There are several steps before a drug becomes available in Canada. We will follow the steps that must be taken by the manufacturer of a new drug for its approval by Health Canada and its eventual inclusion on the List of medications of Quebec. This article will help you understand why a new drug, currently available in France or the United States, is not yet authorized in Canada. And why a drug, authorized in Canada, is not necessarily reimbursed by the Quebec public drug insurance plan.

In Canada

Consider the fictitious example of a manufacturer who wants to market its new anti-diabetic drug XYZ in Canada. He completes the New Drug Submission document and forwards it to the Health Products and Food Branch of Health Canada (HPFB). HPFB is the national authority that regulates, evaluates and monitors the efficacy, safety and quality of therapeutic and diagnostic products available to Canadians. If, after the examination, the conclusion is positive, a Notice of Compliance and a Drug Identification Number (DIN) are assigned for this drug. All market authorizations for a new drug in Canada must meet the requirements of the Food and Drugs Act1.

Regulatory controls continue after the drug is marketed. Healthcare professionals and the distributor of the medicine must communicate any new information relating to the efficacy, safety or the presence, or absence, of adverse effects that may have an impact on its approval.

As for the manufacturer’s drug XYZ, Health Canada has finally completed its analysis and issued a notice of compliance and assigned a DIN. The drug is now authorized for sale in Canada.

The next step for the manufacturer is to submit an application for inclusion of their medication on the List of medications of Quebec.

In Quebec: 3 levels

A) National Institute of Excellence in Health and Social Services (INESSS)

INESSS, created on January 19, 2011, is the result of the merger of the Conseil du medicament and the Agency for the evaluation of technologies and modes of intervention in health (AETMIS), which are organizations still present in the other Canadian provinces. .

One of the main functions of INESSS is to evaluate requests from manufacturers for the inclusion of drugs on the list of the Régime général d’assurance maladie du Québec (RGAM). All Quebecers must be insured for their medication, either publicly or privately, in order to benefit from the RGAM. A person who does not have private prescription drug insurance is compulsorily covered by the public prescription drug insurance plan administered by the Régie de l’assurance maladie du Québec (RAMQ).

Our manufacturer of drug XYZ must therefore submit a request to INESSS for its drug XYZ to be included on the List of medications of Quebec. Their request is assessed by the Scientific Committee on Medicines for Registration (CSEMI). The Committee is made up of scientists, clinicians, ethicists, managers and citizens. All members have scientific training enabling them to fulfill their mandate. After an in-depth analysis of the file, which spans a period of approximately 6 months, the committee submits its recommendations to the board of directors, then to the Minister of Health and Social Services, who is ultimately responsible for the decision to registration for the RGAM.

To be entered on the List of Medications, the medication must meet the criteria set out in the Act respecting INESSS2. The first criterion concerns the therapeutic value of the drug: how does this new drug provide additional benefit or advantage over drugs already available on the market? If INESSS considers that the therapeutic value has not been demonstrated, it submits an opinion to the Minister on this subject.

If the therapeutic value of the drug is demonstrated, the fairness of the price is then taken into account, as well as the relationship between the cost and the effectiveness of the drug, the consequences on the health of the population and on the health network. This evaluation respects the objective of the RGAM, which is to ensure reasonable and equitable access to the medications required by the person’s state of health.

Based on these criteria, not all drugs will necessarily be listed in the RGAM. INESSS may indicate in its Notice to the Minister that it does not recommend inclusion of a drug on the list and the reasons for its decision.

Let’s retrace the course of the drug XYZ. Following its evaluation, INESSS submits a Notice to the Minister, recommending that the medication be entered on the List of medications but in the “Exceptional medications” section. In this case, this decision was made because the drug does not have therapeutic benefits justifying a higher cost than that associated with the use of other drugs that are already listed. The doctor must then complete a special form or indicate the code linked to this drug if he considers that his patient meets the conditions required for the prescription of this new drug XYZ.

B) Ministry of Health and Social Services (MSSS)

The Minister of Health and Social Services establishes by regulation3 the List of Medications. This list includes medications and supplies whose cost is guaranteed by the RGAM, which includes the public plan, the plans of institutions in the health network (e.g. hospitals) and private plans. The Minister also reviews and periodically updates the list, taking into account the recommendations made by INESSS. The final decision whether or not to include a drug on the list rests with the Minister. The latter can accept the INESSS recommendation, refuse it or require more studies before making a decision.

The List also presents exceptional medications whose cost is covered by the RGAM under certain conditions or for the therapeutic indications that the Minister determines by regulation.

Taking into account the recommendations of INESSS, the Minister decides to authorize the drug XYZ as an exception drug and to include it in Schedule IV of the List of Medications. Reimbursement will be permitted on an exceptional basis if drug XYZ meets the established criteria.

C) Quebec Health Insurance Board (RAMQ)

The Régie reports directly to the Minister of Health and Social Services. Its mandate is to administer the public health insurance and drug insurance plans. The public prescription drug insurance plan covers prescription drugs in Quebec that appear on the List of medications published periodically.

Drugs covered by private insurance plans

The coverage offered by private insurance plans may differ from plan to plan. However, all private insurers must at least cover drugs on the List of Medications.

In conclusion

As you can see, access to medication is very structured and well supervised, both at the level of Health Canada and the various authorities in Quebec. It is the manufacturer who decides to apply to market their drug in Canada. To do this, it must comply with several requirements. The final stage of the process consists of its registration on the List of medications of Quebec, which is updated regularly and which is available for consultation on the website of the Régie de l’assurance maladie du Québec. Quebec. The whole process can take several months to a few years.

Do not hesitate to consult your pharmacist, your doctor or a healthcare professional if you have any questions on this subject.
1. Food and Drugs Act, R.S.C. 1985, c. F-27

2. Act respecting the National Institute of Excellence in Health and Social Services, chapter I-13.03

3. Regulation concerning the list of medications covered by the general prescription drug insurance plan, chapter A-29.01, r.3

N.B. We would like to thank Mr. Pierre Lucier, pharmacist, and Mr. Marc Parent, institutional pharmacist at the CHU  of Quebec, for their invaluable collaboration.