Canada Gazette, Part I, Volume 153, Number 19: Regulations Amending Certain Regulations Made Under the Food and Drugs Act (Sale of a New Drug for Emergency Treatment)

May 11, 2019

Statutory authority

Food and Drugs Act

Sponsoring department

Department of Health

REGULATORY IMPACT ANALYSIS STATEMENT

(This statement is not part of the regulations.)

Issues

The Food and Drug Regulations (FDR) contain emergency provisions, which can be used in certain circumstances to provide Canadians with access to human and veterinary drugs in medical emergencies when the drugs are not authorized in Canada. These provisions are administered through the Special Access Program (SAP) for human drugs, and through the Emergency Drug Release Program (EDR) for veterinary drugs. Evolving disease patterns and global health incidents with a domestic impact have emerged, requiring new drugs, which are often not available in Canada, as manufacturers may not submit these drugs to the Canadian market due to its small size. These conditions have reduced timely access to drugs for Canadian patients and animal owners.

Health Canada is committed to ensuring Canadians have the timeliest access possible to drugs that may be needed to treat diseases or in a medical emergency. To continue to meet the needs of Canadian patients and the health care system, changes are needed to the FDR to facilitate access to drugs when a drug is required in the following circumstances:

  1. To treat a patient in a medical emergency where a given drug is either unsuitable or unavailable for sale in Canada (sale of a new drug for emergency treatment); and
  2. To be used by a public health official to address a public or military health emergency, event or incident (public or Canadian Armed Forces health emergencies — drugs for immediate use or stockpiling).

Background

In 2016, Health Canada launched a series of regulatory and policy initiatives to improve the regulatory review of drugs and devices. footnote 1 The intent of the initiative was to adapt to a changing and rapidly evolving health care system and build regulations that adapt to changes in health care delivery, while providing Canadians with faster access to the drugs and medical devices that they need. The plan included renewing the Special Access Program to improve access to products that are not currently authorized for sale in Canada and better supporting access to other needed drugs for Canadians.

I. Sale of a new drug for emergency treatment

The FDR aims to support access to drugs for Canadians, while helping to ensure that all drugs for human and veterinary use are safe, effective and of good quality. The FDR includes detailed provisions requiring drug manufacturers to submit robust safety and effectiveness data to support their drug submissions, should they wish to pursue market authorization in Canada. For manufacturers to obtain this data, most often clinical trials are required, which take years to complete. Market authorization is granted once Health Canada conducts a thorough review and determines that the drug’s benefits outweigh its risks. Recognizing the length of time to bring a drug to market, set against the need to provide access to life-saving medication, the FDR was amended in 1966 to create emergency provisions that permit the sale of unauthorized drugs (drugs not approved in Canada) to provide Canadians with access to human and veterinary drugs in medical emergencies.

These regulatory provisions allow a manufacturer to sell an unauthorized drug to practitioners footnote 2 to treat human or animal patients in a medical emergency. The programs that administer these provisions are called the Special Access Program (SAP) [for human drugs] and the Emergency Drug Release program (EDR) [for drugs for veterinary use]. These programs are used by practitioners to request access to unapproved drugs in situations where there is a drug for treating patients with serious or life-threatening conditions when conventional treatments have failed, are unsuitable, or are unavailable. The decision to authorize or deny a request for use of an unapproved drug is made on a case-by-case basis.

How it currently works

The SAP is a widely used 24/7 service, with access provided to 75 000 patients and 5 000 physicians, and with over 16 000 requests per year. footnote 3 One third of all drugs accessed through the SAP are used to treat rare diseases, while many others are used to treat diseases that have a high prevalence in the Canadian population such as cardiovascular diseases (e.g. heart failure, hypertension), neurological disorders (e.g. epilepsy, multiple sclerosis), cancers and microbial infections. On average, there are approximately 500 drugs with active status on the SAP (i.e. drugs that have been authorized in the past year). Drugs considered for authorization by the SAP in accordance with the FDR include pharmaceutical, biologic, and radiopharmaceutical drugs as well as natural health products.

The EDR program for veterinary drugs receives between 600 and 1 000 requests per year. Drugs are accessed by veterinarians through the EDR program to treat diseases in a large number of species, including companion animals, food-producing animals, wildlife species and fish. An average of 45 drugs have an active status in the program.To request access to drugs through either the SAP or the EDR program, practitioners submit a request to Health Canada for a drug that is otherwise unauthorized for sale in Canada to treat a patient.

