Order Amending the Fees in Respect of Drugs and Medical Devices Order (Public Health Emergency Drugs): SOR/2024-247

Canada Gazette, Part II, Volume 158, Number 26

Registration
SOR/2024-247 December 4, 2024

FOOD AND DRUGS ACT

The Minister of Health makes the annexed Order Amending the Fees in Respect of Drugs and Medical Devices Order (Public Health Emergency Drugs) under subsection 30.63(1)footnote a of the Food and Drugs Act footnote b.

Ottawa, December 3, 2024

Mark Holland
Minister of Health

Order Amending the Fees in Respect of Drugs and Medical Devices Order (Public Health Emergency Drugs)

Amendments

1 Paragraph 6(2)(c) of the Fees in Respect of Drugs and Medical Devices Order footnote 1 is replaced by the following:

2 (1) Paragraph 14.1(1)(a) of the Order is replaced by the following:

(2) Subsection 14.1(2) of the Order is replaced by the following:

Remission — no previous submission

(2) The remission referred to in subsection (1) is granted if the person has not previously filed a submission for that designated COVID-19 drug.

Coming into Force

3 This Order comes into force on the day on which the Regulations Amending Certain Regulations Made Under the Food and Drugs Act (Agile Licensing) are published in the Canada Gazette, Part II but if this Order is registered after that day, it comes into force on the day on which it is registered.

REGULATORY IMPACT ANALYSIS STATEMENT

(This statement is not part of the Order.)

Executive summary

Issues: The amendments to the Fees in Respect of Drugs and Medical Devices Order (Fees Order) are directly related to the Regulations Amending Certain Regulations Made Under the Food and Drugs Act (Agile Licensing). The Agile Licensing amendments apply regulatory flexibilities, including rolling submissions that previously applied to designated COVID-19 drugs to new drug submissions and supplements to new drug submissions for public health emergency drugs. Unlike regular drug reviews, rolling reviews of submissions for public health emergency drugs do not have a fixed regulatory timeline for the submission of additional information by manufacturers. As a result, the full review of rolling review submissions may not be possible to complete within the set performance standards. As such, an exception is required to the requirement for the Minister to remit fees for performance standards that are not met for new drug submissions and supplemental new drug submissions for public health emergency drugs that use rolling review option.

Since the Agile Licensing amendments repeal the definition of “designated COVID-19 drug”, the Fees Order needs to be amended to maintain the eligibility of qualifying designated COVID-19 drugs for remission.

Description: The first amendment to the Fees Order replaces “designated COVID-19 drug” with “public health emergency drug” and extends the fees remittance exception from designated COVID-19 drugs to new drug submissions and supplemental new drug submissions for public health emergency drugs.

The second amendment in the Fees Order allows the definition of ‘designated COVID-19 drug’ which has been repealed by Agile Licensing to continue to operate for those submissions for a notice of compliance under the Food and Drug Regulations that were also the subject of an application filed under the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 for designated COVID-19 drugs.

Rationale: The purpose of these amendments is to ensure alignment of the Fees Order with the regulations for public health emergency drugs made under Agile Licensing as the regulations are broadened to allow Health Canada the flexibility to quickly address emerging public health needs in the future.

Benefits and Costs: No resulting costs or benefits have been identified from these amendments to the Fees Order.

One-for-one rule and Small Business Lens: The one-for-one rule and small business lens do not apply to this Fees Order as it does not impose any new requirements.

Issues

The amendments to the Fees in Respect of Drugs and Medical Devices Order (Fees Order) are directly related to the Regulations Amending Certain Regulations Made Under the Food and Drugs Act (Agile Licensing). For public health emergency drugs (PHEDs) that use the rolling review option, the full review of rolling review submissions may not be possible to complete within the set performance standards. As such, an exception from the requirement to remit fees if performance standards are not met for new drug submissions (NDSs) and supplemental new drug submissions (SNDs) for PHEDs that use rolling review option is required.

Additionally, with the repeal of the definition of “designated COVID-19 drug”, the Fees Order requires an amendment for the continued remission of fees for qualifying designated COVID-19 drugs.

Background

The Agile Licensing amendments replace “designated COVID-19 drug” with the broader concept of “public health emergency drug” and applies regulatory flexibilities, including rolling submissions that previously applied to designated COVID-19 drugs to NDSs and SNDSs for PHEDs.

The Fee Remission Scheme

Under the Fees Order, Health Canada is required to remit, in part, the examination fee where the Department’s performance standards for the examination of a drug submission or device application are not met. These performance standards are based upon the assumption that a drug submission or device application would include all the required information at the time it was accepted for review.

Rolling Reviews for Designated COVID-19 Drugs

Previously, manufacturers of designated COVID-19 drugs who submitted an NDS using the rolling review option were allowed to file a submission upfront with certain information missing, which could be submitted at a later time. In all cases, the entirety of the information must have been available to the Minister to review prior to the issuance of a notice of compliance under Part C, Division 8 of the Food and Drug Regulations (FDR).

Existing Exception to Remit Fees in the Fee Remission Scheme

Since the rolling review of designated COVID-19 drug submissions does not have fixed regulatory timelines for the submission of the additional information by manufacturers, the full review of these types of submissions may not be possible to complete within the set performance standards. As such, there is an exception to the requirement to remit fees by the Department for such submissions.

