits us to do. So, that is the question.
DR. KRAUTHAMMER: So why do we
take x-rays and do liver function tests?
CHAIRMAN KASS: Gentlemen, we
have a schedule, and --
PROF. SANDEL: And we have a
topic for next time don't we?
CHAIRMAN KASS: Thank you for
a wonderful presentation, and a wonderful discussion. Twelve minutes.
(Whereupon, at 10:06 p.m., the
meeting was recessed and resumed at 10:24 p.m.)
CHAIRMAN KASS: Again, it is a
great pleasure to have Ms. Suzi Leather, the Chair of the Human
Fertilization and Embryology Authority with us. And we look very much
forward to your presentation and discussion. Thank you for being with
us.
MS. LEATHER: Thank you very much
indeed. Chairman and Council Members, it is a very great privilege for
me also to be invited to attend this meeting, and to present to you the
U.K. model of regulating assisted reproductive technologies and human
embryo research.
Thank you very much for this
opportunity and I am sure we are going to learn as the presentation
follows the order of your helpful list of questions broadly.
I must begin by saying that the
Human Fertilization and Embryology Authority which I Chair is an
example of a rather eccentric British institution, a non-departmental
public body. This mean that we report to the U.K. Department of
Health, specifically to the Minister for Public Health.
We have an independent status of
government, and like Baroness Kennedy before, I speak to you today in
my capacity as Chair of the HFEA, and not as a representative of the
British Government.
I also speak as someone who has
not been in place for very long. I took over from my excellent
predecessor, Dame Ruth Deach, only in March of this year.
And before that I was the Deputy
Chair of the Foods Standards Agency, which in some ways is rather
similar, in that we deal with the interspace between public
understanding and perception and science.
So clearly we don't have the
ethical dimension and the feelings dimension as strongly in the food
safety debates as we do in these debates, but there is some that do
cross.
By background, I am not a lawyer,
unlike both of my predecessors. My background is in social sciences,
particularly in political science, and also in social work training. I
have worked mostly for consumer organizations, and focused on health.
Now, Chairman, your first
questions were about the HFEA's mandate and structure. The Human
Fertilization and Embryology Authority, as I am sure you know, was the
first regulatory authority of its kind in the world.
And it was set up following a
very widespread public debate, the most notable feature of which was
the Warnock Committee Report in 1984, which recommended amongst other
things the creation of a new statutory licensing authority to regulate
both the research and those infertility services which the committee
thought should be the subject of control.
And it established the principles
by which we work today. These include respect for human life at all
stages of its development. Respect for the rights of people who seek
treatment and the need for their fully informed consent.
Concern for the welfare of the
resulting child, independent of the interest of the adults involved;
and the recognition of the benefits which can flow from
responsibilities perceived of medical and scientific knowledge.
Established in 1991 by an Act of
Parliament, the HFEA's role is principally to regulate the
creation, storage, and use of human embryos outside the body, both in
treatment and research.
And we also regulate assisted
conception techniques which use their native gametes, and the storage
of gametes. The HFEA's system of regulation is national, covering
clinics and research centers in all four countries of the United
Kingdom.
We make no distinction between
the public and private sector. Constitutionally, as I have said, the
HFEA is a non-departmental public body. This means that it is at a
distance from central governments, being headed by an authority board
rather than by ministers or government employees.
And we have those functions. We
publish a code of practice, which gives guidance to clinics about how
they should conduct their activities. We keep a register about
treatments, about children born, and about donors.
We provide advice and information
to patients, and to donors, and to clinics, and we review developments,
and have also an advisory function. Now, having said that we are
independent, we are not wholly independent.
Our members are appointed by
ministers following open public advertisement of the sort of that
Baroness Kennedy talked about, and we are responsible and accountable
to Parliament through the Secretary of State for Health.
Our membership is very wide
also. We comprise people who are appointed in an individual capacity
rather than as representatives of organizations, but they have
background in clinical and research medicine, nursing, science, the
law, ethics, religion, psychology, social work, regulation, and the
media.
We currently have 21 members, and
no more than half of our members may be from science or medicine. In
addition, neither the Chair nor the Deputy Chair may be other than lay
members.
We have an executive staff of
about 48, plus or minus a few from time to time, and in addition we
have a part-time inspectorate of about 60 clinicians, scientists,
ethicists, counselors, and lay people, and we have about a pool of
about 50 internationally respected peer reviewers who advise us on the
research license approvals.
Our present structure developed
from what was essentially a self-regulatory model, which operated from
1985 to 1991. We currently have an annual budget of 2.7 million
pounds, which is about $4.2 million to cover the research of 122
storage treatment and research centers in the U.K., to cover the
comprehensive data collection and storage function, and the executive
staff to support the authority, as well as our internal committees.
Since inception in 1991, the
context in which the HFEA operates has changed very significantly.
Demand for IVF treatment has more than doubled. About one percent of
births in the United Kingdom are the result of IVF, and we do not I
should say cover gamete inter-fallopian transfers.
So we don't cover GIFT, and
that is not a license in fertility treatment under our system. We also
as you have seen a significant increase in particular in the complexity
of treatments, such as ICSI, PGD, assisted hatching, and now of course
there are new techniques, such as antecloding screening and the use of
frozen eggs coming on stream.
There has also been a very
significant change in public attitudes with very much greater demands
for openness and public involvement. The HGC is one of the expressions
of government's answer to those demands.
And there are also significantly
higher expectations of corporate governance, and rigorous risk-based
regulation across all organizations in the field, but these changes
have certainly had a very remarkable impact in the health sector.
The HFEA is responding to these
changes, and we have recently put a business case to governments to
enlarge the capacity of the organization to support and enhance
regulatory function.
I hope that this should mean
amongst other things that we will be able to move towards a much more
demanding evidence-based, rather than judgment-based, inspection
system, and have a greater capacity to audit treatment information and
provide guidance on best practice, rather than the set of minimum
standards.
Now, this rather complex slide
shows the interrelationship, and I'm sorry, but the white print
doesn't show up very well. It shows the interrelationship between
our licensing activities and some of our policy formation, because we
license clinics, and we audit what happens in clinics, and we inspect
clinics annually.
And from the monitoring of that,
that feeds back into our policy and into our code of practice. So, for
instance, I guess the best example is the number of embryos.
We under our code of practice say
that there should be two embryos transferred, and only in exceptional
circumstances, three, and I believe that is fairly different from some
of the practice in the U.S.
And I personally would be keen to
move as closely as we could to natural practices. Some of the European
countries are looking at that and to single embryo transfer, and
clearing there would be benefits in terms of reducing the burden of
multiple births.
The organization powers and
duties of the HFEA are based on and circumscribed by statute. We
essentially implement the Human Fertilization and Embryology Act of
1990, as amended by a handful of subsequent legislation, such as the
Human Fertilization and Embryology research purposes regulations in
2001, which permits human embryos to be used to derive stem cell lines.
Our foundation is therefore
established by decisions of Parliament primarily when it passed the Act
almost 12 years ago. The main responsibilities of the HFEA under the
Act as I have said are to license and to inspect IVF clinics, and to
license and regulate embryo research, to ensure that only research
which is necessary for, and in keeping with the purposes set down by
Parliament, takes place.
As I have indicated the
HFEA's regulation of infertility treatment applies equally to
private clinics, as well as to the social provision carried out within
the National Health Service.
Similar with research, the
funding source, public or private, is immaterial. Now something about
what we don't do. We do not act as a pressure group. We are not
acting to increase the amount of infertility treatment. That is not
one of our primary roles.
We are not an ombudsman or
ombudsperson. We are not a research or treatment funding organization,
and let me in fact repeat that we don't in fact regulate all
infertility treatment. We don't regulate GIFT, and clearly we
don't regulate what happens in bedrooms.
In your questions to me,
Chairman, you asked whether the HFEA has any formal responsibility to
advance British competitiveness in biotechnology. It does not.
And indeed as a regulator, I
would emphasize the importance of maintaining an evenhanded stance with
regard to particular companies and research groups operating within the
United Kingdom.
Furthermore, the HFEA is not
involved in funding as I have said either treatment or research, or
indeed in directing resources of any kind in this way, although we do
have an important role to play with medical funders, such as the MRC,
and we are currently talking to them on setting up good research
projects and looking at the outcomes of infertility treatment.
Now, this is some of the recent
public consultations that we have done, and we are about to launch in
fact on Tuesday of next week a sex selection consultation.
We have be invited by government
to do so, and we last consulted the public about this in 1993, and it
will be interesting to see whether there has indeed been a shift in
public attitudes. Certainly only yesterday there were reports in our
media of family couples coming ot the States to make the use of
MicroSort techniques, because they wanted to determine the sex of their
next child.
But at the moment the position in
the U.K. is that sex selection is only permitted to enable couples to
avoid serious sex link disease and not for social purposes.
One of the purposes of regulation
I feel is to maintain public confidence in the area regulated, and I
believe that we have a responsibility to act openly, and to consult the
public as widely as we can, and to inform public debates about the
activities, benefits, and costs of reproductive technologies.
As well as to carry this debate
forward through public education. But I do emphasize that this derives
from our responsibility for informing the public and not from any
interest in the furtherance of science or the promotion of U.K.
biotechnology.
If we do carry out our tasks
openly and intelligently, I hope nevertheless that the public debate
will be an important contribution to the future of these technologies.
Let me turn now to your questions
about the guiding principles and ethical basis of our work. As I have
said the HFEA was set up to implement an act of Parliament. That
legislation was itself a result of concern about the human embryo, and
the possibilities that arose as a consequence of the creation of
embryos in the laboratory.
The Warnock committees'
approach, which was subsequently endorsed by Parliament, and embodied
in the legislation setting up the HFEA, was to focus not on the
definition of the status of the embryo, but rather on how it should be
treated.
In the Committee's view, the
developmental potential of the early embryo made it deserving of
respect, but not of being regarded as a human person. Following the
committee's report, certain absolute prohibitions were codified in
the legislation.
