Chris Laliberté – McGill Journal of Law and Health

9th Annual MJLH Colloquium in Review: Indigenous Health and Access to Medicines in Canada

Posted By Chris Laliberté

On Saturday, February 11th, the McGill Journal of Law and Health hosted its ninth annual Colloquium Event. Held in the Moot Court, the event titled “Access and Equity: Indigenous Health and Law in Canada” featured two panels of experts and activists who regularly engage with First Nations peoples and the challenges they face accessing healthcare in Canada.

The morning panel featured Dr. Cindy Blackstock, PhD, Professor Larry Chartrand, and Dr. Janet Smylie, MD, MPH. The discussion centred on the systemic and social barriers to equitable healthcare for First Nations peoples.

Dr. Blackstock discussed the dissonance between the Crown’s spoken intentions to provide aid to First Nations communities and the repeated use of technicalities to defeat cases before the court can address the merits. In particular, she cited an instance where the Ministry of Indian Affairs failed to provide emergency aid funding for suicide prevention programs because the requests came at an awkward time in the funding cycle. Of the $200M needed, only one third – $60.38M – made it to the communities in desperate need of help.

“If it’s not good enough for the Canadian Human Rights Tribunal, why is it good enough for you?” –Dr. Cindy Blackstock on Parliament’s excuses for inaction on First Nations issues

Next, Prof. Larry Chartrand offered a critical perspective on Hamilton Health Sciences Centre v. D.H., clarifying the contentious points as regards the application of s. 35 Aboriginal Rights. Chartrand argued that Western interpretations and applications of the law tend to ignore the collective nature of Aboriginal Rights so as to threaten their independence and render them meaningless. In fact, the imposition of Western notions of the “best interests of the child” inherently denies the sovereignty of First Nations peoples and the principles of First Nations law—such as the Haudenausonee nation’s core tenet to act in the best interests of their children. In the spirit of reconciliation, Chartrand asked neither agreement or even endorsement, only understanding, trust, and respect for First Nations peoples’ self-determination in healthcare.

Dr. Janet Smylie, as a practicing physician, recounted her first-hand experiences with the injuries and deaths suffered by First Nations patients due to negligence motivated by racist assumptions among hospital staff. Smylie emphasized the need for intersectional approaches to law and healthcare, pointing to systemic, epistemic, and attitudinal racism as predominant barriers to the equitable provision of health services. She cited the tragic Brian Sinclair case and the demonstrable failure to provide emergency interventions for First Nations patients as examples of death by discrimination. To combat the underlying prejudicial effects of colonialism on the health of First Nations peoples, hospitals and staff in Canada must implement anti-racist training and practices to account for unconscious bias and provide more equitable care.

After a short lunch, the afternoon panel featured Mr. Normand D’Aaragon, Dr. Christopher Lalonde, PhD, and Dr. Ronald Niezen, PhD. The discussion centred on the causal relationships underlying the high rates of suicide among many First Nations communities, and means of addressing this crisis.

Mr. Normand D’Aragon opened the afternoon with a discussion of his work helping First Nations families heal the wounds of intergenerational trauma due to a history of colonial violence and oppression. D’Aragon relayed his experiences working with two families. The first family, he said, had lost their eldest son to suicide, and feared for the well-being of their second. He traced their family’s story to the grandmother’s two brothers, who never returned from residential schools. Future sons in the family, he said, were deprived of their individuality as a result of the unresolved grief over the ancestral loss of life. Another case concerned a family in which a girl who attempted suicide had lost three cousins and an uncle to self-harm. D’Aragon traced this grief back to the trauma of the great grandparents, who lost five children in infancy due to toxic water on the reserve and neglectful treatment at the hospital.

Dr. Christopher Lalonde presented his team’s work quantifying the suicide crisis among First Nations communities so as to identify pain points and causation in an effort to direct and distribute interventions that will result in healing for the affected communities. Among other misrepresentations, Lalonde dispelled the implication conveyed through the media that being of First Nations heritage is itself a risk factor for suicidal ideation, an idea he described as “insulting and clearly false”. In fact, First Nations communities show immense variability in suicide rates by health region and census region, with over half showing a 0 rate of suicide. The data collected by Lalonde’s team suggest an inverse correlation between the suicide rate and a variety of social factors, including cultural continuity, inclusion of women in government, political autonomy, and access to mentorship and education services. Communities proved healthiest when granted the autonomy to preserve and promote traditional practices while navigating a clear and unified path towards the future.

