FRIDAY, December 3, 2004
Session 5: Biotechnology and Public Policy: The New Canadian
Ian Shugart, Assistant Deputy Minister, Health Canada
CHAIRMAN KASS: Good morning. I think we should probably
start. I think there are a couple of our members who've indicated
that they will be coming late, but I don't think we should delay
any further. This morning we continue our attention to the subject
of the regulation of new biotechnologies. And as everybody here,
I think, knows, the Canadian Parliament last spring enacted major
legislation creating a new broad and comprehensive system of regulation
of assisted reproductive technologies. The legislation is the culmination
of a very long and careful process that was begun by the work of
Royal Commission, the chairman of which, Patricia Baird, addressed
this Council, I want to say more than two years ago.
But between activity of the Commission and the enactment of the
law, it was not an easy or simple task and we are very fortunate
to have with us some people who are heavily involved in that legislative
activity. Three gentlemen at the table, Ian Shugart, who is the
Assistant Deputy Minister of Health Canada, Health Canada being
the equivalent of our Department of Health and Human Services.
He is joined by Michael Vandergrift, who is the Director of Health
Science Policy Division and Glen Rivard, who is the general counsel
of Health Canada. Welcome to all three of you.
We had the privilege at the office, the staff and I, of hearing
a presentation by these three men about two months ago, describing
not just the content of the law but in the discussion exploring
how it was possible for them to bring this about and while Canada
and the United States, though friends, are not identical twins in
political matters, we thought that it would be extremely useful
for this body, as we continue our thoughts on regulation, to learn
about what the Canadians have done and how they did it and so thank
you very much for returning, for offering us your thoughts and we
look forward to the presentation.
MR. SHUGART: Thank you very much, Dr. Kass and it is very
much a pleasure for us to be here and to have sat in the public
rows yesterday and enjoyed and benefited enormously from the discussion
of the range of issues that you have on your agenda at this meeting.
We do appreciate the honor of being invited to present to the council
and we hope it will be useful for you and we know that it will be
useful for us as you share your views and your reactions with us.
Canada/US relations have been very much at the top of our minds
over the last week as the President visited Ottawa and Halifax and
both the Prime Minister and the President reiterated the desire
of both countries to work closely together on a range of issues
and it may be that in our own small way on this topic, we can contribute
to the relationship between Canada and the United States.
In this presentation, we intend to provide some context for the
experience that we've had in Canada, give an overview of the
content of the legislation and then provide some thoughts really
drawn from the experience that we have been through and indeed are
continuing to go through. In the presentation, I think it will
be useful to touch on some of the issues that were discussed yesterday
afternoon in the presentation by Professor Fukuyama. We'll
touch, for example, on the key role of legislators in this process.
That was, I think, an important issue that you touched on and with
reference to Dr. McHugh's comments, the Canadian Parliament
didn't set out to put up its dukes, but we certainly did deal
with the issues of research in the context of an emphasis on addressing
the health and safety implications of this particular area of biotechnology
The Chairman has referred to the history of this experience in
Canada. It has been a complex one and a long one. One might say
that it had a greater than 10-year gestation. The Canadian policy
environment had been driven by the Royal Commission on Reproductive
Technologies that was established in the late 1980s. It's interesting
to note that the Commission came about as a result of pressure from
the public to address new developments in the area of assisted human
reproduction and these technologies, particularly from women's
groups, bioethicists and geneticists, and also faith-based groups
and some others.
Since the report of the Royal Commission was tabled, Canada has
had a voluntary moratorium on a variety of practices: Regulations
governing the safety of sperm donation and their storage and three
different legislative processes. The first legislative attempt
focused only on prohibitions. It was fairly roundly criticized
on the grounds that it did not provide a regulatory framework to
deal with some of the issues that were relevant.
The second attempt was a draft bill for pre-study by a parliamentary
committee and then finally the last initiative saw legislation passed
by our Parliament in April — excuse me, March of this year,
almost two years after its first introduction. I personally on
this file have worked with three different ministers of health and
with the fourth now working on the process of the developing the
regulations to implement that act.
In the end, a key factor in achieving passage of this legislation
was the fact that it had been over 10 years since the Royal Commission
first dealt with it. For some this has been perhaps a symptom of
a broader issue in which the challenge of keeping public policy
responsive and keeping pace with developments in science and technology
is, I think, a profound challenge for our societies.
Very quickly, let me describe to you the environment for assisted
human reproduction in Canada. As a general rule of thumb, you can
take the population of Canada and other factors and multiply by
10 in the United States context. Not everything follows that rule
but it's a general idea of the size of the country. We estimate
that one in eight Canadian couples turns to AHR techniques to deal
with the problem of infertility. In 2001, over 1200 children were
born in Canada using these procedures. Most of the services are
provided in physician's offices, private clinics, which are
corporately constituted as independent commercial entities.
Approximately 25 of these centers mostly in the largest urban
centers, Vancouver, Toronto and Montreal and about 104 facilities,
are involved in either sperm distribution, importation or processing.
We also need to set as part of the context, that Canada, like the
United States, is a federation and the constitutional division of
powers is an important feature of how we have addressed the bill
and also the Charter of Rights and Freedoms which was put into our
constitution in the early 1980s is an important dimension of addressing
the issue as well.
The major aspects of the bill that we're going to refer to
and in a moment, I'll invite my colleague Glen Rivard, to give
you a brief synopsis of the different components of the bill. The
Canadian legislation contains, as we heard yesterday afternoon from
Professor Fukuyama, a Declaration of Principles, a set of prohibitions,
a number of controlled activities, and the rules by which those
controlled activities can occur, a section dealing with the reporting
of information related to health, rules for the licensing, inspection
and enforcement of the provisions of the bill, and then finally,
the establishment of the Assisted Human Reproduction Agency of Canada.