For example, research on embryos
up to 14 days is permitted, but only for specific purposes as defined
by Parliament, and only with the approval of a research license from
the HFEA.
In public debate about the
creation of embryos outside the body, this gives rise to three main
concerns. Is it right, and is it safe, and where might it lead.
Public opinion on these questions
is varied, and in the United Kingdom, as in the U.S., there are some
people who are opposed to IVF and the use of embryos in any research.
However, in the U.K., the
experience of over 10 years of regulation has provided reassurance that
the activities of researchers and clinicians can be controlled in such
a way that it allows the benefits of these technologies to be explored
and enjoyed responsibility.
And certainly the debate in 2000
and 2001 surrounding the derivation and use of embryonic stem cells
showed that concern had moved on from anxieties that characterized the
debates in the 1980s over the regulation of IVF and the acceptable use
of embryos in research.
However, the HFEA must I think do
more to come back to one of your questions, Chairman, and must do more
than merely reflect public opinion on these matters.
In particular, when there was a
question of licensing the implementation of new techniques, these must
be judged first against the parameters set down by Parliament, i.e.,
there is a role in interpreting the lawmakers.
And then in light of the
principles that underlie them to which I have already alluded, in these
matters the HFEA fulfills I think an essential function, in that we are
an expert body appointed to address questions that are sometimes
technically difficult, and always ethically complex, and in which the
public is not necessarily interested, or the implications of which it
does not see necessarily straight away.
So while we consult widely, and
often in collaboration with other bodies, and sometimes with the HGC,
it is not possible or I think appropriate to consult on every new
development.
Or indeed to develop or to decide
some of the sensitive issues as it were by plebiscite. Typically the
HFEA's process involves a movement from consideration of principles
to the consideration of consequences or utility.
Only when legal, technical, and
ethical questions may ask can it be done, may it be done, ought to be
done, have been fully considered does the HFEA then reach the point at
which in turning to more concrete and practical questions we have to
balance the potential benefits that technologies might provide with any
risks associated with them, both in terms of public health, and in
terms of public morality.
The decisions which the Authority
makes are frequently the subject of a great deal of media interest. An
area of current focus is embryo screening.
Consistent with the outcome of a
large scale public consultation, the HFEA permits the implantation
genetic diagnosis in cases where there was a serious significant risk
of a child inheriting a serious genetic disease.
Now, precisely what this means is
a matter of judgment. There is no positive list of diseases or disease
categories. Instead, seriousness is judged in the context of each
clinical situation, with reference to the abortion guidelines from the
U.K. Royal College of Obstetricians and Gynecologists.
In other words, if a condition is
so serious that two doctors would allow a doctor to terminate her
pregnancy if the fetus had it, then pre-implantation and genetic
diagnosis may be allowed so that the woman can begin her pregnancy,
confident that the fetus she will carry is unaffected.
However, the possibilities
available through pre-implantation genetic testing are not restricted
of course to the avoidance of disease, and this was clearly the concern
of the architects of the legislation.
Decisions concerning the
selection of genetic characteristics have themselves raised questions
in the public mind about the circumstances and the extent to which
couples should be allowed to select for or against characteristics.
Increasingly the HFEA is faced
with decisions involving the use of assisted reproductive techniques in
non-infertility settings. Two important decisions have been made by us
this year.
In February the HFEA allowed a
couple undergoing IVF with PGD to select an embryo, which as well as
being free from a serious disease, is also selected to enable cord
blood from the resulting baby to be used to treat an older sibling
suffering from beta fallacemia, and this is sometimes referred to as
the Hashmead case.
In reaching its public policy,
the HFEA established a number of criteria under which it would see the
use of such a technique being acceptable. I apologize for the small
print, but I think these are quite important.
So firstly the condition of the
affected child should be severe or life threatening or of a sufficient
seriousness to justify the use of PGD. The embryos conceived during
the course of this treatment should themselves be at risk from the
condition by which the existing child is affected and that is a very
crucial clause, and it relates to another case that I am going to talk
about in a minute.
All other possibilities of
treatment and sources of tissue for the affected child should have been
explored. The technique should not be available where the intended
recipient is a parent, and the intention should be to take only cord
blood for purposes of the treatment, and not other tissues or organs.
PROF. SANDEL: Does that include
bone marrow?
MS. LEATHER: No. In another
subsequent case which did not meet the criteria, specifically of
embryos conceived in the course of this treatment should themselves be
at risk by which the existing child is affected, the Authority has not
allowed HLA matching, and this case is sometimes called the
Whittaker case.
These were two pretty important
decisions by the HFEA,a nd they both received an enormous amount of
media coverage. Our reasoning for making this distinction involved the
acceptance of three premises.
Firstly, the principle that
persons should not be regarded merely as means to other people ends,
and the need to respect the interests of any child being created as
separate from the interests of anyone else, even a seriously ill older
sibling.
Second, a recognition that embryo
biopsy is a procedure which has not been subject to lengthy clinical
trials. The risks associated with it are therefore yet unquantified,
but must be balanced against any benefits accruing to a person which
develops from the biopsied embryo, and this point came up in your
discussions yesterday.
Thirdly, the view that where such
a procedure is being undertaken, and the interests of the future child,
an additional step which does not involve additional anticipated harm,
but which may confer a sufficient lateral benefit, maybe be permitted.
Thus, if the benefits essentially
accrue only to another person then we thought that it was unethical to
allow the creation of a person whose interests have been compromised in
this way.
Both decisions as I have said
provoked widespread controversy, and I'm sure will be the subject
of continuing discussion and review. The underlying issue, which is
how far U.K. society wishes to go in making use of these techniques for
purposes other than the simply avoidance of serious disease, is
unresolved at this time.
PROF. SANDEL: Could you just
explain how Condition B was not resolved in the case that you turned
down so we can understand it?
MS. LEATHER: I'm sorry, the
case we turned down?
PROF. SANDEL: Yes.
MS. LEATHER: The child that we
created did not themselves stand a chance, any more of a chance of you
or I inheriting -- well, not in inheriting, but in suffering from the
disease that its sibling had.
PROF. SANDEL: And you knew that
because of the genetic testing?
MS. LEATHER: The sibling had
black fananemia and was not judged to be a genetic illness. So
subsequent siblings it was felt would not stand any more chance of
having that disease than anybody else.
So if you were going to allow HLA
typing in order simply to have a match for an older sibling, that that
was ethically unacceptable we felt.
PROF. SANDEL: Was it in the
first case --
MS. LEATHER: In the first case,
beta fallacemia, a second child themselves would have been at risk of
that disease. So they themselves benefitted from pre-implementation
genetic diagnosis. We felt that therefore at the same time that you
could choose an embryo at the same time that you were doing an embryo
biopsy to avoid that child having beta fanacemia, you could choose an
embryo which tissue matched the older sibling.
PROF. SANDEL: Thank you.
MS. LEATHER: It is difficult to
explain these differences, which are very fine judgments, and clearly
fall with the families concerned that are hugely painful.
And it is difficult to explain
them, and even here it is very difficult to explain them to the media,
but nevertheless it did seem to us to be a very important ethical
decision and one that we should at this time protect.
And can I come to the sex
selection consultation now? This is an area as I have said that we are
consulting. Now, once it is a matter of policy, sex selection using
pre-implantation genetic diagnosis, is only permitted in the United
Kingdom for medical reasons.
And sperm sorting follows by
artificial insemination, where this uses fresh sperm of a woman's
partner, is not controlled currently. And the consultation which we
are going to publish next week has followed a year long review, which
has included the commissioning of independent reports on the scientific
and ethical aspects of the treatment, as well as market research into
the nature of public understanding and discussions of this subject.
And we are going to address three
main areas. Firstly, should the use of sperm sorting be regulated in
the United Kingdom. Secondly, should sperm sorting be available for
medical indications, bearing in mind the current uncertainly as to its
reliability and long term side effects.
And thirdly should sex selection
in general been available for any non-medical reasons. Let me turn
now, Chairman, to your questions on our processes and actions, and in
particular embryo research.
We make a distinction in the U.K.
between publicly and privately funded system conception centers, nor
between research which is funded by public bodies, which as the Medical
Research Council. and private organizations, such as pharmaceutical
companies.
All activities which involve the
storage of human gametes, the creation outside the body, the use and
treatment, and research of human embryos up to 14 days, are subject to
our license and inspection procedures.
The approval process for research
licenses is rigorous. The HFEA has first to be confident that the
proposed use of any embryos is necessary for the purpose of the
research, and the activities conducted in the course of the research
are in keeping with Parliament's accepted purposes.
The 1990 Act defines these
purposes, firstly, as promoting advances in the treatment of
infertility, and increasing the knowledge about the causes of
congenital disease, and increasing knowledge about the causes of
congenital disease, increasing knowledge about the courses of
miscarriage, developing more effective techniques of contraception, or
developing methods for detecting the presence of gene or chromosome
abnormalities in embryos before implantation.
But these purposes were generally
to do with infertility is explained by the way in which human embryo
research developed in the U.K. in pursuit of more effective means of
overcoming infertility.
So the historical reason for the
HFEA's remit covering both treatment and research, and in the
context that it was a short step for techniques to move from
development to implantation, and quite often as connections, of course,
between people who are involved in research, and people who are
involved in treatment.
In January of 2001, following
large majorities in both Houses of Parliament, which were on three
votes, and so people weren't voting along particular party lines,
but individual consequence on the issue, three additional research
purposes were added.
Firstly, increasing knowledge
about the development of embryos, and increasing knowledge about
serious disease, or enabling such knowledge to be applied in developing
treatments for serious disease.
The addition of these purposes
confirmed the HFEA as the appropriate body to license and regulate
embryo research, a confidence that was then endorsed by the House of
Lords on that committee later that year.
