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2001
Comparative Primordial Stem Cell Regulation: Canadian Policy Options
A paper commissioned by the
Canadian Biotechnology Advisory Committee
By Lori P. Knowles LLB BCL MA LLM
January 11, 2001
Table of Contents
-
Background
-
Why are primordial stem cells relevant?
-
What are the ethical issues that generate the
controversy about ES and EG cell research?
-
International policy recommendations for
ES and EG cells research
-
What policies exist in Canada that would apply
to primordial stem cell research?
-
How might Canadian Policy address Primordial Stem
Cell Research?
-
Conclusion
-
Appendix
Human stem cells can be derived from a number of sources and offer
fertile areas of scientific research that hold great medical
potential. Some stem cells are found in human umbilical cord blood,1 some in placental tissue and recent
research has focused on the medical potential of somatic or
“adult” stem cells.2
However, by far the most controversial of human stem cells are
primordial stem cells, known as human embryonic stem (ES) and germ
cells (EG). ES and EG cell research offers the potential of great
medical benefit, in particular, the potential to provide an endless
supply of transplantable tissue. The source of these cells, being
human embryos and aborted foetuses respectively, raises difficult
ethical issues and complicates policy development.
With respect to the policy dimensions of primordial stem cell
oversight, a number of existing regulatory schemes may provide partial
or adequate regulation. These include human subjects research
regulation, embryo research regulation, foetal tissue research and use
regulation, research funding legislation and guidelines, practice
guidelines for use of human biological materials, health and safety
legislation and criminal law, among others.3
There has been considerable interest in the use of stem cells for
therapy in the international community.4 This paper will canvass the responses,
conclusions and recommendations of various governmental and
non-governmental bodies to the issue of stem cell research. Particular
emphasis will be placed on the responses of the United States and the
United Kingdom, with reference to the response of the ethics advisory
group to the European Commission and statements by Germany and the
Vatican. Primary focus will be placed on the use of ES and EG cells as
a source of stem cell research. Existing Canadian regulations will be
examined to determine whether Canadian policy is sufficient to deal
with research and use of primordial stem cells or whether new policy
is needed.
-
Background
At the end of 1998, almost simultaneously, one team of
researchers announced that it had isolated human embryonic stem
(ES) cells5 and another
announced that it had isolated human embryonic germ (EG)
cells.6 Embryonic stem cells
are derived from five-to-seven day old embryos known as
blastocysts. If implanted, the outer layer of the blastocyst is
destined to become the placenta. The remainder of the
blastocyst, called the inner cell mass, is destined to become
the foetus. Embryonic stem cells are isolated from this inner
cell mass and the derivation of these cells necessarily involves
the destruction of the embryo. Embryonic germ cells are derived
from immature aborted foetuses. They are derived from a small
set of stem cells that were set aside in the embryo and
prevented from differentiating. They are referred to as
embryonic germ cells because they were destined to give rise to
the eggs or sperm of the next generation.7 EG cells are not, however, the same
thing as foetal eggs, they are the precursors to the cells that
might eventually become foetal eggs if the foetus was female and
proceeded to term.
-
Why are primordial stem cells relevant?
ES and EG cells have two noteworthy properties. First, the cells
are thought to divide indefinitely when cultured in cell lines,
which makes them excellent tools for manipulation by
researchers.8 Second, they
are said to be pluripotent.9
Other cells in the human body are differentiated to some degree,
which means that they have turned into a specific type of cell,
such as blood, nerve or skin cells. By contrast, ES and EG cells
can turn into many cell types. As of yet, researchers have not
been able to successfully direct their differentiation to an
extent that would be clinically useful, however, the hope is
that someday soon these cells will be used to generate specific,
transplantable tissues.
-
What are the ethical issues that generate
the controversy about ES and EG cell research?
Despite the potential for medical benefit offered by ES and EG
cells, the origin of these cells raises policy and ethical
concerns. The policy issues primarily concern the use of
existing legislative and regulatory schemes to govern research
using ES cells and the sources of funding for research involving
human embryos and foetal tissue. The ethical concerns are
primarily related to the moral status of the embryo and the
aborted foetus.
How one evaluates the act of deriving ES cells depends on
whether one believes the human embryo is a person, a mass of
human cells, or something in between which requires special
respect.10 Science cannot
answer this question for us. Currently, many western countries
permit embryo research for specific purposes and within certain
strict limits.11 They proceed
from the view that embryos have neither the moral status of
persons nor that of mere cells; because of their special
connection with the human community they enjoy an intermediate
position that requires that they be treated with special
respect.12
The use of foetal tissue to isolate EG cells is less problematic
than the similar use of human embryos for three reasons. First,
the removal of EG cells from foetal tissue does not occasion the
destruction of a live foetus. Secondly, there is no question of
creating foetal tissue specifically for research. Thirdly, the
use of foetal tissue to develop therapies for people unrelated
to reproduction has been raised before in the context of foetal
tissue transplantation, and therefore a number of laws and
policies exist regarding this use. Consequently, EG cell
researchers and funders should be aware of safeguards and
guidelines regarding the use of foetal tissue in research.13
-
International policy recommendations
for ES and EG cells research
The United States
EG cell research:
Human foetal tissue has been used in research aimed at
developing therapies for disorders, such as Parkinson’s
disease, by transplanting that tissue into afflicted people.
Prior to 1993, laws in the United States prohibited the use of
federal funds for this research since the tissue used is
obtained from aborted foetuses. In 1993 President Clinton lifted
that ban. A number of restrictions exist to ensure that foetal
tissue for research is obtained in a manner that respects the
women from whom it is taken, and that such research does not
encourage abortion.14 These
restrictions can and should apply to EG cell research.
