Regulations Amending Certain Regulations Concerning the Sale of Drugs (Public or Canadian Armed Forces Health Emergencies): SOR/2023-18

Canada Gazette, Part II, Volume 157, Number 4

Registration
SOR/2023-18 February 3, 2023

FOOD AND DRUGS ACT
PATENT ACT

P.C. 2023-68 February 3, 2023

Her Excellency the Governor General in Council, on the recommendation of the Minister of Health with respect to the provisions of the annexed Regulations other than section 6, and on the recommendation of the Minister of Health and the Minister of Industry with respect to that section 6, makes the annexed Regulations Amending Certain Regulations Concerning the Sale of Drugs (Public or Canadian Armed Forces Health Emergencies) under

Regulations Amending Certain Regulations Concerning the Sale of Drugs (Public or Canadian Armed Forces Health Emergencies)

Food and Drugs Act

Food and Drug Regulations

1 Subsection C.01.020.1(2) of the Food and Drug Regulations footnote 1 is amended by adding the following after paragraph (c):

2 (1) The portion of subsection C.10.001(1) of the Regulations before the first definition is replaced by the following:

C.10.001 (1) The following definitions apply in this section and in section C.10.002.

(2) Paragraph (d) of the definition public health official in subsection C.10.001(1) of the Regulations is replaced by the following:

(3) Paragraph C.10.001(2)(b) of the French version of the Regulations is replaced by the following:

3 (1) Paragraph C.10.003(b) of the French version of the Regulations is replaced by the following:

(2) Paragraph C.10.003(c) of the Regulations is replaced by the following:

4 The Regulations are amended by adding the following after section C.10.011:

DIVISION 11

Public or Canadian Armed Forces Health Emergencies — Drugs for Immediate Use or Stockpiling

C.11.001 (1) The following definitions apply in this Division.

foreign regulatory authority
has the same meaning as in subsection C.10.001(1). (autorité réglementaire étrangère)
initial public health official
means the public health official named in an authorization issued under subsection C.11.003(1). (responsable de la santé publique initial)
public health official
means
  • (a) the Chief Public Health Officer appointed under subsection 6(1) of the Public Health Agency of Canada Act;
  • (b) the Chief Medical Officer of Health, or equivalent, of a province;
  • (c) the Medical Officer of Health, or equivalent, of a municipality;
  • (d) the Surgeon General of the Canadian Armed Forces; or
  • (e) the Chief Medical Officer of Public Health for the Department of Indigenous Services. (responsable de la santé publique)
subsequent public health official
means any public health official, other than the initial public health official, who obtains the quantity of a drug, or a portion of the quantity, that is specified in an authorization issued under subsection C.11.003(1). (responsable de la santé publique subséquent)

(2) This Division applies to a drug for human use in dosage form for which a drug identification number has not been assigned under subsection C.01.014.2(1) or for which a notice of compliance has not been issued under section C.08.004 or C.08.004.01, including drugs that have ceased to be considered to be natural health products by virtue of subsection 103.15(2) of the Natural Health Products Regulations.

C.11.002 (1) In order to address an actual, imminent or potential emergency, event or incident affecting public health or the health of members of the Canadian Armed Forces, a public health official may, on application to the Minister, obtain an authorization that permits a drug manufacturer to sell a specified quantity of a drug to the public health official, for immediate use or stockpiling or both.

(2) The application must

(3) The public health official must provide the Minister with any additional information or document that the Minister determines is necessary for the purpose of reviewing the application, by the date specified by the Minister.

C.11.003 (1) The Minister may, after review of the application, issue an authorization to a manufacturer authorizing the sale of a specified quantity of the drug to the public health official for the use described in the application.

(2) In reviewing the application, the Minister must consider whether there is an alternative mechanism that would address the emergency, event or incident.

(3) The authorization must

C.11.004 The initial public health official must notify the Minister, in writing, of any change to the information provided under paragraph C.11.002(2)(g), subparagraph C.11.002(2)(i)(iv), paragraph C.11.002(2)(j) or subsection C.11.002(3), within 30 days after the day on which they become aware of the change.

C.11.005 (1) Subject to subsection C.11.008(2), these Regulations, other than sections A.01.010, A.01.014 and A.01.045, subsections C.01.001(1) and (1.1) and this Division, do not apply to a drug that is sold in accordance with an authorization.

(2) In the case of a drug described in Schedule C or D of the Act, a drug that is sold in accordance with an authorization is exempt from the application of section 12 of the Act.

C.11.006 (1) The initial public health official must ensure that the drug bears a label or is accompanied by a document that clearly sets out the following information in English and French:

(2) Any subsequent public health official must ensure that the drug bears the label or is accompanied by the document.

(3) If the initial public health official becomes aware of a change to any of the information referred to in paragraph (1)(a), (h), (j), (k) or (l), they must

(4) If the person notified under paragraph (3)(b) is a subsequent public health official, they must notify of the change, in writing and without delay, any person to whom they have sold any quantity of the drug.

(5) Any person who is notified under paragraph (3)(b) or subsection (4) must ensure that the updated information accompanies, in writing, any quantity of the drug that remains in their possession.

C.11.007 (1) In addition to the information required under subsection C.11.006(1), the initial public health official or any subsequent public health official, as the case may be, must make the following information available to the following persons, in writing, in English and French:

(2) If the initial public health official becomes aware of a change to any of the information referred to in subsection (1), they must, in writing and without delay, notify the relevant persons of the change.

C.11.008 (1) If the initial public health official is a person referred to in paragraph (d) of the definition public health official in subsection C.11.001(1), they must submit a written report to the Minister in respect of any serious adverse drug reaction to the drug, and include in the report the information referred to in paragraphs C.01.020.1(2)(b) to (l), no later than the 30th day after the day on which they become aware of the reaction.

(2) If the initial public health official is a person referred to in any of paragraphs (a) to (c) or (e) of the definition public health official in subsection C.11.001(1), the written report is not required and section C.01.020.1 applies in respect of the provision of information relating to serious adverse drug reactions.

