CHAIRMAN KASS:  Again, it is a great pleasure to have Ms. Suzi Leather, the Chair of the Human Fertilization and Embryology Authority with us.  And we look very much forward to your presentation and discussion.  Thank you for being with us.

MS. LEATHER:  Thank you very much indeed.  Chairman and Council Members, it is a very great privilege for me also to be invited to attend this meeting, and to present to you the U.K. model of regulating assisted reproductive technologies and human embryo research.

Thank you very much for this opportunity and I am sure we are going to learn as the presentation follows the order of your helpful list of questions broadly.

I must begin by saying that the Human Fertilization and Embryology Authority which I Chair is an example of a rather eccentric British institution, a non-departmental public body.  This mean that we report to the U.K. Department of Health, specifically to the Minister for Public Health. 

We have an independent status of government, and like Baroness Kennedy before, I speak to you today in my capacity as Chair of the HFEA, and not as a representative of the British Government.

I also speak as someone who has not been in place for very long.  I took over from my excellent predecessor, Dame Ruth Deach, only in March of this year.

And before that I was the Deputy Chair of the Foods Standards Agency, which in some ways is rather similar, in that we deal with the interspace between public understanding and perception and science.

So clearly we don't have the ethical dimension and the feelings dimension as strongly in the food safety debates as we do in these debates, but there is some that do cross.

By background, I am not a lawyer, unlike both of my predecessors.  My background is in social sciences, particularly in political science, and also in social work training.  I have worked mostly for consumer organizations, and focused on health.

Now, Chairman, your first questions were about the HFEA's mandate and structure.  The Human Fertilization and Embryology Authority, as I am sure you know, was the first regulatory authority of its kind in the world. 

And it was set up following a very widespread public debate, the most notable feature of which was the Warnock Committee Report in 1984, which recommended amongst other things the creation of a new statutory licensing authority to regulate both the research and those infertility services which the committee thought should be the subject of control.

And it established the principles by which we work today.  These include respect for human life at all stages of its development.  Respect for the rights of people who seek treatment and the need for their fully informed consent.

Concern for the welfare of the resulting child, independent of the interest of the adults involved; and the recognition of the benefits which can flow from responsibilities perceived of medical and scientific knowledge.

Established in 1991 by an Act of Parliament, the HFEA's role is principally to regulate the creation, storage, and use of human embryos outside the body, both in treatment and research. 

And we also regulate assisted conception techniques which use their native gametes, and the storage of gametes.  The HFEA's system of regulation is national, covering clinics and research centers in all four countries of the United Kingdom.

We make no distinction between the public and private sector.  Constitutionally, as I have said, the HFEA is a non-departmental public body.  This means that it is at a distance from central governments, being headed by an authority board rather than by ministers or government employees.

And we have those functions.  We publish a code of practice, which gives guidance to clinics about how they should conduct their activities.  We keep a register about treatments, about children born, and about donors.

We provide advice and information to patients, and to donors, and to clinics, and we review developments, and have also an advisory function.  Now, having said that we are independent, we are not wholly independent. 

Our members are appointed by ministers following open public advertisement of the sort of that Baroness Kennedy talked about, and we are responsible and accountable to Parliament through the Secretary of State for Health.

Our membership is very wide also.  We comprise people who are appointed in an individual capacity rather than as representatives of organizations, but they have background in clinical and research medicine, nursing, science, the law, ethics, religion, psychology, social work, regulation, and the media.

We currently have 21 members, and no more than half of our members may be from science or medicine.  In addition, neither the Chair nor the Deputy Chair may be other than lay members. 

We have an executive staff of about 48, plus or minus a few from time to time, and in addition we have a part-time inspectorate of about 60 clinicians, scientists, ethicists, counselors, and lay people, and we have about a pool of about 50 internationally respected peer reviewers who advise us on the research license approvals.

Our present structure developed from what was essentially a self-regulatory model, which operated from 1985 to 1991.  We currently have an annual budget of 2.7 million pounds, which is about $4.2 million to cover the research of 122 storage treatment and research centers in the U.K., to cover the comprehensive data collection and storage function, and the executive staff to support the authority, as well as our internal committees.

Since inception in 1991, the context in which the HFEA operates has changed very significantly.  Demand for IVF treatment has more than doubled.  About one percent of births in the United Kingdom are the result of IVF, and we do not I should say cover gamete inter-fallopian transfers. 

So we don't cover GIFT, and that is not a license in fertility treatment under our system.  We also as you have seen a significant increase in particular in the complexity of treatments, such as ICSI, PGD, assisted hatching, and now of course there are new techniques, such as antecloding screening and the use of frozen eggs coming on stream.

There has also been a very significant change in public attitudes with very much greater demands for openness and public involvement.  The HGC is one of the expressions of government's answer to those demands.

And there are also significantly higher expectations of corporate governance, and rigorous risk-based regulation across all organizations in the field, but these changes have certainly had a very remarkable impact in the health sector.

The HFEA is responding to these changes, and we have recently put a business case to governments to enlarge the capacity of the organization to support and enhance regulatory function.

I hope that this should mean amongst other things that we will be able to move towards a much more demanding evidence-based, rather than judgment-based, inspection system, and have a greater capacity to audit treatment information and provide guidance on best practice, rather than the set of minimum standards.

Now, this rather complex slide shows the interrelationship, and I'm sorry, but the white print doesn't show up very well.  It shows the interrelationship between our licensing activities and some of our policy formation, because we license clinics, and we audit what happens in clinics, and we inspect clinics annually.

And from the monitoring of that, that feeds back into our policy and into our code of practice.  So, for instance, I guess the best example is the number of embryos. 

We under our code of practice say that there should be two embryos transferred, and only in exceptional circumstances, three, and I believe that is fairly different from some of the practice in the U.S.

And I personally would be keen to move as closely as we could to natural practices.  Some of the European countries are looking at that and to single embryo transfer, and clearing there would be benefits in terms of reducing the burden of multiple births.

The organization powers and duties of the HFEA are based on and circumscribed by statute.  We essentially implement the Human Fertilization and Embryology Act of 1990, as amended by a handful of subsequent legislation, such as the Human Fertilization and Embryology research purposes regulations in 2001, which permits human embryos to be used to derive stem cell lines.

Our foundation is therefore established by decisions of Parliament primarily when it passed the Act almost 12 years ago.  The main responsibilities of the HFEA under the Act as I have said are to license and to inspect IVF clinics, and to license and regulate embryo research, to ensure that only research which is necessary for, and in keeping with the purposes set down by Parliament, takes place.

As I have indicated the HFEA's regulation of infertility treatment applies equally to private clinics, as well as to the social provision carried out within the National Health Service.

Similar with research, the funding source, public or private, is immaterial.  Now something about what we don't do.  We do not act as a pressure group.  We are not acting to increase the amount of infertility treatment.  That is not one of our primary roles.

We are not an ombudsman or ombudsperson.  We are not a research or treatment funding organization, and let me in fact repeat that we don't in fact regulate all infertility treatment.  We don't regulate GIFT, and clearly we don't regulate what happens in bedrooms.

In your questions to me, Chairman, you asked whether the HFEA has any formal responsibility to advance British competitiveness in biotechnology.  It does not. 

