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Private Members' Business

Food and Drugs Act

2026-06-10 Sitting 133 Showing 1–9 of 9

A bill to let the government make a list of special pre-approved medicines for people with serious conditions; the Liberals thanked and congratulated each other, a Conservative talked about a recent high school cancer fundraiser, and members mostly discussed other topics.

Official Hansard ↗

Tamara Kronis

Conservative 5:30 p.m.

“I want the bill studied in committee. We should make sure it has strong rules and doesn't let companies skip the normal process. We need to hear from many experts to make the bill stronger.”

Official Hansard

Mr. Speaker, I am grateful for the chance to finish my remarks about Bill C-265, an act to amend the Food and Drugs Act regarding a list of therapeutic products pre-approved for special access. In the interregnum between the first and second half of my remarks, members of my community sought me out to discuss how the bill would apply in complex cases. They reminded me of some things that should be considered at committee. First, we should avoid loopholes that could unintentionally weaken Canada's drug approval framework or allow inappropriate products to bypass proper scrutiny. Parliament should closely examine how products would qualify for inclusion on the proposed pre-approved list. While the bill references foreign approvals and clinical evidence, committee members should ensure that those standards are clearly defined and appropriately rigorous. Committee members should also study how oversight would function once a product is granted special access. If adverse outcomes occur, what reporting mechanisms would exist? How would Health Canada monitor safety data? Would there be transparency requirements so that Canadians can understand how these decisions are being made? Those are all reasonable questions. Another issue that deserves scrutiny is whether pharmaceutical companies could exploit the system in unintended ways. Compassionate access programs should exist for patients, not as alternative market entry strategies for manufacturers seeking to avoid the normal approval process. Parliament should ensure that the bill would not inadvertently create incentives for companies to delay seeking full Canadian approval while still gaining widespread access through an expedited pathway. Likewise, safeguards should ensure that access remains focused on exceptional circumstances involving serious or life-threatening conditions where comparable approved Canadian therapies do not exist. Clinical judgment really matters in medicine, and I appreciate that the bill acknowledges the role that physicians play in emergency decision-making. However, clear guardrails would still be necessary to maintain public confidence and consistent application across the country. We should also acknowledge that access alone does not solve every problem. Many advanced therapies are extremely expensive. Some treatments for rare diseases cost hundreds of thousands or even millions of dollars annually. Families already struggling emotionally should not be left facing impossible financial uncertainty after finally obtaining access to therapy. That broader conversation around affordability, provincial coverage and rare disease strategy must continue alongside the bill. One thing I hope we can all agree on is that Canadians facing devastating diagnoses should not feel abandoned by their health care system. At the same time, Canadians also expect Parliament to proceed carefully when it comes to medical safety and regulatory oversight. Those principles are not in conflict. Committee work exists precisely for bills like this one. It allows Parliament to hear from physicians, rare disease advocates, pharmacologists, regulators, patient groups, ethicists and health care administrators. It allows members to test assumptions, identify weaknesses and strengthen legislation before it advances further. It also allows parliamentarians to hear from patients. Perhaps committee study will reveal areas where the bill should be amended. Perhaps stronger oversight mechanisms will be needed. Perhaps definitions will need tightening to prevent unintended consequences. That is not a flaw in the legislative process. That is the legislative process working as it should. I also believe that Canadians are increasingly frustrated when Parliament simply shuts down debate at the outset rather than engaging constructively with proposals that may have merit. I think we will see some of that shutting down today on other matters. We should be willing to study good-faith ideas seriously, especially when they concern patients facing life-threatening illnesses. In closing, this is an issue that Parliament should be willing to study seriously, because if we can respond and reduce delays in a responsible manner, especially for cases that are exceptional, and empower physicians while maintaining strong safeguards, then Canadians will thank us.

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Maxime Blanchette-Joncas

Bloc Québécois 5:35 p.m.

“I want to look like I care about sick people. I will vote yes at second reading so I don't look bad. But Quebec needs to be in charge. The provinces shouldn't have to pay. And the rich shouldn't be the only ones who can get treatment. I have a lot of questions and concerns. We need to study this bill carefully in committee. We need to make sure treatments are safe and everyone can afford them. I will take all the time we need to talk to many experts.”

