e-4528 (Health)

Health Canada recognizes the importance of ensuring that patients have access to potentially life-saving drugs. As the regulatory authority responsible for authorizing new prescription pharmaceutical drugs, the Health Product and Food Branch (HPFB)’s Pharmaceutical Drugs Directorate’s work in the area of Parkinson’s Disease has involved reviewing submissions for new drugs or clinical trials and in providing advice to various stakeholders regarding what is generally required to support an authorization.

Health Canada is aware that Kynmobi (marketed by Sunovion Pharmaceuticals Canada Inc.) was discontinued on September 29, 2023 and that Movapo (marketed by Paladin Labs Inc.) will be discontinued on October 31, 2023. The Department is also aware that existing supplies of Kynmobi in Canada are expected to last for months beyond the discontinuation date. In both cases the decision to withdraw the products from the market was made by the market authorization holders. Unless there are safety or efficacy reasons to withdraw a product, the decision to maintain market authorization of a product in Canada rests with the market authorization holder. 

Ensuring Canadians can get the medicines they need is one of Health Canada’s top priorities. The Food and Drug Regulations require manufacturers of prescription drugs to report and discontinuances within specified timeframes on www.drugshortagescanada.ca. Reporting of discontinuations provides timely, comprehensive and reliable information essential for drug manufacturers, provincial and territorial governments, drug supply stakeholders, health care professionals and patients to prevent or manage the adverse health effects of drug discontinuations, helping to protect the health and safety of Canadians.

In the absence of an application from a company, Health Canada cannot authorize the marketing of a pharmaceutical drug, regardless of whether the product is authorized elsewhere. Drugs that have not received marketing approval in Canada are typically only available for research purposes, clinical trials, or through the Department’s Special Access Programme (SAP).

 Health Canada regularly engages with stakeholders to better understand concerns and values the input of all actors within the health system, including health practitioners and patient groups. The Department understands there is a need for healthcare professionals specializing in Parkinson’s Disease. The Government of Canada oversees the delivery of healthcare professional training and it has set aside $25 billion dedicated to the signing of bilateral agreements with the Provinces and Territories to invest in four key shared health priorities, one of which is supporting health workers.

While the provinces and territories are responsible for the delivery of treatment services, the Federal Government plays a role in making sure appropriate and evidence-based treatment options are available for those who need them. HPFB is ready to work with any manufacturer to support an authorization for apomorphine. The Department provides sponsors with an opportunity for early advice on their submissions, including a pre-submission meeting, which typically occurs when they are ready to file. Health Canada also collaborates with the Canadian Agency for Drugs and Technologies (CADTH) in Health such that, at the sponsor’s discretion, reviews can happen concurrently by both agencies, with the intent of shortening time to market by advancing reimbursement recommendation decision times. Lastly, the Department also offers advanced consideration and priority review pathways, which reduce review timelines from 300 days to less than 200 days, depending on the pathway.

As part of its national surveillance mandate, the Public Health Agency of Canada (PHAC) works with all provinces and territories through the Canadian Chronic Disease Surveillance System (CCDSS) to collect data on diagnosed parkinsonism, including Parkinson Disease, and twenty other chronic conditions. The CCDSS enhances the scope of data on chronic diseases in Canada and supports the planning of health resources and the development of public health policies and programs. Data on diagnosed parkinsonism, including Parkinson Disease, are routinely collected to better understand its prevalence, incidence and all-cause mortality by age group, sex, province and territory, and over time.

Through the Canadian Institutes of Health Research (CIHR), the Government of Canada is supporting research on Parkinson’s disease, including studies on the underlying mechanisms of the disease, prevention, diagnostics, and the discovery of novel treatment approaches. Between 2016-17 and 2020-21, CIHR invested approximately $72.7 million in Parkinson’s research at Canadian universities and research institutions, including $16.9 million in 2020-21 alone.