Food and Drugs Act

Bill C-265, An Act to amend the Food and Drugs Act (List of Therapeutic Products Pre-approved for Special Access) · Second reading · now at committee in the House Where it stands

What Bill C-265 would do

The bill would create a list of therapeutic products pre-approved for special access. It would also set rules to guide the Minister of Health in authorizing the sale of new drugs for emergency treatment. The published material gives no further detail.

Official text (opens in a new tab)

4 statements

Sonia Sidhu, Brampton South

Liberal
“I support this bill. It makes it faster for very sick patients to get unapproved drugs when other treatments do not work, while still keeping them safe.”
Official Hansard

Mr. Speaker, I rise today in support of Bill C-265, introduced by my colleague, the member for Thunder Bay—Rainy River. I want to thank him for bringing forward this important legislation and for his advocacy on behalf of patients and families across Canada. In my riding of Brampton South, I regularly hear from residents navigating serious and complex health challenges. I often hear the same message, which is that patients want timely access to safe and effective treatments. Rare diseases are often perceived as uncommon, but collectively, they are not rare at all. Today, approximately one in 12 Canadians, or nearly three million people, live with rare diseases, and roughly two-thirds of those affected are children, yet treatments exist for only a small percentage of these conditions. Throughout my time in Parliament, I have heard closely from patients, caregivers, health care professionals, researchers and advocacy organizations. As the chair of the all-party diabetes caucus, I have witnessed how medical innovation has transformed diabetes care over the years. New medication, new technologies, continuous glucose monitoring systems and advancement in treatment have dramatically improved the lives of Canadians living with diabetes. Innovation saves lives, reduces complications and improves quality of life. My riding of Brampton South is one of Canada’s fastest-growing and most diverse communities. It is home to families who closely follow medical advancement taking place around the world. Increasingly, residents are aware of therapies that are available in other jurisdictions and often wonder why we cannot have that timely access and why access in Canada can take longer. They want to know what options exist when conventional treatments have failed, and whether promising innovations may be available to them or to their loved ones. For families facing serious illness, every day matters. That is why Bill C-265 deserves careful consideration. At its core, this bill is about patients. It is about Canadians living with serious, life-threatening, chronic or rare conditions who have exhausted available treatment options and are searching for hope. Canada’s special access program plays an important role in our health care system. It allows health care professionals to request access to drugs that have not been approved for sale in Canada when conventional therapies have failed, are unsuitable or are unavailable. The program exists because we recognize there are circumstances where patients require access to treatments that fall outside the traditional approvals pathway. However, we know the current process can be complex and time-consuming. Physicians are often required to submit individual requests for each patient, even when the same therapeutical products have already been reviewed numerous times. While these safeguards are important, the administrative burden and red tape can create delays for patients whose conditions continue to progress. Bill C-265 seeks to address this challenge by establishing a list of products that have been pre-approved for special access. Under this proposal, therapies that meet established criteria could be placed on the national list, allowing health care providers to access them more efficiently through the special access program while maintaining appropriate oversight. Importantly, this bill would not remove safeguards. Products would continue to undergo scientific review, Health Canada would retain oversight authority and an expert advisory committee would provide recommendations regarding additions and removals. Products could be removed from the list if new evidence raised concerns regarding safety or effectiveness. In other words, this bill would seek to reduce administrative barriers without compromising patient protection. Canada would not be stepping into uncharted territory by considering a more efficient pathway for special access. Many of our international partners have already established mechanisms that allow patients with serious illness to access promising therapies before they receive full market authorization. In the United States, the Food and Drug Administration operates an expanded access program often referred to as compassionate use, which enables patients with serious or life-threatening conditions to access investigational therapies when no satisfactory alternatives exist. The European Union has implemented compassionate use programs to support patients suffering from chronic, life-threatening disease who have exhausted available treatment options. Similarly, the United Kingdom’s early access to medicine scheme was designed to provide patients with earlier access to promising innovative medicine while maintaining rigorous oversight and monitoring. These programs demonstrate that improving access and maintaining safety are not mutually exclusive. We can continue to uphold Canada’s high standards, while also finding ways to respond more quickly to the needs of patients facing urgent circumstances. I have heard similar concerns from patients living with chronic illness who closely follow emerging therapies and innovations that have the potential to improve outcomes and quality of life. While therapies ultimately require rigorous evaluation and regulatory oversight, we should also be examining whether they are opportunities to make promising treatments available more efficiently for patients facing serious health challenges. Bill C-265 encourages us to have that conversation. I also appreciate that the legislation includes mechanisms to promote transparency and accountability. The establishment of an expert advisory committee would ensure that decisions are informed by clinical expertise and scientific evidence. The proposed timelines for reviewing submissions would help create greater predictability for patients and health care providers. The ability to remove products from the list if safety concerns emerge reinforces the principle that patient safety must remain at the centre of every decision. This is why I believe this bill deserves to move forward. Committee members will have the opportunity to hear from patients, physicians, researchers, regulatory and advocacy organizations, and health care professionals. They will be able to access international best practices, evaluate potential risks and benefits. Bill C-265 seeks to improve access while maintaining the strong safeguards Canadians expect. By reducing unnecessary delays and strengthening the special access program, it keeps patients at the centre of care. For these reasons, I support this bill in its second reading and look forward to its study at committee.

