Thursday, June 20, 2002
Lori Knowles, The Hastings Center
Session 1: Regulation 2: Genetic and Reproductive Technologies:
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
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
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
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,
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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,
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.
CHAIRMAN KASS: Thank you very much, Ms. Knowles.
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
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
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 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
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
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
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
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
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 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
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
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
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
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,
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
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
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
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.
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
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 KASS: Please.
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
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
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.
CHAIRMAN KASS: Shall we take responses before we go down? Please, Ms.
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.
CHAIRMAN KASS: I'm sorry?
MS. KNOWLES: Do you know who it is right now? I'm not sure who it has
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?
PROF. GLENDON: No.
CHAIRMAN KASS: Dr. Baird.
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
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
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
CHAIRMAN KASS: Please.
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
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.
CHAIRMAN KASS: Thank you.
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
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
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 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
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.
CHAIRMAN KASS: Thank you.
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
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.
CHAIRMAN KASS: Thank you.
DR. ROWLEY: Can I just interject?
CHAIRMAN KASS: Please.
DR. ROWLEY: As you may well be aware, the AMA is now reconsidering that
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.
CHAIRMAN KASS: Thank you.
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,
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
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.
CHAIRMAN KASS: Thank you.
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
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?
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."
CHAIRMAN KASS: Janet.
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
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.
CHAIRMAN KASS: Thank you.
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
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
MS. KNOWLES: I believe it's when — I'm not sure. I'll have to look that
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
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
We are ten of 11. Five after 11, 15 minutes; we'll just move everything
back 15 minutes or so.
(Whereupon, the foregoing matter went off the record at 10:52 a.m. and
went back on the record at 11:09 a.m.)