An Act to amend the Food and Drugs Act (List of Therapeutic Products Pre-approved for Special Access)

Sponsor

Marcus Powlowski  Liberal

Introduced as a private member’s bill. (These don’t often become law.)

Status

In committee (House), as of June 10, 2026

Subscribe to a feed (what's a feed?) of speeches and votes in the House related to Bill C-265.

Summary

This is from the published bill.

This enactment amends the Food and Drugs Act to establish a list of therapeutic products pre-approved for special access to allow streamlined access to treatment for patients with serious or life-threatening conditions or where there is an unmet need. It also provides parameters to guide the Minister of Health in issuing letters of authorization for the sale of new drugs for emergency treatment under the Food and Drug Regulations .

Elsewhere

All sorts of information on this bill is available at LEGISinfo, an excellent resource from Parliament. You can also read the full text of the bill.

Bill numbers are reused for different bills each new session. Perhaps you were looking for one of these other C-265s:

C-265 (2022) National Perinatal Mental Health Strategy Act
C-265 (2021) Émilie Sansfaçon Act
C-265 (2016) Secure, Adequate, Acessible and Affordable Housing Act
C-265 (2013) Canada Post-Secondary Education Act

Debate Summary

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This is a computer-generated summary of the speeches below. Usually it’s accurate, but every now and then it’ll contain inaccuracies or total fabrications.

Bill C-265 aims to reform the Special Access Program by establishing a pre-approved list of therapeutic products for serious conditions and streamlining access for physicians. Proponents argue this reduces bureaucratic delays, while some members seek amendments to address potential safety and regulatory concerns.

Liberal

  • Streamlining the Special Access Program: The Liberals support Bill C-265 to reduce bureaucratic red tape in the Special Access Program, allowing physicians to access life-saving, unapproved medications more quickly for patients facing medical emergencies.
  • Creating a pre-approved drug list: The bill proposes a pre-approved list of medications that pharmacies can stock in anticipation of use, enabling immediate treatment for critical conditions without waiting for case-by-case bureaucratic approval.
  • Empowering clinicians over bureaucrats: The party advocates for shifting decision-making authority about unapproved emergency treatments from government officials to expert clinicians who understand the immediate needs and best interests of their patients.
  • Maintaining rigorous safety standards: The Liberals emphasize that the bill maintains safety by allowing the health minister to restrict usage and remove products from the list if concerns arise, preventing pharmaceutical companies from circumventing standard approval.

Conservative

  • Reducing bureaucratic healthcare delays: The party supports the bill's intent to reform the special access program, arguing that current bureaucratic processes create life-threatening delays for patients needing drugs already proven safe in other jurisdictions.
  • Exclusions for controlled substances: Conservatives express concern that the legislation lacks explicit safeguards to prevent addictive substances, such as pharmaceutical heroin, from being added to the pre-approved list for direct access by practitioners.
  • Preventing regulatory bypass: The party warns that the bill could allow pharmaceutical companies to bypass standard Health Canada safety and efficacy reviews, potentially turning the pre-approved list into a loophole for avoiding rigorous regulation.
  • Strengthening oversight and independence: They demand amendments to ensure that clinician joint treatment plans involve independent reviewers to prevent rubber-stamping and seek greater clarity regarding the composition and standards of the proposed advisory committee.

Bloc

  • Support for the bill: The Bloc Québécois supports the bill as it streamlines Health Canada's special access program, potentially reducing processing times for life-saving drugs not yet available for sale in Canada.
  • Importance of provincial consultation: The party emphasizes that Quebec and the provinces must be consulted because they manage the healthcare systems and drug insurance programs required for these treatments to be accessible to patients.
  • Ensuring equitable drug access: There are concerns that without proper coordination and cost management, only the wealthiest individuals will benefit, violating the fundamental principle of accessibility found in the Canada Health Act.
  • Further committee-level review: The Bloc intends to consult experts during the committee stage to address ethical questions regarding the advisory committee, application processes, and the sufficiency of current cost provisions.
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Food and Drugs ActPrivate Members' Business

May 8th, 2026 / 1:15 p.m.

Liberal

Marcus Powlowski Liberal Thunder Bay—Rainy River, ON

moved that Bill C‑265, An Act to amend the Food and Drugs Act (List of Therapeutic Products Pre-approved for Special Access), be read the second time and referred to a committee.

Mr. Speaker, Canadian physicians are, at times, even in life-threatening situations, prevented from using the drugs they believe they should be using. My private member's bill looks to change this by making significant changes to the special access program, or SAP. These changes would considerably reduce the red tape associated with the program, create a pre-approved drug list for medications frequently requested and approved, and allow pharmacies to stock many life-saving medications in anticipation of their use.

Furthermore, it would transfer the authority to make difficult decisions about whether to use an unapproved drug in a life-threatening situation, where the evidence of the efficiency of that drug is unclear, to the expert clinicians rather than the bureaucrats in Ottawa.

The SAP was created under the food and drug regulations. It states that medications not approved by Health Canada may be made available for medical emergencies, which Health Canada interprets as “serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable” in Canada.

Why are medications not approved by Health Canada? There are several reasons. Sometimes these are medications that are still undergoing clinical trials, but at times there are medications that have gone through vigorous testing. For example, the Princess Margaret Cancer Centre in Toronto told me that they are frequently part of big, randomized control trials. It can take four years from the time those trials show efficacy to the time they are actually able to give those medications to people. On average, it takes Health Canada a year to a year and a half longer than the FDA to approve a medication.

For other medications, including, at times, medicines that have been previously approved in Canada, or medicines for rare diseases, the Canadian market is simply too small or the profit margin is too slim for manufacturers to want to seek approval in this country.

Many drugs that are available under the SAP have been widely used for years. For example, IV caffeine, which is routinely used in neonates, was, for a long time, available only through the SAP. Similarly, ibuprofen lysine, which is a treatment for patent ductus arteriosus in premature infants, has been used for over 30 years, but again, only through the SAP. IV methadone, to prevent narcotic withdrawals in ventilated patients, has been available in the United States for over 20 years, but in Canada it still requires the special access program.