However, with the introduction of
these new purposes, the HFEA is realizing more than ever before a need
to collaborate closely with other organizations and bodies with an
interest in the development and use of knowledge techniques in cell
lines originating in embryo research, specifically with the Medical
Research Council.
In addition to thinking about the
requirements for embryo research, in addition to passing the first
hurdles which I have described, which are the necessity and appropriate
purposes test, all research applications have to have the approval of
a properly constituted ethics research committee.
And the research is then subject
to our peer review process. The research facilities are inspected, and
the proposed license holder for the project and many of their team will
be interviewed before a final report is considered by an HFEA licensed
committee.
Applicants wishing to undertake
research to drive stem cells from embryos are further required to do
the following. Firstly, to justify why embryonic stem cells are to be
used, rather than other types of stem cells.
Secondly, to provide detailed
information on what happens to the stem cells throughout the project;
and to place a sample of all cell lines in the MRC stem cell bank.
Chairman, you asked me also about
human cloning. The U.K. has taken the lead in positively outlawing
human reproductive cloning. The Human Reproductive Cloning Act of 2001
makes it an offense under criminal law to place a cloned human embryo
into a woman.
And any clinician found guilty of
doing so in the U.K. would be liable to a prison term of up to 10
years, and also to a fine. Somatic cell nuclear transfer, sometimes
called therapeutic cloning, or I think in your last report, cloning for
biomedical research, on the other hand, is permitted under the law.
Indeed, one of the intentions of
the Research Purposes Regulation of 2001 was to permit the deprivation
of stem cell lines from embryos created by cell nuclear
transplantation.
And so together these two pieces
of legislation positioned the U.K. in your ban plus regulation
category. The HFEA is therefore allowed to issue licenses for
therapeutic cloning. However, it has yet to do so.
Furthermore, the HFEA has
announced that it will not issue any such licenses until the House of
Lords, acting as the final Court of Appeal in litigation brought by the
Pro Life Alliance, puts beyond doubt the question of whether human
embryos created by cell nuclear transplantation are in fact embryos
within the terms of the regulatory legislation.
Your final set of questions,
Chairman, were most difficult. You asked me to make some general
reflections, and I think to make some suggestions for your country,
which I really don't think is in a sense my business to do.
But certainly the benefit of
hindsight is attractive. Looking back, a notable feature I think of
the legislation which established the HFEA has been its remarkable
durability.
The HFEA Act has continued to
provide a workable framework and prove robust enough to cope with the
proliferation of scientific developments and treatment possibilities --
ICSI, pre-implementation, and genetic diagnosis, antecloding screening,
assisted hatching.
There have, however, been some
drawbacks in the legislation. In a very practical sense, we have been
hampered by the very stringent definition of confidentiality under the
Act.
This was incorporated in order to
protect patients, donor, and off-spring confidentiality, but it has
imposed in fact significant practical constraints on the HFEA.
It means, for instance, that the
HFEA has been unable to engage outside contractors to improve its IT
systems, and it suffered from a qualification on its accounts due to
the fact that these can't be independently verified.
So these are not necessarily
issues for you, but they are certainly issues that have made a bit of a
difference to us.
In terms of recommendations, it
is difficult I think to read across very closely from the U.K. to the
U.S. The different histories and traditions, not least the fact that
the U.K. does not have a written constitution, or a Federal structure,
but does have an established church, and I think a less publicized
civil service, makes generalizing from one setting to another
particularly precarious.
Additionally as I have said, our
regulatory history over the past 10 years or so has given public debate
a different complexion, and I think it is fair to say that public
opinion in the U.K. is less polarized on these issues than it is here.
That said, let me suggest some
issues for debate. Firstly, the core question I think for us for
regulation of assisted reproduction technologies is to what extent is
this so different an area of health care that it justifies and requires
a distinct regulator restructure.
And in the U.K. in 1990, it was
certainly judged to require just that. There were a number of factors
which justified setting up the HFEA, and not least of course ethical
sensitivity about embryo research and infertility treatment.
In addition, access to
infertility treatment has never been generally available under our
National Health Service. So rather like cosmetic surgery, most
providers were in fact in the private sector, and so it required a
system which operated across both public and private provision.
From the U.K. perspective, I can
certainly point to many benefits of regulation in the area of assisted
reproduction. A reliable and publicized standard of service provision
for patients, and public confidence that these standards will be
maintained, compulsory data collection in the interests of public
health.
And consistency, transparency,
and independence of decision making in line with clear moral standards
in what is an ethically difficult area. But having said all of this,
it is important to remember I think that each national jurisdiction
will have to reach its own conclusions on the acceptability of forms of
assisted conception and embryo research.
And to implement those within or
under the rubrics of its own political system. There may be some uses
of reproductive technology which are so offensive to moral sense and
natural justice that they merit international condemnation and
prohibition.
Human reproductive cloning, and
cloning to produce children, and eugenic selection of racial
characteristics may fall into this category. But for others, I think,
it is a case of determining what the moral consensus in each culture
can approve in the interests of medical benefits and scientific
advance.
The U.K. experience has been that
it is possible to reach consensus, or at least an accommodation in this
area. But the road to legislation was a difficult one, and in another
context it might prove more difficult still.
Consequently, in the research
context, very real issues arise with regard to the exploitation of
biotechnology discoveries made in other jurisdictions, and for those
wishing to import biological material which originates in other
countries for research.
In the first case, given that
biotechnological inventions have the potential to provide significant
health benefits, and to alleviate profound suffering, possibly for
great numbers of people, one must ask I think how should one approach
the use and practice of biotechnological discoveries, and the knowledge
that these may have been generated in ways which would be ethically and
legally unacceptable in a domestic setting.
This is unlikely to be a question
that can be resolved in the abstract, but nevertheless certain
parameters may be established. In the U.K., they are either codified
or implicit in the HFEA Act.
In the second case, and perhaps
more immediately, the question which must be addressed is to what
extent may research be allowed to progress on imported biological
material derived in a way that might not be acceptable locally.
This is a question which has
already risen in Europe with individual jurisdictions, and having to
find particular solutions to this problem. In conclusion, Chairman, I
would say that rather than simply lock the gateway to embryo research,
the British approach has been to appoint a gatekeeper.
The role and actions of this
gatekeeper will no doubt be the subject of infinite -- and I hope --
healthy debate, and I think it is particularly helpful to have
international debate.
I am not saying we should be
having an exchange of ideas about what is morally appropriate, right
and wrong, but we are actually faced with a situation where citizens
from the U.K. can say we can do it, and citizens in the U.S. say why
should I have to pay the airfare to get there. Thank you for inviting
me.
CHAIRMAN KASS: Thank you very
much for a very lucid and forthcoming, and very responsible
presentation. May I ask just a few questions from the Chair?
Yours is really the only existing
regulatory body. There are lots of advisory commissions, and there are
other places that have statutes that prohibit certain sorts of things,
but this is a group that not only sits down regulations, and monitors,
and inspects.
And I guess my question is have
you had experience in finding things in which people are not playing by
the rules, and what has happened, (a).
And I guess a corollary to that
is what is the response of the regulated to what they perceive to be
unreasonable restrictions on practices that in fact could benefit
people's health.
In this country, we would have a
very hard time, I think, imposing these kinds of restrictions, and
having a monitoring system where there are penalties for
non-compliance. Has there been non-compliance, and what has happened,
and how do people react?
MS. LEATHER: Okay. Well,
firstly, I think there are some cultural differences in attitudes to
regulation between the U.K. and the U.S. I think that in contrast
perhaps to the U.S. that the U.K. -- and Helena can agree with me or
not on this, that we quite like a bit of regulation. It makes us feel
safe.
And indeed the Warnock Committee
report talked about this and establishing the 14 day boundary. That is
a 14 day boundary of what is in biological terms a process, and so in a
sense it is artificial to draw it to any one place.
But they were mindful of the need
to do that in order to establish public confidence, and that approach
has shown itself to be extremely successful, and we do want the whole
field safe for this. There is an important degree of acceptance of
moral consensus that that was the right boundary.
Now, you asked about the action
of the regulators. Well, I guess that most organizations -- and I
would include mine -- don't necessarily welcome the people that
regulate us. I mean, it is just a human response.
I think that most clinics see the
benefit of having a regulations structure because it clearly tells them
what they should and shouldn't do, and what they can and can't
do. It has the power or we have the power to close clinics if we find
that they really are doing things which they shouldn't be doing.
CHAIRMAN KASS: Have you ever?
MS. LEATHER: Yes, we have closed
clinics. And that also gives patients a degree of confidence, and I
think that it is interesting that quite a lot of people from other
European countries come to the U.K. to have treatment.
And I guess that one of the
reasons that they do that is not only that they have very good
information published by -- independent information published on the
success rates, but also they know that the practices in clinics is well
regulated.
CHAIRMAN KASS: Let me ask
also --
MS. LEATHER: Do people welcome
being put out of business? No, absolutely not, but I should say that
this is extremely rare, and we do annual inspections and inspection
teams go in, and they comprise different people.
So clinicians, scientists, and
nurses, counselors, and people with an expertise, and they will look at
the practices in the clinics, and say this isn't okay, or this is,
and change it. And we can make additions upon licenses, and give
people a certain amount of time to change practice.
CHAIRMAN KASS: Let me also
ask about commerce in gametes, and the like, and I know that you have a
policy on this, but I think it would be good for the record if you
would comment on that.
As you know, in this country
there are on the internet advertisements for oocytes, depending upon
one's accomplishments, and now up to $50,000. And even many of the
hospitals are now -- many institutions are charging now up to $7,500
for oocytes, and there is now competition for this in this country.
What is the British policy and
are people obeying?
MS. LEATHER: In the whole we
have tried to remove human tissue from the marketplace as far as
possible. So, we don't, for instance, pay blood donors. And the
same approach, and we have taken the same approach with regards to
gametes and embryos.
