Legal, medical, and policy experts share insights and prescriptions

On the 40th anniversary of the Canada Health Act (CHA) last spring, several interrelated health crises raised an urgent question: How can law, regulatory, and policy reforms improve health-care quality and access for Canadians – and people around the world?

Nearly seven million Canadian adults are without a family doctor or other access to primary care. Canada’s drug prices are the third highest among the 38 member countries of the Organization for Economic Co-operation and Development (OECD). One in five Canadians have no insurance to cover prescription drug costs. Many wait months or years for surgery, while others spend countless hours in hospital emergency rooms before seeing a physician. The COVID-19 pandemic has intensified these problems, while also exposing the huge health vulnerabilities and unequal distribution of health-related harms within Canada and globally.

In this multi-segment feature, five leaders – Queen’s Law Dean Colleen M. Flood, former Queen’s Health Sciences Dean Jane Philpott MD, plus three prominent law school alumni with a range of critical perspectives – share expertise and insights on pressing national, provincial, and international issues affecting health care today.

Jump to Section

• Guaranteeing everyone has a place to go for primary, dental, and drug care
• AI tools can help transform health care – but only if the right regulation is in place
• Strong local and global health accords needed to bridge deep, widening health divides
• Canada’s drug regulator pivots to speed access and ensure safety for innovative medicines and products
• Looking ahead

Guaranteeing everyone has a place to go for primary, dental, and drug care

Health law and regulations have a critically important role to play in improving many aspects of health care for Canadians. Colleen M. Flood, Dean of Law, one of Canada’s leading scholars in health law and policy, says that legal reform is urgently needed to address the crisis in access to health care. “When the Canada Health Act was frozen in place 40 years ago, protection against having to pay out of pocket for hospital and physician services was key. Now, prescription drugs, and soon, artificial intelligence tools, will rival those services as an expense. Moreover, the CHA doesn’t provide any real detail on what reasonable access should mean in terms of primary care or wait times for other kinds of treatment. The CHA needs to be substantially revised, or new legislation is required to provide real standards for access to care for Canadians.”

Jane Philpott, MD, former Dean of Health Sciences, who was appointed Chair of the Government of Ontario’s Primary Care Action Team effective Dec. 1, 2024, focuses on the primary care crisis in Health for All: A Doctor’s Prescription for a Healthier Canada (Penguin Random House Canada, 2024). Her bestselling book proposes a transformative, health-equity-based legislative solution to give every Canadian the legal right to access a primary care home. Based on specific community needs, homes would be staffed by a team that includes doctors, nurse practitioners, nurses, and other workers – such as physiotherapists, occupational therapists, physician assistants, midwives, social workers, dietitians, pharmacists, and community paramedics. “The proposed Canada Primary Care Act would involve the federal and provincial governments working together to provide every Canadian with access to a primary care team – within 30 minutes of their home or work – just as access to public school is available to every child,” she says. “Think of this proposal as a sister to the Canada Health Act.”

Co-operative federalism is crucial to make reasonable access a reality for all, says Philpott, who envisions the federal government offering the provinces conditional funding with the incentive and obligation that they provide access to primary care services to each resident, while allowing regional flexibility. “We simply don’t have enough family doctors to provide one-to-one care to everyone in this country,” she says. “We know from models in other countries that team-based approaches can provide high-quality care and deliver it more widely and efficiently than the traditional physician-based model.”

Canada could apply lessons learned from the bold legislative initiatives of other countries, such as Norway. “Its federal Public Health Act legislated a right to primary care, and now 99 per cent of residents have access,” she notes. “Norwegians have better health outcomes than Canadians and they spend less on health per capita. Germany, the Netherlands, New Zealand, and Britain each provide over 95 per cent access to residents, and Canadians can and should enjoy this level of access.”

Philpott, who now leads Ontario’s Primary Care Action Team, has hoped all along that the big idea proposed in her book would be a catalyst for change. “People latch onto the metaphor of universal access to public education. It offers a framework to imagine what’s possible in transforming and building a primary care system on a team-based model,” she says. “Political will gets built on public will: the more people who say, ‘This is what we want,’ the more likely the idea will be implemented.”

Flood, for her part, envisions innovative and creative methods for the federal government to address health care access issues. For instance, the recently announced Canadian Dental Care Plan does not involve transferring funds to the provinces in exchange for their co-operation. Instead, it directly insures low-income children, seniors, and individuals with disabilities through a third-party payer. “This approach heralds a new way to address the traditionally contentious relationship between the federal and provincial governments in health care,” Flood says, “ensuring that one level of government – in this case, the federal government – is directly accountable for the delivery of the program.”

