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Recent Amendments to Canada’s Medical Assistance in Dying (MAID) Legislation – The Good, the Bad and the Ugly

Contributed by Laiba Asad

Introduction

Medical assistance in dying has long been debated in Canada. The recent amendments made to Canada’s medical assistance in dying (MAID) regime on March 17, 2021 have been met with varying opinions. This blog post will discuss the original MAID legislation, the Superior Court of Québec’s decision in Truchon v. Attorney General of Canada which challenged this legislation and subsequent amendments made to MAID legislation. Finally, it will discuss how these amendments have been received by various groups.

The Original Medical Assistance in Dying Legislation

With the Supreme Court of Canada’s decision in Carter v Canada (2015), provisions in the Criminal Code prohibiting medical assistance in dying (paragraph 241(b) and section 14) were ruled to be unconstitutional under s.7 of the Canadian Charter of Rights and Freedoms, which guarantees life, liberty, and security of the person. As a result, in June 2016, the Parliament of Canada passed federal legislation – the Medical Assistance in Dying Act (MAID Act) – allowing eligible Canadian adults to access medical assistance in dying. MAID legislation allowed for two legal medical practices as seen in section 241.1 of the Criminal Code: administration of a substance directly by a physician or a nurse practitioner that causes death of a patient and prescription of a substance by a physician or a nurse practitioner that can be self-administered by the patient.

This new legislative scheme imposed restrictive eligibility requirements for people requesting MAID. They needed to:

  • be eligible for government funded health services in Canada,
  • be at least 18 years old with the capacity of making decisions concerning their health,
  • have a grievous and irremediable medical condition (serious and incurable illness) with their natural death being reasonably foreseeable,
  • have made a voluntary request for MAID free of any external pressure, and
  • give informed consent to receive MAID after having been presented with all the necessary information, such as means available to relieve their suffering (palliative care), forms of treatment, among others.

Additionally, MAID legislation was further restricted by procedural safeguards including:

  • checking that people requesting MAID are aware that they can withdraw their request at any time,
  • making sure that two medical professionals confirm through written opinions that the individual in question fulfils all eligibility requirements, and
  • ensuring that final consent is given before MAID is administered.

Truchon v. Attorney General of Canada (2019) and amendments to MAID law

Soon after coming into effect, eligibility criteria in the MAID Act were challenged on the basis that they were unconstitutional. In September 2019, the applicants in Truchon v. Attorney General of Canada, Jean Truchon and Nicole Gladu, took issue with the validity of s.241.2(d) of the MAID Act and s.26(3) of Quebec’s Act Respecting End of Life Care. Truchon, who had cerebral palsy and Gladu who had post-polio syndrome, claimed that the provisions, which had prevented them from accessing MAID, were too restrictive. The applicants argued that the requirement under s. 241.2(d) of the MAID Act that their “natural death must be reasonably foreseeable” violated principles set out in the Charter, as well as s.7 (rights to life, liberty, and security) and s.15 (right to equality) of the Charter.

At the Superior Court of Québec, Justice Baudouin concluded that the requirement that “natural death must be reasonably foreseeable” infringed on the applicants’ right to life under s.7 of the Charter seeing that it “exposes individuals such as Mr. Truchon and Ms. Gladu, to a heightened risk of death” [522]. She goes on to explain how the requirement also violates their rights to liberty and security under s.7 of the Charter because it “directly interferes with their physical integrity, causes them physical and psychological pain and deprives them of the opportunity to make a fundamental decision that respects their personal dignity and integrity” [534]. As for s.15 of the Charter, Justice Baudouin concluded that the requirement violated the applicants’ right to equality since it created a distinction based on the nature of a disability (cerebral palsy and post-polio syndrome) which sustained disadvantage and prejudice for them. She further stated that this infringement of rights was not justified since the restriction imposed by the requirement of reasonable foreseeability of death had damaging effects on people in similar situations to the applicants, which were disproportionate to the benefits of the requirement. Finally, Justice Baudouin concluded that s.241.2(d) of the MAID Act was overly broad and disproportionate to its object of protecting people from ending their life in a moment of vulnerability, thus making it incompatible with the principles of fundamental justice.

Even though the declaration of invalidity in Truchon is only applicable in Quebec, the federal government decided to respond to the court’s decision by bringing amendments to the MAID Act. Consequently, in February 2020, Bill C-7 : An Act to Amend the Criminal Code (Medical Assistance in Dying) was presented in Parliament. After having received royal assent, Bill C-7 became law on March 17, 2021.

The new medical assistance in dying legislation

The changes made to Canada’s MAID legislation reflect the decision in Truchon, meaning that the legislation presently expands MAID to those whose deaths are not reasonably foreseeable, potentially expanding the class of people now eligible for MAID. People whose deaths are reasonably foreseeable are still eligible for MAID, while the other eligibility criteria from the original legislation remain. 

The amended law provides for two approaches to procedural safeguards depending on whether the individual’s death is reasonably foreseeable or not. For those whose death is reasonably foreseeable, additional and strengthened safeguards have been put in place such as eligibility assessments that must take at least 90 days unless the individual is losing their capacity to make decisions relating to their health. On the other hand, those whose death is reasonably foreseeable are subject to eased and existing safeguards in that final consent is no longer required or can be waived in certain circumstances before the administration of MAID for example.