Official Hansard

Mr. Speaker, before I address Bill C‑265, I would like to take a few moments to highlight a major milestone for my region: the 50th anniversary of Culture Bas-Saint-Laurent. I would have liked to be there with its members to celebrate the anniversary in person, but I wanted their contribution to be recognized here in the House of Commons. The 50th anniversary of Culture Bas-Saint-Laurent is an essential reminder of what sets us apart as a region. Let us not forget that Culture Bas-Saint-Laurent grew out of the very first cultural council in Quebec. For 50 years, the organization has been opening doors, bringing the cultural community together and contributing to raising the Lower St. Lawrence region's profile. I want to commend all the people who have kept the organization going all these years: the artists, the cultural workers, the partner organizations, the volunteers and everyone who believes in the power of culture to boost our communities. As the member for Rimouski—La Matapédia, a riding that includes La Mitis, Les Basques and La Neigette, I want to acknowledge the enormous contribution that Culture Bas-Saint-Laurent has made to our region. I wish Culture Bas-Saint-Laurent a very happy 50th anniversary and many more years of success. Many happy returns. I will now continue with the topic at hand today, Bill C‑265. The Bloc Québécois has done its job since the official first reading of this bill in the House on March 11. We have taken the time to carefully analyze all of the proposed amendments to the Food and Drugs Act with a view to creating a list of pre-approved therapeutic products under Health Canada's special access program. Let me be clear from the outset: The Bloc Québécois will be supporting this bill at second reading. The idea behind this bill is simple. It will enable certain seriously ill patients to access treatments more quickly when standard options have been exhausted. It addresses a reality that many of us have witnessed in our ridings: patients with serious or life-threatening illnesses who have exhausted all therapeutic options and wish to access a promising treatment that is sometimes already available elsewhere in the world. In those situations, every day counts. Every administrative delay becomes an additional burden for people who are fighting for their lives. We understand the legitimate desire to have access to alternative treatments when all else has failed. No one wants a patient to be denied a treatment option simply because administrative procedures move more slowly than their disease is progressing. I think many of my colleagues will relate to what I am about to say. At one time or another, we have all received a call or an email from a family desperately seeking a solution for a loved one who is seriously ill. Behind these requests are people who are almost out of options and who are still hoping for one more chance. The special access program was created for just this kind of situation. It is intended to provide access to certain treatments when conventional options are no longer sufficient and the patient's condition requires it. When we look at the path leading to the approval of a new drug, we quickly realize how complex the process is. From research to discovery, through clinical trials, regulatory reviews and approval by Health Canada, before a drug even makes it onto pharmacy shelves, it is clear that the process is like something out of The Twelve Tasks of Asterix. The creation of a list of drugs pre-approved for the special access program could help reduce the time required to process requests, in particular by easing the administrative burden. In principle, this is a step forward that deserves our support. However, the commendable intent aside, we have a duty to examine this bill diligently and judiciously to ensure that this measure is feasible and truly accessible to everyone. Quebec already has its own mechanisms for providing exceptional access to drugs under certain circumstances. This shows that our health care systems are already striving to strike a balance between access to treatment and the responsible management of public resources. That is why it is essential that Quebec be fully involved in any reform affecting access to treatment. First, we have concerns about how Quebec and the provinces have been left out of this process, even though they are the ones responsible for administering health care and, more importantly, managing drug plans. Facilitating access to a drug is one thing. Ensuring that it is truly accessible to members of the public, regardless of their financial situation, is quite another. Without close collaboration with Quebec and the provinces, the government could end up reinforcing inequality when it comes to access to care. Let us not forget that, under the existing special access program, drug prices are set by the manufacturer, so it is possible that some costs might have to be borne by hospitals, public or private insurers, or even, in some cases, patients or their families. We need to ensure that it is not just the wealthiest patients who are able to access these treatments, while others have to do without. That would go against a fundamental principle of our health care system, which is accessibility. Speeding up access to a drug should not mean sticking the provinces and Quebec, health care institutions or families with the bill. We cannot create a system where there is hope for everyone but where only those who can pay can really benefit from it. Innovation is important, but so is fairness, which is why we want to know whether there are any mechanisms planned to take into account the cost and coverage of these drugs. I would also like to hear what the sponsor of the bill has to say on the matter. Does he believe that the special access program's current mechanisms are sufficient to ensure financial accessibility, or does he think adjustments will need to be made? We agree that certain drugs should be made available more quickly, but certainly not at the expense of Quebec and the provinces, hospitals or even patients. Second, we must consider the delicate balance between rapid access and patient safety. Health Canada must continue to rigorously evaluate drugs before they are distributed. In health care, nothing should ever be used as an excuse to bypass the science. Urgency must never override caution. When a person is vulnerable and their options are limited, our collective responsibility is all the greater. We must offer hope, but not under just any conditions. Furthermore, Canada is already one of the most expensive countries for prescription drugs. There is no magic solution. Improving access to new treatments quickly often comes at a significant cost. We must therefore proceed with caution. We do need to move faster, but without driving up costs or cutting corners on safety. Lastly, a number of questions remain about the conditions for adding drugs to this list. In particular, we wish to hear from experts regarding the criteria for adding a drug to the list, the composition of the advisory committee that will be responsible for making recommendations, the follow-up mechanisms that will ensure patient safety, and ethical considerations regarding access to these new treatments. The Bloc Québécois intends to take all the time that is needed to hear from experts, health care professionals, researchers and all stakeholders at the committee stage. Bill C‑265 is ultimately about patients who are running out of options and searching for one more chance. When someone is seriously ill, hope means a lot. Our role as legislators is to ensure that this hope is based on real, fair access. That is why we support the principle of Bill C‑265. Yes, we need to improve access to innovative treatments when conventional options have been exhausted. Yes, we need to reduce red tape when it becomes an unnecessary barrier. However, we must also ensure that these treatments remain accessible to everyone, regardless of income, and that Quebec and the provinces are fully involved in the process. We must also uphold the highest standards of safety and scientific evaluation because, when it comes to public health, public trust is paramount. We will act openly and diligently, in the belief that better access to treatment must never come at the expense of fairness.

