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Stem Cell Research Policy in CanadaAnita Fang Salem Abdel-GhaniSara AtallahWinnie Chan

The Assisted Human Reproduction ActStem Cell

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 CanadaNo laws until March 2002, when CIHR announced its guidelines for stem cell research.Federal granting agencies adopted the guidelines.

Federal LevelNo 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 Research1- Purpose of Embryo CreationWhile it is ethical to create embryos for reproductive purposes, it is immoral to create them solely for research purposes.2- Viability of EmbryosThe 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 painThe 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 DonorsFree 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 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 GuidelinesResearch that study human embryonic stem (ES) derived from human embryosShould be created for reproductive purposes. No commercial transaction is allowed in any way.

Research that studies human stem cell from the umbilical cord and placentaFree 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 personIncompetent personDead 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

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.Federal LevelActs 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.

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.13Influences 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. Fundamental scientific, legal, social, and ethical uncertainties that have put pressure on policy making.Owing to its concentration on ethical and social issues. It prohibits a variety of genetic related technologies. The policy path for reproductive technologies has been a more precautionary one-in the sense of restricting what is possible in light of uncertainties and moral implications.

14Influences responsible for determining this policy outcomeOne 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.

Chief among these is the emergence of a particular feminist discourse at the outset of discussions on reproductive technologies governance. By the end of 1980s,after a prolonged lobbying effort the royal commission on new reproductive technologies was established. The commission's mandate was to investigate "current reproductive technologies" in order to consider their "social, ethical, health, research, legal and economic implications and the public interest. The commission chair Dr. Patricia Baird, a pediatrician and medical geneticist. It recommended two immediate actions be taken by Parliament like prohibiting certain practices related to the use of reproductive technologies and establishing a national regulatory.During this period of policy development, from the RCNRT to the outcome, it was clear that the feminist discourse had gained a position of political authority in this arena

15Influences responsible for determining this policy outcomethe 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.

Although the announcement of President Bush restricted federal funding to embryonic stem cell research, the majority of research in the US is funded by private companies. Therefore, Canadians realized the need to take a clear position within Canadian boarders to stop cross-boarder shopping. Cross-boarder shopping in this case refers to reproductive tourism. 16Influences responsible for determining this policy outcomeThe 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. because the UK was felt as a model of an early regulator in this field. Even though the UK was a model for Canada in regulating stem cell research, Canada established an exclusive value-based framework based on a intensive period of consultation and debate.

17Influences responsible for determining this policy outcomeJurisdictional 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.

there were continuous difficulties in getting all the provinces on board which plague the AHR Act even after it passed.

18Normative 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.The public opinion seems to be divided according to the type of research. For example, there is almost a social consensus over techniques like sperm donation and in vitro fertilization. On the other hand, there is a lack of social consensus on embryonic stem cell research.

The lack of consensus have a great influence on regulations that will be produced, especially in producing criminal prohibitions. 19Research dataAll 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).A great deal of the appropriateness of the results of public surveys and focus groups depends on how the questions are asked and the context within which they are placed. Some commentators said the results of these studies are misleading. 20The 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.

. As highlighted by these surveys, there is simply no evidence of a broad consensus.21Normative AnalysisThe role of the governmentPolicymakers 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 UKThese themes provide the oversight necessary to address issues associated with human safety, research ethics, and the commodification of human reproductive material, while not foreclosing continued public debate on the intractable moral issues8.

22WinnersCanadian Society in general- support Canadian value ( life = )- health and safety- can't create human embryos just for research purposeUS researcher and companies- the stability in Canadian policy

23There are no problems surrounding the method of research, but the main controversy lies in the source of the stem cells, which are either from the pluripotent cells in human embryos or fetus. Given this underlying value, human life is a gift which should not be bought, sold, or treated like a consumer commodity. The principle is to protect the health and safety of Canadians and their children undergoing AHR and prevent trade in the reproductive abilities of women and men.US researcher and companiesUS law for stem cell research is highly volatile and has limited federal support, depending on the politics. Although the regulations banning therapeutic cloning research, there are still significant research opportunities available for using embryos that were originally produced for reproductive purposes. Moreover, stem cells derived from adults and animals are not subject to any special regulations in Canada beyond the usual regulation for medical research. The stabilizing effect of Canadian act can give those researchers and investors comfort that their researches are less likely to get interrupted by sudden change in regulation.

Clinical and Lab researchPros- patients (winners)- treating a wide range of medical problem- Controlled research - obtain license - no reproductive and therapeutic cloning- no half human/animal...etcCons- brain drain in Canada24Beneficiary group- patients- potentially help treating a range of medical problems. Parkinsons Disease Alzheimers Disease Heart Diseases, Stroke and Diabetes Birth Defects Spinal Cord Injuries Replace or Repair Damaged Organs Reduced Risk of Transplantation

The regulation clearly states that extreme practices including cloning humans, growing human embryos for research, creating animal/human half-breeds, growing animal embryos in women, taking ova or sperm from a corpse and using it in reproduction are not allowed

Even though this regulation can prevent the scientists doing any "outrageous" activities, it will also force researchers to forgo valuable research. Some scientists will leave the jurisdiction to pursue prohibited research in a foreign country where it is not banned. This will accelerate the brain drain in Canada. Another potential pitfall of this regulation is driving the prohibited researches underground, which will result in even more harmful consequences.

Fertility IndustryPros- over the decades, various treatments have been developed through stem cell research - AHR Act banning all potential commercial business around buying/selling embryos and surrogacyCanadian 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) 25Fertility IndustryOver the decades, various treatments have been developed through stem cell research to help infertile couples improve their chances of conceivingAll appear to be breaking Canadian law, however, according to the experts that Health Canada has no way to control those underground trade and it is unlikely that any of those posting ads will face any repercussions for their seeming legal transgressions.