“Give Cindy Blackstock all the money she ever asks for.” –Dr. Christopher Lalonde on activism for First Nations peoples access to medical care

Dr. Ronald Niezen concluded the panel by recounting his experience working with First Nations communities, and his observations as to the social patterns underlying the development of suicide crises. In the six months he spent working with intervenors on the reserve, there were 144 reported interventions and 9 suicides. Niezen explained that suicide clusters like this one emit a certain social influence that encourages mutual action, and that the ideation of suicide spreads throughout the community as a response to colonial trauma. He also expressed concerns that the publicity given to interventions creates a tension between the call to action for relief funding and the risk of stereotyping First Nations peoples in the public perception.

Revisiting Hamilton Health Sciences Corporation v. D.H.

Posted By Chris Laliberté

When illness threatens to steal a child from their community, tensions can reach their limits as time runs out. Parents, doctors, social services, and others clash over how best to care for someone too young to comprehend what is happening to them. In the past, courts have grappled with complex issues where religious freedoms conflicted with life-saving operations, compelling parents to withhold consent. In the fall of 2014, the Ontario Court of Justice had these cases in mind as Justice Edward J. was tasked with deciding whether an eleven year-old First Nations girl (J.J.), suffering from acute lymphoblastic leukemia (ALL), would be taken into custody for chemotherapy treatment. The decision in this tragic case concerned a child’s capacity to consent to care, the applicability of Aboriginal rights claims to traditional practices, and whether parents choosing alternative treatments in good faith can be deemed to be endangering their child. Continue reading “Revisiting Hamilton Health Sciences Corporation v. D.H.”

Recap of the 9th Annual MJLH Colloquium: Assisted Reproduction Law Reform Post-Term in Canada

Posted By Chris Laliberté

On February 6, 2016, the McGill Journal of Law and Health hosted its 9th annual Colloquium to explore the legal framework surrounding assisted reproduction practices in Canada. The controversial issue brought together doctors, lawyers, and professors to discuss the impact of the Assisted Human Reproduction Act (AHRA) and the criminalization of third-party reproduction on Canadian families.

Panelists for the day included fertility law practitioners Sara R. Cohen and Sherry Levitan, doctors Arthur Leader and Neal Mahutte, and professors Margaret Somerville and Françoise Baylis.

Me Sara R. Cohen opened the discussion with a practical, what she called “on the ground”, perspective of the issue through her work with clients seeking to start a family through surrogacy. She spoke about how in her work with Fertility Law Canada, she aims to help hopeful parents-to-be overcome the complex legal hurdles that mark the track from the pre-conception planning stage to the finalization and execution of the surrogacy contract.

Me Cohen argued that the state of the law in Canada, in particular the criminal sanctions imposed pursuant to s. 6(1), 6(2), 6(3) and 7(1) of the AHRA, contravene the regulatory purposes of protecting women who wish to provide surrogacy services, and families who have chosen surrogacy as the preferred, and in some cases, only means to start a family. For example, the s. 6(1) prohibition on payment has created a spirit of secrecy due to fear of harsh penalties under the law, says Me Cohen. Although she admitted to no knowledge of charges brought against women offering surrogacy services or the families who hired them, the practitioner emphasized that the threat of enforcement alone causes harm through engendering reproductive tourism and a lack of medical safety from deregulation.

Professor Margaret Somerville then took the podium to defend the Canadian criminal prohibitions as a means of preventing the commodification of human lives and bodies. She first contended that the current debate suffered from an error in perspective: the needs of the parents are placed at the forefront while the best interests of the child are seemingly left out of consideration. Professor Somerville went on to claim that the child, in the context of a surrogacy contract, is treated as a product rather than as a party. Her reasoning framed the discussion as a conflict between the rights of a child to a happy life and the rights of adults to be parents. She argued in defense of a child’s right to the equal freedom afforded by a natural birth through the “genetic lottery” rather than the predestination of a genetic design, which she likened to manufacturing a product.

Professor Somerville also argued that the decriminalization of surrogacy services would threaten the safety of socioeconomically disadvantaged women, who are most vulnerable to exploitation. She compared the power dynamics to those involved in prostitution, making the claim that consent to these arrangements cannot be free and enlightened when a woman in a desperate situation has to choose between offering her body or starving. Me Cohen would rebut this point during the Q&A period, arguing that the situation is not so bleak in the Canadian context, and that proper regulation would advantage and empower women in our healthcare system, not subject them to exploitation.

