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Thursday, June 20, 2002

Session 1: Regulation 2: Genetic and Reproductive Technologies: International Models

Lori Knowles, The Hastings Center

MS. KNOWLES: Well, thank you very much.

Can you hear me?

Thank you very much for inviting me to speak with you today, and I'll just bring your —

CHAIRMAN KASS: Can she be heard in the back? Good. I'm sorry.

MS. KNOWLES: Thank you.

And I'll just bring your attention to in the handout portion the supplementary material. I provided a copy of the overheads so that you can follow along on them if you prefer rather than looking up at the screen.

And I'll also bring your attention to and obviously in your briefing books you've seen there are two fuller papers that focus on international stem cell regulation that I wrote at various points in the last three or four years that will give you some more detail.

Well, we have actually just been discussing why we are looking at the regulatory frame works, and so I'll just say that it's worth, in my opinion, making international comparisons because some systems work better than other systems. Some allow for new scientific developments, such as those we've seen in the last three or four years, to be incorporated easily without disrupting the system, and some do not. You have to rewrite the system.

And some provide a high quality of quality control and patient protection, and some, of course, don't provide such a high quality. So it's worth making the comparisons to see where the strengths and weaknesses are. And some of those we can teas out obviously through Dr. Barrett's presentation and through discussion afterwards as well.

I've been asked specifically to focus on four countries, with particular emphasis on the United Kingdom and also to touch on Canada, Germany, and France.

And sine Dr. Barrett is going to talk about Canada, I'm really just going to make a few statements about that so that we don't duplicate our material too much.

And we'll be looking at how the systems are structured and how regulation, particularly of embryo research, is structured. And I'm just going to tease out then what the implications are for the various legislative acts, what the implications are for human reproductive cloning, and for therapeutic cloning, which I understand you're giving a different name, which I think is actually appropriate.

And then I'll end with what commonalities we can find that might guide such an endeavor here should you choose to embark on that by looking at sort of common guiding principles, common limits, and common prohibitions that you'll find through some of the regulatory frameworks in the other countries, including those that we won't actually be looking at in detail.

So, in general, I've pulled out what I think are six major regulatory frameworks, the first of which is a nonlegislative framework, no over arching legislation of any particular sort, but a guiding in some respects by ad hoc judicial precedent, legal cases, for example, the disposition of frozen embryos after a couple of divorces. We have cases that talk about consents, et cetera, in situations like that that provide some guidance.

And that's usually coupled with local or regional regulation, and here I'm talking about IRBs. In Canada they're called research ethics boards, REBs.

So that's one type of framework, not particularly comprehensive and not necessarily coherent because, of course, it varies from region to region and case situation to case situation.

Secondly, there are regulatory frameworks that use very specific targeted legislation for each different application or issue. So, for example, cloning legislation, human reproductive cloning legislation, many countries have this, or embryo research law that looks specifically at embryo research and provides prohibitions or limitations.

The third is an assisted reproductive technology legislation, a more comprehensive look at a use of embryos generally in treatment and in research, and the sort of paradigm case and country for this is the United Kingdom. So I'll be spending some time looking at a more comprehensive ART legislative scheme.

The fourth is human subjects research legislation that looks, for example, at the use of fetal tissue and human subjects research and a use of embryos, use of in utero or human subjects research as well.

And so you can find some countries that focus on that framework as their way of looking at how one should use embryos or embryonic tissue.

The fifth I have in brackets because I don't consider it necessarily a regulatory scheme, but in almost all the countries that have a regulatory scheme, you have advisory panel or commission reports usually that precede a regulatory scheme, and in this country we have some of those, but they don't fall into then a larger regulatory scheme, and hopefully that's what this body will do at some point.

And the sixth is perhaps the most common, which is a combination of all or some of these. Specific legislation, comprehensive ART legislation, human subjects research, which compliments it, advisory reports that go before it, judicial precedent, et cetera.

So most countries have a primary legislative framework and then some supplemental regulation of some sort as well.

Now, this chart I'm not going to run through, but essentially it shows you where much of the work is done in some of these countries, and you'll see that a lot of the countries are looking at putting the primary emphasis on ART legislation as the context in which to regulate embryo research and embryo use.

Many countries actually have regulation that's in progress or legislation that's in progress. The Netherlands just came out with a research embryo use statute last week. So a lot of this is really very, very current.

So now let's look at the comprehensive ART legislation at the paradigm case, the best example, which is the United Kingdom. This is the oldest comprehensive ART framework. It's been extremely successful because of the way it was drafted. It was drafted with very general, broad recommendations, and discretion given to the over arching authority, the body that would, in fact, direct the work to make individual decisions. So I'm going to talk a little bit more about that, and it's often copied as the model.

The act that guides this is the Human Fertilization and Embryology Act, which was put into place in 1990, came into effect in 1991.

Before the act, as a historical footnote, there was the first advisory report of its type, the Warnock Report. That's the short title for it, which was published in 1984. So you'll see there's always some sort of gap of time between the time when the commission reports are published and they can actually get the legislative framework up and running.

And I'm sure Pat is going to mention that. Canada has had a long gap in time with lots of attempts.

And this is interesting the way this was structured. It was created as a non-departmental public body. So it has a degree of political independence that has proved to be quite successful and quite useful, and it's not answerable to the Department of Health, but it is accountable, as I'll mention later on.

And this non-departmental public body is called the Human Fertilisation and Embryology Authority, the HFEA. That's what we're going to call it in our discussions.

The scope of the HFEA is both private and public. So it's not related to funding as things are in this country, but private and public clinics and laboratories. So it is extremely comprehensive in terms of application.

And the act actually set up a licensing scheme for the following areas: treatment services, so clinical work; storage of gametes and embryos, clinics of course and laboratories; and embryo research.

So you have all of these coming under a licensing scheme which has proved to be quite, quite successful.

The act also sets out limits and restrictions on the use of embryos. An example of the limit would be that you need donor consent to be able to do things with the embryos or that you need local IRB review before an application comes forward, and an example of a restriction would be that you can only use research on embryos up to a 14-day period outside of the human body. That's what I mean by restrictions.

And the violation of the act is a criminal offense. So it does have some significant sanctions, usually fine and/or imprisonment, and a violation of the act would be operating without a license, for example.

Now, the HFEA, this is the authority we're talking about, the over arching body. The membership has 23 members. So it's quite a large body, and in the act, it's written that there must be men and women on the authority, and in fact, there's about 60 percent women on the Authority, which is significant.

And it's also stated that the membership must be predominantly nonscientists and nonclinicians. That's also quite significant because they'll be working with scientists and clinicians. So they get significant input from the community.

And in fact, speaking from people who are on the Authority, there's quite a bit of partnership between the scientific and the clinical community and the Authority. It's really a working relationship that they have.

And the Authority is appointed by the Secretary of State, the membership is, and it is accountable to the United Kingdom, the British parliament through the Minister for Public Health.

So there is accountability, even though even though it's outside of the department.

Now, the functions of the Authority — we're talking about the Authority here — are to license these various things, this treatment services, the storage and the research, divide licenses through licensing committees. They don't do it all in the full Authority. They have specific licensing committees composed of five members.

And clinics are licensed for up to three years to provide particular treatment. So it's quite specific what their license covers.

The secondary function is or second, not secondary; the second function is to monitor and inspect the premises and the licensed activity. So there's significant sort of surveillance and enforcement in the act, as well, that the Authority is responsible for.

And thirdly, they maintain an information registry, which includes information about donors, of various reproductive materials, about the treatments, and this includes outcomes, as well. They really do follow and monitor the treatment outcomes and the research outcomes, and children born from treatment.

This is relatively high degree of follow-up and information that's available to actually the public and other clinics through the HFEA and to the government.

Additional functions are a standard setting function. They set standards for the practice of ART through a code of practice that they're responsible for developing and maintaining and making sure that this code of practice is guidance for clinics about the conduct of license activity that is expected.

They have an education function, which is to advise and inform patients and donors and clinics. So it's quite a wide function, and to report to the government. They're accountable through an annual report to the Secretary of State.. So it's quite comprehensive.