Extending the Fee Remission Exception to Public Health Emergency Drugs (Agile Licensing Amendments)

Through the Agile Licensing amendments, the flexibilities that were applicable to designated COVID-19 drugs under the FDR, including the rolling submission option, now apply to NDSs for PHEDs and SNDSs for PHEDs. As with the designated COVID-19 drugs where a rolling submission was filed, it is expected that the full review of a PHED submission could extend beyond the current performance standards given there is no fixed timeline for the complete submission of information. Therefore, consistent with the rationale for the exception respecting those COVID-19 drug submissions submitted under the rolling submission option, fees for these PHEDs will not be remitted where the performance standards are not met. The Fees Order is amended to reflect this.

Remission of Fees for Designated COVID-19 Drugs

Under the Fees Order, Health Canada provides a remission of fees for a submission for a notice of compliance issued under the FDR for a designated COVID-19 drug that was previously the subject of an application filed under the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 (ISAD Interim Order).

The ISAD Interim Order authorized the importation, sale and advertising of drugs used in relation to COVID-19. On March 18, 2021, the ISAD Interim Order expired and transitioned into the FDR through the Regulations Amending the Food and Drug Regulations (Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19): SOR/2021-45. As a result, designated COVID-19 drug applications under the ISAD Interim Order were able to transition and file drug submissions under the FDR.

The Agile Licensing amendments repeal the definition of “designated COVID-19 drug” and to ensure that qualifying designated COVID-19 drug submissions continue to receive the benefit of remission they have under the FDR, the Fees Order is also amended.

Objectives

The objective of the amendments is to align the Fees Order with the Agile Licensing amendments which broaden COVID-19 flexibilities to other drugs used for future public health emergencies.

It does so by ensuring that fees will not be remitted when performance standards are not met and allowing qualifying COVID-19 drug submissions to continue to receive the benefit of remission they have under the FDR.

Description

The amendment to section 6(2)(c) of the Fees Order replaces “designated COVID-19 drug” with “public health emergency drug” and extends the exception of fee remittance from designated COVID-19 drugs to NDSs and SNDSs for PHEDs.

The amendment to section 14.1 of the Fees Order continues the operation, for the purposes of section 14.1, of the definition of ‘designated COVID-19 drug’ that has been repealed by Agile Licensing.

Coming into Force

The coming into force of the amendments to the Fees Order will be aligned with the public health emergency drug provisions in Agile Regulations.

Regulatory Development

Consultation

In February 2023, Health Canada launched a public consultation on the amendments to the Fees Order for the extension of the exception to the remittance requirement for Health Canada for designated COVID-19 drug to PHEDs where the performance standards cannot be met. The Notice of Intent informed interested stakeholders of the intent of the Minister of Health to make a consequential amendment to the Fees Order to change the remission exceptions (section 6(2)(c)) from “designated COVID-19 drug” to “public health emergency drug”. The Department received two comments from stakeholders which referenced Agile Licensing rather than the amendments to the Fees Order. As a result, the comments were deemed out of scope for the purposes of this consultation and were instead considered under the Agile Licensing amendments.

The repeal of the definition for “designated COVID-19 drug” was part of the Agile Licensing regulatory proposal. Stakeholder feedback was requested following pre-publication of the Agile Licensing Regulatory Impact Analysis Statement and the proposed Regulations in Canada Gazette, Part I. The 130-day consultation ran from December 17, 2022 to April 26, 2023. The Department did not receive any comments on the repeal of the definition of ‘designated COVID-19 drug’, as it would apply to the fee remission exception.

Modern treaty obligations and Indigenous engagement and consultation

No impact with regard to modern treaty obligations has been identified for these amendments to the Fees Order.

Instrument choice

Fees for regulatory activities related to drugs in Canada are charged as per the Fees Order and this is the only option to achieve the Department’s objective.

Regulatory analysis

Benefits and costs

No resulting costs or benefits have been identified by the Department from these amendments to the Fees Order. The realized benefits and costs of the regulatory package are related to Agile Licensing amendments and not to the Fees Order itself.

Small business lens

The Department does not anticipate any impact on small businesses.

One-for-one rule

The one-for-one rule does not apply because these amendments will not cause administrative burden to any stakeholders.

Regulatory cooperation and alignment

The amendments to the Fees Order are not related to a work plan or commitment under a formal regulatory cooperation forum.

Strategic environmental and economic assessment

The Fees Order is considered administrative in nature. It is therefore exempt from completing a Climate Nature and Economic Lens analysis in accordance with Section 2.2 of the Cabinet Directive on Strategic Environmental and Economic Assessment.

Gender-based analysis plus

No gender-based analysis plus (GBA+) impacts have been specifically identified for this proposal.

Rationale

Agile Licensing expands the flexibilities for COVID-19 drugs to other PHEDs, including the option of a rolling review of the submission which allows Health Canada the flexibility to quickly address emerging public health needs such as COVID-19 in the future. The amendments to the Fees Order will allow Health Canada to support these regulatory activities under the FDR.

Implementation and service standards

Forms and web pages will be updated to reflect the new remittance provisions under the Fees Order. Existing performance standards, as per the Performance Standards for the Fees in Respect of Drugs and Medical Devices Order document, will continue to be applicable.

Contact

Bruno Rodrigue
Executive Director
Office of Legislative and Regulatory Modernization
Policy, Planning and International Affairs Directorate
Health Products and Food Branch
Health Canada
Holland Cross, Suite P2108
11 Holland Avenue
Ottawa, Ontario
K1A 0K9
Address locator: 3000A
Email: hc.lrm.consultations-mlr.sc@canada.ca