“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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