Now, interesting, I put this last because it is interesting about the policy making aspect of the HFEA, and they are expected to make policy with respect to novel issues. This has not been something that goes to the parliament. It's at the level of the HFEA.

And in order to avoid a novel issue that comes through a protocol going to a particular licensing committee, which would then make policy for the country — and there's only five people — that's a bit of a statutory problem that they had because the protocols come through to licensing committees.

They've worked out a relationship where when there's a novel issue that's raised, before the licensing committee actually looks at it, it gets referred up to the full Authority; that before they look at it, they give it to a working group.

So they give it to a working group on new reproductive technologies, or they give it to the ethics committee, or they give it to the code of practice committee. But some working group will look at it, discuss the fact that there are ethical and new scientific issues involved.

Then it goes to the full authority. They then provide guidance and opinion, and then it goes to the licensing committee. So they've really worked out a way that a novel issue gets appropriate treatment and input from a wide group of representatives and from those who have particular expertise in an area.

So with respect to the embryo research, prior approval by a local they're called research ethics committees in the U.K. — it's an IRB equivalent — by local IRB is required before an application will be entertained or considered by the authority.

So there is an initial vetting to make sure that a certain level is achieved, and individual research protocols are licensed, which is different than the treatment scenario where a facility is licensed and an individual is responsible.

So it's the protocol that's licensed in the research orientation.

Now, significantly, only the purposes that are specified in the act are available for licensing with respect to embryo research. So they have specified specific purposes for which embryo research protocols will be entertained and only those purposes.

I have a star on that because those have actually been recently changed, and I'll talk about that in a minute.

But the purposes include essentially the advancement of knowledge or the improvements of treatments related to infertility, congenital problems, contraception and miscarriage. So a whole range of reproductive issues.

And secondarily, detection of embryonic genetic and chromosomal abnormalities. That's a purpose for which embryo research will be entertained, and the included — and this is quite significate — the sort of general rider, such purposes as might be added by regulation or through regulation.

So they kept a window open recognizing that at that point, they believed they had covered all of the purposes, but there might, in fact, be other purposes that they would choose to include later on for embryo research, and in fact, that's what's happened.

This I want to underline only because it's proved to be extremely successful and an extremely flexible approach. So rather than licensing or — excuse me — permitting certain specific techniques with respect to embryo research, they included purposes.

And the purposes then allow specific techniques to fall into the various purposes as the techniques are developed. So it's a much more flexible approach than allowing specific techniques to be used.

With respect to reproductive cloning and stem cell research, cloning is actually forbidden. Reproductive cloning is actually forbidden under the act. However, recently, last year, in the U.K. they passed the human reproductive cloning act which specifically prohibits human reproductive cloning.

And they did that on the recommendation of some advisory committees because they felt that there was more legislative and symbolic importance in having a specific act to say this we think must not go forward rather than just having it fall under the particular act. So that's significant.

And purposes recently have been added to the act. I was just mentioning that, that allow therapies unrelated to infertility; embryo research to be conducted for therapies unrelated to infertility. So, for example, to address mitochondrial disease.

And of course, they were doing this in the context of the embryonic stem cell debate.

So the third point I'm going to make is that the language that's chosen with respect to a particular act is very significant because the definition of cloning that's in the U.K. act didn't actually include what we call SENT. It was slightly different.

So there was some challenge as to whether this would be covered or wouldn't be covered, and that, of course, is the limitations of making your language very specific or not specific enough as the case might be.

And recently, as well, there was a challenge to whether the products of cloning techniques fell under the definition of embryo in the U.K. because it was defined as the products of fertilization.

So in fact, it sounded like it didn't fall in, and there was a challenge, and it went to the high court, and the challenge was upheld and went to the appeal court, and in fact, they held that it actually fell under the act.

It's obviously very good that it did fall under the act so that they could regulate this area of technology, but I'm not so certain that there wasn't some real legitimacy to that court case to begin with.

So that's important. How you define embryo in all of these acts is extremely important because, of course, that's shifting ground.

The next point is that in the U.K. it's possible to create embryos for research, and this is quite unusual because many countries draw the line and say there is a supply, ready supply, of embryos from surplus IVF embryos. So we should use those rather than create new embryos, but not in the U.K. The U.K. is extremely liberal with respect to scientific freedom, and they permit the creation of embryos for research.

And the last point I want to make with respect to this area is that it's also possible to use what they call cell nuclear replacement, which we think of as our traditional cloning technique, the SENT, for those purposes.

So not only can you create embryos through the research, but you can use cloning technology to create embryos for research. So the true concept of therapeutic cloning would be available for an embryo research protocol where those ends possible, but they can actually make embryos in that fashion in the U.K.

Also highly unusual. The only place I know of at this moment where you can actually do that. You may be able to do it other places where there isn't any regulation, but under a regulatory scheme.

Now, I'm really going to go very quickly over the Canadian because, as I was talking to Pat, she's really going to cover a significant amount of this material.

But the bottom line with the Canadian scheme is that there is a new act, the Assisted Human Reproduction Act, that's actually in the process of going through the various readings in the House of Commons and the senate, and it's really modeled on the HFEA Act. It sets up a licensing scheme. It sets up an overall authority. It, you know, adheres to public and private research and goes through prohibited activities and controlled activities setting out limits and restrictions, as well.

And the two things that I want to mention and that Pat will also mention is that there is a significant difference in the U.K. in that really focuses on the regulation of commercial transactions in human reproduction. That's not a focus of regulation in the U.K.., and that it includes surrogacy, not included in the U.K.

And I would also then mention from a point of legislative understanding that the guiding principles are actually imbedded in the act. They're not in the preamble, just to give you sort of a sense of what the act is about. They are part of the legislation itself.

And that, I think is quite significant. It has given them real primacy under a section called declaration of principles in Clause 2 of the act.

And then with respect to human reproductive cloning and stem cell research, neither are permitted in terms of the cloning technology, no reproductive cloning, no therapeutic cloning, but stem cell research is permitted on surplus IVF embryos. So no creation of embryos through cloning technologies, creation of embryos at all.

Germany is interesting because they are an example of what I earlier called specific legislation, specific legislation in this case being specific embryo research legislation, and they have as their over arching act the Embryo Protection Act that's been in place since 1990, and it's one of your strictest embryo research laws if not the strictest embryo research law.

IT's a criminal statute. So the focus in on criminal sanctions for violation of the act, and essentially there is no embryo research that's allowed because interventions that are not conducted for the well-being of the embryo are permitted.

So to say that in a positive way, only interventions that are conducted for the well-being of the embryo are permitted, and that necessarily means no embryo research.

All right. And it prohibits the reproductive and therapeutic cloning and the derivation of ESLs clearly not for the well-being of the embryo. Reproductive cloning also not for the well-being of the embryo.

Now, new legislation was passed on April 25th, really recently. It comes into force next week; on July 1st it actually comes into force. And this is very significant, given Germany's historical pass. We talk a lot about what happened under the Nazis and that they do not want this kind of research going forward. They're very focal and expressive about it.

And so to actually have some loosening of the embryo research area is relatively significant and reflects a lot of the scientific and public debate about embryonic stem cells.

Now, this new law will permit importation of embryonic stem cells. They looked explicitly at what President Bush put in place, and they said we can live with something like that, and it permits the importation of stem cells, only those that were produced before January 1st, 2002. So they've kind of drawn a line as well, although there has been some explicit talk in the French context about the fact that if you allow the importation of stem cells from countries that don't have a very strict system of regulation, you may be getting things in your country that you would never want in your country given how they were produced or the atmosphere in which they were produced.

So there's a real tension in the German and the French context as to whether this is, in fact, better in some respect. But this is the compromise that they've come with recently.

Now, it is, in fact, arguably stricter than the previous law, the Embryo Protection Act, the previous version, because under that act it said nothing about importation of stem cells. So this is slightly a tightening because it says you can important them, but there are very strict conditions attached to that, and only those lines produced before January 1st, 2002.

France has what they call bioethics laws, three bioethics laws that were put in place in 1994.

Now, these have been under revision since about 1999. It has taken them a significantly long time to revise these laws because of all of the changes that are coming forward because they also have a very strict embryo research background, and they're trying to loosen it, and that's quite difficult to do.