And indeed as a regulator, I would emphasize the importance of maintaining an evenhanded stance with regard to particular companies and research groups operating within the United Kingdom.

Furthermore, the HFEA is not involved in funding as I have said either treatment or research, or indeed in directing resources of any kind in this way, although we do have an important role to play with medical funders, such as the MRC, and we are currently talking to them on setting up good research projects and looking at the outcomes of infertility treatment.

Now, this is some of the recent public consultations that we have done, and we are about to launch in fact on Tuesday of next week a sex selection consultation. 

We have be invited by government to do so, and we last consulted the public about this in 1993, and it will be interesting to see whether there has indeed been a shift in public attitudes.  Certainly only yesterday there were reports in our media of family couples coming ot the States to make the use of MicroSort techniques, because they wanted to determine the sex of their next child.

But at the moment the position in the U.K. is that sex selection is only permitted to enable couples to avoid serious sex link disease and not for social purposes. 

One of the purposes of regulation I feel is to maintain public confidence in the area regulated, and I believe that we have a responsibility to act openly, and to consult the public as widely as we can, and to inform public debates about the activities, benefits, and costs of reproductive technologies.

As well as to carry this debate forward through public education.  But I do emphasize that this derives from our responsibility for informing the public and not from any interest in the furtherance of science or the promotion of U.K. biotechnology.

If we do carry out our tasks openly and intelligently, I hope nevertheless that the public debate will be an important contribution to the future of these technologies.

Let me turn now to your questions about the guiding principles and ethical basis of our work.  As I have said the HFEA was set up to implement an act of Parliament.  That legislation was itself a result of concern about the human embryo, and the possibilities that arose as a consequence of the creation of embryos in the laboratory.

The Warnock committees' approach, which was subsequently endorsed by Parliament, and embodied in the legislation setting up the HFEA, was to focus not on the definition of the status of the embryo, but rather on how it should be treated. 

In the Committee's view, the developmental potential of the early embryo made it deserving of respect, but not of being regarded as a human person.  Following the committee's report, certain absolute prohibitions were codified in the legislation.

For example, research on embryos up to 14 days is permitted, but only for specific purposes as defined by Parliament, and only with the approval of a research license from the HFEA.

In public debate about the creation of embryos outside the body, this gives rise to three main concerns.  Is it right, and is it safe, and where might it lead.

Public opinion on these questions is varied, and in the United Kingdom, as in the U.S., there are some people who are opposed to IVF and the use of embryos in any research.

However, in the U.K., the experience of over 10 years of regulation has provided reassurance that the activities of researchers and clinicians can be controlled in such a way that it allows the benefits of these technologies to be explored and enjoyed responsibility.

And certainly the debate in 2000 and 2001 surrounding the derivation and use of embryonic stem cells showed that concern had moved on from anxieties that characterized the debates in the 1980s over the regulation of IVF and the acceptable use of embryos in research.

However, the HFEA must I think do more to come back to one of your questions, Chairman, and must do more than merely reflect public opinion on these matters. 

In particular, when there was a question of licensing the implementation of new techniques, these must be judged first against the parameters set down by Parliament, i.e., there is a role in interpreting the lawmakers.

And then in light of the principles that underlie them to which I have already alluded, in these matters the HFEA fulfills I think an essential function, in that we are an expert body appointed to address questions that are sometimes technically difficult, and always ethically complex, and in which the public is not necessarily interested, or the implications of which it does not see necessarily straight away.

So while we consult widely, and often in collaboration with other bodies, and sometimes with the HGC, it is not possible or I think appropriate to consult on every new development.

Or indeed to develop or to decide some of the sensitive issues as it were by plebiscite.  Typically the HFEA's process involves a movement from consideration of principles to the consideration of consequences or utility. 

Only when legal, technical, and ethical questions may ask can it be done, may it be done, ought to be done, have been fully considered does the HFEA then reach the point at which in turning to more concrete and practical questions we have to balance the potential benefits that technologies might provide with any risks associated with them, both in terms of public health, and in terms of public morality.

The decisions which the Authority makes are frequently the subject of a great deal of media interest.  An area of current focus is embryo screening. 

Consistent with the outcome of a large scale public consultation, the HFEA permits the implantation genetic diagnosis in cases where there was a serious significant risk of a child inheriting a serious genetic disease.

Now, precisely what this means is a matter of judgment.  There is no positive list of diseases or disease categories.  Instead, seriousness is judged in the context of each clinical situation, with reference to the abortion guidelines from the U.K. Royal College of Obstetricians and Gynecologists.

In other words, if a condition is so serious that two doctors would allow a doctor to terminate her pregnancy if the fetus had it, then pre-implantation and genetic diagnosis may be allowed so that the woman can begin her pregnancy, confident that the fetus she will carry is unaffected.

However, the possibilities available through pre-implantation genetic testing are not restricted of course to the avoidance of disease, and this was clearly the concern of the architects of the legislation.

Decisions concerning the selection of genetic characteristics have themselves raised questions in the public mind about the circumstances and the extent to which couples should be allowed to select for or against characteristics.

Increasingly the HFEA is faced with decisions involving the use of assisted reproductive techniques in non-infertility settings.  Two important decisions have been made by us this year. 

In February the HFEA allowed a couple undergoing IVF with PGD to select an embryo, which as well as being free from a serious disease, is also selected to enable cord blood from the resulting baby to be used to treat an older sibling suffering from beta fallacemia, and this is sometimes referred to as the Hashmead case.

In reaching its public policy, the HFEA established a number of criteria under which it would see the use of such a technique being acceptable.  I apologize for the small print, but I think these are quite important.

So firstly the condition of the affected child should be severe or life threatening or of a sufficient seriousness to justify the use of PGD.  The embryos conceived during the course of this treatment should themselves be at risk from the condition by which the existing child is affected and that is a very crucial clause, and it relates to another case that I am going to talk about in a minute.

All other possibilities of treatment and sources of tissue for the affected child should have been explored.  The technique should not be available where the intended recipient is a parent, and the intention should be to take only cord blood for purposes of the treatment, and not other tissues or organs.

PROF. SANDEL:  Does that include bone marrow?

MS. LEATHER:  No.  In another subsequent case which did not meet the criteria, specifically of embryos conceived in the course of this treatment should themselves be at risk by which the existing child is affected, the Authority has not allowed HLA matching, and this case is sometimes called the Whittaker case.

These were two pretty important decisions by the HFEA,a nd they both received an enormous amount of media coverage.  Our reasoning for making this distinction involved the acceptance of three premises.

Firstly, the principle that persons should not be regarded merely as means to other people ends, and the need to respect the interests of any child being created as separate from the interests of anyone else, even a seriously ill older sibling.

Second, a recognition that embryo biopsy is a procedure which has not been subject to lengthy clinical trials.  The risks associated with it are therefore yet unquantified, but must be balanced against any benefits accruing to a person which develops from the biopsied embryo, and this point came up in your discussions yesterday.

Thirdly, the view that where such a procedure is being undertaken, and the interests of the future child, an additional step which does not involve additional anticipated harm, but which may confer a sufficient lateral benefit, maybe be permitted.

Thus, if the benefits essentially accrue only to another person then we thought that it was unethical to allow the creation of a person whose interests have been compromised in this way.

