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Meeting Transcript
October 18, 2002

Hotel Monaco
700 F Street, NW,
Washington, DC 20002


Leon R. Kass, M.D., Ph.D., Chairman
American Enterprise Institute

Rebecca S. Dresser, J.D.
Washington University School of Law

Daniel W. Foster, M.D.
University of Texas, Southwestern Medical School

Francis Fukuyama, Ph.D.
Johns Hopkins University

Mary Ann Glendon, J.D., L.LM.
Harvard University

Alfonso Gómez-Lobo, Dr. phil.
Georgetown University

William B. Hurlbut, M.D.
Stanford University

Charles Krauthammer, M.D.
Syndicated Columnist

William F. May, Ph.D.
Southern Methodist University

Paul McHugh, M.D.
Johns Hopkins University School of Medicine

Gilbert C. Meilaender, Ph.D.
Valparaiso University

Janet D. Rowley, M.D., D.Sc.
The University of Chicago

Michael J. Sandel, D.Phil.
Harvard University



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?

BARONESS KENNEDY:  Five years was really only chosen because we felt that anything less than that was probably too short in terms of devising policies on welfare reform.

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.


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:  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?


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.


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.

SESSION 6: REGULATION 9: INTERNATIONAL MODELS (UNITED KINGDOM)                                                        

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?


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. 


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.


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.


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 ..


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.


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?


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.


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 ..


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.


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."


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.


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?


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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