And this is interesting because what they did in France was they added relevant provisions to the criminal codes, to the civil code, to existing legislation. So it's actually relatively hard to tease out what these laws were, the changes were. And that's because in France they have a Napoleonic code where everything is in a sort of tabled code, all of the articles are in one piece of law.

So this makes France a little bit different from the common law systems where we have specific legislation and judicial precedent.

But you will see that some of the provisions have been added in the context of use of the human body, use of the human tissues of the human body, transplantation and reproduction, and a registered data act, use of information as well.

So they tend to fall in those general areas.

And the laws prohibit various activities, specify conditions for regulated activities, and are also applied to the oversight of ART, Assisted Reproductive Technology Centers.

As with Germany, interventions that are not in the interest of the embryo are not permitted. So effectively there's no embryo research that has been permitted to date, and reproductive cloning is explicitly prohibited.

Now, this act, as well, has been revised in January of this year, and it sits in sort of a political limbo right now. It's not actually in force, but with the change of governments, there was sort of an understanding that the law would be brought in by the next government in the format it's in, but with the conservative coalition coming in, they're not sure they're going to actually honor that. So it's in flux is ultimately the bottom line.

But the new, the revised bioethics laws for our purposes would permit stem cell research on surplus IVF embryos only. So no creation of embryos, and would not allow therapeutic cloning.

And they also have created — and this is a trend that obviously we're seeing — an agency which translated is the agency for procreation, for embryology, and for human genetics. It's quite a large agency, a national agency, and it would have oversight of infertility treatments, prenatal diagnostics, a specific focus in France, and embryo research.

Also a violation of the act would give rise to criminal sanctions.

Now, with respect to pulling out some of the common threads of these in the 25 minutes that I may already have run over, the guiding principles that you'll see in many of these acts, not just these four areas for regulation or countries that I've covered that have regulation including the follows:

Respect for human life and human dignity, which is something that one doesn't hear, the human dignity portion, in the United States very much, but it's a very live concept in both Canada and in Europe, and it's usually explicit as a guiding principle in this area.

Also, the quality and safety of medical treatment, particular, particular emphasis on the safety of women, usually brought out in these acts, recognizing that it's women that are really the focus of these medical interventions in the infertility context.

Protection of children's health and well-being, usually spelled out because children are obviously central in this whole equation, and their protection and their health and their well-being — and they do spell out both as different concepts, usually highlighted.

Respect for a free and informed consent. Integral to making this work, and in most countries a noncommercialization of reproduction is a guiding principle, and I'm sure Pat's going to talk about that in Canada, a really strong held principle in the Canadian act.

And of course, minimizing harm and maximizing benefit.

Common limits in embryo research now include informed consents. The more detailed they are, the more situations they cover. What do you want done if you divorce? What do you want done if you both die? What do you want done if one of you dies, et cetera?

The better the system works, the more situations that you can cover with respect to disposition of frozen embryos and gametes.

Time limits put on how long you can actually work on an embryo outside of the body, usually 14 days before the 17th day appearance of the primitive streak, et cetera.

Embryos must be necessary for a research protocol. There must not be some other way you can do your research or get this information. There must not be an appropriate animal model. It must be necessary that you use embryos for this research.

There must be protocol review, and by that I mean IRB or REB or REC, depending on what you call it, but some kind of protocol review before it comes to the authority that's licensing a particular protocol.

There needs to be regulatory oversight. So we're looking at regulatory oversight usually national if you're looking at ART legislation, and most acts include the limit of using only spare IVF embryos, those that already exist and that might be destroyed anyway rather than creating embryos, although, of course, the U.K. is quite significantly different in that respect.

Common prohibitions include reproductive cloning, the most common really prohibition. Therapeutic cloning is also commonly prohibited in a lot of these acts, not in all though as we saw in the U.K. I mentioned embryos for research. Commercialization, a common prohibition, with some flexibility as to whether you can provide payment for expenses or reasonable expenses or some payment or no payment.

Germ line intervention is routinely prohibited. This is not the case. Actually right now there has been some activity in this country with respect to germ line interventions.

Creation of hybrids or chimera, common; cross-species implantation, common; and use of fetal eggs, eggs from aborted fetuses for embryo research, not permitted.

So those ar then some of the commonalities that might be useful to pull out of these countries when you're looking at regulation in this country.

Thank you.

CHAIRMAN KASS: Thank you very much, Ms. Knowles.

Dr. Baird.

Wait. Maybe we should get the equipment set up.

DR. BAIRD: Good morning, and thank you for your invitation to be here.

It's a privilege to be presenting to such an eminent and knowledgeable group.

Now, your Chairman's letter said you were currently exploring the topics of human cloning and research involving human embryos, and he said you were interested in how in Canada we've dealt with this.

Now, our revolving policy response to these topics is not a run-off. It's not isolated, but it's integrated and imbedded in our approach to regulating the field of reprogenetic technologies as a whole.

So what I'm going to do is start by giving you a brief history of what is involved in Canada with regard to the oversight of the field of reproductive technologies. And by the time I've finished, I hope you'll have some understanding of how cloning and embryo research fits into this overall schema and how we hope to regulate other activities, such as IVF and pre-implantation genetic diagnosis.

Now, as context, I want to note that Canada and the United States have different histories, and they perhaps have more different cultures and values than you might be led to believe by our common language and our shared exposure to the same Hollywood movies and television sitcoms.

And Seymour Martin Lipsett has written a classic analysis of some of the differences in a book called Continental Divide.. He notes that the attitude to government and to regulation is different between our two countries.

Canadians' attitude, in general, is that government is there to act in the public interest. He finds Americans, in general, have a greater mistrust of government and are more likely to see it as desirable to have as little as possible.

As Lipsett puts it, one society leans towards communitarianism, the public mobilization of resources to fulfill group objectives; the other sees individualism, private endeavor as the way an unseen hand produces optimum socially beneficial results.

A principle that I think seems more prominent for Canadians is solidarity, and it's on this core concept that our publicly supported health care system rests, where individual freedom has a very prominent place in the United States.

And I think this difference in how the individual relates to the collective means that there isn't as strong a place for the market in some facets of our lives.

A second relevant part of the context is that Canada is a federated state, which makes things more interesting, but it sure makes them more complex. The United Kingdom, for example, didn't have to take into account other governments when it put the human fertilization and embryo authority into place.

In Canada, although the federal government does health research and public health education, and it transfers funding to the provinces that partially subsidizes the health care services, the provinces are responsible for health care delivery, and they have jurisdiction over hospitals and health care professions. So there's an enduring federal provincial tension, which means the federal government usually tries to insure buy-in of the provinces for significant legislation in the health field.

So with this sort of context and background, I'm going to move on to give you a brief overview of events in the evolution of policy with regard to reproductive technologies in Canada.

By the end of the 1980s, calls for public policy to deal with this area had come from many sources: legal groups, medical professional groups, women's groups, religious groups. And in Canada, we have an instrument of public policy making, which is called a Royal Commission, and such commissions are appointed by the Prime Minister, but they're independent of government. They have to stay completely arm's length, and they're giving the resources to carry out whatever work they see as necessary to fulfil their mandate, including research or wide public consultation.

And in response to all of these calls, at the end of 1989, the Prime Minister struck a Royal Commission on new reproductive technologies, and the commission was asked to recommend to the Canadian government how in Canada we should deal with reproductive technologies in the public interest.

While the commission undertook its task by consulting very widely as you can see on the overhead there, as well as public hearings, as we say in Canada, from sea to sea to sea because we have three, and hundreds of written submitted briefs, we set up toll free telephone lines because not everyone can easily come to public hearings, which over 6,000 people called.

We had surveys of randomly selected Canadians because, of course, everybody who comes to a commission voluntarily is self-selected, and we had over 15,000 individuals that way.

And we had several other ways of getting at people's opinions and allowing them to have input. And you know more than 40,000 people dealt and interacted directly with the commission before we were through.

And some of these individuals, for example, people who represented labor unions or religious organizations, actually gave us input on behalf of many other people that they had consulted. And by the time we were finished, we had had more interaction and input from the public than any other Royal Commission.