So you can get your expenses,
plus a little bit more, but it is a very, very small amount of money
for donating sperm and eggs. And we import, and we allow the
importation of sperm and eggs really on the same basis, and so we are
not happy with the idea that somebody should be a donor because they
were offered a great deal of money.
That said, there is of course
international trade as it were in gametes, and we are -- we do face a
shortage, and we have always faced a shortage of eggs, but we are not
facing quite a serious shortage of sperm.
And it may be that we may have to
review this policy. But also since 1991, the approach has been that
you shouldn't donate your characteristics so openly as you have
here.
So we have a kind of -- I suppose
that consumers in the U.K. are rather blinder than your consumers, in
terms of what they may be getting. We do go to great lengths to screen
for health reasons for sperm, for instance, but we don't say here
is somebody who has a Ph.D. in physics. Do you want this one rather
than someone who is a farmer.
CHAIRMAN KASS: But there is
this policy, but if individuals wanted to offer their gametes to
market, it is legal in Britain, or is it not?
MS. LEATHER: It is not legal for
the clinics to do that, no. You can't pay somebody a great deal of
money. What you can do is to donate eggs and get cheaper treatment.
We have allowed that to happen.
So you may say what is the
ethical difference to that, and that itself has been accepted, but it
does set up certain problems I think for some women, because it means
that somebody might have tried to have either treatment that has not
been successful, and they donated some of their eggs, and they have a
feeling that there is somewhere else a woman who has conceived using
her eggs. These are difficult problems.
CHAIRMAN KASS: Thank you.
Michael Sandel.
PROF. SANDEL: I thought this was
a very instructive presentation, and it brings out very -- it seems to
me that the U.K. has struck a very sensible balance in this system, and
in this whole domain that we are still struggling towards, and it has
alluded us so far.
And what your presentation I
thought brought out very powerfully was the connection between the two
differences between the U.S. and the U.K. You mentioned that public
opinion in the U.K. is less polarized on these issues than in the
United States. And you also mentioned that there is more of a
tradition of government regulation, and its acceptance in the U.K., and
what struck me thinking about how you have arrived at this balance is
how connected those two things are.
It seems to me that in the United
States one of the reasons public opinion is so polarized on these
questions is precisely because there is such hostility at least in some
questions at least to government regulation because of the belief in
unfettered markets.
And that every choice, that every
decision about embryo research or stem cell research is all or
nothing. So that on the one hand, IVF clinics are completely
unregulated. Tattoo parlors or barber shops are required to more
licensing requirements than fertility clinics in the United States. We
don't regulate them at all.
So in principle, provided that it
is done with private funds, you could have not only sex selection, but
all kinds of trait selection, buying and selling, because we are such
believers in completely unfettered markets. We don't regulate even
IVF clinics.
And then when it comes to
discussing possibly life sustaining new technologies or forms of
research, we say, well, there would be a slippery slope here, because
it is against the background of an unfettered market and no regulation.
And no authority like yours to
actually enforce regulations on the clinics, and so if we accept a life
sustaining form of research here, well, it could lead to a parade of
horribles. The slippery slope argument.
And what your -- and so it is
either all or nothing. Either we must ban it, because if we permit it
in this purely unfettered market, then there is no way of stopping the
parade of horribles, the slippery slope.
And what your regulatory body
provides is a way to make the slope less slippery, and a way to -- and
that in turn permits the debate the public debate, about whether or not
to avail ourselves of this or that technology, or medical research.
It makes it possible for that
debate to proceed with less polarization, because it is not an all or
nothing affair. The slippery slope looms less large because of an
institution like yours.
MS. LEATHER: I think that is an
extraordinary insightful comment, and in fact when the debates were
being had in Parliament at the end of 2000 and 2001, people made
precisely that comment. We would have found it very difficult I think
as you did to accept therapeutic cloning if we hadn't had over a
decade of experience of responsible regulation that on the whole has
worked well.
No regulation is ever perfect,
and there are always going to be things that it doesn't know about,
but on the whole it has worked extremely well, and it is perceived as
having done so.
CHAIRMAN KASS: Gil
Meilanender and Rebecca, and Alfonso.
PROF. MEILAENDER: I have two
questions, and they are just factual ones, and they are entirely
unrelated I believe, but they just occurred to me at different
moments. One is that when you were discussing PGD and it can be done,
and if there is a possibility of a serious genetic disease, and you
said there was no list.
That in a sense it is a
determination made case by case, I guess, is what you said. But I just
wondered if you could narrow that for me. So that, for instance, would
something like cystic fibrosis constitute a serious genetic disease,
even though someone can live quite a lot time with it, for instance?
Would a propensity to
schizophrenia or something constitute a serious genetic disease? If
you could just sort of narrow it for me at all, just in terms of what
your own experience of cases tells, that would be interesting to me.
And then second, and an entirely
different kind of question, but you have 21 members I think you said on
the HFEA right now. And I am wondering if any of those 21 members
opposed, say, to embryo research, or would this way of dealing with the
question in a non-polarized setting effectively exclude from kind of
important roles in public deliberation people who held certain kinds of
views? So those are my two questions.
MS. LEATHER: Okay. Thank you
very much indeed. You have asked me to do precisely in a sense what we
have struggled to avoid, which is to start a list. In my view, yes,
cystic fibrosis is such a serious life threatening disease, and we have
accepted it for pre-implantation genetic diagnosis.
Schizophrenia has not obviously
come up yet, and were it to come up -- and I can only answer this in a
personal capacity at this stage. I was once a mental health manager,
which meant that we reviewed section orders for people who were
detained under mental health legislation, because I chaired the NHS
trust which provided mental health services.
My experience of people suffering
from certainly extreme forms of schizophrenia is that that is very deep
human suffering, and not only for that person, but for other people who
love and who are related to them.
So I would also regard that as
being in the category as it were. Your question 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
U.K. at the moment, and I don't think we need them continually on
the committee saying that I am opposed to all of this, and I am opposed
to all of this, because I think that would stop the decision making
that we have to do.
CHAIRMAN KASS: Rebecca.
Rebecca Dresser.
PROF. DRESSER: Thank you very
much for these two presentations showing us that at least it can be
done in some way. I had some questions about the -- I guess it is a
subcommittee or a separate committee that reviews the research
proposals, the embryo research proposals. Is that correct?
MS. LEATHER: A license
committee, yes. It is not in fact -- we can have license committees to
look at research proposals made up of Authority members, and in the
same way as we have license committees for treatment made up of
Authority members.
PROF. DRESSER: I was wondering,
as I understand that it does peer reviews, and so does it also include
non-scientists? And in reading our staff's description of your
system, and I guess on one of your slides you had some criteria, such
as the potential importance of the research, and whether the use of
human embryos is justified.
And I wondered if there is also
consideration of whether there are -- and perhaps this is part of the
last principle, alternative approaches to getting the same information,
and a justification for the embryos are the only alternative.
So I wondered if there are people
on there to make value judgments apart from scientists, and this ties
in a little bit with the previous question. And I guess it
wouldn't necessarily be that -- I mean, one position would be that
you could have some people who are very skeptical of using these, and
would oppose them at all times.
And then another would be that
there would be a range of opinions, and so there might be some people
who would say only in the very, very compelling case would it be
justified. And then there would be others that might take a more
liberal position.
And so I was interested in that
part, and then I just had one related question. It says in our
documents that you have received 135 applications for research
licenses, and of these 115 were granted.
I was curious whether you know
anything about the ones that were turned down and why, and then --
MS. LEATHER: Okay. Thanks very
much.
PROF. DRESSER: Should I ask one
more or wait until you --
MS. LEATHER: Let me deal with
those first. The question about the justiciability in a sense of using
embryonic stem cells rather than other stem cells. We are using that
justiciability, not in the moral sense. We have determined that has
been decided by Parliament.
But what we mean is this
scientifically justified, and one of the benefits of having the stem
cell bank, which we will have in the U.K., is that we will know exactly
what are the stem cell lines that are being created.
So it will be much easier for us
in reviewing potential research licenses to say that this hasn't
been done or this has been done. If it has already been done, it is
already there, and we don't need to do science twice, of use more
embryos unnecessarily.
The peer reviews that you talked
about, they are scientists. We do not or don't have lay peer
reviewers, but we do have lay members of the license committee, and
also low research ethics committees under the U.K. system also have lay
members when properly constituted. What was your other question?
PROF. DRESSER: The ones that
were turned down, the licenses?
MS. LEATHER: My guess is that
those researchers were trying to do something that either wasn't
licensable under the legislation, or we weren't satisfied that they
were the proper research group to do it. But if you would like me to
get back to you with further information, I can.
PROF. DRESSER: That might be
interesting.
MS. LEATHER: Okay.
PROF. DRESSER: The one other
question that I had was that in our notes it said that the 2001 law
included a prohibition on altering the genetic structure of any cell
while it forms part of an embryo.
MS. LEATHER: Yes.
PROF. DRESSER: And I wondered,
and maybe you could both comment on that, but does that mean a
prohibition on germ line interventions, or what was that all about?
MS. LEATHER: That means that you
can't do cell nuclear replacement on a blastomere. So we have
permitted it to be used in an egg, although as I have said in fact we
are waiting on the House of Lords' decision on whether embryos so
created, because they actually have not been created as a process of
fertilization, are in fact embryos within the terms of the Act as they
are already under the earlier legislation.
PROF. DRESSER: So our
understanding of this is that it just applies to the somatic cell
nuclear transfer organisms, whether they are embryos or not. I
wondered if there are any developments in the U.K. about germ line
interventions in humans that might be helpful for us to know about?
Has that been an issue on the table recently
Because we have some people here
in this country who are beginning to say that maybe we should start
thinking about this.
MS. LEATHER: Okay. I am not
aware of that, but again I will get back to you if that is different.
CHAIRMAN KASS: Alfonso.
