Chapter 5: Genetic and Reproductive Control
This is the first of two chapters on new and emerging technologies. This chapter will be an examination of stem cell research, issues surrounding genetic testing and gene therapy, and issues that attach to assisted reproductive technologies. The nature of the knot that ties these issues together in the realm of bioethics cannot be easily described, but it has less to do with the common themes of embryos and future lives. Rather, the commonality has, perhaps, more to do with the enormity of the decisions, the multitude of implications, and the complexity of the questions that arise when we put these technologies to use. The underlying shared theme may not simply be in the actual substrate of cells and genes that is common to these fields, but in the recognition that in all of them, researchers and societies will often find themselves asking: “Is this really something we ought to be doing?” The state of these technologies in Canada and the Canadian bioethics perspective on these questions will be examined.
A discussion of stem cells and stem cell research will set the stage. Stem cell research is carefully regulated in Canada. The concept and the issues will be briefly introduced, and then a discussion of the relevant regulations and oversight will follow as an examination of how Canadians address the issues involved. Genetic testing, and the implications of such testing, will be examined next. A discussion of regulation and oversight will be the thrust of the topic, but with special emphasis on the notion of genetic non-discrimination. The chequered past of eugenics and gene therapy will be an introduction to the responsible use of gene therapy in the future. There are no current gene therapies in commercial use in the world, but legislation, regulation and sound policy must, nevertheless, be in place for such things. Canada’s role in anticipation of the arrival of technologies pertaining to gene therapy will be discussed, and managing the issue of enhancement technologies will be introduced. Finally, a lengthy discussion of assisted reproductive technologies will be had. An introduction to the stakeholders and the issues will be followed by the Canadian response to these issues through measures such as the Assisted Human Reproduction Act. Finally, related issues, such as pre-implantation genetic diagnosis and access to reproductive technologies, will be examined.
STEM CELL RESEARCH AND CLONING
Few technologies have animated scientists, ethicists, politicians, and the general public like the breakthroughs in isolating and studying stem cells which occurred in 1998. It is a field of research that has enormous potential for improving human health, but at the same time, enormous potential for trespass into morally unsavoury behaviour. Researchers walk a fine line; one misstep will find them in ill odour with the law, with religious authority, or with the public; institutions that stray from tightly regulated protocol risk grave financial and legal repercussions and the moral outrage of the public. And yet, none of this has halted the march of progress in this technological realm—the stakes are too high to abandon, the benefits too many. Stem cells have been looked to for curing or aiding diseases such as Diabetes, Parkinson’s Disease, and Alzheimer’s Disease; there is hope that they can be the key to the repair of worn or damaged tissues (even tissues that were previously thought to have no or little regenerative capacity like cardiac and neural tissue); and the most optimistic of researchers even see a future wherein stem cells provide the necessary substrate for “made to order” organs for transplant. Governments ignore this emerging technology at their peril, for being “left out of the club” means missing potential benefits for their people, losing research funding for their academic institutions, and missing an opportunity to contribute to the ethical debates and shape responsible public policy.
Putting aside the contentious and evolving ethical debates and issues, stem cell research in Canada is a fairly straightforward and rather simple topic; in Canada, there are clear guidelines, there is productive research, and Canada finds itself in a fairly non-controversial, neutral position in the global community. This discourse is largely about the straightforward aspects of human stem cell research in Canada, but no treatment of this subject could be had without the briefest of introductions to the topic, the terminology, the issues and controversies. While the weightier issues and full explication of the moral dilemmas will be left to the bulkier bioethics texts and papers, this discussion will touch on these only to establish the geography of the issue, and in order to give meaning to, and enhance understanding of, the role Canada plays in this realm.
As noted, an understanding of the terminology of stem cell research is essential to understanding and making sound policy judgements and formulating a robust normative ethics. For the purposes of this paper, human embryonic stem cells (hESC) and adult stem cells will be distinguished largely by virtue of where they are derived (from embryos and differentiated somatic cells respectively), but also with recognition of the fact that embryonic stem cells are pluripotent (capable of developing into almost any tissue) and adult stem cells are multipotent (capable of developing into many types of related tissue). A flurry of research is now being done to regress multipotent adult stem cells into pluripotent stem cells, yet just what to call such cells (embryonic or adult) is still debatable. Cloning is another poorly understood term; it essentially means copying and can be applied to the cloning of genes (recombinant DNA technology), the cloning of cell lines (such as those used in tissue culture research), the cloning of stem cells, or the cloning of whole organisms. It is the latter two that cause the stir, the former two have been used in research and for therapeutic purposes for many years. But one must also delineate another dichotomy in the nomenclature, therapeutic cloning involves stem cell cloning for therapeutic reasons (tissue regeneration or organ formation for instance) whereas reproductive cloning refers to reproducing organisms. Again, it is the latter that is largely controversial, or uniformly condemned, in the case of human cloning. The term embryo can also be difficult to define, for although we describe the process of sperm meeting egg (either in the lab, in vitro; or in the body, in vivo) as fertilization, just what do we call the transfer of somatic cell DNA into an ovum that has its nucleus removed (so called somatic cell nuclear transfer or SCNT)? It is something akin to an embryo because it has all the potential, but it did not arrive at that position through fertilization. Most researchers still call this an embryo, but the creation of these entities is quite controversial.1
Terminology along the timeline of development of an embryo is also important, and temporal concerns must be considered. In many places research is allowed on embryos up until 14 days of development. It is at this point that the embryo can no longer divide to form another human (usually such splitting, and the formation of a pair of twins, occurs much earlier). More importantly, it is also at this time that the embryo starts to develop distinguishing features such as an orientation (head, tail, right and left) and the beginning of specialization of certain tissues, most notably the “primitive streak” which will develop into the nervous system. Moving on in time, an embryo is an embryo until approximately 10 weeks of development at which time it is generally considered a fetus.
Keeping to the facts, the taxonomy of the ethical issues runs along these lines: questions about personhood and the moral status of embryos (are the embryos destroyed in hESC research persons?), questions about the morality of cloning (human dignity and identity issues), safety of cloning (will the resultant cloned organisms be healthy or defective?), where to derive the stock material for hESC research (from discarded IVF embryos or from stem cell lines that already exist?) and similarly whether or not it is ethical to produce embryos specifically for research (paying for the creation of embryos or paying for discarded embryos?), and finally the melding of species’ DNA using stem cell technology (creating “chimeras”). This is an incomplete list. None of these questions will be definitively answered, but the Canadian position on these issues will be exposed and discussed relevant to the Canada’s place in the global village.
