Fees payable for a request for the scientific evaluation of a drug
Since July 19, 2018, any manufacturer submitting a request to the Institut national d’excellence en santé et en services sociaux (INESSS) to conduct a scientific evaluation for listing purposes is required to pay the fees set out in the Regulation respecting the fees payable to the Institut national d’excellence en santé et en services sociaux for the conducting of a scientific evaluation for listing purposes.
On June 24, 2021, this Regulation was amended, notably to establish a new fee schedule for scientific evaluations, subject to annual indexation.
In addition, on September 17, 2026, a new Regulation to amend the Regulation respecting the fees payable to the Institut national d’excellence en santé et en services sociaux for the conducting of a scientific evaluation for listing purposes comes into force. It broadens the categories of items that may be the subject of a scientific evaluation by INESSS, sets out the definitions and fees applicable to these new categories, and introduces a fee for the reevaluation of a product for which the Minister has deferred the decision for a period exceeding 48 months. The fees payable under this Regulation are detailed below.
Fees payable
The fees payable vary according to the scientific evaluation that the Institut decides to conduct after receiving the request from a manufacturer.
The fees payable for scientific evaluations are non-refundable.
The fees are subject to annual indexation on January 1 of each year, in the manner set out in chapter VIII.1 of the Financial Administration Act (chapter A-6.001).
Fees payable for a request for scientific evaluation for listing purposes
ORDER IN COUNCIL EFFECTIVE ON SEPTEMBER 17, 2026
| Scientific evaluation | |||
|---|---|---|---|
| Item evaluated | Type of evaluation | Registration checklist (for information purposes) | Current fee (per indication or per request) |
| New cellular or gene therapy | First request | Checklist 1 or 2 | 105,414$ |
| Reevaluation | Checklist A | 70,276$ | |
| New drug with a companion diagnostic or new indication for a currently listed drug with a companion diagnostic or new stable blood product with a companion diagnostic | First request | Checklist 1, 2, BSP 1 or BSP 2 | 80,820$ |
| Reevaluation | Checklist A or BSP A | 42,165$ | |
| New drug or new indication for a currently listed drug or new stable blood product | First request | Checklist 1, 2, BSP 1 or BSP 2 | 70,276$ |
| Reevaluation | Checklist A or BSP A | 42,165$ | |
| New cutting-edge therapeutic product or off-label therapeutic product | First request | Checklist 1 or 2 | 105,414$ |
| Reevaluation | Checklist A | 68,864$ | |
| New radiopharmaceutical | First request | Checklist 1 or 2 | 105,414$ |
| Reevaluation | Checklist A | 42,165$ | |
| New technology | First request | Checklist MD 1 | 70,288$ |
| Reevaluation | Checklist MD A | 42,165$ | |
| New biosimilar drug | First request | Checklist 5 or 12 | 10,542$ |
| Subsequent evaluation (i.e., addition of an indication) | Checklist 5 or 12 | 10,542$ | |
| Reevaluation | Checklist 5 | 5,271$ | |
| New presentation, new strength or new form of a currently listed drug that has already been the subject of a notice of listing | First request | Checklist 4 | 10,542$ |
| Reevaluation | Checklist B | 5,271$ | |
| New nutritional formula or new combination of drugs having already been the subject of a notice of listing or new diagnostic agent of a non-proprietary name already listed on the lists of medications | First request | Checklist 3, 7 or 8 | 7,027$ |
| Reevaluation | Checklist 3, 7 or C | 3,514$ | |
| New dressing | First request | Checklist 10 | 14,055$ |
| Reevaluation | Checklist 11 | 7,027$ | |
| Exemption from the application of the lowest price | Any request for an exemption | Checklist 13 | 10,542$ |
| New digital application or evolution of a device | First request | Checklist MD 2 | 10,542$ |
| Reevaluation | Checklist MD B | 5,271$ | |
| New post-protection expiry drug | First request | To be determined according to the type of evaluation and product | 10,542$ |
| Reevaluation | To be determined according to the type of evaluation and product | 5,271$ | |
| New stable blood product of a non-proprietary name having already been the subject of a notice of listing | First request | Checklist BSP 3 | 10,542$ |
| Reevaluation | Checklist BSP B | 5,271$ | |
No fees are payable for listing requests for multiple-source drugs (generic drugs or natural health products) for which the indications are already listed on the lists of medications.
Evaluation request
To submit a request for a scientific evaluation for listing purposes, see the Registration application section.
For any questions regarding billing, please contact client@inesss.qc.ca.
For any questions regarding a scientific evaluation for listing purposes, please contact inscription@inesss.qc.ca.
Frequently asked questions – Fees payable for the conducting of a scientific evaluation for listing purposes
Are the fees refundable?
No. As set out in the Regulation respecting the fees payable to the Institut national d’excellence en santé et en services sociaux for the conducting of a scientific evaluation for listing purposes, fees paid are non-refundable and are payable as soon as the evaluation begins, even if the manufacturer withdraws its request during the evaluation.
What is the revenue from the fees used for?
This revenue will allow INESSS to:
continue responding to government requests in order to promote faster access to drugs, cutting-edge technologies, blood system products and medical devices connected with the administration of drugs;
meet the objectives of its commitments regarding scientific evaluation timelines, as set out in its Declaration of Services to Citizens;
provide timely support to the Minister of Health in its ongoing negotiations within the pan-Canadian Pharmaceutical Alliance.
Are fees payable for the evaluation of multiple-source drugs (generic drugs or natural health products)?
Usually not. The Regulation respecting the fees payable does not provide for fees for the evaluation of multiple-source drugs (generic drugs or natural health products), unless the evaluation involves the addition of an indication that is not included on the lists of medications or the modification of an existing indication.
Are there fees for a request to add a new package size of a product that is already listed?
No. The Regulation does not provide for fees for requests to add a new package size of a product that is already listed.
Will the collection of fees influence the recommendation sent to the Minister by INESSS?
No. Collection of fees for the scientific evaluations conducted by INESSS will not affect the nature of the recommendation made to the Minister or the decision of the Minister regarding listing or coverage.
Please note that, as provided for by law and good practice, INESSS has implemented various mechanisms that allow it to maintain its independence and avoid situations of conflict of interest. Moreover, collection of fees for evaluations is a common practice among health technology assessment agencies in Canada and around the world.
A structured administrative process, under the responsibility of the Direction des services administratifs and separate from the scientific evaluation process, has been implemented to manage billing.
For any questions about billing, please contact the Direction des services administratifs at client@inesss.qc.ca.
Does INESSS have to report on this practice?
Yes. As provided for in the Policy on Funding Public Services, INESSS must report on this practice in its Annual Management Report.
How were the fees determined?
The fees were determined by INESSS based on the government’s Policy on Funding Public Services. The total costs of delivering scientific evaluations were established. The funding level, i.e., the proportion of total costs covered by manufacturer fees, was set at 50% by the INESSS Board of Directors, considering that the benefit is shared between manufacturers and society as a whole.
Are the fees indexed?
The fees have been subject to annual indexation since January 1, 2020, in the manner set out in chapter VIII.1 of the Financial Administration Act. More specifically, INESSS uses the rate published by the Minister of Finance on the Minister’s website and in the Gazette officielle du Québec. This rate corresponds to the annual change in the overall average consumer price index for Québec, excluding alcoholic beverages and tobacco products, for the 12-month period ending on September 30 of the year preceding the year for which a fee is to be indexed.
When will we know the type of evaluation selected, the amount payable and the payment deadline?
Upon receipt of your letter notifying you that the evaluation activities has begun, an invoice will subsequently be issued by the Direction des services administratifs.