With the original MAID legislation, requests for MAID solely on the basis of mental disorder generally didn’t fulfil the reasonable foreseeability of death requirement. However, since this requirement is now repealed, the new MAID legislation will also enable individuals to request MAID solely on the basis of a mental disorder. This will come into effect in two years. During these two years governments and medical bodies are expected to decide on guidelines and safeguards regarding these requests.

The new MAID legislation will also enable individuals to request MAID solely on the basis of a mental disorder.|| (Source: pixabay // Tumisu/1028 images)

How the new MAID legislation has been received

The possibility that MAID might be available to individuals solely on the basis of mental disorder remains a contentious topic among psychiatrists, with many doubting whether MAID in that context can ever be carried out safely. Some have contended that MAID for individuals with mental disorders would only be limited to a small number of people such as those who have had prolonged mental illness and have received various treatments. Others have said that since prognosis of mental illness is always unsure, the focus should be on psychiatric palliative care for severe cases instead. Advocates from Canada’s Black and Indigenous communities have also argued that the possibility of requesting MAID solely on the basis of a mental disorder could put vulnerable people at risk. For instance,  Indigenous people  often live in conditions linked to higher rates of mental illness and suicide and often don’t feel safe requesting medical services due to stigma and discrimination. Advocates would rather the federal government tackle anti-Indigenous and anti-black racism in the healthcare system before expanding MAID. 

Furthermore, many have argued that the new MAID legislation will particularly affect people with disabilities. For instance, the Council of Canadians with Disabilities contends that the bill will push people with disabilities towards MAID since there is a continued lack of appropriate support and services available to them. On the other hand, the Canadian Association of MAiD Assessors and Providers emphasizes that medical professionals take great care in assessing the vulnerability of an individual requesting MAID.

The possibility that MAID might be available to individuals solely on the basis of mental disorder remains a contentious topic among psychiatrists, with many doubting whether MAID in that context can ever be carried out safely.|| (Source: pixabay // Bru-nO/5419 images)

Conclusion

The new MAID legislation expands the class of people who can now access MAID by removing the reasonable foreseeability of death requirement, making it so that individuals can request MAID solely on the basis of mental disorder. It remains to be seen if advance requests for MAID – where a competent person makes a request for MAID that could be honoured in the future after they lose their capacity to make their own medical decisions – will be accepted as part of Canada’s MAID regime in the future.

Laiba Asad is a Junior Online Editor with the McGill Journal of Law and Health. She is in her first year of the BCL/JD program at McGill University’s Faculty of Law. Prior to beginning law school, she completed her DEC in Health Science (IB) at Collège Jean-de-Brébeuf. 

Virtual Health Expansion: Challenges and Changes

Contributed by Dylan Yan

Introduction

The COVID-19 pandemic has caused a drastic shift in Canadian healthcare. Since the onset of the pandemic, several new digital technologies, medical licensing schemes and privatized services were introduced into the Canadian healthcare ecosystem, each altering the way Canadians receive healthcare. Since the first wave of COVID infections, one of the greatest changes has been inpatient care, which has since shifted from in-person visits to virtual services, with over half of all Canadian healthcare being delivered virtually. This is a stark contrast to pre-pandemic averages, with less than 1 in 10 Canadians polled reporting use of virtual healthcare. While this virtual shift is necessary to slow the spread of the virus and save Canadian lives, it also bring about new problems like higher prices, uninsured payments and gaps in coverage that our legislature must address.

This article seeks to outline the growing privatization of virtual healthcare and elucidate how Canada’s health laws must adapt to these novel challenges.

The Expansion of Virtual Healthcare

During the COVID-19 pandemic, physician home-care visits have dropped, in-person hospital screenings have declined, and fewer patients are visiting their doctor’s office. Even the volume of emergency department visits have declined. So where are Canadians getting their healthcare?

This decline of inpatient care has been offset by a surge of activity in new healthcare media; more Canadians are following the increasing trend towards using virtual services. Family doctors can now be booked for a phone consult. Dermatologists can be found online. Even specialized conditions, like musculoskeletal disorders, can have preliminary assessments completed virtually.

This digital shift of healthcare has created new technological interfaces: individualized portals for patient records, electronic prescription transmission and self-assessment tools. As patients adapt, so must healthcare practitioners. Provinces like Ontario have created new billing regimes specific to virtual care. Private companies like the Maple Corporation have created online platforms on which physicians can provide care.

These changes have clear advantages. Virtual care increases the accessibility of patient services, allowing treatment to be readily provided in remote areas, across borders and to those with mobility concerns. Online platforms are also incredibly convenient; Canadians can easily access test results, schedule appointments and refill prescriptions on their smartphone or personal computer. Most significantly, virtual services prevent the transmission of COVID-19, avoiding physical contact and allowing the patient to be treated from the safety of their home.


Even specialized conditions, like musculoskeletal disorders, can have preliminary assessments completed virtually.|| (Source: pixabay // mohamed_hassan)

Public Latency and Private Expansion

Despite the massive benefits of virtual healthcare, public virtual infrastructure in Canada remains limited. Those services that do exist, like Ontario’s Telehealth Network, are suboptimal, suffering from long wait times and devastating system crashes.