Both decisions as I have said provoked widespread controversy, and I'm sure will be the subject of continuing discussion and review.  The underlying issue, which is how far U.K. society wishes to go in making use of these techniques for purposes other than the simply avoidance of serious disease, is unresolved at this time.

PROF. SANDEL:  Could you just explain how Condition B was not resolved in the case that you turned down so we can understand it?

MS. LEATHER:  I'm sorry, the case we turned down?

PROF. SANDEL:  Yes.

MS. LEATHER:  The child that we created did not themselves stand a chance, any more of a chance of you or I inheriting -- well, not in inheriting, but in suffering from the disease that its sibling had.

PROF. SANDEL:  And you knew that because of the genetic testing?

MS. LEATHER:  The sibling had black fananemia and was not judged to be a genetic illness.  So subsequent siblings it was felt would not stand any more chance of having that disease than anybody else.

So if you were going to allow HLA typing in order simply to have a match for an older sibling, that that was ethically unacceptable we felt.

PROF. SANDEL:  Was it in the first case --

MS. LEATHER:  In the first case, beta fallacemia, a second child themselves would have been at risk of that disease.  So they themselves benefitted from pre-implementation genetic diagnosis.  We felt that therefore at the same time that you could choose an embryo at the same time that you were doing an embryo biopsy to avoid that child having beta fanacemia, you could choose an embryo which tissue matched the older sibling.

PROF. SANDEL:  Thank you.

MS. LEATHER:  It is difficult to explain these differences, which are very fine judgments, and clearly fall with the families concerned that are hugely painful.

And it is difficult to explain them, and even here it is very difficult to explain them to the media, but nevertheless it did seem to us to be a very important ethical decision and one that we should at this time protect.

And can I come to the sex selection consultation now?  This is an area as I have said that we are consulting.  Now, once it is a matter of policy, sex selection using pre-implantation genetic diagnosis, is only permitted in the United Kingdom for medical reasons.

And sperm sorting follows by artificial insemination, where this uses fresh sperm of a woman's partner, is not controlled currently.  And the consultation which we are going to publish next week has followed a year long review, which has included the commissioning of independent reports on the scientific and ethical aspects of the treatment, as well as market research into the nature of public understanding and discussions of this subject.

And we are going to address three main areas.  Firstly, should the use of sperm sorting be regulated in the United Kingdom.  Secondly, should sperm sorting be available for medical indications, bearing in mind the current uncertainly as to its reliability and long term side effects.

And thirdly should sex selection in general been available for any non-medical reasons.  Let me turn now, Chairman, to your questions on our processes and actions, and in particular embryo research.

We make a distinction in the U.K. between publicly and privately funded system conception centers, nor between research which is funded by public bodies, which as the Medical Research Council. and private organizations, such as pharmaceutical companies.

All activities which involve the storage of human gametes, the creation outside the body, the use and treatment, and research of human embryos up to 14 days, are subject to our license and inspection procedures.

The approval process for research licenses is rigorous.  The HFEA has first to be confident that the proposed use of any embryos is necessary for the purpose of the research, and the activities conducted in the course of the research are in keeping with Parliament's accepted purposes.

The 1990 Act defines these purposes, firstly, as promoting advances in the treatment of infertility, and increasing the knowledge about the causes of congenital disease, and increasing knowledge about the causes of congenital disease, increasing knowledge about the courses of miscarriage, developing more effective techniques of contraception, or developing methods for detecting the presence of gene or chromosome abnormalities in embryos before implantation.

But these purposes were generally to do with infertility is explained by the way in which human embryo research developed in the U.K. in pursuit of more effective means of overcoming infertility.

So the historical reason for the HFEA's remit covering both treatment and research, and in the context that it was a short step for techniques to move from development to implantation, and quite often as connections, of course, between people who are involved in research, and people who are involved in treatment.

In January of 2001, following large majorities in both Houses of Parliament, which were on three votes, and so people weren't voting along particular party lines, but individual consequence on the issue, three additional research purposes were added.

Firstly, increasing knowledge about the development of embryos, and increasing knowledge about serious disease, or enabling such knowledge to be applied in developing treatments for serious disease.

The addition of these purposes confirmed the HFEA as the appropriate body to license and regulate embryo research, a confidence that was then endorsed by the House of Lords on that committee later that year.

However, with the introduction of these new purposes, the HFEA is realizing more than ever before a need to collaborate closely with other organizations and bodies with an interest in the development and use of knowledge techniques in cell lines originating in embryo research, specifically with the Medical Research Council. 

In addition to thinking about the requirements for embryo research, in addition to passing the first hurdles which I have described, which are the necessity and appropriate purposes test, all research applications  have to have the approval of a properly constituted ethics research committee.

And the research is then subject to our peer review process.  The research facilities are inspected, and the proposed license holder for the project and many of their team will be interviewed before a final report is considered by an HFEA licensed committee.

Applicants wishing to undertake research to drive stem cells from embryos are further required to do the following.  Firstly, to justify why embryonic stem cells are to be used, rather than other types of stem cells.

Secondly, to provide detailed information on what happens to the stem cells throughout the project; and to place a sample of all cell lines in the MRC stem cell bank.

Chairman, you asked me also about human cloning.  The U.K. has taken the lead in positively outlawing human reproductive cloning.  The Human Reproductive Cloning Act of 2001 makes it an offense under criminal law to place a cloned human embryo into a woman.

And any clinician found guilty of doing so in the U.K. would be liable to a prison term of up to 10 years, and also to a fine.  Somatic cell nuclear transfer, sometimes called therapeutic cloning, or I think in your last report, cloning for biomedical research, on the other hand, is permitted under the law.

Indeed, one of the intentions of the Research Purposes Regulation of 2001 was to permit the deprivation of stem cell lines from embryos created by cell nuclear transplantation. 

And so together these two pieces of legislation positioned the U.K. in your ban plus regulation category.  The HFEA is therefore allowed to issue licenses for therapeutic cloning.   However, it has yet to do so.

Furthermore, the HFEA has announced that it will not issue any such licenses until the House of Lords, acting as the final Court of Appeal in litigation brought by the Pro Life Alliance, puts beyond doubt the question of whether human embryos created by cell nuclear transplantation are in fact embryos within the terms of the regulatory legislation.

Your final set of questions, Chairman, were most difficult.  You asked me to make some general reflections, and I think to make some suggestions for your country, which I really don't think is in a sense my business to do.

But certainly the benefit of hindsight is attractive.  Looking back, a notable feature I think of the legislation which established the HFEA has been its remarkable durability. 

The HFEA Act has continued to provide a workable framework and prove robust enough to cope with the proliferation of scientific developments and treatment possibilities -- ICSI, pre-implementation, and genetic diagnosis, antecloding screening, assisted hatching.

There have, however, been some drawbacks in the legislation.  In a very practical sense, we have been hampered by the very stringent definition of confidentiality under the Act.

This was incorporated in order to protect patients, donor, and off-spring confidentiality, but it has imposed in fact significant practical constraints on the HFEA.

It means, for instance, that the HFEA has been unable to engage outside contractors to improve its IT systems, and it suffered from a qualification on its accounts due to the fact that these can't be independently verified.