DR. GÓMEZ-LOBO: Thank you for
the very clear presentation. I think I have more comments than
questions at this point, and in regard to Gill's second question, I
tend to see quite clearly that given that the mandate for the authority
for the HFEA is under the terms of the Act of Parliament, it seems
rational to say that only those persons who are in agreement should be
part of it.
I don't know, but it seems to
me a coherent reply. Now, that said, I would like to say that my own
opinion is that I hope we do not here in the United States adopt the
same procedure. And by procedure I mean the whole process.
I am starting from the widely
shared assumption I guess that morality is or should be above the law.
That the fact that the something has been enacted doesn't mean
necessarily that it is morally right, no matter how much consensus
exists.
That is the problem with ethics
always, and unfortunately it is not a matter of democracy. It is not a
matter of the majority of votes. It is a matter of reason, and
that's why I wanted to exclude any argument to the effect that some
of this would be based on religious beliefs, and therefore it is not
part of the public debate.
I hope that everything else is
well founded on reason, and not on theology. Now, what worries me a
lot is the fact that many of these ideas that we are enshrining in the
law were developed starting from the Warnock Report.
And for those of you who have not
read the report, I would like to stress one aspect of it, and it is
that philosophically that really it works with two ethical principles.
One is the principle of utilitarianism, which of course as we all know
justifies actions by reference to the consequences, the good
consequences.
And that is why utilitarians talk
a lot about balancing, and other traditions don't talk about
balancing. They only talk about balancing when it is morally
legitimate actions.
You know, should I go to this
movie, or to the movie, but if there is action, which by its very
nature is unethical, then of course there is no room for balancing that
action against any good that might come of it.
Now, that strain in the Warnock
report is tempered by an appeal to moral sentiments, which is very much
a British tradition coming from Hume, and while the contemporary
versions of that are so-called emotivism, but there the question is
only whether certain kinds of actions are going to emotionally affect
people.
People are going to say, oh, this
is terrible, and I feel that this is terrible and I shouldn't do
it. But I don't see a real deep meditation based for instance on
the -- well, on other ways of doing moral philosophy.
Now, I don't want to go into
a lecture here, but my own preference in the United States would be to
have that deep ranging debate because the perils of utilitarianism are
really very great indeed.
Practically anything could be
justified by reference to good ends. I can think of severe
restrictions of civil rights in the United States in order to fight
terrorism.
I lived through a very well known
application of utilitarian principles during the military dictatorships
in Argentina and Chile, where the justification of torture was always
that, oh, this is going to benefit so many people, and in so many ways.
Now, of course, there is an
important difference there, several kinds, but again it is this pattern
of thought that it seems to me that we should be very well aware.
And the question is, well, are
there any cases in which wonderful ends simply do not justify means.
So that is a problem that I have here. Now, of course, all of this
depends on the 14 days decision. And the Warnock report, of course,
admits that it is totally artificial.
I mean, there is no doubt about
that. There is a human embryo developing according to a genetic
program, and it is making progress in the direction that is well known
to embryologists and to myself, and therefore, it just doesn't seem
rational to me to say, oh, here we have a cut-off point.
Everyone agrees I think that the
cut-off point is something of a convenience, and I'm sorry that
Mike Gazzaniga is not here, and something as he said that I feel
comfortable with.
Well, it is not a matter of
whether we feel comfortable with or not. It is what is there, and what
is this organism, and what are its properties, and what is its nature.
How is it different from other
organisms, and of course all of that is something that has to be looked
at before we take the step of saying that there is no need to respect
dignity before 14 days, and there is a need to respect dignity after 14
days, although there, there is the morally questionable provision in
the law if I read it correctly, and it is that the embryo should be
destroyed, or should not be allowed to go beyond the 14 days.
I suppose that an embryo could be
frozen at that point, right? But again --
MS. LEATHER: I'm sorry, but
the 14 days doesn't include the freezing time, but you can't
freeze something on day 13 and then do a lot more work on it later.
BARONESS KENNEDY: I believe that
wasn't what was being suggested.
DR. GÓMEZ-LOBO: No, it was. It
was. It=s just, you know my ignorance, but from a moral point of view
it=s along the same lines. So, my encouragement to the United States,
and I feel a deep moral responsibility, being a U.S. citizen and being
a member of this council, is that all of these philosophical issues
that are going to inform the law should be a matter of great concern
and a deep debate. And again, we, I think, as a counsel should try to
work on that. Now, baroness Kennedy says we=ll never agree. I don=t
know. I=m a socratic, and I would not foreclose a discussion before
it=s even started. Well, it has already started. I just trust that
there has to be, there has to be, a rational way of discussing these
things. I was reminded, for instance, of the remark by Bill Hurlbut in
Nature magazine this past July. There was an article that=s quite
illustrative of what goes on in the human embryo before the 14 days. So
I would say the science doesn=t allow us to decide this of course, but
the science, the new insights into embryology, into how important those
few hours or days are, those are clues, those are part of the evidence
I think that we have to take into account when we advise the republic
on what we should do in these matters. Not the kingdom, but the
republic.
CHAIRMAN KASS: Thank you. I have frank
and the two Bills. And we will B okay.
PROF. FUKUYAMA: I have a couple
of questions about the politics of the HFEA. The Human Fertilisation
Embryology Act was put forward under a conservative government, but you
said party discipline didn=t apply so it was a free vote. And there
was a very large majority in both parties in favor. Could you just
talk a little bit about the politics of that? I mean was there, for
example, particularly strong opposition from the British IVF industry
to being regulated in an area where it had been left up to
self-regulation, and just how did it fall out between the different
political positions, ideological positions?
And then the second question is a
procedural one about who has the authority to appoint the 21 members?
And if there is .. I mean, presumably, there's not been a lot of ..
well, actually, this is a question. I mean in cases where there's
division among those 21 members, what are your procedures for coming to
a decision?
MS. LEATHER: Thanks very much.
The question of self-regulation, were the clinics opposed to it? No,
they weren't, and in fact there was this self-regulatory model. So
I think what the clinics wanted and what the researchers wanted was
certainty about what the country as a whole thought was okay. And you
colleague talked of it as just a sort of pragmatic decision and it was
just to do with outcomes, and it wasn't. I mean the debate was
also about right and wrong, and it continues to be.
But it wasn't .. the votes
that were taken were free votes, and within all the parties there is a
range of views about the ethics of this. I don't think it's
fair to say that one party is particularly more divided than another,
really. There's a range of views everywhere.
PROF. SANDEL: On the free vote,
when Frank was talking about the free vote, I think he was referring to
the vote on expanding the research purposes. You said that was a free
vote ..
MS. LEATHER: Yes.
PROF. SANDEL: .. not the vote to
set up the authority in the first place.
MS. LEATHER: That was free, yes,
yes. All these procedures have been passed on free votes.
You asked about who appoints to
the authority. They are ministerial appointments, and some people come
and go, but they don't .. there's no automatic change if the
administration changes, nothing like that. How do we vote? Do we
vote? We try and achieve a consensus, and that is not always
possible. So, for instance, we have recently had a debate about
whether we should get rid of donor anonymity, and most of us felt that
in fact we shouldn't say to people who have been created as a
result of IVF that they had less right to know their genetic origins
than everybody else. So we thought, and our advice to government, is
that prospectively we should get rid of donor anonymity but not
respectively, that there should be a voluntary register considered for
donor information, retrospectively. But some people disagreed with
that. Some people felt that it was wrong to get rid of donor anonymity
because of the effect, for instance, on the supply of sperm that the
Chairman referred to earlier.
PROF. FUKUYAMA: But do you
actually have internal procedural rules? Let's say in the future
you got a really polarized issue. Could 11 members vote against ten
members to make a decision?
MS. LEATHER: I think as a Chair
in that case I would say we are undecided about this, and if we are so
undecided about this, it seems pretty difficult to proceed to change.
BARONESS KENNEDY: Can I just
comment on that?
MS. LEATHER: A bit like the
position you're in, perhaps, sir.
BARONESS KENNEDY: I'm just
going to comment on that. On the recent decision that was made by the
HFEA on the Hashmi case and the other cases that were mentioned where
pre-genetic diagnosis was allowed for a subsequent child. There was
quite a lot of controversy over that, and there was a feeling that that
sort of matter should, because it's so controversial, should back
before a committee of the House of Commons. I mean there was some
debate about whether that was a course that should be taken. Now, the
decisions were made and they were made with sufficient unanimity, but
if there were the sort of tightness that you're describing of seven
to six, I think that there would be a feeling that it would not be
something that should be left to the HFEA.
MS. LEATHER: I mean that vote,
that decision was taken against a background of public consultation, so
we were guided partly by what the public response to that had been. If
there were issues that were very new about which the public had never
had an opportunity to debate, then I think Helena's point is even
more strongly made.
DR. GÓMEZ-LOBO: Yes. Very
briefly, it's a clarification. I don't doubt for a second that
the question of right and wrong is raised. The question is how
it's answered. If it's answered by reference to consequences,
then, you know, we're clearly in utilitarian context.
CHAIRMAN KASS: Bill May, then Bill
Hurlbut.
PROF. MAY: I'm not clever
enough to put my ruminations in the form of question, but I do want to
return the discussion to the question of regulation. Oftentimes our
difficulties with regulation are explained in terms of the fact
we're not an island, we're a continent. There's another
way of explaining that where we say, "You're at fault,"
because this country emerged in the setting of rebellion against King
George III, and we tend to think of the government still as a kind of
foreign power, not an instrument of national purpose, which tends to
make us suspicious of regulatory agencies, especially on the part of
the national government. And it carries through in our suspicion of
bureaucrats, a sign of which is either we starve regulatory agencies,
we don't provide enough regulators in the SEC or the IRS and so
forth so that the private economy operates as it will, or we hem in our
bureaucrats massively with regulations. That's the other response
of suspicion to bureaucrats. So bureaucracy happily metastasizes at
the hands of its sworn enemies. It's a huge irony in American
life.
