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View Ruby Sahota Profile
Lib. (ON)
View Ruby Sahota Profile
2020-03-12 15:14 [p.2025]
Mr. Speaker, I will be sharing my time with the member for Dorval—Lachine—LaSalle.
I am honoured to take part in today's opposition motion debate on pharmacare. Ensuring that Canadians have timely access to therapeutic products, including prescription drugs and medical devices, is a clear priority for our government. A strong regulatory system capable of efficiently assessing and monitoring therapeutic products as they move from concept to market is necessary in order for Canadians to have timely access to the products that they need.
I would like to speak to colleagues about the progress being made in Canada to further improve our government's approach to the regulation of these important therapeutic products.
Health Canada has has been working towards a more agile regulatory system that better responds to health care system needs. This commitment to improve access to necessary prescription medications and medical devices was supported through funds allocated in budget 2017.
Health Canada has undertaken a number of initiatives to better serve the needs of Canadian patients in this area, including aligning regulatory processes with health care partners and international regulatory authorities, building capacity to be able to respond to changes in technology, using real-world data to bring more drugs and devices to Canadians and appropriately manage risks once products are on the market, modernizing the emergency provisions in the food and drug regulations to arrive at a less burdensome process for drugs accessed through the special access program and facilitating access to unauthorized drugs to address public and military health emergencies through an appropriate regulatory mechanism.
Health Canada is achieving this while maintaining its world-class and highly respected review of the safety, efficiency and quality of therapeutic products.
Within Canada, our government is working with health partners across the drug and medical device access spectrum to ensure earlier access to needed therapeutic products. We are reducing the time between initial approval and the reimbursement recommendation that is a key factor for a product to be made available. Portions of these reviews are now being completed in parallel, streamlining the multiple steps needed to get products to Canadians.
Health Canada is also facilitating access by expanding critical priority review pathways to ensure that the therapeutic products that are needed most by the health care system are reviewed more quickly.
Given the globalization of therapeutic product development, Canada cannot work in isolation. Health Canada has therefore committed to leveraging the knowledge gained from international counterparts, such as Australia, Europe and the United States, and is actively participating in international work sharing and collaborative drug reviews.
This international collaboration is strengthening relationships with foreign regulatory partners, improving alignment in regulatory processes and improving the efficiency and expediency of reviews. It is also maximizing the use of international scientific and regulatory expertise when reviewing drugs for safety, efficiency and quality. The change will also encourage the filing of submissions for approval of some products that would not otherwise be available in Canada.
Health Canada has also increased its capacity to review submissions for generic and biosimilar drugs so that these important and often more cost-effective therapeutic alternatives are made available to Canadians in a timely manner.
The special access program, or SAP, is an important mechanism for providing Canadians with access to drugs that are not yet marketed in Canada but are needed to treat serious or life-threatening diseases. Health Canada has published proposed regulatory changes to reduce the program's administrative burden and to make it more responsive to the needs of patients and physicians.
Regarding medical devices, Health Canada has developed a targeted review process for digital health technologies. It provides capacity to review these emerging innovative technologies in a more rapid manner. With this greater availability, these technologies will create potential cost savings in the health care system by shifting care from health care institutions to the home.
Finally, under the umbrella of access, Health Canada has finalized regulations supporting the public release of clinical data from therapeutic product submissions following a regulatory decision. Making this information available enables independent analysis by researchers and can offer new insights and perspectives that can benefit patient care.
Building on the work Health Canada is doing to support access to therapeutic products in Canada, the department has recently launched a new modernization plan focused on reducing barriers to innovation.
In response to the government's targeted reviews of the health and biosciences sector in 2018, Health Canada is advancing important work to make its regulations for therapeutic products more agile without compromising patient safety. This includes modernizing clinical trial regulations so that Canadians can access more treatment options through new and innovative clinical trial designs. Health Canada is also looking at its core market approval processes to make sure that they are flexible enough to accommodate continuous change in the sector.
Taken together, these initiatives play a key role in supporting greater access to innovative treatments needed by the health care system for all Canadians. The national pharmacare strategy will continue to build on the foundation set by Health Canada's regulatory modernization efforts.
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