Maggie Chi, Parliamentary Secretary to the Minister of Health

Liberal
“I support this bill and want it sent to committee. It cuts paperwork so very sick patients can get unapproved medicines faster.”
Official Hansard

Mr. Speaker, I am pleased to rise today to speak to Bill C-265. I want to first thank my good friend, the member for Thunder Bay—Rainy River, for bringing forward this important bill and legislation. As many members know, he brings a unique perspective to the House as a physician. The ideas reflected in the bill are grounded not only in his own experience caring for patients but also in conversations with clinicians across Canada. who have seen first-hand the challenges that can arise when patients require access to treatments that fall outside the usual pathways. That is why the special access program is so important. At its core, the bill is about patients. The special access program serves a critical role in Canada’s health care system. It allows health care practitioners to request access to drugs that are not currently authorized for sale in Canada when they believe those therapies may benefit a patient with a serious or life-threatening condition. Every year, thousands of requests are made through the program. Those requests support patients living with cancer, rare diseases, serious infections and other complex health conditions. In many cases, the program provides access to treatments that would otherwise not be available. The program is an important success story, and it reflects a careful balance between timely access and patient safety. Unfortunately, as worthwhile as the program is, it is not without its flaws. The member for Thunder Bay—Rainy River has shared stories he has heard from doctors and clinicians across Canada who needed urgent access to medicine, only to run into unexpected administrative hurdles. While these may be rare instances, given that people turning to the special access program are doing so because they are in life-or-death situations, an administrative hurdle can have serious consequences. That is where this bill comes in. The bill would make two changes to the Food and Drugs Act that would be a lifesaver for many Canadians. The first proposed change would establish a list of therapeutic products that would be pre-approved for access through the special access program. In practice, this could help streamline access to certain therapies that are already well understood and frequently requested. For patients facing urgent medical situations, even modest reductions in wait time can be meaningful. For clinicians, it may help reduce administrative burdens and allow them to focus more of their time on patient care. The second change would expand the evidence that may be considered when requests are submitted through the program. Medicine is constantly evolving. New therapies emerge, new evidence becomes available, and clinicians are often at the forefront of identifying innovative treatment options for their patients. This proposal recognizes the value of clinical expertise and seeks to provide greater flexibility in how evidence can be assessed when special access requests are considered. Taken together, these proposed measures aim to improve efficiency, support clinical decision-making, and help ensure that patients can access promising therapies when appropriate. These objectives align closely with broader efforts under to modernize Canada’s regulatory system. Last summer, our government launched a red tape review. As part of this work, we are modernizing Health Canada’s regulatory approach so that it focuses on agility, enhancing international collaboration and supporting timely access to therapeutic products, while maintaining the rigorous safety standards Canadians expect. We have also launched the pharmaceutical and life sciences sector task force, bringing together leaders from across the sector to strengthen Canada’s capacity to develop, manufacture and deliver the medicines Canadians rely on. The goal is straightforward: improving access to treatments while fostering innovation and long-term growth right here at home. Bill C-265 aligns with these goals, and I want to applaud the member for Thunder Bay—Rainy River for putting forward a bill that showcases the kind of innovative thinking we need during this critical time. As with any piece of legislation, there are details that warrant careful study. Committee review would provide an opportunity to hear from patients, physicians, researchers, regulators and other experts to ensure that the bill achieves its objectives while remaining aligned with Canada’s broader regulatory framework. That is exactly how Parliament should approach legislation such as this: thoughtfully, collaboratively and with a shared focus on the people who stand to benefit. I again want to thank the member for Thunder Bay—Rainy River for bringing the bill forward. At a time when Canadians expect us to work together to improve health outcomes and strengthen access to care, the bill offers an opportunity to do exactly that. I look forward to its being studied at committee, and I encourage all members to support sending it there for further consideration.