C.11.009 (1) The initial public health official must monitor the response to the drug in the emergency, event or incident — including monitoring information they receive relating to serious adverse drug reactions — and must take reasonable steps to obtain information on that response.

(2) The initial public health official must, on request of the Minister, submit a written report to the Minister on the monitoring of the response to the drug in the emergency, event or incident during the time period specified by the Minister, as well as on any corrective measures taken as a result of the monitoring.

C.11.010 (1) The initial public health official must maintain all information about the sale and use of the drug in a way that allows them to submit the information, notices and reports referred to in sections C.11.004 and C.11.008 and subsection C.11.009(2).

(2) The initial public health official and any subsequent public health official must maintain all information about the sale and use of the drug in a way that allows them to communicate with persons to whom the drug has been administered if the health of those persons may be endangered by its use.

C.11.011 The initial public health official or any subsequent public health official, as the case may be, must retain the information, notices and reports referred to in sections C.11.004 and C.11.008, subsection C.11.009(2) and section C.11.010, as applicable, for 15 years after the end of the period to which the information, notices and reports relate.

C.11.012 The initial public health official must account to the Minister for any unused quantity of stockpiled drug remaining in their possession at the end of the preceding calendar year by the January 30 that follows the first full calendar year during which the drug is stockpiled and then by January 30 of each subsequent year.

C.11.013 (1) The Minister may cancel an authorization if the Minister has reasonable grounds to believe that the drug presents a serious or imminent risk of injury to human health.

(2) If the Minister cancels an authorization, the initial public health official must, without delay, notify of the cancellation any person to whom they have directly distributed any quantity of the drug.

(3) These Regulations apply to any unused quantity of the drug as of the day on which the cancellation takes effect.

C.11.014 (1) The Minister may issue an authorization that permits an initial public health official who is a person referred to in paragraph (a), (d) or (e) of the definition public health official in subsection C.11.001(1) to sell a specified quantity of a stockpiled drug to a practitioner for use in the emergency treatment of a person under the care of that practitioner, if

(2) This Division, other than this section, does not apply to a drug sold in accordance with an authorization issued under subsection (1).

Natural Health Products Regulations

5 The Natural Health Product Regulations footnote 2 are amended by adding the following after section 103.1:

Public or Canadian Armed Forces Health Emergencies

103.15 (1) Sections C.11.002 and C.11.003 of the Food and Drug Regulations apply in respect of natural health products for which a product licence has not been issued.

(2) If the Minister issues an authorization to sell a specified quantity of a natural health product under subsection C.11.003(1) of the Food and Drug Regulations, any quantities of the drug that are sold in accordance with the authorization cease to be considered to be natural health products as of the time of sale.

Patent Act

Certificate of Supplementary Protection Regulations

6 Subsection 1(2) of the Certificate of Supplementary Protection Regulations footnote 3 is replaced by the following:

Definition of authorization for sale

(2) In these Regulations and for the purposes of section 104 of the Act, authorization for sale means an authorization under the Food and Drugs Act, or any predecessor enactment relating to the same subject matter, that permits the sale of a drug in Canada, but does not include an interim order permitting the sale of a drug under section 30.1 of that Act, a certificate issued under section C.08.015 of the Food and Drug Regulations, an exemption under subsection C.10.002(1) or C.10.008(1) of those Regulations or an authorization under section C.05.006, C.05.008 or C.08.010 or subsection C.11.003(1) or C.11.014(1) of those Regulations, section 67 or 71 of the Natural Health Products Regulations or section 21 or subsection 24(2) of the Clinical Trials for Medical Devices and Drugs Relating to COVID-19 Regulations.

Transitional Provision

7 (1) In this section, new Regulations means the Food and Drug Regulations as they read on the day on which these Regulations come into force.

(2) A letter of authorization that was issued under subsection C.08.010(1) of the Food and Drug Regulations before the day on which these Regulations come into force is deemed to be an authorization issued under subsection C.11.003(1) of the new Regulations, if the medical emergency in respect of which the letter was issued is a public or Canadian Armed Forces health emergency.

Coming into Force

8 These Regulations come into force on the day on which they are published in the Canada Gazette, Part II.

REGULATORY IMPACT ANALYSIS STATEMENT

(This statement is not part of the Regulations.)

Issues

Evolving disease patterns and global health incidents, like the current COVID-19 pandemic, require Canadian public health officials (PHOs) to respond rapidly with effective emergency measures. These measures may include the need for drugs that are not available on the Canadian market as it is a manufacturer’s decision to seek market authorization in Canada. While there are emergency provisions in the Food and Drug Regulations (FDR) to allow such drugs for use in emergencies, they have not always adequately supported emergency preparedness and response activities undertaken by PHOs in Canada when these drugs were needed. These PHOs include federal, provincial, territorial and municipal officials who are responsible for public health in their jurisdiction and the Surgeon General of the Canadian Armed Forces (CAF), responsible for military health.

Health Canada is committed to ensuring that PHOs have the timeliest access possible to drugs that could be used to treat mass populations during a Canadian public or military health emergency, such as a naturally occurring disease or an intentional chemical release. To meet the needs of Canadians during an emergency, event, or incident, these amendments create a regulatory framework in the FDR, which provides authorities to allow PHOs access to a quantity of an unauthorized drug for immediate use in, or stockpile in anticipation of, a public or military health emergency.

Background

The responsibility for public health is shared among different levels of government, with municipal governments usually having primary responsibility in their jurisdictions. If a public health emergency extends beyond a municipality’s boundaries or its ability to address the emergency, then the provincial or territorial governments would step in. If it extends beyond the provincial or territorial boundaries, the Public Health Agency of Canada (PHAC) plays a role. While all levels of government may have a stockpile of emergency medical supplies, including drugs, the PHAC maintains the National Emergency Stockpile System to provide health and social service supplies quickly to provinces and territories when their own resources are insufficient during an emergency. As such, the PHAC procures drugs and medical supplies for use in emergencies. The CAF perform similar activities to the PHAC; however, it maintains a stockpile of drugs and medical supplies for use on military bases or abroad on missions.