To make matters worse, very little legislation covers virtual healthcare. While provinces like Ontario have legislated some areas of virtual care, and others have implemented strategies to combat perceived issues in virtual healthcare, many jurisdictions have inadequate laws regarding virtual services. Provinces like Quebec have been slow to adapt to match the requirements of this evolving landscape, creating “holes” of unregulated healthcare policy

In this policy vacuum, with little public competition, privatized healthcare has flourished. A rush of virtual private providers, including Maple Corporation and Dialogue Health Technologies have seen rapid growth and massive profits. In the year following the onset of the COVID pandemic, Maple Corporation went from taking a few hundred appointments per day to several thousand and saw its profits quadruple. Dialogue has recently gone public with its company shares, resulting in gross proceeds of roughly 100 million dollars.

Validating Critiques of Private Virtual Care

The growing privatization of virtual healthcare has created a new set of problems and drawbacks for Canadians. Private providers frequently have patients pay out-of-pocket for their virtual appointments. Other private services write extensive warrantees that release the company from responsibility for the quality of healthcare services rendered on their own platform. Critics of these private processes argue that the industry operates in a legislative “gaps” and “violat[es] the core tenets of medicare in Canada” by making Canadians pay for medical necessities that are covered by provincial health insurance.

How is it possible for Canadians to be charged for healthcare that is already covered? Provincial insurances (like RAMQ in Quebec and OHIP in Ontario) have general provisions that pay out public healthcare professionals directly. “Non-participating healthcare professionals” operating in the private sector are not covered. Thus, a patient using private virtual services cannot claim for reimbursement with RAMQ. They either need to pay out-of-pocket or file a claim with private insurance. Ultimately, many Canadians who want virtual care are forced to balance the inaccessibility and long wait times of the public sector with the costly timeliness of the private services.

Even creative solutions for virtual healthcare oversight, like Ontario’s new billable coding system which covers phone and online healthcare, have gaps in coverage. The system only regulates phone-call appointments and certain types of online care, leaving several virtual tools unregulated  – including text message, Facetime and Skype. This allows private providers like Maple to skirt billing restrictions by offering expensive services in unregulated formats, such as pricey text-message appointments.

How accurate are these concerns? A report by the Canadian Medical Association in 2019 raised many issues similar to those of contemporary critics. Findings in the report advocate for restrictions on privatized virtual care: a pressing need for regulatory framework that ensures the affordability and quality of virtual services, a comprehensive increase to bodies that regulate virtual physician licensing, and restrictive caps on as-of-yet unregulated billable processes, like text-message appointments.

Private Billing Models and the Principles of Canadian Healthcare

Cofounder and CEO of Dialogue Cherif Habib defends the integrity of his company’s billing policy by pointing out that Dialogue operates only through group and employer insurance. In other words, the patient must access Dialogue through previously-compatible private insurance plan, and are not billed by Dialogue directly. However, Dialogue is the only private healthcare service in Canada to follow this insurance-billing model. The rest of the private industry still allows for out-of-pocket payments. Furthermore, by Dialogue’s own terms of service, patients are still responsible to pay for “services that are not included in your [private insurance] plan.”

Most importantly, these private insurance plans are still paid for by the patient. By providing a publicly-available healthcare service on private insurance, the patient to pay twice: once in taxes and again for private coverage. The operation of privatized healthcare providers like Dialogue in practice appears to be at odds with the preamble of the Canada Health Act, which aspires to “continued access to quality healthcare without financial or other barriers.”

Conclusion: Filling in the Gaps

The transition to virtual healthcare is inevitable, especially with the advent of COVID-19. Virtual care presents clear benefits in terms of accessibility, convenience and safety. However, Canada’s limited public virtual care and lack of legislative coverage has allowed privatized actors to flourish in the field. While these actors provide necessary and desired services, these services come at the direct expense of Canadians. This for-profit model of healthcare is fundamentally at odds with the ethos of the public healthcare system. Canada’s public healthcare policymakers need to address these service and policy oversights in a timely manner, or they risk having more of the public system usurped by further privatization.


Canada’s public healthcare policymakers need to address these service and policy oversights in a timely manner, or they risk having more of the public system usurped by further privatization.|| (Source: flickr // bastamanography)

Although such a Canadian framework would be uniquely adapted to solve Canadian healthcare concerns, policymakers can look to other countries with universal healthcare for inspiration. For example, the National Healthcare Service of the United Kingdom created a long-term plan that includes a massive virtual overhaul of healthcare platforms. France and Australia have also both enacted comprehensive legislative reforms for digitized care. It is up to Canada to follow the same path.

Dylan Yan is a Junior Online Editor for the McGill Journal of Law and Health. Dylan is a recent transfer BCL/JD student at McGill University’s Faculty of Law.

Previously, Dylan studied law at Osgoode Hall Law School, where he was awarded the Ivan Cleveland Rand Prize and the Samuel Rubinoff Prize for Legal Research and Writing. During his time at Osgoode, Dylan was a student caseworker for Mahdi Weinstock LLP and Community Legal Aid Service Providers, focusing on immigration and refugee practice.

