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Good afternoon, everyone.
I call this meeting to order.
Welcome to meeting number 26 of the House of Commons Standing Committee on Health.
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I recognize that we are meeting on the unceded territory of the Algonquin Anishinabe peoples.
Today's meeting is taking place in a hybrid format, which means that there are those of you here in person and there is a witness who is virtual.
There are some bits of housekeeping that I have to tell the witnesses to remind you of certain things.
Please wait until I recognize you by name before speaking. For those participating virtually, I need to ask you to click on the microphone icon to activate your microphone, but mute it unless you're speaking. At the bottom of your screen, you will see a little round globe. That is to get interpretation. You can choose floor, English or French.
I will remind you that all comments must be addressed through the chair.
For members in the room, you know the drill. If you wish to speak, you have to raise your hand so that I can see you before I see other people, hopefully. Also, remember that the clerk and I will try very hard to manage the speaking order as we sort the hands that are up. We appreciate your patience and understanding in this regard.
Without further ado, we are now on the order of the day.
Pursuant to Standing Order 108(2) and the motion adopted by the committee on Tuesday, September 23, 2025, the committee will begin its study of Canadian pharmaceutical sovereignty.
I would like to welcome our witnesses.
For the first hour, we have the president of the Canadian Medical Association, Dr. Margot Burnell.
Welcome.
I'd like to welcome, from Grifols Canada, Mary Hughes, who is vice-president, sales and commercial operations. Her associate is also here to give her advice should she need it.
We also have, online, Arianne Trudeau, executive director of Médicament Québec.
Here is the drill. Each group will have five minutes. You can pick who is going to speak for the five minutes. I will give you a one-minute shout-out, because I know that sometimes if you're reading, you can't see me. Then I will give you a 30-second shout-out so you can wrap up. You will get to answer questions later on to expand on what you didn't get to say.
That is it.
I shall begin now with the president of the Canadian Medical Association, Dr. Burnell, for five minutes, please.
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Thank you, Madam Chair.
I acknowledge with gratitude that we gather today on the traditional and unceded territory of the Anishinabe Algonquin nation and appreciate their stewardship of the land over generations.
My name is Dr. Margot Burnell. As president of the Canadian Medical Association, I have the privilege of representing physicians and medical learners from across this country and, through them, the people we care for.
Thank you for the invitation to share the CMA perspective as part of your study on Canada’s pharmaceutical sovereignty.
I’m sure the committee will agree that the people of Canada deserve a health care system that is modern, high-quality, patient-centred and cost-effective. Prescription medications are essential to achieving this, yet access isn’t always reliable. Every day, physicians see how access to medication can mean the difference between timely treatment and avoidable harm. When we can’t get the right drug at the right time, patients wait. Their treatments have to be delayed, and their surgeries have to be postponed.
When there’s no suitable alternative, patients may not get the full benefit of their treatment or they may have more side effects. Even when alternatives exist, switching medications can be confusing, especially for people who have been on the same drug for a long time.
The effects of these shortages are serious not only for individual patients, but for the health care system as a whole. Patients may need extra appointments to adjust their medications or emergency care that could have been avoided. That added pressure builds up quickly. Physicians, nurses and pharmacists have to spend more time searching for alternatives and adjusting treatment plans, which pulls them away from other patients.
Meanwhile, governments and pharmacies face financial strain when supply chain disruptions drive up drug prices. In the end, though, it’s patients who pay—and pay dearly—through delays, side effects, worsening health and lost confidence in a system that’s supposed to support them.
Canada's vulnerability is clear: 68% of the drugs used here are imported, and 83% of activities related to drug production take place outside our borders, including manufacturing, packaging and labelling.
The CMA has been sounding the alarm for many years. Since 2005, we've called for a comprehensive, well-resourced system to monitor Canada's drug supply. We've also recommended a review of supply processes for drugs and equipment essential to medical practice.
COVID-19 made the stakes clear: Canada didn't invest enough in stockpiles to meet demand. This lesson must guide us now as we look to build our pharmaceutical sovereignty and better protect patients.
First, the CMA recommends that the federal government invest more in producing medications in Canada. Having our own reliable source will help us manage shortages and build a system we can count on.
Second, we're asking for the federal government to partner with provinces and territories to prioritize buying medical products that are made in Canada. This helps strengthen our supply chain and supports Canadian innovation.
Third, we must take steps to strengthen our health care system overall. When drug shortages increase demand for care, we need a health workforce that can manage the impact safely and effectively. That means expanding team-based care, training and licensing more doctors and other health professionals and using technology to make care more efficient.
In closing, I want to highlight the scale of Canada's health industry and the impact our recommendations can have in strengthening it.
The health industry currently employs three million people in Canada, contributes $200 billion annually to our GDP and drives billions in spending on technology, pharmaceuticals and medical equipment. There's a real opportunity to keep more of this investment at home by strengthening domestic innovation and manufacturing.
Yes, let's absolutely keep economic value, jobs and intellectual property in Canada, but as importantly, let's ensure people in Canada can rely on safe, effective and consistent access to medications no matter what's happening elsewhere in the world. The CMA stands ready to work with the federal government, provinces and territories, and partners across the health system to reach this goal.