In the global arena, policy and the politics of human stem cell research is as diverse as the nations themselves. Regulations and oversight run from the more permissive (for example the UK) to the middle ground (where Canada is located) to the truly restrictive (for example Germany).2 There are many nations in the less developed world that do no stem cell research. And then there is the United States that has a very unique and unusual position; and one that is actively changing as of this writing. The status of stem cell research on the world scene is also quite fluid, but generally speaking, the vast majority of the world permits hESC research and most countries are considered “permissive” or place only moderate restrictions on conducting such work.3 An example of one such permissive country is the UK, which allows somatic cell nuclear transfer into enucleated (where the nucleus of the cell has been removed) ova—again some would consider this the first step toward cloning.1, 2, 4 Under the tightest of regulations, UK researchers could even be allowed to create human-nonhuman chimeras for research purposes (but never to be allowed to develop beyond the embryo stage). The UK hESC research is overseen by the Human Embryology and Fertilisation Authority and regulated by the UK Human Fertilisation and Embryology Act of 2008.5 On the other end of the spectrum, a restrictive country such as Germany, until recently, banned all stem cell research and stipulated that even working abroad on hESC research was a criminal offence.4
The American situation deserves special note not simply because American and Canadian culture are tightly interwoven (geopolitically, socially and economically), but because the US has an unusual stance on hESC research. It was American researchers that first found ways to isolate and study embryonic stem cells in 1998,1 and yet, there has been a “love hate relationship” with them ever since. The Bush administration banned federal funding on hESC research in 20016, but privately funded stem cell research has thrived in California and states along the eastern seaboard. Each state has its own legislation. The moratorium on funding has meant that researchers in the publicly funded arena have had to make do with stem cells and stem cell lines in existence at the time of the moratorium. Reproducing hESC’s from the same lines (i.e. research cloning), is not specifically outlawed in the US, whereas there are such laws prohibiting this in many other nations. Also of note is that US researchers do allow for the insertion of hESC’s into non-humans (chimera creation) to study tumour formation etc., yet this is a practice explicitly banned in many other nations including Canada. US President Obama has taken bold steps toward striking down the ban on public funding for hESC research in the US. In March 2009 he signed an executive order to permit public funding of hESC research, with first preliminary and then final comprehensive National Institutes of Health (NIH) guidelines to oversee stem cell research put in place by the summer of 2009.6-8 In Canada this has been met with some ambivalence as these initiatives threaten to knock Canada from its leadership role in hESC research in North America.9 Americans and Canadians both want their countries to be leaders in stem cell research but, while in Canada it is another biotech field, it is becoming the “poster child” of biotech in the US.10 Americans differ significantly with the Canadian public on the issue of embryo use in hESC research, with Americans less likely to endorse use of discarded embryos and more strongly opposed to the creation of embryos for research purposes.10
Canada has a rich history in stem cell research. It was Canadian researchers Ernest McCulloch and James Till, during 1961-1963, that first proved the existence of stem cells and published their findings internationally.11, 12 They were later named the “fathers” of stem cell research. This set the stage for a string of collaborative and individual Canadian successes in stem cell research which continues to this day. In April 2009 Canadian researchers were once again in the spotlight with news of an innovative way to induce pluripotent stem cell production from somatic cells.13 This technology holds the promise of dispensing with the need for embryos in stem cell research altogether (thereby simultaneously dispatching the attendant moral problems), and research teams around the world are in a race to perfect it. The University of Ottawa is the home of an internationally renowned centre for excellence in this research, the “Stem Cell Network”, which funds research in other institutions and acts as a catalyst to gaining funding and enabling research initiatives.14 Canadians have been strong endorsers of stem cell research and 75% of respondents in a nationwide poll in 2006 felt that stem cell research holds great promise to improve their lives in the next 20 years.15
With the allure and promise of cures for horrible degenerative diseases, cures for cancer, and the possibility of unlimited organ supplies, science has advanced at a tremendous pace and was largely unregulated until the new millennium. Up until 2002 there were no strict regulations nor was there oversight on Canadian hESC research. The last several years has seen several checks and balances placed, and this has been accomplished largely without the legislative acrimony and heated public debate the US has endured. In Canada, hESC research is regulated by guidelines derived by the Canadian Institutes of Health Research (CIHR),16, 17 and an independent Stem Cell Oversight Committee (SCOC)18 which oversees research initiatives to ensure that they adhere to the CIHR guidelines. In addition, all research protocols receiving funding from one of Canada’s main funding bodies and involving humans must adhere to the Tri-Council Policy Statement 2nd Edition (TCPS2)19 which guides researchers and Research Ethics Boards (REBs) in the formulation of ethically sound and justified protocols. The TCPS2 has been amended to reflect the values and regulations laid out by the CIHR. Legal regulations regarding the creation of embryos is stipulated in the Act Respecting Assisted Human Reproduction and Related Research, known as the Assisted Human Reproduction Act (AHRA) which became law in March 2004,20 but this law does not pertain to embryonic stem cell lines created prior to the act. The aim of these documents is clear regulation and oversight as well as resolution of ethical issues in a manner that reflects the sentiments and the core values of Canadians.
The CIHR was created in 2000 as the federal funding agency for health research and is (as one of the main controllers of the purse strings) often the agency called upon to weigh in on new or controversial research. The CIHR began work on stem cell questions in 2001 and after extensive scholarly and public input created a report from its working group that was adopted as policy in 2002 for the guidance of stem cell research.17 This document was considered to be both an interpretation of, and an extension of, the TCPS (then in the earlier first edition21), and as such the core principles and values were and are:
- Research undertaken should have potential health benefits for Canadians;
- Free and informed consent, provided voluntarily and with full disclosure of all information relevant to the consent;
- Respect for privacy and confidentiality;
- No direct or indirect payment for tissues collected for stem cell research and no financial incentives;
- No creation of embryos for research purposes;
- Respect individual and community notions of human dignity and physical, spiritual and cultural integrity16
In 2007 these guidelines were amended and supplemented in order to accommodate changes in the technology and new insight into stem cell capabilities and pitfalls.16, 22 These amended guidelines strongly and clearly stipulated that there should be a moratorium on somatic cell nuclear transfer (SCNT). In addition, they forbid research involving the grafting of hESC’s to human or nonhuman embryos, nor nonhuman stem cells to any embryos; in short “chimeras” (animals of mixed genetic composition) are strictly forbidden. However, the grafting of hESC’s to nonhuman animals after birth, with the intention to create tissues and organs or to conduct tumour research, is permitted (for example growing human tumour cells in mice). Research can be performed on either discarded embryos (up to day 14) or on pre-existing embryonic stem cell lines, or on discarded tissue after therapeutic abortion, although the latter would require close scrutiny. No embryos can be bought or otherwise derived from solicitation or coercion; and no gametes procured similarly with the specific intent of creating embryos for research. All embryos must be anonymized, and no identifying data can link them to the donors. One very important point, and one that distinguishes Canada from the US, is that these guidelines, policies, and their oversight are in place irrespective of the funding source. There is no distinction, and no compromise, regarding ethical stem cell research performed in Canada: privately or federally funded, whether government academic or private sector, all stem cell research must adhere to the same regulations and receives the same scrutiny. In a similar vein, researchers are obligated to disclose any of their financial funding, their commercial interests and any conflict of interest to the research ethics boards, to the Stem Cell Oversight Committee, and to the donors of embryos; full disclosure is the rule.
