432-00849 (Health)

The Government of Canada is committed to strengthening Canada’s health care system, supporting the health of Canadians, and working together with provinces, territories, and stakeholders to improve access to prescription medications.

Prescription drugs are an important part of Canada’s health care system. They can help diagnose, cure, control and prevent disease and improve the well-being of Canadians. When Canadians are in good physical and mental health, they are able to live healthier and happier lives. No Canadian should have to choose between paying for prescription drugs and putting food on the table, yet many are still forced to make this impossible decision. This is why the government remains committed to a national, universal pharmacare program.

The Government of Canada is working together with provinces, territories, and stakeholders to build the foundational elements of national universal pharmacare. These foundational steps include establishing a Canadian Drug Agency, a national formulary, and a national strategy for high-cost drugs for rare diseases, as outlined in Budget 2019, the Speech from the Throne and the Fall Economic Statement.

The government has established a Canadian Drug Agency Transition Office and is taking steps to develop a national formulary. Health Canada has also initiated public and stakeholder engagement to support the development of a national strategy on high cost drugs for rare diseases, which will help patients and families with rare diseases access the medication they need. The government has allocated up to $1 billion over two years starting in 2022-23 and up to $500 million ongoing in support of this strategy.

The Government of Canada has modernized the way patented drug prices are regulated in Canada by amending the Patented Medicines Regulations to provide the Patented Medicine Prices Review Board (PMPRB) with the tools and information needed to protect Canadians from excessive patented medicine prices. This was the first substantive update to the regulations since 1987 and it is expected that these amendments, published in Canada Gazette, Part II on August 21, 2019, will save Canadians billions in drug spending over the next 10 years. 

The federal government is also working with provinces and territories as an active member of the pan-Canadian Pharmaceutical Alliance (pCPA). The pCPA combines governments’ collective buying power to negotiate lower prices on brand name drugs for all public plans, and sets the price point for many generic drugs. As of May 6, 2021, the pCPA has completed more than 420 joint brand drug negotiations and achieved price reductions on nearly 67 of the most commonly prescribed drugs and, as of April 1, 2019, the pCPA was estimated to have achieved approximately $2.26 billion in annual cost savings for public drug plans.

Under the Food and Drugs Act, Health Canada regulates the safety, efficacy, and quality of therapeutic products, such as drugs and vaccines for use by humans in Canada before and after the products enter the Canadian marketplace. This includes oversight at all stages of a product’s life cycle, from early testing in clinical trials, to the scientific review of submissions, to post-market surveillance of adverse drug reactions and compliance monitoring and enforcement activities.

Fees are charged to industry in relation to these regulatory activities. Canada is not alone in this approach; other international counterparts, such as the European Medicines Agency, and the United States Food and Drug Administration, also charge fees for delivering similar regulatory services.

Health Canada’s fees support unbiased, rigorous and independent scientific assessments. These fees are paid even if a drug is not approved.

Before a therapeutic product is authorized for sale in Canada, the manufacturer must provide evidence of its safety, efficacy and quality, as defined by regulations, including:

• manufacturing details and controls to ensure consistent quality;
• pre-clinical data (animal and cell studies) to support safety; and,
• clinical data to support the proposed indication, including substantial evidence of effectiveness.

Scientists review every drug submission to assess the product’s safety, efficacy and quality in order to determine whether the risks associated with the product are acceptable in light of its potential benefits. If authorized for sale in Canada, procedures for safety monitoring and plans to minimize identified risks outlined by the manufacturer are also reviewed.

Health Canada reviewers are scientists and physicians with many years of experience reviewing therapies, and with expertise in different domains including, but not limited to, clinical medicine, toxicology and pharmacology, biochemistry, virology, immunology, microbiology, and other scientific disciplines relevant to the development, testing and manufacture, and quality control of drugs and vaccines. This expertise ensures high standards in the advice given to stakeholders, and in the review of health products before they are prescribed.

Health Canada has also developed work-sharing agreements with leading and trusted international regulatory authorities, which helps us leverage international expertise, increase efficiencies in access to safe, effective and high quality medicines, and ensure our review processes are aligned and at the leading edge internationally.

Health Canada is also developing ways to better use information from real world experience to assess and monitor drug and device safety and effectiveness. Through regulatory modernization initiatives, we are working with health system partners to optimize the use of information gathered from a variety of sources.

Launched in 2018 as part of Health Canada’s Regulatory review of Drugs and Devices initiative, the process for “Aligned reviews between Health Canada and Health Technology Assessment (HTA) agencies” reduces the time between Health Canada approvals and HTA reimbursement recommendations, and contributes to important progress in building a program to provide early parallel scientific advice with HTAs to assist new drug development. These initiatives help to speed up access for patients to drugs.

The Government of Canada will continue to take action to improve the affordability, accessibility and appropriate use of prescription drugs through regulatory improvements, enhanced partnerships and better integration of drug review processes.