Sound Body, Ailing Mind: the Complexities of Assisted Dying for the Mentally Ill

Posted By Liam Harris

Introduction

One of the more salient questions surrounding Canada’s new assisted dying regime concerns requests by persons suffering exclusively from mental illnesses to end their lives. While this option is not currently available in Canada, due to the requirement that death be reasonably foreseeable, Bill C-14 requires the government to conduct an independent review of issues relating to these requests within the next two years.

Global approaches to this issue are mixed. Belgium and the Netherlands permit such requests in cases where the mental illness causes “unbearable suffering with no prospect of improvement”, but the American Psychiatric Association recently approved a policy statement preventing its members from participating in assisted dying. While this is somewhat of a moot point in the United States, where medically assisted dying is not legal, the statement may have an impact here in Canada given the important persuasive role the APA plays in defining the “voice and conscience” of the psychiatric profession generally.

The right to die of the mentally ill has the potential to become the next great battle in the debate around medically assisted dying, raising unique legal challenges and flagging a potential role for the psychiatric profession in non-state regulation of the practice. While mental illnesses are diverse and not all challenges will apply to all conditions, the following themes and legal issues are expected to pose challenges in at least some cases.

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The Carter decision catalyzed Parliament to legalize assisted dying for those suffering from an irremediable physical illness, but what of those whose suffering is mental? || (Source: Dying With Dignity)

Reasonably foreseeable death

The requirement that “natural death has become reasonably foreseeable” excludes mental illness from the ambit of Canada’s new legislation. Since mental illness does not result in natural death, it alone can never constitute the grievous and irrevocable medical condition required to allow the option of physician-assisted death under section 241.2 of the Criminal Code. Notably, the inclusion of this criterion proved controversial at the drafting stage, as it contravened a recommendation of the Joint Special Committee that non-terminal conditions be included. Indeed, Professor Peter Hogg of Osgoode Law School suggested during his testimony that including this condition would make the law vulnerable to constitutional challenge as the Supreme Court alluded to no such criterion in Carter.

Allowing requests for physician-assisted death where mental illness is the sole medical condition is only possible if Parliament removes the reasonable foreseeability requirement. Interestingly, the outcome of the independent review may impact the approach to other non-terminal physical illnesses. Allowing cases of mental illness to circumvent the legislation’s criteria while continuing to require it in the case of physical illness appears logically inconsistent.

Never irremediable?

Another issue that arises in the cases of mental illness is the degree to which mental illness fulfills the criteria of being “irremediable”. Under Canada’s legislation, the requesting individual’s condition must be “grievous and irremediable”, which includes the criteria that it be “incurable” and cause “an advanced state of irreversible decline in capacity”. Psychological problems, being less tangible and less well-understood than physical ailments, complicate the assessment of remediability.

In conformity with the increasingly central recovery-based model of treatment, a variable combination of medical, therapeutic and social interventions might manage suffering such that mental illness is deemed “remediable”. In particular, in light of the fact that a large proportion of individuals suffering from mental illness do not have access to the resources they require, it may be difficult to say with certainty that a given case of mental illness cannot be effectively remedied: there is always the possibility that a different approach or more social support could reverse the decline in an individual’s condition.

Even though a mental illness may be incurable, it seems somewhat less likely, due to the complex causes and varied treatment options, that a psychiatrist would be willing to say that the progress of any given mental illness is irreversible and, therefore, irremediable. Without clear criteria for determining the remediability of mental illnesses, it is unclear how these cases could fit within the C-14 scheme.

Informed Consent

Another issue that complicates assisted dying for the mentally ill is their ability to give the informed consent as required to initiate the assisted dying process. Given that suicidality is a symptom of mental illnesses like severe depression, it may be difficult to separate a reasoned judgment to end suffering from a symptom of the disease. Deciding to end one’s life due to psychological suffering inevitably conflicts with the legal notion that psychological conditions that alter our reasoning can vitiate consent.

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The Carter decision and Bill C-14 took great care in handling issues regarding the patient’s consent. Providing medical assistance in dying for mentally ill patients will prove an even more onerous task. || (Source: Wikimedia Commons)

While most cases of mental illness do not result in a loss of general legal capacity, the president of the Canadian Psychiatric Association believes that when it comes to the specific decision of ending their lives, those suffering from certain mental illnesses may not have capacity to give informed consent. The forthcoming independent report will hopefully address the obtention of informed consent from patients whose decision-making capacity is impaired, but this will not be an easy task.