So these are not necessarily issues for you, but they are certainly issues that have made a bit of a difference to us. 

In terms of recommendations, it is difficult I think to read across very closely from the U.K. to the U.S.  The different histories and traditions, not least the fact that the U.K. does not have a written constitution, or a Federal structure, but does have an established church, and I think a less publicized civil service, makes generalizing from one setting to another particularly precarious. 

Additionally as I have said, our regulatory history over the past 10 years or so has given public debate a different complexion, and I think it is fair to say that public opinion in the U.K. is less polarized on these issues than it is here.

That said, let me suggest some issues for debate.  Firstly, the core question I think for us for regulation of assisted reproduction technologies is to what extent is this so different an area of health care that it justifies and requires a distinct regulator restructure.

And in the U.K. in 1990, it was certainly judged to require just that.  There were a number of factors which justified setting up the HFEA, and not least of course ethical sensitivity about embryo research and infertility treatment.

In addition, access to infertility treatment has never been generally available under our National Health Service.  So rather like cosmetic surgery, most providers were in fact in the private sector, and so it required a system which operated across both public and private provision.

From the U.K. perspective, I can certainly point to many benefits of regulation in the area of assisted reproduction.  A reliable and publicized standard of service provision for patients, and public confidence that these standards will be maintained, compulsory data collection in the interests of public health.

And consistency, transparency, and independence of decision making in line with clear moral standards in what is an ethically difficult area.  But having said all of this, it is important to remember I think that each national jurisdiction will have to reach its own conclusions on the acceptability of forms of assisted conception and embryo research.

And to implement those within or under the rubrics of its own political system.  There may be some uses of reproductive technology which are so offensive to moral sense and natural justice that they merit international condemnation and prohibition. 

Human reproductive cloning, and cloning to produce children, and eugenic selection of racial characteristics may fall into this category.  But for others, I think, it is a case of determining what the moral consensus in each culture can approve in the interests of medical benefits and scientific advance.

The U.K. experience has been that it is possible to reach consensus, or at least an accommodation in this area.  But the road to legislation was a difficult one, and in another context it might prove more difficult still. 

Consequently, in the research context, very real issues arise with regard to the exploitation of biotechnology discoveries made in other jurisdictions, and for those wishing to import biological material which originates in other countries for research.

In the first case, given that biotechnological inventions have the potential to provide significant health benefits, and to alleviate profound suffering, possibly for great numbers of people, one must ask I think how should one approach the use and practice of biotechnological discoveries, and the knowledge that these may have been generated in ways which would be ethically and legally unacceptable in a domestic setting.

This is unlikely to be a question that can be resolved in the abstract, but nevertheless certain parameters may be established.  In the U.K., they are either codified or implicit in the HFEA Act.

In the second case, and perhaps more immediately, the question which must be addressed is to what extent may research be allowed to progress on imported biological material derived in a way that might not be acceptable locally.

This is a question which has already risen in Europe with individual jurisdictions, and having to find particular solutions to this problem.  In conclusion, Chairman, I would say that rather than simply lock the gateway to embryo research, the British approach has been to appoint a gatekeeper.

The role and actions of this gatekeeper will no doubt be the subject of infinite -- and I hope -- healthy debate, and I think it is particularly helpful to have international debate.

I am not saying we should be having an exchange of ideas about what is morally appropriate, right and wrong, but we are actually faced with a situation where citizens from the U.K. can say we can do it, and citizens in the U.S. say why should I have to pay the airfare to get there.  Thank you for inviting me.

CHAIRMAN KASS:  Thank you very much for a very lucid and forthcoming, and very responsible presentation.  May I ask just a few questions from the Chair? 

Yours is really the only existing regulatory body.  There are lots of advisory commissions, and there are other places that have statutes that prohibit certain sorts of things, but this is a group that not only sits down regulations, and monitors, and inspects.

And I guess my question is have you had experience in finding things in which people are not playing by the rules, and what has happened, (a). 

And I guess a corollary to that is what is the response of the regulated to what they perceive to be unreasonable restrictions on practices that in fact could benefit people's health.

In this country, we would have a very hard time, I think, imposing these kinds of restrictions, and having a monitoring system where there are penalties for non-compliance.  Has there been non-compliance, and what has happened, and how do people react?

MS. LEATHER:  Okay.  Well, firstly, I think there are some cultural differences in attitudes to regulation between the U.K. and the U.S.  I think that in contrast perhaps to the U.S. that the U.K. -- and Helena can agree with me or not on this, that we quite like a bit of regulation.  It makes us feel safe.

And indeed the Warnock Committee report talked about this and establishing the 14 day boundary.  That is a 14 day boundary of what is in biological terms a process, and so in a sense it is artificial to draw it to any one place. 

But they were mindful of the need to do that in order to establish public confidence, and that approach has shown itself to be extremely successful, and we do want the whole field safe for this.  There is an important degree of acceptance of moral consensus that that was the right boundary.

Now, you asked about the action of the regulators.  Well, I guess that most organizations -- and I would include mine -- don't necessarily welcome the people that regulate us.  I mean, it is just a human response.

I think that most clinics see the benefit of having a regulations structure because it clearly tells them what they should and shouldn't do, and what they can and can't do.   It has the power or we have the power to close clinics if we find that they really are doing things which they shouldn't be doing.

CHAIRMAN KASS:  Have you ever?

MS. LEATHER:  Yes, we have closed clinics.  And that also gives patients a degree of confidence, and I think that it is interesting that quite a lot of people from other European countries come to the U.K. to have treatment.

And I guess that one of the reasons that they do that is not only that they have very good information published by -- independent information published on the success rates, but also they know that the practices in clinics is well regulated.

CHAIRMAN KASS:  Let me ask also --

MS. LEATHER:  Do people welcome being put out of business?  No, absolutely not, but I should say that this is extremely rare, and we do annual inspections and inspection teams go in, and they comprise different people. 

So clinicians, scientists, and nurses, counselors, and people with an expertise, and they will look at the practices in the clinics, and say this isn't okay, or this is, and change it.  And we can make additions upon licenses, and give people a certain amount of time to change practice.

CHAIRMAN KASS:  Let me also ask about commerce in gametes, and the like, and I know that you have a policy on this, but I think it would be good for the record if you would comment on that.

As you know, in this country there are on the internet advertisements for oocytes, depending upon one's accomplishments, and now up to $50,000.  And even many of the hospitals are now -- many institutions are charging now up to $7,500 for oocytes, and there is now competition for this in this country.

What is the British policy and are people obeying?

MS. LEATHER:  In the whole we have tried to remove human tissue from the marketplace as far as possible.  So, we don't, for instance, pay blood donors.  And the same approach, and we have taken the same approach with regards to gametes and embryos. 

So you can get your expenses, plus a little bit more, but it is a very, very small amount of money for donating sperm and eggs.  And we import, and we allow the importation of sperm and eggs really on the same basis, and so we are not happy with the idea that somebody should be a donor because they were offered a great deal of money.

That said, there is of course international trade as it were in gametes, and we are -- we do face a shortage, and we have always faced a shortage of eggs, but we are not facing quite a serious shortage of sperm.