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Sonia Sidhu

Liberal 5:45 p.m.

“I want to look good for voters who have rare diseases. I support this bill. I'm going to talk a lot about all the good things this bill will do. It will help people who are sick. I'm going to use lots of nice emotional words. This bill deserves to move forward. It will improve access while maintaining strong safeguards. It keeps patients at the centre of care.”

Official Hansard

Mr. Speaker, I rise today in support of Bill C-265, introduced by my colleague, the member for Thunder Bay—Rainy River. I want to thank him for bringing forward this important legislation and for his advocacy on behalf of patients and families across Canada. In my riding of Brampton South, I regularly hear from residents navigating serious and complex health challenges. I often hear the same message, which is that patients want timely access to safe and effective treatments. Rare diseases are often perceived as uncommon, but collectively, they are not rare at all. Today, approximately one in 12 Canadians, or nearly three million people, live with rare diseases, and roughly two-thirds of those affected are children, yet treatments exist for only a small percentage of these conditions. Throughout my time in Parliament, I have heard closely from patients, caregivers, health care professionals, researchers and advocacy organizations. As the chair of the all-party diabetes caucus, I have witnessed how medical innovation has transformed diabetes care over the years. New medication, new technologies, continuous glucose monitoring systems and advancement in treatment have dramatically improved the lives of Canadians living with diabetes. Innovation saves lives, reduces complications and improves quality of life. My riding of Brampton South is one of Canada's fastest-growing and most diverse communities. It is home to families who closely follow medical advancement taking place around the world. Increasingly, residents are aware of therapies that are available in other jurisdictions and often wonder why we cannot have that timely access and why access in Canada can take longer. They want to know what options exist when conventional treatments have failed, and whether promising innovations may be available to them or to their loved ones. For families facing serious illness, every day matters. That is why Bill C-265 deserves careful consideration. At its core, this bill is about patients. It is about Canadians living with serious, life-threatening, chronic or rare conditions who have exhausted available treatment options and are searching for hope. Canada's special access program plays an important role in our health care system. It allows health care professionals to request access to drugs that have not been approved for sale in Canada when conventional therapies have failed, are unsuitable or are unavailable. The program exists because we recognize there are circumstances where patients require access to treatments that fall outside the traditional approvals pathway. However, we know the current process can be complex and time-consuming. Physicians are often required to submit individual requests for each patient, even when the same therapeutical products have already been reviewed numerous times. While these safeguards are important, the administrative burden and red tape can create delays for patients whose conditions continue to progress. Bill C-265 seeks to address this challenge by establishing a list of products that have been pre-approved for special access. Under this proposal, therapies that meet established criteria could be placed on the national list, allowing health care providers to access them more efficiently through the special access program while maintaining appropriate oversight. Importantly, this bill would not remove safeguards. Products would continue to undergo scientific review, Health Canada would retain oversight authority and an expert advisory committee would provide recommendations regarding additions and removals. Products could be removed from the list if new evidence raised concerns regarding safety or effectiveness. In other words, this bill would seek to reduce administrative barriers without compromising patient protection. Canada would not be stepping into uncharted territory by considering a more efficient pathway for special access. Many of our international partners have already established mechanisms that allow patients with serious illness to access promising therapies before they receive full market authorization. In the United States, the Food and Drug Administration operates an expanded access program often referred to as compassionate use, which enables patients with serious or life-threatening conditions to access investigational therapies when no satisfactory alternatives exist. The European Union has implemented compassionate use programs to support patients suffering from chronic, life-threatening disease who have exhausted available treatment options. Similarly, the United Kingdom's early access to medicine scheme was designed to provide patients with earlier access to promising innovative medicine while maintaining rigorous oversight and monitoring. These programs demonstrate that improving access and maintaining safety are not mutually exclusive. We can continue to uphold Canada's high standards, while also finding ways to respond more quickly to the needs of patients facing urgent circumstances. I have heard similar concerns from patients living with chronic illness who closely follow emerging therapies and innovations that have the potential to improve outcomes and quality of life. While therapies ultimately require rigorous evaluation and regulatory oversight, we should also be examining whether they are opportunities to make promising treatments available more efficiently for patients facing serious health challenges. Bill C-265 encourages us to have that conversation. I also appreciate that the legislation includes mechanisms to promote transparency and accountability. The establishment of an expert advisory committee would ensure that decisions are informed by clinical expertise and scientific evidence. The proposed timelines for reviewing submissions would help create greater predictability for patients and health care providers. The ability to remove products from the list if safety concerns emerge reinforces the principle that patient safety must remain at the centre of every decision. This is why I believe this bill deserves to move forward. Committee members will have the opportunity to hear from patients, physicians, researchers, regulatory and advocacy organizations, and health care professionals. They will be able to access international best practices, evaluate potential risks and benefits. Bill C-265 seeks to improve access while maintaining the strong safeguards Canadians expect. By reducing unnecessary delays and strengthening the special access program, it keeps patients at the centre of care. For these reasons, I support this bill in its second reading and look forward to its study at committee.