Thank you for your time. I'd be pleased to answer your questions.
Meegwetch.
Madam Chair and honourable members of the committee, my name is Mary Hughes and I'm the vice-president of sales and commercial operations at Grifols Canada. In terms of academic background, I have a bachelor's degree in genetics, a master's in gene therapy, an M.B.A. and a Ph.D. in hemostasis and thrombosis.
Thank you for the opportunity to appear before you today. I appreciate the chance to tell you about the work Grifols is doing in partnership with Canadian Blood Services to help Canada strengthen the country's self-sufficiency in plasma medicines and improve security of supply for Canadian patients whose lives depend on these medicines.
Plasma-derived medicines treat rare, chronic and life-threatening conditions. For many patients, immunoglobulin therapy is not optional. It is the only effective way to survive and maintain a better quality of life. These medicines can be made only from human plasma, donated by people who help others.
Thousands of patients across Canada rely on these treatments. To treat one patient with primary immunodeficiency for a year, it can take 130 plasma donations, and 465 donations are needed for patients with CIDP, a complex neurological condition.
The availability of treatment depends entirely on a stable, reliable supply of plasma.
The COVID-19 pandemic and a global shortage of immunoglobulins have shown how reliance on external supply for critical health products creates a significant vulnerability for Canadian patients. As a result, Canadian Blood Services made it a national priority earlier this decade to increase domestic self-sufficiency to 50%. Grifols stepped up to support this vision, and in 2022 we signed a long-term renewable agreement with Canadian Blood Services to build a fully domestic plasma ecosystem from the ground up.
Under the agreement with Canadian Blood Services, all plasma collected in Canada by Grifols is for the exclusive benefit of, or on behalf of, Canadian Blood Services. Further, Grifols provides a service whereby it processes all such collected plasma to deliver all immunoglobulin that may result from such collected plasma. As and when directed by Canadian Blood Services, Grifols may process any intermediate products that result from the process of manufacturing immunoglobulins to produce other plasma-derived medicine proteins, such as albumin.
A strong and reliable Canadian plasma supply and manufacturing capacity are vital to avoid the impact of factors outside of Canada's control. As a Canadian, I am proud that Grifols is supporting our country in this effort. Since the start of our partnership together, we have more than doubled Canada's domestic supply of immunoglobulins, going from 15% to 33%. Our progress means fewer imports, greater health care sovereignty and a stronger access to life-saving medicines for Canadians. This is possible thanks to our 800 Canadian employees, whom I proudly represent today, who are focused on helping Canadian patients.
Through Grifols' long-term commitment to Canada's plasma infrastructure and supply chain, we have invested approximately $1 billion to build a domestic plasma fractionation network and a Montreal-based plasma manufacturing facility. This is what self-sufficiency looks like in practical terms: Canadian donors, Canadian collection and Canadian production to create Canadian medicines for Canadian patients.
Our agreement with Canadian Blood Services means that plasma collected through this partnership is used to produce immunoglobulin medicines for Canadian patients. Once all the immunoglobulins are isolated to produce this medicine, the remaining proteins can be used to make another kind of medicine called albumin.
While Canada does not have enough immunoglobulins, our country has more than enough albumin to fulfill patient needs. This leaves the question of what to do with the excess albumin protein. The choice is to throw it away or use the excess to benefit patients in other parts of the world.
Let me be clear: Canadian patients and donors come first—always. For immunoglobulin, this means that every donation is fully and exclusively used to serve Canadian patients. For the by-product albumin, however, Canadian Blood Services has determined that once Canadian needs are met, the excess albumin can be used to provide life-saving medicine for patients outside of Canada. In fact, the proceeds from selling this excess albumin offset the cost of immunoglobulin medicines for Canadian patients.
Together with CBS, Grifols is contributing to Canada's national goal to achieve immunoglobulin sovereignty. We are expanding plasma collection, strengthening domestic manufacturing capacity and reducing reliance on foreign supply, while protecting Canadian patients' access to life-saving medicines.
Thank you very much for your attention. I'll be pleased to answer your questions.
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Madam Chair and committee members, thank you for giving me this opportunity to speak to you.
My name is Arianne Trudeau. I'm the executive director of Médicament Québec.
COVID‑19 revealed a number of findings and lessons concerning our dependence on pharmaceuticals. In particular, our ability to prepare and strengthen supply chains depends on our capacity to bring together all stakeholders and to develop a collaborative and flexible system poised to take on new challenges.
At the same time, we must recognize that the pool of technology platforms in Quebec and Canada is one of the cornerstones underpinning this system. University platforms group together a variety of tools, equipment, infrastructure, expertise and services designed to support university research and, to some extent, industrial research.
Médicament Québec grew out of these findings and out of a clear desire to increase the autonomy of Quebec and Canada and to build a real drug supply chain that can ensure a more solid local supply and create innovative solutions for the benefit of society.
Médicament Québec focuses on the development of structuring and collaborative platforms. With support from the Quebec government's department of the economy, innovation and energy, over $24 million was allocated to 20 structuring projects. These projects generated almost $18 million in return in strategic areas such as small‑molecule drugs, vaccines and RNA‑based therapies.