Limitations of the use of foetal tissue in transplantation
include three main restrictions. First, the physician is
required to obtain the woman’s informed consent to use
foetal tissue removed from her body. Second, to ensure that the
possibility of donating tissue to benefit medical science does
not influence a woman’s decision, the donation of foetal
tissue can only be discussed following a decision to terminate
the pregnancy. Finally, restrictions mandate that a woman cannot
direct that her foetal tissue be used to benefit a particular
person. Both the National Bioethics Advisory Commission and the
National Institutes of Health indicated that these guidelines
should be expanded to apply to EG cell research.15 Changes to the informed consent
required to use foetal tissue would mirror those indicated below
with respect to the use of donated embryos, including specific
consent to the use of the tissue for stem cell research.16
ES cell research:
In the United States, existing federal law prohibits federal
funding of research using human embryos.17 The law limits the ability to
conduct research on embryos that would lead to the discard or
destruction of the embryo, in which case only interventions
intended to benefit the embryo and conducted on embryos intended
for implantation would be permissible. Consequently, private
corporations have taken the lead in this research and have, as
mentioned above, isolated the first human ES cells. In November
1998 President Clinton appealed for guidance to the National
Bioethics Advisory Commission (NBAC).18 In January 1999 the Director of
the National Institutes of Health (NIH) issued a moratorium on
NIH-funded research using human pluripotent stem cells derived
from human embryos and foetal tissue pending examination of the
law. That same month the NIH received a legal opinion that the
current law can be interpreted so that it is legal to fund
research on human ES cells so long as federal funds are not used
to support the derivation of those cells.19
Although this legal interpretation may be technically sound, it
places the American government in the paradoxical position of
withholding funds from research to derive ES cells but
permitting funds for research on ES cells once they have been
derived using private funds, or once they have been imported
from countries without restrictions on embryo research. This
paradox is explicitly acknowledged by the French National
Commission: “We are approaching a paradoxical situation as
a result of legislation: … experimentation or therapeutic
research on [stem cells] from embryos in vitro are
banned, but it is possible to import cells from collections
established without any observance of specific ethical law
applicable in France to embryonic cells”.20 The same situation applies in
Australia where research on ES cells is being conducted on cell
lines created in Singapore.21
Despite the foregoing, the NIH guidelines, discussed below, are
based on that legal opinion.
-
National Bioethics Advisory
Commission
In response to the President’s letter of November
1998, NBAC was charged with the task of analyzing the
ethical implications of primordial stem cell research and
recommending directions for future regulation of this
research. NBAC published its report Ethical Issues in
Human Stem Cell Research in September 1999.With
respect to EG cells, NBAC endorsed the use of foetal
tissue for the derivation and use of these cells provided
the restrictions in the foetal tissue transplantation laws
already in effect were followed. NBAC also specifically
recommended that changes are needed to make it explicit
that the restrictions on the use of tissue from aborted
foetuses for transplantation should apply to the research
on EG cells from that tissue.22
NBAC debated the ethics of ES and EG research and,
convinced that the promise of primordial stem cell
research was great, recommended a partial lifting of the
embryo research law so that embryo research, both deriving
stem cells and using derived stem cells, could be eligible
for federal funding. 23
Of particular importance was the finding that a
distinction between the derivation of ES cells and the use
of those cells was not morally relevant. 24 In addition, NBAC stated
that relying on cell lines derived exclusively by
privately-funded researchers could severely limit
scientific and clinical progress, and would diminish the
scientific value of the activities receiving federal
support. NBAC gave the following reasons in support of
their assertion:
-
Researchers using ES cell lines will derive substantial
scientific benefits from a detailed understanding of
the process of ES cell derivation
-
Significant basic research needs to be conducted
regarding the process of ES cell derivation before
cell-based therapies can be realized, and this work
must be pursued in a wide variety of settings including
those exclusively devoted to basic academic research
-
ES cells are not indefinitely stable in culture,
therefore it is especially important in the first few
years of ES cell research to be able to repeatedly
derive ES cells in order to ensure that the properties
of the cells that are being studied have not changed.
Consequently, NBAC recommended that provisions be enacted
applicable to funding by all federal agencies that would
carve out a narrow exception for funding of research to
use or to derive human ES cells from embryos that are
being discarded by infertility treatment programmes.25
In reaching this conclusion NBAC recommended the following
limitations to ES cell research:
-
Funding should be available only for research on
embryos that were created by in vitro
fertilization (IVF) for fertility treatments and
are no longer needed by the individuals undergoing
treatment
-
No embryos are to be created specifically for research
purposes
-
Funds should not be available for the use of ES cells
produced by the cloning technique Somatic Cell Nuclear
Transfer (SCNT)
-
Embryos and cadaveric foetal tissue should not be
bought or sold
-
All stem cell research should be subject to both
national as well as local oversight:
-
A National Stem Cell Oversight and Review Board
(SCORB) should be established to review all
protocols deriving and using ES or EG cells to
ensure that derivation or use is conducted in
conformance with the ethical principles and
recommendations contained in the report. SCORB
should:
-
-
Be multidisciplinary in composition
-
Certify that ES and EG cell lines result
from approved protocols,
-
Maintain a public registry of approved cell
lines
-
Establish a database of certified and
approved cell lines
-
Use the database to track the use of the
cell lines and the ultimate results of the
protocols to aid in policy assessment and
formulation
-
Establish requirements for and provide
guidance to sponsoring agencies on the
social and ethical issues that should be
considered in the review of research
protocols that derive or use ES or EG cells
- Provide yearly reports to the DHHS
Secretary on this follow up and other
relevant ethical and social issues.
-
Local review should involve protocol review of
derivation protocols by Institutional Review
Boards (IRBs)26
In addition, the Commission stated that voluntary
compliance with the recommendations by the private sector
should be encouraged.
-
National Institutes of Health
The NIH published draft guidelines on the use of human
pluripotent stem cells on December 2, 1999. NIH received
over 50,000 comments from various groups, members of
congress and private citizens in the 90-day public comment
period. On August 25, 2000 the NIH published and brought
into effect National Institutes of Health Guidelines
for Research Using Human Pluripotent Stem Cells (NIH
Guidelines). These Guidelines lifted the January 1999
moratorium on research using human pluripotent stem cells.
The NIH Guidelines apply to human pluripotent stem cells
derived from foetal tissue or from embryos that are the
result of IVF, are in excess of clinical need, and have
not reached the stage at which the mesoderm is formed.
They do not impose requirements on federal funding of
research involving stem cells from human adults, umbilical
cords, or placentas.
The NIH Guidelines endorsing ES and EG cell research are
based on the conclusion that no single source of stem
cells may be best or even suitable for all therapies. The
Guidelines further highlight the importance of research
comparing the potential of adult stem cells with
primordial stem cells derived from embryos and foetuses in
order to determine the best source for the specialized
cells and tissues needed for new treatments. In addition,
the Guidelines note that adult stem cells may be more
limited in potential and in availability than primordial
stem cells, and may be more prone to genetic defects.27
The Guidelines state that funds may be used to derive
human pluripotent stem cells from human foetal
tissue, but may not be used to derive human primordial
stem cells from human embryos. Unlike the NBAC
recommendations, the NIH Guidelines draw a distinction
between the derivation and the use of ES cells; the former
is not eligible for funding while the latter is. With
respect to ES cells the Guidelines are similar to
NBAC’s recommendations in that NIH funds may be used
for research on stem cells only if they were derived from
embryos left over from infertility treatment. NIH-funded
researchers may not use ES cells derived from embryos
created by SCNT nor embryos created specifically for
research by any means. The result of these Guidelines is
that derivation of ES cells will be funded with private
money.