Dylan also attended McGill’s Faculty of Science, in which he holds a bachelor’s degree in Microbiology and Immunology and the J.W. McConnell Entrance Scholarship. During his undergraduate studies, Dylan conducted research as part of the Lady Davis Institute. His efforts there focused on HIV enzymes, characterizing the effects of HIV drugs in order to optimize combination HIV therapies.

Exploring the Potential Discriminatory Effects Arising from the Use of AI in Healthcare

Contributed by Annelise Harnanan

Introduction

The Canadian health care sector is increasingly making use of new technologies that encompass Artificial Intelligence (AI). AI is a broad term that refers to computer algorithms that can perform human-like activities such as reasoning and problem solving. In health care, technologies encompassing AI have the potential to improve many areas of patient care. However, authors in the field have observed that sometimes, these algorithms can have discriminatory effects. Therefore, care must be taken when using technology that incorporates AI. Many people have noted the presence of systemic racism in health care in Canada, and we must ensure that these biases are not perpetuated  as a result of the algorithms we use.   This blog post will discuss the use of AI in health care, explore the potential discriminatory effects that can occur when using AI, and briefly examine the role that the law might play in protecting individuals from these discriminatory effects.

What is AI?

AI-based computer programs analyse large amounts of data to perform certain tasks, such as making predictions. Many of these new technologies utilize machine learning, a subset of AI. Machine learning “refers to the ability of computers to improve their performance on a task without being explicitly programmed to do so”. Machine learning techniques are advantageous because they can process enormous amounts of input data and perform complex analyses. Furthermore, some of these technological advances encompass deep learning, which use multiple levels of variables to process data and predict outcomes.

AI-based computer programs analyse large amounts of data to perform certain tasks, such as making predictions. || (Source: creativecommons // deepakiqlect)

How can AI be used in healthcare?

Many have heralded AI for its potential to help improve efficiency in the health care sector. Experts in the field believe that it can “improve the ability of health professionals to establish a prognosis” and “improve diagnostic accuracy”. AI can also be used in managing health complications, assisting with patient care during treatment, and in research “aimed at discovery or treatment of disease”. For example, at Toronto’s Hospital for Sick Children,  researchers have come up with a computer model to predict  “whether a patient will go into cardiac arrest  in the next five minutes”.

In addition, some researchers have proposed that AI can address racial disparities in health care. This suggestion may seem to contradict the premise of this article that AI can be discriminatory. However, it is important to note that AI is not inherently good or bad. Rather, it can have desirable or undesirable results depending on the data used to train the algorithm. In a recently published study, Pierson et al used a machine learning algorithm on a dataset of knee radiographs. They claim that because they used a racially and socioeconomically diverse dataset, their algorithm was able to “reduce unexplained [pain] disparities in underserved populations”.   Their conclusion was that the algorithm’s predictions “could potentially redress disparities in access to treatments like arthroplasty”. Notably, the study had limitations. Because of the “black box” nature of the algorithm (a common critique of AI is that it can be unclear how exactly the algorithm arrives at its results), the authors admitted that they could not identify which features of the knee the algorithm used to predict pain. As a result, it was not evident what features were being missed by radiographers and it is therefore unclear whether altering treatment plans for these individuals would confer any benefits on them. Nevertheless, this study is an example of the possible positive impact that algorithms can have on providing health care.

While it is exciting that AI has the ability to improve efficiency in the health care setting, and might even help to reduce disparities, many authors in the field warn of the need to proceed with caution. They cite concerns over the lack of algorithmic transparency (especially when governmental bodies use AI to make important, life-changing decisions), the impact on an individual’s privacy, and the potential for these algorithms to have an indirectly discriminatory effect. Given that discrimination within health care is systemic and often indirect, it is important to be attentive to the use of these new technologies and to ensure they do not promulgate discrimination.

In a recently published study, Pierson et al used a machine learning algorithm on a dataset of knee radiographs. || (Source: creativecommons // Minnaert)

How can AI in healthcare have a discriminatory effect?

AI can be biased. Barton et al explain that an algorithm might make predictions that disparately impact a particular group of people, causing them to experience certain harms, “where there is no relevant difference between groups that justifies such harms”. This bias can can show up in many different phases of a project entailing AI, but Barton et al contend that there are two especially problematic causes of bias: historical human biases and unrepresentative data.

They explain that historic human biases and “deeply embedded prejudices” can become amplified in computer algorithms. For example, an algorithm used by judges to determine whether offenders were likely to reoffend (impacting whether or not they should be released on bail) used multiple variables to determine an offender’s risk score. These variables included defendant demographics and arrest records. Barton et al explain that “African-Americans were more likely to be assigned a higher risk score” when “compared to whites who were equally likely to re-offend”. Given that they were comparing individuals that were equally likely to re-offend, why were members of one group more likely to be assigned a higher risk score by the algorithm? It had to do with the use of arrest records in the training data. The authors highlight the importance of the social context and the role of historical human biases: “if African-Americans are more likely to be arrested and incarcerated […] due to historical racism, disparities in policing practices or other inequalities within the criminal justice system, these realities will be reflected in the training data and used to make suggestions about whether a defendant should be detained”. 