Stem cell research is not without its problems in Canada. While the above guidelines for research are clear and strictly enforced, a survey in 2006 revealed that 40% of Canadians felt that oversight in biotech was lax and a further 20% were unsure of the oversight process.15 Furthermore, it has been argued that even with special attention to the issue, in the 2007 stem cell guidelines, issues of consent are inadequately represented.23 This sentiment acknowledges that with the ethics of stem cell research the “elephant in the room” is often the ethical issues mentioned above (personhood, cloning etc.), but an oft neglected piece of the puzzle is the consideration for the couple who are contemplating donating their embryos. In reality these are, in all likelihood, the greatest stakeholders in this issue and they deserve the most informed, respectful, and considerate treatment in what could be a very important decision for them as individuals and as partners. Couples need enough information to make free and informed decisions, and should be granted insight into what the potential uses of their embryos entails. The guidelines call for the discussion of these facts at the time of gamete donation and zygote formation, and again once the decision is to be made on whether to freeze the remaining embryos, and then further discussion at the point of deciding the disposition of the frozen embryos. So, decisions on the fate and disposition of embryos should be discussed before the creation of the embryo, and at every step of the way thereafter. The consent of both gamete providers is required, and if the resulting embryo is donated to another person or couple, their consent is also required for research to go ahead. In order to diminish any chance of coercion (real or perceived), informed consent must be obtained by persons other than the treating physicians (in an IVF situation) after the embryos are formed, but the treating IVF physicians can obtain consent before the gametes meet.
The discussion thus far has largely avoided the topic of cloning. There are deep moral concerns with cloning in Canada and the world. On March 8, 2005 the United Nations General Assembly adopted, by overwhelming majority, a Declaration on Human Cloning by which member states were called upon to adopt all measures possible to prohibit cloning.24 Canada (and Canadians) has always endorsed a ban on cloning in the spirit of the UN notion of the issue. Owing to imprecision with the definitions and terms (alluded to above) confusion remains as to just what is being banned.25 A broad definition of cloning would include the creation of stem cell lines and other technologies in current and frequent use in labs across the US and Canada; but that is not the intent of the UN ban. The Canadian guidelines for stem cell research expressly prohibit research on human reproductive cloning; hESC research cannot be performed on embryos beyond 14 days and there is a moratorium on somatic cell nuclear transfer (the latter being a necessary part of any attempt to replicate an existing human). This, ultimately, adequately and accurately captures the sentiment and intent of the UN declaration, and of course sits well with Canadian moral sensibilities.
Interest in heritable diseases has been with us for centuries, but no meaningful insight was achieved, arguably, until Gregor Mendel’s work in the latter part of the 19th century. The intervening decades have brought much sharper scientific understanding to the subject, but the interest expanded exponentially in the last 30 years with the emergence of the field of genomics, the field of study that strives to understand the complete genetic makeup of an organism. The Human Genome Project26, a multinational endeavour that was initiated and centered in the US, accomplished a complete mapping of the human genome in 2003. Genomics is concerned with an understanding of the genome, but this understanding has two spinoff technologies: first, the testing for the presence of gene associated diseases and second, the manipulation of genes for therapeutic intervention (or enhancement). Several disease states have been found to be due to identifiable and heritable gene mutations, and hundreds more have been studied and identified as having genetic and environmental contributions. Peering into our genetic makeup has yielded great insight into the nature of human disease and wellbeing. The menu of tests available is broad, and expanding rapidly. From pre-implantation genetic testing of embryos, to chorionic villus sampling of fetuses, to definitive tests for diseases such as Huntington’s chorea, to the less certain predictive testing of genes associated with breast cancer (BRCA1 and 2) and other diseases, genetic testing has implications at every stage of life. Such powerful tools and knowledge have led to equally significant ethical concerns and considerations.
Genetic testing carries with it a great many far reaching implications. This is predicated on three characteristics of genetic testing that give it distinction from other clinical investigation: genetic testing is simultaneously individual and familial; genetic testing involves disease states that often will be manifest in the future or be of an enduring nature; and genetic testing often involves investigation into disease states for which there is no effective treatment or prevention.27 This discussion will focus on the Canadian response to these issues but a detailed discussion of the ethical issues and the science of the subject is beyond the scope of this chapter.
There is a quagmire of ethical problems associated with genetic testing and this situation is not amenable to a methodical ethical analysis; genetic testing raises problems that extend in many dimensions simultaneously. An example is the notion of respect for autonomy in genetic testing: respecting autonomy is difficult when there are many stakeholders in the equation. Genetic testing must be done with consent of the individual (or the surrogate decision maker of the individual) being tested, but informed consent is difficult at best because the impact of the information derived is liable to change as more insight is gained into the genetic condition. Genetic tests open up doors to information that will continue to grow and grow; the notion of truly “informed” consent to open a potential Pandora’s Box is absurd. Furthermore, respecting autonomy is difficult when the nature of the test is not, in fact, on one individual but potentially the individual’s entire family, and this opens up issues of when and how to disclose information or when confidentiality must be sacrificed in a duty to disclose potentially devastating information. This topic was discussed in more detail in Chapter 2.
There are other issues with genetic testing that remain with the individual. The psychological burden of potentially catastrophic revelation of late onset genetic diseases (for example the uniformly poor prognosis of Huntington’s chorea) must be considered. The costs and benefits of any action must be weighed, but costs and benefits of embarking on genetic testing is even harder to predict than other avenues of medical investigation, if for no other reason than there is often little that can be done once the test is known. Still, people want to know, indeed have a right to know. The implications for the individual don’t end with the results of the test. People must be supported not only in their desire to have the testing done but the post-test implications have to be accommodated also. There is enormous potential for harm to the individual in the form of marginalization and discrimination. People can be discriminated against in the work place or in applying for medical or other insurance; the notion of the “pre-existing condition” takes on a whole new meaning with genetic testing. While, as yet these fears have not been realized in Canada, looking to the future, mechanisms must be put in place to accommodate the expanding menu of genetic testing available to people.
Finally, there are implications of genetic testing that are the inverse of the above. While we often consider the ramifications of testing, consideration must also be given to ramifications of not testing. In Canada newborns are routinely screened for Phenylketonuria (PKU) which is a genetic disorder that can cause severe mental retardation but is treatable with diet restrictions. Not testing, or not having access to testing, is unjust, and the consequences devastating to the infant. Every province and territory screens for this disorder but as more genetic testing becomes available for imminently treatable diseases there must be policy (now lacking) in place to accommodate and ensure such screening.
In Canada in 2007-2008 there was $262.5 million allocated by the Canadian Institutes for Health Research (CIHR) for genetic research.28 The Institute of Genetics (IG) is one of 13 virtual institutes at the CIHR and oversees government funding for genetic research. While the IG does not provide direct oversight into the ethical practices of genetic testing and research, ethical legal and social issues are identified as “priority themes” of research endorsed by this institute. The Canadian College of Medical Geneticists does spell out ethical guidelines which recognize the above issues and serves as a guide for practicing geneticists and medical institutions.29 Furthermore, the Tri-Council Policy statement, which governs research and guides research ethics boards across Canada, is meticulous in its guidelines concerning genetic research on humans. It demands of researchers: 1) a firm plan in their research protocol for dealing with genetic information derived by the research; 2) the provision of thorough counselling for any participants subject to genetic testing; 3) a plan for the inclusion and sharing of information with family members (and groups or communities); and 4) adherence to strict rules governing the banking of genetic materials.19 This final topic is taken up again in Chapter 8.
