In the McGill Journal of Law and Health’s pilot episode of Medical Records, Journal Executive Lauren Hanon interviews Professor Shauna Van Praagh on the legal and social issues that arose surrounding the events of the tragic death of Éloise Dupuis in October of last year. In this episode, Professor Van Praagh discusses informed consent, the right to refuse treatment, religious freedom, and how we, as a society, engage with these issues when there are conflicts between what is right in law, and what feels right morally.
The International Committee of Medical Journal Editors (ICMJE) recently proposed that journals should require researchers to share patient-level data from clinical trials as a condition of publication. Full disclosure of supporting facts has long been “the bedrock for scientific discourse”. Open science – making research data accessible to a broader community of scientists – is enjoying a renaissance in this era of cloud computing and infrastructure science. The ICMJE joins a chorus of researchers, research institutions, funding agencies, and regulators calling for open and timely clinical trials data sharing, in order to accelerate biomedical innovation and enhance scientific transparency. How will this policy sea change affect innovation, the obligations and careers of researchers, and the privacy of participants?
On Thursday, October 27th, 2016 the Faculty of Medicine’s Research Ethics Office (Institutional Review Board) convened a forum of researchers and ethicists to discuss clinical trials data sharing. The forum was chaired by Dr. Shari Baum (Associate Dean Research – Faculty of Medicine) and organized by Sacha Young (Ethics Review Administrator). Speaker presentations are available here.
Ms. Jane Burpee, who leads research data curation services at the McGill Library, began by recounting shocking tales of fraud in biomedical science. Researchers topping the charts of infamy on RetractionWatch.com built successful careers on fraudulent science. And they would have gotten away with it, too, if it wasn’t for a gang of meddlesome researchers who inspected the raw data. In sum, can we really trust research results without access to all the data: the summary (peer reviewed article), the code and the raw data?
Earlier this year, a team of doctors successfully carried out a new fertility technique that resulted in the birth of a child containing the genetic information of three people: the mother, the father, and a female donor. The technique allowed the intended parents to have a healthy baby after all of their previous children had died of Leigh syndrome, a debilitating neurological disease.
What are the risks and benefits of MRT? And what can these developments tell us about our reproductive legal regime in Canada?
The vast majority of human genetic information is carried in the cell’s nucleus. However, there is also DNA contained in sub-cellular structures called mitochondria. Unlike nuclear DNA (nDNA), mitochondrial DNA (mtDNA) is inherited exclusively from the mother. While mtDNA accounts for a very small portion of the genome (about 1%), mutations in these genes can cause serious disease due to the mitochondria’s critical role in cellular energy generation and signalling.
Leigh syndrome is one of these diseases. Patients with Leigh syndrome experience a progressive loss of movement and neurological function. This decline often begins in early childhood, resulting from the inability of their neurons to metabolize energy effectively. These patients will rarely live more than a few years.
This new procedure allows prospective parents to conceive a child from their own genetic materials without the risks carried by faulty mitochondrial DNA. || (Source: CBC News)
MRT aims to prevent Leigh syndrome in the children of mothers carrying mutant mtDNA genes. The mother’s egg is harvested and the nucleus, which contains the vast majority of genetic information she would pass to her child, is removed. The rest of the egg, including the disease-causing mitochondria, is discarded. The nucleus from the mother is then inserted into a donor’s egg. This hybrid egg, containing the mother’s nDNA and the donor’s mtDNA, is then fertilized by the father’s sperm, resulting in an embryo that is implanted in the mother through in-vitro fertilization (IVF). The result is a child whose nDNA comes from both parents, but with a mitochondrial genome inherited from a third party. This genetic material will, in turn, be passed on to future generations if that child is female and has biological children of her own.
Opposition to MRT is based on two main arguments, one medical and one ethical. First, because the technique is new, its side effects are heretofore unknown. Some suggest that it could result in higher rates of cancer or early aging. While experts have no evidence showing the technique to be unsafe, uncertainty persists.
The result is a child whose nDNA comes from both parents, but with a mitochondrial genome inherited from a third party. This genetic material will, in turn, be passed on to future generations if that child is female and has biological children of her own.
