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Different provincial, national and international regulations govern, in turn, how clinical trials are authorized, conducted, completed or suspended. If the results of the clinical trials are positive, federal and provincial authorizations are also required to make the new treatment available to the public.
Once the clinical trial has been authorized, it is implemented at one or more institutions (or sites). Participants are then recruited based on the authorized research protocol.
During the study, the trial is regularly reviewed by various types of committees, including, for example, a Data and Safety Monitoring Board (DSMB), which is responsible for periodically evaluating the conduct, data and results of the trial to ensure participants’ safety. If adverse effects appear over the course of the project, they are reported to different authorities (REB, Health Canada, etc.) which informs their decision on the need to suspend or discontinue the study.
The findings of the clinical trial are also reported as a scientific article in a specialized medical journal. Before publication, the article is reviewed by other scientists in the same field of research. These specialists assess the quality of the approach and the scientific rigour of the clinical trial before authorizing publication.
The results are published, but the participants in the clinical trial remain anonymous.
Health Canada, the ethics committee or the sponsor can discontinue a clinical trial at any time. Although this rarely happens, the trial can be discontinued if one or more unexpected severe side effects are observed, or if the efficacy of the treatment has not been demonstrated. Sometimes, the number of people recruited for the clinical trial is too small for the study to continue.
When a clinical trial is discontinued, the research team informs the participants as soon as possible and tells them what the next steps are.
The mandate of the Institut national d’excellence en santé et en services sociaux (INESSS) includes assessing applications for the listing of drugs, blood products and medical devices in order to make recommendations to the Minister of Health. The Minister of Health makes a decision based on the recommendations, and Régie de l’assurance maladie du Québec (RAMQ) puts the payment in place.
INESSS carries out its drug evaluation mandate based on the five aspects provided in Section 7 of its act of incorporation. INESSS conducts an overall evaluation of the value of the treatment, including its clinical benefits (therapeutic value) and economic benefits (pharmacoeconomic value) to ensure optimal use of resources in the health and social services sector. The information is based in part on the findings of the clinical trials submitted by the manufacturer.
Any interested person or group (including clinical specialists, patient organizations and the public) can submit comments and opinions on a drug that is subject to an INESSS evaluation.
Based on this evaluation, INESSS may or may not recommend to the Minister of Health that the health product or device be listed on the public drug plan formulary for a given therapeutic indication.
In most cases, this leads to price negotiations across Canada, and the Minister of Health lists the health product or device in the public drug plan formulary, if applicable. INESSS sets out the payment criteria (also known as reimbursement criteria) that will be managed by RAMQ or by health facilities.
Each year, INESSS evaluates more than 100 promising drugs. The list of drugs under evaluation is available on the INESSS website.
Canada’s Drug and Health Technology Agency (CADTH), Institut national d’excellence en santé et en services sociaux (INESSS) and Health Canada work together to provide timely access to drugs and medical devices. As part of the aligned drug review process, the three organizations can assess manufacturers’ submissions almost simultaneously when they have received the authorization to do so.
This process reduces the time between Health Canada’s Notice of Compliance and INESSS recommendations. The aligned review process does not change the respective requirements, decision-making or processes of Health Canada and INESSS. Visit this site to learn more about the aligned review process.
Once the Minister of Health authorizes the enrolment of a treatment in the public plan, Régie de l’assurance maladie du Québec (RAMQ) will cover accessibility and part or all of the costs of the treatment for the public.
If the Minister of Health refuses to evaluate the treatment, it will not be listed in the public plan and will not be covered by RAMQ.
Health Canada’s Special Access Program (SAP) allows healthcare professionals to request access to drugs or medical devices that are not yet available for sale in Canada. This program targets humanitarian situations or emergencies, for example, in cases where people have serious medical conditions or where standard treatments are not available.
Under the SAP, the manufacturer generally covers the cost of the drug or medical device to provide it to those for whom the special access request was made.Learn more
The listing of a health product or device as an "exception drug" allows anyone wishing to obtain coverage for certain drugs, usually not covered, to obtain coverage under certain conditions and if the latter are used in compliance with the indications recognized for their payment by the INESSS.
For example, a psoriasis cream, usually not covered, may be covered as an exception drug in the event that the use of another treatment (as determined by the INESS) is insufficient for people suffering from the medical condition.
The “exception patient” measure is used in exceptional situations to cover the cost of drugs not included on the list of authorized drugs. The measure can also be used to cover the cost of exceptional drugs prescribed for a therapeutic indication other than the one prescribed on the INESSS list.
For both types of access, a healthcare specialist must make a prior authorization request.Learn more about RAMQ access measures (FR)