In contrast, she notes, pharmacare had been promised for years, but only small steps have been taken. “Sadly, Canada has long stood out among developed countries for not including prescription drugs within its basic health-care benefits. We pay a lot for drugs in Canada and still many people are uninsured – for people with diabetes, for instance, the results are scary in terms of avoidable deaths and associated morbidities.” Flood cites research published in the American Diabetes Association’s journal Diabetes Care, which shows people with diabetes in Ontario under 65 who were not insured had significantly higher death rates than those over 65 whose medications were covered.

Globally, unequal access to life-saving vaccines was a huge issue early in the pandemic. Wealthy countries, with about 20 per cent of the world’s population, stockpiled 60 per cent of the vaccine supply, leaving billions of people in poorer countries unprotected. Obijiofor Aginam, LLM’98, is a global health expert recently appointed Director of the United Nations Educational, Scientific and Cultural Organization’s Mahatma Gandhi Institute of Education for Peace and Sustainable Development. He served on the World Health Organization (WHO) Review Committee regarding amendments to the International Health Regulations (IHR) in 2005, and also on recent revisions finalized at the World Health Assembly in Geneva.

He’s encouraged that on June 1, WHO member countries agreed by consensus to amend the IHR to help developing countries gain better access to financing and medical products during global health emergencies. “We need strong and effective global health governance instruments, such as the recently modernized IHR, and hopefully an international pandemic treaty by the end of the year, to compel and incentivize individual nations to act rapidly, responsibly, and collectively in a world where microbes don’t need passports and an outbreak in one country affects all countries.”

Aginam’s prescient book, Global Health Governance: International Law and Public Health in a Divided World (University of Toronto Press, 2005), describes the mutual vulnerability of developed and developing countries to emerging infectious diseases. He opens with a poignant personal story. His mother gave birth to him on a highway outside a rural village during the Nigerian civil war in the late 1960s. His parents had to walk to the nearest medical clinic, a 20-minute drive away, due to gasoline shortages. “My father, a teacher, became my mother’s emergency midwife, nurse, and gynecologist,” he writes. “I look around the world today and see many women in my mother’s situation – and that scenario is a microcosm of the health divide between the developed and developing worlds.”

Flood and Philpott, with three other academics, co-edited another book that calls for equity in the global response to pandemics: Vulnerable: The Law, Policy and Ethics of COVID-19 (University of Ottawa Press, 2020, open access). “We gathered contributions from 69 authors across different disciplines to offer guidance on legal, ethical, and policy responses to the unequal distribution of harms within Canada and across the world, and the vulnerabilities for different groups and the interconnectedness that the pandemic made visible,” says Flood.

AI tools can help transform health care – but only if the right regulation is in place

Artificial intelligence (AI) is being applied to health care at breakneck speed. Emerging tools have the potential to improve quality, efficiency, and access to health care for patients, helping track patient data, triage care, improve diagnostic accuracy, reduce medical errors, tailor treatment plans, read medical images, and prepare referral letters for specialists. “The AI health space is on fire in terms of innovation, and the potential for improvement is enormous,” says Dean Flood. “To fully realize this potential, however, Canada urgently needs to radically change how it regulates medical devices to ensure AI is deployed safely.”

Last February at Queen’s Law, Dean Flood and then-Dean Philpott led a panel discussion, “Can AI Cure the Primary Care Crisis?” One solution discussed was AI Scribe, a tool that automatically summarizes or transcribes conversations between a doctor and patient, with patient consent. “Family doctors spend an average of 19 hours a week filling out forms and doing other administrative work,” Flood says. “If tools like AI Scribe could liberate physicians from even half of that, it would free up another day to see more patients.” She notes that the Ontario Medical Association has partnered with the Ontario government on a pilot project with over 150 primary care doctors to test it.