It's important to know that the legislation is established
under the criminal law head of power in our Constitution. This
gives us the ability to regulate health and safety, our Food and
Drugs Act, for example, which roughly corresponds to the legislation
governing your own Food and Drug Administration. It takes place
under the criminal law head of power. And one of the purposes
of the criminal law is to, in the rather old language, prevent a
public evil and under that category, some of the ethical dimensions
of these technologies are addressed.
Glen, I'll invite you take us briefly through the scope of
the Act and the subsequent pages.
MR. RIVARD: Thank you, Ian. The diagram in front of you
is an attempt to pictorially summarize what is and what is not covered
by the legislation and of course, the first major distinction is
to realize that the legislation focuses on assisted human reproduction
only and, in particular, this encompasses then the collection and
treatment of the gametes that would be used for these processes,
the processes surrounding artificial fertilization and then if you
will, the uses or the outcomes of that process, the uses of the
resultant embryo. The primary purpose for this, of course, under
the legislation, would be creation of embryos for reproductive purposes
and the legislation governs the treatment of that embryo and the
process of its transfer into the woman.
And it is at that point that the legislation ceases to apply.
At that point, the woman is pregnant as in any other fashion and
the legislation really has nothing more to say about the pregnancy,
the embryo within the woman, birth, anything of that sort. It's
— the legislation is concerned with and only with assisted
There are other outcomes pertaining to, or possible outcomes with
respect to, the resultant embryo. The embryos can — artificial
embryos or embryos can only be created artificially only for the
purpose of reproduction, but given the state of the technology,
if you will, there are embryos that are surplus to that process
and the legislation does envisage as well, the ability to donate
them to third parties for reproductive purposes, research on the
very limited circumstances or the possibility of disposal of the
embryos as well.
The only notable exceptions to this framework are the provisions
that deal with surrogacy, particularly the commercial aspect of
surrogacy. And the legislation basically allows for surrogacy but
prohibits payment for surrogacy with an exception relating to expenditures.
But other than that, all the activities fall within that framework.
I'm going to focus on really four aspects of the bill, the
first being the Declaration of Principles. This serves, I suppose,
many purposes, but at least in terms of the legal use of the provision,
it really in Canadian law has two effects. The first is where there
is ambiguity in the application of the Act, a particular situation,
the courts can refer to the Declaration of Principles to provide
some guidance and secondly, the Act specifically provides that the
Agency must operate in accordance with the principles. So that
in the process of granting licenses, for example, to undertake in
vitro fertilization procedures or any other regulated procedure,
it must pay attention and apply the principles.
The — the principles are not organized in — there's
no priority to the principles with one exception and, therefore,
the process of applying them will be a matter of considering the
ones that are relevant to the particular decision and balancing
of these factors. The one exception is the first principle where
the language explicitly gives priority to the health and well-being
of children who would be created as a result of these procedures.
The other principles of importance include the benefit —
reference to the benefits of the technology and the need to protect
health, safety, dignity and rights. As well, there's a reference
to the protection of the health and well-being of women, importance
given to free and informed consent as a fundamental principle for
these activities, reference to non-discrimination, a reference to
the concerns relating to commercialization of donations, for example,
and a principle pertaining to the need to protect the integrity
of the human genome.
As Ian mentioned, the legislation is based on the criminal law
power, which under the Canadian Constitution is an exclusive federal
jurisdiction and therefore, makes it relatively easy for us to pass
legislation that's applicable across the country. The criminal
law power has a rather wider interpretation — wide interpretation
in Canada. It includes the ability, of course, to legislate with
respect to matters of public morality, which is what most people
think of when they think of criminal law, but it has also been interpreted
by the courts to include legislation with the purpose of protecting
health and safety of Canadians and it's under that heading,
for example, that we regulate food and drugs under our Food and
This is very similar in approach. The legislation can be conceived
of achieving two objectives. The first is the — the first
objective is really that covered by the prohibitions in which we
set out limitations on activities, limitations that are primarily
driven by ethical concerns and the second pertains to provisions
that are intended to protect the health and safety of those participating
in activities that are deemed to be basically ethical and those
are the controlled activities and we'll come to that very shortly.
But just to quickly run through the prohibitions, you can see that
— I won't go into great detail on all of them, but clearly
human cloning is prohibited. All forms of human cloning and for
any purpose is prohibited under this legislation, as is germ-line
genetic alteration. Sex selection for non-medical purposes is prohibited.
There has been some, I know, concern around this Commission about
phenomenon such as the parentless child. There is a prohibition
against creating an embryo from a cell of another embryo or fetus.
The — an artificially created embryo must be implanted within
a woman within 14 days to — we were quite concerned about
the notion of embryos developing sort of to who-knows what end point
outside the body of a woman. The 14 days is 14 developmental days.
So if the embryo is frozen as is typically the case in the in vitro
fertilization process, the clock stops ticking on that particular
provision. There are also, again, provisions dealing with prohibiting
chimeras and hybrids for most purposes, for reproductive purposes.
And again, I've mentioned in the past, commercialization of
the reproductive capacities of individuals, this — there's
no prohibition against commercialization of the industry and this
is a common misunderstanding. It is a private sector industry as
it were, and that's not affected by this except that there are
provisions that address the reproductive capacities of individuals
who deal with — who basically make it illegal to pay for donation
of gametes, to pay for embryos, to pay for surrogacy.
The second major head of activity is what we call the controlled
activities. These are essentially activities that are prohibited
unless they are carried out in accordance with the Act and the regulations
created under the Act. And these activities all require a license
that will be issued by the agency. These are the activities that
we feel are fundamentally acceptable but that we have concerns about
the need for measures to protect the health and safety of people
participating in them. And they are defined in very general terms
which will allow us, in turn, to a great deal of flexibility in
developing the regulations. So the two primary heads are the provisions
allowing us to regulate collection, storage, handling and use of
human reproductive material to create an embryo, and then the storage,
handling and use of an in vitro embryo for any purpose. As well,
there is authority that allows us to authorize the reimbursement
of expenditures of donors and surrogate mothers. Just to note,
both the prohibitions and the controlled activities carry some very
significant penalties as well.