How it previously worked

The Special Access Program (SAP) administers the emergency provisions of the FDR (i.e., sections C.08.010 and C.08.011). These provisions allow a manufacturer to sell an unauthorized drug to a practitioner for the treatment of an individual patient in a medical emergency through an exemption from the Food and Drugs Act (the Act) and the FDR. Prior to the creation of this new regulatory framework, the Chief Public Health Officer of Canada and the Surgeon General of the CAF used the existing medical emergency provisions to submit requests to the SAP for either immediate use or for stockpiling purposes in anticipation of an imminent or potential emergency. Following an assessment of the information provided by the PHO and information available to the Minister of Health (the Minister) at the time of the request, the Minister made a decision whether to authorize the sale of the drug from the manufacturer to the PHO.

Challenges with the previous regulatory framework

The medical emergency provisions under Division 8 of the FDR were not designed to respond to, or prepare for, a public or military health emergency. They were designed to provide a practitioner with the ability to request access to a drug that is not available for sale in Canada to treat their patient in a medical emergency (i.e., for patients with serious or life-threatening conditions). While the SAP has accommodated these requests, the Division 8 emergency provisions are focused on a direct practitioner-to-patient relationship, where the practitioner monitors the patient who is administered the drug. The medical emergency provisions under Division 8 were not intended for authorization of a drug to be used on a mass population. In the case of public health emergencies, it is a PHO acting as the practitioner to a population, who determines which drug is the best treatment for use in a particular public or military health emergency. This is determined through risk/threat assessments of the public or military health emergency and based on the available scientific information on a particular drug that is proposed to be used in the emergency.

Existing regulatory framework to access drugs for urgent public health needs

Public health officials at the federal, provincial and territorial levels may use Division 10 of Part C of the FDR, entitled “Access to Drugs in Exceptional Circumstances”, as another mechanism to access unauthorized drugs for immediate use to address an urgent public health need. To access a drug through this pathway, the PHOs need to notify the Minister of Health of the urgent public health need, and provide certain information on the drug and how it is expected to help address the health emergency in their jurisdiction. If the requirements of the FDR are met, the name and other details of the drug are then published on the List of Drugs for an Urgent Public Health Need (the List), at the discretion of the Minister. Drugs on the List may only be sold and be imported for sale in the requesting jurisdiction. Drugs remain on the List for one year, after which they are removed unless Health Canada receives a new notification from the PHO for continued access to the drug to address an urgent public health need for immediate use.

The medical emergency provisions under Division 10 of the FDR are intended to only allow access to drugs that are not authorized in Canada on an immediate basis and do not allow for emergency preparedness activities such as stockpiling a quantity of an unauthorized drug. In addition, only drugs that have been authorized by foreign regulatory authorities in the United States, European Union or Switzerland can be accessed through this pathway. These regulations do not afford PHOs an ability to access investigational drugs or drugs approved in other foreign jurisdictions to address a public or military health emergency.

On May 11, 2019, proposed regulatory amendments were pre-published in the Canada Gazette, Part I. They contained both the proposal for changes to the FDR to better reflect the process undertaken by SAP for access to drugs, which are unavailable for sale in Canada in the context of a direct practitioner-to-patient relationship, and the proposal to create specific provisions to facilitate access to such drugs in the context of a public or military health emergency. The former proposal, titled the Regulations Amending Certain Regulations Made Under the Food and Drugs Act (Sale of a New Drug for Emergency Treatment), received final approval and was published separately in the Canada Gazette, Part II on October 14, 2020.

Objective

The objective is to provide an appropriate regulatory mechanism that will facilitate access to drugs for emergency preparedness and response activities proposed by PHOs by permitting an application to the Minister to authorize the sale of a specified quantity of a drug not otherwise authorized in Canada for:

Description

1. Creation of a new division (Division 11) entitled “Public or Canadian Armed Forces Health Emergencies — Drugs for Immediate Use or Stockpiling”

These Regulations create a new division in the FDR that provides a regulatory framework for access to drugs to address an actual, imminent or potential emergency, event or incident affecting public health or the health of members of the CAF.

The new Division 11 provides the authority for the Minister to issue a letter of authorization permitting the sale of a drug from a manufacturer to a PHO, for use in an immediate public health or military health emergency or for stockpiling the drug in anticipation of a future emergency, event or incident. Similar to the medical emergency provisions in Division 8, a drug eligible for authorization under Division 11 can be any drug that is approved in a foreign country, a drug under development, or a drug that was previously approved in Canada, but is no longer available on the Canadian market. Unlike the public health provisions under Division 10, there is no requirement that the drug be authorized by a foreign regulatory authority.

The Minister also has the authority to cancel an authorization issued under Division 11 if there are reasonable grounds to believe the drug presents a serious or imminent risk of injury to human health.

While the PHAC and the CAF were the main users of the existing medical emergency provisions under Division 8, Division 11 allows for requests to be submitted by PHOs at different levels of government (federal, provincial, territorial or municipal) to respond to, or prepare for, a public health emergency. Unlike in Division 10, the definition of “public health official” in Division 11 of the FDR includes municipal-level PHOs. This definition of PHO also includes the Chief Medical Officer of Public Health of Indigenous Services Canada and the Surgeon General of the CAF. This is in line with the current governance structure for emergency preparedness activities as described in the National Emergency Response System, where municipal governments usually have the primary responsibility in their jurisdiction to address a public health emergency.

Although each province and territory has its own governance structure for coordinating emergency response within their jurisdiction, federal departments frequently manage emergencies or provide support to provinces and territories depending on the scope and nature of the emergency. Division 11 reflects the level of governance by allowing for the distribution of drugs from the PHO who initially receives authorization to be sold a drug that is unauthorized in Canada (referred to herein as “initial PHO”) to other PHOs (referred to herein as “subsequent PHOs”).

