“I like that this bill would make unlicensed drugs easier to get. It has flaws though. It could let the minister approve heroin. It could also let companies sell drugs without good reviews. I want the bill to go to committee so we can make it better.”
Official Hansard
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.
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