Stem Cell Research Policy in Canada

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Stem Cell Research Policy in Canada
The Assisted Human Reproduction Act

• Anita Fang
• Salem Abdel-Ghani
• Sara Atallah
• Winnie Chan

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Stem CellStem 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.

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Stem Cell Research in Canada

• No laws until March 2002, when CIHR announced
  its 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.

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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.

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• 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.

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Regulations

• The Guidelines for Human Pluripotent Stem Cell
  Research by CIHR

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• Guiding Principles
• The research should have potential health
  benefits.
• Donor should be provided with full information
  regarding 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.

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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.

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• 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

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• 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.

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Commercial interest

• 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.
• 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.

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Federal Level

• Acts prohibited under assisted human reproduction
  act
• 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.

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Federal Act

• 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.

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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.

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Influences responsible for determining this
policy outcome

• One of the most important influences was the
  feminist-informed activism which was calling for
  protecting womens 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.

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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.

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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.

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Influences responsible for determining this
policy outcome

• Jurisdictional considerations between federal and
  provincial governments..
• 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.

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Normative AnalysisWhat 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 Canadas 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.

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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).

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• 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.

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Normative AnalysisThe 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

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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
• 2,50010,000 for egg donation (grade A FDA
  approved)
• (from national post, 2009/02/13)

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• 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

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Losers

• Stem cell business
• - conflict of interest
• financial interest over public concerns/trust
• - not enough investment to sustain
• Genetic engineering

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Regulatory Reforms
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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.

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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.

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(No Transcript)
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Concerns

• Reproductive tourism
• 80 of babies conceived in Canada through donor
  sperm have American DNA
• Commercialization
• Britian is in a similar situation

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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

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International

• German most restricted ban all activities
• Britian The Human Fertilization and
  Embryological Authority (HFEA)
• Australia and Canada in between
• US no clear restrictions

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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.

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Conclusion

• California Octomom
• Moral Values Religious Views

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The Future

• end of controversies
• to ease human suffering of future generations
• missed opportunities to advances

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• Thank you for listening