And it may be that we may have to review this policy.  But also since 1991, the approach has been that you shouldn't donate your characteristics so openly as you have here. 

So we have a kind of -- I suppose that consumers in the U.K. are rather blinder than your consumers, in terms of what they may be getting.  We do go to great lengths to screen for health reasons for sperm, for instance, but we don't say here is somebody who has a Ph.D. in physics.  Do you want this one rather than someone who is a farmer.

CHAIRMAN KASS:  But there is this policy, but if individuals wanted to offer their gametes to market, it is legal in Britain, or is it not?

MS. LEATHER:  It is not legal for the clinics to do that, no.  You can't pay somebody a great deal of money.  What you can do is to donate eggs and get cheaper treatment.  We have allowed that to happen. 

So you may say what is the ethical difference to that, and that itself has been accepted, but it does set up certain problems I think for some women, because it means that somebody might have tried to have either treatment that has not been successful, and they donated some of their eggs, and they have a feeling that there is somewhere else a woman who has conceived using her eggs.  These are difficult problems.

CHAIRMAN KASS:  Thank you.  Michael Sandel.

PROF. SANDEL:  I thought this was a very instructive presentation, and it brings out very -- it seems to me that the U.K. has struck a very sensible balance in this system, and in this whole domain that we are still struggling towards, and it has alluded us so far.

And what your presentation I thought brought out very powerfully was the connection between the two differences between the U.S. and the U.K.  You mentioned that public opinion in the U.K. is less polarized on these issues than in the United States.   And you also mentioned that there is more of a tradition of government regulation, and its acceptance in the U.K., and what struck me thinking about how you have arrived at this balance is how connected those two things are. 

It seems to me that in the United States one of the reasons public opinion is so polarized on these questions is precisely because there is such hostility at least in some questions at least to government regulation because of the belief in unfettered markets.

And that every choice, that every decision about embryo research or stem cell research is all or nothing.  So that on the one hand, IVF clinics are completely unregulated.  Tattoo parlors or barber shops are required to more licensing requirements than fertility clinics in the United States.  We don't regulate them at all.

So in principle, provided that it is done with private funds, you could have not only sex selection, but all kinds of trait selection, buying and selling, because we are such believers in completely unfettered markets.  We don't regulate even IVF clinics.

And then when it comes to discussing possibly life sustaining new technologies or forms of research, we say, well, there would be a slippery slope here, because it is against the background of an unfettered market and no regulation.

And no authority like yours to actually enforce regulations on the clinics, and so if we accept a life sustaining form of research here, well, it could lead to a parade of horribles.  The slippery slope argument.

And what your -- and so it is either all or nothing.  Either we must ban it, because if we permit it in this purely unfettered market, then there is no way of stopping the parade of horribles, the slippery slope.

And what your regulatory body provides is a way to make the slope less slippery, and a way to -- and that in turn permits the debate the public debate, about whether or not to avail ourselves of this or that technology, or medical research.

It makes it possible for that debate to proceed with less polarization, because it is not an all or nothing affair.  The slippery slope looms less large because of an institution like yours.

MS. LEATHER:  I think that is an extraordinary insightful comment, and in fact when the debates were being had in Parliament at the end of 2000 and 2001, people made precisely that comment.  We would have found it very difficult I think as you did to accept therapeutic cloning if we hadn't had over a decade of experience of responsible regulation that on the whole has worked well.

No regulation is ever perfect, and there are always going to be things that it doesn't know about, but on the whole it has worked extremely well, and it is perceived as having done so.

CHAIRMAN KASS:  Gil Meilanender and Rebecca, and Alfonso.

PROF. MEILAENDER:  I have two questions, and they are just factual ones, and they are entirely unrelated I believe, but they just occurred to me at different moments.  One is that when you were discussing PGD and it can be done, and if there is a possibility of a serious genetic disease, and you said there was no list.

That in a sense it is a determination made case by case, I guess, is what you said.  But I just wondered if you could narrow that for me.  So that, for instance, would something like cystic fibrosis constitute a serious genetic disease, even though someone can live quite a lot time with it, for instance?

Would a propensity to schizophrenia or something constitute a serious genetic disease?  If you could just sort of narrow it for me at all, just in terms of what your own experience of cases tells, that would be interesting to me.

And then second, and an entirely different kind of question, but you have 21 members I think you said on the HFEA right now.  And I am wondering if any of those 21 members opposed, say, to embryo research, or would this way of dealing with the question in a non-polarized setting effectively exclude from kind of important roles in public deliberation people who held certain kinds of views?  So those are my two questions.

MS. LEATHER:  Okay.  Thank you very much indeed.  You have asked me to do precisely in a sense what we have struggled to avoid, which is to start a list.  In my view, yes, cystic fibrosis is such a serious life threatening disease, and we have accepted it for pre-implantation genetic diagnosis.

Schizophrenia has not obviously come up yet, and were it to come up -- and I can only answer this in a personal capacity at this stage.  I was once a mental health manager, which meant that we reviewed section orders for people who were detained under mental health legislation, because I chaired the NHS trust which provided mental health services.

My experience of people suffering from certainly extreme forms of schizophrenia is that that is very deep human suffering, and not only for that person, but for other people who love and who are related to them.

So I would also regard that as being in the category as it were.  Your question about should we have people who are opposed to it.

PROF. MEILAENDER:  The question is do you.

MS. LEATHER:  No, we don't.  This does come up as an issue, and I think that the government has felt in a sense of what would be the purpose of having somebody there.  It is not as if we are not continually reminded that there are many people who hold very firm views against what we do.

And I believe that those views should be respected, but they are out with the moral consensus in the U.K. at the moment, and I don't think we need them continually on the committee saying that I am opposed to all of this, and I am opposed to all of this, because I think that would stop the decision making that we have to do.

CHAIRMAN KASS:  Rebecca.  Rebecca Dresser.

PROF. DRESSER:  Thank you very much for these two presentations showing us that at least it can be done in some way.  I had some questions about the -- I guess it is a subcommittee or a separate committee that reviews the research proposals, the embryo research proposals.  Is that correct?

MS. LEATHER:  A license committee, yes.  It is not in fact -- we can have license committees to look at research proposals made up of Authority members, and in the same way as we have license committees for treatment made up of Authority members.

PROF. DRESSER:  I was wondering, as I understand that it does peer reviews, and so does it also include non-scientists?  And in reading our staff's description of your system, and I guess on one of your slides you had some criteria, such as the potential importance of the research, and whether the use of human embryos is justified.

And I wondered if there is also consideration of whether there are -- and perhaps this is part of the last principle, alternative approaches to getting the same information, and a justification for the embryos are the only alternative.

So I wondered if there are people on there to make value judgments apart from scientists, and this ties in a little bit with the previous question.  And I guess it wouldn't necessarily be that -- I mean, one position would be that you could have some people who are very skeptical of using these, and would oppose them at all times.

And then another would be that there would be a range of opinions, and so there might be some people who would say only in the very, very compelling case would it be justified.  And then there would be others that might take a more liberal position.

And so I was interested in that part, and then I just had one related question.  It says in our documents that you have received 135 applications for research licenses, and of these 115 were granted.

I was curious whether you know anything about the ones that were turned down and why, and then --

MS. LEATHER:  Okay.  Thanks very much.