Flood, team lead for Machine M.D. – a multidisciplinary research project funded by the Canadian Institutes of Health Research to investigate the law, ethics, benefits, and risks in health-related AI – has collaborated with multiple Canadian innovators who develop AI tools for complex health-care tasks. One is Zachary Kaminsky from The Royal Ottawa Mental Health Centre, who developed a suicide prevention app by mining publicly available Twitter data. “The app can predict, using text analysis, a patient’s heightened suicide risk,” explains Flood.” Another innovator’s triage tool uses big data to figure out which patients arriving at Toronto’s SickKids Hospital should be taken directly for an X-ray. “If a child has fallen from a climbing frame, the tool can determine with nearly 100 per cent accuracy whether the child has a broken arm and should be X-rayed immediately, instead of waiting for hours in the emergency room.”

Other case studies on innovations examined by Machine M.D. include an intelligent, powered wheelchair and an OR Black Box, designed to improve surgical quality and efficiency and reduce errors in the operating room. Through these case studies and comparative legal studies, Flood has partnered with scholars in Canada, Brazil, France, Hong Kong, New Zealand, Nigeria, the United Kingdom, and United States, to analyze existing legal governance of AI in health care and develop proposals to reform laws as needed. For AI tools to move the needle on improving health care, they must be safe.

“I’m an AI optimist, but health AI risks are real,” Flood says. One such risk is algorithmic bias. “If AI is trained on data that primarily reflects one segment of the population, such as certain demographic groups, it may not accurately detect health conditions across all individuals,” Flood notes. “For instance, this could lead to AI missing skin cancer lesions on people with different skin characteristics. Such biases could potentially result in errors in diagnosing or treating various medical conditions.”

AI health tools pose other dangers. “In the past our laws have mainly relied on informed consent and ensuring health data can’t be traced to an individual patient to protect their privacy, but AI can re-identify the patient relatively easily,” explains Flood. As well, when patients give informed consent to share personal health information, there’s a risk the data will be unknowingly shared outside their circle of care. “Physicians may not know how the data is being used, or perhaps they signed contracts with the AI developer or their hospital that permit it to be divulged. Third parties want that data because they can sell it very profitably without patients necessarily knowing.”

To inform adaptive regulation of health-related AI within Canada – and globally – relevant, timely evidence is critical. Flood is pioneering work that would compare adaptive regulatory approaches to Australia, Brazil, Europe, Nigeria, the United Kingdom, and the United States. As defined by most regulators today, a medical device includes not only hardware like insulin pumps or artificial heart valves, but also software alone, or combinations of both – such as a pacemaker with AI software that can predict a heart attack, or a wearable device that uses AI to help people with diabetes better control their blood sugar and predict any dangerous swings.

“Health Canada’s job is to protect patients and clinicians against these risks,” says Flood. “Our research aims to create legal and policy options for optimal governance of AI in health care that could inform optimal regulation.” An adaptive approach with strong post-market oversight is critical, she adds. “Machine learning tools are designed to evolve and overseeing them calls for a different regulatory mindset. We need a paradigm shift in thinking about the regulation of health AI: not just on or off, green light or red light, but amber all the time.”

Some of the answers in building adaptive, “amber” safeguards may reside in AI itself, such as techno-surveillance, which could pick up small signals across large populations that might suggest, if there were concerns in different places across the country, that an issue warranted fuller investigation.

Developing the best regulation for Canada also depends on getting buy in from AI innovators. “Historically they’ve been very concerned about overregulation, regulation costs, and unneeded bureaucratic red tape,” Flood says. “We’re trying to persuade innovators that the right regulation is truly in their best interests. Because if bad health AI is approved and patients are harmed, there will be calls for heavier regulation, which might impede the industry and cause a loss of trust with patients and clinicians.”

Strong local and global health accords needed to bridge deep, widening health divides

Early in the pandemic, hoarding of COVID-19 vaccines by richer countries, including Canada, led to an estimated 1.3 million additional deaths in poorer countries by the end of 2021, as reported in Nature Medicine. “Another unintended consequence of vaccine apartheid was to create more opportunities for SARS-CoV-2 to mutate in unvaccinated people into more transmissible vaccine-resistant variants, such as Omicron,” says Obijiofor Aginam, who served on the World Health Organization’s International Health Regulations (IHR) Expert Review Committee. “If you leave out half the world’s population, the other half will still be potentially vulnerable as a result. Enlightened self-interest should compel all countries to contribute their respective skills, strengths, and capacities towards the promotion and protection of health everywhere in an interdependent world.”

