Category: Blog

Canada’s Mental Healthcare System at a Crossroads

Contributed by Stephanie Kay

Introduction

Enacted in 1984, the Canada Health Act (CHA) establishes that all provincial or territorial plans must cover “medically required” or “medically necessary” hospital services, physician services and surgical‑dental services for Canadians. The primary goal of Canadian healthcare policy is to “protect, promote and restore the physical and mental well-being of residents of Canada and to facilitate reasonable access to health services without financial or other barriers.” As such, the CHA remains the closest piece of legislation to a national health strategy and plan of action. Still, many services that are considered an integral part of healthcare by many Canadians, such as psychological services and prescription drug coverage, remain outside the scope of services that provinces and territories must cover according to the CHA.

The importance of mental health is well recognized, as is the importance of integrating mental health services into primary and general healthcare. In 2016, the United Nations Human Rights Council stated that access to adequate mental healthcare is central to the full realization of the right to health. Despite the recognition that health is a fundamental rightfor all Canadians, most do not have access to regular visits to psychiatrists or counsellors under the CHA. It is estimated that the annual economic cost of mental illness in Canada is over $50 billion per year. This estimate includes not only the cost of healthcare, but also the cost of reduced productivity and quality of life. As established in the CHA, each province or territory is responsible for its own health laws and services, including those related to mental health and wellbeing. Different approaches taken by provinces and territories have resulted in similarities across Canada’s mental healthcare services, as well as significant clinical differences, such as the definition of what constitutes a mental illness or disorder. 

With 1 in 3 Canadians projected to be affected by a mental illness during their lifetime, Canada’s healthcare system is at a crossroads. This article seeks to explore how the CHA currently approaches mental health as well as potential ways to improve the delivery of mental healthcare services across Canada.

The Status Quo: Canada’s Current Mental Healthcare System

Before delving into how to improve mental healthcare, it is important to analyze the current state of Canada’s public healthcare system as a whole. According to the CHA, each of Canada’s provinces and territories must provide healthcare insurance plans that are public, comprehensive, universal, portable and accessible. Canada’s healthcare system has been under strain for years as it attempts to meet these criteria, as demonstrated by Emergency Department closures, staff burnout and shortages, long wait times, and delayed access to care. Additionally, over the past three years, the COVID-19 pandemic has further increased the stress on the Canadian healthcare system. Data supports that the COVID-19 pandemic has caused heightened levels of stress, anxiety and depression, and increased substance use among Canadians. Since the onset of the pandemic, 37% of Canadians reported a deterioration in their mental health. The pandemic clearly highlighted the pre-existing gaps in providing adequate care for people with mental health and substance use issues. 

Under the CHA, most mental health and substance use health services are only covered if they are delivered by physicians or in hospitals. As a result, mental health services are delivered to Canadians through a complicated, uncoordinated patchwork system delivered across the private, public and not-for-profit sectors. Mental health services remain inaccessible for many Canadians due to cost, geographical location, long waitlists and other barriers. Although provinces and territories are largely responsible for the administration and delivery of healthcare, the federal government is also supposed to ensure access to free, public and universal healthcare across Canada. Overall, mental health services have been chronically neglected as health policy in Canada has evolved. While some long-term federal funding has been provided to the provinces and territories for mental health through measures like the 2017 Shared Health Priorities, not-for-profit community mental health services remain chronically underfunded, and the current patchwork system is unsustainable. 

The Multifaceted Impact of Canada’s Mental Healthcare System Failures

Research shows that there is a connection between mental health and its impact on physical health. Similarly, substance use health and mental health are intrinsically linked. People with mental illnesses are twice as likely to have a substance use disorder, and people with substance use disorders are up to three times as likely to have a mental illness. However, Canada’s mental health crisis does not only impact its healthcare system. The stark reality is that mentally ill people are over-represented in the criminal justice system, and potential solutions must involve the public mental healthcare system. According to Canada’s Department of Justice, it is imperative that the courts and the criminal justice system do not expand their scope to become the principal dispensers of mental healthcare. The Department of Justice maintains that the best solution to the mental healthcare crisis is reinvesting in the public healthcare system, as its failures are directly impacting the criminal justice system. 

Long-term, stable federal funding would create a more robust, integrated, and responsive mental health system and help reduce the burden on the criminal justice system. As such, there is a strong business case for the federal government to invest in provinces and territories’ mental healthcare systems because it could decrease the number of people that interact with the criminal justice system. This not only saves money and improves people’s overall health, but better access to mental healthcare reduces the risk of re-offending. Canada’s criminal justice system is ill-equipped to manage mental illness and typically worsens prognoses. Since the way each province and territory manages public mental healthcare differs, there are glaring differences across Canada in terms of how people with mental illness are treated in the healthcare and criminal justice systems. In 2015, the Department of Justice suggested that, at a minimum, there be more uniformity across Canada, particularly where mental health legislation and the Criminal Code intersect. This could potentially be accomplished through a Federal Mental Health Act that ensures that criminal law treats people with mental illness equally, regardless of how provincial healthcare legislation may differ.

Making Canadian Mental Healthcare Universal

Most provinces and territories have not integrated services like counselling, psychotherapy and substance use treatments, which forces many Canadians to rely on employee benefits or pay out of pocket for these services. Conservative estimates suggest that Canadians pay over $1 billion each year for private psychological services alone. Most people who cannot afford these private services are simply unable to obtain the care they require. By applying the principles of the CHA, some argue that all Canadians should have access to publicly funded mental health and substance use health services wherever they live. These crucial and life-saving services should be equally available to all, be portable when moving between provinces and territories, and be provided for free and without discrimination. Many organizations, including the Canadian Mental Health Association (CMHA) and the Centre for Addiction and Mental Health, are joining the growing number of calls for mental healthcare to be available to everyone under public health insurance.