As well, for drugs for rare diseases, the number of patients who have been treated may be too small to be able to statistically prove efficacy, which is what is required for Health Canada approval. Currently, medications that have not been approved by Health Canada can be accessed through the SAP or an N-of-1 clinical trial, with one patient, which is an even more cumbersome process.

The SAP and the clinical trial process need to be reformed. Before telling this House some of the troubling stories as to why, let me say that I know there are a lot of really good people working for Health Canada. When I talked to clinicians about the SAP, many told me that, in general, Health Canada people were really good.

However, many pharmacists, particularly pharmacists working in children's hospitals, told me about having to spend considerable time each week faxing or on the phone with the SAP, often for drugs they have been using for years. They repeatedly have to fax requests for the same medication the same week.

Setting up a clinical trial with an N of 1, which is required for rare diseases and experimental drugs, is even more cumbersome and costly, so much so that one children's hospital told me they simply do not have the resources to do that.

In another case, an ICU doctor at a children's hospital told me of spending six hours resuscitating a child with liver failure and bleeding esophageal varices. For four hours during that time, the pharmacist was on the phone trying to get approval for a drug that is the first-line treatment for this condition in the United States. They had it on hand, but it required SAP approval. Finally, they got it. The child lived. However, the clinician told me that had that child been on that medication to begin with, the child would have never been in that situation.

In addition, I have heard of numerous cases of progressive neurological diseases in children where access to a medication that would have significantly delayed the progression of the disease was refused, stayed or significantly delayed by requiring it to go through the clinical trial process.

This is even though, as one pediatric neurologist told me, if a kid is started on this medication while the kid is still able to walk, the child will continue to be able to walk, and if it is started while the kid is still is able to speak, the kid will continue to be able to speak, but if this is not done, the child will not be able to.

Infectious disease people were particularly critical of the current program. One hospital told me about a neutropenic child, which means they have a low white blood cell count and are susceptible to infection, who had sepsis due to a drug-resistant organism. The hospital had the antibiotic, but it was only available through the SAP program. It was 5:30 at night and neither the SAP program nor the manufacturer were available. As a result, the child was only started on the antibiotic the next morning, 18 hours later, even though the evidence clearly shows that antibiotics ought to be started in the first hour in this situation.

Another infectious disease specialist told me of having a patient in their ICU, again due to a drug-resistant organism. The patient was in their thirties. The drug could only be accessed through the special access program. It took seven days for approval. Unfortunately, the patient died one day before that. This specialist told me this was not uncommon. He also said that, if Health Canada did not think there was a problem, it was because it did not have to look family members in the eye and tell them that their loved one died when there was a treatment that could have saved the patient.

In another case, a newborn with a mother who was HIV positive, the child should have received antiretrovirals within six hours. They applied, and the antiretroviral was given at 15 hours, even though it was yet to be approved. Health Canada finally came through with the approval 48 hours after it was requested.

Someone from Alberta Children's Hospital sent me a very nice email. They told me they had recently conducted a retrospective review of all patients who received two antibiotics before and after the introduction of a future use pilot. This pilot enables hospitals to use on-hand stock and immediate treatment when certain criteria are met. Basically, it is similar to the pre-approved drug list in my bill, Bill C-265. They found that the program significantly reduced time-to-drug initiation from the time of request. In the case of one antibiotic, it was a little over seven days, and in the case of another, it was over 10 days, and both were reduced to less than an hour from the time of diagnosis.

Of note, the pre-approved drug list in my bill would be akin to the future list program. The pharmacists, in their letter, concluded, “while we do now have these two antibiotics as future-use, the institutional approval to stock them took approximately six months per application, and there remain additional critical antimicrobials that are not included in the pilot.” They concluded, “Bill C-265 would go a long way towards addressing these issues.”

I will give one last case. In pediatric ICUs, when there is a kid who will not stop seizing, they like to use pentobarbital, which is the go-to drug in the United States, but it is only available here under the special access program. Instead, they use phenobarbital in really high levels because it is simply easier to access.

Access to medications under the SAP is often denied because the drug is somewhere on an ongoing clinical trial. Yes, where possible, people should go in clinical trials. However, in some cases, this creates considerable hardship for the patient. For example, I had one friend who had cancer. His brother had to bring him back and forth from Thunder Bay to Duluth to get chemotherapy because the special access program denied him access. Similarly, I heard from the pediatric hospital in Montreal that it has to send patients to Toronto because the randomized control trial is in Toronto.

I trust my bill would go a long way in addressing all of these issues. Toronto's Hospital for Sick Children, the number one ranked children's hospital in the world, came to me with its problems with the special access program a number of months ago, and I said, “Why don't you write me a PMB?” The first version of the PMB was in fact the hospital's, and it has gone through several reincarnations since. Sick Kids has certainly had a lot of input.

I also want to thank my colleagues who work at Sainte-Justine Hospital in Montreal, who helped me a lot with the bill.

I would also like to thank Princess Margaret in Toronto, the Health Sciences Centre in Winnipeg, the BC Children's Hospital, London Health Sciences Centre, the William Osler Health System in Brampton and the Thunder Bay Regional Health Sciences Centre.

I thank all the clinicians, pharmacists, lawyers and administrators who helped me draft this bill. This is as much their bill as it is mine. I would also like to thank William Stephenson, law clerk and drafter extraordinaire, for his magic in turning ideas into actual laws.

What would the bill do? It would do a few things. First, it would establish a pre-approved drug list. Pharmacies could stock medications on this list in anticipation of their use and medications could be used without prior approval. There would be a requirement for notice afterwards. Presumably, the pre-approved drug list would include pretty well all the drugs in the scenarios I just talked about. I would also suggest that some of the chemotherapy drugs that it takes Princess Margaret four years to be able to use could be on the list.

A committee of experts would advise the minister as to what drugs ought to be on the list. Furthermore, the minister would be able to limit the use of drugs on the pre-approved drug list. For example, they could limit the use of antibiotics to infectious disease specialists or require that they be used in certain settings, like an ICU, or that they be used only by doctors with certain qualifications. For other non-approved products, either for use in the emergency treatment or for the prevention of the progression of serious or life-threatening conditions, this requirement would remain. The special access program would still exist.