Drugs that receive an authorization under this new Division have not undergone regulatory review and approval in Canada as would be the case for market-authorized drugs. These drugs may be approved in a foreign jurisdiction or may still be under development. As such, they do not have standard, Canadian-approved labelling. Because of this, the Regulations place certain labelling, reporting and monitoring obligations on the PHOs to ensure safe use and handling of the drug. More specifically:

The Regulations also allow the Chief Public Health Officer of Canada, the Surgeon General of CAF or the Chief Medical Officer of Public Health of Indigenous Services Canada to distribute a quantity of stockpiled drug authorized under Division 11 to a practitioner who has requested the drug under Division 8 (i.e., through the SAP) for use in the emergency treatment of a person under the care of that practitioner. Distribution of the requested drug to the practitioner would occur only once the manufacturer receives authorization under the SAP to sell a quantity of that drug to the practitioner. This new authority supports rapid access to drugs not otherwise authorized for sale in Canada in the rare situation when there is a need to address a serious or life-threatening situation for an individual emergency that falls outside of the mandate for public or military health emergencies and the shipping of the drug from the foreign country would not be timely enough.

The new Division 11 includes transitional provisions which deem any drug that is currently authorized for sale under the SAP for a public or military health emergency, and stockpiled by either the Chief Public Health Officer of Canada or the Surgeon General of the CAF, to be a drug authorized for immediate use or stockpiling under Division 11. This ensures that all requirements under Division 11 apply to these deemed drugs.

2. Additional amendments related to Division 11

(a) Amendment to Division 1

To require hospitals to report SADRs for drugs authorized under Division 11 for a public health emergency, the list of prescribed information to be provided in a SADR report under C.01.020.1(2) is revised to include the identifying name, code, number or mark, if any, for a drug authorized under C.11.003 of the FDR. This change in how SADRs are reported has been made to be more consistent with the existing SADR reporting requirement for drugs authorized for an urgent public health need under Division 10 of the FDR.

(b) Amendments to Division 10

The definition of “public health official” in Division 10 is amended to reflect the new Department of Indigenous Services. Minor non-substantive amendments have also been made in this Division to better align the English and French text and reflect modern drafting standards.

(c) Amendment to the Natural Health Products Regulations

The changes in Division 11 are intended to apply to any drug that is not authorized in Canada, including drugs which would be considered to be natural health products. A minor change is made to the Natural Health Products Regulations (NHPR) to ensure that the specified quantity of drugs authorized under Division 11 are not considered “natural health products” (NHPs) for the purposes of the NHPR in order to allow the new Division 11 requirements to apply to these products as well.

(d) Amendments to a set of regulations under the Patent Act

The Certificate of Supplementary Protection Regulations (CSP Regulations), under the Patent Act, establish an additional period of protection for drugs containing a new medicinal ingredient or a new combination of medicinal ingredients that are protected by an eligible patent. This protection, which is intended to partly compensate for time spent in research and obtaining marketing authorization, provides patent-like rights in respect of drugs containing the new medicinal ingredient or the new combination. A certificate of supplementary protection may only be issued in relation to the first authorization for sale of a drug containing a new medicinal ingredient or a new combination of medicinal ingredients. The type of authorization for sale that is eligible for a certificate of supplementary protection is a notice of compliance issued under section C.08.004 or C.08.004.01 of the FDR.

In order to ensure that an authorization issued under the new Division 11 is not considered an “authorization for sale” for the purposes of the CSP Regulations, this definition in the CSP Regulations is amended to add the Division 11 authorizations to the list of exclusions from the definition.

Regulatory development

Consultation

Consultations have been undertaken with stakeholders throughout the development of the Regulations over the past several years.

Summary of consultations received during pre-publication in the Canada Gazette, Part I

The proposed regulations were pre-published in the Canada Gazette, Part I on May 11, 2019, followed by a 70-day comment period, ending on July 19, 2019. During the same time period, Health Canada also consulted on a guidance document entitled “Draft Guidance Document: Public or Canadian Armed Forces Health Emergencies — Drugs for Immediate Use or Stockpiling”.

Four submissions were received on the proposed regulatory amendments. Submissions included a response from a professional regulatory body, and responses from three provincial health authorities provided jointly with their Chief Medical Officers of Health (CMOHs). Two of the provincial responses referenced both the regulations and guidance in their responses.

Comments received relating to guidance were considered and addressed as part of the process to finalize the guidance document. All comments within the scope of the regulatory amendments are summarized and responded to below.

Overall, respondents were supportive of the regulatory amendments to provide a mechanism for PHOs to access drugs not available in Canada for public or military health emergency preparedness and response activities.

1. Recommended dose of the drug to be indicated when drug is for immediate use

One respondent noted the importance of having ready access to information on the recommended dosage of a drug that is authorized for immediate use. They noted that the PHO should be required to provide this information in writing to the persons to whom the drug is administered and to the persons who administer the drug. This information would support the safe and appropriate use of a drug not approved for sale in Canada as information on the appropriate dose may be harder to find if the drug for immediate use is not labelled in English or French.

Health Canada response: Health Canada agrees with the respondent. The Regulations have been updated to apply labelling requirements for all drugs authorized under Division 11, including any drugs authorized for immediate use, to ensure safe use and handling. Information on the recommended dosage of a drug will be required to be included on the label of any drugs authorized for stockpiling or immediate use or on any document accompanying such drug. In addition, information on the recommended dosage of a drug will be included in the authorization issued to permit the manufacturer to sell a specified quantity of drug to the PHO.

2. Responsibilities of Provinces and Territories

One respondent expressed concerns that this new regulatory framework places new responsibilities on provinces and territories. According to the respondent, provinces and territories do not have systems in place, including regulations, to support these new responsibilities. The respondent commented that it would be better for Health Canada and the PHAC to take on responsibilities to support the framework including directing the use of the drug, monitoring for adverse events and language translations. Further, the respondent suggested that the responsibility for the risk associated with the use of the unauthorized drug be at the federal level.