Unrepresentative data poses another problem. Barton et al point out that if data used to train the algorithm is under-representative of a certain group, the predictions the model makes might be less accurate for that group. On the other hand, algorithms might include and rely on too much data pertaining to a particular group and therefore “skew the decision toward a particular result”.

What can be done about this risk of discrimination?

Many have wondered how individuals can be protected against this risk. First, it is important to consider the complexity of the problem. It might be difficult to avoid disparate impacts in practice because (apparently neutral) variables used in algorithms can easily, and without any intention on the part of the developer, function as a proxy for individuals belonging to a group protected from discrimination under the law. However, the solution is not to simply remove all proxies that can result in bias. Cofone explains that “proxies for a protected category could also be a proxy for useful and legitimate information”, so removing proxies might have the effect of removing accuracy as well. Additionally, it might be difficult for developers to foresee the effects of using the variables they choose. Nevertheless, the problems discussed above can be mitigated by a more careful and deliberate selection of the training data being used as input in these algorithms; Cofone therefore recommends regulating the data used as an approach to combat discrimination. He points out that regulation can entail requiring companies to modify their training data, for example by training their models in such a way that they treat groups equally in the decision-making process of the algorithm, as opposed to entrenching real-world biases.

Because of the importance of the data selected to train an algorithm, researchers propose an ex-ante approach to regulating AI. For example, in the United States, lawmakers have proposed an “Algorithmic Accountability Act” to regulate AI, which would  require companies “to conduct impact assessments for existing and new ‘high-risk automated systems’”. Impact assessments have been suggested as a useful tool in regulating AI. They entail an evaluation of “how an automated system is designed and used, including the training data it relies on, the risks a system poses to privacy or security, and various other factors”. In a similar vein, Canadian legislators may consider legislation that would require companies, service providers (such as hospitals), and decision makers to check for bias that might occur from their use of AI.

Another proposal for addressing algorithmic discrimination is to update Canada’s privacy laws by requiring “public bodies to log and trace their data collection and processing systems” and giving Canadians the right to know exactly which personal information, reasons and factors formed the basis for decisions made about them. Although this suggestion was made to address algorithmic decisions made by federal public bodies, it might also be a useful tool to regulate decisions made by hospitals given the importance of these decisions on an individual’s life. This might entail an update of existing provincial health privacy legislation, such as Ontario’s Personal Health Information Act.

Conclusion

Exciting technological advances that encompass the use of AI in health care have the potential to dramatically improve the lives of patients across Canada. However, these advances are not without their risks. Given the high stakes in health care, Canadian lawmakers should work to ensure that when AI is used, it does not have the unintended effect of perpetuating biases and disadvantaging individuals, especially ones who have historically faced barriers to equal access to health care. Many commentators are calling for the government to regulate AI. It is imperative that these calls, and their legal responses, seek to address the risks of discriminatory effects resulting from the use of AI in health care.

Annelise Harnanan is a Senior Online Editor with the McGill Journal of Law and Health. She is in her third year of the B.C.L./ LL.B. program at McGill University’s Faculty of Law. She holds a BA with distinction in Political Science from Dalhousie University and has a keen interest in health policy.

Les tentatives du CEPMB de réduire le fardeau du coût élevé des médicaments au Canada

Contribué par Anita Sengupta

Introduction

Les prix des médicaments brevetés au Canada sont parmi les plus élevés au monde. Le Canada est le seul pays, avec un plan de santé publique national et universel, qui n’inclut pas une couverture de médicaments par prescription. Sous le Loi canadienne sur la santé, seulement les médicaments utilisés dans les hôpitaux sont couverts, alors que ceux pris à la maison ne le sont pas. Environ 20% de Canadiens déclarent qu’ils paient leurs médicaments sur ordonnance de leur poche, tandis qu’un Canadien sur cinq a du mal à payer ses médicaments d’ordonnance.

En 1987, le gouvernement fédéral du Canada a créé l’organisation indépendante du Conseil d’examen du prix des médicaments brevetés (CEPMB), ayant pour but de contrôler la tarification extrême des médicaments. Malgré cela, le coût des médicaments est plus élevé au Canada que dans les autres pays de l’Organisation de coopération et de développement économiques (OCDE), à l’exception des États-Unis et de la Suisse. Pour remédier à cela et rendre les médicaments brevetés plus abordables et accessibles, le CEPMB a annoncé que tous les nouveaux médicaments brevetés seront assujettis aux nouvelles lignes directrices réglementaires du CEPMB.

Bien qu’on estime que les nouveaux règlements génèreront des épargnes de CA$12.6 milliards au cours des dix prochaines années, ces règlements sont très impopulaires auprès des parties prenantes. Cet article examinera les directives du CEPMB les plus contestées, les raisons derrière les défis des parties prenantes qui ont paru devant les tribunaux, et l’impact social potentiel des changements proposés.