A last key element of the legislation, at least the last I'll
speak to, is that of health information and the council, I know
has identified — or the Commission has identified the importance
of creating good information in this area so that we can make more
informed decisions about the health and safety aspects of this technology.
That is a very — very much something that we hope to be able
to do as a result of the information and privacy provisions in the
Act. The provisions provide — they create a fairly wide authority
to collect, retain, use and disclose health information of people
who are undergoing these procedures and also people who are donors.
They create a privacy framework that is — applies both to
the licensees under the Act for example, the in vitro fertilization
clinics, and also the agency that Mr. Shugart mentioned. The —
precisely because — well because of the sensitivity of the
information and because of the fairly broad scope pertaining to
the collection of the information, this is balanced in the legislation
with a privacy regime that, in fact, is stricter than the general
privacy regime that applies to information in the hands of the Federal
So there's been a balance struck there, a balance which received
favorable comments from the Privacy Commissioner in Canada.
MR. SHUGART: Thank you, Glen. Three points which I think
are particular advances for our country in this area are the creation
of the agency, the information framework that Glen has just talked
about and the comprehensiveness of the approach. The agency is,
of course, modeled to some extent on the United Kingdom model.
It will be independent of the Department of Health, although within
the portfolio of health agencies reporting to the Minister of Health,
no different than what occurs within the domain of several agencies
here reporting to the Secretary of Health and Human Services. It
will be governed by a board that will be broadly representative,
although the appointments to the board are to the person. They
are not formally representative of specific sectors of Canadian
society and it will be led by a chief executive officer to be styled
The agency's mandate is to implement the Act, issue the licenses,
and operate the information registry. The ongoing policy responsibility
remains with the Minister and assisted by the Department. In fact,
it's our view that the Agency will be a home over time, to the
debates that continue related to this field. It is inevitable that
these debates will occur in Parliament as well and in other parts
of society but in a coherent and ongoing way, the agency at the
level of the Board will undoubtedly be a vehicle, a forum, for transparent
and systematic debate about these issues as the field continues
It will provide an anchor for debate in what is sometimes a slippery
slope and it will be a focal point for Canadians as that —
as the field evolves. The information framework is, in our view,
hugely important because it provides a view over time of what is
actually going on in the sector. We do not have today any reliable
or comprehensive information about the nature of the activity, the
extent of the activity, the effects of the activity and this information
framework over time will provide us with that.
The comprehensiveness of the package is something that can be
turned to, providing some principles. They may not be universally
accepted but it will provide stability in this sector and ultimately
for the families who benefit from this sector as well as the research
enterprise relevant to it.
Let me focus then, on three challenging issues which we encountered
and which will continue to be, I suspect, hotly debated from time
to time. The first is donor identity. These issues are a challenge
to the proposition that it is only the issue of research relative
to embryos that is bioethically significant and important. The
question of whether offspring should have access to the identity
of their biological parents, that is the donors of sperm or ova,
without the consent of the donor, was key and central to this debate.
Many offspring gave passionate stories about how they felt they
needed this information to understand themselves, their roots, their
identity and this view was strongly supported by many parliamentarians.
Here there was a difficult tension at play. The potential for
injury to the infertile given the serious concern that removing
donor anonymity would deter donations and reduce the supply of gametes,
reducing the chances to have a family through these technologies
over against the legitimacy of the desire of the offspring to understand
their identity. There was a further factor, somewhat technical
rooted in law, given that most provinces had not amended their family
law, which occurs at the level of provinces, to insure that a donor
is not considered the parent in law. As such the provinces were
very opposed to a system of mandatory donor identification without
having made the changes in family law.
In our study of this issue, we found that all countries that have
mandatory donor identification have clarified the legal status of
the donor. With respect to identity, the Canadian legislation uses
a two-key approach. The offspring can request information about
the identity of the donors and the agency will receive such a request
and seek the consent of the donor in a neutral way, not applying
pressure but simply exploring whether the donor would consent to
provide that identity.
The offspring, however, will receive health related information
on the donors. This is part of the information regime that is established
by the legislation. This whole question of donor identification
was resolved in the parliamentary committee studying the bill by
one vote and that carried through into Parliament where the decision
of the committee was retained.
The second issue which, again, is very significant from the perspective
of bioethics is commercialization. This issue was raised most frequently
in the context of sperm donation and of surrogacy. And again, there
were two principles involved. On the one hand, a principle of the
legislation, that is that these procedures and the human capacity
for reproduction ought not to be commercialized and the pragmatic
effect on the other hand of insuring the availability of reproductive
material to provide the basis for building families.
As we mentioned, payment for gametes is now prohibited. The prohibitions
are in effect as a result of the law. However, concerns over the
continued availability of gametes in this environment of non-commercialization
is easily the single most significant issue heading into the implementation
phase. We're in a transition period right now. Payment is prohibited
but the requirement of receipted expenditures for expenses is not
This regime will require Canada to develop an altruistic culture
of donation such as applies now with blood and with organ donation.
We believe that it can be done, but it is going to require work
and effort to bring that culture about and help it to mature. And
I might just note that it is an interesting complexity in the Canada
imports - donated sperm from the United States.
Finally, embryo research; the legislation was considered in the
context of the debate over embryonic stem cell research. However,
the legislation again, to restate what Glen pointed out, applies
only to embryo research in general. It does not cover the broader
issue of research using existing stem cell lines. The legislation
prohibits the creation of embryos for research purposes other than
a carefully constructed provision that allows research to improve
IVF treatments themselves.