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Dan Mazier

Conservative 5:45 p.m.

“This bill wants to fix a broken system. The system makes it hard for doctors to give rare drugs to sick people. The fix is to make a pre-approved drug list. Doctors can use this list without asking for each drug again and again. Conservatives like parts of this bill. But we have questions too. The bill has problems that could let bad drugs get approval. It could help people get hard drugs like meth and heroin. We must close these loopholes at committee.”

Official Hansard

Mr. Speaker, in this country, there are important life-saving drugs that Canadians suffering from serious conditions may not be able to access, not because the science is uncertain or the risks are unknown but because of the paperwork and the bureaucratic delays. That is the problem before us today. Health Canada's special access program was designed as a lifeline. It was designed for Canadians with serious or rare conditions when no approved treatment existed. The special access program was supposed to open a door to therapies already proven effective elsewhere. The intent was good, but the results have been a failure. In 2025, the special access program processed nearly 12,000 requests. Many of those were for drugs that Canadian physicians had requested before, drugs approved in jurisdictions where we consider regulatory peers, and drugs with years of real-world data behind them, yet each request is still treated as novel. Each application starts from scratch. A physician who has navigated this process a dozen times for a dozen patients with the same drug must continue to go through it again and again. There is no recognition of precedent or streamlining for well-established use cases. Instead, it is just more forms and more waiting. Part of the reason is structural. For rare conditions affecting small patient populations, Canada's market is sometimes not large enough to justify a full regulatory submission by manufacturers. The Canadian Organization for Rare Disorders has documented what this costs in human terms. Only 60% of rare disease treatments reach Canada at all, and those that do arrive up to six years after patients in the United States and Europe have access to them. For someone with a progressive, life-threatening illness, that can literally be the difference between life and death. Allowing a bureaucratic and broken system to withhold life-saving treatment from Canadians does not make drugs safer. The safety record of these therapies is already established by foreign regulators, by years of clinical use, and by the same Health Canada reviewers who approved the identical requests last month and the month before. The paperwork does not generate new knowledge, but it does consume time. For patients with serious conditions, time is one thing they just do not have. For many Canadians, the special access program becomes the only viable pathway to access treatment. Right now that pathway is hindered by layers of administration that fail to deliver the outcome that was intended. Bill C-265 intends to address this problem with a straightforward proposal. It would direct the Minister of Health to establish a standing, pre-approved list of non-marketed therapeutic products for serious or life-threatening conditions. Physicians would be able to prescribe directly from this list without starting from zero every time a new patient needs what the last patient received. Eligibility for this list is intended to be grounded in existing evidence. A product would need to have previously received special access program authorization, have held an authorization not withdrawn for safety reasons, or be currently approved by a recognized foreign regulator. Conservatives support advancing the bill to committee. I want to personally thank the member for Thunder Bay—Rainy River for his work on it. He has been open and collaborative throughout this process, and that is really special in these times. I know that the sponsor has seen this broken system first-hand, given his work as a doctor. That said, there are provisions in the bill that need to be fixed. First, the bill would create a presumption of approval when two specialist clinicians submit a joint treatment plan. On the surface, having two physicians validate a treatment plan would seem to add legitimacy to that course of action and help expedite emergency treatments. However, there are no provisions in the bill that would require those two clinicians to be independent of one another and of the treating physician. This could very easily lead to a situation where a relationship between two physicians, whether personal, professional or commercial, could cause one to pressure or influence the other to support a clinical treatment that in fact goes against their best clinical judgment. The second opinion means very little if it belongs to the doctor in the next office who owes the other one a favour, or is their supervisor or even a sibling or spouse. Members should consider an amendment to address the potential abuse and conflicts that could arise from this. Second, the bill contains no explicit exclusion of substances from the pre-approved list or the letter of authorization process. If the bill passes as presented, it would open the door for dangerous drugs to make it onto the pre-approved list. This would effectively create a loophole that would make it just as easy for people suffering from drug use to be prescribed methamphetamine as to be prescribed liquid caffeine. This is far from being a hypothetical concern. Through the special access program, requests for drugs such LSD and MDMA have in fact been made. Members will also recall that restrictions existed on the special access program to limit opioid diversion, under the Harper government. In 2013, then minister Rona Ambrose amended the program after learning that Health Canada had approved a request granting 21 patients with chronic addictions access to prescription heroin. However, the Trudeau Liberal government later lifted the restrictions that the Conservatives had imposed on illegal and harmful substances such as heroin and cocaine. Conservatives had put those restrictions in place for a reason. We will not support legislation that would open that door, given that the current government has approved decriminalization and supports taxpayer-funded hard drugs. To ensure that this legislation would not become another pathway to decriminalizing hard drugs, we will seek amendments at committee. Given that the sponsor has said, “We certainly have to ensure...that there is no diversion of those drugs”, I hope he will support these proposed changes. Third, the bill would permit pharmacists, hospitals and medical non-profit organizations, not just licensed practitioners, to nominate products for the pre-approved list. There is no definition as to what a medical non-profit organization is, which would open up the potential for major abuse. A large medical corporation could easily set up a non-profit organization to submit a drug approval request for its own product, and I am unsure why the sponsor did not limit these criteria to physicians. Therefore, Conservatives will propose amendments to add guardrails about who should be allowed to submit requests for drugs to be added to the pre-approved list. This should not be something every man and his dog can do. We need criteria that have proper limits so these requests would be coming from professionals who use the special access program in their day-to-day work. If not, the proposal would risk being abused by activists. There is a larger point worth making: The bill exists because Health Canada's bureaucracy has made the existing special access program so difficult to use that Parliament is now being asked to build a separate lane around it. We would not be reforming a system. The health minister has failed to reform her own department. The bill would offer some relief. However, the deeper problem would remain unaddressed. The Conservatives would go to committee with important questions, including questions on the independence between attesting clinicians, questions on the exclusion of substances from the scope of the pre-approved list and questions on who would be permitted to submit products for consideration. These technicalities are the difference between a bill that would work and a bill that would create new problems while doing little to solve old ones. Done right, the legislation could reduce the burden on physicians who spend hours on repetitive applications instead of treating patients. It could get proven therapies to Canadians who have no other options. However, done wrong, in the hands of drug manufacturers, a back door around the rules could fan the flames of the opioid crisis and worsen the tragedy that has already been permitted to grow to alarming proportions under the Liberal government. The measure of a health care system is not how well it protects its own processes. It is whether the people who need care actually get it. On that measure, the special access program has been failing for too long. Doctors should be caring for Canadians and not wasting endless hours a day filling out paperwork for bureaucrats in Ottawa. Bill C-265, strengthened at committee, could begin to make meaningful progress for Canadians who deserve results.