By looking at Canada’s mental healthcare system, it is clear that the care currently available to Canadians is far from universal. A lack of investment at all levels of government into mental healthcare has resulted in a nationwide mental health crisis, and its impacts are felt beyond just the healthcare system. By making mental health services more accessible to all Canadians, the federal government could help decrease the stigma associated with mental health. Additionally, as highlighted by the CMHA, providing consistent funding for community organizations that provide mental health services is imperative to ensure meaningful access to mental healthcare for all, particularly within vulnerable communities. To successfully address this mental health crisis, investing in primary and hospital-based care for mental health is not enough.

The mental health crisis in Canada is costly in more ways than one, and it is evident that the current mental healthcare system is at a crossroads. In its current form, the CHA falls short of guaranteeing access to mental health services to all Canadians and the organizations providing these services are badly underfunded. In order to effectively improve access to quality, timely, and equitable mental health services, the Government of Canada must continually invest in the public healthcare system, including the multitude of community organizations delivering mental health services. Additionally, the federal government should enact legislation that will ensure equitable and free access to life-saving mental healthcare across Canada. While there is admittedly no easy solution to this ongoing crisis, continuing to underfund the mental healthcare system will not help countless Canadians access the care they desperately need and deserve.

About the Author

Stephanie Kay is the Senior Online Editor of the McGill Journal of Law and Health. She is currently in her second year of the BCL/JD program at McGill University’s Faculty of Law. Before starting law school, Stephanie completed a Bachelor of Health Sciences (Honours) at McMaster University and worked in communications.

The Role of Health Professional Regulation in Addressing Racism in Health Care

Contributed by Mark Faassen

Following the killing of George Floyd in the United States in 2020, many health organizations in Canada issued statements denouncing racism and discrimination in health care. These organizations were varied and included national (for example, see here, here, and here), provincial/territorial (for example, see here, here, here, and here), and practitioner/learner organizations (for example, see here, here and here), and educational institutions.  

In addition to citing systemic racism and discrimination, some statements acknowledged the existence of anti-Black and anti-Indigenous racism in Canada. Some expressed solidarity with these communities and with other people of colour. The Toronto Board of Health and the Canadian Nurses Association declared anti-Black racism as a public health crisisand a public health emergency respectively. Fewer statements acknowledged the role of police in the death of Mr. Floyd and/or the deaths of Black and Indigenous individuals in Canada.

Some organizations issued supplementary statements to their initial statements. One issued a further statement after many of its members “asked what active steps we are taking to address systemic racism.” Another explained it was a mistake to reference only the death of George Floyd initially and went onto recognize “the racialized Canadians who have died in encounters with police during wellness checks, including Ontarians Regis Korchinski-Paquet, D’Andre Campbell, Caleb Tubila Njoko and Ejaz Choudry.”

Research by Brown et al evaluating the initial statements by medical schools and organizations in Canada and the United States found that they tended to minimize the pervasiveness of anti-Black racism and externalize its existence “as outside the institution, and deflected institutional accountability by emphasizing individual action instead of institutional change.” Research by Kalifa et al considering the efforts of Canadian medical schools to address anti-Black racism in 2020 found that “since most medical schools did not have any Black faculty, particularly in leadership positions, and had historically neglected issues of anti-Black racism within their institution, schools relied heavily on Black medical students for guidance and direction.” The authors note that while students viewed this reliance on them as burdensome and inappropriate, “they felt compelled to remain involved to keep their medical school accountable beyond the statement.”

Several health organizations in Canada issued similar statements condemning anti-Indigenous racism following reports in June 2020 of health workers in British Columbia Emergency Rooms playing a game to guess the blood alcohol level of Indigenous patients (for example, see here), the death of Joyce Echaquan at a hospital in Joliette, Québec in September 2020 (for example, see here, here, here, here, here, and here), and following the discovery of the remains of 215 children at a former residential school site in Kamloops, British Columbia in May 2021 (for example, see here and here). Incidentally, the Truth and Reconciliation Commission of Canada’s Calls to Action were released in 2015 (with action numbers 18 to 24 related to health).  

Since mid-2020, several health professional regulators across Canada have also issued statements committing to learning and examining how to better address systemic racism and discrimination in their role as regulators. British Columbia Health Regulators (a collaboration of all health regulatory colleges in the province) and the Nova Scotia College of Nursing, for example, emphasized the regulator’s role in ensuring that health care providers deliver qualified, safe, and ethical care to all patients, including by establishing codes of ethics, standards of practice, and other guidelines to promote justice and prohibit discrimination. The College of Physicians and Surgeons of Ontario committed to addressing all forms of discrimination through “bringing equity, diversity, and inclusion (EDI)” to its processes and policies. As noted by the external Task Force that reviewed systemic anti-Black racism within the College of Physicians and Surgeons of Nova Scotia in 2021, “vocal allyship, as necessary and appreciated as it might be, will have minimal impact, if any, without a genuine commitment and actions to dismantle systemic anti-Black racism.”

With the passage of time since mid-2020, there is an opportunity to survey how some health professional regulators in Canada are beginning to contend with systemic racism, diversity, equity, and inclusion as legal-regulatory concepts. While there appears to be a willingness to embrace these concepts, initiatives are relatively nascent. It remains to be seen what meaningful structural changes to health professional regulation, if any, are being explored, proposed and implemented. 

It is useful to recall that the health professions in Canada are regulated at the provincial/territorial level by statute establishing professional self-regulation. Regulators are meant to serve the public interest through their core regulatory functions: licensing members; ensuring quality care is provided by members; investigating and adjudicating complaints from the public about members (including potential discipline); and developing professional standards/guidelines. The regulated health professions go beyond the traditional disciplines of medicine, nursing, dentistry, and pharmacy, and include a variety such as midwifery, physiotherapy, message therapy, and acupuncture. In Ontario alone, there are 29 distinct health professions regulated by 26 colleges. 

As this extended introduction has tried to show, the discussion of the role of health professional regulation in addressing racism is occurring within a larger discussion of racism in health care and health education, including in medicine and nursing (for example, see here, here, here, here, and here),which is ongoing. No health professional regulator has devised a master framework, including in the United States where regulators are having similar discussions. To get a sense of where Canadian health professional regulators are in their processes, this post will focus on one profession – medicine – with examples from two provinces; Manitoba and Ontario. 