Marcus Powlowski, Thunder Bay—Rainy River

Liberal
“I wrote this bill with help from doctors and children's hospitals to help sick people get drugs faster. I heard your concerns. I am open to changing the bill so three doctors must approve a drug instead of two. I also want to make sure these drugs do not end up on the street.”
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Official Hansard

Mr. Speaker, I talked about this bill a month or so ago at some length, and I am certainly not going to try to repeat that right now. I would like to, first and foremost, thank everybody here for staying up and being here, and the many people who actually seem to have read and understood the legislation. I have to say that a lot of the comments that we received, especially from the other side, were excellent comments. I have certainly taken them to heart. I would also like to thank those people with some experience with the program or those with family members who have benefited from the program. It is those kinds of experiences more than anything else that have motivated me in writing this bill. I would like to thank the very many people who helped me draft this bill, which I did not do the first time around. Let me start off with the SickKids hospital in Toronto. The Hospital for Sick Children is the number one ranked children’s hospital in the world. I dare say, if our country ought to be good at one thing, it would be looking after the health of kids. I am really proud to have, at one point, actually studied at the SickKids hospital. It came to me a number of months ago with a number of valid concerns about the special access program and has been of tremendous assistance to me in drafting this legislation. I know I cannot refer to anyone in attendance in the gallery, but if I could I would refer to some people from SickKids, namely Dr. Charlotte Hepburn and Katherine Aldred. There are a couple of people who I do not think are here, Tamana Hafid and Rida Anmol, who are lawyers who work for the hospital. Let me also mention tangentially RareKids‑CAN. They worked along with SickKids in drafting this bill. I also want to thank my colleagues at Sainte‑Justine Hospital in Montreal who helped me a great deal with this bill. I especially want to thank the hospital’s excellent chief pharmacist, Denis Lebel. I would also like to thank Catherine Litalien and Dr. Nguyen. I would also like to thank the doctors and pharmacists at a number of hospitals across Canada: Princess Margaret; Health Sciences Centre Winnipeg; Alberta Children’s Hospital; BC Children’s Hospital; Dr. Nigro and Dr. Del Paggio at Thunder Bay Regional Health Sciences Centre, who contributed in different ways to this; and Mrs. Lori Anderson and Dr. Philip Kuruvilla. Let me briefly mention a couple of the concerns that came up, both today and the other day, in debate. One of them was a concern about the two-doctor override and having too much faith in two doctors. From my experience at the MAID committee, I certainly share the concern about having too much faith in doctors. I think part of the answer lies in the regulation of the profession, particularly with specialists. The law requires two people with the requisite knowledge; they would be specialists. Certainly, if we are going to question their behaviour of prescribing things that may be inappropriate, the appropriate body to address that issue would be the Royal College of Physicians and Surgeons. I would also point out that in the law itself there is a section that allows the minister to prohibit the use of a drug if they believe the use poses a risk to health. I have, as a result of the concerns, suggested and would entertain an amendment that it be three physicians rather than two. I would also suggest there is a possibility that the advisory board, which would advise on a pre-approved drug list, would also advise the minister with respect to the special access program and have a role in recommending to the minister that perhaps there should be restrictions on the use of a drug under the program. Lastly, the issue of controlled substances is very important to me as well. I would hate for this law to fuel the fires of the drug problem that is ravaging our country. I will work with the members of the opposition on the issue to make sure there is no diversion. I will work with the members on the opposite side on all the provisions, because certainly there is a lot of work to be done here. I will do my best to work with everyone to that end.

Kevin Lamoureux, Parliamentary Secretary to the Leader of the Government in the House of Commons

Liberal
“I am asking all parties to let me present questions and requests for papers.”
Official Hansard

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

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