Debates of May 8th, 2026

Military Justice System Modernization Act

[Alex Ruff, Conservative, Bruce—Grey—Owen Sound, ON]

Mr. Speaker, because of the programming motion and the time allocation on this, I am going to be the last individual to speak in this chamber, unless the bill comes back, and there is a very high probability that it may come back, based on the Minister of National Defence's indication earlier in this chamber.

When I spoke to the bill earlier this week, I highlighted the importance that we get it right. This is about the victims. This is about our military justice system. This is about retaining the credibility of our military police and our military prosecutors, but in the end, it is all about a victim-centred, trauma-informed decision within our Canadian Armed Forces.

I have highlighted before that ultimately the decision was made in late 2021 by the director of military prosecutions, in light of the report that came out by Justice Arbour, to try to transfer all Criminal Code sexual offences to the civilian authorities.

In the last five years, we have learned that the civilian police of jurisdiction do not have the resources or the capacity to deal with all these Criminal Code sexual offences. Part of the reason is that sometimes the cases are historical in nature and the courts do not view that they are in the best interest of public safety here in Canada. However, they are definitely in the best interest of justice within the Canadian Armed Forces, discipline and the necessary requirements that we need of our Canadian Armed Forces members.

If all the amendments that were done, in some cases with all-party consensus, get removed and Bill C-11 passes in its current form, the challenge we are going to have is that the victims are not going to get justice. There are two things that I think we are going to see happen at the Senate. Based on the minister's own commentary here in the chamber, he is open to the sunset clause amendment that did pass at committee, which the government has since removed, to be put back into the bill.

The other thing I think needs to be included in the bill is some sort of data collection provision. The biggest challenges we hear all the time, especially as these cases get transferred to civilian authorities, are how many they actually take, how many result in a charge being laid and how many end up with something occurring. These are all very important things that I think we need to do, and I encourage those members in the other place to take this into consideration as the bill goes forward.

However, the ultimate disappointment I have with the government's decision not to respect the victims and the decisions made at committee is that we are not going to get this right. As I said before, I predict that those of us who will have the privilege of still being in this chamber in a few years will be dealing with the next iteration of this bill and, unfortunately, apologizing to the victims who are not going to get the justice they deserve.

[The Assistant Deputy Speaker, John Nater]

It being 1:15 p.m., pursuant to order made on Monday, May 4, 2026, it is my duty to interrupt the proceedings and put forthwith every question necessary to dispose of the third reading stage of the bill now before the House.

The question is on the amendment.

If a member participating in person wishes that the amendment 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.

[Alex Ruff, Conservative, Bruce—Grey—Owen Sound, ON]

Mr. Speaker, I respectfully request a recorded division.

[The Assistant Deputy Speaker, John Nater]

Pursuant to Standing Order 45, the division stands deferred until Monday, May 25, at the expiry of the time provided for Oral Questions.

[Kevin Lamoureux, Liberal, Winnipeg North, MB]

Mr. Speaker, I suspect if you were to canvass the House, you would find unanimous consent at this time to call it 1:30 p.m. so we could begin private member's hour.

[The Assistant Deputy Speaker, John Nater]

Is it agreed?

[Some hon. members]

Agreed.

Food and Drugs Act

[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.

[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?

[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.

[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?

[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.

[Jacques Ramsay, Liberal, Parliamentary 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?

[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—

[The Assistant Deputy Speaker, John Nater]

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

[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?

[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.

[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—

[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.

[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.

[Ryan Turnbull, Liberal, Parliamentary 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.

[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.

[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.

[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.)