PROF. DRESSER:  Should I ask one more or wait until you --

MS. LEATHER:  Let me deal with those first.  The question about the justiciability in a sense of using embryonic stem cells rather than other stem cells.  We are using that justiciability, not in the moral sense.  We have determined that has been decided by Parliament. 

But what we mean is this scientifically justified, and one of the benefits of having the stem cell bank, which we will have in the U.K., is that we will know exactly what are the stem cell lines that are being created.

So it will be much easier for us in reviewing potential research licenses to say that this hasn't been done or this has been done.  If it has already been done, it is already there, and we don't need to do science twice, of use more embryos unnecessarily.

The peer reviews that you talked about, they are scientists.  We do not or don't have lay peer reviewers, but we do have lay members of the license committee, and also low research ethics committees under the U.K. system also have lay members when properly constituted.  What was your other question?

PROF. DRESSER:  The ones that were turned down, the licenses?

MS. LEATHER:  My guess is that those researchers were trying to do something that either wasn't licensable under the legislation, or we weren't satisfied that they were the proper research group to do it.  But if you would like me to get back to you with further information, I can.

PROF. DRESSER:  That might be interesting. 

MS. LEATHER:  Okay.

PROF. DRESSER:  The one other question that I had was that in our notes it said that the 2001 law included a prohibition on altering the genetic structure of any cell while it forms part of an embryo.

MS. LEATHER:  Yes.

PROF. DRESSER:  And I wondered, and maybe you could both comment on that, but does that mean a prohibition on germ line interventions, or what was that all about?

MS. LEATHER:  That means that you can't do cell nuclear replacement on a blastomere.  So we have permitted it to be used in an egg, although as I have said in fact we are waiting on the House of Lords' decision on whether embryos so created, because they actually have not been created as a process of fertilization, are in fact embryos within the terms of the Act as they are already under the earlier legislation.

PROF. DRESSER:  So our understanding of this is that it just applies to the somatic cell nuclear transfer organisms, whether they are embryos or not.  I wondered if there are any developments in the U.K. about germ line interventions in humans that might be helpful for us to know about?  Has that been an issue on the table recently

Because we have some people here in this country who are beginning to say that maybe we should start thinking about this.

MS. LEATHER:  Okay.  I am not aware of that, but again I will get back to you if that is different.

CHAIRMAN KASS:  Alfonso.

DR. GÓMEZ-LOBO:  Thank you for the very clear presentation.  I think I have more comments than questions at this point, and in regard to Gill's second question, I tend to see quite clearly that given that the mandate for the authority for the HFEA is under the terms of the Act of Parliament, it seems rational to say that only those persons who are in agreement should be part of it.

I don't know, but it seems to me a coherent reply.  Now, that said, I would like to say that my own opinion is that I hope we do not here in the United States adopt the same procedure.  And by procedure I mean the whole process. 

I am starting from the widely shared assumption I guess that morality is or should be above the law.  That the fact that the something has been enacted doesn't mean necessarily that it is morally right, no matter how much consensus exists. 

That is the problem with ethics always, and unfortunately it is not a matter of democracy.  It is not a matter of the majority of votes.  It is a matter of reason, and that's why I wanted to exclude any argument to the effect that some of this would be based on religious beliefs, and therefore it is not part of the public debate.

I hope that everything else is well founded on reason, and not on theology.  Now, what worries me a lot is the fact that many of these ideas that we are enshrining in the law were developed starting from the Warnock Report.

And for those of you who have not read the report, I would like to stress one aspect of it, and it is that philosophically that really it works with two ethical principles.  One is the principle of utilitarianism, which of course as we all know justifies actions by reference to the consequences, the good consequences.

And that is why utilitarians talk a lot about balancing, and other traditions don't talk about balancing.  They only talk about balancing when it is morally legitimate actions. 

You know, should I go to this movie, or to the movie, but if there is action, which by its very nature is unethical, then of course there is no room for balancing that action against any good that might come of it.

Now, that strain in the Warnock report is tempered by an appeal to moral sentiments, which is very much a British tradition coming from Hume, and while the contemporary versions of that are so-called emotivism, but there the question is only whether certain kinds of actions are going to emotionally affect people.

People are going to say, oh, this is terrible, and I feel that this is terrible and I shouldn't do it.  But I don't see a real deep meditation based for instance on the -- well, on other ways of doing moral philosophy.

Now, I don't want to go into a lecture here, but my own preference in the United States would be to have that deep ranging debate because the perils of utilitarianism are really very great indeed.

Practically anything could be justified by reference to good ends.  I can think of severe restrictions of civil rights in the United States in order to fight terrorism.

I lived through a very well known application of utilitarian principles during the military dictatorships in Argentina and Chile, where the justification of torture was always that, oh, this is going to benefit so many people, and in so many ways.

Now, of course, there is an important difference there, several kinds, but again it is this pattern of thought that it seems to me that we should be very well aware.

And the question is, well, are there any cases in which wonderful ends simply do not justify means.  So that is a problem that I have here.  Now, of course, all of this depends on the 14 days decision.  And the Warnock report, of course, admits that it is totally artificial.

I mean, there is no doubt about that.  There is a human embryo developing according to a genetic program, and it is making progress in the direction that is well known to embryologists and to myself, and therefore, it just doesn't seem rational to me to say, oh, here we have a cut-off point.

Everyone agrees I think that the cut-off point is something of a convenience, and I'm sorry that Mike Gazzaniga is not here, and something as he said that I feel comfortable with.

Well, it is not a matter of whether we feel comfortable with or not.  It is what is there, and what is this organism, and what are its properties, and what is its nature. 

How is it different from other organisms, and of course all of that is something that has to be looked at before we take the step of saying that there is no need to respect dignity before 14 days, and there is a need to respect dignity after 14 days, although there, there is the morally questionable provision in the law if I read it correctly, and it is that the embryo should be destroyed, or should not be allowed to go beyond the 14 days.

I suppose that an embryo could be frozen at that point, right?  But again --

MS. LEATHER:  I'm sorry, but the 14 days doesn't include the freezing time, but you can't freeze something on day 13 and then do a lot more work on it later. 

BARONESS KENNEDY:  I believe that wasn't what was being suggested.

DR. GÓMEZ-LOBO:  No, it was. It was. It=s just, you know my ignorance, but from a moral point of view it=s along the same lines. So, my encouragement to the United States, and I feel a deep moral responsibility, being a U.S. citizen and being a member of this council, is that all of these philosophical issues that are going to inform the law should be a matter of great concern and a deep debate. And again, we, I think, as a counsel should try to work on that. Now, baroness Kennedy says we=ll never agree. I don=t know. I=m a socratic, and I would not foreclose a discussion before it=s even started. Well, it has already started. I just trust that there has to be, there has to be, a rational way of discussing these things. I was reminded, for instance, of the remark by Bill Hurlbut in Nature magazine this past July. There was an article that=s quite illustrative of what goes on in the human embryo before the 14 days. So I would say the science doesn=t allow us to decide this of course, but the science, the new insights into embryology, into how important those few hours or days are, those are clues, those are part of the evidence I think that we have to take into account when we advise the republic on what we should do in these matters. Not the kingdom, but the republic.