At the same time, the next overhead, we had a research and evaluation program which found out what was actually going on across the country, and we gathered data both from clinics and also from several thousand patients.

And the research program extensively examined the issues with projects and analyses in many disciplines, including the social sciences and ethics and law, as well as medicine. Over 300 researchers at some 50 institutions participated, and our budget of $30 million meant that we could have substantial interaction with the public across Canada on these issues, as well as carry out many needed research projects.

The next overhead shows that through these two streams of work, by the end of 1993, the commission was able to provide for the first time a picture of new reproductive technology uses in our country and substantial social, ethical, and legal analysis of the implications of using or of not using the technologies.

The commission made its decisions in the light of both the research findings and the broad input from the public, using explicit principles to guide the policy choices we made, and the broad ethical orientation that the commission took was an ethic of care, a stance that gives priority to the mutual care and connectedness between people and their communities, and then within that orientation, a set of eight guiding principles.

And the commission made its recommendations to government and produced, as you can see in the next overhead, a two volume final report with 15 volumes of supporting research studies, and the report sets out the science and the many issues raised, we hope, in a clear and comprehensive way, and we outlined for each policy our thinking and our reasoning for coming to the recommendations that we made.

And there's a copy on the way to your office, but it can also be obtained through that source if anybody is interested.

So in brief, what did the Royal Commission recommend? Well, it recommended that the Canadian government, as guardian of the public interest, must do two things. It must put boundaries around the use of new reproductive technologies and put in place a system to manage them within those boundaries and not just for now, but importantly, in a flexible, responsive, ongoing way. These issues are not going to go away. They are going to burgeon.

We recommended, as the next overhead shows, legislation to prohibit several aspects of the new reproductive technologies, certain kinds of human embryo research, as you can see there, using eggs from female fetuses for implantation; selling human eggs, sperm embryos, fetuses or fetal tissues; and paying for or acting as an intermediary for surrogacy arrangements.

Our analysis suggested to us that these should not be done, and there was much support across the country for these.

At the same time, as you can see on the bottom there, we strongly recommended that the Canadian government establish a national regulatory body with licensing being mandatory for the provision of new reproductive technologies to people.

We said that Canada should not continue with its present patchwork of harmful and inequitable standards and uses that we had documented when we went across the country. We found clinics and practices that ranged from exemplary to downright harmful.

There was a very strong consensus that a regulatory body was needed, and that a national approach was needed, too, because technologies have social implications that you cannot contain within the borders of one province. And allowing technology use in one province but not another would encourage reproductive tourism.

The next overhead shows the recommendation of a national regulatory body to regulate and license facilities, and that it be arm's length from government.

We recommended that women should normally make up half of the membership, and that it should be composed of people with a broad range of experiences and perspectives.

We said that members did not have to be reproductive medicine experts. They can get expert input.

We said that it was important that people who were on it shouldn't feel that they're representing particular constituencies to whom they're accountable. That's a recipe for stalemate. They should be people who wear a citizen's hat in making the judgments. They're there as parliamentarians are, to make judgments in the public, not special interest, just as this council is, I would think.

And to insure openness and transparency, we recommended that license hearings should be public, and the agency should report annually through parliament on what's occurring in Canada in uses of reproductive technology.

We saw an advantage of a regulatory body being that specific legislation didn't have to cover everything, just as Lori has said, and although the law would require a license to handle embryos and to provide services to people, the policies and the rules to be complied with to hold that license could be shaped in a way that responds to change and that continues to evolve without having to change the law.

And as I'm sure you're all very aware, this is a field where the technology is changing rapidly, and inevitably it takes many years to change legislation.

Now, the commission reported eight and a half years ago, in December '93. So what's happened since?

Next overhead, please.

Well, a year and a half later, in July 1995, the federal Minister of Health asked for a voluntary moratorium on nine items, saying that the provincial governments supported this moratorium, and that a further response was being worked on.

Now, the press across the country found this a totally inadequate response. As one editorial rather pungently put it, "In spite of a broad public consensus on the need for federal leadership, the minister's handling of this pressing issue has been disgracefully lame."

The media also that very same day quoted clinic directors who said they weren't going to abide by it.

Two different committees, as you can see, were formed to give advice to the minister on embryo research and reproductive technologies.

Then in June 1996, an act respecting new reproductive technologies, Bill C47, was introduced. This received its first and second reading, but it died on the order paper when the next year, in '97, the federal election was called.

Now, that Bill C47 was believed by many, including me, to be inappropriate because it addressed only prohibitions, very similar to the earlier call for moratorium.. It was unbalanced because it neglected the other side of the coin, which is insuring safe and beneficial technology use.

People who use these technologies to build their family need to be confident that standards of service provision, information disclosure and record keeping are being kept, and we had heard almost unanimously from all sectors that a regulatory body was needed.

So after the election, the bill died, and in spite of growing calls for a response, the federal government didn't respond, except to have extensive consultation, in particular, with the provinces through discussion documents.

Then in May last year, the federal Health Minister sent proposed legislation governing assisted reproduction to the parliamentary standing committee on health, not to the parliament; to the parliamentary standing committee on health. They were asked to examine it and report back to him.

They did so. With some changes now, the resulting legislation was put before the House of Commons early last month. It's proposed to make available the option for those provinces that wish to to put in place an equivalency agreement for other than the prohibitions. You can see how being a federated state complicates things and makes it take longer.

I sent you some background information on the legislation. This bill that's before the house has had its first and its second reading, and it's been approved in principle by a vote of 170 to 63 on May 27th.

It's now gone back to committee, and there isn't time for it to come back for a vote, the final vote, before the end of the present session tomorrow. So it's very likely to come back in the fall.

The next overhead shows the stated purposes of the legislation, which are to protect the health and safety of Canadians; to prevent commercial exploitation of reproduction; and to protect human individuality and diversity and the integrity of the human genome.

The legislation addresses clinical and ethical standards as well as the information needs of people using assisted reproduction, and the bill applies to two different purposes: the activities used to help some people have children, and the use of human embryos in research.

And written consent of gamete donors is an important feature in both areas.

The draft legislation prohibits some activities, and it makes other activities — next overhead — subject to control under regulation. And this overhead shows the activities that are regulated.

And as you can see, facilities providing infertility treatment, such as IVF or handling eggs or sperm and embryos would be regulated and be required to have a license. They would have to comply with conditions, collect specified data on outcomes, report certain medical information, et cetera, et cetera.

The act creates the Assisted Reproduction Agency of Canada to oversee all facilities doing regulated activities.

The next overhead shows the functions that that agency would have. It would be responsible for issuing and renewing licenses, collecting and analyzing health information, setting policies and monitoring compliance.

And I sent you some background describing the agency and its 13 member board.

The legislation also has some prohibitions. Next overhead. It prohibits, as Lori has said, making human embryos by nuclear transfer cloning or embryo splitting. It prohibits making embryos for research, except to improve assisted reproduction treatment procedures.

It prohibits commercial surrogacy, but permits altruistic surrogacy without payment in licensed facilities.

It prohibits identifying the sex of an embryo unless there's a medical indication and prohibits making genetic alterations to the embryo that will be passed on to future generations.

The legislation has teeth. It would prevent that it prohibited. If a prohibition has been violated, then a jail term of ten years and a half a million dollar fine is imposed.

Lesser offenses, including violation of the terms and conditions of the license have correspondingly less severe penalties.

Now, here I'd like to read you a paragraph of a presentation I made to the parliamentary committee that looked at the current legislation. I think it's much more important to get a regulatory system established than delay and delay over particular specifics.

Currently many of the people using these technologies are doing so without benefit of fully disclosed information on risks and benefit; without good data collection and record keeping, and so without reliable information on outcomes of treatment.

The important thing is that licensing of these activities will be mandatory. It will be possible to make changes when an overall system is in place.

I want now to highlight what the bill says with regard to human cloning and then with regard to research involving human embryos.