Resistance from Psychiatrists

Furthermore, another key consideration relevant to assisted death for those with mental illnesses is the extent to which the psychiatric profession may exert its normative power to blunt the occurrence of assisted death by psychiatrists. Bill C-14 does not require doctors to provide medical assistance in dying, leaving them free to decline to offer the treatment as long as they comply with their professional obligations. If Canadian psychiatrists adopted a similar policy position as the APA has just taken, we may see the profession en masse refuse to offer assisted death for patient who are suffering solely from a mental illness. Therefore, even if the government adopts changes to allow the practice, the practical effect could be minimal if psychiatrists continue to oppose the idea.

Conclusion

As our government continues to study the issue of medical assistance in dying for persons suffering exclusively from mental illness, it remains an open question if and how these cases will be brought within the Bill C-14 framework. The particularized treatment of mental illness as compared to physical illness reflects an ongoing struggle to understand and destigmatize psychiatric conditions. It seems natural in this largely uncharted territory – perhaps we should turn to medical experts to guide lawmakers – and it remains to be seen what kind of influence the psychiatric community will have on the future of this legal issue in Canada. Of equal importance, though, is ensuring a place for the voices of those suffering from mental health issues at the center of this discussion. Only through meaningful engagement with a broader subset of stakeholders can the legislature and the Courts strike the fine balance required for such a sensitive issue.

From Lab to Court: Neuroscientific Evidence and Legal Decisions in Disorders of Consciousness and Beyond

Posted By Dr. Anastasia Greenberg

For many, the term “vegetative state” brings to mind the American case of Terri Schiavo and her decade long legal battle (1992-2002) surrounding the “right-to-die”. Terri sustained serious brain damage in 1990 following a cardiac arrest, which led to an eventual diagnosis of a persistent vegetative state. Terri’s husband fought for the right to remove her feeding tube while her parents were desperate to keep her alive, believing she was conscious. Ultimately, Terri’s artificial life support was withdrawn in 2005, stirring an ongoing debate on the difficult ethical and legal implications in similar cases. Progress in neuroscience gives us hope in being able to answer key questions about brain and behaviour with direct relevance for the legislature and the courtroom.

Disorders of Consciousness

Vegetative state can be defined as “wakefulness without awareness”, in which patients show normal sleep-wake cycles (unlike a coma which is analogous to a deep sleep) but without any evidence of purposeful behaviour connected to awareness of the self or the environment. While wakefulness is straightforward to detect based on sustained eye opening and specific electroencephalogram (EEG) activity, the existence of awareness poses a much more complicated question.

In order to measure consciousness or awareness, we rely on behavioural evidence of “command following” as a proxy to make inferences about mental states. For example, locked-in syndrome patients have lost almost all ability to make voluntary movements but retain the ability to respond to “yes” or “no” questions by moving their eyes or eyelids in a consistent manner. This residual ability to form purposeful behaviour leaves no question that the patient is indeed conscious.

Hospital BedAdvances in medical science have changed our understanding of consciousness in patients in a “vegetative” state. || (Source: Flickr // Presidencia de la República Mexicana)

Unfortunately, the difficulty with vegetative state patients is that they do not show any such meaningful behaviour or evidence of language comprehension. These patients will stare into space, move their eyes in an inconsistent manner and may even burst out into laugher or tears; however, none of these behaviours are linked to environmental stimuli.

For a long time, it was believed that such patients were completely unconscious. However, in the last decade this orthodox notion has faced serious scrutiny, regarding at least some of these patients, due in large part to the work of Canadian neuroscientist Dr. Adrian Owen from the University of Western Ontario.

Neural Activity as A Proxy for Behaviour

Dr. Owen’s research method allows certain patients who are labelled as vegetative to communicate solely by modulating their brain activity, recoded using functional magnetic resonance imaging (fMRI). fMRI makes inferences about brain activity indirectly by measuring blood flow, which is temporally linked to neural activity in that recently active cells require a fresh supply of oxygenated blood. This allows scientists to gauge which parts of the brain are involved in various cognitive tasks with high spatial resolution.

In a notable study, Dr. Owen’s team asked “vegetative state” patients in the fMRI scanner to imagine playing tennis or to imagine walking around their house from room to room. When healthy patients are asked to perform this same task, imagining playing tennis shows activation in a part of the brain called the supplementary motor area (SMA) while walking around the house activates parahippocampal corticies (PPA) which are involved in real and imaginary spatial navigation.

