Order Amending the Fees in Respect of Drugs and Medical Devices Order (COVID-19 Drugs): SOR/2021-47
Canada Gazette, Part II, Volume 155, Number 7
SOR/2021-47 March 19, 2021
FOOD AND DRUGS ACT
Therefore, the Minister of Health, pursuant to subsections 30.61(1)footnote a and 30.63(1)footnote a of the Food and Drugs Act footnote b, makes the annexed Order Amending the Fees in Respect of Drugs and Medical Devices Order (COVID-19 Drugs).
Ottawa, March 19, 2021
Minister of Health
Order Amending the Fees in Respect of Drugs and Medical Devices Order (COVID-19 Drugs)
1 Subsection 6(2) of the Fees in Respect of Drugs and Medical Devices Order footnote 1 is amended by striking out “or” at the end of paragraph (a), by adding “or” at the end of paragraph (b) and by adding the following after paragraph (b):
- (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.
2 The portion of section 14 of the French version of the Order before paragraph (a) is replaced by the following:
Remise — besoins urgents en matière de santé publique
14 Remise est accordée à la personne visée au paragraphe 9(2) qui dépose une présentation de drogue nouvelle au titre de l'article C.08.002 du Règlement sur les aliments et drogues ou qui dépose une demande d'identification numérique au titre de l'article C.01.014.1 de ce règlement d'une somme correspondant au prix à payer visé au paragraphe 9(1) si, à la date où la personne dépose la présentation ou la demande d'identification, à la fois :
3 The Order is amended by adding the following after section 14:
Remission — designated COVID-19 drug
14.1 (1) Remission is granted to the person referred to in subsection 9(2) of the amount of the fee that is payable under subsection 9(1) if the person has
- (a) filed an application for a designated COVID-19 drug under the ISAD Interim Order; and
- (b) subsequently filed a submission for that drug.
Remission — no previous submission
(2) The remission referred to in subsection (1) is granted if the person has not previously filed a submission for the designated COVID-19 drug.
Submissions in support of a drug, other than a disinfectant, that contains a medicinal ingredient not previously approved in a drug for sale in Canada and that is not a variation of a previously approved medicinal ingredient such as a salt, ester, enantiomer, solvate or polymorphfootnote 1
5 Schedule 1 to the Order is amended by adding the following at the end of that Schedule:
Coming into Force
6 This Order comes into force on the day on which 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) are registered, but if it 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.)
The current fees for the examination of a drug submission set out under the Fees in Respect of Drugs and Medical Devices Order (the Fees Order) are not consistent with the Minister of Health's (the Minister) intent to remit fees in respect of a submission for a COVID-19 drug that was previously applied for under the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 (the ISAD Interim Order).
To help address the immediate, significant risk to the health and safety of Canadians posed by COVID-19 and the associated public health need in Canada, the Minister, using the power granted under section 30.1 of the Food and Drugs Act (the Act), made the ISAD Interim Order (effective September 16, 2020), which provides an optional, expedited authorization pathway for the importation, sale and advertising of drugs to be used in relation to COVID-19. The ISAD Interim Order is in effect until September 16, 2021.
As of February 1, 2021, the ISAD Interim Order has supported the authorization by Health Canada of two vaccines as well as another drug for the treatment of COVID-19. Numerous other applications have been made and are undergoing review.
To encourage the early filing of applications under the ISAD Interim Order, fees for the review of these applications were not charged.
The associated Regulations Amending the Food and Drug Regulations (Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19) will introduce flexibilities into the new drug submission (NDS) pathway to permit manufacturers who have filed under the ISAD Interim Order and who wish to sell their COVID-19 drug after the interim order ceases to have effect to obtain a notice of compliance (NOC).
Fees for the review of information submitted with these submissions would normally be recovered as per the Fees Order. The Minister has decided not to recover such fees because she considers that the information in support of the submission making use of these flexibilities would be similar to that which was reviewed in support of the corresponding ISAD Interim Order application. Fees for these submissions would be remitted. Remission would only be available for those submissions transitioning a drug with COVID-19 indications (referred to as a “designated COVID-19 drug”) for which the manufacturer had made an application under the ISAD Interim Order.
The objective of this amendment is to ensure that an appropriate fee is assessed for the review of information in a submission that has been filed in support of the transitioning of a COVID-19 drug that has been previously the subject of an application under the ISAD Interim Order. In this instance those fees will be remitted in full to the applicant.
The amendments to the Fees Order will
- clarify the description of “new active substance” (NAS) such that a medicinal ingredient in a COVID-19 drug is not considered to be previously approved in a drug for sale in Canada by reason of the Minister authorizing it under the ISAD Interim Order;
- remit fees for the review of the first submission [new drug submission (NDS), supplement to a new drug submission (SNDS), or abbreviated new drug submission (ANDS)] for a COVID-19 drug which an application had previously been filed under the ISAD Interim Order; and
- indicate that in the case of a “rolling submission” for a COVID-19 drug, fees will not be remitted if the performance standard has not been met.
New active substance
If a medicinal ingredient (or a variation of that medicinal ingredient) had not been in a drug previously approved by the Minister (other than in an ISAD Interim Order authorization) the fee for examination of an NDS would be the NAS fee. The description under column 2 of item 1 in Schedule 1 was clarified to indicate this.
The fee for examination of an NDS, an SNDS or an ANDS for a COVID-19 drug that is filed under Division 8 of the Food and Drug Regulations (FDR) and for which an application had been previously filed under the ISAD Interim Order will be remitted in full to the person that files the submission. This remission only applies to the initial filing and any subsequent submission regarding that drug would be subject to full fees. As such, submissions for COVID-19 drugs for which an application under the ISAD Interim Order had not been made will not be eligible for remission on this basis.