However, the bill would explicitly address many of the current problems associated with the system. For example, once implemented, Health Canada could not deny someone access to a drug simply because a randomized controlled trial was going on somewhere in the world, all other available and approved drugs have not been tried or the evidence for the use of the drug was dated. These are all reasons I hear of frequently for access to a drug being denied.

In addition, importantly, the act would create a presumption, which would be determinative when the evidence for use of a drug may be unclear. This presumption would allow two clinicians with the requisite expertise in the field to override a denial if they attest to the treatment plan as being the one in the best interest of the patient, to the benefits outweighing the risks and to the patient having given full and informed consent knowing of a higher risk with an unproven drug.

The drug approval system needs to be improved for other reasons. For example, treatments in cancer are now targeted to the specific genetic sequence of that cancer, so being able to expeditiously do a randomized controlled trial and show statistical evidence of the efficacy of a drug rapidly is pretty well impossible. We need a drug approval system that is more nimble than what we currently have.

In conclusion, to deny someone who may be dying access to a medication that expert clinicians believe might help them is, I think, cruel. I also think that most Canadians would agree that the decision of whether to try such a drug when the evidence is unclear is best left to clinicians with an expertise in the area rather than bureaucrats in Ottawa.

I do have a word of caution. We also need to protect the public from unsafe medications and from the predatory marketing of pharmaceuticals. Health Canada certainly has a duty to look after the public interest. We must, as much as we can, continue to safeguard against the marketing of drugs that have not been proven. In addition, we do not want the SAP to be used as an end run around our drug approval system, and I have tried to put in provisions to ensure that in this legislation.

There are competing interests involved, and what is required is compromise. I believe this bill is such a compromise. I again thank all those who helped me and all members who are here for coming out on a Friday afternoon.

Food and Drugs ActPrivate Members' Business

May 8th, 2026 / 1:30 p.m.

Conservative

Burton Bailey Conservative Red Deer, AB

Mr. Speaker, I would like to thank the hon. member for his work on this private member's bill. It is very important work.

Former health minister Rona Ambrose banned substances, such as heroin and other dangerous drugs, from the special access program, stating that the Government of Canada puts the safety and security of Canadians first. Is there anything in the legislation that would restrict non-marketed drugs, such as prescription-grade heroin, from being added to the pre-approved list of therapeutic products?

Food and Drugs ActPrivate Members' Business

May 8th, 2026 / 1:30 p.m.

Liberal

Marcus Powlowski Liberal Thunder Bay—Rainy River, ON

Mr. Speaker, that is a difficult question. There is, as I recall, a provision that would allow the minister to restrict the use of a drug to protect the public interest. We certainly have to ensure, and I think this is most important, that there is no diversion of those drugs. There are examples, and I would suggest one would be IV methadone, which perhaps should be on the pre-approved drug list to only be used for ICU patients who are already on methadone and would otherwise be going into withdrawal.

There are good reasons we might want to put that on the list, but I understand the member's concerns. It would certainly be something we could talk about when it goes to committee.

Food and Drugs ActPrivate Members' Business

May 8th, 2026 / 1:30 p.m.

Bloc

Mario Simard Bloc Jonquière, QC

Mr. Speaker, I congratulate my colleague on his bill, which is intrinsically valuable and very interesting. I only have a small concern that I wish to share. Generally speaking, prescription drugs and health are areas of jurisdiction that fall to Quebec and the provinces. When we look at this bill more closely, it is clear that it is lacking a process for carrying out direct consultation.

Perhaps the member should have included some form of consultation with Quebec and the provinces in the bill. Is that maybe coming later?

Food and Drugs ActPrivate Members' Business

May 8th, 2026 / 1:30 p.m.

Liberal

Marcus Powlowski Liberal Thunder Bay—Rainy River, ON

Mr. Speaker, I thank my colleague for this great question. People who work at Sainte‑Justine Hospital in Montreal helped me a lot with this bill.

It is challenging to identify jurisdiction when it comes to health. The two levels of government each have a role to play in this field. The provinces are responsible for regulating medical professions, while the Government of Canada has responsibility over prescription drugs.

Food and Drugs ActPrivate Members' Business

May 8th, 2026 / 1:30 p.m.

La Prairie—Atateken Québec

Liberal

Jacques Ramsay LiberalParliamentary Secretary to the Minister of Public Safety

Mr. Speaker, I would first like to congratulate my colleague on this excellent bill. I know he has worked very hard, consulted several experts and sought a range of opinions. It really is a remarkable piece of work.

Some people fear that pharmaceutical companies might use the special access programs to circumvent the usual authorization procedures. Does the member have a view on this matter?

Food and Drugs ActPrivate Members' Business

May 8th, 2026 / 1:30 p.m.

Liberal

Marcus Powlowski Liberal Thunder Bay—Rainy River, ON

Mr. Speaker, I would like to thank the hon. member for asking me another question in French. It is a good question, but I find it difficult to answer it in French. It might be better if I answered it in English.

This is something that I struggled with. We do not want companies to have their drugs go on the pre-approved drug list rather than seeking approval for them. There are provisions that would allow the minister to require the company to give reasons why the companies are not seeking approval from Health Canada and to remove the drug from the pre-approved drug list if it thinks it is necessary. I contemplated the possibility of putting penalty provisions in if a company were to use this process to circumvent authorization by Health Canada—

Food and Drugs ActPrivate Members' Business

May 8th, 2026 / 1:35 p.m.

The Assistant Deputy Speaker John Nater

Questions and comments, the hon. member for Nanaimo—Ladysmith.

Food and Drugs ActPrivate Members' Business

May 8th, 2026 / 1:35 p.m.

Conservative

Tamara Kronis Conservative Nanaimo—Ladysmith, BC

Mr. Speaker, I thank my colleague for bringing this forward. I am wondering if, in his discussions with families and organizations that have been advocating for this, the member has seen first-hand the way that Health Canada's bureaucracy has created so much paperwork and administrative burden that it prevents people from getting access to health care. How would this bill help?

Food and Drugs ActPrivate Members' Business

May 8th, 2026 / 1:35 p.m.

Liberal

Marcus Powlowski Liberal Thunder Bay—Rainy River, ON

Mr. Speaker, it is mostly the pharmacists who have to spend the hours and hours going through the process. The pre-approved drug list should greatly simplify the process to access drugs. I will say that families across Canada are frustrated with this program.