Remarkably, a portion of vegetative state patients (17%), diagnosed based on internationally recognized behavioural standards, show consistent SMA activity when instructed to imagine playing tennis and PPA activity in the case of walking around the house. Even more remarkably, they were then able to use imagining playing tennis or imagining walking around the house to respond “yes” or “no” to questions – with 100 percent accuracy. Using their imagination, this select group of vegetative state patients responded correctly to questions about their own name, their parents’ names, the current year, and so forth.

Ethical Issues

These findings make legal characterizations pertaining to the decision to withdraw nutrition and hydration even more complicated. In a personal communication with Dr. Owen, he mentioned that one such patient was asked whether he wished to continue living. He responded: “yes”. This is exciting news in the context of legal decision-making; perhaps we could simply ask the fMRI-responsive patients to decide their own fate.

24130148711_12dae8e061_kfMRI scans allow doctors to prompt and make inferences about neural activity in patients in a “vegetative” state, in some cases enabling a limited channel of communication. || (Source: Flickr // NIH Image Gallery)

But what can be said for the remaining 83% of patients? Can we conclude that they are simply not conscious, and thus truly fit their derogatory label of “vegetative”? The problem with such a conclusion is one of false negatives. When someone consistently “responds” to high-level questions with their brain activity, we can be sure of their consciousness – arguably to the same extent as someone who is saying “yes” and “no” in plain English (or French).

However, when a vegetative patient fails to show any meaningful fMRI responses, we cannot be certain that they are not conscious. Consider, for example, patients that have lost function in their auditory cortex and thus cannot hear the task instruction nor questions – not to mention many more nuanced neural complications that may prevent successful performance despite consciousness.

Legal Applications for Neuroscience Data

Dr. Owen’s work has received enormous media attention and, most relevant to the legal context, Dr. Owen recently submitted an affidavit that was admitted into evidence by the Supreme Court of British Columbia (BC) in Ng v Ng (2013). Kenny Ng was involved in a motor vehicle collision that left him in a minimally conscious state (higher functioning than vegetative) from 2005 onward. Kenny’s wife, who was entitled to give substitute consent for Kenny under BC’s Patient’s Property Act (PPA) and Health Care (Consent) and Care Facility (Admission) Act (HCCFA), decided to take Kenny off of life support in spite of opposition from his siblings.

In a personal communication with Dr. Owen, he mentioned that one such patient was asked whether he wished to continue living. He responded: “yes”.

Dr. Owen’s affidavit could not speak specifically to Kenny’s case given that Kenny never participated in any studies by Dr. Owen’s team. However, it suggested that Kenny could potentially fall into the category of those with awareness and is a good candidate for further study. Ultimately, though, the court ruled in favour of Kenny’s wife since she held the decision-making authority pursuant to legislation and since the removal of feeding was found to be reasonable given the available medical evidence supporting Kenny’s poor clinical prognosis. The court had no legal mechanism by which to order that Kenny be tested by Dr. Owen, a neuroscientist, and set aside the recommendations of Kenny’s team of medical doctors.

An Eye to the Future

The potential applications of neuroscientific evidence in courtrooms and in end-of-life legislation are exponentially increasing. Publications in the developing study of neuroscience and law, coined “neurolaw”, have spiked since 2006. Both neuroscientists and legal scholars express optimism, but they also emphasize erring on the side of caution when admitting flashy neuroscience into court. While the direct legal relevance of Dr. Owen’s work for use in a courtroom setting is persuasive, it also presents many opportunities for abuse, or innocent misinterpretation, of neuroscientific information.

US courts have admitted brain scans (including fMRI) into evidence in criminal cases involving insanity defenses (called defense of mental disorder in Canada), as well as highly controversial fMRI lie-detection evidence. In Canada, fMRI data has not yet seen its day in court and may raise serious Charter issues in relation to brain privacy. Dr. Owen’s affidavit in Ng v Ng is one of only two Canadian cases to ever mention fMRI in more than an incidental way. In a controversial ruling in Italy, a court reduced a sentence for murder after being presented with neuroscientific evidence in the form of brain scans and genetic evidence that suggested links to poor impulse control.