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Maggie Chi

Liberal 6:00 p.m.

“Thanks for bringing this bill. It wants to help sick people get drugs that aren't approved yet. But the current program has problems. Sometimes people can't get the drugs they need because there's too much paperwork. This bill would make a pre-approved list of drugs that doctors can use without asking every time. It would also let doctors use more kinds of evidence to get drugs approved. This could make things faster and help people who are very sick. But we need to study it carefully at committee to make sure it's done right. This is an important bill and we should all work together to try to make it better.”

Official Hansard

Mr. Speaker, I am pleased to rise today to speak to Bill C-265. I want to first thank my good friend, the member for Thunder Bay—Rainy River, for bringing forward this important bill and legislation. As many members know, he brings a unique perspective to the House as a physician. The ideas reflected in the bill are grounded not only in his own experience caring for patients but also in conversations with clinicians across Canada. who have seen first-hand the challenges that can arise when patients require access to treatments that fall outside the usual pathways. That is why the special access program is so important. At its core, the bill is about patients. The special access program serves a critical role in Canada's health care system. It allows health care practitioners to request access to drugs that are not currently authorized for sale in Canada when they believe those therapies may benefit a patient with a serious or life-threatening condition. Every year, thousands of requests are made through the program. Those requests support patients living with cancer, rare diseases, serious infections and other complex health conditions. In many cases, the program provides access to treatments that would otherwise not be available. The program is an important success story, and it reflects a careful balance between timely access and patient safety. Unfortunately, as worthwhile as the program is, it is not without its flaws. The member for Thunder Bay—Rainy River has shared stories he has heard from doctors and clinicians across Canada who needed urgent access to medicine, only to run into unexpected administrative hurdles. While these may be rare instances, given that people turning to the special access program are doing so because they are in life-or-death situations, an administrative hurdle can have serious consequences. That is where this bill comes in. The bill would make two changes to the Food and Drugs Act that would be a lifesaver for many Canadians. The first proposed change would establish a list of therapeutic products that would be pre-approved for access through the special access program. In practice, this could help streamline access to certain therapies that are already well understood and frequently requested. For patients facing urgent medical situations, even modest reductions in wait time can be meaningful. For clinicians, it may help reduce administrative burdens and allow them to focus more of their time on patient care. The second change would expand the evidence that may be considered when requests are submitted through the program. Medicine is constantly evolving. New therapies emerge, new evidence becomes available, and clinicians are often at the forefront of identifying innovative treatment options for their patients. This proposal recognizes the value of clinical expertise and seeks to provide greater flexibility in how evidence can be assessed when special access requests are considered. Taken together, these proposed measures aim to improve efficiency, support clinical decision-making, and help ensure that patients can access promising therapies when appropriate. These objectives align closely with broader efforts under to modernize Canada's regulatory system. Last summer, our government launched a red tape review. As part of this work, we are modernizing Health Canada's regulatory approach so that it focuses on agility, enhancing international collaboration and supporting timely access to therapeutic products, while maintaining the rigorous safety standards Canadians expect. We have also launched the pharmaceutical and life sciences sector task force, bringing together leaders from across the sector to strengthen Canada's capacity to develop, manufacture and deliver the medicines Canadians rely on. The goal is straightforward: improving access to treatments while fostering innovation and long-term growth right here at home. Bill C-265 aligns with these goals, and I want to applaud the member for Thunder Bay—Rainy River for putting forward a bill that showcases the kind of innovative thinking we need during this critical time. As with any piece of legislation, there are details that warrant careful study. Committee review would provide an opportunity to hear from patients, physicians, researchers, regulators and other experts to ensure that the bill achieves its objectives while remaining aligned with Canada's broader regulatory framework. That is exactly how Parliament should approach legislation such as this: thoughtfully, collaboratively and with a shared focus on the people who stand to benefit. I again want to thank the member for Thunder Bay—Rainy River for bringing the bill forward. At a time when Canadians expect us to work together to improve health outcomes and strengthen access to care, the bill offers an opportunity to do exactly that. I look forward to its being studied at committee, and I encourage all members to support sending it there for further consideration.

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Helena Konanz

Conservative 6:05 p.m.

“Why do doctors have to keep filling out the same forms over and over for the same drug? This bill wants to make a pre-approved list so doctors don't need to ask every time. But I'm worried it could make it too easy to get hard drugs. We need to change the bill to make sure that doesn't happen. The government should have fixed this problem already, but they didn't.”