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No worries. Thank you very much.
[Translation]
These investments helped to boost innovation, create new organizations, attract new partners and strengthen key links in the drug supply chain.
Médicament Québec has made collaboration between academia and the industry its top priority at every level. Médicament Québec drew on the contribution of over 125 partners, including 62 companies in the life sciences ecosystem, to carry out its programs and activities.
As Médicament Québec prepares to roll out the third round of funding over the coming years, I would like to share a few recommendations with you today.
First, it's vital to encourage and require collaboration at all levels—
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Federal and provincial granting agencies are increasingly encouraging research in partnership with the industry. Yet the university grants available often require quid pro quos from the industry, without these partners having the opportunity to benefit from the grants. In contrast, public funding for the industry requires little collaboration with academia.
Just as certain contracts awarded to defence companies require reinvestment in the Canadian economy, the government could require that a set percentage of any public investment in a life sciences company goes towards research and development activities in partnership with academia. These two‑way partnerships benefit all stakeholders in the ecosystem and create real benefits for society.
The second recommendation is to develop clear guidelines and specific objectives for pharmaceutical sovereignty to ensure consistent approaches. Networking requires clear guidelines, in order to strengthen the positioning of certain strategic sectors or critical components of the value chain. The goal is to make a significant contribution to the implementation of government strategies, policies or plans.
Ultimately, the resulting strategies must be implemented by hybrid teams made up of academic and industry players in order to address specific challenges and produce truly structuring results. We must avoid, at all costs, supporting projects or platforms in silos that remain limited to a single organization.
A better organization of the services provided will prevent the duplication of resources and the development of services sometimes unnecessarily split among several institutions. It also helps to secure and optimize the investment of public funds.
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Lastly, as Canada works toward achieving its commitment of raising military spending, all eyes are turned to defence-related or dual-use research. Once the primary focus of the COVID-19 pandemic, the life sciences sector has been pushed to the background in favour of uncrewed systems, quantum technologies and AI. However, pharmaceutical sovereignty should be discussed more widely through a health security lens and should not become an afterthought. Ensuring the health of both civilian and military populations is a real value driver for a nation, regardless of geopolitical climate.
Sustained government support, whether it be financial or through public policies, for industry, academia or both, is required to maintain a vibrant and robust domestic life sciences ecosystem that can fully contribute to pharmaceutical sovereignty. Government should avoid buzzword-driven ephemeral approaches and instead strive to implement sustainable public policies and funding supported by evidence-based data and robust risk analysis that reflects an integrated vision of Canada's life sciences sector. Although many—
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Thank you, Madam Chair.
First of all, Dr. Burnell, thank you for coming.
We were talking about clinical trials. We've been talking a lot about how this is one of the essential parts of developing new drugs. They're the first pathway through which patients can access new therapies for things like cancer and rare diseases, and they can attract global research to Canada. We apparently have an opportunity right now, given that in the current political climate, we're looking at medical practitioners and researchers from America who are looking for other places to practise and work.
Health Canada recently launched some consultations on a framework to modernize our clinical trial regulations to make them more flexible with risk-based regulatory oversight. Why are these clinical trials so important? Can you give more detailed answers on why we need this in Canada?
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Clinical trials are very important. The reason is that medicines, when they enter into practice, are tested. First of all, are they safe for individuals? What is the appropriate dosing? What is the appropriate interval of dosing? What are the anticipated side effects? We need what we call phase one trials to determine this.
Phase two trials are then tested in patients with the indication that the drug is supposed to benefit. If it's a patient with breast cancer, the phase two trial will take individuals with advanced breast cancer; the drug will be administered to see if it's effective. If it meets the threshold predetermined in the phase two trial, it proceeds to a phase three trial.
A phase three trial compares the new drug with the current standard of care for efficacy and safety, as well as cost-effectiveness, in that order. Safety and toxicity are balanced. If you have a very effective drug but it has a lot of toxicity, then we need to know that. This becomes a discussion about whether you advance the drug and what you describe with patients when you administer or discuss using the drug for their illness.
Phase four is postmarketing studies. They look at reporting adverse events that occur in individuals once you open it up to a larger patient population. Individuals who enter clinical trials are very well screened. They have very tight eligibility criteria. When the drug enters a broader market, other toxicities may come to light.
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First, Médicament Québec doesn't necessarily work on promoting innovations that stem from research partnerships or university research. However, a great many studies have been carried out to show that this situation isn't unique to Quebec. This is happening across Canada. We're seeing a certain valley of death.
On the one hand, the pharmaceutical value chain contains a valley of death. It takes an enormous amount of capital to move innovations from one link in the innovation chain to the next. On the other hand, we lack certain links that would enable us to better harness this value and work together more effectively to move projects forward.
When we talk about developing clearer strategies and clear guidelines for pharmaceutical sovereignty, we're also talking about government guidelines for strengthening one key sector versus another. However, we also need to become clients of these innovations. We need to become the first users of innovations made in Quebec or Canada, so that society as a whole can benefit from them.