Meanwhile, we're given to a
kind of mysticism of the marketplace which tends to make us overlook
the bureaucratic complexities of corporations at play in the
marketplace. In Dallas, I was very impressed by Ken Anderson, the
President of the Parkland Hospital. Given the complexity of the
economics of our health care system, he said he needs 300 people to
handle accounts to yield the payoffs on bills and so forth, which in
fact the Vancouver City Hospital handles with only six people.
It's a very interesting, high degree of suspicion as it relates to
the government and bureaucrats but incredible tolerance of the
emergence of the bureaucracy in the setting of the private economy.
That is not in the form of a question but an introspective comment
generated by your presence here.
(Laughter.)
CHAIRMAN KASS: So noted. Bill
Hurlbut. We're going to move toward break and then to lunch. Bill
Hurlbut and then Paul.
DR. HURLBUT: I want to return to
the complex issue of what you called selection for characteristics as
part of a larger consideration. In deciding about sex selection
techniques, let's speak of pre-implantation genetic diagnosis, is
your concern there with the dangers of characteristics per se and
gender biasing and so forth or are you also concerned about using that
kind of a technique itself? I mean what is exactly going on in the
mind? I mean why not do it, actually?
MS. LEATHER: Why not select for
social reasons?
DR. HURLBUT: Yes.
MS. LEATHER: Well, people have a
number of problems with this or a number of issues, and I suppose the
most important and perhaps the most difficult to express is the feeling
that if people select the sex of their child, there's something
about wanting to do that decision which undermines the essential
quality of parent love, which is unconditionality. And I think there
is a feeling, and certainly our focus work that debated this came up
with this as an issue. Was it actually okay to want to do that, to
want something particular about your child? And would you be
disappointed if it didn't go right?
DR. HURLBUT: Well, for some
people, some social groups and some families, it could be a matter of
balancing first, which does not weigh quite as heavily as just simply
wanting a specific characteristic maybe. But also for some social
groups a very serious matter, use that word "serious"
concerns. To them it's extending the definition of disease into
social realities. I mean you probably .. I don't know what you do
with growth hormone, but you know what I'm talking about, some
cosmetic surgeries are acceptable for social reasons, disfiguring
repairs and so forth.
What I'm getting at here is
is there something about the .. I understand you preempt even sperm
selection, but is there something about the investigation of an embryo
that is even more troubling in that context? No.
MS. LEATHER: I'm not quite
sure I understand what you're saying.
DR. HURLBUT: Well,
pre-implantation genetic diagnosis for what you're calling not
serious things, why not do it? I mean it's .. what I'm trying
to get at is the status of the embryo, according to your principles, is
one that is due respect but not due inviolability, right? Because
otherwise you couldn't justify certain practices like so-called
therapeutic cloning. Do you see what I'm getting at?
MS. LEATHER: Yes. In discussing
the difference between the Hashmi case and the Whitaker case, perhaps I
didn't make it quite clear, but one of the things that worried the
authority was the idea of using somebody as a means to someone
else's ends and, additionally, to exposing them to an
unquantifiable risk where that person wasn't going to benefit. By
definition, somebody else was going to benefit.
DR. HURLBUT: Okay. What I'm
getting at here is even pre-implantation genetic diagnosis for a
serious disorder involves a risk to the normal embryo, right? Because
yesterday one of our speakers told us there was a 50 percent decrease
in successful implantation after this investigation of a given embryo.
Does that .. I'm just asking for your rumination of this, because
I'm trying to figure out in my own mind about it, is that real?
MS. LEATHER: I think goes back
really to the fact that we have .. it's not as if we've ended
the debate on the embryo up to 14 days; it's still there in the
public mind as an important issue. But it's not the focus of
debate. It really is not the focus of debate. We've now moved
through that and we are concerned more about what are the
characteristics we should allow people to choose for and against.
CHAIRMAN KASS: I think we'll move
on. Paul and then we're going to break.
DR. MCHUGH: I also want to thank
you for that helpful discussion and presentation, Ms. Leather, and I
want to come back, really, to also the very important point that
Michael made at our beginnings; that is, whatever is going to happen
here in the United States occurs in this remarkable context of the
free-heeling approaches that we've taken to these matters before.
In fact, for me this is a very telling issue in relationship to the
ultimate development of our regulations related to SCNT and its
products. I'm happy to hear that the House of Lords is struggling
to decide whether the term "embryo" should be applied to
that. We've gone so far in this Council, or at least I've gone
so far in this Council, as to try to impose a new word under that
product to differentiate it from a zygote with only modest success. So
the Lords in their decision-making, in their discussions would be fun
for me to listen to.
But I have two very practical ..
PROF. FUKUYAMA: They'd take
you more seriously.
DR. MCHUGH: Britain, you think
they would? I doubt it. This brings me to two very practical
questions, and it relates to our interest in what regulations would do
and what openness would do in relationship to SCNT even for the best
benefits that we're all very interested in. And one of them is
does your system now, your regulatory system, make it possible for
there to be careful thought about what use over denucleated ova would
be put to in the scientific context of the research so that we
wouldn't develop an open market for searching for thousands and
thousands of eggs and turning many, many women into egg factories?
That's a very important concern to me, and that issue would be
helpful to hear how you have thought about that and where that has
come.
And then the other simple thing,
again, like everybody here at the table, we admire the way the British
are willing to queue up and stay in line .. I just had a fight down in
the front about people not being in a queue or me not being in a
queue. It was a very amusing American scene.
(Laughter.)
But when you were developing your
regulatory bodies and your regulatory processes, was there any
hinderance or hold back of investigations that were going on while the
regulations were being put in place or was there simply a parallel
process, research was going on will-nilly and the regulations were
either catching up with it or not? Those are my two questions.
MS. LEATHER: Okay. I'll try
an answer as best I can. Before the HFEA was set up there was research
and treatment going on. That's different from what's happened
since it's been set up. Since it's been set up all research
and treatment is regulated, okay? So I think that clears that one up.
DR. MCHUGH: Was there a
hesitation period during the process of setting up the regulations
where you said, "Hold on now, you guys. Don't do anything
until you hear from us." Was there?
MS. LEATHER: You're not
allowed to do it unless it's been licensed.
BARONESS KENNEDY: No, but there
was a period .. before the HFEA came into the being ..
DR. MCHUGH: Yes.
BARONESS KENNEDY: .. there was a
period when people were asked again, it wasn't a formal moratorium
but they were asked to hold back on what they were doing ..
DR. MCHUGH: I see.
BARONESS KENNEDY: .. while this
was being debated and so on. And people in Britain, as you have
suggested, are willing to do that. There's a sort of way in which
generally people are prepared to ..
DR. MCHUGH: So the scientific
community was willing to accept this voluntary moratorium. It came
forward and said, "We accept this for ourselves voluntarily while
you, whether a week or a month or years, you set up your things."
That happened?
MS. LEATHER: Yes. What the
scientific community wanted was long-term security ..
DR. MCHUGH: Yes, yes.
MS. LEATHER: .. about what it
was and wasn't allowed to do.
DR. MCHUGH: And it was willing
to pay the price ..
BARONESS KENNEDY: The scientific
community in fact were the initiators. They came into the domain and
said, "We're doing this work. We want to know how the public
feels about this. Where are the parameters on this?" That was
how ..
DR. MCHUGH: I love to hear
this. I hope the scientific community in the United States is
listening and bringing forward something other than signatures.
MS. LEATHER: I think your other
question was about consent and donation and we've set down specific
guidelines for the consent issues involved in donating embryos and
gametes which will be used in deriving stem cell lines, because the
issues for donors I think are rather different. The House of Lords
drew attention to the immortal, as it were, nature, the unceasing
nature of stem cell lines. That has to be explained very carefully to
donors as it has to be explained that although other people may benefit
financially, eventually from the knowledge and possibly from products
derived from applying stem cell line knowledge they as donors won't
be part of that. So we've already drawn that up.
DR. MCHUGH: So, therefore, you
explain to the donors, the voluntary donors, that what is going to
happen or what the implications of this contribution are is. I want to
know whether it worked also from the other direction; that is, that
well-trained scientists and well-developed laboratories and things of
that sort were considered before eggs were being harvested from women.
Here in the United States, for example, in the NIH, one of the issues
in deciding about a research grant is to look at the institution
that's making this application and deciding whether those
laboratories or those people are skilled enough or are effective enough
or have the resources to do what they claim to do in this research.
And many research projects, even though that they are well designed by
the author, are turned down because it said as yet this institution has
not developed the expertise to do this, and we don't want to waste
the resources or the money on the other things on that. And I'm
just wondering whether they considered .. whether your place you are
considering such things before you let donors come forward and give
this important tissue away.
MS. LEATHER: Indeed, we do
consider that, and it would not be permissible for people to use eggs
or sperm or embryos donated for research but not knowingly donated for
stem cell research for stem cell research.
CHAIRMAN KASS: Thank you very much.
Let me make a procedural suggestion to members of Councils. I think we
should conclude this session and thank both of our visitors for really
wonderful presentations and the wonderful spirit of forthright and
responsive conversation. You stimulated us a lot and we have things to
learn, and I do hope that we can remain in contact with you in the
months and years ahead as we go forward.
This was the original scheduled
time for a break for 15 minutes before we reconvened. There are
members of Council who would like to leave early, who have planes to
catch, and although it would be nice to rise and say farewell to our
guests, if we would liberate them from the table but the rest of us
stay, I think we .. my hope is that we can conduct our business in this
session with dispatch and people will not have to leave before the
decision is taken. Is that agreeable?
So that is Council members will
simply stay and let me just thank you both.
(Applause.)
SESSION 7: REGULATION 10:
GENERAL DISCUSSION
CHAIRMAN KASS: All right. This is
the session in which the Council has an opportunity to have a general
discussion of where we stand on this topic of regulation. The topic
was put on our agenda, you will recall, at the very first meeting by
Frank who indicated it might in fact be the most important contribution that
such a body could make above and beyond what it might do on particular
issues. We were reminded by one member at that meeting who harbored a
grave suspicion of regulation that it very often hit the wrong targets. But we've nevertheless pursued our activity.