The Guidelines distinguish between materials required to
apply for NIH funding, conditions required for funding
eligibility and research that is not eligible for NIH
funding. Required in application for funds are assurances
that EG cells were derived following the conditions and
restrictions set out in the Foetal Tissue Transplantation
laws.28 With respect to
ES cells, required in application for funds are assurances
that ES cells were derived from human embryos in
accordance with certain conditions and that the
institution will maintain documentation in support of
those assurances. Researchers seeking funding must provide
the NIH not only with the research protocol proposing to
use primordial stem cells but also documentation of IRB
approval of the stem cell derivation protocol.
The following conditions must be fulfilled for ES funding
eligibility:
-
Only embryos created for purposes of fertility
treatment and remaining in excess of the clinical need
of the individuals seeking fertility treatment may be
used in research
-
No inducements, monetary or otherwise, can be offered
for the donation of human embryos for research purposes
-
Fertility clinics and labs should have specific
written policies and practices to ensure no such
inducements are made
-
There must be a clear separation between the decision
to create embryos for fertility treatment and the
decision to donate human embryos for stem cell research
-
To allow adequate time between decisions only
frozen human embryos should be used for stem cell
research
-
The decision to donate embryos for stem cell research
must be free from influence of researchers
-
The attending physician responsible for the
fertility treatment and the
researcher/investigator deriving and/or proposing
to utilize human pluripotent stem cells should
not be the same person
-
Fertility patients are to be approached about a
donation decision only when they are deciding about the
disposition of excess embryos
-
No directed donation of embryonic tissue or stem cells
derived from that tissue is permitted by the donors29
-
IRB approval is required with respect to the research
protocols for the derivation of both ES and EG cells
With respect to achieving the informed consent of the
embryonic tissue donors the following conditions must be
satisfied:
-
Researchers must specify to the tissue donor whether
information that could reveal his or her identity will
be retained
-
Donors must be informed of possible commercial benefit
resulting from research on donated stem cells and that
the donor will not have access to that commercial
benefit30
-
Donors must be informed that no medical benefit will be
accruing to the donor
The following types of primordial stem cell research are
ineligible for NIH funding:
-
Derivation of stem cells from human embryos
-
Research in which stem cells are utilized to create or
contribute to a human embryo
-
Utilizing stem cells derived from human embryos created
for research purposes rather than for fertility
treatment
-
Research in which stem cells are derived using SCNT
-
Research using stem cells derived from SCNT
-
Research in which human stem cells are combined with an
animal embryo
-
Research in which stem cells are used in combination
with SCNT for the purposes of reproductive cloning of a
human.
With respect to the oversight of primordial stem cell
research, the NIH Guidelines echo the recommendation in
NBAC’s report by providing for the creation of the
NIH Human Pluripotent Stem Cell Review Group. This working
group would review documentation of compliance with the
guidelines for funding requests and provide a yearly
report on research funded and protocols submitted.
It is important to note that the question of funding for
ES cells is far from settled. The selection of the
President will likely have a profound impact on the
Guidelines. Given his stance on abortion, Governor Bush is
unlikely to be in favour of government funding for embryo
research, whereas Vice-President Gore has indicated he is
supportive of ES cell research.31 In addition, there are a
number of bills currently before Congress and the Senate
both expanding and restricting the use of government
funding of ES cell research.32
-
There is no specific legislation currently in force in the UK to
regulate research on stem cells once extracted from embryos or
research aimed at deriving stem cells from other, non-embryonic
sources such as an aborted foetus or adult cells. However, the
United Kingdom has one of the most respected and comprehensive
models of ART regulation. Within that framework it is possible
to accommodate scientific developments and adapt the legislation
with minimal disruption of the system. This is discussed below
in the context of ES cell research.
EG cell research:
A Code of Practice laid down by the Polkinghorne Committee in
1989 governs the use of foetal tissue, while guidance from
professional and research bodies and from the Department of
Health governs research more generally. The code laid down in
the Polkinghorne Report is similar in its restrictions on the
use of foetal tissue to that of the United States mentioned
above. These restrictions should apply to EG cell research in
the United Kingdom.
ES cell research:
The Warnock Report issued in 1984 canvassed the ethical and
policy issues with respect to assisted reproductive technologies
and recommended regulatory authority and guidelines with respect
to embryo research.34 In 1990
the Human Fertilisation and Embryology Act 1990 (HFEA) was
passed. In addition to setting out limits and prohibitions on
embryo research, the HFEA created a regulatory authority, the
Human Fertilisation and Embryology Authority (HFE Authority),
endowed with exclusive power to grant licenses necessary to
conduct embryo research in the UK. Only purposes specified under
the Act are eligible for licensing.
The HFEA, arguably one of the most liberal embryo research acts,
makes no explicit provision for research such as stem cell
research aimed at replacement of diseased or damaged tissues.
However the HFEA provided a mechanism to add research purposes
not currently available for licensing through amendment of the
regulations to the Act. In light of the announcement of the
discovery of primordial stem cells, the Human Genetics Advisory
Commission and the HFE Authority (HGAC/HFEA Statement) issued a
joint report including the following statement in December 1998:
[W]hen the 1990 HFE Act was passed, the beneficial
therapeutic consequences that could potentially result from
human embryo research were not envisaged. We therefore
recommend that the Secretary of State should consider
specifying in regulations two further purposes to be added to
the list [of approved purposes], being:
-
Developing methods of therapy for mitochondrial diseases
-
Developing methods of therapy for diseased or damaged
tissues or organs.35
In addition, the HGAC/HFEA Statement specifically recommended
permitting research of this sort, advising that it would be
unwise to rule out research using cloning techniques (called
Cell Nucleus Replacement [CNR] in the United Kingdom) involving
embryos “that might prove of therapeutic value.”36
The Nuffield Council on Bioethics endorsed this recommendation
by the HFEA/HGAC.37 Rather
than adopting the HGAC/HFEA recommendations however, the British
government responded to the report by setting up an expert
advisory group to further study the need for, benefits and risks
of therapeutic cloning in humans.38 That panel, headed by chief
medical officer Liam Donaldson, issued a report to the
government in May 2000 which was published August 16, 2000
entitled Stem Cell Research: Medical Progress with
Responsibility. Among its primarily recommendations was the
modification of the HFEA to permit stem cell research for the
aims outlined by the HFEA/HGAC Statement above.