Health Canada response: The PHAC maintains the National Emergency Stockpile System to provide health and social service supplies when provincial and territorial resources are insufficient to address an emergency. Although PHAC is the main stockpile for drugs and medical devices, the regulatory framework is intended to capture the levels of government responsible for addressing public or military health emergencies. This regulatory framework enables all levels of government to request their own quantity of drug for use within their jurisdiction in a public health emergency, or to stockpile an unauthorized drug should they choose to do so.

3. Costs

One respondent sought more clarity on the financial implications of the new framework for provinces and territories. They also noted as part of their comment that the requirement for PHOs to ensure that, before stockpiling a drug, the drug bears a label or is accompanied by a package insert would be very resource-intensive depending on the drug and amount being requested.

Health Canada response: Following pre-publication in the Canada Gazette, Part I, the PHAC and the CAF identified costs related to the preparation of labelling information to ensure that the drug bears a label or has an accompanying document such as a package insert. Information on the financial implications of the new framework is provided in the cost and benefit section of this RIAS. Labelling supports the safe and effective use of drug products by health care professionals, patients, and consumers. Manufacturers would not provide drugs without appropriate information about the safe use and handling of the drug. PHOs may negotiate with manufacturers on how to appropriately address the labelling requirements, as part of their contract negotiations, prior to or at the time of purchase.

4. Definition of Chief Medical Officer of Health

One respondent indicated that the definition of “public health official” may not apply to municipal Medical Officers of Health in a province where they are not employed by the municipality and are instead employed by the province. Therefore, according to the respondent, only the provincial CMOH would be able to initiate the process to request authorization for the sale of an unauthorized drug for an emergency or for stockpiling in anticipation of an emergency. This respondent also clarified that they consider this approach to be appropriate given the rarity of the scenario.

Health Canada response: The definition of PHO includes the CMOH for any province or territory and any municipal Medical Officer of Health or any position that is equivalent for a municipality. As this regulatory framework is intended to retain the current overarching governance structure for addressing public or military health emergencies, it reflects the different levels of government and enables the different PHOs to request their own quantity of drug for use within their jurisdiction.

Summary of changes to the Regulations following pre-publication

The Regulations differ from those pre-published in the Canada Gazette, Part I, in the following manner:

1. Definitions

The definition of “foreign regulatory authority” that was proposed for inclusion in Division 10 and 11 of the FDR has been revised to align with the definition currently in use under Division 10. New definitions for “initial PHO” and “subsequent PHO” have also been added to clarify the different PHO responsibilities under Division 11.

2. Contents of the application

The recommended storage conditions for the drug have been included in the list of information that must be provided by the PHO in their application. This was added to reflect the inclusion of this information in the contents of the written authorization.

3. Issuance of authorization

The provision which requires the Minister to consider whether there is an existing stockpile of the drug in Canada when reviewing an application for the authorization to stockpile a drug has been removed. This was removed as the Minister’s consideration of an existing stockpile is already captured in the provision that requires the Minister to assess whether there is an alternative mechanism that would address the emergency, event or incident.

4. Content of the authorization

A requirement has been added to ensure that the authorization from the Minister, which permits a manufacturer to sell a specified quantity of the drug to a PHO, must contain information about the recommended dosage and the recommended storage conditions for the use of the drug.

5. Exemptions

A provision has been added to identify the specific sections under Part A and Division 1 of the FDR that will apply to drugs authorized under Division 11 of the FDR. This change was made to provide clarity on which Part A provisions would apply to a drug authorized under Division 11 and to reflect the mandatory SADR reporting requirement for hospitals.

A provision has also been added to exempt drugs authorized under Division 11 from section 12 of the Act. Section 12 ensures that no radiopharmaceutical or biological drugs may be sold unless the Minister indicates that the manufacturing premises and the process and conditions of manufacture are suitable. This is typically addressed through the issuance of a drug establishment licence. Given that the regulated parties under Division 11 are exempted from complying with the drug establishment licence requirements under the FDR, and as this authority is incompatible with the exceptional nature of Division 11, an exemption was required.

6. Information to be made available for immediate use and for stockpiling

The Regulations have been revised to require that if an initial PHO becomes aware of new information or changes to specified information about a drug that was sold for immediate use, they must notify, in writing and without delay, any person to whom they have distributed a quantity of the drug. In the pre-published regulations, this requirement only applied to drugs sold for the purpose of stockpiling.

Additions to the list of information that the PHO must provide include the recommended dosage for the use of the drug and the requirement for the PHO to provide information on how to report SADRs. These additions were made to provide this information to those administering and receiving the drug.

7. Labelling

The pre-published regulations required drugs to bear a label, or to be accompanied by a package insert, that clearly sets out specified information in English and French for drugs authorized for stockpiling. However, labelling requirements should also apply to drugs authorized for immediate use as this information supports safe use of a drug. As such, the Regulations have been amended to reflect that labelling, or a document, are to accompany the drug under both circumstances, to ensure its safe use and handling.

8. Reporting on new information about the drug

The requirement for the PHO to provide to the Minister any new information that they become aware of concerning the safety, efficacy or quality of the drug in respect of its authorized use has changed. There was concern that the terms “safety, efficacy, and quality” relate to products that have been reviewed before receiving a Canadian market authorization. This wording could be misleading in this context since these drugs do not currently hold a Canadian market authorization. The provision has also been modified to require the PHO to provide, as they become aware of it, any new information or changes to information that was provided in the PHO’s initial application as it relates to safety, efficacy, or quality. This also includes any changes to information that was provided in response to requests made by the Minister during their review of the application.