We've looked at the
activities of several other countries, Canada, Germany and the UK in
particular, we've had an overview from Laurie Knowles, we've
investigated certain things having to do with the Patent Office and
Institutional Review Board overhaul. Both the majority and the
minority in the cloning report touched on the question of regulation
and the need at least to open up the discussion of not just cloning but
a whole range of related technologies and their uses. The stem cell
monitoring that we are engaged in and the exhortation to this body that it
consider the development of guidelines in that area is also
another area where the regulatory topic will come up, and we can
anticipate that that will be before us.
The staff did prepare a working
paper that's in your briefing books. Let me just turn some pages
and without reading it just say that the staff's observation that there
seems to be .. that around the world there seems to have been
recognized the need for some system of regulation in this area, that
the most common focus of the debate in regulation has been on the
question of assisted reproduction, genetics, and embryo research in
particular, that what we see from these various conversations is the
different approaches reflect very much the differences in the character
and history of each society, a point that came out very clearly in the
discussion this morning, that to do this properly, if it should be done
at all, will take a great deal of time and effort, and that at least
our preliminary review indicates that the existing institutions, at
least as now constituted and with the charges they now have, seem not
to be set up in a way to handle the kinds of questions, at least some
of the kinds of questions that have been raised here by this body.
I would also add an editorial
comment that it seems to me the difficulty of proceeding in this area
in this country is that there is a kind of polarization in opposition
to regulation on the one hand from those who want unfettered inquiry
and unfettered commerce and on the other hand from those who want no
regulation because the want nothing to go on at all, which is to say
the people who believe that all embryo research really should be
prohibited. And that means to move toward regulation, at least to
explore this, is to run the risk of antagonizing both parties, both of
the most vocal parties to this discussion.
Editorial comment number two, one
could argue that this is an area in which the principle that Alfonso is the
defender of... might turn out in the end to be the enemy of itself
in which the best is the enemy of the good and in which by holding up
principle in the area in which we care greatly, with the federal
government's involvement, one nevertheless allows the private
industry to proceed down paths that no one wants, and therefore Michael
Sandel can say, "Look, the British have done it right." On
the other hand, one could say that once the principle has been
abandoned it's not clear that there are places along this slope,
and I'm not sure, Michael, whether what you've seen in the
expansion of the UK's 2001 Act of what this is for is an example of how the
slippery slope has been forestalled or how it's greased a little
bit easily, because the British have the most regulated system in
Europe and they have the most liberal policies in Europe, and
that's interesting.
Okay. All of that by way of
background. The question is what shall we ..
PARTICIPANT: I like both
pieces.
CHAIRMAN KASS: I'm not
surprised. What shall we do?
PROF. SANDEL: By the way, much
less liberal than we have.
CHAIRMAN KASS: Not in the private
sector.
PROF. SANDEL: In the private
sector less liberal. The private sector here can do anything they want
to.
CHAIRMAN KASS: Okay. The question is
..
PROF. SANDEL: I'm sorry, it
may be the most liberal in Europe but it's certainly a lot less
liberal than the status quo in the United States.
CHAIRMAN KASS: I'm sorry, I
missed the last. Yes, great. The question is what does this Council
want to do in this area, and the staff in that paper laid out a series
of possible alternatives, procedural alternatives. I don't think
anybody in this room is at the moment prepared to say on the substance
where this Council is likely to come out or should come out in terms of
recommendations, but it seems to me we've done enough preliminary
paperwork that the time has come to make a decision about procedurally
how to go forward.
And mindful of the hour and
mindful of people's need to leave, rather than dialectically
solicit from all of you your various suggestions let me make a proposal
and see whether this .. it is one of the proposals that is in the
working paper. That the Council at this point charge the staff, working
closely with members of the Council who .. with all members of Council
but especially those who because of their interests are willing to take
a leading role in working with the staff -- to go away and come back to
us within six months, which is to say before the April meeting, with a
document which could serve as the basis of serious deliberation by this
body.
I think it's time to produce
paper on this to explore what is going on, what might be going on and
offer some recommendations, if possible, as to what should be going on
in the area of the regulation, and here I want to define the area, in
the area of the uses of those technologies that touch on the beginnings
of human life, including things having to do with assisted
reproduction, having to do with the use of spare embryos and embryo
research, having to do with pre-implantation genetic screening and
diagnosis -- that thing which was abysmally called "repro-genetics" in one
of the drafts of the cloning report as we were working on it.
At least that that's the
domain, that we don't define the domain as the embryo and its uses,
that we don't define the domain simply as assisted reproduction and
its sequelae but we look at the various technologies that touch on the
beginnings of human life, that that's the domain and that we try to
find out, first of all, as much as we can based upon what we've
already done as to what now goes on by way of regulating this activity
in this country, to offer a variety of possibilities as to what might
go on and to maybe, if possible, offer some suggestions amongst them.
And as I say, that the staff be
charged to produce a document working closely with members of the
Council. I could say that at least four members of the Council have
already expressed a willingness to work on this. This goes back to
earlier conversations but Frank and Rebecca and Jim Wilson and Paul
McHugh have expressed a willingness to work on this topic with members
of the staff. Carter Sneed who has joined the staff is in fact
prepared to take the leadership on this project if the Council says,
"Go for it."
I could also mention that
we've begun to have, we've had at least one preliminary
conversation with people in the bio industry, with bio organizations -- because their participation in these conversations I think will be
crucial -- and we've got a lot of work to do in order to bring this
about, and we would bring this up at meetings between now and April, as
necessary, but that this would give us a target date early enough
before our expiration, before November
of next year, where we would have time to refine, argue and see what we
could do. Please, Rebecca.
PROF. DRESSER: I wonder if it
would be worth a few moments on a basic question, which I think is
brought out by our UK visitors, which is that at least part of the substance
came from Parliament, and it seems that if we were to follow that
route, and that is the usual route for administrative law and
regulation that at least partial guidance is provided by Congress,
would you want this draft to talk about substance; that is, these are
the substantive principles that we think ought to be adopted or these
are possible principles that we would recommend?
CHAIRMAN KASS: I think if I have the
... the staff's working paper indicated at least the areas that
ought to be addressed ...
PROF. DRESSER: Right, but
positions.
CHAIRMAN KASS: I'm sorry?
PROF. DRESSER: What about
substantive positions? What should be the considerations that the
regulatory body takes into account? I mean that's a very important
component.
CHAIRMAN KASS: Someone want to just
stay on this topic and respond to this? Alfonso, Michael?
DR. GÓMEZ-LOBO: It's really
not a response but it's closely connected. I would be happy to
contribute to the drafting of the principles of the regulation.
I'm sure I'll be totally incompetent of going to regulations.
Because the question, of course, what are going to be the values that
this regulation is going to uphold? In other words, for me it makes a
big difference whether you regulate how embryos are going to be
destroyed or whether you regulate that no embryos be destroyed. It
makes a big difference, and that's why I'm interested in the
grounding principles of any regulation.
CHAIRMAN KASS: Well, I have, I guess,
sort of two responses, and I'm open to discussion on this. Frank,
you want to respond to this and save me the trouble? Thank you.
PROF. FUKUYAMA: I believe that
we should not hold up Leon's proposal to have the staff do a
working paper until we decide what those regulatory principles are
going to be. Because we will never make any progress if that's the
sequence. For example, I do not think that if you decide that
you're going to go down a regulatory path that does not imply, for
example, the British position where you are permitting research
cloning. The Canadian system that Patricia Baird described is
institutionally almost identical to HFEA but it bans therapeutic
cloning. And so the way I would imagine this is that by April we could
have a paper in which you would clear away a lot of the institutional
design underbrush and say, you know, this is a strategy.
And, incidentally, on
Rebecca's point, it's not as if Parliament acted and then there
was this discussion of how to implement. I mean it came from the
Warnock Commission and then it went to Parliament, so I would say we
are, in a certain way, in the position of the Warnock Commission but we
can substantively come down in a different way. And then I would think
that the staff paper would not commit to one substantive position but
would give us some options for how we would .. I mean because any
regulatory system is going to have certain common characteristics and
we have to get that all sorted out and there has to be a political
strategy for implementing and so forth, but then at that point we could
then have the substantive debate about what ought to be the outcome.
The other possibility is that the
final Council .. since we don't have consensus on those substantive
principles, one option for us as a Council is to send to the President
simply a regulatory proposal that doesn't decide the substantive
issues but simply says, "Look, we need Congress to decide this
because ultimately they're the ones that are going to make the
decision."
CHAIRMAN KASS: Michael.
PROF. SANDEL: Well, I think that
Frank's given a sensible approach. I think that this is a good
idea, that we should go ahead and then it will come back here, and then
we can decide to what extent there's substance built in or agnostic
on the substance once we have a regulatory framework. Then we can
debate that question, discuss it here. So it's not as if the staff
is going to resolve these questions while we're not looking.
DR. GÓMEZ-LOBO: Well, I wish
ourselves well, but I mean how can you regulate unless you decide in
what direction you're going to regulate? I'm sure that there
are vast areas where there's going to be common ground. For
instance, this business about the privacy of the genetic information, I
tend to think that there can be a lot of agreement there.
PROF. SANDEL: Well, let's
give it a try. Leon has identified the topics, and I think to have
identified the topics is already to go enough in the direction of the
substance to enable the staff to formulate a proposal, and then we can
take a look at it and raise these questions at that point. But I would
just add that of the options in the staff working paper, A, B, C, this sounds like kind of a blend between A
and B, a formal subcommittee being A, B being the staff, and this is
sort of a combination of the two.
PROF. MAY: Where the last
sentence of B, in effect, picks up, if you'll notice ..