Performance standards — rolling submissions
Similar to the ISAD Interim Order, the FDR has been amended to allow manufacturers of COVID-19 drugs to file NDSs that are not complete with respect to the information requirements set out under section C.08.002 provided that they include a plan that indicates when that information will be provided to the Minister (“rolling submissions”). This option is available to manufacturers whether or not they had previously filed an application under the ISAD Interim Order. The entirety of the information will have to be available for the Minister to review prior to a decision to issue (or not) an NOC. In order to provide full advantage of this regulatory flexibility, no fixed regulatory timeline has been set for the receipt of the additional information. Therefore, it is expected that the full review of some of these types of submissions may extend beyond the current performance standards, noting that those performance standards were based upon the assumption that an NDS would include all the required information at the time it was accepted for review. As a result, fees will not be remitted in these instances if the performance standards set out in the Fees Order are not met. However, this would only be applicable to rolling submissions if the submission was not the initial submission to transition the COVID-19 drug, as the full fees would have already been remitted in those instances.
Coming into force
The amendments to the Fees Order will come into force on the day that 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) is registered.
On November 30, 2020, Health Canada published a proposal to introduce amendments to the FDR before the ISAD Interim Order expires that would provide a mechanism for COVID-19 – related drugs to gain permanent legal status, as well as a related proposal to amend the Fees Order. Stakeholders were invited to submit comments on this proposal by December 21, 2020. Additionally, a webinar was held by Health Canada on December 11, 2020, to provide an overview and respond to questions. In attendance were 48 individuals including 32 representatives of the pharmaceutical industry, 6 representatives of professional associations, one representative of a provincial health authority and 9 persons of unknown affiliation. In total, three sets of comments were received (one set from a pharmaceutical association and two from individual pharmaceutical manufacturers) that were relevant to the proposed amendments to the Fees Order.
Two respondents requested clarity on the process of remitting fees. In practice, Health Canada will consider the applicable fees as being remitted when the manufacturer files a submission to transition the COVID-19 drug under the FDR.
One respondent requested clarity with respect to how fees would be assessed if a manufacturer had to provide additional information to Health Canada to comply with any terms and conditions imposed on an authorization. Once a manufacturer has obtained an NOC for a COVID-19 drug transitioning from the ISAD Interim Order any subsequent SNDSs will be subject to the applicable fees as outlined in the Fees Order. Health Canada recognizes that certain reporting obligations as a result of terms and conditions may not meet the threshold under the FDR for the filing of an SNDS and as such the review of that information would not be subject to fees.
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.
Two different options were considered: (1) amending the Fees Order to indicate that the fee in respect of an NDS filing for the examination of any information in respect of a COVID-19 drug was $0; or (2) remitting 100% of any of the applicable fees. Option 2 was chosen as it fit into the well-established model of remittance and would require the least regulatory and operational changes in support.
Benefits and costs
These amendments to the Fees Order directly support the Government of Canada's response to COVID-19 and the analytical requirements for cost-benefit analysis have been adjusted to permit a timely and effective response. Health Canada estimates that 8 – 12 product submissions may be received and, as a result, the overall financial burden on the Department would be low and could be managed internally.
The fee remissions granted under the amendments to the Fees Order will help remove financial barriers to transitioning COVID-19 drugs from under the ISAD Interim Order to the oversight of the FDR, thereby directly benefitting the pharmaceutical industry. It is anticipated the amendments will result in indirect benefits to Canadians, by facilitating access to drugs that may be needed for treatment, mitigation or prevention of COVID-19. Quicker and increased access to COVID-19 drugs may reduce health resource burden by keeping Canadians out of hospitals and other professional care, reduce the risk of morbidity and mortality, and reduce the economic impacts from further business shutdowns. These amendments to the Fees Order are expected to benefit all Canadians, including Indigenous and remote communities.
Small business lens
No negative impacts on small businesses are expected.
These amendments to the Fees Order have no impact on administrative burden costs.
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 assessment
In accordance with the Cabinet Directive on the Environmental Assessment of Policy, Plan and Program Proposals, a preliminary scan concluded that a strategic environmental assessment is not required.
Gender-based analysis plus
No gender-based analysis plus (GBA+) impacts have been specifically identified for this proposal. However, in the development of the associated Regulations Amending the Food and Drug Regulations (Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19), a gender-based analysis was conducted, aggregating results from various public studies and sources. COVID-19 was found to have various direct and indirect impact on women, in addition to other Canadian demographics such as indigenous communities and seniors, on a socioeconomic and health level. All Canadians, including those groups who have been disproportionately impacted by the ongoing pandemic in Canada, may be expected to benefit from earlier access to COVID-19 drugs that may be incentivized through the fee remissions outlined in this amendment to the Fees Order.
Due to the health emergency caused by the COVID-19 pandemic, and in order to encourage the filing of applications under the ISAD Interim Order, Health Canada chose not to recover fees for the review of those applications. 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) will require that manufactures who have filed under the ISAD Interim Order and who wish to sell their COVID-19 drug after the interim order ceases to have effect will be required to file an NDS and ultimately obtain an NOC. In consideration of the public good and to continue the policy intent of the ISAD Interim Order, Health Canada chose to remit the entirety of the fee for examination of those submissions.
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, will continue to be applicable.
Office of Legislative and Regulatory Modernization
Policy, Planning and International Affairs Directorate
Health Products and Food Branch
Holland Cross, Suite 14
11 Holland Avenue
Address locator: 3000A