Official Hansard

Mr. Speaker, before I begin, I want to give a quick shout-out and congratulations to the kids at Penticton Secondary School, who recently raised, if members can believe it, $80,000 for the Canadian Cancer Society's Relay for Life with the help of Princess Margaret Secondary, Summerland Secondary and many other local organizations, businesses and community members. I congratulate these great kids, and the best news is that people can still donate, at cancer.ca. I want to start with a simple question. Why does a physician in this country have to fill out the same paperwork for the same drug, for the same condition, over and over again, while their patients wait? That is the problem the bill is trying to solve, and it is a real problem. According to Health Canada's own records, obtained through Order Paper Question No. 1104, the special access program has received over 148,000 requests since 2015. Last year alone, nearly 12,000 requests came through. Many of these are repeat applications for drugs that Canadian clinicians have been successfully requesting for years. These are therapies that are well established and approved by regulators, with real-world track records behind them, yet the system treats every single one as if it is the first time anyone has ever asked. A physician who has prescribed the same therapy for the same rare condition 10 times must submit a fresh application for patient number 11. They fill out the forms, they wait, they answer Health Canada's follow-up questions, and they wait some more. According to the government's own written response to questions tabled in this House, the average processing time for a special access program request is 4.65 days. That might not sound like that much, but the longest processing time on record was 1,641 days. For patients with serious and emergency needs, even a few days of unnecessary delay can mean permanent, irreversible harm. The Canadian Organization for Rare Disorders has put numbers to what this costs. Only 60% of rare disease treatments reach Canada at all. Most arrive up to six years after patients in the United States and Europe have access to them. This is the broken system that Bill C-265 is trying to address. The bill would direct the Minister of Health to establish a standing pre-approved list of non-marketed therapeutic products for serious or life-threatening conditions. Physicians could prescribe directly from that list without starting from scratch every time. Products would be eligible based on prior special access program authorization, a clean safety record or current approval by a recognized foreign regulator. An expert advisory committee would be consulted on the list. However, who those experts would be is not defined. I want to acknowledge the member for Thunder Bay—Rainy River for his work on this. He has approached it collaboratively and with genuine intent. His background as a physician gives him first-hand understanding of just how much time Canadian doctors waste on repetitive administrative processes. Conservatives will support sending this bill to committee, where we will work to address our concerns. My colleague from Riding Mountain raised these concerns before, but I will raise them again. Our first concern is the presumption of approval when two specialist clinicians submit a joint treatment plan. The problem is that the bill places no requirements on these two clinicians to be independent of each other or independent of the treating practitioner. There is nothing in the legislation to prevent the second opinion from coming from a colleague in the same clinic, a supervisor, a business partner or even a family member. A second opinion is only meaningful if it is genuinely independent. Our second concern is the absence of any exclusion of controlled substances from the pre-approved list. In 2013, Conservative health minister Rona Ambrose took special action to restrict the special access program after it was used to approve access to pharmaceutical heroin for patients with chronic addiction. Those restrictions were deliberate and warranted. The Trudeau government later dismantled them. As currently drafted, Bill C-265 would give the Minister of Health the authority to place substances like dangerous hard drugs directly onto a pre-approved list, from which any qualifying practitioner could order them without individual case-by-case review. We have watched the government use every lever available to it to normalize and expand access to hard drugs under the banner of harm reduction. Conservatives are not going to support legislation that would create another pathway for that agenda. The bill's own sponsor has said that diversion of these substances must be prevented. We take him at his word, and we will hold him to it at committee with an explicit amendment to exclude hard drugs from the scope of the pre-approved list. Our third concern involves who gets to nominate products for the pre-approved list. As written, the bill would allow not just licensed practitioners but also pharmacists, hospitals and medical non-profit organizations to submit products for inclusion. The term “medical non-profit organization” is nowhere defined in the legislation. When my colleague from Riding Mountain asked the government in an Order Paper question to tell us how many special access program requests were made, broken down by requester category, whether practitioners, pharmacists, hospitals or non-profit organizations, Health Canada told us that this information is not centrally tracked. That is not good. The government cannot even tell the House who is submitting these applications, and now we are being asked to