Madam Speaker, I rise to speak about this extremely important topic of access to therapies for rare diseases.
I would like to reassure the member and the House that our government recognizes the importance of providing access to medications for patients with serious conditions and few treatment options. The lack of timely access to therapies and the high cost of treatment are barriers often faced by individuals living with rare diseases.
Health Canada's initiative to expand priority review processes for drug submissions is decreasing the review time for health products, including drugs for rare diseases, which in turn allows these medications to become accessible to Canadians faster.
The department is also working to align its regulatory review process with partners such as the Canadian Agency for Drugs and Technologies in Health to reduce the time between approval of a drug and the reimbursement recommendations.
The drug authorization process is initiated when a manufacturer files a submission to Health Canada for review. While Health Canada encourages manufacturers of new drugs to seek authorization for sale in Canada, it is the company's decision whether to apply to market their product in Canada.
Additionally, we recognize that for many Canadians who require prescription drugs to treat rare diseases, the cost of these medications can be extremely high. This is why our government will continue to work with the provinces, territories and other key partners to develop a national strategy for high-cost drugs for rare diseases.
Budget 2019 proposed to invest up to $1 billion over two years, with up to $500 million per year ongoing, to help Canadians with rare diseases access the drugs they need.
To ensure that Canadians have access to safe, effective and high-quality medications, Health Canada conducts a thorough review of every drug for the Canadian market. This thorough review ensures that Canadians are being offered the best possible medications.
However, we also know that every patient will have their own response to a given medication, and that is why there is the special access program that allows access to unauthorized drugs for patients with serious or life-threatening diseases or conditions, under specific circumstances. SAP is available around the clock to respond to physician requests, and delivers a 24-hour service, 365 days a year.
There are situations where Health Canada is unable to authorize a drug available in another country because the manufacturer has not yet applied to market their drug in Canada. An example of this is the drug Trikafta, which my colleague talked about, and which is a breakthrough therapy used for cystic fibrosis. Although Health Canada has not received a new drug submission for this particular drug, there have been 14 requests for this drug through SAP.
We are absolutely committed to working with all our partners, including the provinces and territories, to reduce barriers to treatments for Canadians living with rare diseases. This important work includes improving access to necessary prescription medications and making them more affordable for every Canadian.