First, the wording of the prohibition in the act is that no person shall knowingly create a human clone or transplant a human clone into a human being. And a human clone is defined as an embryo that is the result of manipulation of human reproductive material or an in vitro embryo contains the same nuclear DNA as is found in the cell of a living or deceased human being, fetus, or other embryo.

And this means that reproductive cloning, as well as making human clonal embryos for research is not permitted.

The act also prohibits making an in vitro embryo for any purpose, except "creating a human being or improving or providing instruction in assisted reproduction procedures."

In other words, creating embryos specifically for other kinds of research is not permitted.

However, on the license research with human embryos that are no longer needed for treatment is permitted, provided the progenitors have given their consent in writing. Thus frozen embryos' access to treatment needs may, with consent, rather than being thawed and discarded be thawed and used in research, including stem cell research.

I think these provisions are a humane and sensible response. Making human clonal embryos for their stem cells to be used in research inevitably destroys those embryos. It creates, then destroys a human embryo which has the potential to become a person, and this reduces embryos simply to a commodity to be used.

Most people in Canada think that there's a need to respect the embryos' connections to the human community, and that it would need a very compelling reason before doing this.

It's premature to say that clonal embryos are the only possible source of stem cells. So such compelling reasons don't yet exist.

Stem cell research holds promise, but it's not likely to be the panacea that some have described, and there will be many problems inevitably to be solved. For example, fetal cell transportation was promoted as the solution to Parkinson's disease. Yet clinical research on fetal cell transplantation into the brains of affected people for well over a decade hasn't produced a reliable therapy.

Stem cell research will not come to a halt if we don't make clonal embryos. There are many research questions that need to be answered before it can honestly be said that the only way to get cures is to make clonal embryos.

And we have a provision in the legislation that it will be reviewed by a committee of parliament in three years. So there's an opportunity built in to revisit the question if the evidence, as it accumulates, starts to show that no other approach is viable.

A focused debate with broad participation across society needs to take place when the evidence is in and the field has been explored more than at present.. If by then oversight and regulation have been put in place to make sure reproductive cloning won't occur, and if the majority of the population don't then object, the prohibition could be reexamined.

My feeling is that it will not probably be necessary to.

I think we shouldn't forget that there are other ethical objections to making clonal embryos for research. To do that, you need eggs, and so women providing those eggs have to take the health risks of the hormonal treatment and the retrieval procedure.

There's also a danger of an exploited market in buying and selling human eggs developing. Women who need the money are more likely to be induced to take the health risks and do this. You don't see the well off wives of clinical directors selling their eggs.

Also, unless there's oversight and regulation in place, the existence of clonal embryos in many labs would mean sooner or later they're likely to be implanted for reproductive cloning.

Since all facilities handling human embryos in Canada will have to be licensed, whether they're public or private, all, the agency will be able to set the conditions to be complied with for a license both for research and for treatment activities.

For example, with regard to IVF, it would be able to require standards for the collection of data and for reporting of data. It would be able to require communication of written, understandable, and accurate information to potential patients.

It would be able to require standards of practice. For example, how many embryos are you allowed to implant?

And similarly, it would be able to set standards for pre-implantation diagnosis.

That can come off now.

Well, what do Canadians currently think of all of this? A recent survey of 1,700 people across the country found a very substantial majority said nuclear transfer cloning to produce humans should be outlawed. Eighty-six percent said it's acceptable to take stem cells from existing human embryos not needed for treatment. And more than 80 percent want a regulatory agency to oversee this field.

In short, a large majority of Canadians see a pressing need to put in place ethical regulation of reproductive technologies and research with human embryos. I strongly agree with them. It's long overdue.

Legal prohibitions alone are a very blunt instrument, and in this rapidly changing field a more quickly responsive regulatory body is needed.

The source of stem cells from embryos is not the only issue with regard to stem research. We also need to consider and to oversee what conjunctions of human stem cells or human nuclei with animal cells are permissible. Should human and animal cells be permitted to be put together to form a chimera?

There are commercial interests in this field with little or no oversight and a lot of financial motivation, and it shouldn't be up to an individual scientist to decide preemptively what he or she wants to do, ignoring the wishes of the rest of society and making a human by cloning or putting human pluripotent stem cells with animal embryos and developing them to see what transpires.

In conclusion, I think you can see we've come a fairly long journey in canada over the last decade, but it seems we're getting close to putting clear social policy in place, and we shouldn't forget that lack of policy is a policy. It usually means that the market will take over.

I hope that the proposed legislation is passed this year because we've been far too long in dealing with this field in spite of an ongoing public consensus that limits and oversight are needed.

Thank you.

CHAIRMAN KASS: Thank you very much.

We have half an hour or so for discussion.

Let me ask if you wouldn't mind, Mary Ann Glendon, who's been interested in international and comparative law, if she would want to at least make a comment or raise a question, and then the floor will be just generally open.

PROF. GLENDON: First, I'd like to thank Professor Knowles and Dr. Baird. I consider myself something of a connoisseur for comparative analysis, and I am very admiring of your clarity of presentation. Your remarks will be very helpful to this commission.

I thought it might be helpful if we — may I take a minute or two, Mr. Chairman?


PROF. GLENDON: Since we've been given a spectrum of approaches ranging from fairly permissive approach in England to more restrictive approaches in France and Germany; I thought that it might be helpful to situate them in the context of the two great legal traditions that are in play here, the Anglo-American common law and the Romano-Germanic civil law, with Canada a very interesting hybrid as comparative, say, or combination of the two.

And the two speakers have called attention to three relevant major differences between the civil law and the common law systems that we will have to keep in mind as part of the context for considering the approaches of France and Germany.

The first is, as Professor Knowles pointed out, the emphasis in France and Germany on human dignity, which you noted we don't find much dignity language in our legal system. We find more liberty language.

And just to underline how important your point was, dignity language is constitutional language in these legal systems. The German constitution of 1949 begins with a bill of rights rather than ending with a bill of rights, and the first article of the Germany constitution says, "The dignity of man shall be inviolable and the highest duty of the state shall be to protect it."

So there's an "ur" principle in these civil law systems, a dignitarian principle that provides an important context for the schemes of regulation in France and Germany.

The second difference comes from this word "protect" that Professor Knowles emphasized and is taken up again in the first article of the Germany constitution. The highest duty of the state to protect; the idea of a state, an affirmatively acting state with duties to protect is quite different from a principle that is deeply imbedded in the Anglo-American systems, which is a minimalist approach or, as Dr. Baird said, a more mistrustful attitude toward the state.

The third difference, this matter of commercialization. In the civil law systems, there's another deeply imbedded principle that the human body, everything related to the human body is hors de commerce, outside commerce, and so these interesting legal regulations having to do with commercialization come out of a long tradition which in the 1920s and '30s even required special statutes before people could give blood transfusions.

So that, of course, is the intention, that idea about commercialization and human bodies being outside commerce is intention with this relatively stronger emphasis on the free market in the Anglo-American systems, all of which makes Canada particularly interesting because the thinking in Canada is informed by both the kinds of attitudes that produce the legislation that we see in Great Britain, and these other attitudes about commercialization, protection, and dignity.

Now, Michael Sandel has written a book in which he points out that some of these attitudes that are strong in the civil law are also at least undercurrents or counter currents and sometimes have been quite strong in our legal system.

So I think one of the most interesting things that happened this morning is a reminder to us that there might be some ways, and perhaps you'll speak about this, Michael, in which our legal system could reappropriate or raise to the surface some of those ideas that have been undercurrents and counter currents, but that were definitely there from the founding.

And finally, I will just raise a couple of questions, one general and one specific. I think it would be very interesting and helpful for this group if either of you wanted to say some more about commodification and commercialization and the legal systems that you have presented, how it works in practice, and how it's understood and received in the populations concerned.

And the specific question, if you note, Professor Knowles, on the English commission, it's called the HFEA. It would be interesting, I think, if you could tell us a little bit about who is the chair of that commission, a little bit about the composition of that commission, how they were selected and what the background of the chair is.

Thank you.

CHAIRMAN KASS: Shall we take responses before we go down? Please, Ms. Knowles.

MS. KNOWLES: Well, I can't tell you just with respect to the second question — I can't tell you who the chair is of the commission at this moment. I don't know if Pat happens to know.