CHAIRMAN KASS: Thank you. I have frank and the two Bills. And we will B okay.

PROF. FUKUYAMA: I have a couple of questions about the politics of the HFEA. The Human Fertilisation Embryology Act was put forward under a conservative government, but you said party discipline didn=t apply so it was a free vote.  And there was a very large majority in both parties in favor.  Could you just talk a little bit about the politics of that?  I mean was there, for example, particularly strong opposition from the British IVF industry to being regulated in an area where it had been left up to self-regulation, and just how did it fall out between the different political positions, ideological positions?

And then the second question is a procedural one about who has the authority to appoint the 21 members?  And if there is .. I mean, presumably, there's not been a lot of .. well, actually, this is a question.  I mean in cases where there's division among those 21 members, what are your procedures for coming to a decision?

MS. LEATHER:  Thanks very much.  The question of self-regulation, were the clinics opposed to it?  No, they weren't, and in fact there was this self-regulatory model.  So I think what the clinics wanted and what the researchers wanted was certainty about what the country as a whole thought was okay.  And you colleague talked of it as just a sort of pragmatic decision and it was just to do with outcomes, and it wasn't.  I mean the debate was also about right and wrong, and it continues to be.

But it wasn't .. the votes that were taken were free votes, and within all the parties there is a range of views about the ethics of this.   I don't think it's fair to say that one party is particularly more divided than another, really.  There's a range of views everywhere.

PROF. SANDEL:  On the free vote, when Frank was talking about the free vote, I think he was referring to the vote on expanding the research purposes.  You said that was a free vote ..

MS. LEATHER:  Yes.

PROF. SANDEL:  .. not the vote to set up the authority in the first place.

MS. LEATHER:  That was free, yes, yes.  All these procedures have been passed on free votes.

You asked about who appoints to the authority.  They are ministerial appointments, and some people come and go, but they don't .. there's no automatic change if the administration changes, nothing like that.  How do we vote?  Do we vote?  We try and achieve a consensus, and that is not always possible.  So, for instance, we have recently had a debate about whether we should get rid of donor anonymity, and most of us felt that in fact we shouldn't say to people who have been created as a result of IVF that they had less right to know their genetic origins than everybody else.  So we thought, and our advice to government, is that prospectively we should get rid of donor anonymity but not respectively, that there should be a voluntary register considered for donor information, retrospectively.  But some people disagreed with that.  Some people felt that it was wrong to get rid of donor anonymity because of the effect, for instance, on the supply of sperm that the Chairman referred to earlier.

PROF. FUKUYAMA:  But do you actually have internal procedural rules?  Let's say in the future you got a really polarized issue.  Could 11 members vote against ten members to make a decision?

MS. LEATHER:  I think as a Chair in that case I would say we are undecided about this, and if we are so undecided about this, it seems pretty difficult to proceed to change.

BARONESS KENNEDY:  Can I just comment on that?

MS. LEATHER:  A bit like the position you're in, perhaps, sir.

BARONESS KENNEDY:  I'm just going to comment on that.  On the recent decision that was made by the HFEA on the Hashmi case and the other cases that were mentioned where pre-genetic diagnosis was allowed for a subsequent child.  There was quite a lot of controversy over that, and there was a feeling that that sort of matter should, because it's so controversial, should back before a committee of the House of Commons.  I mean there was some debate about whether that was a course that should be taken.  Now, the decisions were made and they were made with sufficient unanimity, but if there were the sort of tightness that you're describing of seven to six, I think that there would be a feeling that it would not be something that should be left to the HFEA.

MS. LEATHER:  I mean that vote, that decision was taken against a background of public consultation, so we were guided partly by what the public response to that had been.  If there were issues that were very new about which the public had never had an opportunity to debate, then I think Helena's point is even more strongly made.

DR. GÓMEZ-LOBO:  Yes.  Very briefly, it's a clarification.  I don't doubt for a second that the question of right and wrong is raised.  The question is how it's answered.  If it's answered by reference to consequences, then, you know, we're clearly in utilitarian context.

CHAIRMAN KASS:  Bill May, then Bill Hurlbut.

PROF. MAY:  I'm not clever enough to put my ruminations in the form of question, but I do want to return the discussion to the question of regulation.  Oftentimes our difficulties with regulation are explained in terms of the fact we're not an island, we're a continent.  There's another way of explaining that where we say, "You're at fault," because this country emerged in the setting of rebellion against King George III, and we tend to think of the government still as a kind of foreign power, not an instrument of national purpose, which tends to make us suspicious of regulatory agencies, especially on the part of the national government.  And it carries through in our suspicion of bureaucrats, a sign of which is either we starve regulatory agencies, we don't provide enough regulators in the SEC or the IRS and so forth so that the private economy operates as it will, or we hem in our bureaucrats massively with regulations.  That's the other response of suspicion to bureaucrats.  So bureaucracy happily metastasizes at the hands of its sworn enemies.  It's a huge irony in American life.

Meanwhile, we're given to a kind of mysticism of the marketplace which tends to make us overlook the bureaucratic complexities of corporations at play in the marketplace.  In Dallas, I was very impressed by Ken Anderson, the President of the Parkland Hospital.  Given the complexity of the economics of our health care system, he said he needs 300 people to handle accounts to yield the payoffs on bills and so forth, which in fact the Vancouver City Hospital handles with only six people.  It's a very interesting, high degree of suspicion as it relates to the government and bureaucrats but incredible tolerance of the emergence of the bureaucracy in the setting of the private economy.  That is not in the form of a question but an introspective comment generated by your presence here.

(Laughter.)

CHAIRMAN KASS:  So noted.  Bill Hurlbut.  We're going to move toward break and then to lunch.  Bill Hurlbut and then Paul.

DR. HURLBUT:  I want to return to the complex issue of what you called selection for characteristics as part of a larger consideration.  In deciding about sex selection techniques, let's speak of pre-implantation genetic diagnosis, is your concern there with the dangers of characteristics per se and gender biasing and so forth or are you also concerned about using that kind of a technique itself?  I mean what is exactly going on in the mind?  I mean why not do it, actually?

MS. LEATHER:  Why not select for social reasons?

DR. HURLBUT:  Yes.

MS. LEATHER:  Well, people have a number of problems with this or a number of issues, and I suppose the most important and perhaps the most difficult to express is the feeling that if people select the sex of their child, there's something about wanting to do that decision which undermines the essential quality of parent love, which is unconditionality.  And I think there is a feeling, and certainly our focus work that debated this came up with this as an issue.  Was it actually okay to want to do that, to want something particular about your child?  And would you be disappointed if it didn't go right?

DR. HURLBUT:  Well, for some people, some social groups and some families, it could be a matter of balancing first, which does not weigh quite as heavily as just simply wanting a specific characteristic maybe.  But also for some social groups a very serious matter, use that word "serious" concerns.  To them it's extending the definition of disease into social realities.  I mean you probably .. I don't know what you do with growth hormone, but you know what I'm talking about, some cosmetic surgeries are acceptable for social reasons, disfiguring repairs and so forth.

What I'm getting at here is is there something about the .. I understand you preempt even sperm selection, but is there something about the investigation of an embryo that is even more troubling in that context?  No.