CourtLegislators and the courts will have to grapple with the risks and benefits of allowing the adducement of neuroscientific evidence before a judge. || (Source: Flickr // Jordan Schulz)

A deep understanding of neuroscientific technology and methodology is invaluable in drawing valid conclusions based on the data presented. A jury may interpret a colourful fMRI image as analogous to an X-ray – being able to “see” brain activity – when in fact the image is created through a series of inferential steps involving complicated statistical analyses performed on the data. These steps are peppered with human decisions about which statistical thresholds are to be used, which behavioural conditions should be compared, and so forth. Concerns over “overclaim syndrome” relate to the persuasive “wow” factor neuroscientific evidence evokes. In one study, mock jurors were more likely to give a verdict of “not guilty” if a defense of mental disorder was presented along with MRI images.

Neuroscientific evidence also has the potential to influence end-of-life legislation, such as BC’s PPA and HCCFA that were used to transfer consent to Kenny’s wife, by requiring neuroscientific interventions before transferring consent. Currently, however, such a provision can only exist in the parliament of dreams, as neuroscientific tests of consciousness are far from routine procedures.

Neuroscience and law have begun to converge, developing the field of neurolaw with international neurolaw conferences and societies bringing scholars and practitioners from both disciplines together to explore their mutual interests. Professor Henry T Greely of Stanford Law School predicts that neuroscience will revolutionize the law: while the consequences of this neurolaw revolution carry serious risks, a future that offers a “window into the mind” may prove more conducive to justice. For those conscious patients trapped behind a “vegetative” label, neuroscientific evidence may provide sufficient weight to tip the scales of justice.

Dr. Greenberg holds a PhD in Neuroscience from the University of Alberta, and recently began studies at the McGill Faculty of Law.

Medical Records — Dossiers médicaux

Posted By Lauren Hanon & Prof. Shauna Van Praagh

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.

New Policies On the Horizon for Clinical Trials Data Sharing: Is the McGill Community Ready?

Posted By Adrian Thorogood

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?

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The quality and reliability of published research depends on peer review of not just the findings, but also the clinical trials data that support them. || (Source: B.A. Nosek et al. | Science 2015:348)

The Canadian research community is waking up to the possibility of a data sharing policy. The Tri-Council Agencies’ 2016 Statement of Principles on Digital Data Management gives helpful guidance, while pointing out that infrastructure and support needs to be established before data sharing policies are implemented. McGill Library Research Data Service and the Canadian Association of Research Libraries are working tirelessly through collaborations like the Portage network to encourage researchers to preserve, annotate, and share their data responsibly.

Dr. Serge Gauthier – McGill Professor in the Departments of Neurology & Neurosurgery, Psychiatry, and Medicine, and Director of the Alzheimer Disease and Related Disorders Research Unit of the McGill Center for Studies in Aging – shared his perspectives on ethical aspects of data sharing in dementia research, gained through his experience with the Canadian Consortium on Neurodegeneration in Aging (CCNA). The CCNA is a Canadian Institutes of Health Research (CIHR)-funded five-year study following a diverse cohort of 1600 subjects.

The CCNA plans to give primary investigators one year to analyze the data before sharing with the wider scientific community. Agreements will be in place for sharing of both data and samples to ensure users protect the privacy of participants and acknowledge the contributions of the biobank. How should researchers identify and communicate “clinically meaningful findings” to participants, especially when samples and data may be shared and re-analyzed for decades? Guidelines determining clinical relevance are liable to change over time. Further, how should disclosure rules and processes be explained to participants when obtaining consent?

Professor Richard Gold, James McGill Professor at the Faculty of Law, who specializes in intellectual property in the life sciences, addressed ethical transparency in open science. While the primary goal of openness is to accelerate research speed, it can also improve the monitoring of research. However, participants will not know, at the time of consent, what research will be conducted, by whom, and for what goals; all of these points raise questions about informed consent. Professor Gold chairs an independent committee to oversee the McGill Neurological Institute’s “open science” policy.

How should researchers identify and communicate “clinically meaningful findings” to participants, especially when samples and data may be shared and re-analyzed for decades?

The MNI’s policy is to make all data (including models and code) publically available when the first article on a dataset is published, even where the data is generated through industry partnerships. The MNI policy discourages researchers from patenting and does not provide them institutional support to do so. The MNI recognizes that it is itself an experiment in innovation. Will openness increase the use of MNI data and materials? Attract sustainable funding, and leading researchers? Lead to new innovation? Inspire other institutions to follow the MNI’s lead?