MS. KNOWLES: Do you know who it is right now? I'm not sure who it has changed to.

But I do know that the chair and deputy chair must be nonclinicians and nonscientists. That they've specified. So not only have they specified that the membership must be predominantly nonclinician, nonscientist, but the chair and the deputy chair need to also be nonclinician, nonscientist because, of course, the chair plays a fundamental role in directing discussion and bringing up questions and airing opinions. So that I do know.

They are appointed, the membership, and the membership is significantly independent. The people that I know who are on the actual authority are — the people that I know are nonscientists, in fact, have law backgrounds, and they work really hand in hand with the scientific community to understand what's going on, but also to make sure that they can enable research and treatment to go forward.

So it's quite a partnership between the authority and the clinics. It's not a partnership in the way of facilitating just anything to go on, but if the clinic doesn't meet a particular set of standards, they will work with them to highlight what they need to do to reach their standards to be able to be licensed. So it requires individuals who are willing to put in significant time commitment. They meeting monthly; they meet ten times a year. So it's a really significant time commitment, and it requires an ability to communicate across a whole context of disciplines, including the scientific disciplines as well.

Do you have anymore specific questions about the membership?



DR. BAIRD: The chair used to be a lawyer. I don't know if they have changed, but the British have a great and long tradition of sort of appointing the great and the good to these kinds of bodies. So that means you get anyone from bishops to actresses, all of whom are imbued with a strong sense and actually a peer group pressure, I think, to make decisions in the public interest. There is a tradition that they aren't there to act as advocates for a particular point of view, which I think is very, very helpful.

I can't make any particular comment about how our legal system differs with regard to noncommercialization because I'm not a lawyer, but another difference that immediately comes to mind is, for example, our blood system. Our blood donation is, again, completely altruistic. No money is ever accepted.

So I think there's sort of a culturally evolved way of expecting certain kinds of behavior which have contributed to the common good.

MS. KNOWLES: I can just make one comment, if I may, about commercializing modification.


MS. KNOWLES: That principle is so strongly held in continental Europe that there's a declaration, the UNESCO originally, the UNESCO declaration on human rights and the human genome in which the noncommercialization — where they actually spell out as you may not make financial profit from the human genome is an imbedded principle in that act.

And it's in the context of a — actually it's not an act. It's a treaty. It's a convention. It's actually spelled out in the context of this convention which embodies human rights and human dignity language.

So the two concepts, in my opinion, the human dignity and human rights concepts are really linked, a very strong thread through most of continental Europe, and the signatories to that act, obviously, embody that sense of nonmodification in human reproduction and human tissues in general.

CHAIRMAN KASS: Frank, to this bill? I've started a queue, but if it's —

DR. MAY: Well, I heard the word "commercialization," and what I had to say referred to that.

CHAIRMAN KASS: Well, please, why don't you follow up then?

DR. MAY: Most of the discussion of commercialization has related to the generation of knowledge and the generation of therapies. I worry about the other end of commercialization, which is access to the knowledge generated and the therapies generated in the setting of our health care system.

If one asks for the sacrifice of embryos, then one is talking about, if one really respects that sacrifice, it's a word that Michael Sandel has insisted on retaining, that word "sacrifice." Then one is talking about a kind of sacrifice that should contribute to the common good and a test of its genuine contribution to the common good is not indirectly eventually through the miracle of the marketplace system, these gifts will contribute to the raising of all boats in the water, but rather that people will have access to that knowledge and will have access to those therapies.

And that's more than simply the original problem of commercializing and exploiting women. As important as that is with regard to the production of knowledge and therapy, the other end of the distribution of that knowledge and therapy for me is a very serious issue.


The queue is getting sizable. Let's just go. Frank Fukuyama and then Mike Gazzaniga. We'll just go.

PROF. FUKUYAMA: Well, I want to echo Mary Ann Glendon's praise for the two speakers and those fine presentations, and I also appreciated Patricia Baird's reference to Seymour Martin Lipsett. Marty Lipsett and I taught a course, an introductory course on comparative politics for five years together and used the continental divide and also his book American Exceptionalism, which I think Americans who read that book don't understand how different their country is from other countries.

And particularly in an area like regulation, things that are fairly straightforward in Britain or Germany or France or Canada are just incredibly difficult in this country. And I suspect that if, for example, we try to establish a comparable agency to regulate reproductive assisted reproduction in this country, you'd actually get, you know, substantial opposition both from the pro choice and the pro life lobbies. I mean, they would be very suspicious of this body for entirely different reasons that both can't consistently be true simultaneously.

But it wouldn't surprise me at all if, in fact, that was the result our system produced. Nonetheless, I think that that is really the direction, you know, we ought to move in, and I would just remind all of the Council members around this table that all of these regulatory agencies, and I believe you mentioned, started with this kind of a commission.

And one of the outputs, the major output of the commission was actually a detailed recommendation for a regulatory body that would have real enforcement powers that would way outlive, you k now, the discussion group essentially that originated.

I want to get back to the question though of the memberships of both the HFEA, which perhaps Lori Knowles can speak to, and of the proposed regulatory agency in Canada because it seems to me that that's a critical issue of institutional design, is how you select the members of the board.

Now, it's interesting that, you know, there's an attempt to democratize the membership, not leaving it simply up to the scientific community or the industry itself, but you know, statutory requirement to have non-expert members.

And in thinking ahead on how this would work in the United States, how would you — I mean, what is the procedure that prevents that selection process from becoming politicized, and why is it that given, you know, the diversity of the membership on the board, let's say, of the HFEA that everybody gets along so well and, you know, they try to learn from each other and so forth?

Because I could easily imagine, you know, a similar body being established in the United States in which the selection of the individual members would be like the selection of Supreme Court Justices with, you know, the different interested communities, you know, taking a great interest in, you know, why is this person appointed?

And then if you actually do get a diversity of views, you know, having the polarizations that exit in the larger society simply being replicated, you know, within that body, but, I mean, how do you deal with that attempt to democratize the regulatory agency?

DR. FOSTER: Well, Frank, I would say that this Council has done pretty well with diverse views of talking to each other with human dignity as just one minor component of such a worry

DR. BAIRD: I think you've put your finger on the numb of something very important, and that we also struggled with in making our recommendations. It's a very complex and difficult thing to do to pick a group of citizens who are intelligent and wanting to wear a citizen's hat, not just push their own agenda.

I think to be overt about that and say that's what you're trying to do is a start because then that puts pressure on the choosers of whoever is going to be on the body.

I think it's also helpful if you make sure that there's no conflict of interest. I mean I wouldn't want to see somebody on that body making recommendations when the when they had a stake in it in some way.

I don't think there's anything wrong with having people on that body who have had nothing to do with the area before, as long as they're smart, and as long as they're trying to do the best for the society.

So that I think people who have taken strong positions in the past have a track record of really trying to push something I think I wouldn't want to see on that body.

So those are just nascent beginnings of how you would try to select people. I think if the motivation of whoever is selection is really to get an intelligent, but body that's trying to find a way through these very complex dilemmas that's going to be in the long-term public interest, I don't think there's any magic or easy way to do that.

MS. KNOWLES: I can really only add a little bit to those comments, and that is that there isn't that I'm aware of a significant component that needs to be what we refer to as lay representations. These people actually do have a track record regardless of their discipline engaging in academic or public debate of some sort.

That's interesting in and of itself because a lot of committees and authorities will actually make a spot for a lay representative and then have other people representing various voices, and that's not this model, which you've already said, Pat.

From what I understand of the HFEA, the Authority itself, the people who are chosen are chosen — some of them have quite high profile. Some of them don't, but they're chosen with a particular skill set in mind, which means that there has to be a specific knowledge of the individuals before they're chosen.

They also rotate. So they're not appointed for life. There is a rotation, like a board of directors, for example, and I believe — and I'll look it up in the break — that they sit for a term of two to three years.

They can be reappointed and often they are at that point, but there is this ability to have a rotating set of personalities and of disciplines on the Authority, which is important obviously so that you can keep the membership alive and informed and different and diverse. There isn't a polarization of positions.