Manitoba

The College of Physicians and Surgeons of Manitoba (CPSM) recently issued two apologies on Indigenous-specific racism in medical practice to the Anishinaabeg, Anishlnlnewuk, Dakota Gyate, Denesuiine, and Nehethowuk peoples (on January 31, 2023) and to the Inuit (on February 27, 2023). These apologies are not only for racism experienced in their medical care but also for the CPSM’s “failure to regulate the medical profession in the public interest by failing to adequately address Indigenous-specific racism by medical practitioners, whether in their clinical practice or administrative roles.”

Notably, the CPSM states that its responsibility as regulator extends to the “racist actions and inactions of physicians, residents, medical students, clinical assistants, and physician assistants against Indigenous persons” (emphasis added). 

Examples of historical failures of the medical profession to address racist and substandard medical care for Indigenous patients specified in the apologies are for racially segregated and substandard hospitals; residential schools in which physicians provided care and knew or ought to have known of Indigenous children’s physical, mental, and sexual abuses; providing substandard care during tuberculosis outbreaks and in racially segregated TB sanatoriums; failing to obtain consent for treatment, including forced or uninformed sterilization of Indigenous women; and conducting unethical nutrition experiments depriving Indigenous children of food.

Examples of current Indigenous-specific racism named in the apologies include failing to recognize traditional Indigenous healthcare practices alongside Western medicine; accepting or advancing stereotypical perceptions of alcohol and illicit drug consumption or socioeconomic status; inadequate treatment of pain; failing to demonstrate interest, respect, and humility to understand the context of patients’ Indigenous teachings, communications, lived experiences, and circumstances; and committing outright acts of racism, including derogatory comments.

According to the CPSM, the apologies are a first step and result of an organizational priority that began in June 2021 to address Indigenous racism in physician practice. The College engaged Dr. Lisa Monkman to form a Truth and Reconciliation Advisory Circle, which ultimately presented seven initial recommendations for action in September 2022. In addition to creating an apology and an appropriate land acknowledgement, other recommendations include: 

  • developing a new standard of practice to recognize racism as professional misconduct (potentially modelled after the College of Physicians and Surgeons of British Columbia’s Indigenous Cultural Safety, Cultural Humility and Anti-Racism practice standard); 
  • developing ways for Indigenous patients to better participate in the complaints and investigation process, including an emphasis on restorative justice; 
  • broadening Indigenous representation on College committees, Council and staff;
  • requiring College councillors, committee members, staff and physician registrants to undergo anti-Indigenous racism training; and 
  • creating a culture to support Indigenous physicians, including by recognizing the duality of Western medicine and Indigenous medicine, recognizing the duality of Indigenous physicians living in their culture and mainstream culture, and creating an environment where physicians are not fearful of voicing concerns about racism against a colleague or when discussing racism in health care. 

The apologies further contain a commitment to act on most of these recommendations. 

Responses to the apologies and commitments from Indigenous groups have been prudent. While the Manitoba Inuit Association views it as “an amazing step in the right direction, it is meaningless without action.” The Grand Chief of the Assembly of Manitoba Chiefs offers: “I walk away with cautious optimism until I hear and feel from our people the changes you promise here today.” According to the CPSM, the work of the Advisory Circle continues and it will make further recommendations with respect to implementing the College’s new commitments.

Ontario

The College of Physicians and Surgeons of Ontario (CPSO) appointed its first Equity, Diversity, and Inclusion (EDI) Lead, Dr. Saroo Sharda, in January 2021. It acknowledged that systemic racism and discrimination exist in the field of medicine on both the provider and patient side. It began to consider “what steps would meaningfully identify and address systemic discrimination, racism, inequity, and bias in our regulatory processes,” with the goal of ensuring a more equitable system for all.  Information about the College’s activities can be found in its 2021 and 2022 EDI Reports, which included a focus on implicit/unconscious bias and anti-Indigenous racism in 2021 and 2SLGBTQIA+ health and anti-Black racism in 2022.  

With respect to its internal functioning, initiatives to date have included broader EDI education and training for all committees and Council members (including new members), staff, and newly hired peer assessors. With respect to investigating complaints, staff are considering new approaches for addressing complaints of discrimination and have received training on the College of Physicians and Surgeons of Alberta’s approach to managing complaints from Indigenous patients. It is unclear, at present, if changes have been made to the way in which the College investigates and/or processes complaints as a result of these activities. 

An initiative of the College in 2021-2022 was a consultation process with respect to its Professional Obligations and Human Rights policy, which was up for review. After seeking feedback from a range of stakeholders, a draft (and newly named) Human Rights in the Provision of Health Services policy was created and available for public comment until November 2022. Proposed additions to the revised policy include:

  • an expectation that physicians will take reasonable steps to incorporate cultural humility, cultural safety, anti-racism, and anti-oppression into their practices (paragraph 1); 
  • an implicit acknowledgement that racism and discrimination may not only flow from physician to patient but from patient to physician (and between physicians), with guidance on how to navigate patient requests to receive care from a physician with a particular social identity when the reason for the request is perceived to be discriminatory (paragraph 4); and
  • an expectation that physicians will take reasonable steps to stop acts of violence, harassment, and discrimination seen occurring against a patient or another health provider and/or staff (paragraph 13, which seems to contemplate and also apply to medical students and/or postgraduate trainees). 

This last provision is similar yet different to one included in the College of Physicians and Surgeons of British Columbia’s Indigenous Cultural Safety, Cultural Humility and Anti-Racism practice standard, which requires physicians to report acts of racism, but does not expect them to intervene and take reasonable steps to stop them (paragraph 3.1). While the BC policy requires physicians to report acts of racism to the relevant professional regulator, it is unclear if the draft CPSO policy includes a similar reporting obligation to a regulator. The CPSO has also created a draft Advice to the Professiondocument providing further guidance on the policy’s proposed changes, including with respect to how physicians might implement the new expectations. It is unclear what further amendments, if any, will be made to the policy, which the College expects to be finalized by the end of 2023. 