For decades the IHR have been the only near-universal legal instrument for global health protection, designed to lead a public health response to the international spread of disease for 194 WHO member countries. Members are expected to report to WHO disease outbreaks with the “potential to cause a public health emergency of international concern,” and any infection control measures taken. When the pandemic hit, these reporting limitations became clear. “Many countries failed to notify WHO and report immediately and accurately on COVID-19 outbreaks and infection control measures,” Aginam notes. “If more countries had complied with their global health responsibilities, it could have prevented or limited the pandemic’s scope.”

Aginam emphasizes that the recently approved IHR amendments are designed to reward and encourage rapid, accurate, and comprehensive reporting of disease outbreaks and sharing of relevant scientific data. Unfortunately, after South Africa reported the Omicron variant and shared its genomic sequencing worldwide, many high-income countries imposed flight bans on its citizens. “South Africa was punished rather than rewarded for good behaviour, which discouraged other countries from being open and transparent,” he says.

Since late 2021, global political and health leaders have been negotiating an international pandemic treaty, intended to give WHO the power to facilitate universal and equitable access to affordable vaccines, medicines, and diagnostics for future pandemics. Negotiators, however, failed to reach a consensus on the text by the self-imposed deadline of May 27 – World Health Assembly opening day – and then WHO member countries have set a new deadline to agree on a treaty by the end of 2024. Aginam says a strong pandemic treaty could help avert attempts by powerful countries to prevent vaccine access for vulnerable populations. “To promote and protect global health, every country, including Canada, should look at what it can do to improve public health domestically and internationally by supporting more effective IHR regulations and a robust pandemic treaty.”

Keeping health laws and regulations truly up to date is essential, says Teresa Buchanan, Law’07, Assistant Deputy Minister (Physician and Provider Services), Ontario Ministry of Health. “Being nimble in adapting legislation, regulations, and policy to changing issues and needs in health care is critical to maintain the confidence and trust of patients and clinicians, and to improve access and quality of care.”

For example, Ontario’s Connecting Care Act, 2019, was the first in a series of legal, regulatory, and policy changes brought in to build a better, more integrated health system in the province. Since then, Ontario has launched Your Health: A Plan for Connected and Convenient Care, and most recently, established Ontario Health at Home. “The overall objective of these initiatives is to better connect and co-ordinate the care that people need,” says Buchanan.

In the 2024 Ontario budget, a total investment of $546 million over three years was announced to help connect 600,000 people to interprofessional primary care teams. While not as ambitious as Dr. Jane Philpott’s proposed Canada Primary Care Act, this does provide a large, real-world test of the model’s benefits and feasibility in Canada’s most populous province. “Team-based care will improve primary care access for Ontarians with the greatest need,” says Buchanan. “It also leverages the practice scope of different health care professionals and enables patients to get the type of care they need through diverse models, including physician- and nurse-practitioner-led clinics, as well as community health centres.”

In October 2024, the Government of Ontario appointed Dr. Philpott as Chair of its Primary Care Action Team, effective Dec. 1, 2024.

Canada’s drug regulator pivots to speed access and ensure safety for innovative medicines and products

Canada’s Food and Drugs Act and its detailed regulations aim to protect consumers from unsafe products and deceptions, while also encouraging the development of safe and effective new drugs. The FDA regulates four classes of products: drugs, medical devices, food, and cosmetics. As scientific and technological advances accelerate the pace of change, Health Canada has modernized the FDA and customized regulatory requirements for approving innovative health products. These include gene and cell therapies, personalized cancer vaccines, and tissue-engineered, digital-health, bio-printed, and nanotechnology-based products.

“There have been major amendments to the FDA,” says David K. Edwards, Law’89, General Counsel, Health Canada, Legal Services Unit, Department of Justice. “The FDA created a new regulatory framework, the Advanced Therapeutic Product Pathway that gives regulators more flexibility in how they assess the risks and benefits of therapeutics, which standard drug regulations weren’t designed to handle.” Edwards adds, “The goal is to broaden and speed up access to new medicines, including potentially life-saving treatments, while ensuring patient safety.”

Cell-based cancer therapies, for example, are prepared in personalized doses at the point of care, rather than being mass manufactured in a factory, and given to a specific patient using their own immune cells. “The pathway’s flexibility allows regulators to permit the sale of therapeutics, such as chimeric antigen receptor T-cell therapy, that would have been hard to authorize through traditional Phase 3 clinical trial evidence. The regulator needs to be able to approve and allow access to medicines customized to patients,” explains Edwards. “If you delay access to new therapeutic products that are safe and more effective than existing therapies, it harms patient health.”