And of course, your specific question about how one appoints them, I don't know the answer to that in the U.S. context. How one appoints them to make them outside of the political process is an extremely important question, and I don't know the answer to that.

CHAIRMAN KASS: Mike Gazzaniga.

DR. GAZZANIGA:: Any comparative approach is sort of Eurocentric at this point. If you were to throw in — and I Don't know if you can do this briefly — but throw in the Israel experience, the Singapore, China, India and Japan, they all look at this quite differently. Is there a way of capturing that in a brief summary?

MS. KNOWLES: I can't do that for you now. I have all of that information. I'd be glad to supplement the material that I present to you.

Israel actually has quite a long history of embryo research, of very advanced embryo research as well, and they have some recent legislation in this are.

Japan does a lot of comparative work itself before it brings in changes. I don't know of the recent Japanese situation at this point.

And there is so much new activity. For example, Australia has been going through a relatively conservative phase. They wanted to prohibit significantly embryo research and stem cell research. There was a public reaction to that and a scientific reaction to that, and they've backed slightly off of that and will likely fall closer to the Canadian position.

They also have done it in the context of a larger, quite a large volume of information on human subjects research legislation. So they've tried to work through their medical research councils and do things a little differently, and that's also right now changing.

But I'd be glad to present supplementary material to you in paper form if that's useful.


Michael Sandel.

PROF. SANDEL: Well, one solution to the problem Frank raises about how do you generate a committee that approaches these questions with an open minded spirit, but mutual respect would be to provide in the legislation that Chairman Kass be the czar for life of such a —


PROF. SANDEL: In here I'm just drawing on the experience that he's created here with this group. I would like to go back to the questions of modification and commercialization.

Dr. Baird pointed out, and I agree, that with cloning for biomedical research, there is the real danger of, if it's unregulated, of an exploitative market for women's eggs.

That's, of course, also true across the board with IVF, that there's a real danger, specially in this country. We see where there is no regulation of IVF, of an exploitative market for women's eggs, and you see this also in commercial surrogacy, which in the United States, except by various state court decisions, is largely unregulated.

And Bill brought to our attention, Bill Hurlbut, I think in the first meeting, that ad that's run in the Stanford paper and the Harvard student paper offering $50,000 for a woman's egg, providing the woman, the donor meets certain descriptions, including a minimum SAT score, and this has nothing to do with embryo research, this exploitative stance commodifying eggs. It has to do with the fact that we have a wholly unregulated regime with respect to IVF and commercial surrogacy.

So I don't think that embryo research is unique in this respect, but it is certainly a very serious concern for any embryo research. But I would say it's also a concern in this country that's been solved in some of the other countries, the commercialization and the exploitation that goes with that of the market for eggs, for sperm, and for embryos.

And so I would hope that we could take up, and I know we will be taking up, regulatory systems that could deal with that problem across the board, whether to do with embryo research or with IVF or with commercial surrogacy, with a few to the exploitation.

And then I think we also need to take very seriously Bill's point about what becomes of the knowledge of the stem cell lines and the therapies that may be generated from the stem cell lines. Will these become the province of companies that have patents on them and that can use them for profit, or will we take seriously the underlying principles that might lead us to support this kind of research, take seriously the underlying principle having to do with the common good, as Bill says, and provide that any stem cell lines generated have to be accessible, can't be proprietary.

And here really to know how feasible this would be, a question for Professor Knowles. Is it true that in the U.K., that all of the stem cell lines that are established have to be made available or can they be restricted?

MS. KNOWLES: I don't know the answer to that specifically.

PROF. SANDEL: The Warnock Report said that, following Bill's logic, said, as I remember, that any stem cell lines generated from embryo research had to be open and accessible. I don't know whether that was embodied in the legislation or not.

MS. KNOWLES: Actually I have the act here. I'll look it up.

It's a really interesting point that you make, and what I was going to say, I had two comments if I may in response.

The first is that with respect to the patenting question that you both brought up and access, that has been addressed in a number of the commission reports and in the Canadian commission, explicitly that there should not be patenting on a lot of these products that come from human embryos precisely for an access issue, this issue of an access to the treatments if it's going to be permitted.

So I'd be interested to know if it's embodied in the Canadian act. I'm not sure. I haven't seen that language, and I will look up the U.K. Act, and that is explicitly in some of the language in Europe. The patenting issue is addressed, and I know you're going to talk about it tomorrow.

And then the second comment I was going to make is that this issue of the — I call this issue the issue of the invisible woman, the woman who provides the oversights for the research, and she is largely invisible in the equation, but she's definitely there. They are definitely there.

And there is in this stem cell oriented legislation explicit mention of this problem, and in fact, I recall that the discussions on NBAC, they were also talking at that point about this pressure to have extra oocytes donated at the fertility clinic, extra embryos created so that they would be available for research, sine often there's research and treatment at the same time.

So explicitly in the act, there's a discussion of the need to protect women from exploitation of this sort, and I think that can't be underlined.

And the other thing that I wanted just to mention is that the Stanford ad, of course, is sort of paradigmatic in that it appeals to a particular socioeconomic group of women. And when you're talking about getting a supply of eggs for research, it's potentially a different group of women that they'll be pulling on, where they're not looking for particular phenotypic physical characteristics or SAT scores.

And I think that needs to be recognized and kept alive in the discussion.

PROF. SANDEL: In fact, could I just add a brief remark?

We do have a precedent, though we in general, as Mary Ann was pointing out, we have this kind of a Wild West of IVF, completely unregulated.

But if we were to entertain the idea of restricting, prohibiting commercialization, prohibiting sale of eggs or sperm or embryos, we would have to acknowledge — and Rebecca has raised points along these lines — we would have to acknowledge that that would come at some cost to the research. It would mean that there would be fewer eggs available.

But we make that compromise; we make that sacrifice on moral grounds to avoid exploitation in another area already, and that's organ transplants. We don't allow the purchase and sale of kidneys or the bidding of kidneys on E-bay or corneas.

And the result of that is we sacrifice the supply, and we do that on moral grounds, and I think that that is a kind of precedent that we might appeal to, those of us who would want to ban the purchase and sale and the bidding for eggs and for sperm and for embryos.


Let's see.

DR. ROWLEY: Can I just interject?


DR. ROWLEY: As you may well be aware, the AMA is now reconsidering that position —

CHAIRMAN KASS: As we speak.

DR. ROWLEY: — because so many individuals who need organs are dying because of the lack of the supply. So that prohibition comes at some cost, which is now being reassessed.


I'm going to run us over because we've got people in the queue, and this is rich. We've got a fairly porous schedule today. So we can shift the blocks of time.

Gil Meilaender and then Alfonso and, I think, Bill May was in line. Yeah, please.

PROF. MEILAENDER: Yeah, I want to return just to puzzle a little bit about the question of how to understand what these regulatory bodies do and probably risk a moment of American exceptionalism in my question, the line of questioning.

From several different angles, I'd like a little more said to help me understand why political independence or arm's length from government is so desirable since I think of as a means by which I as a citizen might have something to say about what a regulatory body did so that it didn't work in sublime independence from what I as a citizen happen to think about these questions.

So that's one angle from which I'd like to hear more, and then I admit I just do not fully understand what it means to have a kind of or, to use Frank's language, why it would be so important not to replicate the differences of opinion within society or how one has a citizen's view.

I mean, what does it mean? It doesn't mean presumably that one never thought about these matters. That wouldn't be desirable necessarily. Does it mean that one stands nowhere in particular?

I tend to think that if you think you stand nowhere, you're probably deceiving yourself, in fact, and I'd rather have someone who knows that he stands somewhere rather than someone who supposes that he doesn't. So I'm just puzzled.

Does it simply mean that you have certain kinds of civic virtues, that you're willing to listen and talk and so forth?

Well, that's perfectly compatible with holding views on the question. So what does it mean not to be interested? If it means not to have a financial interest or something, I understand that. If it means not to have a view about the moral goods that are at stake for your society, then I wouldn't know why I'd particularly want people on such a body who thought that taking a view of the common good meant excluding any vision you happened to have of what moral goods were involved.

So I admit to just puzzlement about it, and I'd welcome more clarification.