Food and Drugs ActPrivate Members' Business

May 8th, 2026 / 1:35 p.m.

Conservative

Burton Bailey Conservative Red Deer, AB

Mr. Speaker, I rise today to speak to Bill C-265, an act to amend the Food and Drug Act with respect to a list of therapeutic products pre-approved for special access.

I want to start by telling the House about a child. Let us call her Emma. She is a seven-year-old girl diagnosed with a rare metabolic disorder that has no approved treatment available in Canada, yet her physician knew exactly what drug she needed. It had been approved in the United States and used successfully in Europe. Peer-reviewed literature supported its use. The benefits were proven.

Emma's doctor filled out the forms to get permission to use the non-approved drug through what is called the special access program. They submitted the request, then waited and waited. Health Canada's special access program came back with questions. More documentation was required. The application needed revision.

More time passed, and Emma's condition progressed. Her parents, who had already spent months fighting for a diagnosis, now spent every waking hour on the phone, chasing approvals and begging for clarity from a bureaucratic apparatus that seemed entirely indifferent to the fact that on the other end of this paperwork was a little girl whose window for treatment was closing. By the time the approval came through, Emma had lost ground she would never recover.

Emma's story is not unique. It happens across this country to children and adults alike, and it is happening because of a system that prioritizes a bureaucratic process over patients.

Health Canada's special access program was designed with a noble purpose: to provide Canadians who have exhausted all available treatments with access to non-marketed drugs that are proven safe and effective elsewhere. It receives more than 16,000 applications per year, more than 1,000 every single month. It is a necessary program to ensure that Canadians can access the medications they require.

Here is the issue. A significant number of those applications are for drugs that are well established, that have been approved in trusted foreign jurisdictions and that Canadian clinicians have already successfully requested through this very same program, sometimes dozens of times. Often the reason why these drugs have not been approved through the normal process is simple: Canada is not a large enough market to justify the cost of the full regulatory submission.

Health Canada's regulations, meant to keep Canadians safe, are also making it nearly impossible for many people to access the treatment they need in order to survive. For a rare disease especially, the patient population is too small. Canada may never be commercially attractive enough to bother. Every single one still requires a brand new application from scratch for each individual patient.

Think about what that means. A pediatric oncologist who has prescribed the same drug for the same rare condition 17 times still has to submit a fresh application for patient number 18 and wait for a Health Canada reviewer to tell them what they already know: that the drug is safe, that it works and that the child needs it.

For routinely accessed therapies, the special access program serves no function beyond introducing delays and unnecessary administrative burden. When a special access program application is denied, families and clinicians are left with gut-wrenching choices: forgo treatment entirely, enter into a clinical trial program or uproot their lives to seek care outside Canada. According to the Canadian Organization for Rare Disorders, only 60% of rare disease treatments even make it to Canada. Most arrive up to six years later than in the United States and Europe. Six years is a childhood.

What would Bill C-265 do? It proposes a reform to this broken system. First, it would affirm something that should frankly go without saying, that a licensed physician may administer a lawfully available therapeutic product in an emergency when it represents their best clinical judgment. We should not need legislation to say this, yet here we are.

Second, and this is at the heart of the bill, it would require the minister of health to establish and publicly maintain a pre-approved list of non-marketed therapeutic products for serious or life-threatening conditions. Products on this list could be ordered by practitioners directly, without going through the current case-by-case approval process.

To be eligible for this list, a product must have previously received a letter of authorization, have previously held an authorization that was not cancelled for safety reasons, or be currently authorized by a comparable foreign regulator. In other words, these are drugs that we already know work, that trusted peer regulators have already vetted. An independent expert advisory committee would have to be consulted before any changes are made to the list.

The bill would also codify the criteria for issuing emergency letters of authorization so doctors would not be denied these letters for frivolous bureaucratic reasons.

Conservatives recognize the challenges with the special access program, we support making access to life-saving care easier and we support the bill's advancing to committee. However, we have concerns about several provisions that require amendment before we could offer unqualified support. Let me be clear about what worries us.

First, the bill would create a presumption of approval for a letter of authorization when two specialist clinicians submit a joint treatment plan. That sounds reasonable on the surface, but there would be no requirement for those two clinicians to be independent of each other or independent of the treating practitioner. This would open the door to rubber-stamping by associate colleagues, and it could undermine the entire purpose of requiring multiple clinicians to attest.

Second, the bill contains no explicit exclusions for controlled substances from either the letter of authorization process or the pre-approved list. That means substances like pharmaceutical-grade heroin could potentially be placed on this list. There would be a removal mechanism for misuse and diversion, but inclusion should never be possible in the first place. Some members of the House may recall that this is not a theoretical concern.

In 2013, when Rona Ambrose served as minister of health under former prime minister Harper, she took decisive action to restrict special access program approvals for substances like pharmaceutical heroin. At that time, drug enablement advocates were using the special access program to expand access to substances such as heroin. Minister Ambrose recognized the public health risk that special access program authorization for heroin could normalize the prescription of addictive substances in the name of harm reduction or safe supply.

Those restrictions were undone by the Trudeau government. Now, under Bill C-265 as currently drafted, there would be nothing stopping the minister from placing substances such as heroin on the pre-approved list, from which any qualified practitioner could order it directly.

Third, the pre-approved list could become a back door for drug manufacturers seeking to bypass the standard Health Canada regulatory approval process. The sponsor of the bill has publicly acknowledged this concern himself. The bill would allow not just practitioners but also pharmacists, hospitals and medical non-profit organizations, which is an undefined term, to submit products for the list.

Here is how this could be exploited. A pharmaceutical company with a product that is approved in another country but lacks Canadian approval could fund an undefined non-profit health organization. That organization could then submit the product for inclusion on the pre-approved list. Once it is on the list, the manufacturer could sell the product directly to Canadian practitioners without ever going through the safety and efficacy reviews required for full Health Canada approval. They would avoid the cost and the scrutiny that exists in Canada.

The bill would require that products meet “appropriate quality and safety standards”, but it does not define what those standards are or who would verify them. It says that the minister may require manufacturers to explain why they are not pursuing full approval, but “may” is not “must”. We need to ensure that the pre-approval list would be reserved for genuine cases of unmet need, not be used as a shortcut for pharmaceutical companies looking to avoid regulatory review. The broad criteria have potential to invite targeted lobbying efforts, which could be a loophole for pharmaceutical companies to exploit. We need to address this in committee.

