The Regulation respecting the fees payable to the Institut national d’excellence en santé et en services sociaux for the scientific evaluation of a drug or a stable blood product came into effect on July 19, 2018. As of that date, a manufacturer who asks INESSS to conduct a scientific evaluation of a drug or a stable blood product must pay the fees set out in the regulation and detailed in the table below.
These fees vary according to the scientific evaluation that INESSS decides to conduct after receiving the request from the manufacturer.
These fees are non-refundable.
The fees are indexed, on January 1 of each year, in the manner set out in Chapter VIII.1 of the Financial Administration Act (Chapter A-6.001).
Table of fees payable for a scientific evaluation of a stable blood product
|Health techonology evaluated||Type of evaluation||Checklist||Fee|
|New stable blood product|
|$33,307 per submission|
|Reevaluation||$16,654 per submission|
To make a request for a scientific evaluation of a drug for listing purposes, please consult the section Registration application.
Questions about evaluations and billing should be emailed to: email@example.com.
Frequently asked questions – Applicable fees for the scientific evaluation of a drug or a stable blood product
Are the fees refundable?
No. As stated in the Regulation respecting the fees payable to the Institut national d’excellence en santé et services sociaux for the scientific evaluation of a drug or a stable blood product, the fees are non-refundable, even if the manufacturer cancels its request during the evaluation.
What is the revenue from the fees charged used for?
This revenue will enable INESSS:
- To evaluate a larger number of products in a timely manner. This additional revenue will also enable it to take sustained action on the undertaking, that is, to start evaluating a drug before Health Canada has rendered its decision, thus promoting speedier access to certain drugs, as announced in Québec’s Economic Plan;
- To implement those parts of the 2017-2027 Québec Life Sciences Strategy for which it is responsible and to carry out projects aimed at promoting optimal drug use to contribute to decision support in clinical practice.
Will there be any fees for the evaluation of multisource drugs (generics and natural health products)?
Usually not. The Regulation respecting the fees payable to the Institut national d’excellence en santé et services sociaux for the scientific evaluation of a drug or a stable blood product does not provide for fees for the evaluation of multisource drugs (generics and natural health products). With a few rare exceptions, such requests do not, in INESSS’s opinion, require a scientific evaluation.
Are there any fees for a request to add a new size of an already-listed product?
No. The Regulation does not provide for fees for requests to add a new size of an already-listed product.
Will charging fees influence the recommendations INESSS makes to the Minister?
No. The fees for INESSS’s scientific evaluations will have no bearing on the nature of the recommendations it makes to the Minister or on the Minister’s listing or coverage decision.
It will be noted that, as stipulated in the Act and by best practices, INESSS has put in place different mechanisms that enable it to maintain its independence or avoid putting itself in a conflict-of-interest situation. Furthermore, charging for evaluations is a common practice in Canada and elsewhere in the world.
A structured administrative process separate from the scientific evaluation process and under the responsibility of the Direction des services administratifs et du secrétariat général has been put in place to manage billing.
If you have any questions regarding billing, please contact Caroline Roy in the Direction des services administratifs et du secrétariat général.
418 643-1339, ext. 10858
Is accountability provided for?
Yes. As stipulated in the Policy for the Funding of Public Services, INESSS is required to give an account of this new practice in its Annual Management Report.
How were the fees established?
The fees were established by INESSS on the basis of the government’s Policy for the Funding of Public Services. The total cost of providing scientific evaluations was determined. The level of funding, that is, the proportion of the total cost to be funded by charging manufacturers fees, was set at 50% by INESSS’s Board of Directors on the basis of a shared benefit between the manufacturers and society as a whole.
Will the fees be indexed?
The fees will be indexed annually starting on January 1, 2020 in the manner set out in chapter VIII.1 of the Financial Administration Act (chapter A-6.001). Specifically, INESSS will use the rate published by the Ministère de la Finance on its website and in the Gazette officielle du Québec. This rate is the annual difference in Québec’s overall average consumer price index, with the exclusion of alcoholic beverages and tobacco products, for the 12-month period ended on September 30 of the year preceding that for which the rate is to be indexed.
When will we know the type of evaluation chosen, the amount payable and the payment deadline?When you receive your letter of acceptability. Subsequently, you will receive an invoice, which will be payable within 30 days.