| REPORT OF THE COMMITTEE | Tuesday,
March 9, 2004 |
The Standing Senate Committee on Social Affairs, Science and Technology
has the honour to present its
SECOND REPORT
Your
Committee, to which was referred Bill C-6, An Act respecting assisted human
reproduction and related research, has, in obedience to the Order of
Reference of Friday, February 13, 2004, examined the said Bill and now reports
the same without amendment.
Your Committee appends to this report certain observations on the Bill.
Respectfully submitted,
JANE
CORDY
For
the Chair
OBSERVATIONS
The
Standing Senate Committee on Social Affairs, Science and Technology (The
Committee) heard from 54 witnesses during 18 hours of testimony on Bill C-6, The
Assisted Human Reproduction Act.
Members struggled with the diverse opinions that witnesses expressed. One
witness summed up the contentiousness of this bill very effectively by saying:
‘This
is not a flawed bill. This is a controversial bill, and it will never NOT be a
controversial bill. There will never be unanimity.’
The Committee passed the bill without amendment but would like to take the opportunity to make the Senate aware of several issues, which ought to be addressed when regulations are being drafted and during the three-year review, which is mandated in the bill.
The
Legislative Framework
The Committee heard from several witnesses broad concerns over the bill
in its entirety. These concerns pertained to splitting the bill and to the use
of criminal prohibitions.
First,
with respect to splitting the bill, the Committee heard from some witnesses that
this bill would be better split into a bill dealing with prohibited activities
on the one hand (an anti-cloning bill) and a separate bill for controlled
activities.
Despite views that the activities are distinct and lend themselves to
separate legislation, members were aware that separate legislation was not
successful in the past (Bill C-47 in 1996) and accepted the view that the bill
addresses complex ethical, medical and scientific issues that are inextricably
intertwined and splitting it could undermine its objectives.
With
respect to the use of criminal prohibitions, the Committee heard testimony from
a number of witnesses who expressed concern over the Government’s use of its
‘biggest regulatory hammer’ to enforce the provisions of the bill. Witnesses
expressed the view that criminal bans should be an instrument of last resort,
reserved for conduct which is culpable, seriously harmful and generally
conceived of as deserving punishment.
They expressed the position that once an activity has been made criminal,
it is difficult to remove or lessen criminal penalties, even in response to
changes in public attitudes. Professional organizations were of the opinion that
certain activities should be prohibited, however they suggested that it is
inappropriate to use criminal sanctions. Witnesses suggested that public opinion
could change with respect to their views on at least some of the prohibitions
and that criminal prohibitions should be restricted to activities where public
opinion is unlikely to change.
The
response provided by Health Canada regarding the use of criminal sanctions
describes the constitutional powers of the Government and the rationale behind
the use of the criminal law power. Health Canada indicated that a legislative
regime is necessary in order to ensure mandatory compliance with health and
safety standards. Legislation requires a constitutional head of power, and in
the case of Bill C-6 it is the criminal law power. Health Canada suggests that,
of the other heads of power, only the Peace, Order and Good Government power
could be considered an appropriate one but using it would result in the bill
having a less secure and weaker constitutional basis. Health Canada also
emphasized that the criminal law power forms the constitutional basis for
federal health protection legislation, including the Food and Drugs Act,
the Hazardous Products Act and the Pest
Control Products Act
Some
witnesses suggested that it would be better not to have any criminal
prohibitions as set out in clauses 5 through 9 but instead to allow the
prohibitions to be enforced at the regulatory level by the Agency, which is to
be set up under the bill. Health Canada maintains, however, that it would less
responsible for the government to have prohibitions enforced at a bureaucratic
level than at a legislative level.
After
considering the evidence and the responses provided by Health Canada, the
Committee is satisfied that it would be inappropriate to split the bill and that
the use of criminal sanctions is acceptable in this initial piece of legislation
on assisted human reproduction. However, the Committee would like to make the
observation that the considerable concern over the use of criminal sanctions
means that this issue should be addressed in depth during the three-year review.