Second, critics decry the alteration of the genome in a way that can affect future generations. Slippery slope arguments suggest that this is the first step down a road to “designer babies”, where parents modify the genome of their offspring to meet their every whim. In the case of MRT, it is important to remember that mtDNA accounts for only a tiny portion of the genome and that these genes control basic cellular functioning rather than the types of defining traits often pictured in the case of designer babies. This concern may therefore prove less relevant to this particular genetic change. However, caution is warranted whenever a heritable alteration occurs, because this permanently changes the composition of the gene pool, recognized as the common heritage of humanity.
The outright criminalization of heritable genetic alterations seems less and less tenable as new techniques are developed that offer significant medical benefits and manageable risks. In addition to MRT, recent advances in human gene editing have fuelled hopes that inheritable genetic diseases could be eradicated forever, but these procedures would be prohibited under the AHRA for inducing inheritable genetic alterations.
Doctors combine the mother’s nucleus, the donor’s egg, and the father’s sperm to produce a viable embryo for the mother to carry to term. || (Source: Science News)
Meanwhile, the promise of these techniques has begun to attract legislative and regulatory attention worldwide. Last year, the UK Parliament carved out a specific exemption from its prohibition to allow MRT. This legislation addresses a number of practical matters, including the right of the child to request medical information about the donor, and it clarifies that the child is not related to the donor despite the contribution of genetic information. Earlier this year, a report commissioned by the FDA recommended allowing clinical trials of MRT in the United States.
This technique and others like it certainly merit close regulatory attention due to the implications they have for our collective genetic heritage and the uncertainty regarding their side-effects. However, it is impossible to ignore the treatment potential of these techniques in the case of diseases like Leigh syndrome. These developments shine a negative light on the restrictive reproductive landscape in Canada. The embattled AHRA provides neither the flexibility nor the clarity needed to confront these new regulatory challenges. Patients, medical professionals, and the public deserve clear rules that properly manage the risks while securing the benefits associated with this promising new medical frontier.
Canadians have increasingly been donating organs over the past ten years. Shouldn’t we be celebrating? According to the Canadian Blood Services’ early September report, Canada has seen a 23% increase in donations over the past decade. While this is definitely good news, we mustn’t be fully satisfied with our country’s progress on donation rates. According to the International Registry on Organ Donation and Transplantation, Canada lags behind its contemporaries by a large margin. This leads us to wonder: what are we doing wrong? How can Canada catch up to organ donation levels in other Western, industrialized nations?
An increasing number of Canadians have registered as organ donors over the past ten years. Shouldn’t we be celebrating?|| (Source: Flickr // Share GK)
The question remains: how and to what extent can the Federal Government help further Canada’s progress? At least one Canadian parliamentarian, Ziad Aboultaif, believed that a federally mandated organ donor registry would help drive growth in the donation rate. In drafting this bill, he put his heart into his work; or, more accurately, his liver, a piece of which Alboutaif donated to his son. The proposed bill intended, in part, to establish a national promotion strategy for organ donation. The Minister of Health would be tasked with producing an annual report detailing the success level of the previous year’s strategic plan, with a set of recommendations for further improvement.
Despite broad support for the its stated goals, Aboultaif’s proposed private member’s bill was defeated in June. Parliament faced a major obstacle in that organ donation falls ultra vires federal jurisdiction. One doesn’t need to consult a learned lawyer to reach such a conclusion; a glance at the Constitution Act, 1867 would suffice. Provincial authority over matters relating to organ donation flows from jurisdiction to legislate on hospitals, as per section 92 of the Act.
Given these constitutional limitations, what role can the Federal Government play in furthering Canada’s progress promoting interest in organ donation? Records of the House debate indicate strong moral support for the Bill; for example, Kamal Khera, Parliamentary Secretary to the Minister of Health, admits that Aboultaif’s initiative is worthy of praise. She elaborates on how the Trudeau government is committed to further supporting the Canadian Blood Services, and how a formalization of the existing interprovincial sharing guideline is underway. Clearly, Ottawa is determined to help reform the system, but the ‘how’ remains murky.
Parliament faced a major obstacle in that organ donation falls ultra vires federal jurisdiction.
International best practice comparisons may prove useful in this endeavour; for example, one might wonder how Spain’s DPMP rests at more than double that of Canada, at a rate of 39.7. The key to Spain’s success may result from the manner in which its intensive care units operate. Kim Young, director of donation and transplantation for Canadian Blood Services, points to the staffing of Spanish ICU facilities with donation specialists as a the key to their success. Clearly, it would be wise and fair to make this approach a priority in tackling subpar growth in Canadian organ donation.