While we are at it, let us name the elephant in the room. The reason we need this bill at all is that the Health Canada bureaucracy has made the existing special access program so administratively burdensome that clinicians are drowning in paperwork while their patients deteriorate. The Liberal government and the bureaucrats at Health Canada have built a system that puts—

Food and Drugs ActPrivate Members' Business

May 8th, 2026 / 1:45 p.m.

The Assistant Deputy Speaker John Nater

I am afraid I have to interrupt the hon. member. It is time to move on.

The hon. member for Jonquière.

Food and Drugs ActPrivate Members' Business

May 8th, 2026 / 1:45 p.m.

Bloc

Mario Simard Bloc Jonquière, QC

Mr. Speaker, it is a pleasure to speak today on Bill C-265. It is worth emphasizing that the intention behind this bill is a very noble one. Facilitating access to therapeutic products for patients seeking access to innovative drugs or therapies when that is their only remaining option is a highly commendable objective, it must be said. I would like to point out that many members, like myself, have probably, at one time or another in their careers, received letters from patients who wanted access to a drug that is not available in Canada but is available elsewhere in the world. I am sure that all my colleagues also understand that everyone wants to have access to the best treatment when they are fighting for their lives.

For this reason, the Bloc Québécois will be supporting my colleague's bill. The bill will streamline applications submitted under Health Canada's special access program. Creating a list of pre-approved drugs will make it easier to process applications. This program allows a physician or dentist to request access to a drug that is not available for sale in Canada. To qualify, certain criteria must be met. First, the drug must be requested in an emergency situation, in other words for someone suffering from a serious or life-threatening illness.

This program is a last resort, since it means that all other attempts have failed and that the medication is not available in Canada. The manufacturer sets the cost of the drug. In some cases, it may be offered free of charge, but it is possible that certain costs might have to be borne by hospitals, public or private insurers, or even, in some cases, by patients or their families. Applications submitted under the SAP are reviewed based on a variety of criteria, including the level of urgency, available alternatives, medical history, and evidence of the new drug's safety and efficacy.

The bill would streamline the processing of these applications, as the list of approved drugs would reduce the administrative burden associated with assessing the safety and efficacy of a new drug. In theory, this would help reduce processing times. However, we have some concerns regarding the effects of this bill. First, Quebec and the provinces are not included in this initiative. That is what I pointed out to my colleague in my question earlier. As everyone knows, they are the ones that run our health care systems, especially our drug insurance programs. For access to these drugs to become a reality, it is imperative that Quebec and the provinces be consulted so that they can harmonize their systems. Otherwise, only the wealthiest individuals will be able to access drugs, which runs counter to a fundamental principle at the heart of the Canada Health Act: the principle of accessibility.

We would like to know whether the sponsor of the bill considers the current cost provisions in the SAP to be sufficient. This is certainly something that can also be looked at in committee. Quebec already has a program that allows patients, under specific conditions, to access drugs not covered by the Régie de l'assurance-maladie du Québec. It is known as the exceptional medications and exceptional patient program. It does not provide access to drugs that are not marketed in Canada, but it does provide access to drugs that are not on the list of insurable drugs. The bill would therefore not interfere with Quebec's programs.

We still want Quebec and the provinces to be consulted, because it is the hospitals and doctors in the provinces who will have to navigate this program. As for the procedures for adding drugs to the list, we will need to address ethical questions surrounding the creation of the advisory committee and the application process. To that end, the Bloc Québécois will take the time to consult with experts and stakeholders during the committee review of the bill. We will therefore wait until the committee stage to decide on the next steps.

Food and Drugs ActPrivate Members' Business

May 8th, 2026 / 1:50 p.m.

Whitby Ontario

Liberal

Ryan Turnbull LiberalParliamentary Secretary to the Minister of Finance and National Revenue and to the Secretary of State (Canada Revenue Agency and Financial Institutions)

Mr. Speaker, I will begin today by telling members about a child who is sick and whose parents have been told that there is a promising treatment, but it is not yet available in Canada. It is not because it does not work, and not because it is not safe, but because the paperwork has not caught up. The system was not designed with that child in mind.

As a father of three beautiful girls, I cannot imagine the sense of desperation that parents would have in that moment. I definitely feel it imperative to support the bill before us and do everything we can to prevent parents from having to go through this in those life-changing moments. This is the problem that my colleague for Thunder Bay—Rainy River is trying to solve through his private member's bill, Bill C-265.

I am proud to rise today in strong support of this bill, brought forward by my friend and colleague, who is an ER physician and a member of this House. He understands, better than most of us, what it means when a patient's time starts to run out.

This is not a partisan issue. This is about whether we are ready to put patients first, empower clinicians and help reduce barriers to saving lives.

I bring a particular lens to this bill. I have never been a physician, but before coming to this House, many years ago, I spent time working in medical research ethics at the University of London, St. George's Medical School, where I helped oversee more than 500 clinical trials and research projects. I sat in review meetings, I read the research protocols and pored over the applications. I have seen what it takes for promising treatments to move through the system, and more importantly, how long it takes.

I know what rigour looks like, and I know what evidence-based medicine looks like. I can tell members, with confidence, that this bill does not cut corners. Instead, this bill would cut red tape. Those are two very different things.

I have also seen the other side and spoken with families who were told to wait, who were told to be patient, and who watched their loved one deteriorate while a treatment that might have helped sat across a border or in a regulatory queue. That experience stays with us. It is why I wholeheartedly support this bill, and it brought me here today to this chamber to say that we can and must do better.

I will describe what our current system looks like in practice. A doctor, let us say a pediatric oncologist in the world-renowned SickKids Hospital in Toronto, has a nine-year-old patient. She has a rare form of cancer. Her family has exhausted the standard treatments. Her parents are desperate. Her doctor knows about a treatment being used successfully in, say, Europe. It has passed clinical trials abroad. It is being administered to children just like her in Germany, France and the United Kingdom, but it is not yet approved here in Canada. The doctor goes through the special access pathway and fills out forms. She waits, she follows up, she waits some more, she follows up some more, and weeks pass. The child, in that time, is getting sicker and sicker.