Therapeutic
Cloning
The issue of therapeutic cloning was raised by a number of witnesses.
Many feel that this is an activity that should not be prohibited and they quoted
recent public opinion polls that suggest a majority of the Canadian public is
also supportive. While some witnesses argued that the prohibition is unwarranted
on the grounds of either safety or ethics and morality, scientists suggested
that it would unjustifiably limit the scope of medical research.
The
Committee is sensitive to these arguments. However it is comfortable with the
provisions as set out in the bill after considering evidence offered by some
scientists. Their evidence suggested that research could proceed adequately with
the provisions as currently set out. The Committee would like to offer the
observation that the prohibition on therapeutic cloning is another that warrants
a thorough study when this legislation is eligible for legislative review.
Embryo
Research
The
Committee recognizes and is sensitive to the issue of embryo research. The
Committee recognizes that the research and medical communities have a
responsibility to properly validate fertility techniques. Some witnesses
testified that this can require the use, and ultimate destruction of existing
embryos. Such research may be necessary to ensure the health of resulting
children as well as the health of the women being treated. Witnesses
acknowledged that such research has been ongoing since 1987 in an unregulated
environment. Witnesses who expressed strong opposition to embryo research were
faced with the choice of supporting the bill, which permits embryo research, or
not supporting the bill and thereby, in all likelihood, continuing the current
unregulated environment for embryo research, since the bill would die on the
Order Paper. In this context many opponents of embryo research would prefer to
limit the harm as they see it, if such research cannot be realistically
prohibited. Hence they grudgingly supported passage of the bill in its current
form.
Embryonic
stem cell research (ESC) has recently become another area of embryo research.
However, stem cell research is being done using adult stem cells.
This parallel method of research does not exist in the other areas of
embryo research. While the Committee heard from some witnesses who felt strongly
that ESC research is unnecessary given the adult source alternative, others
testified that both avenues should be pursued.
Some testimony suggested that the knowledge that can be acquired through
the study of ESC can then be applied to adult stem cell research potentially to
increase their plasticity.
The
Committee agrees that embryo research, including ESC research, should not be a
unregulated activity. Members feel that in the absence of defining its moral
status, the embryo is, as defined by the bill, a human organism and as such
research that involves embryos must be dealt with in a stringently regulated
manner. The Committee therefore would like to make the observation that the
Agency must provide exemplary oversight to all embryo research. It would like to
emphasize clause 33(1) of the bill, which states that advisory panels may be
established to advise the Board on any issue referred to it.
The Committee feels that a permanent embryo research advisory panel
should be established that would include at least some representation from the
faith community. This advisory panel should be a priority for the Agency. In
addition the Committee is of the opinion that the Agency must keep abreast of
all adult stem cell research and its advances in order that it may best measure
the necessity of embryonic stem cell research proposals.
Genetic
Alteration and Embryos Created for Research
Along
the lines of the concerns over therapeutic cloning and embryo research described
above, disagreement was voiced by some witnesses over the prohibitions on
germ-line genetic alteration (Clause 5(1)(f)) and creation of embryos for
research purposes (Clause 5(1)(b)).
Although the Committee is in agreement with these prohibitions, they are
somewhat sympathetic to the arguments put forward by these witnesses. The
Committee offers the observation that these may be issues on which the views of
Canadian society could change over time and therefore they should be carefully
examined when the legislation is reviewed within three years.
Identifiable
Donation
Some
of the most compelling testimony given to the Committee addressed identifiable
gamete donation.
Several witnesses, including ethicists, the offspring of these
reproductive techniques, as well as individuals who had been through the
fertility process, spoke eloquently and passionately about the need for
mandatory donor identification. It was their position that offspring are
entitled to identifying information regarding their biological origins.