9. Serious adverse drug reaction reporting

In the pre-published regulations, the initial PHO was required to report any SADRs to Health Canada. To be more consistent with existing reporting processes for public health emergencies only, the revised Regulations require hospitals to report SADRs according to the procedures already in place for mandatory reporting. In the case of a military health emergency, the reporting obligation remains with the Surgeon General of the CAF.

The timeline stated in the proposed regulations was revised to require the Surgeon General of the CAF to report any SADRs within 30 days of becoming aware of it. In the pre-published regulations, the PHO was required to report any SADRs within 24 hours if the reaction is fatal or life-threatening and within 15 days in all other cases. The revised timeline aligns with current requirements for SADR reporting by hospitals.

10. Reporting on the use of the drug to the Minister

The initial PHO will no longer be required to report results on the use of the drug annually. Rather, reports will only be required at the request of the Minister. The Minister may request a report under various circumstances. For example, if a SADR has been reported; a subsequent request has been filed for the same drug; or new information, such as contraindications to the drug, have been identified. This change in reporting at the request of the Minister, rather than on an annual basis, reduces the administrative burden for PHOs.

In addition, a change has been made to require the initial PHO to take reasonable steps to obtain information on the response to the drug in the health emergency and assess the information from monitoring the response. This assessment takes into account information respecting SADRs observed to make certain that any new information about the drug and its use is reported to the Minister. This is to ensure that the drug’s use and any SADRs are continuously monitored to inform any actions or future decisions regarding the continued use of the drug to address the public or military health emergency.

11. Record keeping

The requirement for the initial PHO to retain records for a period of 25 years has been reduced to 15 years. This change was made to align with the new records retention period for clinical trials.

In addition, subsequent PHOs who have received a quantity of a Division 11 authorized drug are also responsible for maintaining information about the sale and use of the drug in a way that allows them to communicate with anyone who has been administered the drug if their health may be endangered.

12. Reporting on unused quantities

The Regulations have been revised to clarify that, rather than providing an annual report, the initial PHO must provide the Minister with an annual account (inventory) of the remaining quantity of unused drug that is in their stockpile.

13. Cancellation of authorization

A provision has been added to require that if the Minister cancels an authorization, the initial PHO must communicate to the persons to whom they have directly distributed a quantity of the drug that the authorization has been cancelled.

14. Distribution of a stockpiled drug to a practitioner who requests the same drug under the SAP

A provision has been added to allow the distribution of a quantity of drug from a stockpile authorized under Division 11 to a practitioner who has requested the drug under Division 8 (SAP) for use in the emergency treatment of a patient under their care. The drug must be stockpiled by one of the following three PHOs: the Chief Public Health Officer of Canada, the Surgeon General of the CAF or the Chief Medical Officer of Public Health of Indigenous Services Canada. Once the manufacturer of the drug receives authorization from the SAP to sell the quantity of the drug to the requesting practitioner for the same use as the stockpiled drug, the distribution can take place. Once the PHO distributes the quantity of drug to the practitioner, Division 11 requirements will no longer apply to that distributed quantity and the drug will only be subject to the SAP requirements. This new authority will be used in exceptional circumstances where a drug stockpiled by PHAC, CAF or Indigenous Services Canada is needed to address an immediate serious or life-threatening situation for an individual but shipping the drug from the foreign country would cause delays.

15. Transition of drugs currently authorized under Division 8 for Public and Military Health Emergencies to Division 11

A provision has been added to deem a drug currently authorized under the SAP (C.08010 of Division 8) for a public or military health emergency as being authorized for immediate use or stockpiling under Division 11 (C.11.003). Once the drug is deemed as being authorized under Division 11, all Division 11 requirements will apply. This ensures that all quantities of a drug when distributed or used for a public or military health emergency are subject to the same set of requirements.

16. Consequential amendment to the NHPR

Amendments have been made to ensure that the specified quantity of drugs authorized for use in a Canadian public or military health emergency are not considered NHPs under the NHPR and to ensure that Division 11 of the FDR applies to such drugs. This change ensures the safety of Canadians by maintaining consistent SADR reporting requirements for all drugs authorized under Division 11 of the FDR, including drugs which, if authorized under the NHPR, could be considered NHPs. This amendment is necessary as these drugs are otherwise not subject to the reporting requirements of the NHPR or FDR. Given that only the specified quantity of drugs authorized under Division 11 is excluded from the NHPR, this change does not preclude the same drug from being considered under the NHPR at a later time should the manufacturer choose to seek an NHP licence.

17. Coming into force date

The coming into force date for the Regulations has been revised from the day on which they were registered to the day on which they are published in the Canada Gazette, Part II.

Summary of consultations following pre-publication

Changes made to the Regulations following pre-publication in the Canada Gazette, Part I, were presented to provincial and territorial CMOHs and Health Ministries at the Pan-Canadian Public Health Network in December 2021. Changes pertaining to the SADR reporting requirements for public health emergencies were also presented to hospitals in June 2022. The CAF and the PHAC are supportive of the amendments and no concerns have been raised by provinces and territories or hospitals on the changes.

Since the presentation at the Pan-Canadian Public Health Network in December 2021, additional changes, such as the new coming-into-force date and the exemption from section 12 of the Act, were made to the Regulations. These changes do not significantly impact the policy intent and are not expected to raise concerns from stakeholders.

Modern treaty obligations and Indigenous engagement and consultation

The Regulations are intended to facilitate access to drugs not authorized in Canada for all Canadians, including Indigenous peoples, to address public or military health emergencies. Accordingly, specific consultations with Indigenous peoples were not undertaken. It is anticipated that these amendments will not have an impact on the Government’s modern treaty obligations.

However, in general, Indigenous peoples could be positively impacted by aspects of the Regulations. The Chief Medical Officer of Public Health of Indigenous Services Canada is responsible for Indigenous population health and works alongside government partners, including other federal departments, provinces and territories, and municipalities, on health matters that affect Indigenous groups. The Chief Medical Officer of Public Health has accessed drugs not authorized in Canada that are on the current List of Drugs for an Urgent Public Health Need, established under Division 10 of the FDR, to treat tuberculosis in Indigenous populations. The Regulations provide the Chief Medical Officer of Public Health with an additional regulatory mechanism that allows access to drugs that are not available in Canada to address a public health emergency within Indigenous communities. Unlike the Division 10 mechanism, Division 11 allows for the stockpiling of drugs in anticipation of a public health emergency.