The following conclusions were established in the report and
provide the basis for the Expert Groups’ recommendations:
-
The great potential to relieve suffering and treat disease
provides justification for research across the range of
possible sources of stem cells, including embryos
-
The proposed new research uses to develop treatments for
diseased tissues and organs do not raise fundamentally
different ethical issues from the research uses currently
permitted under the HFEA with respect to surplus embryos
created by IVF for fertility treatments
-
“Transitional” research on embryos created by CNR
is justified by the potential benefit of understanding
mechanisms for reprogramming adult cells, thereby providing
compatible tissue for treatment
-
A system of regulatory controls adequate to provide necessary
safeguards against the inappropriate use of embryos in
research exists through HFE Authority consideration of
applications for research licenses
-
No mechanism exists for monitoring subsequent research
involving cultures of stem cells once they have been
extracted from embryos
The Expert Panel made the following recommendations based on the
above conclusions:
-
Research using embryos, (whether created by IVF or CNR) to
increase understanding about human disease and disorders and
their cell-based treatment should be permitted, subject to
the controls of the HFEA
-
In licensing any research using embryos created by CNR, the
HFE Authority must be satisfied that there is no other means
to meet the needs of the research
-
Donors of gametes used to create embryos for the derivation
of stem cells must give specific consent to the use of their
embryos to derive stem cells
-
An appropriate body to establish whether the research is
delivering the anticipated benefits and to identify concerns
which may arise should monitor the progress of research
involving ES cells.
-
Mixing human somatic cells with live eggs of any animal
species should not be permitted
-
Reproductive cloning should remain a criminal offence
-
The need for legislation to permit the use of embryo-derived
cells in treatments developed from this new research should
be kept under review
-
The Research Councils should be encouraged to establish a
programme for stem cell research and to consider the
feasibility of establishing collections of stem cells for
research use.
At the same time as it released the Expert Group’s report,
the British Government published a response to the report
endorsing all of its recommendations.39 The government subsequently
drafted legislation implementing the recommendations and placed
this legislation before the British Parliament for a free vote.
The proposed expansion of ES cell research was passed by a vote
of 366 to 174 on December 19, 2000.40 The British government has also
promised new legislation explicitly outlawing the reproductive
cloning of human beings – a procedure currently prohibited
under the regulations, but thought to require additional
explicit condemnation. In response to the UK report and
government response the Vatican condemned the proposed
changes.41 The Vatican
position articulates an unambiguous condemnation of ES cell
research as well as EG research which cannot be morally condoned
because by using tissue from aborted foetuses it requires
complicity in abortion, a practice condemned by the Catholic
Church.
-
The Vatican
The Pontifical Academy for Life published from Vatican City,
August 25, 2000 a Declaration on the Production and the
Scientific and Therapeutic Use of Human Embryonic Stem
Cells. That declaration concluded that ES cell research was
in some respects not necessary given the potential for
reprogramming of adult stem cells. Nevertheless, the declaration
states that even if it ES cell research could be shown to be
necessary, it is unethical on its own terms based on the
understanding that from conception a “human identity is
created, which from that point begins its own coordinated,
continuous and gradual development such that at no later stage
can it be considered as a simple mass of cells.” Given
this premise the following reasons were given to explain why ES
cell research is illicit and immoral:
-
A human individual with a right to its own life is created at
conception. Consequently, any intervention that is not in
favour of the embryo is an act that violates that right and
is gravely immoral and illicit. The ends of ES cell research,
although believed to be good, can neither justify such an
immoral intervention nor make right an action that in itself
is wrong.
-
Every type of therapeutic cloning, which implies producing
human embryos and then destroying them in order to obtain
stem cells, is illicit.
-
ES Cells and the differentiated cells obtained from them,
which are supplied by other researchers or are commercially
obtainable cannot be morally used, as such a use would be
morally complicit with the immoral actions of deriving those
cells.42
A similar conclusion was drawn in Germany with respect to the
ability to conduct ES cell research, but for very different
reasons than those articulated by the Vatican.
-
Germany
The German Embryo Protection Act, 1991 is one of
Europe’s strictest embryo research laws and ostensibly
protects human embryos from all harmful research. In discussing
the use of ES cells, the German government came to the
conclusion that there was no need to relax the strict embryo
protection laws to permit ES research, since EG cell research is
permitted under laws relating to the use of foetal tissue.43 Since that time, discussions
have continued between those in favour of liberalising the
embryo research laws to permit some ES cell research and those
against all embryo research.44 These discussions have continued
in earnest since the UK recommendations were announced.45 To date no legislation has been
drafted or tabled.
The European Group on Ethics in Science and New
Technologies to the European Commission (EGE)
On November 14, 2000 the EGE published Opinion No. 15 entitled
Ethical Aspects of Human Stem Cell Research and Use. EU
directives currently exist which prohibit the patenting of
embryos or commercial uses of human embryos. The EGE will issue
a future opinion on the ethical aspects related to the patenting
of inventions involving human stem cells, consequently Opinion
15 does not address these issues with respect to stem cells.
EG cells:
With respect to EG cells, the EGE Opinion reaffirms the need to
ensure that decisions to terminate pregnancy are not influenced
by the therapeutic possibilities the use of fetal tissue may
occasion. As with other regions, the need for specific consent
to use foetal tissue in research is required and commercial
trade in this tissue is forbidden.
ES cells:
The EGE recognizes that the most promising therapeutic
application of ES cells would be the production of specific cell
lines for therapeutic transplantation, while recognizing that
the use of these cells in clinical application is still well in
the future. The EGE underscores the pluralism of the European
Union (EU) by briefly outlining the different approaches to
embryo research in the EU member states. Some states have embryo
research legislation, some do not and some have judicial
pronouncements that direct the permissible scope of embryo
research. Although at a national level stem cell research is not
regulated as such, that situation is in flux as several
countries; notably the UK, the Netherlands and Belgium are in
the process of drafting legislation.46
Where embryo research is permitted for research into
infertility, restrictions ensure that embryos used in such
research must be destroyed (i.e. cannot be implanted).
Consequently, the EGE could find no argument that would prohibit
the expansion of permissible embryo research to include research
aimed at developing new treatments to cure severe diseases or
injuries. The EGE was of the opinion that funding for this
research should be available through the EU Framework programme
of research, if the research complies with the ethical and legal
requirements defined therein.
Specific funding should be allotted in the EC research programme
for stem cell research based on spare embryos, foetal tissue and
adult stem cells. The creation of embryos for stem cell
production, however, was considered ethically unacceptable when
spare embryos exist as an alternative source. In addition,
although the EGE noted that the creation of embryos by SCNT
might be the most effective way to derive stem cells that are
histocompatible, they were not persuaded of the necessity to
fund this research at this time. Balancing the low levels of
success in SCNT and the resulting remote therapeutic prospects
against considerations of trivializing the use of embryos and
exerting pressure on women as a source of oocytes (the provision
of cell lines would require large numbers of oocytes), the EGE
concluded that the creation of embryos by SCNT for research on
stem cell therapy would be premature given existing alternative
sources.