Going Forward

Professional health regulators across Canada are exploring and developing approaches to reflect the role of professional regulation in addressing racism and supporting diversity, equity, and inclusion efforts in health care. This process is ongoing but we can make out the types of things regulators are starting to do, as seen in the initial efforts from Manitoba and Ontario. The CPSM’s public acknowledgement of its failure to regulate racist treatment of Indigenous peoples in the medical profession is significant, and appears to demonstrate institutional critical reflection. It appears to acknowledge that racism is not limited to individual beliefs or actions (perhaps seen in valuable moves to recognize racism as professional misconduct) but can also permeate institutions including regulators. Additional work will be required to evaluate any future institutional or structural changes to health professional regulation, including changes to the complaints and investigation, and adjudication processes undertaken by provincial and territorial regulators and to their internal governance and decision making.

Finally, the role of the Federation of Medical Regulatory Colleges of Canada (FMRAC) should be noted. FMRAC is a national association comprised of provincial and territorial medical regulatory authorities (including the CPSM and CPSO), whose purposes include developing policies, standards, statements and perspectives on aspects of medical regulation in Canada. In December 2022, its Board approved a Framework on Wise Practices and Medical Regulation prepared by its Working Group on Anti-Racism. The framework proposes recommendations and minimum regulatory standards to its medical regulatory members, and is intended to promote pan-Canadian consistency. After acknowledging the existence of systemic-anti-Indigenous racism in medicine and medical regulation, its recommendations made to regulators include to recognize and address Indigenous-specific racism, and all other forms of racism, as professional misconduct; to recognize the importance of cultural humility as an essential component of professionalism in medicine and cultural safety as an essential component of competence; and to regulate physicians who fail to demonstrate cultural humility and commit to cultural safety. FMRAC further states it is incumbent on each medical regulatory authority to develop its own policies and approaches to ensure effective regulation. 

About the Author

Mark Faassen is a lawyer and Junior Online Editor of the McGill Journal of Law and Health. He is currently an LLM candidate at McGill University’s Faculty of Law. His legal practice focuses on professional liabilityand health law.

The New Role of the Patented Medicine Prices Review Board (PMPRB)

Upsetting the Pharmaceutical Patent Bargain Through Stealth Cost Reduction Policy

Contributed by Kieran Moloney

Since 2017, the federal government has been working on passing regulatory changes to how the Patented Medicine Prices Review Board (PMPRB) regulates the excessive pricing of patented medicines in Canada. The latest development in the ongoing drug pricing legal-drama, came in early December with the abrupt resignation of the PMPRB’s Chair. The Board had lacked a permanent chair since November 2021. Its acting occupant resigned from her post as the government concluded public consultations on the latest in a series of controversial reform proposals. 

The Federal Court and Quebec Court of Appeal decisions in Innovative Medicines Canada v. Canada (2022) and Merck Canada inc. v Procureur général du Canada (2022) rebuked the federal government’s initially-proposed changes to the PMPRB as ultra vires the Patent Act. Still, political actors and PMPRB technocrats have seemingly remained intent on using the Board to drive cost savings for drug insurers. Ensuring a robust and predictable patent scheme for pharmaceuticals in Canada is not just an economic imperative, it is also a healthcare necessity. Canada is in danger of losing out on the next wave of medical innovation if the government fails to right the regulatory balance between preventing patent abuse and respecting the patent rights of innovators to earn a profit.

PMPRB OVERVIEW

The PMPRB is an independent federal quasi-judicial body that was established with the statutory objective of preventing manufacturers of patented medicines from charging “excessive prices.” The Board is established through Section 91 of the Patent Act. Sections 79 through to 103 of the Act set out the mandate, structure, appointment process, and jurisdiction of the Board. To review the price of a patented medicine, the PMPRB has historically employed a series of price tests that incorporate reference pricing against a basket of comparator countries. Therapeutically novel medicines have been required to be priced no higher than the median of the comparator countries. While the PMPRB is framed in statute as preventing patent abuse, the effect the Board has had in bringing about broad-based reductions in medication prices is evident. Within six years of the PMPRB’s launch in 1987, Canadian drug prices fell from an average of 23% above PMPRB comparator countries to an average of 5% – 12% percent below the same basket of comparative countries. Section 85 of the Patent Act sets out the statutory criteria the PMPRB is to adhere to in evaluating whether a patented medicine’s price is excessive. The criteria include:

“(a) the prices at which the medicine has been sold in the relevant market; (b) the prices at which other medicines in the same therapeutic class have been sold in the relevant market; (c) the prices at which the medicine and other medicines in the same therapeutic class have been sold in countries other than Canada; (d) changes in the Consumer Price Index; and (e) such other factors as may be specified in regulations.”

The PMPRB’s authority to investigate is not limited to patented medicines that are explicitly branded and sold as such. The Federal Court has ruled that the Board has the authority to investigate pricing whenever there is a “rational connection or nexus” between a patent and a patented medicine, even if the connection is “of the merest slender thread”. This can capture patents for things such as patented chemical ingredients, manufacturing processes, and dosage forms. 

Courts have stressed that the PMPRB’s statutory authority is limited to controlling patent abuse, not pricing regulation, promoting access to pharmaceuticals, or consumer protection. Nevertheless, pharmaceutical litigants have long sought to have the PMPRB stricken as ultra vires the federal government’s constitutional power. Specifically, they have alleged that through the PMPRB, the federal government is attempting to regulate property rights—an area of provincial jurisdiction. It has been argued that an apparent consumer protection objective of the PMPRB deprives the inventor “of the full enjoyment of the monopoly conferred by the patent.” The courts have rejected this argument. The Federal Court of Appeal in Sandoz reiterated that “the control of prices charged for patented medicines comes within the jurisdiction conferred on Parliament over patents under subsection 91(22) of the Constitution Act 1867 when applied to a patent holder or owner.” Lacking from the Sandoz decision was a comprehensive constitutional analysis of the PMPRB and its scope vis-à-vis property rights. Specifically, the constitutional analysis conducted was “peripheral” and did not engage “a pith and substance analysis or a complete and careful division of powers analysis”. Notably, Sandoz has sought leave to appeal the decision to the Supreme Court, which has yet to be ruled on. An eventual Supreme Court review of the matter would provide welcomed clarity surrounding the constitutional scope of the PMPRB’s regulatory mandate. In considering Parliament’s legislative intent while creating the PMPRB, remarks of then-Minister of Consumer Services, Harvie Andre, are telling. Minister Andre stated in Parliament that the PMPRB would exist to “ensure that prices of drugs not yet discovered…will be reasonable” through “enormous checks and balances“. This political foreshadowing that the PMPRB would be used to drive cost savings has seemingly come to roost with the recent PMPRB changes. 

