“A previous health minister banned dangerous drugs like heroin from special access programs. Does this bill stop drugs like prescription heroin from being put on the pre-approved list?”

“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?”

“Too much paperwork at Health Canada stops people from getting the care they need. How will this bill fix that?”

“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?”

“I support sending this bill to committee to fix it. Patients with rare diseases wait too long for medicines that are already proven safe in other countries. This bill helps doctors get those drugs faster, but it needs changes so drug companies cannot use it as a shortcut and hard drugs like heroin are not put on the fast-track list.”

“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—”

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  “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.”

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“I support sending this bill to committee, but it needs changes. It helps sick people get unapproved drugs faster when other treatments fail. However, we must stop dangerous drugs like heroin from being added to the list, limit drug company influence, and add better safety checks.”

“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.”

“I support sending this bill to committee for study. It helps very sick patients get faster access to unapproved treatments that could save their lives.”

“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.”