Other recommendations of interest include provisions to ensure
the safety of women involved in infertility treatments and the
need to ensure that demand for spare embryos and oocytes do not
increase clinical pressure on these women. The EGE also
underlined the need for confidentiality, free and informed
consent, including specific consent to ES cell research by
gamete and embryo donors, and the need to take a precautionary
approach to protect the health of persons involved in clinical
trials involving stem cells. Finally, the EGE emphasized that in
the countries where it is permitted, it is crucial to place ES
cell research under strict public control by a centralized
authority, patterned along the lines of the UK HFE Authority.
Authorizations to conduct ES cell research, whether carried out
by the pubic or private sector, should be awarded on a highly
selective basis and based on a case-by-case approach. National
or European level licensing of stem cell imports and exports
would be appropriate.
The foregoing description of international policy initiatives
with respect to ES and EG cell research is useful in recognizing
what issues connected to primordial stem cell research merited
separate regulatory consideration, rather than using existing
policy. The question posed is whether there exists in Canada a
regulatory infrastructure that can deal with primordial stem
cell research in a manner sufficient to handle the ethical and
policy issues specific to these cells.
-
What policies exist in Canada that would
apply to primordial stem cell research?
In the absence of comprehensive ART regulation in Canada, there
are a few quasi-legal sources of regulatory guidance that should
be examined. In 1989 the Prime Minister appointed the Royal
Commission on New Reproductive Technologies (Royal Commission)
to examine the social, legal and ethical implications of
developments in reproductive technology. Meetings and public
consultation were held over a period of two years and the
commission issued its final report, Proceed with Care: The
Final Report of the Royal Commission on New Reproductive
Technologies in November 1993. Significant guidance exists
in the Royal Commission’s report to aid in the development
of ART policy, including stem cell research, although the report
has no legal force.
Drawing on the recommendations of the Commission, the Minister
of Health issued a voluntary moratorium on nine reproductive
technology practices in July 1995.47 Of interest in the context of this
paper were the inclusion of human embryo cloning and the
creation of animal human hybrids. That moratorium continues to
be in force, however, its voluntary nature means that the
moratorium has no legal force per se including no means for
sanctioning those not in compliance. Researchers receiving
federal funding would likely be under pressure to conform to the
health minister’s call for a moratorium in order to be
seen to be practicing on the highest ethical ground. To the
extent that researchers choose not to comply with the voluntary
moratorium they may be accused of breaching the highest
articulated standards for reproductive research; consequently,
the moratorium may have some persuasive or moral authority in
the private as well as public research spheres. Given the lack
of enforcement and sanctioning mechanisms, it is not surprising
however, that there have been suggestions that the voluntary
moratorium is not working.48
Bill C-47, a federal law, was drafted in which the
recommendations of the Royal Commission were partially
incorporated, including the ban of 13 reproductive technology
practices. The proposed Human Reproductive and Genetic
Technologies Act, included a ban on creating embryos for
research, contrary to the recommendation of the Royal
Commission. It also did not seek to establish a national
regulatory and licensing body as recommended by the Royal
Commission. The Bill died on Order Paper in April 1997. No
further legislation has been tabled as of the writing of this
paper.
In 1994 the three research councils responsible for funding
research in the medical, natural and social sciences began work
on a joint policy on human experimentation. The Medical Research
Council (MRC),49 National
Sciences and Engineering Research Council (NSERC) and the Social
Sciences and Humanities Research Council (SSHRC) formed a
working group that issued three working papers for public and
academic discussion in 1994, 1996 and 1997. The Councils issued
the Tri-Council Policy Statement: Ethical Conduct for
Research Involving Humans in September 1998.50 The Tri-Council Statement
is mandatory only for those individuals and institutions
applying for or receiving funding from any of the government
councils. When the controversy of the independence of
researchers at the Hospital for Sick Children in Toronto
erupted, the MRC indicated that it would try and expand the
policy statement to all research involving humans regardless of
funding source.51 To date
this expansion has not been effected. While this expansion may
not be possible under the current articulation of the
Tri-Council Statement, it is important to note that
there is clearly some desire to ensure that all researchers are
explicitly bound by the standards articulated therein. Like the
voluntary moratorium, the Tri-Council Statement is not
binding on and therefore, has no legal force per se on privately
funded researchers. It may, however, have persuasive or moral
force in that it articulates accepted standards for ethical
practice. Nonetheless, in the absence of a uniformly enforceable
standard of conduct for both private and public researchers, the
legal situation in Canada is somewhat similar to that in the
United States: existing standards relate to public funding
guidelines and the private sector acts without significant
regulation or voluntarily conforms to the public funding
guidelines and moratorium.
The following articles in the Tri-Council Statement
would apply to ES cell research:
-
Embryos may not be created for research purposes (Art. 9.4)
This article would seem to limit the ability of Canadian
researchers to investigate the mechanisms of ES cell formation
and cell differentiation, as the only source of embryos for
research would be surplus embryos from IVF donation. It does
not, however, inhibit the derivation of stem cells from embryos.
-
Surplus embryos created for fertility treatments may be used
in research if the gamete donors give free and informed
consent to the use of the embryos in research (Art. 9.4)
-
Research involving human embryos must take place during the
first 14 days after their formation (Art. 9.4(d))
-
Mixing of human gametes and other animal gametes is not
permitted (Art. 9.3)
-
REB review is required for research involving human tissue,
human embryos or foetuses. (Art. 1.1(b))
The following articles are ambiguous with respect to primordial
stem cell research:
-
Research is acceptable only if it does not involve the
genetic alteration of human gametes or embryos (Art. 9.4(b))
This article would seem on its face to result in the denial of
funding for ES cell research involving SCNT that might
eventually lead to autologous transfer of tissues.
-
It is not ethically acceptable to undertake research that
involves cloning human beings by any means including somatic
cell nuclear transfer (Art. 9.5)
It is unclear whether the wording of this article would, on its
own, restrict the creation of embryos by SCNT for therapeutic
research.
Additionally, articles 9.1, 9.4 and 10.2 provide information on
the informed consent process when using human gametes, embryos
and other tissues. The information that must be communicated to
prospective tissue donors includes the purposes of the research,
any identifiers that might link the donor to the tissue used in
research, potential commercial uses of the tissue, and
implications for donor privacy.