Ottawa has proven generous in directly funding third party organizations, and where money flows, influence follows. This relationship holds true especially as organizations depend more and more on these funds in their financial planning. Since 2008, the provinces and the Federal Government have collectively invested $64 million in the Canadian Blood Services. While the aforementioned constitutional limitations restrict Parliament from direct intervention, Ottawa is still in a good position to effect change from the sidelines.
Jurisdictional boundaries do not necessarily fence off healthcare from federal involvement. || (Source: Flickr // mhambourger)
The weight placed on federal input is largely driven by its generosity and on the system’s dependence on external financial contributions. If the Canadian government wants to advance a strategic plan, its voice will surely be heard as it continues to provide funding. If the Trudeau government is as passionate about the issue as Khera makes it out to be, then it will consider reworking its strategy. Federal funding ought to entail guidelines that factor in best practices established by medical professionals in Spain.
Through deconstruction of the issue at hand, a subtle and important insight emerges: jurisdictional boundaries do not necessarily preclude federal involvement in healthcare. Yes, these matters fall under provincial jurisdiction. No, the Federal Government cannot directly manage national programs that clearly fall outside of its jurisdiction. Just because it cannot hop the constitutional fence, however, what barrier exists to prevent federally-supported third-party charities from taking action where the government cannot?
In last week’s segment, I explored the various extra-legal barriers to accessing hormone replacement therapy for trans individuals, for whom hormones are an essential part of their psychological and physical well-being. The discretion held by the provincial government over insurance coverage of prescription drugs also poses a significant risk to access to hormones, as there is a concern that the government will decide to delist hormones from provincial insurance coverage.
The potential delisting of hormones from insurance coverage is a recurrent fear in trans communities. At the political level, this seems unlikely, as trans rights have entered the progressive collective consciousness and cannot be openly opposed by governments who wish to appear progressive. Furthermore, insurance coverage for medication is largely done on a per-medicament basis, rather than based on the reason for the prescription, and drugs used in hormone replacement therapy are frequently used for other purposes, such as treating polycystic ovary syndrome or hypogonadism, both fairly common illnesses.
Many trans Canadians choose hormone replacement therapy to help manage dysphoria. Given the disproportionate financial disadvantages trans Canadians face, delisting hormones would further threaten their safety and well-being. || (Source: Susan Bein // wizmosis)
In Québec (whereas in the past trans persons have been protected from discrimination under the basis of “civil status”, “disability”, or “sex”) gender identity and expression are explicitly included in the Charter‘s section 10 as of June 10th, 2016.
The potential delisting of hormones from insurance coverage is a recurrent fear in trans communities.
Hogan v. Ontario (Health and Long-Term Care), 2006 HRTO 32, 58 CHRR 317 shows how uncertain guarantees under the Canadian Charter and Québec Charter can be with regards to trans healthcare. While the delisting of genital reassignment surgery in Ontario was found to be prima facie discriminatory, and would likely also have been found discriminatory under the Canadian Charter, it was saved by the bona fide justification analysis.
Trans rights groups have long battled for the human rights protections now entrenched in Canadian law. Governments have a duty to stand by these protections, including access to healthcare. || (Source: Wikimedia Commons)
We are here confronted not with clearly invalid potential regulations, but potential regulations which only may be invalid despite being imminently immoral. As for Hogan itself, I do not believe that it correctly applied the law. Despite the strong legal arguments that can be levied against delisting, Hogan shows a very real risk that any regulations delisting trans healthcare will be upheld as valid by the Courts, a risk that should not exist given the unnecessary anxiety it causes and the moral landscape of hormone replacement therapy in relation to trans well-being.
Ensuring access to hormone replacement therapy is a difficult and multifaceted task, and if improperly handled provides a fertile soil for the exacerbation of trans people’s vulnerabilities. On the legal plane, trans issues surrounding hormone therapy show the limitations of human rights law both in supervising the decisions of governments and private actors who may too easily bestow help on the least vulnerable of the vulnerable, instead of the most vulnerable of the vulnerable, and in addressing broader systemic issues arising from the interrelations between various public and private bodies. In the end, we can only hope that the government takes seriously the words of the Supreme Court of Canada in Eldridge: once the state provides a benefit, it is obliged to do so in a non-discriminatory manner.