Therapeutic cloning is prohibited in Canada, which is a key point
of contrast, as you know, with the approach in the United Kingdom.
The legislation permits research using IVF embryos created for reproductive
purposes but no longer required for these purposes. This is only
permitted under the operation of a license and that license will
be granted taking into consideration factors such as evidence of
full consent from donors, ethics review through the normal procedures
and the use of the in vitro embryo must be deemed by the agency
to be necessary to the purposes of the research.
These provision cause concern amongst those opposed to embryo
research. Many others thought the legislation was too restrictive
in prohibiting and regulating certain areas of scientific inquiry.
And in our view, it was between those two perspectives impossible
to achieve a compromise that everyone would be satisfied with.
However, we tried in the legislation to clearly set out that embryo
research is unique and requires more oversight than any other type
of research. This will be the only basic research in Canada that
requires a government license. And the continuum of views on the
research involving embryos is well-known. At the one end, this
is really tissue morally indistinct from any other. At the other
end that the embryo is an entity with the full moral status of human
life and in the middle a view that this is an entity with potentiality
for full personhood worthy of special consideration. The middle
view was not proposed by the government as a formal philosophical
proposition. This case about as a result of debate, that is to
say that the debate across that spectrum of views was thorough,
was forcefully expressed by parliamentarians. In the end, this
was a combination of legislative pragmatism, philosophical outlook
and an intuition on the part of the Minister and of the Government
and of legislators about what would be acceptable in the end to
the largest number of Canadians.
Now, despite these controversial issues, how did we actually move
to having legislation? Let me mention three aspects. There was
much debate and disagreement about the issue. This was not easy
to resolve in the end but there was more than the intensity of debate,
a consensus that this issue had to be addressed. It was the type
of legislation that no one is 100 percent comfortable with. Probably
every member of Parliament and Senate wanted to change something
but in end there was a strong feeling that we had to start somewhere.
We had to fill a void. Secondly, towards the end of the debate
when it seemed that nothing was going to be certain. Several groups,
women's groups, social advocates, bioethicists and so on, became
even more vocal in support of the legislation even though they were
not 100 percent happy. Their argument was that the real impact
of the bill was to protect the health and safety of women and their
offspring. And it went right back to the origins of the study of
the Royal Commission. They pleaded for decision makers not to lose
sight of the origins of the bill which was that these are technologies
which have enormous potential and they need to come under the scrutiny
of the public's fear and need to be ruled by the public's
The fact that Canada did not have any legislative provision covering
human cloning, particularly reproductive cloning, was a key driving
factor and some developments in the commercial scientific sector
in the United States and an announcement by a group called the Raelians
in 2002 which created a certain amount of public controversy, brought
into relief the void that existed at the time.
We'll conclude with subsequent steps. We made good progress
as I think is evident, but we have not finished this journey by
any means. The legislation, while on the books, in some respects
is only half complete. It requires an extensive set of regulations
to be developed in order to commence the licensing of the procedures
that are controlled and the related research. And this is a major
area of activity in which we are engaged right now through consultation
with the public and with experts.
There is also a clause in the legislation requiring Parliamentary
study of all proposed regulations. We don't anticipate that
there will be that much free time in the day ahead. We need to
establish the agency. We need to recruit the chief executive officer
and the Board of Directors. This will be done again, through a
public process. The legislation provides for a review of the Act
three years following the creation of the agency. This is a clause
right in the law that Parliament will engage in a review of the
law. The purpose of this is to enable Parliamentarians to be up
to date with the latest developments and to satisfy themselves that
it still reflects the public's views on the issue. We're
more than happy, members of the council, to exchange views and provide
any further elaboration. We hope that's been of some use to
CHAIRMAN KASS: Thank you very much for a clear and concise
and comprehensive presentation of the essence of what you've
done. The floor is open for questions and discussions and could
we have the lights. It's very hard to converse in the dark.
Jim Wilson, please.
PROF. WILSON: Could you clarify, Ian, for me, one or two
provisions? What led you to ban the purchase or sale of gametes
and to rely instead on a voluntary contribution system akin to the
supply of blood that occurs in some countries, although not in this
country? Isn't that likely to reduce substantially the supply
MR. SHUGART: There was concern about that, Professor Wilson,
no question. The prohibition really flowed directly from the principle
that these activities and the materials that are used on the activities
should not be the basis of commercial exchange. That these are
societally important decisions that families make and the view of
the Royal Commission, this was one of the main conclusions that
they came to was that this should not be the subject of commercial
activity. And by extension, the implications were for surrogacy,
paid surrogacy and also for the purchase of gametes or the sale
of gametes. So it really was that simple an extension of that principle.
PROF. WILSON: Well, since I don't understand the objection
to commercialization, and please forgive me if I press a bit more
on this, extracting sperm is not an especially difficult matter.
Extracting an egg is a difficult matter and to not pay women for
the sometimes burdensome procedure involved, it seems to me restricts
substantially the supply of eggs for those persons for whom an egg
should happen to be necessary. But the argument against commercialization
in your view covers that ban without exception.
MR. SHUGART: Well, it is what underlies the ban and there's
no question that that was the tension the Parliamentarians faced
and it, in fact, is one of the reasons why Parliament said, "We
want to — we want to look at this law again. We want to see
what the effect is". We will, through the information, the
reporting requirements, be able to know over time what the effect
is, the supply of gametes and as we mentioned, there's no question
that the development of a culture of altruistic donation which applies
in some other countries and has been developed, is going to require
some focus and some work.
Whether in that area the law will absolutely remain the same,
I can't predict, but in our Parliament, there was a very strong
view that this was as important a principle as virtually any other
within the scope of the bill.
PROF. WILSON: If I could just pursue this one more moment,
you do not wish sex selection to be engaged in for anything other
than correcting a sex related disorder. So that a family that has
four girls and would very much like a boy, this cannot be done under
Canadian law by using some PGD procedure increase the odds you're
selecting a male sperm.