EG cell research
Policies that address the use of foetal tissue for therapy
indicate consensus exists that the guiding principles in this
regulation should be respect for the woman’s dignity and
integrity, and respect for human life. The limitations on
research involving foetal tissue in the Tri-Council
Statement include the same limitations articulated above in
the United States regulation52 including the need to obtain free
and informed consent to use the tissue, the need not to
interfere with the woman’s decision to continue or
terminate her pregnancy, the prohibition against directed
donation, and REB approval.53
In addition, the Royal Commission advocated the establishment of
a regulatory and licensing scheme to ensure that research
projects using foetal tissue meet applicable ethical and
scientific research standards.54 Finally, the Commission also
stated that regulations be enacted to avoid the
commercialization of foetal tissue. The Canadian Royal
Commission states that the non-commercialisation of reproduction
is one of their guiding principles. They recommended that no
for-profit trade be permitted in foetal tissue and recommend
that the “prohibition on commercial exchange of foetuses
and foetal tissue extend to tissues imported from other
countries.”55 Whether
similar restrictions should apply to ES and EG cell lines is
unclear.56
-
How might Canadian Policy address
Primordial Stem Cell Research?
The Canadian government has three broad choices for policy
development with respect to primordial stem cell research:
-
Stay with the status quo
One option open to the Canadian government is to make no
changes to the current regulatory structure. This option
would leave the voluntary moratorium and the Tri-Council
Statement as the primary regulatory guidelines within
which stem cell research would be addressed. It is the
opinion of this author that, as currently drafted, this
regulatory structure is not sufficient to deal with the
advent of stem cell research. The conclusions of the Expert
Panel from the United Kingdom articulate why stem cell
research needs to be specifically addressed in regulation.57 In addition, there is
little question that currently unanticipated uses of stem
cells will be developed in the future; leaving the current
framework in place to deal with future scientific
developments in this field could impede socially beneficial
scientific research and will likely create or exacerbate
division between public and private funding in Canadian
embryo research for several reasons:
-
There are ambiguities in the Tri-Council Statement when
applied to primordial stem cell research.58
-
Current restrictions on the creation of embryos would
apply to stem cell research. This limit to scientific
experimentation would take place without the benefit of
public or scientific dialogue balancing the medical
benefits of this research, in particular the promise of
autologous transplantation, with the moral costs
associated with the creation of embryos for research
purposes. Such dialogue is necessary as these concerns
are multi-faceted and public discourse indicates that
opinions about the balancing of these issues are in a
state of flux.
-
No specific guidelines exist with respect to the
importation of stem cells from other countries.
-
No discussion of patenting issues with respect to stem
cell lines or created embryos exists in this context.
Restrictions on commercialisation of reproductive
tissue may or may not be applicable to products of
reproductive tissue.
-
Given the financial potential of therapies developed
from stem cell research and the influx of biotechnology
funding into Canada from multi-national corporations,
it is likely that differences between privately and
publicly funded research will be created or exacerbated
if privately funded researchers are not explicitly
subject to the same standards as publicly
funded-researchers. The situation in the United States,
in which prohibitions in the public sphere serve as an
expedient political response to controversial moral
issues, while private research continues without
similar guidelines should be avoided, especially where
considerable moral consensus exists.
-
No mechanism exists for tracking the progress of stem
cell protocols to determine if the potential benefit
promised is being delivered, if guidelines are being
followed or whether different research models are
warranted.
Another policy option related to the “Status
Quo” option exists. It may be possible to expand,
amend, and revise the current standards articulated by the
voluntary moratorium and the Tri-Council
Statement in order to clarify the ambiguities and
overcome the difficulties noted above. The challenge for
this option, however, is whether such an amendment process
would adequately resolve these conflicts, provide the
necessary clarity with respect to primordial stem cell
research and yet maintain the integrity of the underlying
documents. Nonetheless, with the influx of international
biotechnology capital into Canada it will become
increasingly important that privately funded researchers
are held to enforceable legal standards of conduct in the
future.
-
Enact specific legislation with respect to stem cell
oversight and guidance
While this option has the benefit of addressing specific
issues not currently addressed in the voluntary moratorium
and the Tri-Council Statement it has significant
drawbacks as a method of creating science policy. Ad
hoc legislation in the field of ART leads to
inconsistencies in policy, does not make clear the ethical
commitments a society has in developing science policy,
and is reactive in nature rather that proactive. This
latter quality leads to an inability to create flexible
and consistent policy, which addresses like cases alike
and anticipates scientific developments within the
field.59
-
Enact a broad scheme of regulation which addresses ARTs,
including embryo research, and within that framework
address the scientific, ethical and social issues raised
by primordial stem cell research
This option is the preferred option, although it generally
requires both a longer process and broader vision than
either of the preceding options. This was the
recommendation of the Royal Commission. In the area of
embryo research, national and local regulation has several
advantages over guidelines that apply only to those
institutions receiving federal money. Leaving oversight of
protocols to local REBs does not promote consistency, nor
do most REBs have the time or expertise to create ethical
and scientific guidelines for this research. National
regulation in an area of moral controversy requires that
the ethical commitments implicit in the decision to
permit, restrict or prohibit certain research are explicit
and are uniformly applicable.60 Such transparency and
consistency should be the goal of ART legislation,
including regulation of primordial stem cell research. If
a practice is morally suspect or incurs such moral costs
that it should be prohibited, then there is little reason
to permit such a practice in the private but not the
public spheres. A system like the British system, which
requires researchers to be licensed and research to be
approved, ensures that a society’s ethical
commitments are being respected uniformly.
A regulatory scheme rather than one based on the criminal
law permits greater flexibility and discussion. For
example, where subcommittees are responsible for
overseeing various scientific research protocols in a
given area of research, those subcommittees will develop
specific expertise and can be entrusted with discretionary
authority. Mechanisms for tracking research protocols,
ensuring that the creation of embryos or use of stem cells
is necessary can be part of the mandate of the responsible
authority. In addition, a regulatory scheme can be created
which enables research aimed at new ends or of a different
type to be added through amendment to regulations, rather
than introducing new legislation or repealing overly
restrictive legislation.
In this respect the Royal Commission remains the single
greatest source of policy guidance with respect to
drafting thorough, thoughtful ART policy. Clearly the
Commission’s recommendations would have to be
updated to accommodate scientific developments in
primordial stem cell research. Guidance is clearly also
available in examining the approach taken in the United
Kingdom. For example, the Warnock report adopted
the following recommendation strategy:
-
Frame recommendations in general terms, leaving matters
of detail to be worked out by government;
-
Indicate what should be matters of good practice;
-
Indicate what recommendations, if accepted, would
require legislation, and
-
Any proposed changes apply equally through the UK.61
With respect to embryo research and stem cell derivation
and use, guidance on framing the issues involved can be
found by examining the commonalities in guiding principles
and recommendations strategies outlined by other
countries. In making decisions about using embryos in
research or ART, most national commissions adopted a
long-term vision. This means that recommendations should
be drafted in general terms and allow for flexibility and
adaptability in the face of future developments.