This is one reason why Médicament Québec advocates in particular for collaboration. This collaboration makes it possible to secure and optimize investments in pharmaceutical research. It helps to ensure that, if we invest in a company, an academic partner is also involved. If, for some reason, the company goes bankrupt and gets sold, an academic partner still tends to stay on.
We experienced this in the 2000s, when the big pharmaceutical companies left. The pool of talent and highly qualified employees remained in Quebec and, in many cases, retrained in academia. This would be one way to better reap the benefits of our investments.
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With respect to medications being introduced into preventative care, as I understand your question, drugs are typically tested in people with more advanced disease to identify whether there is a risk that has not come out through the clinical trials.
In cancer drugs, for example, they'll be tested in advanced disease. If there are no surprises with respect to toxicity, and some evidence of benefit, they are moved up to earlier-stage disease. From metastatic breast cancer, they're moved up to early-stage breast cancer. If they're shown to be effective there, then they're moved to prevention.
The reason for doing this in a stepwise fashion is that when you're trying to prevent something, you want to minimize toxicity. You don't want to have a life-threatening toxicity. Whereas if you are fighting a cancer and a patient's life is on the line, the patient will often prioritize the possible benefit over toxicity.
Ms. Hughes, if you walked down any main street in a Canadian city and asked, most Canadians wouldn't be aware of the drugs that you manufacture from Canadian blood donations, but they would be aware, from the news in the last six months, that two donors died not long after donating at two of your blood donation sites.
I appreciate that you've tried to address this today, but I want to ask you this: What can you say to Canadians to reassure them that they can have confidence in your operations, considering these two very unusual and tragic losses of life?
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The meeting is resumed.
I want to welcome the witnesses joining us for this second hour on the study of pharmaceutical sovereignty in Canada.
I'd like to introduce our witnesses.
As individuals, we have Dr. Martyn Judson, who is an addictions specialist, and Dr. Mina Tadrous, associate professor, University of Toronto. From the Canadian Pharmacists Association, we have Dr. Sadaf Faisal, interim vice-president, public and professional affairs.
I will give you a quick rundown. Each of you has five minutes to speak. I will give you a one-minute shout-out so you can start wrapping up and then a 30-second shout-out so you can finish wrapping up. We will then go to a question and answer period. I will time everybody for that period, giving people a few seconds here and there to finish their thoughts. I want to suggest that if you wish to respond, you should speak only when the chair recognizes you.
Dr. Tadrous, you know that you have a “raise hand” function. Please mute your microphone when you're not speaking. When the question and answer period comes up, if a question is directed to you, go ahead and unmute and answer it. There is an interpretation service designated by a little globe at the bottom. You can get English or French or floor. You can use that if you wish to.
Once again, all questions and comments should be made through the chair.
I want to begin by welcoming Dr. Judson.
You have five minutes, please, Dr. Judson.
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Thank you, Madam Chair, for this opportunity to speak before the committee.
I, Martyn Judson, was licensed by the College of Physicians and Surgeons of Ontario to practise medicine for over 50 years, until I retired in April 2025. I engaged in general practice for 10 years and then specialized full time in addiction medicine in 1984.
Over the last 40 years, I've studied the theories of addiction and attended numerous educational seminars pertaining to the management of substance misuse. I achieved certification in the management of substance misuse from the Royal College of General Practitioners in the U.K. and from the International Society of Addiction Medicine. I remain familiar with current suggestions and recommendations for addiction management and continue to teach students at Western University.
In 1991, I was the first physician to prescribe methadone for the management of opioid dependence or addiction west of Toronto. The introduction of methadone was in part a harm reduction strategy intended to minimize the spread of HIV and hepatitis C by contaminated injection equipment. It also combatted the overuse of prescription opioids such as Percocet and OxyContin. Methadone and, latterly, Suboxone are well-recognized opioid replacement therapies that have been significant influences in stabilizing the neurochemistry and neurophysiology of the addicted brain. The consequences achieved are the almost complete eradication of withdrawal symptoms, curbing cravings to use opioids and, most importantly, blocking the access of other opioids, such as hydromorphone and fentanyl, to brain receptors. These receptors, when stimulated, cause damage and harm, which are experienced by the user and society.
It is well known that the pharmaceutical industry, particularly Purdue Pharma, deliberately promoted the use of short-acting opioids in an attempt to induce addiction for those recipients, all the time denying that such a disorder would develop. Opioid agonist therapy had significant success in London until what is best viewed as the introduction of an abundance of short-acting, destabilizing opioids into the community. It is the result of poorly educated, misinformed physicians who do not fully understand the neurochemistry of addiction and therefore over-prescribe. This surfeit of over-prescribing has been aggravated by seemingly substandard medical care, which has not been adequately reviewed by the appropriate licensing authorities.
It is recognized that opioid replacement therapies, such as methadone and Suboxone, do not meet every patient need. Alternative opiate prescribing is acceptable, necessary and sometimes indicated, but this should be in the format of a long-acting opioid. The use of short-acting opioid preparations that do not comprehensively block the opioid receptors significantly increases the risk for patient destabilization, overdosing, homelessness and crime.