Now, picture the same scenario at Princess Margaret Cancer Centre in Toronto, which is one of the top cancer hospitals in the world. Its specialists are seeing the same thing: cutting-edge science at their fingertips, but bureaucracy stands between the treatment and the patient.

This is not hypothetical. This is happening right now in hospitals across the country. Delays are holding up access to life-saving medication, and the impact is not just medical; it is financial and emotional. Families are spending their savings travelling abroad for treatments that are available only elsewhere. Parents take unpaid leave. Siblings grow up in the shadow of a crisis. Our system has the power to ease this, but has not yet.

What would Bill C-265 actually do? I will break this down in plain language, as I understand it, because this matters to every Canadian, not just those who work in medicine.

Right now, if a doctor needs to access a treatment that is not yet fully approved in Canada, they have to navigate a slow, complex, case-by-case process every single time. Bill C-265 would change that by creating a pre-approved list of therapeutic products for special access. Think of it as a curated catalogue of treatments that have already been vetted, that have already been shown to work in other rigorous health systems, and that can be accessed more quickly when a doctor determines a patient needs them. Think of it as a pre-cleared lane at the border. The work has already been done, and the safety checks have already been run. When a doctor needs to act, especially in an emergency, they should not have to start from scratch: They can use their clinical judgment to determine what treatment is in the best interest of the patient.

Critically, the safeguards are in the bill. The bill would not allow just anyone to access any drug any time they feel like it. The health minister would retain the ability to restrict access for specific uses and to specify limitations on practitioners and the settings for those usages. The minister could add new products and remove any of them the moment safety concerns arise.

The integrity of our drug approval system would also be protected. The bill would not allow big pharma to circumvent Health Canada's rigorous regulatory approval process. The bill would give the minister the ability to, on reasonable grounds, ask a manufacturer of a therapeutic product for an explanation if they suspect they are trying to circumvent the regulatory approval process, and could remove that product from the list immediately if the reasons given are deemed unsatisfactory.

The bill would also bring real transparency to the process. There would be a public list of approved products, updated regularly, with annual reporting on access timelines and outcomes. Both practitioners and manufacturers would be required to report. This is accountability built right into the heart of the legislation, not as an afterthought.

One of the things I love most about the bill is that it would trust doctors to be doctors. We train our physicians for over a decade and put them through the most rigorous education and examination in the world, then in the moment of a medical urgency or emergency, we ask them to stop, file paperwork and then wait. When lives hang in the balance, they should be empowered in those moments to do what they do best. Imagine if we asked a firefighter rushing into a burning building to first complete a request form before grabbing the hose. Bill C-265 would empower physicians to use their clinical judgment, especially in emergencies, while still operating within a clear, accountable framework.

The bill includes another important proposed provision: for the health minister to issue letters of authorization for emergency access to new drugs. This would be for emergency situations, when a patient's life is at stake. The letter of authorization would be used by weighing the benefits and risks to the patient if the drug is used or if it is not used, along with all available medical evidence. In cases where the information available may not be conclusive enough, the minister could grant authorization if two practitioners who are expert clinicians with specialized knowledge agree that the use of the therapeutic product is in the best interest of the patient.

If requests are denied, the bill would require written justification of the minister's decision. The bill also outlines limitations of the minister's ability to refuse a letter of authorization, and it includes an emergency hotline to help practitioners access this process at all times. This would mean no more silence, no more wondering why, and greater transparency for doctors, patients and families.

Let me give another example of why this matters. Rare diseases are, by definition, rare. There may be only a few hundred Canadians living with a specific condition. Because the market is small, pharmaceutical companies do not always prioritize getting approval here first. They go to the United States or Europe. Full approval in Canada comes years later, if at all, so a parent in Halifax, Saskatoon or Ottawa watches their child suffer, knowing that a treatment exists, has been proven and is being used right now in other countries but cannot be accessed here. That parent is not asking for miracles; they are asking for fairness, for their child to get the same chance as child born in another country gets.

Bill C-265 would give Canadian patients that fighting chance. It says that if the evidence and international approval are there, we would not make patients wait while the system catches up.

I want to take a quick moment to recognize that it took a lot of work to get this bill to the floor of the House of Commons. Our colleague, the member of Parliament for Thunder Bay—Rainy River, did not write the bill on the back of a napkin. He consulted extensively, talking to patients, families, physicians, emergency room doctors, oncologists, and specialists in rare diseases, and he engaged with legal experts, ethicists and regulatory professionals. This is what good legislation looks like. It is built from the ground up and shaped by the people who live with the consequences every single day.

I also want to acknowledge the patients and advocates who pushed for this change. I give kudos to them. This bill belongs to them.

Good health policy is always a balance. We want to be rigorous. We want to make sure that we give Canadians safe, proven and accountable medications. We also want to be compassionate. We want to be fast enough that the system does not make the decision for the patient before the doctor even gets a chance to.

Food and Drugs ActPrivate Members' Business

May 8th, 2026 / 2 p.m.

Conservative

Grant Jackson Conservative Brandon—Souris, MB

Mr. Speaker, I am proud to rise today to put a few words on the record about the important bill before Parliament today.

Bill C-265 is a piece of legislation that seeks to address an important issue that affects Canadians who are struggling with serious and life-threatening medical conditions. The reality is that, in Canada, individuals suffering from serious medical conditions or rare diseases may not be able to access the vital therapeutic products that are designed to help them when conventional treatments cannot. Some therapeutic products might not be approved for use in Canada and others are not marketed in Canada. These products may be well-established and approved by jurisdictions that Canada trusts, but Canadians cannot access them in the way they typically can access other drugs or other health products.

Health Canada's current special access program was set up to address this issue, but it has serious flaws. The program exists as a way to get non-marketed drugs that have been proven safe into the hands of the Canadians who, oftentimes, have no other options. The issue is that this process of actually accessing these products can be lengthy and overly bureaucratic. The special access program has strict rules requiring health care practitioners to apply for what is known as a letter of authorization before they can access certain non-marketed therapeutic products for a patient.