MR. SHUGART: That's correct.
PROF. WILSON: But that can be done in the United States,
so should we open up another flight from Canadian Airlines to Chicago
to accommodate the customers?
MR. SHUGART: Well, we rejected any notion of extraterritoriality,
so all we could do was put in place the regime that reflected a
Canadian perspective but it is absolutely true that there is an
open border between our countries.
CHAIRMAN KASS: We can also fly to Hong Kong and take advantage
of the, you know, nice Chinese offer. I understand. And a tiny
point in this, Mike Gazzaniga wants the floor in a moment, but just
to clarify, one of the ways in which American fertility clinics
are dealing with this question of the supply of donated materials
is to provide reduced costs to the first couple if they are willing
to make their surplus embryos available to other couples. That's
not exactly the buying and selling — I mean, you could say
that's not exactly the buying and selling of the materials but
the question is, does your law deal with that and would that be
— would that be a way around this that's acceptable in
Canada or not?
MR. RIVARD: That practice has been known in Canada and
it is caught by the prohibition.
CHAIRMAN KASS: I'm sorry?
MR. RIVARD: It is prohibited. It is part of the prohibition.
So the purchase of gametes includes exchange for services, for example,
any exchange of value.
CHAIRMAN KASS: Now, let me repeat. If a couple comes
to an in vitro clinic and says, "We're prepared to allow
the surplus embryos to be donated" and the doctor says, "In
that case, we will give you a reduced rate for the services here",
that is explicitly covered by this prohibition?
MR. RIVARD: I think what would be caught in the prohibition
would be the second part of that phrase, in that case you'd
benefit from a reduced rate.
CHAIRMAN KASS: Okay.
MR. RIVARD: The donation of the surplus embryos is by no
CHAIRMAN KASS: Not a problem. Clear. Michael Gazzaniga.
DR. GAZZANIGA: I'm curious in the history of the debate
that led up to the legislation, the way it's structured now
is the stem cells harvested from leftover IVF embryos can go forward
under licensing; whereas, there is absolutely no capacity to use
therapeutic or biomedical cloning to reap stem cells. We've
been through these moral arguments on that point and a lot of people
have trouble distinguishing those two cases. How did the discussion
go in Canada and when it finally came down to whether this bill
was going to go forward or not, did it turn out to be a vote that
some people simply rejected the view and some didn't and could
you have predicted it by what people believed in their personal
MR. SHUGART: I would say a couple of things on that.
First of all, I think that the starting point of the debate was
influential in this sense. The government in our system for the
most part proposes to the legislature a piece of legislation. It
is not built from the ground up to the same extent as perhaps the
congressional system could be described as doing. So that the decision
of the Minister and of Cabinet in coming down on some of the key
provisions was important as a starting point for the debate.
Of course, the full range of views was expressed by individual
Parliamentarians. It would seem in retrospect that the Minister
and the Cabinet had predicted with some accuracy and reflected with
some consistency the views of a majority of Parliamentarians. So
that while there were opposing views on whether the creation of
embryos for research purposes should be allowed, in the end that
was supported by a clear majority of Parliamentarians.
I understand that objection that fundamentally there is no distinction
in terms of the moral status of an embryo, regardless of its purpose
in coming into being. That does seem, however, to be a point of
gradation along that spectrum of views, that purpose is an important
factor in bioethics. And that the existence of supernumerary embryos
as a result of another purpose is capable of differentiation from
a different purpose which is to produce an embryo for research for
therapeutic purposes. I fully appreciate that that distinction
is not accepted by everyone but I think in the range of views, it
is a qualitatively different point on the spectrum.
We did not, as civil servants, really engage in any predictive
exercise on the basis of members of Parliament, although as we interacted
with them, the views of different Parliamentarians became clear.
We advised and implemented the views of Ministers and the Government
and did our best then with Parliamentarians to provide explanation
and awaited the outcome along with everyone else.
CHAIRMAN KASS: Gil Meilaender?
PROF. MEILAENDER: In our discussion yesterday afternoon,
Paul McHugh expressed, if I'm — if my memory is serving
me all right, a certain kind of skepticism with respect to the surplus
embryo question, the kind of skepticism that one might express by
saying, "Well, if we're going to allow those surplus embryos
to be used for research, the IVF industry will indeed produce plenty
of them. So that technically they're produced for reproductive
purposes but in fact, that's not quite what's going on.
Did that sort of issue get raised and discussed at all? Is it deemed
sort of an overly suspicious and too skeptical kind of view? Did
it just — did it not make its way into the debate at all?
I'm just curious to know whether it even came up and was considered.
MR. SHUGART: Well, Professor Meilaender, I'm trained
to be skeptical but not suspicious. But indeed it did come up and
one of the provisions in the regulations again, driven by Health
and Safety, is to — or will be to put limits on the number
of embryos that can be produced from a particular cycle. The purpose
of that will indeed be to address the health concerns of the subject
of the procedure. The effect of it may well be to provide a check
on the phenomenon of deliberate over-supply of embryos.
CHAIRMAN KASS: Please.
MR. VANDERGRIFT: If I could just mention something, two
other factors that were prominent during the debate, one driven
by news media reports of various developments, one dealt with the
issue of ova freezing and to the extent to which that might be the
solution to this question. And members of Parliament accepted that
the science may not be there yet but I think one could anticipate
that there will be a watching brief on developments in that field
as the regulatory framework moves forward.
The second was discussion about the relationship between investigators
or researchers and clinics themselves and what might be —
how that relationship might be sorted out, for example, in the question
of who can obtain informed consent, for example. So I think this
speaks to what Parliamentarians felt as being the importance of
having an overall regulatory framework because it provides tools
to get at some of these issues as they develop.
