Comment on: Amendment to the Fees in Respect of Drugs and Medical Devices Order
In February 2023, Health Canada will launch a public consultation on an amendment to the Fees in Respect of Drugs and Medical Devices Order.
Purpose
The purpose of this notice is to inform interested stakeholders of the intent of the Minister of Health to make a consequential amendment to the Fees in Respect of Drugs and Medical Devices Order (Fees Order) in order to change the reference for Performance Standard and Remission exceptions (section 6(2)(c)) from "COVID-19 Drug" to "public health emergency drugs". This will give Health Canada the flexibility to quickly implement Interim Orders (IO's) to address emerging public health needs such as COVID-19 in the future.
Background
Health Canada is proposing regulatory amendments to the Food and Drug Regulations (FDR) and Medical Devices Regulations that would deliver on the Department's modernization commitments and leverage long-standing policies and practices. The proposal also considers recent experiences with regulatory agilities introduced in response to the COVID-19 pandemic. An overview as well as draft regulations can be found here: Agile Licensing, Canada Gazette, Part I, while more information on how these changes would be implemented can be found here: Agile Licensing, Guidance.
Currently, section C.08.002(2.3) of the FDR allows manufacturers of designated COVID-19 drugs, as defined in section C.08.001.1, to file a new drug submission that is missing certain information required under section C.08.002 if they include a plan indicating how and when the missing information will be provided (rolling submission). All the missing information must be provided and reviewed before the Minister can decide whether to issue a notice of compliance.
The Agile Licensing proposal would expand this provision respecting rolling submissions for designated COVID-19 drugs to any public health emergency drug (PHED) by repealing the definition of designated COVID-19 drug and introducing the definition of a public health emergency drug.
Currently, the Fees in Respect of Drugs and Medical Devices Order (Fees Order) provides an exception for fee remittance (ref. paragraph 6(2)(c)) in the case of a new drug submission for a designated COVID-19 drug where C.08.002(2.3) applies to that submission. This exception waives the requirement for Health Canada to remit, in part, the examination fee if the department's performance standards are not met.
Per the Guideline on Service and Digital, developed by the Treasury Board of Canada Secretariat, a service standard is defined as: a public commitment to a measurable level of performance that clients can expect under normal circumstances. Health Canada has established performance standards in relation to fees that are payable under the Fees Order.
To provide regulatory flexibility to manufacturers for these rolling submissions no fixed timeline for provision of the missing information has been set. Experience gained throughout the COVID-19 pandemic has shown that performance standards are not always met for these submissions.
Proposed amendment
Health Canada is proposing to amend section 6(2)(c) of the Fees Order to replace "designated COVID-19 drug" with "public health emergency drug", thereby addressing the gap created by the repeal of the definition designated COVID-19 drug and extending the exception respecting fee remittance described above, to all PHEDs.
Reference:
Current Provision
Remission — performance standard
- 6 (1) If the Minister determines that the performance standard has not been met in relation to a fee that is payable under this Order, remission is granted to the person that must pay the fee
- (a) of an amount equal to 25% of the fee; or
- (b) of an amount equal to 25% of the amount that is payable, in the case where remission is granted of part of the fee under any other provision of this Order.
Exceptions
- (2) Subsection (1) does not apply to a fee for the examination of
- (a) an application or submission referred to in this Order in respect of which a joint or parallel review is conducted by the Minister and a foreign regulatory authority;
- (b) an application for a licence that is filed under section 32 of the Medical Devices Regulations if
- (i) the medical device to which the application relates includes a component that is a drug, and
- (ii) the Minister has made a decision in respect of the application to issue or amend a medical device licence under section 36 of those Regulations, or to refuse to issue or amend such a licence under section 38 of those Regulations; or
- (c) a new drug submission for a designated COVID-19 drug if subsection C.08.002(2.3) of the Food and Drug Regulations applies to that submission.
Proposed Amendment to Provision
(c) a new drug submission for a public health emergency drug if subsection C.08.002(2.3) of the Food and Drug Regulations applies to that submission
Consultation
The consultation period for this proposed amendment to the Fees Order will end April 26, 2023.
The Department is committed to respecting the privacy of consultation participants. All personal information created, held or collected by the Department is protected by the Privacy Act.
Privacy notice
The personal information you provide to Health Canada will be used by Health Canada under authority of the Food and Drugs Act, Section 30.62 and handled in accordance with the Privacy Act.
Why are we collecting your personal information? Your personal information is being collected as part of feedback related to this fee proposal and will be used by Health Canada to help understand concerns different stakeholders may have with this proposal. All comments will be gathered and considered for the proposal's finalization.
Will we use or share your personal information for any other reason? Your feedback will be published online on Canada.ca. Feedback can either be published with your name, the name of your organization or anonymously.
What happens if you don't want to provide your personal information? Participation in this consultation is voluntary, and feedback may be submitted anonymously. There are no consequences for opting not to provide any personal information.
What are your rights? You have the right to access and request a correction and/or notation to your personal information. You also have a right to complain to the Privacy Commissioner of Canada if you feel your personal information has been improperly handled. They may be contacted through their online privacy complaint form. For more information about these rights, or about how we handle your personal information, please send an email to cro-brc@hc-sc.gc.ca.
For more information: The collection of your personal information is described in Info Source at infosource.gc.ca. Refer to the personal information bank (PIB) PSU 938 – Outreach Activities.
Contact information
Any inquiries or comments can be directed to Etienne Ouimette, Director General, Resource Management Operations Directorate, Health Products and Food Branch, Health Canada by telephone: 613-957-6690 and/or email: Cost Recovery Office / Bureau de recouvrement des coûts (HC/SC) cro-brc@hc-sc.gc.ca