Transcript Slide 1

The Assisted Human Reproduction Act
Anita Fang
Salem Abdel-Ghani
Sara Atallah
Winnie Chan
Stem Cells
Definition
Stem cells have the ability to divide and renew themselves
and differentiate into other kind(s) of cells or tissues. They
have the ability to replace died and defective cells or tissues
in patients with certain diseases or defects such as:
diabetes, Alzheimer's, multiple sclerosis, Parkinson's, and
heart disease.
Stem Cell Research in Canada
 No laws until March 2002, when CIHR announced it’s
guidelines for stem cell research.
 Federal granting agencies adopted the guidelines.
Federal Level
 No laws until March 2004.
 In March 27, 2004 the Canadian senate approved Bill C-6
which regulates the sexual and reproductive health of
Canadian citizens.
Ethical Issues in Stem Cell Research
1- Purpose of Embryo Creation
While it is ethical to create embryos for reproductive
purposes, it is immoral to create them solely for research
purposes.
2- Viability of Embryos
The argue is whether an embryo is viable or not.
It is morally preferable to use embryos that will not grow
beyond certain stage or those that will be discarded.
3-Embryo Destruction and Relief of Human pain
The purpose of human activity is to save lives, then it is
unethical to destroy embryos, because it relies on the
destruction of defenseless human being. Others believe
that this kind of research will relieve the pain, and even
though embryos are considered human, but they do not
hold the same moral relevance because they lack the
consciousness, reasoning and sentience.
4- Consent of Donors
Free and informed consent should be provided by the
person who donate the embryo.
Regulations
The Guidelines for Human Pluripotent Stem Cell
Research by CIHR
Guiding Principles
 The research should have potential health benefits.
 Donor should be provided with full information regarding
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the research and free and informed consent should be
provided by the participants.
Privacy and confidentiality of the participants should be
respected.
No payment for participants regarding collecting tissues or
any other reproductive material.
Embryos should not be created for research purposes only.
Human dignity, cultural and spiritual integrity should be
respected all through the research.
Types of research that conformed with the
Guidelines
Research that study human embryonic stem
(ES) derived from human embryos
 Should be created for reproductive purposes.
 No commercial transaction is allowed in any way.
Research that studies human stem cell from
the umbilical cord and placenta
 Free and informed consent should be provided.
Research that study human embryonic germ cell
(EG) derived from human fetal tissue or amniotic
fluid
 The pregnant women decision?
Research that studies human stem cell from
human somatic tissues
 Competent person
 Incompetent person
 Dead body
Research that studies anonymized human
embryonic stem cell
 From Canada, (accordance with the guidelines).
 Outside Canada, (laws of the country).
Research that would not conform with CIHR
Guidelines
 Create a human embryo to derive stem cells.
 Research involving cloning.
Commercial interest
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Any financial support to the stem cell research team
from commercial firms supporting their research or
other interested groups in the market supporting their
research must be disclosed to the Stem Cell Oversight
Committee.
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Contracts and other documents between researches and
industry sponsors and all other budgetary information
must be reviewed by Stem Cell Oversight Committee to
evaluate and examine any conflict of interest.
Federal Level
Acts prohibited under assisted human reproduction act:
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To create a human embryo for any other purpose than
creating a human being.
To keep a human embryo outside a female body for more
than 14 days following fertilization.
Sex selection to increase the probability of sex over the
other.
To use non human sperm, ovum or embryo and transfer it
to a human being.
To use human reproductive material or embryos that have
been previously planted in non human body.
Alteration of germ-line gene.
To pay or offer any kind of reimbursement to get
reproductive material from a donor.
Federal Act …
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Creation of a hybrid embryo for the purpose of
reproduction or transfer it to a human being or non
human life.
To purchase, advertise or offer to purchase and sell of
sperms, ova, in vitro embryo and human cells or gene.
Without a written consent from the donor, it is not
allowed to use any donated reproductive material to
create embryos.
To remove any reproductive materials from a dead body
to create embryos, unless the person gave permission
before death.
To obtain reproductive material from a person under 18
years old except for the purpose of preserving it for
future use to create a human being that will be raised by
the donor.
Influences responsible for determining this
policy outcome (Positive Analysis)
 The Assisted Human Reproduction Act (AHR Act) came
into effect after fifteen years of policy development.
 The AHR act is different to other Canadian biotechnology
policy areas. Why??
 There were several influences that have been responsible
for determining this policy outcome.
Influences responsible for determining this
policy outcome
 One of the most important influences was
the feminist-informed activism which was
calling for protecting women’s bodies and
reproductive tissues from commercialization.
 This dominant discourse influenced the
policy development most distinctly during
the years.
 The Royal Commission on New Reproductive
Technologies (RCNRT) was established in
October 1989.
Influences responsible for determining this
policy outcome
 the influence of proximal nations, the United States
and the United Kingdom.
 the majority of research in the US is funded by private
companies.