Health practitioners in Canada are unable to prescribe unlicensed or non-marketed products in the same way they would for medications that are already available in Canada and to Canadians. Instead, approval for use is given on a case-by-case basis by the special access program for each patient seeking access to these unapproved or non-marketed therapeutic products, even if another Canadian was already approved for the same prescription drug. This has created a system where treatment has been proven effective in other countries, and even approved for other Canadians and proven effective, but, because of the administrative burdens of the program, it is still out of reach for new individuals who are diagnosed with a particular condition and who need access.

Receiving over a thousand applications monthly, or more than 12,000 applications each year, the special access program has been a critical pathway for Canadians to receive medications that could help them, but it faces significant delays. At desperate moments in the lives and the health care journeys of those suffering with severe conditions or concerns, this delay often results in thousands of Canadians' losing critical hours, days, weeks or months waiting for a letter or a response to their request, in other words, bureaucratic approvals, as they watch their health decline. In some cases, Canadians lose this precious time waiting just to find out that it is not a positive response and that their application has been denied by the program. This can lead applicants to seek out alternative treatments outside the country or even leave them, sadly, in too many cases, with nowhere else to turn.

Canadians deserve timely access to care, and Conservatives understand that bureaucratic delays are a problem with the program. To address these flaws with the special access program, Bill C-265, which we are considering today, offers important changes that attempt to reshape how unlicensed or non-marketed products are accessed by Canadians. Bill C-265 seeks to make amendments to the Food and Drugs Act to require the Minister of Health to create a publicized list of pre-approved, non-marketed therapeutic products to treat serious or life-threatening conditions. This would include a 120-day deadline for the minister to make a decision about adding such a product to the list. Further, the bill would set limits and criteria related to the Minister of Health's power to refuse emergency letters of authorization for pharmaceutical products.

Bill C-265 would also reinforce the basic principle that health care practitioners should be able to use therapeutic products that are legally available when in the best interest of their patients, which we should all be able to support.

Conservatives understand how and why the special access program needs refinements, and we appreciate the member opposite for bringing forward some proposed solutions to that program. However, we do have a few concerns with the bill, which I hope to outline here as well. Without guardrails in place, the bill has the ability to create risk here in Canada, both for the health of Canadians and the influence of corporations. That said, I want to be clear that we do see potential in this bill and how, in principle, it could benefit Canadians who struggle with different stages of accessing these therapeutic products that may have already been approved and are used by other Canadians.

To get this bill right, considerations must be given to how it would come into force and what unintended consequences it might have without key amendments. One of our broader concerns with this legislation is the lack of a safeguard against controlled substances like diacetylmorphine, also known as heroin, being included on the list. As written, the new authorization process creates an avenue for the Minister of Health to potentially add harmful and illegal substances to the pre-approved list. These are provisions that were removed by a previous government, after having been on the list in the past. Simply put, this would mean health care practitioners could access substances like pharmaceutical-grade heroin, even though they are considered restricted or illegal drugs in Canada.

Under the previous Harper Conservative government, intentional restrictions were placed on the special access program to prevent the approval of many such restricted substances. Despite that work being reversed by Trudeau Liberals, we have an opportunity with this bill to get it right and prevent addictive substances from being placed on this pre-approved list where they could pose significant risks to our public health. This bill would also create blind spots within the pharmaceutical approval process and a lack of oversight of which products are added to the pre-approved list. Not only would it give the minister the power to add or remove products, but it would also allow them to set criteria, standards and conditions without limitations.

A potential safeguard to put in place to ensure due diligence with the pre-approved list is an advisory committee that would need to be consulted before the list is amended. Unfortunately, we have no idea who would sit on that committee or who would determine its composition. Given the important role this advisory committee would play, Conservatives would need to understand its composition and ensure the selection standards are clear.

Finally, our concern is that Bill C-265 would open the door for corporate influence that directly contradicts safeguards already in place for pharmaceutical companies that want their products in the Canadian market. I know the previous member has spoken to that already today. The bill seeks to allow those therapeutic products that are placed on the pre-approved drug list to be exempt from the Food and Drug Act's regulatory power, which means companies could sell their products in Canada without being subject to the stringent reviews that Health Canada requires of the normal process. A similar regulatory bypass created in this bill comes in the presumption of approval for a letter of authorization if just two expert clinicians put forward a joint treatment plan.

While the principle makes sense on the surface, the bill offers no way to ensure these individuals are independent from one another or a verification that one of the two experts is not the practitioner responsible for treating the patient who is seeking the approval. There must be checks and balances in place to ensure drugs added to the pre-approved list and that received the letters of authorization meet clearly defined and verified safety standards.

In closing, Conservatives stand firm in our belief that Canadians deserve timely access to health care. We appreciate that the member is trying to deal with that very real and challenging issue many Canadians face. We also believe that when they access that care, Canadians should not lose their life savings because of unforeseen health complications or expensive prescription drugs.

Conservatives support getting this well-intentioned bill to committee, where we can strengthen it by strengthening safeguards to ensure controlled and addictive substances can not be added to the pre-approved list; improving oversight and accountability around the minister's authority and the advisory committee responsible for review products; closing loopholes that could allow pharmaceutical companies to bypass Canada's existing regulatory approval process; and ensuring the emergency authorization process includes clear independence and verification standards for expert clinicians.

Food and Drugs ActPrivate Members' Business

May 8th, 2026 / 2:10 p.m.

Conservative

Tamara Kronis Conservative Nanaimo—Ladysmith, BC

Mr. Speaker, I am grateful for the chance to speak today to Bill C-265, an act to amend the Food and Drugs Act regarding a list of therapeutic products pre-approved for special access. The bill attempts to address a very real and human problem. I laud the hon. member for Thunder Bay—Rainy River for bringing it forward so we can have the collective opportunity to think about and act on this important issue.

As we have heard this afternoon, across Canada there are patients facing serious illnesses, rare diseases, aggressive cancers and rapidly deteriorating conditions whose approved treatment options either have failed or simply do not exist. In those moments, no one cares about ideology or partisanship. What they need is hope. They want time. They are looking for options, for anything that might help when all other doors appear to be closed. That is the purported purpose of the existing Health Canada special access program. Under the program, health care professionals can request access to therapies that are not yet approved in Canada for patients with serious or life-threatening conditions. In many cases, the program has in fact provided compassionate access to potentially life-saving treatments.