Professor Françoise Baylis closed out the first half of the day with a critical look at what the legislation states and, with greater scrutiny, what it fails to say. In her presentation, she argued that although the legislation, as it is written, clearly defines the state of the law, Health Canada’s reliance on an evasive interpretation of outdated legislation allows for uncertainty due to voluntary omissions where clear regulatory guidelines could dispel any need for quasi-legal circumnavigation. A defined regulatory framework would allow purchasers and providers of surrogacy services to understand how best to proceed without risks of sanctions. Further, the inaction of Health Canada in enforcing the current legislation only creates greater confusion as to what is and is not permitted, or, what will be allowed in spite of the statutes.

Dr. Arthur Leader, a specialist in fertility treatments, opened the second half of the Colloquium with a brief, but insightful comparison of the legislation regarding in vitro fertilization (IVF) and surrogate pregnancies in the UK and in Canada. His presentation holds the UK model as an example for what fertility medicine regulations could look like in Canada after substantial revision. The Canadian model could better serve its people by lifting or loosening restrictions on surrogacy and IVF research and treatment, which would allow the Canadian healthcare community to drive innovation in the field and give Canadian citizens domestic access to the services they need, rather than forcing them to travel abroad.

The Q&A session that followed, co-chaired by Dr. Leader, Dr. Neal Mahutte, and Me Sherry Levitan, touched on a broad spectrum of issues faced by legal and medical practitioners in the field of assisted reproduction. The panel responded to concerns ranging from the framework for IVF funding, to the lack of statutory guidance in disputes over the ownership of frozen embryos, to the effects of donor anonymity on a child’s rights to access their medical history.

Overall, this year’s colloquium has made clear that the legal framework surrounding third-party reproduction in Canada remains oblique at best. As legislators continue to grapple with ethical concerns and struggle to keep pace with advances in medical technology, the absence of clearly defined regulations poses many challenges for Canadians in need of these services to start a family. Until the government addresses this gap in the law, collaboration between fertility doctors and fertility lawyers will continue to prove invaluable in granting these families access to the treatments and services they require.

To join in on the discussion, make your voice heard on the MJLH website, Facebook page, or Tweet @McGill_JLH. For those interested in getting involved with fertility law, Dr. Baylis invites passionate writers to contribute to her website, Impact Ethics. For law students interested in the practice of fertility law, Me Sherry Levitan invites you to contact her about a student position with her firm in Toronto.

Tough Pill to Swallow: the Constitutional Challenge Threatening Access to Pharmaceuticals in Canada

Posted By Chris Laliberté

Not all diseases are created equal. Many incredibly rare conditions, such as paroxysmal nocturnal hemoglobinuria (PNH) and atypical haemolytic uremic syndrome (aHUS), occur in only a small percentage of people. These orphan diseases, defined by the FDA as occurring in less than 200,000 people across the United States, have such low prevalence rates that pharmaceutical companies are rarely willing to undergo the research, development, and manufacturing process necessary for limited commercial opportunities. As a result, many orphan diseases have finite treatment options, if any.

Those suffering from PNH and aHUS can count themselves among the lucky few. Not only do they have a treatment for their conditions, but one that has proven highly effective: Soliris. The only hitch – and a major one, at that – is the price tag, ringing in at over $700,000 per year for the rest of the person’s life. Despite its proven effectiveness and life-saving impact, the hefty cost has made public healthcare plans and services hesitate before approving coverage, leaving Canadians like Glen Dornian wondering if they will live long enough to regain their quality of life.

Without any justification for this exorbitant cost, the federal regulator has filed for a hearing to impose a limit on the price of Soliris in Canada and recoup some of the costs incurred over the past few years. Alexion Pharmaceuticals has responded with a countersuit that could threaten the stability of equal access to treatment in Canada.

Law

The Patented Medicine Prices Review Board (PMPRB), who acts as a regulatory watchdog for pharmaceutical pricing in Canada, filed a statement of allegations against Alexion Pharmaceuticals on January 15th of this year regarding the price of the drug Soliris. The statement claims that Alexion has, since 2012, sold Soliris to Canadians at an excessive price and demands that the company bring its pricing down to reasonable levels.

On September 11th, Alexion Pharmaceuticals filed a countersuit through the Federal Court in an attempt to block the PMPRB’s hearing. Alexion is seeking a writ of prohibition pursuant to s.18 of the Federal Courts Act on the grounds that the Board’s claim lays ultra vires federal jurisdiction. They allege that pharmaceutical pricing falls under provincial powers pursuant to s. 92(13) of the Constitution, which grants regulatory jurisdiction in matters of property to the province.