Physicians working in safe supply clinics are seemingly unaware of the harm caused to the majority of their patients and the community, not to mention the contribution to drug trafficking. Perhaps they choose to deny it—and this is understandable, considering the lamentable absence of education about addiction in most medical schools, which is limited to about one hour over a four-year course.
In London, there are five safe supply clinics located within pharmacies, in which physicians interview patients and prescribe short-acting addictive opioids by video link. There is infrequent interpersonal contact. The patients then visit the attached pharmacy to collect their prescriptions. The ingestion of medications such as hydromorphone is not appropriately witnessed. This is a recipe for diversion. The more patients attend these clinics, the greater the profits for the physicians, pharmacists, pharmaceutical companies and drug traffickers. All the while, the regulatory colleges, such as the Ontario Ministry of Health and Health Canada, take seemingly little or no action.
My 40 years of experience and accrued knowledge attained by listening to those who successfully became healthy have taught me that the essential components of recovery are the development of responsibility and supportive psychosocial connections to other humans. Many addicted persons have difficulty assuming these prerequisites for recovery, but they must be encouraged to try. The government must stop focusing on the short-term solutions. Physicians need to be better educated about addiction management and academics must move on from putting so much emphasis on harm reduction strategies, which are only part of the management. We must promote holistic well-being by moving away from the disease model of addiction and we must, as a society, not ignore those other components of treatment, prevention and enforcement.
The comments provided in this summary can be well encapsulated in the vernacular by stating that we should adopt a policy of providing a hand-up, not a handout.
I'll attempt to answer any questions you may have.
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Thank you, Madam Chair and honourable members of the committee, for the invitation to appear before you today and for bringing focus to this important topic of pharmaceutical sovereignty.
My name is Mina Tadrous. I'm an associate professor at the Leslie Dan faculty of pharmacy at the University of Toronto. I hold the inaugural Canada research chairship in pharmaceutical policy and real-world evidence. I'm also the founding director of the Toronto Centre for Real World Evidence, and I am co-director of the Ontario Drug Policy Research Network.
My research largely focuses on using data to support pharmaceutical policy decision-making in Canada and globally. A large portion of the work I've been doing has examined Canadian and global drug supply chains to better understand the causes and consequences of drug shortages and how to build systems that can help predict and prevent them.
My team has developed world-class tools and technologies that are already being used to help make decisions across Canada today. Our research has been published in some of the world’s top scientific journals and has been commercialized by the university to maximize our impact. Most importantly, our work is actively being used today by decision-makers and health system leaders in Canada and around the world.
Today, I would like to communicate to the committee one central message: True pharmaceutical sovereignty begins with precision and data. We cannot secure what we do not measure, and we cannot secure every medicine in the same way, nor should we try to.
In my view, the core issue is not whether a policy exists; it's whether we know how, when and where to apply it. This is the challenge before us as Canadians.
When it comes to pharmaceutical development, we live in what I describe as an era of abundance. This is both a blessing and a curse. We have thousands of medicines, sourced through deeply interconnected global supply chains, that save and improve Canadian lives every single day, but this abundance also means no country can secure and make every drug themselves. It's simply not possible. Thus, we are forced to choose and prioritize.
The fundamental lesson from my work is not simply that shortages are common and growing, which they are. The fundamental lesson is that shortages are not all the same. Our work has found that not every drug has the same chance of having a shortage. We've also found that not every drug carries the same degree of clinical consequence. To be very direct, not having some drugs will kill patients, while not having others won’t.
For example, a shortage of epinephrine, a life-saving medicine used in hospitals daily, happened a few years ago. This was associated with increased mortality when it was not available. In contrast, a shortage of valsartan, a common blood pressure medication, didn't show any mortality signals.
That doesn't mean those shortages don't matter; it means they don't all demand an equal response, and this is why we need a targeted, data-driven approach to pharmaceutical sovereignty.
The potential policy responses are numerous. Many witnesses will propose some very smart options today and in future meetings, as they have in past ones—things like strategic stockpiles, domestic production, procurement reform, essential medicines lists and even friendshoring. They can all play an important role, but no system can, nor can it afford to, apply every policy to every product when managing thousands of medicines.
That's why a one-size-fits-all approach will fail. This is too complex a problem. What we need to help bolster Canada's pharmaceutical sovereignty is a framework.
Here's a thought experiment to illustrate this. If Canada could build one factory today to manufacture only one drug, what drug should it make? In my view, we should ask ourselves four critical questions: First, which medicines are most critical for Canadians' lives? Second, which are at the highest risk of shortages, and what do we already produce? Third, where can Canada gain economic value? Fourth, what can or should Canada do well?
We must also be honest that this is not just a domestic issue. Canada sits within a complex global market.
It's not only the price a country pays that affects resilience; it's also how its market and regulators function and where it sits in this broader supply chain. For this reason, I urge the committee to think beyond crisis response and towards proactive resilience using evidence and data to identify the medicines that are clinically critical, structurally vulnerable and most likely to fail.