American genetic testing is also tightly regulated: the Centers for Medicare and Medicaid Services (CMS) regulates clinical laboratory testing to ensure laboratory compliance with the Clinical Laboratory Improvement Amendment of 1988, the Federal Trade Commission (FTC) oversees advertising of tests and products, and the Food and Drug Administration (FDA) regulates tests sold as “diagnostic devices.” But it is hard to contain progress in the digital age and in our global village, and despite the tight regulations, a growing American phenomenon is having an effect on Canada and the world; that phenomenon is the Direct-to-Consumer (DTC) marketing of genetic tests. In 2007 there were 84 such DTC tests available in the US and online and often little heed was paid to the regulations, the companies being outside the control of the FDA and other regulatory bodies.30 This potentially ominous trend eludes Canadian regulation as well. While many of these tests are for things such as risk of heart disease or thrombosis, some are for diseases such as Tay-Sachs disease, cystic fibrosis, and breast cancer. The full implications of such testing, and their impact on people when performed outside a genetic counselling setting etc., are not fully understood but potentially very grave.31 The veracity and the utility of these tests is unproven and unknown, but it is known that while the companies themselves capitalize on offering the tests, it is the health care system that ultimately bears the cost burden when these positive “preliminary” tests demand followup testing and thorough investigation. These added costs to the health care system often yield little in health benefit and are seen as an inappropriate health care expenditure.32
While there are many private clinics offering testing in the US, private clinics in Canada have not been successful and have met with lukewarm approval. There has always been great concern among Canadians about expanding outside the universal health care system to offer private medical care, this concern is amplified by this threat of unregulated and potentially unethical care in the realm of genetic testing.31, 33 Currently, genetic testing for diseases of serious consequence are performed only in genetic testing institutions (hospitals, cancer agencies, etc.) and are regulated, including mandatory pre- and post-test counselling. Genome Canada (a large not-for-profit organization established by the Canadian Government in 2000 to develop and implement a Canadian strategy for genomic research) has weighed in on the debate cautiously. In a policy statement in 2010, Genome Canada calls for caution and entertains several options to regulate the DTC trend in genetic testing including legislative measures to restrict or ban access to this testing, improving resources for research around the phenomenon(including a commitment to study the issue and developments), as well as enhancing the transparency and availability of information for consumers and health care professionals.34
While the need for legislation in this area has become apparent, there is no specific legislation regarding genetic testing in Canada. In a government sponsored survey, the majority of Canadians felt that efforts directed toward the preservation of privacy should trump data collection in the realm of genomics.35 Areas of perceived need are in the protection of individuals who have been identified as afflicted with late onset genetic diseases such as Huntington’s disease, or for protection from being tested against one’s will.27,36 The United Nations, the US, and several European Union nations have specific legislation dealing with genetic non-discrimination.36 While the American Congress has been proactive in such matters, in passing the Genetic Information Nondiscrimination Act (GINA) in 2008,37 it is still only being debated in Canada. Insurance companies, amid some scholarly commotion, have indicated a desire to have access to client’s genetic test results, and the right to refuse coverage on the basis of non-disclosure.38 As yet nothing has come of this potential privacy breach in Canada. Victims’ only recourse would be to appeal to the Canada Human Rights Act39 for protection from discrimination against disability (where here, disability would be defined broadly to include genetic predispositions) and there have been common law cases that have tested the act but none with distinct genetic diseases.40,36 Citizens of Canada would also be proactively protected by two federal pieces of legislation, the Privacy Act41 sets strict limitations on the collecting, storage and usage of personal information (including medical information) by the government, and the Personal Information Protection and Electronic Documents Act (PIPEDA)42 which overseas collection, storage and sharing of personal medical information by the private sector and industry. It is argued that both of these fall short of specific legislation such as GINA, and furthermore that the need for such specific legislation will become increasingly pressing as technology progresses and as medical care becomes more individual and tailored, indeed more genetically oriented.
A less than favourable, or a less than optimistic opinion of gene therapy should be forgiven. Society has looked with jaundiced eye on such technology, and with good reason. A series of misadventures in eugenics in the last century, and some misadventures in well intentioned (yet ill fated) genetic therapies have bred scepticism. Nevertheless, the science behind this field is flourishing and the promise of great and helpful cures and treatments may well be realized in a few years. Renewed and cautious optimism is justified.
Canada has had an unfortunate foray into eugenics in Alberta that began in 1928 with the first “Sexual Sterilization Act”.43 This act permitted the sterilization of persons discharged from mental institutions. At the time, the scientific opinion leaned toward criminality, mental illness, and immorality as being strongly heritable disorders; and, furthermore, that eugenics could improve the overall composition of society by prohibiting reproduction of certain persons. Alberta’s legislation, in fact, mirrored American legislation at the time, where since the early 1920’s, 30 US states permitted the sterilization of some 65,000 people. The Alberta act resulted in the sterilization of 2,832 people, many of them children, until it was repealed in 1972. It was the only place in the British Empire to ever have passed such legislation.44 It is a blot on the record of Canada’s history that the eugenic legislation outlasted even the Nazi regime.
Prenatal screening and Pre-implantation Genetic Determination (PGD) are the technologies that lie between genetic testing and gene therapy. (Other issues in reproductive emerging technologies are dealt with in the next section). The expanded access to prenatal screening advocated by the Society of Obstetricians and Gynaecologists of Canada, is seen by some as the new eugenics.45 Indeed, where investigation and screening meet decision and action, is the intersection at which many emerging technologies experience a condensation into bioethical controversy. It is a shifting and fluid landscape, informed by public opinion, legislation, and scientific discovery. Ethical input from philosophers, clergy, judiciary, health care professionals, and patients inspires and forces change. PGD allows infertile couples undergoing in-vitro fertilization, knowledge of the genetic makeup of embryos before they are implanted. Issues that attach to PGD have only come into existence with the birth of these technological advances in the 90’s. The simplest form of PGD is, perhaps, gender determination. Currently the Assisted Human Reproduction Act (2004)20 prohibits gender determination (except for preventing X-linked genetic disorders) but does permit genetic analysis of embryo candidates for implantation. As the menu of options for genetic testing becomes ever larger, and the access to PGD and prenatal screening and diagnosis grows, the option to prevent or abort pregnancies based on these data looms—“new eugenics” or not, gene modification of individuals and hence gene pool modification of society is a reality.