Environ 20% de Canadiens déclarent qu’ils paient leurs médicaments sur ordonnance de leur poche, tandis qu’un Canadien sur cinq a du mal à payer ses médicaments d’ordonnance. || (Source: pixabay // nosheep)

Le rôle du CEPMB vis-à-vis les prix des médicaments brevetés   

Dans le cadre des réformes à la Loi sur les brevets, le CEPMB a été créé pour réguler le prix des médicaments. Le CEPMB est une organisation indépendante et de pleine concurrence de la ministre de la Santé. Il a un rôle régulatoire d’assurer que les prix des médicaments brevetés n’est pas excessif, ainsi qu’un rôle de rédaction de rapports, ce qui inclut des rapports annuels sur les tendances des prix dans l’industrie pharmaceutique. En plus, le CEPMB publie des lignes directrices, sous paragraphe 96 (4) de la Loi sur les brevets, afin de fournir une transparence et une prévisibilité aux détenteurs de brevets sur le processus de la revue des prix.

En 2015, le CEPMB a décidé d’amender les lignes directrices anciennes et a commencé un processus consultatif avec les parties prenantes. Lors de ce processus consultatif, les parties prenantes ont contesté plusieurs changements proposés par le CEPMB. Les nouvelles lignes directrices du CEPMB devaient entrer en vigueur le 1er janvier 2021, mais cette date a depuis été reportée au 1er juillet 2021.

Les changements des lignes directrices les plus contestées

Au cours de la période de consultation du CEPMB, de nombreux intervenants, dont des innovateurs, des gouvernements provinciaux, des organismes, des professionnels de la santé et des chercheurs en santé, ont critiqué les changements apportés aux lignes directrices du CEPMB. Certains ont contesté les trois changements proposés, énumérés ci-dessous, devant des tribunaux fédéraux et provinciaux.

Objections fortes des parties prenantes

Jansen, l’aile pharmaceutique de Johnson & Johnson, craignait que si les sociétés pharmaceutiques étaient obligées de vendre des médicaments à un prix inférieur, elles seraient dissuadées de vendre au Canada, ce qui par inadvertance limiterait l’accès aux médicaments plus efficaces. L’association Médicaments Novateurs Canada a déclaré qu’elle est profondément concernée par l’impact néfaste que pourraient avoir les règlements modifiés sur l’accès aux médicaments rentables et innovateurs au Canada et sur la capacité du pays d’attirer des investissements dans le secteur des sciences de la vie. Les gouvernements provinciaux, comme ceux de l’Ontario et du Québec, sont inquiets que les nouvelles modifications auront un effet négatif sur les industries en sciences de la vie. En Ontario, les industries des sciences de la vie embauchent environ 83 000 employés et constituent 38,5 milliards de dollars du produit intérieur brut de la province. Le Québec essaie d’attirer 4 milliards de dollars en investissements privés en sciences de la vie d’ici 2022, mais cet effort serait probablement affecté par la réglementation rigoureuse des prix du CEPMB. Le gouvernement fédéral a répondu à ces inquiétudes en déclarant que les pays avec des prix plus faibles ont plus d’investissements dans l’industrie pharmaceutique,  ainsi qu’un accès aux médicaments aussi bon ou meilleur qu’au Canada. Pourtant, quand le CEPMB a partagé les lignes directrices modifiées, les parties prenantes étaient loin d’être convaincues et ont contesté la modification devant la Cour fédérale et la Cour supérieure du Québec.

Les cas à la Cour fédérale et la Cour supérieure du Québec

Le 29 juin 2020, Médicaments Novateurs Canada, une association nationale de compagnies pharmaceutiques avec des activités de recherche, et quelques compagnies pharmaceutiques particulières, ont contesté le l’utilisation du CEPMB par le gouvernement fédéral en tant que mécanisme pour réduire de façon généralisée les prix de médicaments brevetés au Canada. Ils ont contesté spécifiquement les trois modifications énumérées ci-dessus. Le 29 juin 2020, la Cour fédéral a émis sa décision dans la revue juridique de le Modification au Règlement sur les médicaments brevetés qui gouverne le CEPMB. La Cour a décidé que la décision de modifier la liste de pays de référence était raisonnable parce que la comparaison simple de prix ne mène pas au contrôle de prix. La Cour a aussi trouvé que les nouveaux facteurs économiques étaient dans le cadre de l’autorité régulatoire du CEPMB et de son rôle de baisser les prix pharmaceutiques excessifs. Toutefois, la Cour a trouvé que les nouvelles exigences de prix pour le calcul des prix de médicaments « dépasse la compétence du Conseil en matière d’établissement des prix du fabricant en vertu de la Loi sur les brevets. » Il a trouvé que cette modification est ultra vires àla Loi sur les brevets parce que la loi inclut seulement la vente par un détenteur de brevet à un(e) client(e), et non le rabais que les parties prenantes ont offert après le fait, ce qui ne faisait pas partie de la première pointe de la vente.

Le 18 décembre 2020, les compagnies pharmaceutiques québécoises ont amené leur cause à la Cour supérieure du Québec. Elles ont soutenu que le régime actuel du CEPMB, de même que les trois modifications, sont inconstitutionnels parce que la réglementation des prix est une compétence provinciale et le gouvernement fédéral ne peut pas réguler les prix excessifs à moins qu’il y ait abus de brevets. La Cour a trouvé que le régime actuel est constitutionnel puisque la prévention des prix excessifs des médicaments a un lien réel, direct et logique avec les brevets et ne porte pas atteinte de manière déraisonnable aux pouvoirs provinciaux. Quant aux trois modifications, la décision de la Cour supérieure du Québec est similaire à celle de la Cour fédérale en ce qu’elle a jugé la liste de référence et les facteurs économiques obligatoires raisonnables. Pourtant, la Cour supérieure du Québec a trouvé que la divulgation des rabais des parties prenantes et la réduction de prix en conséquence serait une incursion directe à la compétence provinciale.