MR. RIVARD: If I can add just a point on that, too, I would
be a little more concerned about that if the — if we had simply
adopted prohibitions in the absence of a governing framework for
say the IVF clinics. These clinics, therefore, they will all have
to be licensed. They will be subject to government inspection and
a fair degree of control and insight into their operations. So
while it's always possible for somebody to try to evade the
law, it's — there's certainly not — they will
not be operating in a vacuum. They will be subject to a fairly
tight regulatory and inspection regime.
CHAIRMAN KASS: Paul McHugh.
DR. McHUGH: Well, I celebrate this enterprise of our Canadian
friends and I think that it will accomplish just want I certainly
look forward to hear by having a forum where coherent discussions,
as well as overall regulations that can be altered, changed and
developed over time by thoughtful citizens. And therefore, I was
very pleased by this wonderful presentation you gave us. I did
just — this is just a simple question tied to this, and that
was, first, this interim voluntary moratorium on non-applications
of reproductive technologies in 1995, did that moratorium cease?
MR. SHUGART: As a result of the coming into force of the
prohibitions in the bill, yes.
DR. McHUGH: So it ceased in 2004.
MR. SHUGART: Yeah.
DR. McHUGH: So it went from 1995 to 2004.
MR. SHUGART: Uh-huh.
DR. McHUGH: And that moratorium was —
MR. SHUGART: As far as we can tell —
DR. McHUGH: Uh-huh, uh-huh.
MR. SHUGART: — in the absence of any reliable information
to know for certain.
DR. McHUGH: Right, but government supports were not given
to that kind of enterprise in research during that time.
MR. SHUGART: No.
DR. McHUGH: And the other thing is, we have had a presentation
here by a person who was the representative of groups of people
who had anonymous donations in their conception and she made a heartfelt
plea for the idea that this was a practice, this anonymity was a
practice that caused considerable suffering on their part. And
given what you've put here in place and given that there will,
if this is the case, be more and more of these people, presumably
your enterprise will be the forum for these people to re-plea their
case, will it, or will it go back to Parliament where one vote swung
MR. SHUGART: In terms of any change in the legislative
and regulatory framework, then Parliament would have to decide but
the issue will no doubt be debated in the forum. I have absolutely
no doubt whatsoever that the Board will be able to advise the Minister
of Health and the Government on regulatory change over time and
therefore, it is by no means irrelevant or secondary to that issue
but again, the potential in the individual case for the link to
be made notwithstanding the law supports anonymity, the individual
may well appeal to the agency to approach the donor and if that
exchange is successful in that case, then there is every possibility
of the donor consenting to the information, the identity being released
but it's a regime that requires the informed consent of the
donor to give that identifying information.
So in the individual case, there is no reason to believe that
identity will always be anonymous.
DR. McHUGH: Yes, that's very interesting. By the
way, does the same apply to adoptions? Is similar anonymity, informed
consent still applied to adoptions — adoptees who later in
life wish to know their parental origins?
MR. RIVARD: That is generally speaking the rule in Canada.
I think historically there was a pure system of anonymity. Increasingly
jurisdictions are moving to a situation where they have the records
that allow an individual to make a request to find their biological
parent's identity and then can provide that with consent. So
it's somewhat parallel.
DR. McHUGH: So once again, it's in parallel. The
biological parent also has the option of saying no.
MR. RIVARD: That's correct, yeah.
MR. SHUGART: And that is governed by provincial law not
CHAIRMAN KASS: Mary Ann Glendon.
PROF. GLENDON: I'm wondering if you could say a little
bit more about informed consent. How detailed would you expect
the regulation to be? For example, would the clinics be required
to give women information about the success rate, the health risks
to the woman, information such as it is that we have concerning
possible health risks to any children that might be brought into
being through this process?
MR. RIVARD: First, I would say that the concept of informed
consent in Canadian law is very similar, if not identical, to American
law. All the fundamental principles are the same. The —
and the legislation expressly incorporates that common law and applicable
provincial statutes into the legislation. It's also foreseen,
however, in the legislation that specific information requirements
will be set out in the regulations and therefore, for example, if
you are a woman going to an IVF clinic, that clinic will have to
provide the information that the regulations require. We haven't
yet reached the stage of defining what that data will be and we
haven't yet consulted on that also but certainly those are all
issues that I think would be addressed in that process.
MR. VANDERGRIFT: If I might, this was an issue that came
up during the parliamentary proceedings and, in fact, a member of
Parliament succeeded in amending the bill to add a provision that
regulate — the clinics in this case must provide to prospective
patients information on success rates so that was actually specified
in the legislation and the rest will be spelled out in further regulation.
CHAIRMAN KASS: I have a series of things and I don't
know whether you prefer I do them one by one or whether you —
why don't I start and then you can — if there's too
much we'll — you can just interrupt me. I, and I think
not only I, am interested in how what you've done differs from
what the British have done and also how it relates to what might
be done here. So let me begin with an observation or comment and
see whether you think this is correct and what might account for
it. If you look simply at the prohibitions or at the things being
regulated, the difference between this and the British system seems
small in some ways. You could sort of point to cloning for biomedical
research prohibition as perhaps the major difference but if you
look at the overall — at the overall package, a number of
things strike me as being very different.
First of all, in the way that domain in the scope and its definition,
even in the very name of the Act is different. I mean, to talk
about fertilization and embryological authorities as opposed to
assisted human reproduction or — you seem to have taken a
broader view and the question is not what do you do with embryos,
but how do we think about human reproduction given these new assistances.
Second, the list of the principles strike me as different. I
don't have the HFEA Act firmly in mind but I would be surprised
if the language, among other things, of protecting human dignity
occurs in that context, and finally, the origins of this, if we
allow the Royal Commission to be part of the history of this story,
suggests that this is not to begin with — well, this may be
somewhat unfair to the Brits but that was undertaken with, I think,
not only the participation of, but I think probably at the instigation
of, the scientific community, that saw that unless they got something
like this in place, that there would be hell to pay and the research
couldn't go forward and in some ways that is a research facilitation
act, whereas this looks to be something which comes from the public
at large and is not somehow driven from inside the community; that
has some bearing on the question of what enabled you to succeed
and what might prevent us from succeeding here. So I wonder if
you'd first comment on whether those perceptions are accurate
and what difference it might make.