Now, s.83 of the Patent Act imbues the PMPRB with rights to enact the following:

(a) reduce the price at which the patentee sells the medicine in any market in Canada, to such extent and for such period as is specified in the order;

(b) reduce the price at which the patentee sells one other medicine to which a patented invention of the patentee pertains in any market in Canada, to such extent and for such period as is specified in the order; or

However, Alexion’s challenge will ask the federal court to rule on whether s.91(22) of the Constitution, which addresses “Patents of Invention and Discovery” and would allow the Board’s motion to proceed, has supremacy over s.92(13).

A Federal Court ruling in favour of Alexion, if not appealed, would establish precedent that handcuffs the PMPRB due to the division of powers in the Constitution. If the Board is incapacitated in this way, it would fall to Provincial Governments to impose limitations on pharmaceutical prices.

Policy

Canadians in need of pharmaceutical treatment already face inequality due to coverage variations from province to province. Since each province decides what its own system will cover, and for what disease – Ontario just recently approved coverage of Soliris prescriptions for aHUS – those in need of life-saving medicine could find themselves fighting an uphill battle for no reason other than holding the wrong health card.

A ruling in this case that places pharmaceutical pricing regulation in provincial hands would likely exacerbate these inequalities. Unless the provinces work together on parallel legislation imposing the same restrictions in every jurisdiction, then disparities in pricing could have serious detrimental effects concerning access to Soliris.

Whether, and how much, each province chooses to limit the sale price of particular pharmaceuticals could drastically affect which Canadians have access to the treatment they need, the cost, and who pays. Provinces could, with both options under their jurisdiction, justify the exclusion of such drugs from public coverage with a limit on the sale price. Rather than work orphan disease treatments like Soliris into the healthcare budget, a province could instead claim the imposition of a “reasonable” price as having done its duty to the patients and insurers who would have to bear the cost.

Alternatively, disparities in price caps from province to province could result in drugs like Soliris becoming unavailable in certain jurisdictions. Alexion has no obligation to offer the drug in every jurisdiction, and would have no reason to distribute in provinces with heavy restrictions on pharmaceutical pricing. Canadians whose lives depend on such treatments would then have to move or travel in order to seek the care they need.

It would seem far more appropriate, then, for the Federal Government and the PMPRB to retain their regulatory powers over pharmaceutical pricing. While federally imposed price caps cannot guarantee that every province will elect to cover the treatment, the lower costs make coverage more appealing while the nationwide consistency ensures equal access and availability to every Canadian. While a pharmaceutical company like Alexion could feasibly limit distribution to provinces with favourable price caps, it seems highly unlikely that a nationwide cap would drive them to withdraw from Canadian markets entirely.

Conclusion

That a life-threatening condition occurs in only a small percentage of the population should not preclude those patients from equal access to treatment in Canada. While the PMPRB has sought to reduce the burden on Canadian healthcare and increase accessibility to treatment by imposing a limit on the excessively priced Soliris, the countersuit by Alexion threatens to produce a ruling that could destabilize the availability of pharmaceuticals due to provincial disparities in regulation. To preserve and enhance equal access to medical treatment across Canada, the Federal Court should reject Alexion’s countersuit and uphold the Board’s power to regulate pharmaceutical prices at the federal level.

Herd Susceptibility: A New Mass Tort?

Posted By Chris Laliberté

“I noticed that her fingers and her mind were not working together and she couldn’t do anything.
‘Are you feeling all right?’ I asked her. ‘I feel all sleepy,’ she said.
In an hour, she was unconscious.
In twelve hours she was dead.”
–Roald Dahl

I am ten years old. Ashley, the babysitter, wakes me up, serves me breakfast, and walks me to the end of the snow-laden, car-free driveway. My bus driver, Mary-Ann, greets me with a knowing smile, but the downward curve in the wrinkles at the corners of her eyes betrays the concern behind her cheer. Mary-Ann loved every kid who rode that bus like her own grandchild, and one of us had taken ill.

While I run around at recess, snooze through long division, and blast my way through StarFox, my parents spend every night in the hospital with my younger brother, Jonah. My parents wring their hands and pace beside Jonah’s hospital bed as every day, his tiny seven year-old body grapples with scarlet fever. Thankfully, with the help of the team at Hôtel Dieu Hospital, my brother survives.

Jonah was the same age then as Roald Dahl’s daughter, Olivia, when measles encephalitis stole the light from her eyes, and from her father’s life. Neither Dahl nor my parents had a proven and effective vaccine available to protect their child against such terrifying diseases; both, having witnessed the devastation wrought upon their beloved children, would have accepted such help without question.