RECENT PMPRB REFORMS

The immediate price-cooling effect that Canada saw following the PMPRB’s inception has diminished over time. Today, Canada has relatively high drug prices compared to other OECD countries. Increases in Canadian drug prices over recent decades precipitated the federal government announcing sweeping price-cooling regulatory changes to the PMPRB in 2017. These draft regulations would have: allowed the Board to consider net-prices (after-rebate pricing) in determining excessive pricing, changed the basket of comparator countries used in evaluating excessive pricing (to remove high-price countries and include lower-price countries), compelled the use of pharmacoeconomic value and market size in the Board’s determining excessive pricing, and required pharmaceutical companies to disclose vast proprietary data on R&D expenditures. The draft regulations were met with fierce opposition from the pharmaceutical industry and patient groups who feared the chilling effect the changes would have on bringing innovative medicines to Canada. The government delayed implementation of the regulations at multiple junctures, during which litigation challenging the government’s proposals was heard by the Courts. 

Both the Federal Court and the Quebec Court of Appeal took issue with the price-reducing objective of the regulatory changes, and found the measures targeting pricing to be ultra vires the Patent Act and Section 92 of the Constitution (division of powers). The PMPRB has always had regulatory authority to monitor drug prices at the “factory gate”, and has never regulated the prices charged to end-line consumers by pharmacists or clinicians. The Board’s exclusive regulation of list pricing is significant because very few Canadians actually pay the list price, or factory-gate price, of patented medications. This is due to a complex scheme of confidentially-negotiated rebates between pharmaceutical companies and the drug insurance plans which provide an estimated 15-25 percent discount off list prices.

BACKING DOWN: THE 2022 PMPRB REGULATIONS 

After judicial rebuke and mounting stakeholder pressure, the federal government acquiesced. The result was a watered-down version of the original proposal proclaimed into force in July 2022. The new regulations proceeded with changing the basket of comparator countries, but dropped most of the other proposed changes, including the proposed consideration of drug rebates in the Board’s pricing reviews. Prior to the new PMPRB regulations coming into force the basket of comparator countries included: France, Germany, Italy, Sweden, Switzerland, United Kingdom and, United States. Therapeutically novel medicines were required by the PMPRB to be priced no higher than the median of the aforementioned list of seven countries. Germany, Switzerland, and the United States have historically been the world’s three most expensive drug price countries. Under the new PMPRB regulations, pricing in the United States and Switzerland are no longer considered. Australia, Belgium, Japan, Netherlands, Norway, and Spain are all new additions to the list.

COST REDUCTION MISSION CREEP:  THE 2022 DRAFT GUIDELINES 

While the new regulations have been proclaimed into force, without the more contentious proposals, it seems the PMPRB is not done with its bureaucratic mission creep. In October 2022, the PMPRB published a new series of draft guidelines [the guidelines] for public consultation. In addition to regulations passed through Order in Council, the PMPRB has the authority to issue operation guidelines that set out how the Board will exercise its discretion to determine the ‘excessive pricing’ criteria under Section 85 of the Patent Act. Although PMPRB guidelines are non-binding and are not law, courts have affirmed any departure from PMPRB guidelines must be justified against Section 85 of the Patent Act.

The draft guidelines are rich in rhetoric but thin in detail. The scrapped 2017 draft guidelines laid out in writing how the PMPRB proposed to conduct investigations. The detailed guidelines were clearly focused on aggressive price reduction, beyond the scope of the statutory mandate of the Board in preventing patent abuse. It is concerning that the new 2022 guidelines exclude details of how the Board’s regulatory role will be operationalized. Instead, the new guidelines provide broad cover in asserting that a case-by-case approach will be taken in reviewing medicines. The lack of an overt price test means that innovators have no way of knowing when their price will trigger an investigation by the PMPRB or how such an investigation will unfold. This is further complicated by a provision in the guidelines allowing for complaints to be registered against a patented medicine by anyone, which will be grounds for an investigation. This seemingly opens the door to allowing frivolous investigations of pricing at the request of any member of the public, including pharmaceutical business competitors or drug insurance plans with the Board deciding what complaints are meritorious of an investigation.

This new trajectory of the PMPRB undermines patent bargain theory in two ways. Firstly, allowing bureaucrats at the PMPRB to, at any juncture in the life of the patent, investigate and mandate a price reduction of an innovative medicine vitiates the economic certainty afforded to the innovator through the patent’s promise of exclusivity. A regulatory monitor which seeks to prevent patent abuse is conceivably a reasonable proposition. Nevertheless, it is a proposition that is poorly reconciled with the utilitarian theory underpinning Canada’s patent regime. Utilitarianism has a difficult time accounting for general contract abuse or unconscionability due to the fact that it assumes rationality among actors. According to bargain theory, patents are only granted when the wealth-maximizing interests of all parties (innovator, state, and society) are satisfied. Otherwise, parties would not have entered into the patent agreement. If the patent did not promise a wealth-maximizing bargain, the state surely would not have issued it, or the innovator wouldn’t have sought it out. Leaving aside the theoretical gaps that emerge when the PMPRB is reconciled with bargain theory, common law principles of unconscionability and improvident bargains can provide some grounding for a patent abuse watchdog like the PMPRB. However, upsetting freely-negotiated bargains on such grounds have long-existed as high-hurdles to prove as features of contract law.