MS. LEATHER:  I'm not quite sure I understand what you're saying.

DR. HURLBUT:  Well, pre-implantation genetic diagnosis for what you're calling not serious things, why not do it?  I mean it's .. what I'm trying to get at is the status of the embryo, according to your principles, is one that is due respect but not due inviolability, right?  Because otherwise you couldn't justify certain practices like so-called therapeutic cloning.  Do you see what I'm getting at?

MS. LEATHER:  Yes.  In discussing the difference between the Hashmi case and the Whitaker case, perhaps I didn't make it quite clear, but one of the things that worried the authority was the idea of using somebody as a means to someone else's ends and, additionally, to exposing them to an unquantifiable risk where that person wasn't going to benefit.  By definition, somebody else was going to benefit.

DR. HURLBUT:  Okay.  What I'm getting at here is even pre-implantation genetic diagnosis for a serious disorder involves a risk to the normal embryo, right?  Because yesterday one of our speakers told us there was a 50 percent decrease in successful implantation after this investigation of a given embryo.  Does that .. I'm just asking for your rumination of this, because I'm trying to figure out in my own mind about it, is that real?

MS. LEATHER:  I think goes back really to the fact that we have .. it's not as if we've ended the debate on the embryo up to 14 days; it's still there in the public mind as an important issue.  But it's not the focus of debate.  It really is not the focus of debate.  We've now moved through that and we are concerned more about what are the characteristics we should allow people to choose for and against.

CHAIRMAN KASS:  I think we'll move on.  Paul and then we're going to break.

DR. MCHUGH:  I also want to thank you for that helpful discussion and presentation, Ms. Leather, and I want to come back, really, to also the very important point that Michael made at our beginnings; that is, whatever is going to happen here in the United States occurs in this remarkable context of the free-heeling approaches that we've taken to these matters before.  In fact, for me this is a very telling issue in relationship to the ultimate development of our regulations related to SCNT and its products.  I'm happy to hear that the House of Lords is struggling to decide whether the term "embryo" should be applied to that.  We've gone so far in this Council, or at least I've gone so far in this Council, as to try to impose a new word under that product to differentiate it from a zygote with only modest success.  So the Lords in their decision-making, in their discussions would be fun for me to listen to.

But I have two very practical ..

PROF. FUKUYAMA:  They'd take you more seriously.

DR. MCHUGH:  Britain, you think they would?  I doubt it.  This brings me to two very practical questions, and it relates to our interest in what regulations would do and what openness would do in relationship to SCNT even for the best benefits that we're all very interested in.  And one of them is does your system now, your regulatory system, make it possible for there to be careful thought about what use over denucleated ova would be put to in the scientific context of the research so that we wouldn't develop an open market for searching for thousands and thousands of eggs and turning many, many women into egg factories?  That's a very important concern to me, and that issue would be helpful to hear how you have thought about that and where that has come.

And then the other simple thing, again, like everybody here at the table, we admire the way the British are willing to queue up and stay in line .. I just had a fight down in the front about people not being in a queue or me not being in a queue.  It was a very amusing American scene.

(Laughter.)

But when you were developing your regulatory bodies and your regulatory processes, was there any hinderance or hold back of investigations that were going on while the regulations were being put in place or was there simply a parallel process, research was going on will-nilly and the regulations were either catching up with it or not?  Those are my two questions.

MS. LEATHER:  Okay.  I'll try an answer as best I can.  Before the HFEA was set up there was research and treatment going on.  That's different from what's happened since it's been set up.  Since it's been set up all research and treatment is regulated, okay?  So I think that clears that one up.

DR. MCHUGH:  Was there a hesitation period during the process of setting up the regulations where you said, "Hold on now, you guys.  Don't do anything until you hear from us."  Was there?

MS. LEATHER:  You're not allowed to do it unless it's been licensed.

BARONESS KENNEDY:  No, but there was a period .. before the HFEA came into the being ..

DR. MCHUGH:  Yes.

BARONESS KENNEDY:  .. there was a period when people were asked again, it wasn't a formal moratorium but they were asked to hold back on what they were doing ..

DR. MCHUGH:  I see.

BARONESS KENNEDY:  .. while this was being debated and so on.  And people in Britain, as you have suggested, are willing to do that.  There's a sort of way in which generally people are prepared to ..

DR. MCHUGH:  So the scientific community was willing to accept this voluntary moratorium.  It came forward and said, "We accept this for ourselves voluntarily while you, whether a week or a month or years, you set up your things."  That happened?

MS. LEATHER:  Yes.  What the scientific community wanted was long-term security ..

DR. MCHUGH:  Yes, yes.

MS. LEATHER:  .. about what it was and wasn't allowed to do.

DR. MCHUGH:  And it was willing to pay the price ..

BARONESS KENNEDY:  The scientific community in fact were the initiators.  They came into the domain and said, "We're doing this work.  We want to know how the public feels about this.  Where are the parameters on this?"  That was how ..

DR. MCHUGH:  I love to hear this.  I hope the scientific community in the United States is listening and bringing forward something other than signatures.

MS. LEATHER:  I think your other question was about consent and donation and we've set down specific guidelines for the consent issues involved in donating embryos and gametes which will be used in deriving stem cell lines, because the issues for donors I think are rather different.  The House of Lords drew attention to the immortal, as it were, nature, the unceasing nature of stem cell lines.  That has to be explained very carefully to donors as it has to be explained that although other people may benefit financially, eventually from the knowledge and possibly from products derived from applying stem cell line knowledge they as donors won't be part of that.  So we've already drawn that up.

DR. MCHUGH:  So, therefore, you explain to the donors, the voluntary donors, that what is going to happen or what the implications of this contribution are is.  I want to know whether it worked also from the other direction; that is, that well-trained scientists and well-developed laboratories and things of that sort were considered before eggs were being harvested from women.  Here in the United States, for example, in the NIH, one of the issues in deciding about a research grant is to look at the institution that's making this application and deciding whether those laboratories or those people are skilled enough or are effective enough or have the resources to do what they claim to do in this research.  And many research projects, even though that they are well designed by the author, are turned down because it said as yet this institution has not developed the expertise to do this, and we don't want to waste the resources or the money on the other things on that.  And I'm just wondering whether they considered .. whether your place you are considering such things before you let donors come forward and give this important tissue away.

MS. LEATHER:  Indeed, we do consider that, and it would not be permissible for people to use eggs or sperm or embryos donated for research but not knowingly donated for stem cell research for stem cell research.

CHAIRMAN KASS:  Thank you very much.  Let me make a procedural suggestion to members of Councils.  I think we should conclude this session and thank both of our visitors for really wonderful presentations and the wonderful spirit of forthright and responsive conversation.  You stimulated us a lot and we have things to learn, and I do hope that we can remain in contact with you in the months and years ahead as we go forward.

This was the original scheduled time for a break for 15 minutes before we reconvened.  There are members of Council who would like to leave early, who have planes to catch, and although it would be nice to rise and say farewell to our guests, if we would liberate them from the table but the rest of us stay, I think we .. my hope is that we can conduct our business in this session with dispatch and people will not have to leave before the decision is taken.  Is that agreeable?

So that is Council members will simply stay and let me just thank you both.

(Applause.)