The new Advanced Therapeutic Product (ATP) framework also permits Health Canada to impose terms and conditions for each advanced product licensed for sale – the machine learning health tools Dean Flood discusses in the “AI tools can help transform health care – but only if the right regulation is in place” section above, for example – which enables increased post-market surveillance to monitor safety and effectiveness. “The terms and conditions allow regulators to suspend or revoke licenses, if deemed necessary, and pull products from the market,” says Edwards, a lawyer with over two decades of experience advising officials in Health Canada and the Public Health Agency of Canada on matters relating to FDA administration, enforcement, and modernization.

Edwards has co-written a new book on these topics, The Regulation of Drugs in Canada: The Food and Drugs Act and Related Intellectual Property Regimes (Irwin Law, 2024). As health product rules become more agile and flexible, it’s a challenge for regulators to reconcile the often-competing goals of expediting access to new medicines and health products while ensuring they’re safe and effective. “Post-market surveillance is critical to protect patients, recognizing that advanced products, such as cell therapies and AI-powered medical diagnostics, continue to evolve after being approved,” he says.

Vanessa’s Law, the Protecting Canadians from Unsafe Drugs Act, 2014, was an early, influential regulatory measure that strengthened Health Canada’s ability to monitor product safety and recall unsafe products, Edwards notes. The catalyst for Vanessa’s Law was the tragic death of 15-year-old Vanessa Young – daughter of former MP Terence Young – from cardiac arrhythmia in 2000, after she took an acid reflux drug, Prepulsid. These FDA amendments required hospitals to report all serious adverse drug reactions and medical device incidents to Health Canada within 30 days.

The intellectual property framework for drug regulation, Edwards says, plays an important role. For example, it regulates competition between brand-name manufacturers, the first to bring a drug to market at higher prices and to obtain patents, and generic or biosimilar manufacturers, which make copies at lower prices. “The regulator is trying to weigh innovation, affordability, and access to medicines,” he says. “The balance between cost-effectiveness and innovation is delicate: we want patients to have greater access to safe and effective new medicines, while keeping health-care costs affordable.”

Looking ahead

It’s clear that as quantum leaps in AI technology continue, there’s an urgent need to rethink approaches not only to AI medical devices, but also to primary care, essential medicines, dental care, and outbreaks of new and emerging infectious diseases if we’re to succeed in improving health-care access, quality, efficiency, and equity for Canadians – and globally.

Dean Flood summarizes what’s required now: “We need to revolutionize our legal and regulatory approaches to health care from tiered, top-down approaches to more fluid, evidence-based, risk-calibrated approaches that evolve and stay current over time and place,” she says. “Further, we need a renewed commitment to the Canada Health Act’s core principles of universality and equity, values that are deeply ingrained in Canadians, and an insistence that all Canadians deserve timely access to care.”

What’s happening in health law at Queen’s?

• Professor Erik Knutsen, winner of Queen’s University’s top teaching award, teaches Health Law. His students tackle the latest challenges, such as the battle between public and private health care, medical malpractice, liability for pharmaceutical or medical device harms, who can consent to medical treatment for others, regulating health-care professionals, and medical aid in dying.
• Professor Lynne Hanson, LLM’93 (Artsci’81, MA’85), teaches Mental Health Law, which explores the protection of the rights of those who suffer from a mental illness, focusing on recent case law that holds the government accountable for a lack of access to treatment and other resources.
• John McIntyre, Law’14, principal lawyer with McIntyre Szabo PC, a health law boutique he co-founded, returned in 2023 to teach Public Health Law as an adjunct lecturer. In this seminar, students examine how health laws affect our daily lives by grappling with real-life issues. In fall 2024, he co-taught the course with Victoria Cistrone, Law’17 (Artsci’14), legal counsel with the College of Physicians and Surgeons of Ontario.
• Queen’s Health Law Club provides students with opportunities to expand their knowledge and build networks in the field.
• Queen’s Disability and Mental Health Law Club promotes wellness and mental well-being among law students and brings attention to the prevalence of mental illness and disability within the profession. Law Dean Colleen M. Flood and then-Health Sciences Dean Jane Philpott marked the 40th anniversary of the Canada Health Act last June by participating in a webinar with the Canadian Health Coalition. Watch their discussion on the principle of accessibility found in the act.

BY MARK WITTEN

This story was originally published in Queen’s Law Reports 2024 in October 2024.