Secondly, if the premise of patent protection is to deliver innovation to the public for society’s advancement, then a regulatory scheme which disincentivizes the launch of innovative medicines is at odds with such a premise. Put differently: when regulatory price meddling causes an innovator to not launch their medicine in Canada, then the patent scheme does not uphold its end of the bargain with Canadian patients. The patent bargain, wherein pharmaceutical companies receive a period of exclusivity in exchange for disclosure, is supposed to confer a benefit of disclosure unto Canadian society. Strictly interpreted, this means an eventual economic right of other companies to replicate the medicine. Practically though, this bargain means access to healing and life-saving treatments. Overly burdensome regulatory pressures on patented medicines simply means that the drug can not be purchased for any price, and pharmaceutical companies simply choose to prioritize launching the drug in another jurisdiction whose patent scheme offers commercial certainty. When this bargain— pharmaceutical profit in exchange for therapeutic access—is forestalled by regulatory obstacles, the patent bargain becomes improvident for Canadian patients dependent on timely access. 

There is already evidence that the PMPRB changes are having a negative impact on new patented medicines launching in Canada. The number of new patented medicines registered in Canada has declined by nearly 30% since 2018 when compared to FDA Novel Drug Approvals, which has remained relatively stable over the same period. A 2022 research study of innovative medicine launches found that regulated decreases in pricing correlate with fewer new medications launching in a jurisdiction. Specifically, the study found that a 25% price decrease in average drug prices would mean up to a 10% decrease in the percentage of new medicines launched in Canada. Beyond preventing drugs from launching in Canada, the study indicated that price-cooling PMPRB regulations would also delay launches as pharmaceutical innovators prioritize jurisdictions where profits are expected to be greatest.

Aiming for reductions in drug costs in a country that prides itself on public and accessible healthcare is a laudable public policy goal. However, it is poorly pursued under the auspices of patent abuse. The PMPRB is allowing the tail to wag the dog in this way. The whole regulatory scheme is seemingly being dictated by this aggressive price-containing folly, and without statutory basis. If policy makers wish to legislate drug pricing, then they have the prerogative to do so. The reason they haven’t, and won’t, is because of the chilling effect it would have on bringing desperately-needed medical innovation to this country. It would decidedly alter the patent bargain on offer, shattering the bedrock on which Canada’s entire patent scheme is built. 

Kieran Moloney is a second-year J.D. student at Osgoode Hall Law School and holds a Bachelor of Public Affairs and Policy Management (BPAPM) degree from Carleton University. 

Legal Barriers to Access: Canada’s Trans Health Care Crisis

Contributed by Stephanie Kay

Introduction

In June 2017, Bill C-16 amended the Canadian Human Rights Act’s list of federally protected grounds to include “gender identity” and “gender expression.” At the time of Bill C-16’s enactment, virtually every provincial and territorial jurisdiction in Canada already provided explicit human rights protections for transgender people. Bill C-16 aimed to “protect individuals from discrimination within the sphere of federal jurisdiction” due to their gender identity or expression, including within health care settings. However, over five years later, transgender and non-binary people in Canadian jurisdictions continue to experience a multitude of complex and discriminatory legal barriers. 

According to a recent research report published by the Department of Justice Canada, identity documents (ID) that do not correspond with a person’s identity can significantly affect their overall health and well-being. Providing transgender and non-binary people with access to accurate IDs is an essential step in protecting them from discrimination and treating them with dignity and respect. This article explores the need for legislation in Canada to go beyond the legal recognition of transgender and non-binary people through accurate IDs (e.g., passports, health cards). These laws should also advocate for comprehensive and accessible gender-affirming health care for these communities.

Québec’s Bill 2 & Legal Recognition through Identity Documents

Initially introduced in October 2021, Québec’s Bill 2 was met with backlash from many transgender advocates. Others highlighted a lack of consultation with members of the 2SLGBTQIA+ community who this piece of legislation would directly impact. The amended version of Bill 2, adopted in June 2022, addressed these criticisms by removing the requirement for proof of gender-affirming surgery to modify one’s gender marker on official identity documents. Bill 2 also allows people to select the non-binary gender marker X, instead of F or M. 

It is well-established that having access to IDs that match an individual’s gender identity can seriously impact their overall quality of life. Given this, all provinces and territories have committed to allowing transgender and non-binary people to change their gender markers. In Ontario, non-binary gender markers have been available for provincial documents, such as birth certificates and driver’s licenses, since 2017. Federal documents in Canada have allowed citizens who do not identify as either female or male to list their gender as  “X” since 2019. However, the reality is that each jurisdiction across Canada has “different onerous, elaborate application requirements and processes,” for changing gender markers and names. Navigating these time-consuming and resource-intensive processes can pose a significant barrier to transgender and non-binary people. 

Additionally, when an individual’s IDs do not reflect their name or gender identity, it is more than a mere inconvenience. IDs are a structural determinant of health because they impact a person’s ability to access adequate health care and other social services (e.g., banking). In fact, accurate IDs promote positive mental health amongst transgender and non-binary people. While legislation like Bill 2 has laid the groundwork for improved legal recognition of transgender and non-binary people in Québec through IDs, more progressive legislation is still needed to address the systemic barriers these communities face in accessing health care. 

What is Gender-Affirming Health Care?

Transgender and non-binary people experience inequities when accessing all forms of health care in Canada. Many gender non-conforming folks report mistreatment, neglect, and abuse by health care professionals, which can prevent or dissuade them from seeking essential health care services in the future. Gender-affirming health care is crucial for members of the transgender community as it “holistically attends to transgender people’s physical, mental, and social health needs and well-being while respectfully affirming their gender identity.” Gender-affirming health care goes beyond just transition-related care and focuses on providing transgender and non-binary people with an affirming experience in all health care encounters.

