Drugs - Resources

Health Canada evaluates and authorizes all drugs for sale in Canada. For more information, see: How drugs are reviewed in Canada . To find information regarding drugs and other medical products in Canada, visit the page Drugs and health products .

• To find out if a drug is authorized in Canada, consult the Drug Product Database (DPDB).

For access to a drug that is not authorized by Health Canada, there is a program called the Special Access Program.

Quebec

Evaluation of a drug to determine if it will be reimbursed

In Quebec, it is the Institut national d’excellence en santé et en services sociaux (INESSS) which evaluates drugs for reimbursement by Quebec’s Public Prescription Drug Insurance Plan. These drugs must be authorized by Health Canada or in the process of being authorized.

Drug evaluation process and criteria used by INESSS: the evaluation framework was updated in July 2018. See also the Notice to the Minister published in November 2018 which speaks of a « paradigm shift » for the evaluation of certain innovative drugs with a « promise of therapeutic value ». This may apply to the evaluation of drugs for rare diseases.

• To find a drug currently being evaluated or that has been evaluated: INESSS: Drugs products undergoing evaluation and evaluated Recommendations relating to drugs evaluated for registration purposes by INESSS are published regularly in a Notice to the Minister presented to the Minister of Health and Social Services.

**** Note that INESSS invites citizens, patients, caregivers, and healthcare professionals, as well as their associations and groups, to take part in the consultation on drugs that will be the subject of a scientific evaluation to determine if they should be reimbursed.The RQMO helps patients and caregivers participe in this evaluation process See here >>>>

Lists of drugs reimbursed in Quebec:

• • In pharmacies: List of medications reimbursed by the Public Prescriptionl Drug Insurance Plan
  • In hospitals: List of medications provided in establishments

Other general information:

• The Quebec Public Prescription Drug Insurance Plan
• What is the Quebec program “Médicament d’exception”? A drug for which there are precise criteria for use. Doctors must make a request for their patient to the Régie de l’assurance santé du Québec (RAMQ).
• What is the program “Patient d’exception”? A special measure which allows the doctor to request reimbursement for his patient for a medication not listed on the list of medications or which is listed for a disease other than the patient’s disease.

Other provinces and territories

It is Canada’s Drug Agency (CDA) which evaluates and makes recommendations for drug reimbursement in provinces and territories other than Quebec. To learn about the process, see: Reimbursement Reviews Process in Brief

• To find out about a CDA decision on a drug, see: Search |
• To find out which drugs are being evaluated: Open calls for Input and Feedback| CDA

***** Note that patient organizations may provide comments during CDA’s review of a drug: Stakeholder Feedback | CDA

For more information on orphan drugs and the RQMO’s services on this subject, consult this page.

Health Canada does not have a separate database for orphan drugs. You must consult its general database for all medications: Drug Product Database .

To find out if there is an orphan drug on the market or in development elsewhere in the world, consult the following sites:

• United States (Food and Drug Administration): Orphan Drug Designations and Approvals
• Europe (European Medicines Agency): Community Register of Orphan Medicinal Products.
• Orphanet (Europe): By disease name

Quebec

• Changes to the evaluation of innovative drugs for rare diseases took place at INESSS in 2018. See the introduction to this INESS report on a drug for Fabry disease.
• In the Quebec Action Plan for Rare Diseases 2023-2027:
  • “Objective 2.3 Improve access to care for people with
    a rare disease causing oral consequences”, including the establishment of a reimbursement program for oral care costs.
  • “Objective 2.4 Continue efforts to improve access to care and
    pharmaceutical services”, including: improving the offering of the Quebec Food Program for the treatment of hereditary metabolic diseases; optimizing access to stable blood products not distributed by Héma-Québec

Canada

• March 2023: The Government of Canada improves access to affordable and effective drugs for the treatment of rare diseases – Canada.ca

• Implementation Advisory Group (IAG) for the National Strategy for Drugs for Rare Diseases

• Government of Canada Consultation Report 2019-2022: Building a National  Strategy for Drugs for Rare Diseases: What We Heard from Canadians – Canada.ca
• Document submitted by the RQMO as part of the federal consultation
• Positions of the Canadian Organization for Rare Disorders

Other countries

• Eurordis
• National Organization for Rare Disorders: Orphan Drug Act

• Find a clinical trial: see our “Research” page
• Understanding Drug Research and Development: Eupati Toolbox
• Patients at heart : to understand what a clinical trial is and help make the decision whether or not to participate in a clinical trial.

• Question for a pharmacist
• Report a side effect of a health product, medication or medical device – Canada.ca
• Order of Pharmacists of Quebec
• Drugs and health products (Health Canada)
• WebMD – Drugs and medication
• Biologic drugs or biosimilars
  • Fact Sheet: Biologic drugs (Canada)
  • Biosimilar drugs – Health professionals – MSSS (gouv.qc.ca)
• Search for approved natural health products : Health Canada also evaluates and authorizes natural health products and non-prescription drugs for sale in Canada.
• Create your own drug tracker: Editable templates to create your own medication trackers (edit.org)
• Apps to track your medication
• Use of marijuana for medical purposes (Health Canada): in Quebec, the use of cannabis products for medical purposes can only be authorized by a doctor as part of a research project. View : Quebec Cannabis Registry – Information for patients.

The RQMO has adopted policies governing relations with commercial companies, including those in the pharmaceutical industry:

• Policy relating to relations with commercial enterprises (French)
• Conflict of interest policy for all directors, representatives and members of standing committees of the RQMO board (French)

See the Code of Ethics developed by Innovative Medicines Canada for its member companies and which sets standards for relations with health professionals, professional associations and patient associations.

Article: Principles for interactions with biopharmaceutical companies: the development of guidelines for patient advocacy organizations in the field of rare diseases – PMC (nih.gov)