Instrument choice

Health Canada considered regulatory and non-regulatory options.

1. Status quo

In the status quo option, Health Canada would continue to rely on the current emergency provisions (sections C.08.010 and C.08.011) in the FDR administered by the SAP for public and military health emergencies. PHOs requesting access to drugs for these incidents would therefore have to rely on the SAP, which place a burden on the PHO and the program, as the SAP was not designed to respond to, or prepare for, a public or military health emergency. Health Canada is of the view that a specific framework intended to address the above-mentioned scenarios would create greater predictability and clarity within the Regulations.

2. Non-regulatory option

Under this option, Health Canada would continue to administer the existing emergency provisions (sections C.08.010 and C.08.011) of the FDR, and establish processes to address certain limitations of these provisions through policy. However, continuing to address the limitations of these provisions through policy-based decisions was not recommended. Regulatory changes to better reflect the activities undertaken by PHOs to address public and military health emergencies would provide greater predictability and clarity.

3. Regulatory option

Amending the FDR was the recommended option. There was a need for the FDR to address how drugs that are not available for sale in Canada are authorized and monitored for public or military health emergency preparedness and response activities (i.e., either for immediate use or for stockpiling purposes in anticipation of a potential emergency). The Regulations support current activities and provide the appropriate authorities to drug manufacturers and PHOs.

Regulatory analysis

Benefits and costs

The cost-benefit analysis aims to quantify the benefits and costs of the Regulations on implicated parties. A costing survey was shared with the CAF and the PHAC in summer 2020 for their input to assist with data collection for this analysis. All calculations for the costs and benefits are projected over a 10-year period, and the net present value is discounted by 7% as required by the Treasury Board of Canada Secretariat. The analysis concludes that the Regulations are low impact.

Costs
Costs to Government

The total direct cost of the Regulations to the Government of Canada is estimated at $677,607 in present value (PV) terms or $96,476 annualized over a 10-year period with a 7% discount rate.

Administrative Requirement Costs

The SAP previously administered the existing emergency provisions in the FDR to respond to requests for drugs for public or military health emergencies. In preparation for Canada Gazette, Part I, the assumption was that the incremental cost of implementing the Division 11 regulatory framework would be minimal for businesses, consumers and Canadians.

Following pre-publication in the Canada Gazette, Part I, the PHAC and the CAF, principal users of the SAP for accessing unauthorized drugs for immediate use or for stockpiling purposes to address a potential, imminent or actual health emergency, reassessed their costs. As such, further engagement in the form of a cost benefit survey took place with the PHAC and the CAF. Through this engagement process, the CAF and the PHAC identified costs related to updating standard operating procedures for the implementation of the Regulations and the costs associated with the preparation of information that is to be provided to those who will administer and receive the drug(s) authorized under Division 11 of the FDR.

Based on survey responses received from the CAF and the PHAC, the Regulations will result in on-going fixed costs for requirements of approximately $10,686 and $5,268 dollars respectively per drug authorized for immediate use or stockpiling. These fixed costs primarily relate to the preparation of the application, accompanying document and labels accompanying the drug, record retention, and reporting. The CAF and the PHAC anticipate procuring 27 and 12 new drugs respectively, with a combined total of 39 drugs over the next ten years. On a per year basis, the CAF would average three drugs and PHAC would average one. This level of procurement, under the Regulations will result in incremental costs of $247,048 PV, or an annualized average of $35,174, to the Government of Canada. This cost will be implemented in year one, the year the Regulations come into force.

The Regulations also require those who are authorized access to drugs for immediate use or stockpiling under the framework to ensure that updated information to the labelling or the accompanying document follows the drug. PHOs base their decisions to request the use of a particular drug through this framework on a risk/threat assessment of the public or military health emergency, and the benefits and risks of using the requested drug for a particular public or military health emergency. Some of these drugs may still be under development. As such, feedback indicated the continually evolving nature of these unauthorized drugs is likely to result in each procured product requiring an update to its benefit-risk assessment for the use of the drug in a public or military health emergency during the first ten years. The CAF has identified the incremental cost of these activities at $8,092 per drug and the PHAC has said the incremental cost to them will be $29,443 per drug. As mentioned, on a per year basis, the CAF would average three drugs and PHAC would average one. Based on this assumption, the anticipated costs to the Government related to the Regulations will total $401,606 PV over the 10-year period or an annualized average of $57,180. This on-going cost will start in year one, the year the Regulations come into force.

Finally, with respect to SADR reporting, the CAF has identified no incremental costs resulting from the Regulations; however, the PHAC has indicated they expect to incur a total cost of $70,447, in current dollars, related to identifying the corrective action stemming from the SADR. Based on recent history, the assumption, for costing purposes, is that the PHAC would access one drug authorized through Division 11 for public distribution over the next ten years. Given this assumption and deployment 10 years following the coming into force of the Regulations, the resulting cost will be $35,812 PV or an annualized average of $5,099. This cost is assumed to be incurred in year ten.

Compliance and Enforcement Costs

Under Division 11, provisions of the Act, such as the prohibitions related to the manufacturing, preparing, preserving, packaging or storing of drugs under unsanitary conditions, apply. As a result, if an issue arises with respect to Division 11 drugs, Health Canada has the authority to perform inspections and take compliance and enforcement actions.

The Regulations present a regulatory mechanism for PHOs to stockpile drugs in anticipation of a public or military health emergency. Stockpiling drugs generates the possibility for issues with respect to the storage conditions, which could trigger the need for an inspection.