 Canadian policymakers wanted to ensure that
research in Canada must be monitored and licensed.
Influences responsible for determining this
policy outcome
 The UK is a source of inspiration to Canada in stem cell
research policy.
 In AHR policy, Canada has chosen to imitate the UK
Human Fertilization and Embryology Authority (HFEA).
because the UK was felt as a model of an early regulator in
this field.
Influences responsible for determining this
policy outcome
 Jurisdictional
considerations
provincial governments..
between
federal
and
 The
negotiations between federal and provincial
jurisdictions are one of the reasons why Canada could not
be an early regulator in this field as the UK.
 The resistance of physicians to comply with the voluntary
moratorium in the mid 1990s was a major factor in shaping
the criminalization thread of the AHR Act.
Normative Analysis
What the public wants?
 The development of policy for stem cell research is a good
example of the challenges associated with regulating an
area where there is a lot of different opinions and a lack of
social consensus.
 Social consensus is one of the primary explicit justifications
for Canada’s criminal prohibition in the AHR Act of a
variety of reproductive and therapeutic cloning techniques.
Health Canada documentation states that there is a “broad
consensus”.
Research data
 All the research available demonstrates that there is no
social consensus.
 A Canadian Ipsos-Reid (2001) poll found that of those
surveyed, 21% opposed any law that restricts research into
human cloning; 39% supported a ban on human cloning
while allowing research on cloned embryos; and only 33%
supported a complete ban on all human cloning.
 A 2002 poll found that six in ten Canadians approved of the
creation of cloned human embryos for collecting stem cells
(Ipsos Reid 2002).
The data from surveys and public consultations shows that
the public strongly oppose reproductive cloning, but there
is almost a lack of social consensus on other techniques,
such as creating embryos for research purposes and
therapeutic cloning.
Normative Analysis
The role of the government
 Policymakers should not use social consensus as a
justification for regulatory action, especially if there is a
strong evidence of lack of consensus in Canada.
 It must be explained how the choice of regulatory
instrument relates to public views.
 The social consensus should not stand as a policymaking
roadblock and criminal law should be as instrument of last
resort.
 Existing models
balanced approach
UK
Winners
Canadian Society in general
- support Canadian value ( life =
)
- health and safety
- can't create human embryos just for research purpose
 US researcher and companies
- the stability in Canadian policy
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Clinical and Lab research
Pros
- patients (winners)- treating a wide range of medical
problem
- Controlled research
- obtain license
- no reproductive and therapeutic cloning
- no half human/animal...etc
Cons
- brain drain in Canada
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Fertility Industry
Pros- over the decades, various treatments have been
developed through stem cell research
- AHR Act banning all potential commercial business around
buying/selling embryos and surrogacy
Canadian ad offers a price list:
$15,000 ~ $18,000 for carrying baby to term
$2,500~$10,000 for egg donation (“grade A & FDA approved”)
(from national post, 2009/02/13)
 Infertile patients (~15%)
 - potential winner under AHR Act but not as beneficial as it
seems
 - have option but not much choices
 - reproductive tourism
 Donors
 - loser- no incentive, no protection
 - Health Canada- in process of establishing a registry
Losers
Stem cell business
- conflict of interest
 financial interest over public concerns/trust
- not enough investment to sustain
 Genetic engineering
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Constitutional Challenge
• In June 2008, the Quebec Court of Appeal
– overlap with the provincial jurisdictions of health care
• Supreme Court of Canada
• If the challenges raised by Quebec are deemed a
success, then human assisted reproduction will solely
be under the private medical decisions of individuals
in consultations with clinicians.
Constitutional Challenge
• The Evangelical Fellowship of Canada (EFC) and the
Canadian Conference of Catholic Bishops (CCCB) are
acting jointly as interveners.
• “The research development and use of new
reproductive technologies involve national concerns
that cut across social, ethical, legal, medical, economic
and other considerations and institutions.”
Concerns
 Reproductive tourism
 80% of babies conceived in Canada through donor
sperm have American DNA
 Commercialization
 Britian is in a similar situation
Stem Cell - USA
• January 2009:
loosen guidelines in clinical trials
involving stem-cells and allow Geron Corporation in
California to inject embryonic stem cells into eight to
ten patients suffering from spinal-cord injuries, in the
hopes developing new nerve tissue.
• March 2009: Obama lifting
restrictions on federal funding
for stem cell research by Bush
International
 German : most restricted – ban all activities
 Britian – The Human Fertilization and Embryological
Authority (HFEA)
 Australia and Canada : in between
 US : no clear restrictions
Stem Cell Tourism
 China, Mexico, Britain and Israel
 cost up to tens of thousands of dollars
 prematurely and without evidence to prove safety and
effectiveness.
Conclusion
 California “Octomom”
 Moral Values & Religious Views
The Future
 end of controversies
 to ease human suffering of future generations
 missed opportunities to advances
Thank you for listening