Bill C-265 seeks to streamline parts of that process by creating a publicly maintained list of therapeutic products that could qualify for faster access under certain circumstances. There is merit in studying this proposal carefully at committee, and I am pleased to rise today to support doing exactly that, because government systems should work efficiently to respond to real human needs. When bureaucracy creates unnecessary delays for critically ill patients, we have a responsibility in this place to ask whether those processes can be improved while maintaining proper safeguards.

I believe we should also recognize the difficult realities faced by patients living with rare diseases. Members of my immediate family live with a rare disease called hereditary neuropathy with liability to pressure palsies, or HNPP. We are lucky that it was diagnosed within a reasonable time and has so far had minimal impact on our lives. However, many rare disease patients spend years searching for diagnoses, specialists and treatment options.

Families become experts themselves because they have no other choice. They monitor clinical trials around the world. They follow developments in the United States and elsewhere. They advocate tirelessly for access to therapies that may still be working their way through Canada's approval process even though they are available elsewhere. For patients in these situations, time matters. It is frustrating, terrifying and a host of other emotions to watch someone we love suffer and in some cases die while bureaucratic rules put up roadblock after obstacle, barrier, impediment and hurdle.

This issue is particularly relevant for many of our communities on Vancouver Island and across rural Canada. Patients without family doctors already face long travel times for specialized care. Families in rural areas often experience delays in accessing diagnostics, specialists and advanced treatments. Whether we or someone we love is fighting a fast-moving illness, every additional layer of delay can feel overwhelming. Bill C-265 seeks to address that concern by allowing certain therapies to be placed on a pre-approved list for faster consideration under the program.

The idea deserves thoughtful examination, and many people in the House, including the proposer of the bill, have talked about the issues that need to be studied at committee, so I am not going to go through them here. What I am going to do is thank my colleague across the way for taking the time to really think about what we can do in this place to help real families and real people across the country to live full, better lives not spent chasing therapies they may or may not be able to access in the long run.

Food and Drugs ActPrivate Members' Business

May 8th, 2026 / 2:15 p.m.

The Assistant Deputy Speaker John Nater

The time provided for the consideration of Private Members' Business has now expired, and the order is dropped to the bottom of the order of precedence on the Order Paper.

Before we adjourn, I will wish all mothers in the House and across the country a very happy Mother's Day.

It being 2:17 p.m., the House stands adjourned until Monday, May 25, at 11 a.m., pursuant to Standing Orders 28(2) and 24(1).

(The House adjourned at 2:17 p.m.)

The House resumed from May 8 consideration of the motion that Bill C-265, An Act to amend the Food and Drugs Act (List of Therapeutic Products Pre-approved for Special Access), be read the second time and referred to a committee.

Food and Drugs ActPrivate Members' Business

June 10th, 2026 / 5:30 p.m.

Conservative

Tamara Kronis Conservative Nanaimo—Ladysmith, BC

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.

Food and Drugs ActPrivate Members' Business

June 10th, 2026 / 5:35 p.m.

Bloc

Maxime Blanchette-Joncas Bloc Rimouski—La Matapédia, QC

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.

Food and Drugs ActPrivate Members' Business

June 10th, 2026 / 5:45 p.m.

Liberal

Sonia Sidhu Liberal Brampton South, ON

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.

Food and Drugs ActPrivate Members' Business

June 10th, 2026 / 5:50 p.m.

Conservative

Dan Mazier Conservative Riding Mountain, MB

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.

Food and Drugs ActPrivate Members' Business

June 10th, 2026 / 6 p.m.

Don Valley North Ontario

Liberal

Maggie Chi LiberalParliamentary Secretary to the Minister of Health

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.

Food and Drugs ActPrivate Members' Business

June 10th, 2026 / 6:05 p.m.

Conservative

Helena Konanz Conservative Similkameen—South Okanagan—West Kootenay, BC

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.

Food and Drugs ActPrivate Members' Business

June 10th, 2026 / 6:15 p.m.

Conservative

Ellis Ross Conservative Skeena—Bulkley Valley, BC

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.

Food and Drugs ActPrivate Members' Business

June 10th, 2026 / 6:25 p.m.

The Assistant Deputy Speaker John Nater

The hon. member for Thunder Bay—Rainy River now has his right of reply for five minutes.

Food and Drugs ActPrivate Members' Business

June 10th, 2026 / 6:25 p.m.

Liberal

Marcus Powlowski Liberal Thunder Bay—Rainy River, ON

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.

Food and Drugs ActPrivate Members' Business

June 10th, 2026 / 6:30 p.m.

The Assistant Deputy Speaker John Nater

The question is on the motion.

If a member participating in person wishes that the motion be carried or carried on division, or if a member of a recognized party participating in person wishes to request a recorded division, I would invite them to rise and indicate it to the Chair.

Food and Drugs ActPrivate Members' Business

June 10th, 2026 / 6:30 p.m.

Liberal

Kevin Lamoureux Liberal Winnipeg North, MB

Mr. Speaker, I propose it be adopted on division.

Food and Drugs ActPrivate Members' Business

June 10th, 2026 / 6:30 p.m.

The Assistant Deputy Speaker John Nater

I declare the motion carried on division. Accordingly, this bill stands referred to the Standing Committee on Health.

(Motion agreed to, bill read the second time and referred to a committee)

Food and Drugs ActPrivate Members' Business

June 10th, 2026 / 6:30 p.m.

The Assistant Deputy Speaker John Nater

I believe the hon. parliamentary secretary to the government House leader is rising on a point of order.

Food and Drugs ActPrivate Members' Business

June 10th, 2026 / 6:30 p.m.

Liberal

Kevin Lamoureux Liberal Winnipeg North, MB

Mr. Speaker, there have been discussions among the parties, and I suspect you would find unanimous consent for me to be able to present the Questions on the Order Paper and Notices of Motions for the Production of Papers.

Food and Drugs ActPrivate Members' Business

June 10th, 2026 / 6:30 p.m.

The Assistant Deputy Speaker John Nater

Is it agreed?

Food and Drugs ActPrivate Members' Business

June 10th, 2026 / 6:30 p.m.

Some hon. members

Agreed.