Le CEPMB a répondu aux commentaires des intervenants et aux décisions de la Cour fédérale et de la Cour supérieure du Québec et ont apporté quelques changements aux modifications proposées.

Le coût humain des prix élevés des médicaments

Au Canada, les régimes de santé publique ne couvrent pas les médicaments par prescription en dehors du cadre des hôpitaux. Si un patient reçoit un traitement intraveineux dans un hôpital, ce patient n’encourt aucun frais. Pourtant, si on prescrit des médicaments pour prendre à domicile, comme des pilules prises par voie orale ou des médicaments auto-injectables, qui composent 60% de tous traitements pour le cancer, le patient doit assumer lui-même le coût de ces médicaments. Le coût du traitement pour le cancer est approximativement 6 000 $ par mois, et ce traitement peut durer pour plus d’un an. Les patients sont alors obligés de faire des choix difficiles, comme réhypothéquer leur maison, encaisser leur épargne-retraite et, dans certains cas, refuser le traitement de peur de mettre leur famille en faillite.


Si un patient reçoit un traitement intraveineux dans un hôpital, ce patient n’encourt aucun frais. || (Source: creativecommons // that one asian)

Conclusion

Le débat ne devrait pas être axé sur la question de savoir si le prix de médicaments devait baisser, mais plutôt sur la meilleure façon de les baisser. Il y a un équilibre qui est difficile à établir entre les besoins des patients et l’industrie. Depuis cinq ans, le CEPMB, via son processus consultatif, a essayé de trouver cet équilibre. Pourtant, en considérant le nombre de contestations par l’industrie et les gouvernements provinciaux aux lignes directrices de CEPMB, c’est difficile de dire si cet équilibre a été véritablement atteint. Les alternatives, comme inclure les médicaments par prescriptions dans le cadre de couverture des régimes de santé publiques, devraient aussi être considérées, afin de complètement enlever le fardeau des prix élevés des médicaments par prescriptions des consommateurs canadiens.

Anita Sengupta est la rédactrice en chef en ligne de la Revue de droit et santé de McGill. Anita est une étudiante BCL/JD en deuxième année et la détentrice de la bourse Wainwright à la Faculté de droit à McGill. Anita a un baccalauréat spécialisé en lettres et en biologie à l’Université Carleton, ou elle a reçu la Médaille du Sénat pour son rendement académique exceptionnel. Anita travaille dans le domaine du droit de la propriété intellectuelle à Innovation, Sciences et Développement économique Canada. Lors de ses études de baccalauréat, Anita a reçu une bourse du Conseil de recherches en sciences naturelles et en génie du Canada (CRSNG), qu’elle a utilisé pour mener des recherches en biologie moléculaire et en génétique. Anita aussi a présenté une affiche sur sa recherche en soins palliatifs à la Conférence de la santé mondiale 2018 à l’école de médecine à l’Université d’Ottawa.

A Shot in the Dark: The Legality of Mandatory Immunization

Contributed by Ian Bernstein

Introduction

Following the recent approvals of COVID-19 vaccines, it is reasonable to wonder whether or not it will eventually be mandatory for people to receive a vaccine. Once the vaccines become more widely available, they can be used as a means to attenuate the severity of the global pandemic and return to a greater sense of normalcy in society. The following article will address if and how governments in Canada and the United States can legally impose mandatory vaccination programs, as well as how likely they would be to implement such measures. In addition, whether or not mandatory vaccination for specific sectors of the population can be imposed will be discussed, along with alternative methods that are being derived to incentivize populations to receive a COVID-19 vaccine.


Many may be wondering whether mandatory immunization against COVID-19 will be implemented now that vaccines for the virus have been approved and rolled out. || (Source: Pixabay // Arek Socha)

Governments and Public Health

To date, no government in Canada has implemented compulsory immunization against COVID-19, and it is unlikely that they will do so. However, these governments do have jurisdiction to enforce mandatory vaccines through their power to regulate matters of public health in each particular province. For instance, in Quebec, upon the declaration of a public health emergency, which has been done amidst the COVID-19 pandemic, the Public Health Act grants the provincial government and the Minister of Health a high degree of power as a means to respond to the emergency. Such powers include the ability to “order compulsory vaccination of the entire population or any part of it against…any…contagious disease seriously threatening the health of the population.”

Moreover, the Alberta Public Health Act grants the Lieutenant Governor in Council the powers to order immunization against a disease in the presence of an epidemic or public health emergency. However, Jason Kenney, the current Premier of Alberta, wants to change this by amending the statute. If he is successful, this would constitute a striking difference between Alberta’s Public Health Act and that of Quebec. A future government would have the ability to reinstate this section of Alberta’s Public Health Act if they are in favour of mandatory immunization, but this would require the development and passing of legislation.