Turning to gene therapy in the proper sense, we see, again, a history of some unfortunate misadventures. Understanding the genetic nature of diseases brought with it great optimism in the treatment of such diseases by manipulating newly discovered errant genes. These therapies have met with limited success and have encountered significant setbacks and pitfalls. While a thorough explanation of gene therapy is not possible here, a brief introduction is necessary to introduce the ethical issues that attach to this field. Gene therapy can be implemented on somatic cells46 of an individual to replace genes that are deficient or defective. Genetic material is inserted into somatic cells, usually via a virus, carrying a “good” copy of the missing or defective gene in order to produce normal copies of the deficient, defective, or absent proteins that causes the disease. That is: an abnormal gene causes an abnormal protein in the afflicted individual, and this causes the manifestation of the disease—inserting the normal gene, corrects the protein production and rectifies the problem. What in theory appears straightforward, in practice has proven exceedingly difficult; for getting a sufficient quantity of the gene into enough cells is difficult in an adult with a trillion cells. Even though not every cell needs to be corrected, it is still difficult to target enough cells to make a difference.
Targeting enough cells would be possible in germ line therapy, but for good reason, germ line therapy is not being contemplated in humans. The insertion of gene modifications into germ line cells will mean future generations of offspring will carry the normal gene. As discussed below, even somatic cell gene therapies have produced large and unforeseen consequences, this could only be amplified by extending the reach of gene modification to multiple generations and to the human gene pool in general.47 Germ line therapies are prohibited by law in Canada. The way forward in gene therapy is likely the merging of stem cell research with gene therapy as the proposed gene modifications are likely to see success if inserted first into stem cells in the lab, and then strategically reinserted into a patient’s body.
Disease states that hold promise as candidates for such therapy are forms of severe immunodeficiency that are the result of single gene problems. One disease, a type of SCID (severe combined immunodeficiency) that is fatal to afflicted infants, met with some promising results in very limited trials.48 In the last decade, another form of SCID, an X-linked variation, initially showed promise with gene therapy when, suddenly, unforeseen problems emerged—many of the patients who underwent gene therapy developed a form of leukemia and trials of therapy were halted.49 Another case that sharpened the awareness of the pitfalls of gene therapy was that of Jesse Gelsinger in the US. He was a young man with a rare genetic disease, ornithine transcarbamylase (OTC), which was actually relatively well controlled without the gene therapy proposed to him by a research team at the University of Pennsylvania. He volunteered for a gene therapy study but died 4 days after receiving the treatment, seemingly from complications of infection from the viral vector.50 The US FDA stopped the research immediately after. Clearly, what at once seems straightforward in theory, has the potential to dash hopes and destroy lives in its implementation; gene therapy is a sword that can cut both ways.
Nevertheless, gene therapy research and trials are ongoing in the US, Canada and the world. There remains optimism that the mistakes and misfortune of the past will not be repeated. To that end, there has been considerable progress in the legislation and regulation of gene therapy research. Since 1995 Canada has chosen to regulate gene therapy through its Food and Drugs Act,51 that is, gene therapy is overseen by the same regulation and legislation of drugs and pharmaceuticals.52 To this day, gene therapies (along with vaccines and other biotechnology products) are considered “biologics” and are approved by, and tightly regulated by, Health Canada under this act. Before marketing a gene therapy the producer must receive a Notice of Compliance from the Health Canada Biologics and Genetic Therapies Directorate (BGTD), and in order to do so must submit rigorous and compelling scientific evidence proving benefit. At this point, gene therapies per se are not in usage (outside of research) in Canada or the world, and, as yet, there is no commercialized gene therapy. 47 Any future clinical trials must go through a clinical trials application with the BGTD. Treatments for Parkinson’s disease, Cystic Fibrosis and diabetes are likely candidates for investigation in the near future.
In the near future lie two more aspects of genomic sphere emerging technologies, namely pharmacogenomics and nutrigenomics. Where, so far, consideration has been of the ways to insert genes as therapy, these new fields represent a new brand of personalized medicine, the field in which a person’s genetic makeup is taken into consideration for targeted drug and nutritional interventions. A majority of Canadians in a 2005 survey strongly supported research in pharmacogenomics, many of them felt that it was a logical and refined next step to pharmacologic therapy already in existence.10 In spite of this, in terms of pharmacogenomic specialization, Canada is fourth of the G7 countries and a minor player in the global scene, in terms of research and output.53 Canada is overshadowed by the bold strides and the strong initiatives shown in the US in this field. Ethical considerations in this field connect back to many of the same genetic testing issues dealt with above. Intervention is targeted to specific genetic predispositions and this is predicated upon a thorough personal genomics knowledge. Such knowledge brings with it issues of consent, privacy and potential for discrimination.53 For example, once a patient gains the knowledge of his high risk for heart disease, this information could be damaging to him if it were “leaked” to his boss or his insurance company. The wave after pharmacogenomics is felt to be nutrigenomics, predicated on an even broader base of genomic information and the broader potential for abuse or discrimination.54
While none of these bioethical concerns have yet been realized, researchers and stakeholders will be repaid in being proactive; with knowledge comes power and with power responsibility. Perhaps nowhere is this truer than in consideration of enhancement potential in the realm of genetic therapy. Gene therapy, at present, is targeted toward reducing the burden of catastrophic diseases. Pharmacogenomics and nutrigenomics are aimed toward preventive medicine, such as prevention of heart disease or diabetes, and reducing the long term burden of such diseases. With advances in gene therapy, pharmacogenomics and nutrigenomics comes the attendant spectre of risk of abuse and unfair enhancement. From cheating in sport(so-called “gene-doping”), to unfair advantage in the workplace, to widening the gap between those who can afford and those who cannot, the possibilities for enhancement (and bioethical transgressions) through gene manipulation are enormous.55 Canada is well poised, with its tightly regulated health care system, its tightly regulated Food and Drugs Act,56 and oversight by the Health Canada Biologics and Genetic Therapies Directorate, to confront genomics issues in the coming decades.
EMERGING REPRODUCTIVE TECHNOLOGIES
The previous chapter dealt with many beginning of life ethical issues. This section deals with the ethical considerations of emerging reproductive technologies which include Assisted Reproductive Technologies (ART). There is considerable overlap between these topics but this discussion will be limited to technological innovation and the ways and means of reproductive manipulation in Canada, as well as the legislation policy and oversight in this realm.
The world saw the birth of the first “test-tube baby” in 1978.57 The last 30 years have seen significant technological advances, not to mention refinements in the terminology. Some definitions will be used to introduce the landscape of the issue. ART is a broad and ever growing medical discipline that includes the following items (and an attendant “alphabet soup” of acronyms):
- The first step in the quest for pregnancy often involves fertility drugs such as clomiphine, or human gonadotropins. These are available through a woman’s gynecologist or a specialized fertility clinic.
- Surrogacy is an option for women who cannot carry a pregnancy.
- Gamete donation used to mean only sperm donation but with the increase in yield of ova harvesting for IVF procedures, excess ova can be donated to sub-fertile couples.
- Therapeutic Insemination (TI) includes both artificial insemination (AI), and donor insemination (DI). TI, whether using sperm from a husband, partner, known or anonymous donor, uses a syringe to place sperm into a woman’s vagina. Donor sperm is available from fertility clinics and sperm banks.