-
Conclusion
Although the responses of the various groups and regions
examined are diverse, one can discern a few points of emerging
consensus. It seems clear that the question of ethical
acceptability of EG cell research is less controversial than ES
cell research. It is also apparent that the question of the
acceptability of ES cell research is intimately bound up with
the issue of embryo research. In general, where embryo research
is permitted for some purposes, the use of spare embryos for ES
cell research is deemed appropriate. There is little agreement
on the acceptability of creating embryos for research and
relatively little support for the creation of embryos using SCNT
at this time. Most countries express both a desire to create
policy that specifically addresses primordial stem cell
research, and a desire to regulate that research in a careful
and on-going fashion so as to gage the research outcomes.
Concerns about informed consent, the health and safety of women
and confidentiality are also integral to creating stem cell
policy.
The Canadian government is faced with an opportunity to build
upon the thoughtful work of both the Royal Commission and the
three research councils in responding to the advent of
primordial stem cell research. Should the government decide to
create policy in this area, there is significant wisdom in
analyzing the response of countries with similar cultural
backgrounds and legal traditions. It is to be hoped that there
will be a thoughtful and balanced response from the Canadian
government that respects the principals articulated in the Royal
Commission, including respect for human life and dignity and
respect for women.
-
Numbers in brackets refer to page in document where event is
discussed.
Noteworthy Events shaping Primordial
Stem Cell Policy in The United States:
-
November 1998
-
Announcements of ES and EG cell breakthroughs (2)
-
NBAC charged by President Clinton to study and report
on ethical issues and policy directions in stem cell
research (5,6)
-
January 1999
-
NIH director issues moratorium on NIH-funded research
using pluripotent stem cells pending examination of the
law (5)
-
NIH legal opinion issued (5)
-
September 1999
-
NBAC report published endorsing partial lifting of
embryo research ban (6-8) December 1999
-
NIH draft guidelines published (public comment period
follows) (8) August 2000
-
NIH final guidelines published, January 1999 moratorium
lifted (8-12)
Noteworthy Events shaping Primordial Stem
Cell Policy in The United Kingdom
-
November 1998
-
Announcements of ES and EG cell breakthroughs (2)
-
Decembre 1998
-
HFEA/HGAC publishes recommendations for expanding
embryo research to include research aims of primordial
stem cell research (13-14)
-
July 1999
-
Expert Group struck to study need for, benefits and
risks of therapeutic cloning (14)
-
April 2000
-
Nuffield Council report endorses HFEA/HGAC
recommendations (14)
-
May 2000
-
Expert Panel (Donaldson) Report submitted to British
government (14-15)
-
August 2000
-
Government response endorsing recommendations published
(16)
-
December 2000
-
Parliamentary free vote passes regulations by a large
majority (16)
-
1 See the European Group on
Ethics in Science and New Technologies to the European Commission
(EGE) Opinion No. 15 Ethical Aspects of Human Stem Cell
Research and Use, 14 November, 2000. Hass J. 1999, “A
little biological insurance.” The Globe and Mail, 11
May, A19.
-
2 2000, “Breakthrough in stem cells set to fuel
row over embryo research.” Agence France Presse, 19
September.
-
3 It is not within the scope of this paper to examine
all these sources of regulation, however several Canadian
regulatory structures are examined below.
-
4 See L. P. Knowles, “International Perspectives
on Human Embryo and Foetal Tissue Regulation” in National
Bioethics Advisory Commission Ethical Issues in Human Stem Cell
Research, Vol 2 Commissioned Papers.
-
5 James A. Thomson and his colleagues at the University
of Wisconsin made the announcement of the isolation of ES cells.
Thomson’s team isolated ES cells from “spare
embryos”; that is, embryos created in a fertility clinic by
IVF (in vitro fertilization) that are no longer needed for transfer
to a woman.
-
6 John Gearhart and his colleagues at Johns Hopkins
University announced the isolation of EG cells. Gearhart’s
team isolated EG cells from immature aborted foetuses.
-
7 L. P. Knowles & E. Parens, The Science and
Ethics of Embryonic Stem Cell Research, Encyclopedia
Britannica: Book of the Year, 1999.
-
8 2000, Ibid. Note however, that the NBAC
report indicates, “ES cells are not indefinitely stable in
culture. As these cells are gown, irreversible changes occur in
their genetic makeup.” National Bioethics Advisory Commission
Ethical Issues in Human Stem Cell Research, Executive
Summary at 5.
-
9 2000, “Everything you ever wanted to know about
stem cells.” New Scientist, 19 August, 14-15.
-
10 See European Commission, European Group on Ethics in
Science and New Technologies, Opinion No 12, Ethical Aspects of
Research Involving the Use of Human Embryo in the Context of the
5th Framework Programme, 23 November 1998.
-
11 L.P. Knowles, “Primordial Stem Cell Regulation:
Implications of Assisted Reproductive Technology Policies Among
Nations” Journal of Women’s Health and Law
1999, p.19-51. See infra information on the United States
and the United Kingdom.
-
12 See Proceed with Care: The Final Report of the
Royal Commission on New Reproductive Technologies, Vol. 1,
Minister of Government Services Canada, 1993, p. 632. (Proceed
with Care).
-
13 In the United States see DHHS Regulations for the
Protections of Human Subjects, 45 CFR 46 §46.210, and NIH
Reauthorization Act (1993) Ss. 111, 112 amending Public Health
Service Act, 42 USC 289 et seq. For international regulations
see for example: United Kingdom, Committee to Review the Guidance
on the Research Uses of Foetuses and Foetal Material.
Report (The Polkinghorne Report) London: HMSO, 1989
[hereinafter Polkinghorne Report]; World Medical
Association, Foetal Tissue Transplantation Statement,
1989, Canada, Tri-Council Policy Statement, at 9.4 and
Proceed with Care, Vol 2 at 967-1015; Australia, National
Health and Medical Research Council Statement on Human
Experimentation and Supplementary Notes, 1992, Supplementary Note 5
- The Human Foetus and the Use of Human Foetal Material; France,
Opinion No. 53.
-
14 DHHS Regulations for the Protections of Human
Subjects, 45 CFR 46 §46.210, and NIH Reauthorization
Act (1993) Ss. 111, 112 amending Public Health Service Act, 42
USC 289 et seq. September.
-
15 National Bioethics Advisory Commission Ethical
Issues in Human Stem Cell Research, Executive Summary at 4,
NIH Guidelines, Part IIB.
-
16 See infra.
-
17 Departments of Labor, Health and Human Services,
and Education, and Related Agencies in the Omnibus Consolidated and
Emergency Supplemental Appropriations Act, Fiscal Year 1999,
Public Law 105-277, S.511.