Medical
professionals, gamete collectors and other individuals who struggle with
infertility expressed equally passionate positions that mandatory donor
identification would effectively eliminate all gamete donations, especially in
the absence of reasonable compensation for the donations. These witnesses
testified that currently under family law in all but two provinces and one
territory, a non-anonymous sperm donor is deemed to be the father of any
child(ren) born as the consequence of his sperm. The Committee was told that the
anonymity provision cannot change until family law is changed in all
jurisdictions. Additionally, family law does not assign maternity to
egg donors currently in any Canadian jurisdiction. The position was clearly
expressed that Canada should not make donor identification mandatory before
family law has been appropriately addressed to protect the donors.
The
Committee understands the difficulty in requiring donor identification at this
time. However, we would observe that this issue should be carefully examined
when this legislation is reviewed within three years.
Permissible
Compensation
Several
witnesses testified to the Committee that the restrictions on compensation are
excessive.
Their position is that this prohibition will essentially reduce the
choices available to the infertile community by significantly reducing the
amount of gamete donations and surrogate services that will be offered. They
also speculated that the non-commercialization provisions would drive the
practice underground or cause Canadians travel to other jurisdictions to seek
treatments unavailable in Canada because of the non-commercialization provisions
in the bill.
Also
compelling was the testimony that human beings cannot be reduced to a commercial
transaction, as some witnesses would argue is the current situation with
commercialized gamete donation. The Committee heard that Canadians do not accept
the commercialization of other human tissues or organs such as blood, bone
marrow or kidneys, and that it is inconsistent and contrary to the views of
Canadian society that payment or compensation be offered for reproductive
material, embryos and surrogacy services.
The
Committee supports the non-commercialization provisions of the bill but is
nevertheless concerned about the effect this will have on donations.
The Agency has a responsibility via clause 24(1)(f) to inform the public
about fertility issues and the risk factors involved. This responsibility should
include awareness and sensitizing campaigns that could inform the public about
the need for gamete donations and thereby, hopefully, minimize the negative
impact on availability.
In addition, the Committee would like to offer the observation that the Agency should
establish a national system of altruistic sperm and egg donation/ banking
similar to that which exists for blood and blood products.
Further,
the Committee wants the Agency to study the actions of those countries that also
prohibit commercialization in order to identify the strategies that have ensured
access to donor gametes by the infertile community.
Surrogacy
Bill
C-6 proposes to prohibit surrogacy for profit, or compensation for surrogacy
services.
Witnesses who represented faith communities did not support the practice
at all, not only the commercial aspect of it. One of the reasons for their
adamant opposition of the practice of surrogacy is the interpretation of the
term ‘mother’.
Although supporters of surrogacy maintain that the mother is only the
social mother, others disagree and insist the ‘mother’ needs to be properly
defined in legal terms.
While
your Committee heard arguments against the prohibition on payment for surrogacy
services, we are in general agreement with those witnesses who are in support of
such a ban. None the less we have a number of observations that should be made
pertaining to the practice of surrogacy. Members feel strongly that the best
interests of the child should not be overshadowed by the desire for a child, and
some witnesses felt that surrogacy may not be in the best interests of the
child. We are all of the opinion that data must be collected so that sound
evidence-based decisions can be made. Some of the crucial information that could
be obtained through an-depth outcomes study includes:
·
the
type of counselling that is appropriate and necessary;
·
the
effects (physical, emotional) on the children and their families as well as the
surrogates and their families;
·
the
level of compensation that is appropriate (receipted expenses, or more); and,
·
the
profiles (socio-economic, demographic, etc.) of the women who offer surrogate
services.
Agency
Overall, there was considerable support for the creation of the Assisted
Human Reproduction Agency of Canada. Witnesses applauded the creation of both a
public registry, for access to Agency information, and a private registry, for
health reporting information.
The
intent of the Bill is clear with respect to the transparency that the Agency is
to respect, as specified in clause 19.