expand the nomination criteria to include an undefined class of organizations with no meaningful guardrails. That appears like an open door that can be abused. Conservatives will propose amendments to restrict nomination rights to licensed practitioners who use the special access program in their day-to-day clinical work. There is a broader point worth making also. The health minister has had every opportunity to reform how this program operates currently and has not done so. Bill C-265 would offer some relief but would not fix the underlying problem. What it would do, if strengthened at committee, is reduce the repetitive administrative burden on physicians, provide a clear and faster pathway to proven therapies for patients who have no other options and do so without opening new doors to hard drugs or creating a regulatory bypass for pharmaceutical manufacturers. If amendments are accepted, the legislation would make a meaningful difference for Canadians who are waiting for treatments that already exist and are already proven. They have waited long enough.

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Ellis Ross

Conservative 6:15 p.m.

“I want to make it easier for sick people to get life-saving drugs without a lot of paperwork and waiting. The special access program was supposed to help, but it makes doctors and patients reapply over and over for the same drug. That's too slow and stressful. My own brother had to self-medicate while waiting for his pain medicine. But this bill might make it too easy to get dangerous drugs too, like meth. Conservatives put restrictions on before, but Trudeau lifted them. We need to fix this bill so it doesn't let bad drugs through.”

Official Hansard

Mr. Speaker, there are important life-saving drugs that Canadians might not be able to access in a timely manner. Some Canadians are suffering from serious conditions and cannot access proven life-saving drugs. We know the risks, and we know the science behind these drugs is sound. Those are not the problems. The problems facing Canadians trying to access life-saving drugs are too much paperwork and too much bureaucracy. That is why we are debating Bill C-265 today, so we can get life-saving drugs to Canadians who need them in a timely and efficient manner. This is an act to amend the Food and Drugs Act. To be more clear, it is meant to provide a list of therapeutic products pre-approved for special access. “Pre-approved” is the key word. Pre-approved drugs cut down on time and bureaucracy. Canada already has a program designed for Canadians with serious or rare conditions when no other treatments exist. It is called the special access program. The problem is that there are no provisions for pre-approved drugs that are based on precedent. The special access program was meant to open a door to therapies already proven to be effective elsewhere. The intent was there, the intent was good, but the implementation failed. In 2025 alone, over 11,000 requests were processed, but each request was treated as a new request. Repeated requests were treated as new requests, instead of a consistent and efficient system that recognized the suffering and complications that some Canadians were experiencing. These are drugs requested before by Canadian doctors, drugs approved by jurisdictions that we consider to be our peers and drugs with real-world data behind them, yet each application started from scratch. Not only do doctors have to go through this process time and time again, but the patients also have to apply time and time again. My own brother, who suffers from a rare spinal disease, had to go through this for years. When his medications ran out, he would have to wait for his application to be approved so he could resume pain management. This left a gap. This left him to self-medicate with non-prescription drugs, which he hated to do, but he could not bear the pain, and I do not blame him. How many other people have considered this option? If the special access program was streamlined for well-established use cases, people like my brother would have less pain and definitely less stress, especially when the drug is referred to as “life-saving”. The paperwork and bureaucracy do not produce or generate new data. They do not generate new knowledge, but they take up time. For patients with serious conditions, time is a valuable commodity. There is no doubt that the Conservatives support this bill, but there are problems with it. My time is limited, so I will not go through them, but many of my colleagues have pointed out the problems with the bill. It is our wish that this bill go to committee. One of the problems is that the bill, as presented, would open the door for dangerous drugs to make it onto the pre-approved list and would effectively create a loophole that would make it easy for people suffering from drug use to be prescribed methamphetamine as liquid caffeine. This is far from being hypothetical. Through the special access program, requests for drugs like LSD and MDMA have in fact been made. Members may also recall that restrictions on the special access program existed to limit opioid diversion under the Harper government. In 2013, then health minister Rona Ambrose amended the program after learning that Health Canada had approved a request granting 21 patients with chronic addictions access to prescription heroin. However, the Trudeau Liberal government later lifted the restrictions that Conservatives had imposed on illegal and harmful substances, such as LSD, heroin and cocaine. Conservatives had put those restrictions in there for a reason. We look forward to seeing this go to committee for more amendments.

