A-6.001, r. 6.1 - Regulation respecting the fees payable to the Institut national d’excellence en santé et en services sociaux for the scientific evaluation of a drug, stable blood product or technology for listing purposes

Updated to 24 June 2021

This document has official status.

chapter A-6.001, r. 6.1

Regulation respecting the fees payable to the Institut national d’excellence en santé et en services sociaux for the scientific evaluation of a drug, stable blood product or technology for listing purposes

Financial Administration Act

(chapter A-6.001, s. 83.8).

O.C. 861-2018; O.C. 770-2021, s. 1.

1. A manufacturer who asks the Institut national d’excellence en santé et en services sociaux to conduct a scientific evaluation of a drug, stable blood product or technology shall pay the fees set out in Schedule 1.

These fees vary according to the scientific evaluation that the Institut decides to conduct after receiving the request from the manufacturer and determining its eligibility for scientific evaluation.

O.C. 861-2018, s. 1; O.C. 770-2021, s. 2.

2. As used in this Regulation,

“scientific evaluation” means the structured evaluation of a drug, stable blood product or technology that can concern both its direct effects and its indirect and unintentional consequences, with the objective of guiding decision-making;

“manufacturer” means a person or group of persons that manufactures, produces, imports or sells a drug, stable blood product or technology, under its own name or under a brand name;

“nutritional formula” means a therapeutic nutritional product;

“indication” means an indication for use requested by a manufacturer;

“drug” means a product that can be entered on the list of medications referred to in section 60 of the Act respecting prescription drug insurance (chapter A-29.01), the list of medicines referred to in section 116 of the Act respecting health services and social services (chapter S-4.2), or the list of medications referred to in section 150 of the Act respecting health services and social services for Cree Native persons (chapter S-5), which is not otherwise contemplated by this Regulation;

“biosimilar drug” means a biologic drug introduced onto the Canadian market that is highly similar to a biologic drug already marketed in Canada and whose efficacy and safety do not diverge significantly from the reference biologic drug for the same indications;

“dressing” means a medical instrument used to treat wounds for an indication recognized on the lists of medications;

“radiopharmaceutical” means a radioactive product used to diagnose or treat a disease;

“stable blood product” means an acellular component of blood with the storage characteristics of drugs that is used to treat certain disorders due to an imbalance in the circulatory system or certain specific diseases and that can be entered on the Québec list of blood system products that may be distributed by Héma-Québec;

“cutting-edge therapeutic product” means a health product that is so new, complex and distinct that the current legislation is not able to take it into account, but that may still be entered on the list of medications referred to in section 60 of the Act respecting prescription drug insurance (chapter A-29.01), the list of medicines referred to in section 116 of the Act respecting health services and social services (chapter S-4.2), or the list of medications referred to in section 150 of the Act respecting health services and social services for Cree Native persons (chapter S-5);

“companion diagnostic” means a diagnostic test, a pharmacogenetic test or a therapeutic monitoring test designed to select only the patients for whom a treatment is likely to be beneficial among all the patients diagnosed with a given condition, based on their results for the predictive marker identified by the test;

“cellular or gene therapy” means a therapy to transfer living cells to a patient or to modify a patient’s genetic materials in order to treat or heal a condition.

O.C. 861-2018, s. 2; O.C. 770-2021, s. 3.

3. The fees stipulated in this regulation are non-refundable.

O.C. 861-2018, s. 3.

4. The fees stipulated in this regulation are indexed in the manner set out in chapter VIII.1 of the Financial Administration Act (chapter A-6.001).

The Minister of Health and Social Services shall publish the result of the indexation in Part 1 of the Gazette officielle du Québec.

O.C. 861-2018, s. 4.

5. (Omitted).

O.C. 861-2018, s. 5.

SCHEDULE I

(s. 1)

FEES PAYABLE FOR VARIOUS SCIENTIFIC EVALUATIONS

Scientific evaluation		Fee
Item evaluated	Type of evaluation
New cellular or gene therapy	First evaluation	$89,796 per indication
	Reevaluation	$59,864 per indication
New drug with a companion diagnostic or new indication for a drug currently listed with a companion diagnostic	First evaluation	$68,844 per indication
	Reevaluation	$35,918 per indication
New drug or new indication for a currently listed drug or new stable blood product	First evaluation	$59,864 per indication
	Reevaluation	$35,918 per indication
New cutting-edge therapeutic product	First evaluation	$89,796 per indication
New radiopharmaceutical	First evaluation	$89,796 per indication
	Reevaluation	$35,918 per indication
New medical device directly connected with the administration of a drug	First evaluation	$59,874 per submission
	Reevaluation	$35,918 per submission
New biosimilar drug	First evaluation	$8,980 per submission
	Subsequent evaluation (i.e., addition of an indication)	$8,980 per submission
	Reevaluation	$4,490 per submission
New strength, new content or new form of a currently listed drug	First evaluation	$8,980 per submission
	Reevaluation	$4,490 per submission
New nutritional formula or new combination of currently listed drugs or new diagnostic agent of a currently listed non-proprietary name	First evaluation	$5,986 per submission
	Reevaluation	$2,993 per submission
New dressing	First evaluation	$11,973 per submission
	Reevaluation	$5,986 per submission
Exemption from the application of the lowest price	Any exemption request	$8,980 per submission

O.C. 861-2018, Sch. I; O.C. 770-2021, s. 4.

TRANSITIONAL

2021

(O.C. 770-2021) SECTION 5. This Regulation applies to a request for a scientific evaluation received by the Institut national d’excellence en santé et en services sociaux on or after 24 June 2021. It also applies to a request for a scientific evaluation received before 24 June 2021 that is found to be incomplete in order to be eligible for a scientific evaluation and that requires the submission of supplementary information after that date.

REFERENCES

O.C. 861-2018, 2018 G.O. 2, 2774

O.C. 770-2021, 2021 G.O. 2, 1626