A second question has to do with how it was that you were able
to effect this kind of compromise. I mean, you did indicate in
the slides, and they impressed me, as to what the key factors were
that enabled you to move this forward. And one additional thing
might be to ask, I mean, is it the case that you don't have
the kind of polarization that's been caused here by the Roe
v. Wade decision as the kind of political background and that
somehow made life a little easier for you? Why is it that you didn't
have an aggressive sort of scientific community lobbying against
this, and is it that the lobbying practices in Canada are different
from what they are here? How was it that you were able to get people
who might be very powerfully unhappy either with certain prohibitions
or with certain permissions to say, "Okay, this is the best
that we can do"? Because that isn't the spirit that has
governed these discussions in this country at least not to the present
time and especially if Frank's proposal comes in with his dukes
up, he is unlikely to succeed in the current Congress for the foreseeable
MR. SHUGART: Could I stop you there?
CHAIRMAN KASS: Please.
MR. SHUGART: Please, sir, may I leave the room, my brain
is full? I'll respond to those and invite my colleagues to
join in. The difference with the UK and prospects for the United
States, I will sidestep that question precisely as you put it, particularly
anything predictive about the United States. I would make a couple
of observations. I think in retrospect it would be difficult to
overstate the importance of the fundamental purpose of the legislation
being to address health and safety issues. I think that provided
the debate about the ethical principles, certainly not to disappear,
not to be diminished in their importance, but put in the company
of principles and purposes that were, in their own right, profoundly
important. In other words, constraining these technologies and
the use of these technologies in the interest of couples, of women
in particular, and of children in particular.
I think that there's no question that that had a salutary
benefit on the whole public discussion, including consideration
of the ethical principles. And there as a trail of purpose, there
was a clear public record, outlining that was the kind of issue
that was driving this discussion.
Secondly, the government was confronted on occasion with suggestions
to split the bill and hive off the issue of cloning from the regulatory
dimensions. In other words, makes some prohibitions about human
cloning. The government held fast on the holistic view that these
issues needed to be addressed as a piece. There were, in fact,
implications of the prohibitions for the controlled activities and
the need for regulations. And that if one split the bill, that
would potentially lose the grounds on which one could develop a
regulatory approach and would put at considerable jeopardy the prospects
of ever returning to the health and safety considerations which
were hugely responsible for initiating the discussion in the first
And secondly, there was prime facie, no reason to believe that
splitting the bill would provide a peaceful resolution of issues
in regard to cloning, for example. So it was very important that
the government held to that proposition. And it was able to do
so largely because of the time in question, the government of the
day commanded a majority in the House of Commons. At the moment,
that is not the case.
Thirdly, with respect to researchers, I'm not a sociologist,
I'm not a scientific sociologist, I don't know the extent
to which different views among and of researchers would compare
with the United States. It is a continental if not global fellowship,
of course, but it may have something to do with the nature of public
discourse in our two countries. I did say that as a general rule
of thumb take what happens in Canada and multiply it by 10. It
may be that that principle could apply to intensity of public debate
But it was very important that the positioning of scientists themselves
was supportive overwhelmingly supportive of the approach that the
government was taking. Scientists in Canada in this field and in
related fields, were saying we need a regulatory regime. Self-regulation
in this domain is not in the long run appropriate and so at no point
did the government find itself face-to-face, toe-to-toe with the
research community. On specific points, yes, of course, there was
variation of views within that community and there were some who
took the view that the criminal law was an utterly inappropriate
way of dealing with this whole field.
It was important to make the distinction between a jurisdictional
head of power and a law that would be written to criminalize certain
kinds of activity but again, the government took the view that some
provisions of this bill were enormously important for the nature
of human life and of reproduction and of society and if the criminal
head of power was not appropriate for some of these issues, where
was it appropriate.
But in the main, there was a strong view from researchers that
this was — this regulatory framework was a necessary thing
to do. With respect to the issue of polarized debate, I have a
hunch that while it was awkward and difficult at times, the serialization
of this debate over a number of years may actually in the end have
been helpful in achieving some resolution because it gave a profile
to some of the issues and time for views to mature, time for exchange
to occur and ultimately in Parliament there was a recognition that
it was time to move. The requirement that the government table
with the committee the regulations that were proposed and the Parliamentary
review that is built into the legislation where I think safety valves
as well that allowed ultimately a decision to go ahead, it reduced
somewhat the enormity of the stakes as some would have viewed them.
I think all of those are factors. I don't know, colleagues,
if I've left out anything serious?
MR. RIVARD: I guess I would just add, too, that the —
really the primordial issue was the question of legislation versus
no legislation. I mean, that was the reality in Canada. There
was no legislation in this area. And so you know, at some point
everyone who had some issue or some question with the bill, had
to face that reality and there's sufficient consensus developed
that, although not perfect in anyone's eyes, this was a much
better state of affairs than what existed.
MR. VANDERGRIFT: I would also just quickly add that I
think one could easily anticipate a very vigorous three-year review
of the act as a number of issues that people accepted for the time
being will definitely, I think, come back on the table again at
that point in time. So I think, the depiction of that as a safety
valve, I think was quite accurate.
CHAIRMAN KASS: If I might, I have two more. One is the
question of the importance of gathering the information and the
issue of privacy. This is a difficult problem here. And in fact,
one of the arguments against doing longitudinal studies for outcomes,
one of the reasons we haven't had it is the patient groups are
— zealously guard the privacy of the information and our own
recommendations in the Reproduction And Responsibility report that
we should in fact, have supported longitudinal studies — until
we got in there, the participation should be voluntary, et cetera,
et cetera — we were really very much badgered on this question.
