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

Occurrences0
Full text
Updated to 15 February 2024
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).
The fees prescribed in the Regulation have been indexed pursuant to the notice published in Part 1 (French) of the Gazette officielle du Québec of 18 February 2023, page 143. (Sch. I) (Effect from 1 January 2023)
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 evaluatedType of evaluation 
New cellular or gene therapyFirst evaluation$95,579
per indication
Reevaluation$63,719
per indication
New drug with a companion diagnostic or new indication for a drug currently listed with a companion diagnosticFirst evaluation$73,278
per indication
Reevaluation$38,231
per indication
New drug or new indication for a currently listed drug or new stable blood productFirst evaluation$63,719
per indication
Reevaluation$38,231
per indication
New cutting-edge therapeutic productFirst evaluation$95,579
per indication
New radiopharmaceuticalFirst evaluation$95,579
per indication
Reevaluation$38,231
per indication
New medical device directly connected with the administration of a drugFirst evaluation$63,730
per submission
Reevaluation$38,231
per submission
New biosimilar drugFirst evaluation$9,558
per submission
Subsequent evaluation
(i.e., addition of an indication)
$9,558
per submission
Reevaluation$4,779
per submission
New strength, new content or new form of a currently listed drugFirst evaluation$9,558
per submission
Reevaluation$4,779
per submission
New nutritional formula or new combination of currently listed drugs or new diagnostic agent of a currently listed non-proprietary nameFirst evaluation$6,371
per submission
Reevaluation$3,186
per submission
New dressingFirst evaluation$12,744
per submission
Reevaluation$6,371
per submission
Exemption from the application of the lowest priceAny exemption request$9,558
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