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—