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 registry26Infertile patients The prevalence rate of infertility in Canada is 15%. Due to the technology and policy, it enables patients to have children, even late in women's reproductive cycle. However, in the regulation, there is no clear addressing on whether AGE should be a factor. There are a lot of health-related concerns involved. For women who want to become pregnant but unable to do so in Canada due to its policy, have been traveling to offshore locations a blooming business that is called as reproductive tourism. The trend is so significant that AHR Canada held a conference on cross border reproductive care in Ottawa, January 2009

DonorsAnother issue is that Canada facing a significant shortage of donating eggs and sperms. From CTV news, Canada only has 33 sperm donors in a population of 30 million and 80% of Canadian women who conceived through the donors are getting the sperm from US. It is not as easy as donating blood. Without any incentive, people are not willing to donate. With very limited donors making dozens or even hundreds of donations, the number of offspring from the same donor can number into hundreds of people. In the regulation, the donor's info is not mandated. Currently, there is an urgent need to create a registry listing all the family and medical information for the people who conceived through this technology.

LosersStem cell business- conflict of interestfinancial interest over public concerns/trust- not enough investment to sustain Genetic engineering

27Conflict of interestfinancial interest would affect the way researchers conduct their experiments, there is a potential that scientists fail to take the public concerns seriously. A violation of the public's trust is foreseeable. And when such a violation occurs, governmental support in term of grant money and infrastructure for Canadian stem cell research may quickly vanish.

Corporate influence on research agendawith all well-intended policy on banning commercializing reproductive ability, it doesn't regulate what should be allowed but leave the direction of the stem cell research to the hands of corporations. However, due to the political controversy, venture capitalists have not provided enough investment to sustain the stem cell companies in BC. Genetic Engineeringit is a safety protection for Canadian in general. However, some medical researchers argue cloning or genetic alteration is needed for prevention and better understanding of treating abnormal human development. By banning the genetic alternation research, this branch is a loser under the policy.

Regulatory Reforms

Constitutional ChallengeIn 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.

In mid 2008, Quebec challenged the AHR Act and the case was brought up to the Supreme Court of Canada.

Basically, Quebecs argued that the AHR regulations overlaps with the provincial jurisdictions of health care.

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.

The result of this case will not only decide the fate of legislative power in reproductive technologies, but ultimately the genetics of future generations.

29Constitutional ChallengeThe 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. Acting as interveners for the case, the bishops believe that the research development and use of reproductive technologies affects the country too much and should remain in federal control.

They are in fear that it will be very difficult to protect and maintain current limits established to control inappropriate usage of reproductive materials with no federal power over reproductive technologies.

Such as human-animal chimeras30

ConcernsReproductive tourism80% of babies conceived in Canada through donor sperm have American DNACommercializationBritian is in a similar situation

However, with the current tight restrictions, there are concerns where everyone will travel abroad for sperms, eggs or embryos. Currently, it is estimated that 80% of babies conceived in Canada through donor sperm have American DNA. In the US, some donors are paid $100 USD per visit.

On the other hand, with more flexibility, there could be problems such as the commercialization of reproductive materials.

Britian is in a similar situation as in Canada and they are in the process of revising their regulatory approaches in donor payment restrictions.32Stem Cell - USAJanuary 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 fundingfor stem cell research by Bush

In 2009. the US had started to loosen up regulations in stem cells research.

First in January, guidelines were loosen and certain clinical trials were permitted.

Later in March, Obama announced the life on federal funding restrictions formerly established by George Bush.33InternationalGerman : most restricted ban all activitiesBritian The Human Fertilization and Embryological Authority (HFEA) Australia and Canada : in betweenUS : no clear restrictions

To compare Canadas policy with other countries,

German uses a restrictive approach where all activities involving gametes or embryos research are banned.

In Britian, there is some flexibility and there is a regulatory body named The Human Fertilization and Embryological Authority (HFEA) in British to analyse on a per case basis.

Australia and Canada policies are in the between the restrictive and flexible approach where a number of activities revolving around reproductive technologies are restricted but policy leaders are still in the process of determining better approaches.

In the US, there are no clear restrictions.34Stem Cell TourismChina, Mexico, Britain and Israelcost up to tens of thousands of dollarsprematurely and without evidence to prove safety and effectiveness.

US and most countries worldwide do not seem to have clear restrictions on the conduct of reproductive technologies. Counties including China, Mexico, Britian and Israel are known to have fewer limitations and have become the destinations for stem cell tourisms where patients travel abroad to accept stem cell therapies.

Such therapies are very expensive and may cost up to tens of thousands of dollars but when in need, patients are willing to pay what is required to improve health conditions.

However, serious concerns had been raised where stem cell based therapies in these countries were sometimes offered prematurely and without evidence to prove safety and effectiveness. 35ConclusionCalifornia OctomomMoral Values & Religious Views

It is understandable why the public had raised further concerns about the moral acceptability of reproductive technologies after the incident of the California Octomom who implanted frozen embryos and gave birth to octuplets.

Many people emphasize the importance of moral values and religious views.36

The Futureend of controversiesto ease human suffering of future generationsmissed opportunities to advances

Even reforms made to the current Canadian regulatory system of the AHR will not mean it will be an end of controversy in stem cells and reproductive technologies in Canada.

However, as the Canadian government fail to make these investments in promoting scientific technologies, there will be missed opportunities to advances in the curing of threatening diseases and compromise the health conditions of future generations.

37Thank you for listening