Pharmaceutical sovereignty does not mean making everything in Canada, which is neither realistic nor necessary. If Canada is serious about pharmaceutical sovereignty, it must build a precision-based national resilience strategy, which would position Canada to contribute where it can lead globally.
Thank you very much.
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Good afternoon, Madam Chair and honourable members of the committee. On behalf of the Canadian Pharmacists Association, I'm pleased to be here today to talk about the important issue of pharmaceutical sovereignty and how we can strengthen Canada's drug supply chain.
CPhA represents more than 40,000 pharmacists across Canada. Pharmacists are among the most accessible health professionals in the country and are often the final point of contact before medications reach the patient. As such, pharmacists see first-hand the impact that drug shortages and supply disruptions have on Canadians.
In late 2022, Canada faced a crisis as shelves sat empty of children's fever medications. Parents were forced to ration doses, travel long distances or improvise care at home. For many, a routine illness became a moment of real concern.
Drug shortages are becoming increasingly common. Each year, more than 2,000 shortages are reported in Canada, with somewhere between 1,500 and 2,000 active shortages at any given time. Pharmacists are on the front lines of managing these shortages. Our research shows that pharmacists can spend up to 20% of their day managing drug shortages—time that would otherwise be spent providing care to Canadians.
In the past few years, we have seen the number of drug shortages increase as the COVID-19 pandemic and geopolitical changes have resulted in significant disruptions to global supply chains, revealing weaknesses in Canada's manufacturing capacity. At the same time, new policies under the Trump administration, including most favoured nation policies and the threat of tariffs on pharmaceutical products, threaten to impact drug pricing in Canada and around the world.
Pharmaceutical sovereignty does not mean complete domestic self-sufficiency. Rather, it means building a resilient, diversified and reliable supply chain that reduces overreliance on a limited number of global sources. Before we can invest more into Canada's pharmaceutical manufacturing industry, we need to understand where Canada sources its drugs and raw material from.
Canada relies almost exclusively on imports for active pharmaceutical ingredients. Most of them are imported from India, followed by China, Mexico, Italy and Spain. Only 2% of APIs are manufactured in Canada. The U.S. is Canada's top trading partner for pharmaceuticals, representing 31% of Canada's imports. Around 50% of Canada's pharmaceutical imports originate from the European Union countries.
From a pharmacy perspective, six key priorities stand out.
First, Canada must strengthen domestic pharmaceutical manufacturing. There is a clear opportunity to reduce reliance on both imported drugs and raw materials. To support this shift, the federal government should strengthen relationships with diverse trading partners to ensure reliable access to APIs, while also providing targeted investment and incentives for companies to manufacture in Canada. These incentives could include expedited regulatory review processes for drugs made with Canadian-sourced ingredients and reduced review fees for domestically produced products.
Second, Canada should establish and maintain a list of medications at high risk of shortage. This action would support federal, provincial and territorial governments in planning and maintaining appropriate reserves, ensuring preparedness and continuity of care.
Third, there is a need to invest in tools, data collection and technologies to strengthen drug shortage monitoring and response. Improved data systems would enable earlier detection of supply disruptions and more effective coordination across jurisdictions.
Fourth, Canada must examine procurement practices that prioritize lowest cost over supply resilience. More balanced procurement models that value reliability, redundancy and supply security will be critical to prevent further shortages.
Fifth, we need a coordinated pan-Canadian approach, which is essential to ensure alignment across federal, provincial and territorial governments in managing supply risks and responding to shortages.
Finally, an inconsistent scope of practice across jurisdictions limits pharmacists' ability to respond to drug shortages in a timely and effective way. Enabling pharmacists to practise to the full extent of their training, including adapting prescriptions and performing therapeutic substitutions independently, would improve continuity of care and ensure more timely access to treatment for patients.
Pharmaceutical sovereignty is ultimately about ensuring Canadians have reliable, timely and equitable access to medications. Achieving this will require a balanced approach that strengthens domestic capacity, diversifies global supply, reforms procurement practices and improves coordination across jurisdictions.
Pharmacists play a critical role in managing shortages and ensuring continuity of care and must be supported to practise to the full extent of their training. CPhA looks forward to working with government and other partners to strengthen Canada's drug supply and ensure pharmacists can continue supporting patients across the country.
Thank you for the opportunity to appear today. I welcome any questions.
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It's not easy to answer simply.
Opioid safe consumption sites have an advantage in preventing overdoses and give an opportunity for staff to engage with patients and hopefully encourage them to move down the continuum of care to get into treatment and to make some radical changes.
Unfortunately, the closure of some centres will inevitably, depending on where they're located, lead to the movement of patients from those centres to other areas in the town where they were previously located, so you've just moved safe consumption sites to perhaps an unsafe consumption area in the city. However, with regard to whether there are going to be fewer people seeking treatment, I think this particular study was conducted over a short period of time—maybe 26 weeks—and this is probably not long enough to see the long-term effects of a closure.
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Well, safe supply was really pioneered in B.C. in about 2012. As I said in my opening remarks, the ideal treatment for opioid dependence or addiction is to use a long-acting opioid agonist—namely, methadone. However, it has its risks and has now really been replaced by Suboxone, which is much safer, particularly for less-experienced physicians to use, because there's less risk of overdose.