Similar to how processes differ for IDs across jurisdictions, the ability of Canadians to access gender-affirming health care depends greatly on their province or territory and whether they live in urban or rural areas. The coverage and funding for gender-affirming health care, such as surgery and medications, vary significantly across Canada. The disparity between jurisdictions in terms of the quality and availability of gender-affirming care further perpetuates the barrierstransgender and non-binary Canadians face within the health care system. These barriers would decrease if provinces and territories committed to improving overall access and coverage of medically necessary gender-affirming health care. Except for Yukon, most jurisdictions in Canada place an “undue burden” on transgender and non-binary populations who often require gender-affirming health care.

Yukon Case Study: The Need for Comprehensive Coverage across Canada

In March 2021, the Yukon government announced changes that would significantly improve access to gender-affirming health care. Yukon’s newly expanded health care insurance coverage was heralded as the “gold standard” for members of the transgender and gender-diverse communities. This comprehensive coverage aligns with the World Professional Association for Transgender Health’s internationally recognized standards of care for effectively supporting individuals undergoing gender-affirming health care. The policy announcement highlights that gender-affirming procedures such as voice therapy and facial feminization surgery are “not cosmetic and are life-saving for transgender people.” Yukon’s announcement also acknowledges the delay or denial of “transition-related health care can cause significant harm.” 

In Canada, Yukon’s gender-affirming care policy is the most comprehensive of its kind. However, transgender and non-binary Canadians as well as advocates are calling on the federal government to implement better gender-affirming health care coverage across the country. In recent years, the evidence regarding the importance of gender-affirming care for transgender and non-binary people has grown exponentially. The data supports the connection between gender-affirming health care and improvements in mental health outcomes and overall well-being. However, it is not enough for just one of Canada’s thirteen provinces and territories to adopt a progressive gender-affirming health care policy. In order to ensure equitable health care access for all transgender and non-binary Canadians, other provinces and territories should follow Yukon’s lead.

Conclusion

In 2017, Canada’s Bill C-16 intended to provide equal protection under the law to transgender and non-binary people. Five years later, Québec’s Bill 2 introduced ‘X’ gender markers. While both are steps toward the inclusion of transgender and non-binary people, legislative work is still required to support these communities in Canada effectively. Transgender and gender-diverse people in Canada continue to experience substantial barriers to accessing gender-affirming health care. 

From difficulty changing gender markers on health cards to inadequate public health coverage for gender-affirming care, these marginalized communities often have few viable administrative and legal remedies to tackle barriers within the Canadian health care system. Canadian policymakers and legislators should go beyond creating laws and policies that legally recognize the existence of transgender and non-binary people. Instead, policymakers and legislators should work to reduce the significant burden placed on transgender and non-binary people by the health care system they rely on to access various forms of gender-affirming health care.

Stephanie Kay is the Senior Online Editor of the McGill Journal of Law and Health. She is currently in her second year of the BCL/JD program at McGill University’s Faculty of Law. Before starting law school, Stephanie completed a Bachelor of Health Sciences (Honours) at McMaster University and worked in communications.

More Beds, Better Care Act 2022: Ontario’s Recent Passing of Bill 7

Conrtibuted by Peter Soliman

Ontario’s Healthcare Crisis

With record-setting hospital wait times and emergency departments closing their doors for hours at a time due to staffing shortages, Ontario’s healthcare system has been experiencing severe strain. Without a doubt, COVID-19 has exacerbated this strain, as the healthcare system struggles with a shortage of family doctors, a lack of walk-in clinics and an unprecedented number of nurses leaving the profession. Ontario Health statisticsshow that, on average, patients spent 20 hours in the Emergency Department before getting a bed in a ward. Emergency Department overcrowding and wait times are linked to many overlapping factors, one of them being patient discharge backlogs caused by a shortage of hospital beds and home-care support. The lack of beds available for acute care patients produces a cascade of adverse effects on hospital systems’ overall efficiency and functionality. In an effort to address this issue, the Ontario government introduced amendments to the existing Fixing Long-Term Care Act (‘FLTCA’) by implementing Bill 7 – the More Beds, Better Care Act 2022. But what were some of the factors that drove the government to make this amendment? 

Long-Term Care Homes & Alternate Level of Care

Every year, Ontario’s long-term care (LTC) homes provide 24/7 nursing care and support to more than 115,000 people and their families. Licensed and funded by the Ministry of Health and Long-Term Care, LTC homesstrive to provide a safe environment and compassion-oriented assistance for people who may have difficulty directing their care. 

Patients occupying a hospital bed but not requiring the intensity of resources or services provided in that care setting are designated as requiring an Alternate Level of Care (ALC) by an attending clinician. An ALC designation can be given once the patient’s care goals have been met, progress has reached a plateau, the patient has reached their potential in that level of care, or an admission occurs for supportive care because the services are not accessible in the community. The patient can be discharged or transferred to various locations depending on the need, one of those locations being a long-term care home.  This ALC designation does not apply to patients waiting at home, in an acute care bed/service waiting for another acute care bed/service, or waiting in a tertiary acute care hospital bed for transfer to a non-tertiary acute care hospital bed (repatriation to community hospital).

The overcrowding of hospitals by ALC patients continues to be a critical challenge for Ontario hospitals.Looking at Ontario’s health data, as of August 17th, 2022, there were approximately 5930 ALC patients inhospitals. As of May 2021, there were about 38,000 people on the waitlist to access a LTC bed in Ontario, with the median wait time being 171 days for applicants. These wait times exacerbate the effect of emergency department overcrowding and bed shortages, decreasing available resources for patients in need of critical care. 

A shortage of community-based care has evidently made hospitals the default place for many elderly patients in Canada. In fact, many LTC patients are not actually waiting for long-term care. Instead, they are waiting for another type of care, such as rehabilitation or complex continuing care, for which all hospital beds are full.  Other LTC patients in understaffed hospitals may not need medical assistance anymore, but remain as spaces in LTC homes are scarce, or their preferred LTC home is unavailable. Additionally, the COVID-19 pandemic highlighted some of the substandard care provided in certain LTC homes, furthering their undesirability by much of the elderly population. 