-
18 This appeal was spurred in part by news that bovine
eggs had been fused with human DNA to create embryos as a source
for stem cells. Wade, N. 1998, “Researchers Claim Embryonic
Cell Mix of Human and Cow.” New York Times 12
November, A-1.
-
19 1999 “Embryonic stem-cell research exempt from
ban, NIH is told.” 397 Nature, 21 January, 185.
-
20 French National Consultative Ethics Committee for
Health and Life Sciences, Opinion No. 53, “Opinion
on the establishment of collections of human embryo cells and their
use for therapeutic or scientific purposes,” 11 March 1997.
The French Conseil d’Etat recommended that the French
bioethics legislation be amended to allow stem cell research under
strict conditions and only on surplus embryos left over from IVF.
It proposes the creation of a body, akin to the Human Fertilisation
and Embryology Authority in the United Kingdom that would approve
research protocols on a case-by-case basis.
-
21 2000, “Multi-centre team grows human nerve
cells from stem cells” 355:9212 The Lancet, April
15, 1344.
-
22 See discussion above.
-
23 See National Bioethics Advisory Commission,
Ethical Issues in Stem Cell Research, Vol. 1: Report and
Recommendations of the National Bioethics Advisory Commission,
September 1999.
-
24 Ibid. Chapter 4 at 58-59. In fact, at NBAC
meetings Commissioner Capron described enshrining the distinction
as “disingenuous.”
-
25 Ibid. at 70.
-
26 The U.S. equivalent of Canadian Research Ethics
Boards. September.
-
27 See also Smaglik, P. 2000, “Embryo stem-cell
work gets NIH go-ahead.” 406 Nature, 31 August, 925.
-
28 See above.
-
29 This restriction would clearly have to be revisited
should autologous transfer become possible.
-
30 Note that an alternative that was not adopted was to
deny access to commercial benefit not only to the tissue donors,
but also to the researchers involved in the informed consent
process.
-
31 2000 “Awkward inconsistencies of a stem-cell
rule.” 406 Nature, 31 August, 921.
-
32 See Healy, P. 2000 “When it comes to research
funds, Arlen Specter won’t take no for an answer.”
Chronicle of Higher Education 12 May.
-
33 In addition to the reports mentioned below the Royal
Society also drafted an opinion entitled Therapeutic Cloning: A
submission by the Royal Society to the Chief Medical
Officer’s Expert Group, Report of the Royal Society, (www.royalsoc.ac.uk/policy/)
-
34 Report of the Committee of Inquiry into Human
Fertilisation and Embryology, London: HMSO, 1984 (The
Warnock Report)
-
35 HGAC/HFEA Statement at para. 9.3.
-
36 HGAC/HFEA Statement at para. 5.4. The
European Society for Human Reproduction and Embryology (the ESHRE)
has issued a similar endorsement for the use of therapeutic
cloning. See “European embryology experts offer to advise on
ethics of cloning” Nature Vol 400 8 July 1999 at 103.
-
37 Stem Cell Therapy: the ethical issues (www.nuffield.org.uk/bioethics/)
(see Nature 404, 697; 2000).
- 38 1999 “Expert group to look at UK cloning law…” 400 Nature, 1 July, 4. The mandate of the panel was
to assess the anticipated benefits of new areas of research using human embryos, the risks and the alternatives and, in the light of that assessment, to advise whether these new areas of research should be
permitted.
-
39 Government Response to the Recommendations Made in
the Chief Medical Officer’s Expert Group Report: “Stem
Cell Research: Medical Progress with Responsibility”
Cloning Vol 2 No 2 2000
-
40 2000 “U.K. Stem Cell Research Expansion Gets
House of Commons Go Ahead.” The Blue Sheet December
20, 15.
-
41 2000 “UK posed to pass legislation to become
first country in world to permit some form of human cloning.”
10:16 Transplant News, August 28.
-
42 Note that this argument with respect to the
complicity of one action with another is analogous to the position
of the Catholic Church with respect to the use of medicines or
vaccines derived from the use of aborted foetal tissue. In that
case the use of the products of the research is tainted by the
abortion and would render the use complicity in the abortion,
considered by the Church to be illicit and immoral.
-
43 DFG Statement concerning the question of human
embryonic stem cells, March 1999.
-
44 2000 “German researchers seek legal backing for
stem cell work.” 404(6777) Nature, Mar 30, 424; 2000
“Germany edges toward stem-cell accord.” 405(6786)
Nature June 1, 499.
-
45 2000 “UK posed to pass legislation to become
first country in world to permit some form of human cloning.”
16:10 Transplant News, August 28.
-
46 The Netherlands bill which has been submitted to the
Lower House for consideration is described in a brief by the
Ministry of Health, Welfare and Sport, Embryos Bill: Conditions
and limitations governing the use of oocytes, spermatozoa and
embryos. That bill proposes that ES cells be cultured from
spare IVF embryos only and be used only for medical research,
education and other medicinal purposes. The bill 1344. proposes a
three-year ban on the creation of embryos for research purposes
with provision that the ban may be reconsidered and repealed.
-
47 Connor, S. 1995 “Marleau right to be cautious
on reproductive technologies.” The Toronto Star, 4
August, A25.
-
48 Ford, T. 1998 “There may be some good things
about cloning humans.” The Toronto Star, 30 July.
-
49 The Canadian Institutes of Health Research, formally
launched on June 7, 2000, replaced the MRC. See (http://www.cihr-irsc.gc.ca/e/news/7721.shtml)
-
50 Tri-Council Statement.
-
51 Weber J. 1998 “The Doctor vs. the
Drugmaker” Business Week 30 November 87-88; Talaga T. 1999
“Olivieri case sparks research rules” The Toronto
Star 28 January A8; Spurgeon D. 1998 “Canadian
whistleblower row prompts broader code of conduct.” 396
Nature 24/31 December, 715.
-
52 See above.
-
53 Arts. 9.4 C and 10.1.
-
54 See also Tri-Council Statement Art. 9D.
-
55 Proceed with Care, at 1003.
-
56 1999 “Recent patents in stem cell
research.” Nature Biotechnology 17 April, 396.
-
57 See above.
-
58 See above.
-
59 A fuller discussion of the role of law in science
policy if available in Knowles, L.P. 2000 “Science Policy and
the Law: Reproductive and Therapeutic Cloning” in Legislating
Morality: The Debate over Human Cloning, N.Y.U. J. Legis. &
Pub. Pol’y Vol 4 No 1, 13-22.
-
60 Shapiro, HT. 1999. Reflections on the interface of
bioethics, public policy, and science. Kennedy Institute of
Ethics Journal. 9(3): 209-22.
-
61 The Warnock Report, pp. 6-7.
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