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Marcus Powlowski

Liberal 6:25 p.m.

“I'm filling time with kind words and saying nothing anyone could pin down later. I want doctors and hospitals to decide which drugs everyone else should pay for.”

Official Hansard

Mr. Speaker, I talked about this bill a month or so ago at some length, and I am certainly not going to try to repeat that right now. I would like to, first and foremost, thank everybody here for staying up and being here, and the many people who actually seem to have read and understood the legislation. I have to say that a lot of the comments that we received, especially from the other side, were excellent comments. I have certainly taken them to heart. I would also like to thank those people with some experience with the program or those with family members who have benefited from the program. It is those kinds of experiences more than anything else that have motivated me in writing this bill. I would like to thank the very many people who helped me draft this bill, which I did not do the first time around. Let me start off with the SickKids hospital in Toronto. The Hospital for Sick Children is the number one ranked children's hospital in the world. I dare say, if our country ought to be good at one thing, it would be looking after the health of kids. I am really proud to have, at one point, actually studied at the SickKids hospital. It came to me a number of months ago with a number of valid concerns about the special access program and has been of tremendous assistance to me in drafting this legislation. I know I cannot refer to anyone in attendance in the gallery, but if I could I would refer to some people from SickKids, namely Dr. Charlotte Hepburn and Katherine Aldred. There are a couple of people who I do not think are here, Tamana Hafid and Rida Anmol, who are lawyers who work for the hospital. Let me also mention tangentially RareKids‑CAN. They worked along with SickKids in drafting this bill. I also want to thank my colleagues at Sainte‑Justine Hospital in Montreal who helped me a great deal with this bill. I especially want to thank the hospital's excellent chief pharmacist, Denis Lebel. I would also like to thank Catherine Litalien and Dr. Nguyen. I would also like to thank the doctors and pharmacists at a number of hospitals across Canada: Princess Margaret; Health Sciences Centre Winnipeg; Alberta Children's Hospital; BC Children's Hospital; Dr. Nigro and Dr. Del Paggio at Thunder Bay Regional Health Sciences Centre, who contributed in different ways to this; and Mrs. Lori Anderson and Dr. Philip Kuruvilla. Let me briefly mention a couple of the concerns that came up, both today and the other day, in debate. One of them was a concern about the two-doctor override and having too much faith in two doctors. From my experience at the MAID committee, I certainly share the concern about having too much faith in doctors. I think part of the answer lies in the regulation of the profession, particularly with specialists. The law requires two people with the requisite knowledge; they would be specialists. Certainly, if we are going to question their behaviour of prescribing things that may be inappropriate, the appropriate body to address that issue would be the Royal College of Physicians and Surgeons. I would also point out that in the law itself there is a section that allows the minister to prohibit the use of a drug if they believe the use poses a risk to health. I have, as a result of the concerns, suggested and would entertain an amendment that it be three physicians rather than two. I would also suggest there is a possibility that the advisory board, which would advise on a pre-approved drug list, would also advise the minister with respect to the special access program and have a role in recommending to the minister that perhaps there should be restrictions on the use of a drug under the program. Lastly, the issue of controlled substances is very important to me as well. I would hate for this law to fuel the fires of the drug problem that is ravaging our country. I will work with the members of the opposition on the issue to make sure there is no diversion. I will work with the members on the opposite side on all the provisions, because certainly there is a lot of work to be done here. I will do my best to work with everyone to that end.

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Hon. Kevin Lamoureux

Liberal 6:30 p.m.

“I think everyone will agree to let me do my routine task now.”

What they said. What they meant.

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