I spoke to the inherent tensions between openness and participant privacy. This tension often preoccupies research ethics boards (REBs) who oversee open science protocols. Indeed, data sharing calls into question assumptions that research data can be kept anonymous and confidential. Is anonymity feasible – or even desirable – in a Big Data era, where research is fueled by voluminous individual-level data, linked across various sources, and tracked over time? Is confidentiality meaningful where research data is available to wide communities of scientists, bound together by loose organizational relationships and immature IT networks?

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Granting peers access to clinical trial data is an essential step in the life-cycle of data management for clinical trials. || (Source: Matthias Töwe | ETH-Bibliothek)

In light of these uncertainties, how do REBs oversee data sharing? They may be able to assess data sharing plans, to ensure security safeguards and accountability mechanisms are in place. They could also assess data sharing plans to ensure data will be made available in a timely and streamlined fashion. To hold researchers accountable for openness, REBs could even withhold approvals from researchers who consistently fail to share data that has consent to be shared.

The questions posed to the panel reflected a mix of enthusiasm and anxiety about data sharing among the McGill community. While data sharing principles have been articulated, many attendees were unsure what data sharing will mean in practice for innovation, researchers, and patients. What does “open” really mean? What types of data will be shared, with who, and when? What technical infrastructure and governance structures are needed? Who will pay for it? Will researchers be encouraged to share, or forced to do so? How will generation of valuable research data be recognized and rewarded? What incentives will be in place for researchers to share?

There are many possible directions. Funders could inspect investigators’ history of sharing and the quality of data sharing plans during grant applications. An “impact factor” could be developed to measure a researcher’s contribution of valuable data to the research community. To make it easier to identify researchers who fail to share, policies can include a clear deadline (e.g. data must be shared within 18 months of publication). This makes it easy to identify who has failed to share in a timely manner, but may not offer flexibility for different research contexts. Data quality was another prominent concern. Publications are peer reviewed, but there is no clear arbiter for the quality of individual-level patient data shared through a repository.

The emergence of citizen science presents new opportunities for individuals to engage with research, by sharing their health data through web portals, or by accessing and analyzing datasets. This raises new questions about the bounds of “openness”: who can be trusted to use clinical trials data appropriately, and keep it safe?

Data sharing also impacts the relationship between researchers, participants and society. It remains unclear if participants in clinical trials will be given a choice to opt-out of data sharing, or if sharing will be a mandatory component of participation. Special considerations are needed for data generated through partnerships with developing countries that emphasize benefit sharing and capacity building. The emergence of citizen science presents new opportunities for individuals to engage with research, by sharing their health data through web portals, or by accessing and analyzing datasets. This raises new questions about the bounds of “openness”: who can be trusted to use clinical trials data appropriately, and keep it safe?

While it is still early days for clinical data sharing, it is reassuring to see that there is already a diverse and passionate community at McGill keen to move towards open science. It is time we aligned our efforts.Adrian Thorogood is Coordinator of the Regulatory and Ethics Working Group of the Global Alliance for Genomics and Health, a public-private consortium developing technology and forward-looking policies to promote the international sharing of genomic and health-related data. (Bio.)

Three’s a crowd? Three-Parent Babies and the Future of Assisted Reproduction in Canada

Posted By Liam Harris

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.

However, the mitochondrial replacement technique (MRT) remains highly controversial, both medically, due to unknown side-effects, and ethically, because the donor’s genetic information will be passed on to future generations. In fact, American doctors performed this procedure in Mexico to bypass an American ban. MRT is illegal in Canada under the Assisted Human Reproduction Act (AHRA), but other jurisdictions such as the UK have legalized the technique.

What are the risks and benefits of MRT? And what can these developments tell us about our reproductive legal regime in Canada?

The Science

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.

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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.

The Risks

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 Law

The replacement of the egg’s mtDNA with that of the donor alters the genome in a way that is potentially inheritable, placing the technique within the ambit of prohibited practices in Canada. Section 5(1)(f) of the AHRA states that “[n]o person shall knowingly alter the genome of a cell of a human being or in vitro embryo such that the alteration is capable of being transmitted to descendants”. Doctors carrying out the procedure in Canada could face harsh penalties: up to $500,000 and a ten-year prison term.

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.

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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.