PROF. SANDEL: That the staff may
be directed by the subcommittee. Yes. I think that's a good
idea. I don't think that we .. I think we should .. you mentioned
the four, and if there are others who come forward to work with the
staff would be good. I think we should avoid C, farming this out to
some other group of experts.
CHAIRMAN KASS: Absolutely. And I
also think that .. we've talked about this further since the staff
working paper was drawn up .. that a formal subcommittee of this body,
our body being small and our conversations being intimate, seems not
necessary. This is not as if some subgroup of this is then going to
come in to report on things that nobody else has heard of. It seems to
me that we've got an opportunity to exchange things and process, to
have updates at the various meetings, but at least the staff should
know who is most likely to be both interested, knowledgeable, and
willing to spend time on this. I think that's sort of helpful
internally, and it's a way of getting the most out of the members
that they're willing to give while placing the responsibility where
it's most likely to be actually executed.
Now, I think .. let me speak .. I
mean this is a proposal that we have made, and I think I stand behind
it. There is a concern and I think Alfonso is in a way, if I may speak
for him, and if I speak wrongly, you'll correct me, that there
seems to be a suggestion that once one starts down this road and
invests Council time and energy there will be a certain kind of, shall
we say, slippery slope to approval of some such proposal when it really
ought to be an open question for us, pending the result of this
research, whether in fact this is something that this Council wants to
recommend. And it's in that spirit that I mean to do this.
I mean there are people probably
sitting out there with pencils and saying, "I'm going to run
back to tell the industry, this Council is now ready to put police into IVF
clinics, et cetera, et cetera." There's no substantive
presupposition about the outcome of this inquiry, but it seems to me we
can't simply hash out our own discussions about this in the absence
of some kind of work and some kind of paper, and I think we've
reached the point that we either produce that or we give up this
topic. I think that was my sense, Alfonso, that a document could come
back here and the majority of the Council might say, "Look, this
is a very bad idea." And I mean that genuinely, that there's
no prejudgment, at least on our part, that this is a high-stakes,
high-gain, high-loss venture, but it seems to me worth looking into at
this stage.
Gil.
PROF. MEILAENDER: Just a couple
things. I agree that probably in order usefully to go farther in
discussion we do need a focused proposal. I mean I think just the
conversation will go best if that happens. That said, I wanted to just
accentuate the point you just made. As one who sort of tends at least
to hold what Bill May regards as the classically American and incoherent
position on regulation, I really .. I have doubts about the degree to
which it's possible to separate sort of formal and material
considerations in drawing up a scheme. I have .. I'm happy to wait
and see it, so I don't oppose proceeding, but the notion of a
regulatory scheme that was a pure blank as far as substantive
considerations is concerned strikes me as a puzzling one. I just think
it .. I'd just like to see it. I'm happy to see it, but I just
want to be on record as suggesting that it strikes me as a very hard
thing to do, something that is both useful and yet entirely free of any
tilt.
CHAIRMAN KASS: Paul, do you want to
respond?
DR. MCHUGH: Yes. I just want to
say that I agree with what Frank has put forward, and I want to
emphasize the small point I was making late this morning, and that is I
was extremely disappointed by the scientific community in America that
as we brought forth our discussion and our interests and our concerns
about these issues, particularly about SCNT, that we had hardly closed
the door before 4,000 signatures appeared, not a discussion, not a
consideration of what we were concerned about, not an answer really to
our questions, but just 4,000, maybe 10,000 signatures. In the process
of writing and putting up the regulations that we have in mind, this
will be a good invitation to the scientific community to see what this
Council was intended to be, namely a spur of public discussion and a
place to register proposals to answer public concerns. If we do not go
in this direction, if we do not try to build up something of this sort,
there will be no forum for us for the future, there will be no forum
for the scientific interests to come and speak to us.
CHAIRMAN KASS: I would like
to ask, if I might, if I could at least have a comment from everybody
if there are reservations or concerns, it would be good to have them.
Bill Hurlbut.
DR. HURLBUT: What procedure
would we use to try to get input from the National Academies of Science
on the various professional societies in writing up these regulations?
It seems like the people in the trenches ought to have a lot to say
about this.
CHAIRMAN KASS: This is not a question
of writing up the regulations.
DR. HURLBUT: I understand, but
even setting up the structure, the formal structure for it.
DR. MCHUGH: I think come and
talk the way they've been .. I mean they came once. They can come
with something substantive.
CHAIRMAN KASS: Okay. It seems to me
perfectly possible, and there are no plans on the drawing board far
enough to, but just thinking out loud, perfectly reasonably to say we
are thinking about the way current institutions .. the lacunae and the
way current institutions address the ethical questions of the growing
powers over the beginning of human life, reproductive and genetic. And
we would like to have the input of the National Academy of Sciences, of
the National Institutes of Health, or the Bio Organization, or the
National Right to Life, and have various kinds of people come and make
presentations that would be relevant to our thinking about this. Staff
can go and meet independently with people, but there's no reason
why we couldn't invite testimony on these matters even before a
document is produced but also once that goes forward.
DR. HURLBUT: I personally would
like to have a session or two where there was some background for
people like me trained primarily in science to understand how you
translate the varied interests of different perspectives in a
pluralistic society into laws and regulations. I feel like I just
don't know some basic things about our tradition on that score.
You often hear the comment, "Well, that's your private belief
and so be it," but listening these discussions today I was
continuously aware that there are certain impositions of general social
belief over .. it was interesting, for example, that in England they do
not fund, I guess, for the National Health Service, gamete
interfallopian transfer, which would represent the interests of a
particular concerned minority that's not willing to do in vitro
fertilization. And I was thinking, gee, that's an interesting way
of seeing it. Somehow the majority ruled in that case.
CHAIRMAN KASS: Question about .. we
can ask Frank to provide ..
DR. HURLBUT: Frank can give us a
tutorial.
PROF. FUKUYAMA: Well, I mean the
biggest .. I mean the most respected expert on precisely this topic is
a member of our Council, and that's Jim Wilson.
PROF. SANDEL: Jim. Jim can give
us a tutorial or they can give us a joint tutorial.
CHAIRMAN KASS: Alfonso, was that a
hand?
DR. GÓMEZ-LOBO: Yes. I'm
sorry to go back to this, but I was thinking how does the staff draft
regulation about IVF clinics? There could be a rule, depending on the
goals we set for the staff, that says one and only one embryo may be
fertilized and implanted, depending on certain principles, or we can
say any number of embryos may be fertilized because the rest of them,
even if three, four are implanted, the rest of them are going to be
used for research. So in that set of values or goals ends up with very
different regulations. I'm just puzzled how you do this.
PROF. FUKUYAMA: Well, if I could
just answer. You know, I guess the way I would conceive of what
we're doing is trying to see whether there are models for
alternative regulatory systems, the ones we have now that actually do
inject some ethical values into the regulatory process. But,
currently, we have this mixture of completely unregulated sectors and
heavily regulated sectors. The heavily regulated sectors can only
regulated on the basis of safety and efficacy so that, for example,
under the current system there was just a case that was reported in the
Wall Street Journal about ten days ago where the FDA intervened to
prevent a fertility clinic from mixing the cytoplasm of a third party
in addition to the parents of a child and did it on safety grounds.
But other fertility clinics are able to do things that I suspect you
would really blanch at right now, because there simply is no statute
regulating that. If you wanted to create a chimeric embryo implanted
in a uterus, all sorts of things can go on right now.
So I think that in general I
guess this is how political scientists think about this more. It's
more a question of what are alternative institutional models whose
specific content can be filled in later? For example, is the FDA ..
the FDA claims authority over certain IVF procedures, but the statutory
basis for that is really not clear, so we can ask the question, is the
FDA actually a good body to be doing this, can the statute be modified
to expand its authority or is it necessary to .. does that have
downsides, is it better to do what the British did and create a
completely separate institution that would have a different statute
that would incorporate other kinds of ethical concerns. And these are
all options, I think, that can be laid out fairly specifically, and you
wouldn't have to touch the question of what does this body .. you
know, how many embryos and what do you do with them and how many days
and that sort of thing. I think that there are much more generic
principles of institutional design that we can very usefully study that
you would have to go through first before you even got to the kinds of
questions that you're worried about.
CHAIRMAN KASS: Dan, do you want to
enter?
DR. FOSTER: No, because I'm
going, but I mean I support going ahead with the plan that's here.
What I worry about is just going back to the very start of the Council
again to start asking these questions again, and if you're not
going to do anything, there's not so much point in having a
regulatory body, I wouldn't think. I mean it's just like the
British said, I mean I don't know .. I mean I can understand the
principles of an institutional thing, but if there's nothing to
regulate, there's no point in the .. you know, if the Council wants
to say, "Well, okay, you're going to do one embryo or no
embryos and so forth," then it seems sort of irrelevant to discuss
the regulation of those things. But I would like to see like the rest
.. I'm open to see what happens.
CHAIRMAN KASS: Look, I mean it's
.. leaving aside regulation, if you simply talk about monitoring and
oversight activities, never mind setting down rules, it's
astonishing that when in the amidst of all the stem cell debate a year
ago no one within an order of magnitude knew how many embryos were
frozen in freezers. One just simply didn't know the facts about
this sort of thing. Whereas the Brits, whether you like what
they've got or not, can tell you all kinds of things and they know
what's going on, and that can't help but be somewhat helpful to
a sensible formulation of policy. Is there someone who's not
spoken on this who wants .. do I have the sense that without prejudging the outcome that this particular plan of developing this
project has the support of the members?
PARTICIPANT: Yes.
CHAIRMAN KASS: Anybody else besides
the four names mentioned who wants to let us know that they'd like
to be, I think the term in the office is "taking a leading role" in this,
let us know. But we will call out all of you for help in due course on
this and other matters. Thank you very much for your time. Travel
safely. Make your planes.
(Whereupon, at 12:29 p.m., the
Council meeting was concluded.)
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