To know a loved one, especially a child, is at the mercy of a deadly pathogen—a force over which medical professionals have only limited control after infection—induces the worst kind of fear, the fear that this intrusion on your loved one’s health could cause them permanent harm. That the risks adopted by another parent could introduce such a threat to a vulnerable child poses more than an ethical dilemma—I propose that the endangerment of others through the disruption of herd immunity raises a possible cause for legal action in the doctrine of negligence.

Herd Immunity & the Duty to Vaccinate

In large part, vaccines owe the success of their inoculative effects to the herd immunity principle. Contagions require viable hosts for the infection to spread; in a vaccinated community the immunized population creates a barrier that protects those who, for health reasons, cannot receive vaccinations themselves.

The success of herd immunity depends on immunizing the greatest possible proportion of the population. While most can accept vaccines without issue, a small percentage of people cannot due to various health-related reasons, including pregnancy, allergies, or compromised immune systems. Every person able but unwilling to accept vaccinations therefore increases the risk of exposure for this vulnerable minority. In effect, this risk implies a moral duty to vaccinate.

A Legal Right to Refuse Treatment…

The issue proves more complex when trying to establish a legal duty. All persons in Canada retain a right to refuse medical treatment. This right is entrenched in arts. 10-18 CCQ in Quebec, and under legislation such as s.10(1) of Ontario’s Health Care Consent Act in the Common Law provinces. To force anyone to accept vaccinations would violate this right to bodily integrity.

Further, since opting out of vaccinations poses no substantial or immediate risk to the child’s well-being, it seems unlikely that Courts would deprive parents of their authority over their child’s medical care, a right confirmed in B(R) v Children’s Aid Society of Metropolitan Toronto. Under ordinary circumstances, s. 7 of the Charter protects a right to personal autonomy, including a parent’s “right to choose medical treatment for their infants.” A Court would therefore likely not force a parent to have their child vaccinated.

The entrenchment of and need to protect these rights causes me to question both the ethics and the effects of bringing criminal negligence charges against parents who refuse to vaccinate their child, as some have suggested. Assuming an identifiable party at fault for an outbreak, innocent families who have suffered could find a more reasonable and, arguably, effective recourse in civil action.

…and a Legal Wrong to Cause Harm

While many might consider this refusal an omission, I would consider the exercise of any right, even one of refusal, an action. The importance of this distinction lies in the need to first establish a duty to act before an omission constitutes negligence. This step does not exist in claims based on actions, as actions carry the “legal duty to refrain from conduct that a reasonable person would know […] might constitute an unreasonable risk of harm to others.” It is therefore much simpler to sue on an action rather than an omission since the right to act in a certain way does not protect against the risks incurred by the action.

Harvard Law professor Arthur L. Caplan and his co-writers recently laid out a roadmap for success in a hypothetical civil suit, and the same criteria could satisfy the Canadian test for negligence. Caplan argues that, in the case of a rare disease like the measles, “epidemiological analysis could link the two children with a high degree of confidence” to provide a reliable case for causation.

With causation established, a civil action grounded in the tort of negligence relies on proof of a failure to take reasonable precautions by the party at fault. A failure to account for the foreseeable possibility of an unvaccinated child contracting measles and exposing peers to the disease could prove a breach of duty of care, and strengthen the case for prima facie tortious negligence.

In terms of damages, plaintiffs could make arguments for pain and suffering as well as the quantifiable medical costs incurred.

Conclusion

Parents who exercise their right to refuse vaccinations for their child retain the right to do so pursuant to legislation that protects the integrity of the person and allows patients to refuse medical treatment. The exercise of this right, however, should not release parents who refuse to vaccinate from the duty to take reasonable care to protect herd immunity and the health of those who lack the option to vaccinate. A failure to take these reasonable precautions could cement a prima facie claim of tortious negligence against the parents at fault.

Both the moral and legal situations surrounding the right to refuse vaccinations prove as clear to some as they are nebulous to others. No reasonable person, however, can ignore the fact that measles, whooping cough, and other formerly scarce diseases continue to mount a resurgence in direct correlation with the lowest vaccination rates in decades. We have forgotten the threat these diseases pose, the reason we sought their eradication. As more tragedies like the recent Disneyland outbreak unfold, I hope more parents will remember Roald Dahl’s plea after the death of his daughter:

“It is not yet generally accepted that measles can be a dangerous illness.
Believe me, it is. In my opinion parents who now refuse to vaccinate
their children are putting the lives of those children at risk. […]
It really is almost a crime to allow your child to go unimmunized.”