As a conservative estimate, we assume Health Canada would continue compliance and enforcement activities over a 10-year period at a cost of $4,214 PV or an annualized average of $600 per yearfootnote 4. This cost with respect to the inspections and any compliance and enforcement actions will be absorbed by Health Canada using existing resources. This cost will start in year one, the year the Regulations come into force.

Benefits
Streamlined Reporting Benefits to Government

The Regulations set out a framework to provide greater transparency and predictability for the use of unauthorized drugs for public or military health emergencies. This framework allows PHOs to ensure necessary drugs are available for use in an emergency setting that requires a rapid response. In addition, the framework also provides certain requirements to ensure safe use and handling of the drug and continuous monitoring, such as reporting on the use of the drug and the ability to track a drug in the distribution chain. Requirements for reporting on the results of the use of a drug in a public or military health emergency, event or incident contribute to further understanding of the use of the drug in situations where limited information is available. These requirements also inform any decisions undertaken by the PHO on the benefits for continued use of the drug based on these results. As a result of the new framework, the CAF indicated it is expected to realize cost savings from streamlined reporting. The savings are anticipated from a decrease in workload for staff resulting in a total savings of $15,767 over a 10-year period. These savings amount to $11,074 in PV terms or an annualized average of $1,577. These savings will start being realized in year one, the year the Regulations come into force.

Qualitative Benefits

Increased Supply and Safety for Canadians

Stockpiling drugs that would otherwise not be immediately available for use in an emergency allows rapid procurement and distribution of the drugs by PHOs, thereby enabling an effective coordination of the supply of drugs in an emergency. The requirement for appropriate labelling of a drug ensures that anyone who receives a quantity of the drug can be made aware of the relevant information related to the safe use and administration of the drug as well as the appropriate storage conditions.

Cost-benefit statement

Number of years: 10 years (2022-2032)
Base year for costing: 2021
Present value base year: 2022
Discount rate: 7%

Monetized costs*
*Numbers may not add up due to rounding

Impacted stakeholder

Description of cost

Base year Period 1

Final year Period 10

Total (present value)

Annualized value

Government

Administrative requirements

$35,174

$35,174

$247,048

$35,174

Government

Post-market requirements

$57,180

$57,180

$401,606

$57,180

Government

SADR reporting

$0

$70,447

$35,812

$5,099

Government

Compliance and Enforcement

$600

$600

$4,214

$600

All stakeholders

Total costs

$92,954

$163,401

$688,680

$98,053
Monetized benefits*
*Numbers may not add up due to rounding

Impacted stakeholder

Description of benefit

Base year

Final year

Total (present value)

Annualized value

Government

Streamlined reporting

$1,577

$1,577

$11,074

$1,577

All stakeholders

Total benefits

$1,577

$1,577

$11,074

$1,577
Summary of monetized costs and benefits*
*Numbers may not add up due to rounding

Impacts

Base year

Final year

Total (present value)

Annualized value

Total costs

$92,954

$163,401

$688,680

$98,053

Total benefits

$1,577

$1,577

$11,074

$1,577

NET COST

$91,377

$161,824

$677,607

$96,476

Small business lens

A small business is defined as a firm, including affiliates, with fewer than 100 employees or less than $5 million in annual gross revenues.

Small businesses are not among the stakeholders impacted by the Regulations.

One-for-one rule

The one-for-one rule measures the incremental changes to the amount of administrative burden imposed on businesses through regulations under the Red Tape Reduction Act.

As the impacted stakeholders of the Regulations are government entities, the one-for-one rule does not apply.

Regulatory cooperation and alignment

The Regulations facilitate access to unauthorized drugs to address a potential, imminent or actual emergency, event or incident in a way that is consistent with how they are available for the same purpose in other international jurisdictions, such as the United States, the European Union and Australia. For example, in the United States, the Project Bioshield Act allows for stockpiling and distribution of vaccines not tested for safety and efficacy in humans. Similarly, the European Medicines Agency may grant a marketing authorization in exceptional circumstances to enable products to be used in particular circumstances (such as in the case of a pandemic or in the presence of a particular life-threatening disease), in the absence of comprehensive efficacy and safety data under normal conditions of use.

While an authorization issued under the Regulations would allow the sale from a manufacturer to a PHO, manufacturers are not obligated to provide access to address a public health or military health emergency. Further, the Regulations do not require manufacturers to change any aspect of their product to meet Canadian requirements with respect to providing access to a drug for use in Canadian health emergencies.

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; therefore, a detailed analysis was not warranted.

Gender-based analysis plus

Consideration of gender and other social and cultural-related factors was taken into account during the development of this regulatory change. No gender-based analysis plus impacts have been identified for this regulatory change, as these factors do not determine whether a drug is authorized for use to address a public or military health emergency.

Implementation, compliance and enforcement, and service standards

Implementation

The Regulations came into force on the day on which they were published in the Canada Gazette, Part II. Guidance on implementation of the regulatory change is outlined in Health Canada’s “Guidance Document: Public or Canadian Armed Forces Health Emergencies — Drugs for Immediate Use or Stockpiling”.

Compliance and enforcement

Provisions of the Act, such as prohibitions related to the manufacturing, preparing, preserving, packaging or storing of drugs under unsanitary conditions, apply to drugs authorized under Division 11. If there is a failure to comply with the Act and the Regulations, this may result in Health Canada taking compliance and enforcement actions in line with the existing compliance and enforcement policy for health products (i.e., Compliance and enforcement policy for health products (POL-0001)). When an issue arises, Health Canada chooses the actions and tools that are most appropriate for the situation, based on an assessment of available evidence and risks. The type of action may include, for example, seizing and detaining the drug or requiring tests and studies or an assessment of the drug.

In addition, the Minister has the authority to cancel an authorization issued under Division 11. If an authorization is cancelled, compliance and enforcement requirements under the FDR would apply to any unused quantity of the drug. Health Canada would assess the best course of action, which could lead to the seizure or destruction of a detained product.

Contact

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