Ontario’s Plan to Stay Open

In March 2022, Ontario released its “Plan to Stay Open: Stability and Recovery” framework to build a stronger, more resilient health system by tackling healthcare’s most pressing issues. The plan includes five areas of focus:

·        Preserving hospital capacity 

·        Providing the right care in the right place 

·        Further reducing surgical waitlists

·        Easing pressure on our emergency departments 

·        Further expanding Ontario’s health workforce 

Under the second area of focus, part of the plan (Supporting Transitions to Long-Term Care and Preventing Hospitalization) is to better connect seniors to the most appropriate care settings by providing faster access to care and reducing the number of emergency department visits. In hopes of achieving this goal by 2028, the Ontario government aims to build 30,000 new LTC beds outside of hospitals. Other promises include the investment of $5 billion over four years to hire more than 27,000 LTC staff, including nurses and personal support workers. In addition to creating more bed space, improving LTC resources and increasing the workforce, newly implemented legislation aims to address the overpopulated hospital beds by placing certain ALC patients in long-term homes, as will be discussed in the subsequent section. This new policy is said to provide patients with the care they need and a better quality of life in a more appropriate setting. By transferring ALC patients to LTC homes, the government anticipates hundreds of hospital beds to be available once again for those in need of acute care, and better support future patient outflow.  

Existing Legislation: Pre-Bill 7

Prior to recent changes, the Fixing Long-Term Health Act, 2021(FLTCA) set out the legal framework supporting a patient’s transition from a hospital to long-term care. Briefly, the FLTCA outlined that ALC patients can apply to a placement coordinator for admission to the homes of their choosing. ALC patients (with some exceptions) are asked to choose and rank up to 5 LTC homes. Once a bed becomes available in a home of their choice, the patient is discharged and is to be admitted into that home. The Act prescribes several elements that constitute patient consent (section 52); it [consent] must be related to admission, be informed, voluntary, and not obtained through misrepresentations or fraud. Before Bill 7, a recently passed legislation in Ontario, a patient refusing a valid admission into a LTC home could be charged an uninsured fee to remain in the hospital. However, the FLTCA did not permit unconsented admission into LTC homes by any means.

Recent Legislation: Scope of Bill 7 

Titled the “More Beds, Better Care Act,” Bill 7’s provisions came into effect on September 21st, 2022. The Bill is part of the larger plan outlined earlier to ease pressures on the healthcare system and emergency departments by freeing up hospital beds. Fundamentally, the Bill amends the FLTCA, with respect to patients requiring an alternate level of care. A new provision is added for patients occupying a public hospital bed who are designated as ALC, authorizing certain actions to be carried out without the consent of these patients. The amendments allow a placement coordinator (assigned by the attending clinician) to perform the following action authorized by the attending clinician:

·        Determine the patient’s eligibility for a LTC home

·        Select a LTC home in accordance with the geographic restrictions that are prescribed by regulations 

·        Provide the licensee of an LTC home with the assessments conducted by the attending clinician to determine ALC eligibility, and a patient’s personal health information

·        Authorize the ALC patient’s admission to a home

Implications: Consent, Vulnerability & Costs

It is noteworthy that the placement coordinator cannot perform the actions outlined above without first making a reasonable effort to obtain consent from the patient. Likewise, the amendment brought forth by Bill 7 does not authorize the use of restraints in order to carry out the actions or the physical transfer of an ALC patient to a LTC home without their consent. Despite this, the amendment does allow the placement coordinator to make decisions and take actions without the ALC’s consent, only if a “reasonable effort to obtain consent” has been made. With no clarifications in the Bill regarding what a “reasonable effort” entails, regulations may be the only safeguard against forced removal from the hospital.

An ALC patient is given two options once the placement coordinator authorizes their admission into a LTC home and the attending clinician discharges the patient: move into that LTC home, or face a daily charge of $400 as of November 20th, 2022. Geographically, the assigned LTC home could be as far as 70km from the patient’s home community in southern Ontario, and 150km in northern Ontario. This presents a genuine concern for patients and families who wish to remain in close proximity to each other.

Although Bill 7 was welcomed by some Ontario hospitals as aims to reduce overflow, many critics argued that moving the elderly into LTC homes away from families could significantly impact their mental and physicalhealth. While the effect of the law remains unclear, ALC patients and families are expected to bear the burden of its implementation.

Responses: Healthcare Advocates, Medical Associations and Families

In support of the government’s new plan, Anthony Dale, the president of the Ontario Health Association (OHA), says: “Ontario’s hospitals are rapidly becoming the health-care provider of last resort for thousands of people who actually need access to home care, long-term care and other services. This is not appropriate for thesepatients.” 

The Ontario Medical Association president, Dr. Rose Zacharias, shared similar sentiments:

“We, as Ontario’s physicians, understand and appreciate that in times of health care system crisis, difficult decisions are required and will be made.”

She adds, however: “We hope that these regulations would be implemented with flexibility, with compassion, with an understanding that patients do better when they are surrounded by their loved ones and caregivers…These are difficult decisions. And we will always advocate for the very best well-being of our patients, as decisions like this are being made. “

Many hospitals across the Greater Toronto Area support the legislation as an “important tool to ensure patients are receiving the right care, in the right place.” Some claim that they have yet to use and will unlikely use the powers conferred by the Bill.

A significant criticism relates to the government’s decision to bypass public hearings in order to pass the Bill quickly. In doing so, the general public, healthcare advocates and those primarily affected could not voice their concerns about the detrimental effects of this Bill.

Healthcare advocates also describe the Bill as fundamentally discriminatory against the elderly. In fact, the Ontario Health Coalition and the Advocacy Center for the Elderly are in the process of preparing a potentialConstitutional challenge against the Bill. With the challenge almost underway, it will be interesting to see the strategy behind arguing the Bill’s violation of Sections 7 and 15 of the Charter of Rights and Freedoms.

Peter Soliman is a Junior Online Editor of the McGill Journal of Law and Health with a keen interest in access to medical care and mental health. He is currently in his first year of the BCL/JD program at McGill University’s Faculty of Law. Prior to starting law school, he completed a Bachelor of Health Sciences with a Children’s Health Specialization at McMaster University.