Latterly, safe supply has shifted from giving three injections of an opioid in the course of a day to the patients' being dispensed a day's supply of short-acting opioids to take by mouth. They take the first daily dose when the pharmacy opens at eight o'clock in the morning, and then they're given a bottle of hydromorphone, which is short-acting, to take home. They promptly sell it or divert it in some way in order to procure a stronger-acting opioid, such as fentanyl, and that's what's causing the harm.
I can see from my own work in London that in the clinic I used to work at—which employed 22 doctors and had 1,400 patients before the abundance of these safe supply clinics came about—we were containing the use of opioids. However, now the clinic is down to six doctors and 480 patients because the majority of the patients have migrated to an office at which they can get the short-acting opioids, which effectively encourages people to keep on using euphorigenic opioids. In other words, it's keeping them locked in their addiction.
I'd like to thank all the witnesses who have come today to provide testimony and support us on this very crucial study.
My first question is for Dr. Tadrous online.
First of all, your testimony was excellent. I really found it informative and intriguing at the same time. You described how we're in an “era of abundance”. This struck a chord with me. Your approach, your proposed action plan, I find really reasonable.
I want to pick your brain and ask you to maybe help us expand on this framework. You outlined a more targeted approach to pharmaceutical sovereignty, focusing on critical supplies, higher-risk medicines and economic values in this country. What would this type of precision-based national resilience framework look like in practice? How should we decide which medicines fall into which category?
:
Thanks again for the opportunity to be here.
This area of work is something that I've been thinking about for a very long time. Canada is not the only one grappling with this. You heard Dr. Faisal speak eloquently about the different components and how every country is largely dependent on somebody else. For drugs to end up in Canada, some of them will go through four or five or even eight different countries before they end up on a shelf in a pharmacy here. This is true for the United States, the world's largest consumer of pharmaceuticals. This is true for Europe and many of our allies that do this work.
What they're all grappling with is that, let's say you want to invest in and build a factory. One factory can cost anywhere between half a billion dollars and $1 billion, depending on what you want to do, and it can take many years. It's a large investment, but it may produce only a small number of products. I'm not saying it's not very important, because domestic production is critical, but the issue becomes this: If you have thousands of drugs, which ones are you going to pick to do this for? Even the United States has admitted they cannot produce all of their own drugs. However, we know that we want to produce some of them.
In terms of what we have produced, what we've proposed in a lot of our research and our work is that, to think about what the most important drugs are, you need to think about two factors.
First, which drugs are at the highest risk of a shortage? We can predict this based on a variety of different factors. How much domestic production do we have? How many products are in it? Is it an IV? What kind of drug is it?
Second, what is critical for an acute clinical situation? I laid out two examples in my opening statement. You have epinephrine, a medication that is needed when someone has an anaphylactic shock or they're in the hospital and they need it at that moment, versus a blood pressure medication for which we have other options. It's preventative. It's important, but you can do with other options there.
That's the kind of thing you can think about. It can help you fine-tune and bring it down from thousands. You can probably pick your top 50 or top 100, depending on which policy you want to implement.
:
That's a really great question. Some of these proposed frameworks are more about what is preventative. When we think about drug shortages and supply chains, there are preventative and there are reactive things. We want to minimize anything reactive, because this is when things go awry. For the preventative, there are things like building factories and developing stockpiles, but that means an investment from the Canadian government.
If you have a limited amount of funds and you want to put it towards a certain place, you would implement the list and think about, “Okay, let's pick the 50 drugs that we want to make sure we control the supply of.” We ensure that they're made in Canada, and that's what we're going to invest in. We can then apply the same list and use it slightly differently to say, “Let's make sure we get the next 50 important ones from friendly allies.” You can imagine that this helps prevent future shortages, because we know that, even by going from one manufacturer active in the market to two, it can reduce shortages with a 20% probability. This is a big deal when you have hundreds of shortages happening within a single year.
Reactively, at the ground level, there are a lot of different policies that I want to flag. We need to empower pharmacists to respond, and we need to empower ourselves to respond quickly. I will note that we've done research in this space, in which we compared a shortage that hits Canada versus one that hits the United States. What we found, and it is something I am pretty proud of, is that Canada responds better—40% better, actually. The reason for this is that we empower some responses: We have tables and task forces. When you have policies that help you respond, you can do better in the way you respond to these shortages.
:
I can't say that it's the supply causing risk. It's because there are physicians who are prescribing it, and it's not the recommended line of treatment. In B.C., when safe supply first came in, it was for the administration of either tablets or injections of morphine under witnessed, supervised conditions three times a day.
Now, particularly in Ontario, it has degenerated into a daily dispensing of a day's supply of hydromorphone tablets, supposedly to be taken by the patient over the 24 hours, but we know full well, just by observation....
We can see that patients get their prescription of hydromorphone, take the first dose as a witnessed dose in front of the pharmacist and take the balance home. They're meant to take it throughout the day to prevent withdrawal and cravings, but instead, that is what they sell. It is diverted. That's where the danger is. It's not so much the supply that's then supplied in turn to the pharmacy; the problem stands with the physicians who are prescribing it.
