Food and Drugs Act

Bill C-265, An Act to amend the Food and Drugs Act (List of Therapeutic Products Pre-approved for Special Access) · Second reading · now at committee in the House Where it stands

What Bill C-265 would do

The bill would create a list of therapeutic products pre-approved for special access. It would also set rules to guide the Minister of Health in authorizing the sale of new drugs for emergency treatment. The published material gives no further detail.

Official text (opens in a new tab)

4 statements

Tamara Kronis, Nanaimo—Ladysmith

Conservative
“I want this bill to go to a committee for careful study. We need to help very sick patients get new medicines faster. But we also must make sure these drugs are safe, and that drug companies cannot use this rule to avoid regular safety checks.”
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.

Dan Mazier, Riding Mountain

Conservative
“I support sending this bill to committee, but it needs changes. Sick Canadians wait too long for life-saving drugs because of government paperwork. This bill helps doctors get pre-approved medicines faster. However, we must make sure dangerous street drugs are banned from this list, prevent conflicts of interest between doctors, and limit who can ask for drugs to be added.”
  • A repeated line

    “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.”

    Said 3 times by 3 members since May 8.

    Every time it was said
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.

Helena Konanz, Similkameen—South Okanagan—West Kootenay

Conservative
“I support sending this bill to committee, but it needs changes. Right now, doctors have to do the same paperwork over and over to get special medicine for sick patients. This bill creates a pre-approved list so patients can get these drugs faster. However, we must make sure hard drugs cannot be put on this list, require second opinions to be truly independent, and limit who can ask to add drugs to the list.”
  • A repeated line

    “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.”

    Said 3 times by 3 members since May 8.

    Every time it was said
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.

Ellis Ross, Skeena—Bulkley Valley

Conservative
“Canadians who are very sick wait too long for life-saving medicine because of government paperwork. I want this bill to go to committee to fix this problem by pre-approving certain drugs. However, the bill needs changes so it does not make it easier for people to get dangerous illegal drugs.”
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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