Stem Cell Research Policy in Canada

1. Stem Cell Research Policyin Canada The Assisted Human Reproduction Act Anita Fang Salem Abdel-Ghani Sara Atallah Winnie Chan

2. 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.

3. Stem Cell Research in Canada • No laws until March 2002, when CIHR announced it’s guidelines for stem cell research. • Federal granting agencies adopted theguidelines. 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.

4. 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.

5. 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.

6. Regulations The Guidelines for Human Pluripotent Stem Cell Research by CIHR

7. 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.

8. 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.

9. 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

10. 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.

11. 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.

12. 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.

13. 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.

14. 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.

15. 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.

16. 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.

17. 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.

18. 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.

19. 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 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”.

20. 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).

21. 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.

22. 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

23. 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

24. 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

25. 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)

26. 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

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

28. Regulatory Reforms

29. 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.

30. 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.”

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

33. 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

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

35. 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.

36. Conclusion • California “Octomom” • Moral Values & Religious Views

37. The Future • end of controversies • to ease human suffering of future generations • missed opportunities to advances

38. Thank you for listening