CHAIRMAN KASS: Dr. Baird, do you want to speak to this?

DR. BAIRD: It's not that, for example, the agency that we've recommended is completely inaccessible in terms of the public. I mean, they're going to be relating a great deal with the public and having public input about the policy. They also report via the Minister of Health to parliament every year with reports, and the minister himself is responsible to parliament for the actions of that agency.

So if it started to act in a very egregious fashion, there are mechanisms via parliament by which it certainly can be addressed by the polity.

I don't think either Lori or myself used language that suggested that the people who were on such a body would not be interested in any moral questions. That certainly isn't the point. You would want some people who did become engaged and who were analytic and who were trying to sort their way through the dilemmas in terms of the public interest.

And it may be that some of the people as they learn more, they're going to have extremely strong opinions, but I think one of the dangerous things is having people come from particular constituencies and feeling that they are accountable to those particular constituencies because then you come away from an argument and you either one or lost in terms of your constituency, and I think what we're trying to do here is try to reason our way through and come to compromises often on very difficult situations hopefully that will, in the long term be in the best public interest.



PROF. GÓMEZ-LOBO: I have a question for Professor Knowles concerning two things really: the wording of some statutes and possible consequences which may have been tested by precedent or jurisprudence already, and it's this.

For instance, if I understood correctly, the U.K. act prohibits reproductive cloning, right? Now, how is that worded? What is actually prohibited? Is it the cloning itself or the implantation or what?

And then the next question is: what happens if someone violates the law? Now, of course, the person gets fined, but is the pregnancy expected to be carried to term or does the law implicitly require stopping the pregnancy?

Thank you.

MS. KNOWLES: Well, with respect to your last question, the law does not actually require termination of such a pregnancy in such a situation. That's not one of the things that it uses as its sanctions.

And now the actual act that governs that is the Human Reproductive Cloning Act, also covered, as I say, under the HFEA, the act, the actual act, and the wording that they use is they say embryos must not be created by, and they actually have a particular description of a technique, the replacement of a nucleus in a — et cetera, et cetera, which didn't cover explicitly the way that Dolly, for example, was created. So they needed to clarify that this was a type of procedure that was actually not permitted.

So that's unusual in that usually they use purposive language, purposes with respect to sort of delineating what can and cannot be done.

The sanctions that are attached to the HFEA for violation, so that if you created an embryo in this way, and it only really focuses on the use and creation of embryos; it does not focus on particular types of pregnancy, for example, or interventions in pregnancy. So that's where they actually draw a line in the act.

So they don't include surrogacy, for example. They don't include diagnostic techniques within the act, whereas some regulatory situations do.

So the sanctions are criminal sanctions, including fine and imprisonment, and imprisonment is not actually quite as hefty, nor the fines, as they are in Canada. They're a little bit shorter prison terms, but it's a violation of the act creating these things outside of the licensing scheme that gives rise to the criminal sanctions.

Does that answer your question?

Just two more, and then I think we will break. I have Bill May and Janet.

DR. MAY: I have a question about the gestation period in England and Canada from the Warnock Report to the Human Fertilisation and Embryology Act, six years in Canada from 1995, the voluntary moratorium, to 2002, the bill before parliament.

Do you think that's just the accident of these two countries that it's a six-year period and the time in history when this all happened?

Because I think about our wrestling with an issue of particular line of inquiry. Does one argue go ahead with it, with regulations, or argue for a moratorium because it will take an extended period of time to get the regulations in place?

DR. BAIRD: I think you have an inevitable delay on something as complex and value laden as this. I think you have to get policy coalitions forming and coming together to press for things. You have policy learning to go on. You need to develop regulations and really think through this.

You have to get politicians willing to actually make statements of where they stand, which is sometimes difficult. And you've got to get commitment of a political party that's in power.

So I think it's not surprising that it takes a number of years. Someone once did an evaluation of how long it took policy to be implemented after a Royal Commission, if in fact it was implemented, and on average it takes about eight years.

And I think that's because you don't have something handed to you as a Royal Commission unless it's complex and difficult to see immediately the way through and the societal institutions you already have.

I think you were into trying to change public consciousness and make space for politicians to then act. So that's why I think one of the added advantages of a Royal Commission is being able to be a little bit of a watershed in how the issues are framed and thought about in the population, which then gives space to politicians to say, "Yes, we're going to go this way. We're going to put these kinds of measures in place, and there's support by the public for it."


DR. ROWLEY: Well, I'd like to come back to this question of the regulatory body, but from the aspect of the previous experience both in Canada and possibly U.K. and elsewhere of other regulatory bodies, and I'm thinking particularly in the United States scientists actually pressed for the establishment of a regulatory body with regard to recombinant DNA, and so we have at least that precedence within our own country.

And I wondered how Canada, for example, handled, if it did at all, recombinant DNA and technology and oversight of that, and also other countries.

And it doesn't have to be limited to that, but that's the one example I can think of in America for an example that might be applicable to this situation.

DR. BAIRD: We did have regulations put in place with regard to recombinant DNA. One comment I would have about scientific self-regulation is certainly when we went across the country and we took the public pulse, we heard time after time after time and very strongly that self-regulation may be sufficient but it's not enough — I mean, may be necessary, but it's not sufficient, because there is increasingly, I think, a recognition that the difficult decisions and the dilemmas that are facing us in these new fields are actually based on values, and that scientists are perhaps no more equipped to make those kinds of decisions for everyone; that it is only a valid process if you get input from the population.

So it was seen that a self-regulatory body would be illegitimate.


I think we should break. Sorry. Forgive me. I'm sorry.

MS. KNOWLES: It's not a problem at all. I just wanted to address the U.K. question, and in the context in trying to make some comparison with the U.K.

First of all, a more global issue is that the bodies, FDA, for example, which looks at some of these issues, which just recently looked to ooplasm transfer, which is definitely related in this fertility type arena. They are seen as health and safety. So their mandate specifically excludes larger ethical and societal issues.

So what is important in recognizing and looking at these agencies is they have explicit and, in fact, mandated explicitly in the Canadian act that they must address these ethical issues, and that makes what they do different from sort of scientifically based committees that look at is the research valid, you know, what's gone before, is there an animal model, a whole other range of extremely important, somewhat amorphous and difficult moral questions that must be and, in fact, are addressed in these other countries.

And I was just going to say that the professional societies, for example, usually it looks in terms of working towards regulation that there's professional societies that first adopt codes of practice, et cetera, but there is this sense that that is not enough. That has been the experience that really there are those people who live up to it and do excellent, high quality, ethical work, and there are those that just don't.

So without something more, those don't work well on its own, and with respect to the U.K. specifically, they have a companion commission, the Human Genetics Advisory Commission, which is non-legislative, which is interesting in that it's not a statutorily enabled body with criminal sanctions. It's an advisory board, and it works in areas of genetics, human genetics that are not HFEA necessarily technologies. It works in a companion and an advisory capacity, but it isn't like the HFEA.

PROF. SANDEL: Leon, a very quick clarification.

I don't understand the answer, Ms. Knowles to Professor Gómez-Lobo's question. On the human reproductive cloning prohibition, when is the crime committed? Is the crime committed when somatic cell nuclear transfer is performed with a certain intent, or is the crime committed only when there's an implantation?

MS. KNOWLES: I believe it's when — I'm not sure. I'll have to look that up.

CHAIRMAN KASS: We should break.

I want to at least raise a question which maybe we could get some answers to afterwards. I wonder whether they have organized biotech in these other countries and what role they have played in the ongoing discussions because they've played a very large role at least in our recent debates here in this country.

But that I think could be for later.

I want to thank Lori Knowles and Patricia Baird for really wonderful presentations, for opening our eyes to what's going on elsewhere and giving us a lot to think about as we proceed both with the narrow questions immediately before us, but with this larger project of what, if anything, we can suggest relevant to the United States that comes out of pondering what other countries have done.

We are ten of 11. Five after 11, 15 minutes; we'll just move everything back 15 minutes or so.

Thank you.

(Whereupon, the foregoing matter went off the record at 10:52 a.m. and went back on the record at 11:09 a.m.)

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