- In vitro Fertilization (IVF) is a multi-step procedure that involves the stimulation of a woman’s ovaries using hormonal treatment in order to produce a number of eggs (ova), the surgical retrieval of ova from the ovaries, fertilization of the mature ova with sperm in a Petri dish, and transfer of the resulting embryo(s) into a woman’s uterus. Excess ova can be donated, and excess embryos can be “frozen” (cryopreserved) for future use.
- Gamete Intra-Fallopian Transfer (GIFT) is increasingly rare. It involves the same initial procedure for procuring ova, however, after retrieval, the eggs and sperm are injected into the fallopian tube to allow fertilization to occur in vivo, as opposed to in vitro, where fertilization occurs in a Petri dish.
- Intra-Cytoplasmic Sperm Injection (ICSI) is currently the most common method of IVF. It consists of injecting a single sperm into an egg with a microscopic needle. If fertilization occurs, the resulting embryo is transferred to a woman’s uterus. This treatment is used to augment primarily male infertility (low or absent sperm count or compromised sperm integrity). It is also used often before Pre-implantation Genetic Determination (PGD) in cases where a genetic disorder is going to be screened for.
As was discussed in Chapter 4, the ethical issues at the beginning of life are many and varied. Many of these ethical considerations have to do with a new life and the family that she or he will enter into. With increasing technology we are seeing the number of stakeholders grow. With assisted reproductive technologies come a new set of roles, and tensions between the individuals filling these roles. Today, there are up to five players when it comes to reproductive efforts. There are the gamete donors (the genetic father and mother), there is the carrier of the pregnancy (the surrogate or the intended social parent) and the intended parents. And, of course, there is the child. (The status of the embryo is dealt with in the previous chapter, and the status of the pre-implanted embryo is discussed above under Stem Cell research.) Each of these people has concerns and considerations in the process, and all of them contribute to a very complicated web of potential ethical issues. Furthermore, the traditional roles and historical norms are being challenged as Canada becomes increasingly more comfortable with same sex unions. Also, women who were at one time disqualified by age or menopause, are now able to conceive and carry a pregnancy through enhanced fertility options and technology.58 A derivative ethical problem of some of these expanded roles is the imposition of traditional roles on the unwilling; women in the past may have chosen to end their pursuit of maternity due to their age or inability to conceive, but assisted reproductive technologies risk imposing a duty to have children.58
Canada has taken strong initiatives in researching the field of ART starting with the Royal Commission on New Reproductive Technologies of 1993. The Commission’s landmark publication, Proceed With Care, set the stage for policy and legislation that is still being shaped today.59 The Assisted Human Reproduction Act of 200420 (AHRA) was 11 years in the making and is still undergoing revisions. The act set out a list of prohibited activities, and set out regulations governing assisted reproductive therapies and research in this realm (including spinoff research such as stem cell research on embryos). The AHRA clearly stipulates that human cloning, payment for ova sperm and embryos, and payment for pregnancy surrogacy are prohibited, and amendments to the Criminal Code were made to reflect this. The act also banned combining human and non-human DNA for reproductive purposes, and the alteration of germ line cells as mentioned above. Furthermore it informed other aspects of the Canadian Institutes for Health Research policy on stem cell research. It reproved the use of ART for gender selection or for “family balancing”. In developing the act, Canadian legislators were informed by legislative practices and regulations in the UK, the US and other common law countries. In addition, Canada places a priority on its legislation being commensurate with international human rights regulations.60 The AHRA is entirely consistent with the World Medical Association Statement on Assisted Reproductive Technologies.61
Surrogacy is used much less frequently in Canada than the US.62 Surrogacy for profit is illegal under the AHRA. That being said, the reimbursement of donors and pregnancy surrogates for their expenses is allowed; surrogacy is acceptable, but “wombs for hire” is not. Canadians often use surrogacy in situations where the woman has viable ova but is unable to actually carry a pregnancy, for example, if she has had a hysterectomy, or has a significant health condition like diabetes, which significantly increase the health risks of her and the fetus. Although claims of such things are common in the US, there is little empirical evidence in Canada supporting claims of women using surrogacy for convenience or to circumvent the discomforts of pregnancy.62 Arguments for and against surrogacy for profit can be found in the bioethical literature but these arguments are moot in terms of the practical aspects of surrogacy in Canada because the AHRA is clear in its prohibitions.
The AHRA has very precise and demanding stipulations for the informed consent in using embryos and in the creation of embryos. These guidelines, under Section 8 of the act, were some of the last to come into effect in 2007 and are considered to be some of the strictest in the world. The implications that flow from some of these regulations involve the rights of children born of the technology. Although anonymous gamete donation was permissible in the past, clinics implementing ART now must collect and protect the identity of donors. A child born of ART has the right to know his parentage, but only with the written consent of the donor. The child is entitled to anonymized health information about the donor.60
The strictness of the AHRA has meant circumvention of several issues that are present in other countries. It was noted above that surrogate pregnancies are permitted in Canada, but the paying of surrogates (above and beyond the expenses for costs such as time from work etc.) is forbidden. In a similar vein, paying for egg and sperm donation is illegal in Canada. In countries where this is permitted (such as the US) there are a multitude of ethical issues that attach to the burgeoning business of selling ova to the highest bidders—issues that involve potentially unscrupulous behaviour on behalf of the businesses and the egg donors. In addition, desperate potential parents (and poor egg donors) can be taken advantage of, and wealthy parents-to-be can outbid the less wealthy for the “best” eggs. Also, allowing parents to choose the genetic makeup of the embryo (by choosing the genetic contribution of the biological mother and/or father—their height, intelligence, hair color, etc.) can result in the existence of made-to-order babies, once more dredging up concern over a new form of eugenics. The AHRA would permit none of this. Eggs and sperm can be donated but not sold. Excess ova, sperm and embryos can be given away (and fertility clinics can facilitate this)62 but there is no business or profit to be made on these transactions, nor is there to be any bidding for “desirable” gametes nor designer babies for the wealthy. The stability of this arrangement will surely soon be challenged as the unregulated selling of gametes continues just a short plane ride away, in the US.
Health policy and regulation are made much more complicated by the jurisdictional split of the Canadian health care system; health care is federally funded but it is the provinces and territories that set legislation and policy regarding services and access. The legitimacy of the AHRA (a federal act) in regulating health care oversight (a provincial responsibility) has been questioned. In 2008 Quebec launched an action against the Federal Government questioning whether the AHRA was commensurate with the Charter and found, ultimately, that several sections of the AHRA were invalid.63 Quebec was joined by Saskatchewan, New Brunswick and Alberta in raising a constitutional challenge to the law and ultimately it was brought before the Supreme Court of Canada. The SCC ruled on the 22nd of December, 2010. In a split (4-4-1) decision it ruled that most of the AHRA is constitutional with respect to what is and is not allowed in reproductive and stem cell research, but that federal regulation of fertility clinics (as stipulated by the AHRA), is in fact unconstitutional, and these things could now be regulated by suitable legislation at the provincial level.64 The act has not been entirely cast out as unconstitutional and just how this ruling will change ART in Canada remains to be seen.