While governments in Canada have not signalled plans to mandate immunization against COVID-19, their power to regulate public health enables them to do so. || (Source: creativecommons // Mightydrake)

In the United States, individual states are granted similar powers as the Canadian provinces, as they have the authority to regulate public health, and have previously mandated vaccines in extraordinary circumstances similar to those we are currently facing. Indeed, the constitutionality of state-mandated vaccines as a means to protect public health and safety was upheld by the Supreme Court in Jacobson v. Massachusetts, in which case a mandatory vaccination program against smallpox was at issue. In fact, even cities can be granted such powers, which was done in Williamsburg, Brooklyn in 2019 amidst a measles outbreak. Thus, in the context of COVID-19, the question is not whether mandatory vaccination is legal, but rather, whether it will be enforced.

Mandatory Vaccination for Specific Groups

Although the majority of Canadian provinces do not intend on imposing mandatory vaccination against COVID-19, statutory legislation geared towards particular sectors of the population can leave certain individuals with essentially no choice but to get a vaccine. For instance, Ontario’s “Occupational Health and Safety Act stipulates that employers have an obligation to get rid of known hazards in the workplace and protect employees from work-related illness or injury,” and the British Columbia Workers Compensation Act requires employers in the province to maintain a safe workspace for its employees. As such, employers have a duty to “take precautions to limit the spread of infectious diseases in the workplace,” thus granting them the authority to mandate immunizations for their employees. In the United States, “the U.S. Occupational Safety and Health Administration has stated that employers can legally impose a flu vaccine requirement on their workforce,” and employees can be terminated for refusing to get immunized.


Certain sectors of the population, such as employees, may be subject to mandatory immunization against COVID-19 even without a government-imposed mandate. || (Source: creativecommons // CulturaGovBr)

Furthermore, Ontario and New Brunswick require schoolchildren to be vaccinated against certain diseases such as “diphtheria, tetanus, polio, measles, mumps and rubella, while Manitoba requires a measles vaccination.” Whether COVID-19 will be added to this list remains unknown, as the vaccine has not yet been approved for children under 16 years of age. It appears, however, that subsets of the population such as employees and schoolchildren are generally more susceptible to being subject to mandatory vaccination.

These mandates raise legitimate legal and constitutional concerns, as they must accord with human rights laws and constitutionally protected freedoms. Indeed, an employer terminating an employee who cites a valid reason for refusing to get a COVID-19 vaccine can amount to a human rights violation. For example, this may constitute discrimination based on a prohibited ground under the British Columbia Human Rights Code. Vaccine mandates in the workplace must also not be discriminatory towards employees who do not receive the vaccine for religious or medical reasons. Similarly, Ontario’s Immunization of School Pupils Act enables schoolchildren to be exempted from mandatory vaccines for religious or medical reasons. In the United States, employees have the right to request accommodations as well as medical or religious exemptions from mandatory vaccines under federal anti-discrimination laws, such as the Americans with Disabilities Act of 1990 and the Civil Rights Act of 1964, and employees who are part of a union may be entitled to exemptions as well.

Incentivizing Mandatory Vaccination

Even if mandatory immunization against COVID-19 is not enforced by governments, members of the general public who choose not to receive a vaccine may nonetheless find themselves rendered unable to partake in daily life. For instance, Quebec’s Director of Public Health can order people not to visit certain places where there is an outbreak if they have not been vaccinated, including educational institutions, workplaces, and other gathering places. Airlines, restaurants, stores and stadiums can make immunization a condition of doing business with customers, and it is possible that the use of such conditions will be widespread as more people get immunized against COVID-19. In the United Kingdom, places like bars, cinemas, restaurants and concerts plan on demanding proof of vaccination in the near future. Even within Canada, there is talk of a ‘vaccine passport’ to store immunization records, which would allow establishments to know who has been vaccinated and who has not.

Although such measures do not necessarily make immunization mandatory, they have the effect of precluding those who do not get vaccinated from attending certain locations or establishments. However, they are legal, as businesses generally have the right to refuse customers and in the current circumstances, courts are likely to uphold these decisions in the name of health and safety. In addition, under the International Health Regulations, countries can require travellers to provide vaccination certificates, which is currently enforced for yellow fever and has been enforced in the past for polio. Only time will tell whether the same will be done for COVID-19, but nonetheless, it is clear that the notion of immunization passports is not new.

Conclusion

The general public in Canada and the United States most likely do not need to worry about a mandatory COVID-19 vaccine being imposed on them at the provincial, state, or federal levels of government. However, specific groups within the population, such as employees, are more restricted with regards to their choice to receive a vaccine. This in conjunction with measures such as proof of immunization can perpetuate the appearance of a mandate, and may have the effect of placing a high degree of pressure on individuals to get vaccinated against COVID-19, despite the absence of a government-imposed mandate.

Ian Bernstein is a Junior Online Editor for the McGill Journal of Law and Health, and a second year JD/BCL student at McGill University’s Faculty of Law. Prior to beginning law school, Ian completed an undergraduate degree in psychology and linguistics at McGill. During his undergraduate studies, Ian completed two honours theses, one of them being in the McGill Health Psychology Laboratory, which is where his interest in health law stems from. Ian was also involved in research through having been the recipient of an NSERC Undergraduate Student Research Award in 2017, as well as a Psychology Undergraduate Research Award in 2018.