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House Hansard - 325

44th Parl. 1st Sess.
June 5, 2024 02:00PM
Context: House Hansard - 325 - Jun/5/24
Mr. Yasir Naqvi (Parliamentary Secretary to the Minister of Health, Lib.)
  • Jun/5/24 8:11:36 p.m.
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Madam Speaker, I want to thank the hon. member for his very thoughtful question. I appreciated the question when he asked it in the House, and I have had an opportunity to speak to him in the hallways about it as well. The question is regarding the urgent need for effective treatments for pulmonary arterial hypertension, or PAH, as he outlined. This serious condition significantly impacts the lives of many Canadians and can impose severe health risks. We are aware of the recent approval of the drug sotatercept by the FDA in the United States, which offers a new option for those affected by PAH. Naturally, the question arises, as the member is asking, when can Canadians expect to be able to access this new medication here in Canada? Our number one priority is the health and safety of Canadians, which includes supporting them in accessing the necessary medications for the health conditions they face. The process for approving new drugs in Canada is thorough and designed to ensure that any therapeutic product made available on the Canadian market meets our high standards for safety, efficacy and quality. While understanding the need for more therapeutic options, we must also ensure that the benefits of any drug outweigh any potential risks. The approval process for a new drug, like this particular drug that we are talking about, involves several key and necessary stages. To market a drug in Canada, manufacturers must first file a submission with sufficient evidence of the product's quality, safety and efficacy. Health Canada reviews the data, which comes from clinical trials, research studies and other sources, to determine whether the product's benefits outweigh its risks. This rigorous evaluation is necessary to ensure that when a new drug, like sotatercept, is approved, it is safe and effective for use by Canadian patients. I can confirm that Health Canada is currently reviewing this specific drug submission under priority review. Priority review is a pathway that supports access to safe, effective and high-quality products. By accelerating the review process, we are committed to ensuring that potentially life-saving treatments reach patients without unnecessary delays. It is important to note that timing for the completion of Health Canada's reviews depends on many factors, including timelines for receiving requested additional data or information, discussions with the sponsors, and the acceptability and completeness of the information submitted. Given these considerations, the timing of when a decision will be made on this submission is not available at this time. However, we expect a decision to be made in the coming months. In conclusion, Health Canada recognizes the important role that sotatercept could play for patients with pulmonary arterial hypertension, which is why it was granted priority review status. A decision will be made once all of the required information has been thoroughly evaluated by Health Canada and upon ensuring that the benefits of this particular drug outweigh the risks of its use. We are committed to a comprehensive review process to ensure that the products Canadians consume are safe and effective.
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Context: House Hansard - 325 - Jun/5/24
Mr. Yasir Naqvi
  • Jun/5/24 8:16:09 p.m.
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Madam Speaker, again, I thank the member for his thoughtful and considerate way of approaching this really important issue. As I mentioned in my response earlier, there is a priority review that is going on, which requires an expeditious review of the process and the timelines that are associated with it. It requires, of course, the sponsor or the manufacturer of the medication to provide all the necessary data for Health Canada to review. The information that I have available to me is that there is no indication that the process is not taking place. I understand that it is taking place. I am hopeful that, for the sake of Canadians who are suffering from PAH, the review will be completed and approval granted in the requisite time. However, that is not my decision. No politician should be making those types of decisions. That is the decision of officials at Health Canada, ensuring that the health and safety of Canadians remain paramount.
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