In the meantime, for most of the country, the act stands. Health Canada is the federal department responsible for developing legislation and regulations. Assisted Human Reproduction Canada (AHRC) is the agency responsible for overseeing and implementing them.65 There is now an Assisted Human Reproduction Agency located in Vancouver that oversees the licensing of acceptable ART activities in health institutions across Canada, and an inspection program is being developed to oversee these activities. In addition, this agency is developing a registry of personal health information in order to conduct surveillance of the ongoing health of persons using ART, or persons born of ART. What Canada has lacked in stealth it has made up for in the breadth of its oversight and regulatory capacity for ethical issues pertaining to ART.
Pre-implantation Genetic Determination is not mentioned in the AHRA but the intent of the act is meant to govern the ethical concerns with PGD. PGD is, in a broad sense, a form of prenatal screening; but the screening is performed prior to implantation sparing a woman an abortion if the results are unfavourable or incompatible with the life of the future fetus.66 The screening is done at any of several stages of embryo development, and always (and by definition) outside the womb in a laboratory. It is a complicated procedure that includes using recombinant DNA technology by which a genetic analysis of an embryo is achieved and decisions regarding implantation made based on those findings. The controversies that attach to this line of investigation are many and a full elaboration is beyond the scope of this discussion—in fact, the ethical implications are fluid as the technology and regulations regarding them continue to evolve. The most significant ethical considerations involve whether, and to what extent, embryos should be selected and discarded: just what represents a significant genetic defect, and which genetic states should be singled out for excision from the human gene pool or from the family tree? The most obvious and controversial abuse (or use) of this technology is in selecting gender—the controversy located in the “diagnosis” of “femaleness” or “maleness” and that gender then being propelled to the status of disease and found to be deserving of eradication in the name of family balancing.
It is worthwhile examining the history and evolution of the procedure as this brings to light other ethical considerations and controversies. The AHRA is strikingly similar to the legislation in the UK overseeing the same reproductive technologies. In the UK there is a Human Fertilisation and Embryology Act (1990)67 which has undergone several revisions. As well the Canadian Assisted Human Reproduction Agency is similar to the oversight and regulatory body in the UK, the Human Fertilisation and Embryology Authority (HFEA). The similarity invites comparison between the Canadian and UK legislation and oversight,68 and rightly so, the Canadian legislation was drafted with consideration of the UK legislation.69
The debates surrounding PGD turn on the severity of the diagnoses that are being tested and the UK has undergone significant change over the last several years and has found itself in the limelight of the unfolding controversies. Initially the HFEA permitted only very tightly regulated PGD investigations for diseases such as those caused by high-penetrance genes for some cancers (for example, some forms of colon cancer), autosomal and X-linked disorders (such as myotonic dystrophy, “fragile X” mental retardation, cystic fibrosis, etc.), and diseases associated with aneuploidy (trisomies or chromosome deletions, many of which are incompatible with life). It did not allow for the testing of low-penetrance or variable- penetrance genetic diseases such as detection of the known genes for breast cancer (BRCA1 and 2).68 In the last few years this has changed, and the HFEA does allow for the detection of such things as BRCA 1 and 2, as well as forms of colon cancer that have less penetrance. This opens the door to speculation of whether the UK (and by extension Canada) are on a slippery slide toward even broader testing and possibly eugenic programs that stigmatize and discriminate against persons who were never previously considered impaired or diseased, but now suddenly find themselves with a labelled “genetic impairment”.69 The HFEA has also reversed its opinion on another controversial issue; that of “saviour siblings” (whereby an embryo could be screened and selected based on compatibility with a sick sibling for which it could provide stem cells from umbilical cord blood). Where once this practice was discouraged, it is now permitted in the case of certain genetic diseases.68
The UK is not the only influential factor in Canadian lawmaking, as a keen eye is ever toward public and private policy in the US. Currently, there is no legislation regarding PGD specifically in the US.70 A recent survey has found that in private clinics, PGD is being used in many clinics for sex selection for “social” reasons. Even more strikingly, some PGD determinations have been to select for such things as hereditary deafness in order to preserve homogeneity with deaf parents.71 In many countries in the world, PGD is being used for controversial indications such as sex determination.69
The debate has been much less public in Canada. The AHRA does not mention PGD but it does specifically prohibit gender selection for “social” reasons. It does not provide specific guidance on the question of which of the hundred or more tests now available should in fact be made available to parents. It does not weigh in on the option of selecting a “donor child” (or “saviour sibling”). Furthermore there have been no legal actions to test the law in these matters.70 Where there is a lack of policy and regulation, Canadians look to precedents in other jurisdictions as noted above, but they also rely on the professional guidance and ethical practice of health care professionals in this field. Reproductive rights are fiercely guarded in Canada and militant and intrusive policy is eschewed. In this sense, PGD, like abortion law, is deemed a decision that is made between a woman and her care provider. So far the AHRA has not been called upon to influence these decisions, but if the rest of the developed world is any guide, issues of PGD will soon be realized in Canada as well. The majority of Canadian fertility clinics now provide PGD but most of them send the samples out of the region or out of the country for testing. The fact that it is becoming much more commonplace has led to demands for regionalization and regulation of PGD and PGD resources in Canada.72
Where there is a vacuum in legislation, there is professionalism and ethical integrity. Often this is informed by professional policy statements. The Canadian Medical Association Policy on Assisted Reproduction predates the AHRA and is too brief to address any specific issues. As a more global statement, it reinforces the rights of women to reproductive health and safety, upholds the sanctity of the relationship between patient and health care provider, and speaks out strongly against the criminalization of medical procedures and technologies (favouring strong guidance and policy over legislation and prosecution under the law).73 The American Medical Association policy statements are similarly outdated (from 1996-1998) and do little to address specific issues, but at least the opinions referenced are more contemporary.74 However, the Society of Obstetricians and Gynaecologists of Canada (SOGC) has more current guidelines and practical evidence based recommendations for managing ART and prenatal care. While it skirts discussion of ethical dilemmas, it nonetheless offers very clear information on such things as PGD and IVF counselling.75 In a very proactive guideline the SOGC addresses an issue that is emerging as an increasing problem, multiple birth pregnancies. Fertility drugs and IVF have led to a great rise in multiple birth pregnancies, and these carry with them maternal, fetal, and neonatal health problems. The SOGC has suggested limits for the number of embryo implantations per IVF cycle (1 embryo for women under 35, up to 4 for women over 40 etc.) to accommodate this issue and stabilize this trend.76 Reproductive issues in these changing times, at the end of the day, involve patients and health care providers. It is essential that, while the philosophers and politicians write opinions and policy, and while the issues are being weighed and debated, women and families always have good professional guidance and reliable health care in their time of need.