:
Thank you, Madam Chair.
I would like to start, Dr. Tadrous, by saying that I was really impressed with how you emphasize data-driven, evidence-based approaches to drug policy, as well as with your ideas for a framework in terms of prioritizing where we put our efforts when it comes to Canadian pharmaceutical sovereignty.
I'm wondering if you are aware of some of the changes Health Canada is making to the clinical trial process. We have heard in this committee, not only in this study but in previous studies, that at the present time many researchers find that clinical trials take way too long and that they're perhaps not as useful as they should be. Have you had any involvement in Health Canada's developing a more streamlined approach to clinical trials?
:
Some of my work relates to the growing field of real-world evidence. The idea is to use and leverage existing data routinely collected from health care visits and other data that can be drawn from the real world. That's been seen as an opportunity to bolster the ability to rapidly allow trials to exist and do studies.
One issue we're facing in drug development today is that a lot of the drugs coming to market are rare drugs that treat rare diseases, such as rare cancers. They are really innovative things, but the problem is they don't have a lot of people, so it becomes challenging to do these clinical trials in the robust way we've been used to and Health Canada has been used to.
What we're seeing from a lot of regulators around the world, such as the FDA, the EMA and Health Canada, which all work together to develop guidance and international standards, is that we need to bolster how we can do those clinical trials to allow ready access to do that. One space in which we're able to do that and unleash the data capacity of Canada is real-world evidence.
We haven't met that promise yet. Something many of us are trying to work towards is how we tap into the data that's part of our amazing health care systems in Canada—which do require some improvement—as a power for Canada, making it more involved in these global studies. This means we could get earlier access to treatments, study Canadians in these studies who might not always be included and then get access to medications earlier.
I want to make one comment that has to do with some of the comments that came before. When you're thinking about sovereignty, it's really important to consider that there are two pathways for conversations around branded, novel and new treatments and generic drugs. Clinical trials and those pieces are really important to get us new, novel treatments, but some of the things around essential medicines and capacity involve generic drugs as well. Both are important for sovereignty.
Dr. Faisal, to pick up on what Dr. Tadrous just said, you talked about developing a list of essential medications, and I was wondering how you might see this happening.
Actually, there was an attempt at this. Dr. Eric Hoskins, former Ontario minister of health, was charged by the Trudeau government—I think in 2015 or so—with coming up with such a list.
Could you elaborate on how you see that we might do this?
:
We have been discussing this for some time now.
We can't manufacture every drug. There are a lot of drugs, so we need to pick the ones that are really essential.
There could be two approaches. We can look at the drugs that are essential in the sense that there are no alternative treatments available for them if they ran out due to a shortage. For example, right now we are seeing an oncology medication for which there is no alternative treatment available, so this would be considered something that needs to be on the essential or critical drug list.
Then there are certain drugs that people use for chronic disease management and that they have been on for a long time. It is not easy for a physician or a prescriber to switch them from one medication to another. We need to pick and choose the ones that can give us the opportunity to cover most Canadians. We can also look at the usage of the drugs, so the drugs that have been very heavily used in Canada are ones that should be included on the list as well.
:
Thank you, Madam Chair.
I'd like to thank all the witnesses for coming. This has been very useful testimony.
We've heard a lot of testimony about how we need to improve our own manufacturing capacity. It's not the be-all and end-all—every nation has to rely on other nations for some—but we have severely limited capacity. One thing we learned during the pandemic was that we didn't have the ability to make our own vaccines.
Now, I'm going a little far through the mists of time, but some of us may remember Connaught Labs. This was a publicly owned laboratory. It produced a large portion of Canada's vaccines. It was sold in the 1980s by the federal government of the day to private industry, to a private company. This company decided that the best business case for them was to close the Canadian branch, formerly Connaught Labs, leaving us without any vaccine capacity.
Dr. Tadrous and then Dr. Faisal, does this occurrence, as long ago as it was, make a case for publicly owned pharmaceutical manufacturing that would not be at risk for being sold out of country due to a business case?
:
Thank you very much. That's a really interesting question on the balance of this. It speaks to what I'm trying to present to the committee, which is the need to be targeted. We should be bolstering domestic production in some way.
Let's say we went to a company today, told them we'd give them money to make a drug and allowed them to pick whatever they wanted. They would pick the thing that's most profitable. I'm not saying there's anything wrong with that, but as Canadians, we should be selecting on this, or at least working hand in hand: We want to pick a drug that's critical to us and important to Canadians, whether it's vaccines or drug products. We may also want to lean into how we can be valuable to the global economy and where Canada can lead. There are drugs that the United States is unable to produce. They've made this a national security process. There's a really good opportunity in working with other allies. These are the things we can make.
On the public space, there is a really great opportunity to be thinking about some public-private partnerships and different models in which we produce certain products. We've seen this in Alberta. There's a manufacturing site called API that's being produced. There need to be supports in what they can make and how they make it, but there is an opportunity to be thinking creatively about how we can both bolster domestic production and be very pointed on what we make and what Canada needs.