And we also have the Privacy Act, what's the technical —
the HIPAA Act, which gets in the way of — I believe we were
talking about this yesterday — gets in the way of getting
all kinds of indispensable information out.
So if you could say something about how you have managed to steer
the course to get the kind of information — outcomes information
that you need while dealing with this privacy question, that might
be useful to us. And then finally, something on the composition,
the idea for the composition of the — of the regulatory body
itself, not only membership but to — refer to a question that
came up in Frank's presentation yesterday, how do they conceive
of their task? Are they merely the enforcers of the norms tacitly
set by Parliament, or have you indicated that this really is going
to be the place where this debate is going to take place and they're
going to be making some decisions probably on new developments that
the Parliament hasn't had an opportunity even to anticipate?
Are these going to be the followers of public opinion, the shapers
of public opinion, the conscience of Canada? I mean, what sort
of — the anticipated spirit of their activity and what kind
of idea for their composition governs, I don't mean the particular
members, but what's the idea of who these people should be ideally?
MR. SHUGART: With respect to the information and privacy,
I think a number of — I'll ask Glen to comment briefly
in this area as well, but I think that the regulations will need
to pass the standard that the information sought through that regulatory
authority would be appropriate for the public policy purposes behind
it. In other words, it's not simply enabling the gratuitous
collection of information. There needs to be — there needs
to be purpose. The privacy regime and the regulations need to deal
with the issue of the use and disposition of that information, in
other words, provide the safeguards against inappropriate use.
Clearly, the centerpiece of the information requirements is the
medical information that may be particularly germane to the offspring
as well as information relevant to procedures themselves which over
time would be important baseline information for enhancing the safety
of those and efficaciousness of those procedures. This is an area
where we have the interface of the individual clinical experience
and the public health requirements of information where conceptually
the way of dealing with those two things is inherently different.
In public health, typically information is only useful to the extent
that information collected individually is aggregated for the benefit
of more than the individual who provided the information. So there's
an important balance here in terms of the purposes for which the
information is collected and the safeguard is the management of
that information once collected. Glen, is there anything that you
think we should add to that and then I'll address your second
question, Dr. Kass?
MR. RIVARD: Well, I just would add that there are provisions
that will allow for the collection of information up front if you
will, that is prior to donation, prior to participation in a regulated
procedure like IVF. But if by longitudinal studies you mean the
ongoing following of the mother and even more particularly the offspring,
that will require voluntary participation and the department will
have to develop strategies to do that sort of research.
The — I'm familiar with HIPAA. There's similar
legislation in Canada. What we did in effect under this act was,
we created a privacy regime specific to the collection and the use
of the information under this Act. Now, our starting point was
compliance with generally accepted privacy principles and we made
this as congruent as we could conceivably with existing privacy
legislation. As I indicated, there are some fairly broad provisions
up front for collection of information that's balanced by actually
a more restrictive regime governing the disclosure of that information
than is generally applicable.
And that received the endorsement of our privacy commissioners,
so that's how we dealt with that particular problem.
MR. SHUGART: With respect to the Board, I'll answer
a question you didn't ask if I may. It's germane to your
question, however, and that is the provision in the legislation
fairly strong provisions, I would argue, with respect to conflict
of interest of board members. Licensee's, for example, may
not serve on the board. As one reflection of guarding against conflict
of interest. Of course, there was a discussion about the nature
of the board, whether or not to have a board in the first instance.
Once that was resolved, what should be the basis upon selection
of board members, what's the overall character of the board
and it was decided that the board should not simply be a vehicle
for resolving differences of interest or of view. In that sense
there is an echo of yesterday afternoon's discussion with respect
to the history good and/or bad of commissions versus other regulatory
bodies styled somewhat differently.
The selection of members of the board will undoubtedly in the
end reflect a diversity of views and of interests but the basis
upon which board members are selected is individual and not representativeness
of a particular view and that is deliberate. We do believe that
while the board is charged with the oversight of the agency, it
therefore, has an element of good governance practice about it,
quite apart from everything else. The — it also does serve
as a forum for discussion and debate. I would anticipate without
prejudging anything, for example, that the board will have a series
of vehicles for informing itself and the public thereby, of developments
in the field, and the issues that are — seem to arise as a
result of those developments. It will advise the government but
the legislation is quite clear that the policy responsibility rests
with the Department of Health so as to constrain the ability of
the agency simply to define its own future absent broader considerations
of public policy and so on. So that, itself, is a careful balance.
There have been different attempts to characterize it as quasi-judicial,
purely a forum for debate and so on. It's difficult to imagine
after a period of what might in the end be somewhat more organic
development exactly how it will come out, but those constraints
are there. One interesting point to observe is that the —
in the granting of licenses, that task cannot be delegated to staff
of the agency. Granting of licenses must be done by members of
the Board so they do have an important administrative and decision
making role which makes them more than just a collection of interest
There was a debate about whether scientists should be eligible
to serve on the board because "everyone knows what their view
will be." It was resolved in the end that this should be
an informed board and that exclusion of scientists from the board
would not serve that objective. So as you can tell, the discussion
was actually quite varied and extensive. The goal in the end was
to provide oversight, ensure that — given the societal sensitivities
and importance of these issues — that a group visibly charged
with oversight in this area should have that responsibility and
actually in very real terms carry it out, but that it should not
be a vehicle for resolution of narrow interests.
CHAIRMAN KASS: Thank you very much. We've come up
to the time for the break. I want to thank Ian Shugart and his
colleagues for a really very clear, forthcoming and very helpful
presentation. We have a very full next session, so let's be
back at 10:15 and we will start then promptly. Thank you very much.
(A brief recess was taken.)