Canadians staunchly defend their universal medical system. Medicare for all its benefits does have some weaknesses and nowhere is this clearer than in resolving distributive justice issues in emerging technology (see Chapter 1 for more on this matter). Canada’s health care system is expensive and getting more expensive. The debate about whether to fund IVF and other ART hinges on precisely where these technologies are placed on the spectrum from “wants” to “needs” (i.e., on which side of the line between the essential and the elective they fall on). As initial apprehension about ART in Canada has been replaced by widespread endorsement and adoption, the question of cost looms. Ethicists argue from a distributive justice stance, that any just and developed society should provide a remedy for its sub-fertile citizens. Many European nations, Australia, and Israel have policies and public funding for ART (even in the US, many insurance companies will cover ART), but while Canadian legislation protects the right to procreate there is no universal publicly funded access to these technologies.60, 77 Sub-fertile Canadians have felt that they have been dealt an injustice unbefitting a developed nation. Concern is raised that there is an increasing gap between the “haves” who can afford ART procedures (which can cost up to $10,000 or more), and the “have-nots” who can-not. Such a disparity is repugnant to some of those who hold common Canadian values.58 In 1998, a Nova Scotia couple was denied access to fertility treatment and initiated an action against the province contending that this was a violation of their rights under the Canadian Charter. The Nova Scotia Supreme Court deemed IVF to be a non-essential treatment and denied the couple their claim. 78 There remains, in the Charter, no articulated right to the benefits of technology.60
Funding for ART is rapidly changing. Quebec, up until 2010, offered a tax credit of up to $6000 per year for expenses related to ART,79 but in the summer of 2010 began offering funding for up to 3 cycles of IVF. Ontario will fund IVF treatments only for women who have bilateral fallopian tube obstruction (less than 1% of sub-fertility cases) but its Expert Panel on Fertility and Adoption strongly recommended enhanced funding for subfertile couples including IVF funding.80 Manitoba offers a tax credit of up to $8000 per year for ART. A strong lobby for enhanced access to ART is ongoing across the country with many provincial hospital foundation funds and charities providing interim funding for subfertile couples.81
While the above arguments run along distributive justice lines, there is a growing body of empirical evidence to advance the argument for access to ART in the name of fiscal responsibility. In Canada it has been hypothesized that a disproportionate number of couples who cannot access IVF will turn instead to fertility enhancing drugs, and that this has resulted in an increase in multifetal pregnancies and multiple births. Multiple births, in turn, cause a disproportionate burden of expense to the health care system in tending to the delivery and care of the often premature infants, and the fact that these infants often grow into special needs children with lifelong medical care needs.77, 79 The hundreds of thousands of dollars saved in removing this factor, it is argued, would more than pay for access to ART. Then again, this may only be staving off the original problem, and as technology continues to advance, sub-fertile Canadians may again find themselves desiring even newer and grander treatments that cannot be accommodated by fiscal realities and limited health care budgets.
This has been a discussion of genetic and reproduction topics that have in common the scale of their ramifications, and the wide ranging questions about their appropriate use. Any discussion of genetic and reproductive control must encompass a discussion of stem cell research and the problems that attach to such research, and it is from this topic that the chapter embarked. Canada can be found in a middle ground in the spectrum of regulations seen in the global arena; neither extremely restrictive nor permissive in comparison with other countries. Nevertheless, stem cell research is tightly regulated. Canada strives to be specific and definite in its articulation of rules governing stem cell acquisition and usage, and also to hold solidarity with world opinion on the issues—even when world opinion, or the opinion of governments (such as the US), are in a state of flux. There are statutes such as the Assisted Human Reproduction Act and other guidelines, as well as oversight agencies that ensure a few core principles: human procreative cloning is forbidden (but cloning stem cells for research is permitted), no embryos are to be created for research purposes only (but discarded embryos can be used), chimeras are forbidden, and there is to be no buying or selling of human gametes or embryos. Navigating these intricacies is complicated, and the rules change with changing times and in response to new technologies.
Discussion then turned to some of the ethical concerns with genetic testing, and the Canadian response to these concerns. Some sturdy regulation and oversight does exist, but some regulation has been found to be lacking, most notably with respect to the potential for discrimination once genetic testing is undergone and new and potentially dangerous knowledge is gained by individuals (or by meddlesome third parties). The questions of just what types of testing should be available (and what should be obligatory) was probed. Not only is knowledge and understanding possible, so too is the potential for intervention. The implications of some of the genetic testing topics was revisited in a discussion on therapies aimed at treating, enhancing, or otherwise intervening in people’s lives based on genetic testing. Armed with information about our genetic makeup means being armed to improve our lot with pharmacogenomics and nutrigenomics—but just how much of this acceptable is a question that future Canadians will have to answer.
Gene therapy was introduced via a discussion of eugenics and the role Canada has played in such things. It is a blot on the record of Canada’s history that it was the only country in the British Empire to permit the sterilization of mentally ill persons. While Canadians are optimistic about such things as gene therapy, misadventures in such technologies have made them wary, and that has given rise to strong regulations and very strict oversight. While there are currently no gene therapies in use in Canada, or the world, being prepared and proceeding with caution is no bad thing. This tight policy will be necessary as Canada, and the world, enter into an era where gene therapy and related technologies may serve to enhance people in welcome or unwelcome ways.
The last part of this chapter included an examination of assisted reproductive technologies. The stakeholders and their issues were examined, and the ways and means by which these issues have been addressed in Canada was considered. Canada has taken steps, through measures such as the Assisted Human Reproduction Act, to manage some of the issues generated by these technologies. In Canada gametes and embryos cannot be bought or sold, but donation of gametes and embryos that remain after a couple no longer needs them for their own IVF endeavours, is permitted. Canada has very strict regulations pertaining to informed consent for the disposition of unneeded gametes and embryos, and the protection of the donors’ rights and anonymity, as well as the rights of the children born of these technologies. Surrogate pregnancies for profit (“wombs for hire”) are forbidden in Canada, but surrogate pregnancies are permitted and certain compensations to the woman carrying the pregnancy are allowed.
While the regulation and oversight is broad and intricate, it is argued that these measures may still not prove enough, and may be deficient in dealing with things such as pre-implantation genetic diagnosis (PGD). While shielded from immediate controversy inasmuch as there is only limited capacity to perform PGD in Canada; this situation will not remain static, especially because the capacity is growing (and the regulatory aspects lacking), just across the border in the US. While the spirit of the AHRA does not permit genetic modifications, gender selection for family balancing, etc., it does not address specifically PGD and other technologies that may have Canadians facing eugenics-like issues all over again.
Canada prides itself in being a just country with equitable access to health care. All this may be challenged with the arrival of new technologies. Guidelines and oversight do not address the growing concern for access to limited health care resources in Canada. Medicare is at present ill equipped to reconcile the right to health care with the privilege to reproduce when that entails the use of ever more costly and evolving technologies.
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20. Assisted Human Reproduction Act (2004, c. 2), (2004).
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26. It was begun by the National Institutes of Health and the Department of Energy in the US and multinational partners were brought in as the project progressed. The NIH website is comprehensive in its treatment of the subject, http://www.genome.gov/10001772 , but several sites exist with current information.
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