The Committee is concerned, however, that there is no clear obligation
for the work of the Board’s advisory panels to be made public. The Committee
would like to make the observation that the intent of the Bill as it pertains to
Agency transparency must be respected also by the advisory panels it
establishes. The Committee feels that clause 19(f), which states that the public
should have access to information and observations provided to the Agency,
should be interpreted to include the work of such advisory panels.
The
composition of the Agency’s Board of Directors was also addressed by a number
of witnesses. Many feel that the bill is not specific enough in defining
eligibility for the Board and suggested that this lack of specificity would
leave room for members who would have a conflict of financial interest.
We offer the observation that the intent of the eligibility clause 26(8)
must be respected when appointing individuals to the Board and that there must
not be any conflicts of interest, real or perceived.
Finally,
composition of the Board should be reflective of the principles of the Bill as
set out in clause 2.
This clause states that women more than men are directly and
significantly affected by assisted reproduction technologies.
As such the Committee would offer the observation that the Board must be
composed of at least 50% women.
In
order for this Agency to gain the trust and confidence of Canadians, the
Committee feels that these observations must be addressed.
Review
of Legislation
The
diversity of views, disparity between public opinion polls and the rapid pace of
change in the fields of reproductive medicine and related research lead the
Committee to make the observation that careful review of this legislation is
essential at the earliest reasonable time
The
views of Canadians may change even in the near future. The prohibitions on
therapeutic cloning, creation of embryos for research, germ-line genetic
alteration, compensation for gamete donation and surrogacy as well as the
mandatory identification of donors should all be carefully reviewed within three
years following the creation of the Agency.
In
addition, your Committee would like to make the observation that medicine and
science will continue to evolve, as will the views of society, following the
initial review of this Act.
For this reason we are of the opinion that subsequent three year reviews
of the Act should also be required.
Drafting
of Regulations
With respect to the drafting of regulations, concern was expressed that the
processes for appeal should also be outlined in equal detail in the regulations
to the processes surrounding issuance, amendment, renewal and suspension of
licenses.
Finally, some witnesses suggested that any regulatory framework should
incorporate accreditation into inspection and build upon the accomplishments of
regulatory authorities in Canada, the Provinces and Territories. The Committee
would like to make the observation that drafting of the regulations by Health
Canada must not only include extensive consultation with the professional
organizations involved but must also be sensitive to the issues that have been
raised repeatedly by those affected by infertility as well as by donor
offspring. Moreover, these regulations must be drafted on a priority basis and
tabled in both Houses as soon as they become available. There should not be an
inappropriately long period between the creation of the Agency and the tabling
of the first set of regulations.
Conclusion
The Committee has carefully listened to and weighed the testimony of all
the witnesses. Overall, most of the witnesses wanted the bill passed without
amendment, despite their perception of shortcomings, since legislation in this
area is long overdue. The Committee is particularly sensitive to the support
that this bill has received by some individuals and organizations
notwithstanding their careful enumeration of amendments they would like to see
made.
Your
Committee views Bill C-6, The Assisted Human Reproduction Act, as an
important piece of legislation for the health and safety of infertile Canadians
who seek assistance in building their families as well as the children born as
a result of these technologies. It is also an extremely complex bill
comprising a number of controversial issues. It is not perfect. Nevertheless the
Committee is unanimously of the view that Bill C-6 is an enormous improvement
over the current unregulated situation. Given the number of divisive topics that
have little chance of ever satisfying everyone, the Committee concludes these
observations by reiterating the sentiment of one of the witnesses:
‘Pass Bill C-6 now.
If that does not happen, then the good that could be done will not have
been done, and we will be responsible for any ill consequences that result from
the continuing void that is now the status of the law.’…‘Should we pursue
the desire for the perfect to the exclusion of attaining the good’?
Given
the sensitive issues covered in this bill, ‘attaining the good’ is a
significant achievement for the first piece of legislation in this area.