For human and veterinary drugs, the practitioner is required to submit information about the medical emergency, the patient’s medical condition, and information about the use, safety and efficacy of the drug for the medical emergency. Furthermore, after using the drug, practitioners are required to submit a follow-up report to Health Canada on the outcome of the use of the drug.

Practitioners are responsible for ensuring the decision to prescribe the drug is supported by credible evidence. They are also responsible for monitoring and reporting the results of the use of the drug, including any adverse drug reactions. Once the use of the drug is approved by Health Canada, a letter of authorization is sent from the SAP or the EDR program to the manufacturer of the drug, authorizing the sale of a quantity of the drug to a named practitioner. The amount of time that it can take for the drug to reach the practitioner can vary from a couple of days to several months, depending on where the drug is coming from and the type of drug requested. For example, controlled substances take a longer time to arrive in Canada since foreign manufacturers are responsible for ensuring that they meet the regulatory requirements of their own country with respect to the export of drugs to Canada, and they must also obtain an import permit as required under the Controlled Drugs and Substances Act. A manufacturer is under no obligation to sell the requested drug and Health Canada cannot compel a manufacturer to do so.

Drugs authorized through the SAP or the EDR program are meant to be for a limited time to meet specific emergency needs. The programs are not intended as a mechanism to promote or encourage the early use of drugs, to conduct research, or to circumvent the clinical trial or drug review process. Drugs that are authorized for sale under these emergency provisions do not undergo a comprehensive pre-market review, nor are they subject to the same manufacturing and post-market safety requirements as other drugs that a manufacturer would seek approval for the Canadian market through the FDR. For example, the drugs requested through the emergency provisions currently do not undergo a review of good manufacturing practices in Canada (i.e. manufacturing requirements that ensure drugs are produced in sanitary conditions with quality assurance). These are important factors for the practitioner to consider when recommending the use of a drug and in making an appropriate risk/benefit decision in the best interest of the patient.

Challenges with the current regulatory framework

Existing regulatory requirements have served their purpose; however, over the years, practitioners and stakeholders have expressed the following concerns with the program:

The program is viewed as being burdensome with respect to certain requirements: For each drug request submitted to Health Canada, the FDR requires a practitioner to submit data with respect to the use, safety and efficacy of the drug, despite the SAP or the EDR program having previously authorized the same drug in the past for the same medical emergency. This creates an unnecessary paperwork burden for practitioners. A process that reduces this burden on practitioners is proposed to allow practitioners to request a given drug without having to submit data on the drug’s use, safety and efficacy if the drug has been previously authorized through the program and meets certain conditions.

Lack of clarity concerning when foreign manufacturers can bring a drug into Canada in advance of a request by a practitioner: Certain drugs are frequently requested through the SAP and the EDR program. Manufacturers are aware that certain drugs they produce are frequently requested and used in the Canadian health care system. To account for this, and to reduce the length of time it takes to get a drug from a manufacturer to a practitioner for patient use, foreign manufacturers currently export an unauthorized drug into Canada to be placed in a Canadian affiliate’s facility in anticipation of a request for it by a practitioner and the authorization by the SAP or the EDR program (referred to as “pre-positioning”). Through an exercise of enforcement discretion, Health Canada has by policy allowed this by not enforcing the prohibition on import for sale on small individual shipments. Creating a regulatory framework around the practice of pre-positioning would enable certain conditions to apply to manufacturers wishing to pre-position their product in Canada.

II. Public or Canadian Armed Forces health emergencies — Drugs for immediate use or stockpiling

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 (P/T) governments would step in. If it extends beyond the P/T boundaries, the Public Health Agency of Canada (PHAC) plays a role. While all levels of government may have a stockpile for emergency medical supplies, including drugs, PHAC maintains the National Emergency Stockpile System (NESS) to provide health and social service supplies quickly to provinces and territories when their own resources are insufficient during an emergency. As such, PHAC procures drugs and medical supplies for use in emergencies. The Canadian Armed Forces (CAF) perform similar activities to PHAC; however, they maintain a stockpile of drugs and medical supplies for use on military bases or abroad on missions.

Currently, the CAF and PHAC make requests under the existing medical emergency provisions in the FDR administered by the SAP when an unauthorized drug is needed to respond to an immediate military health or public health emergency, respectively, as well as for stockpiling purposes to be used in future health emergencies.

How it currently works

Using the existing medical emergency provisions, the Chief Public Health Officer or the Surgeon General of the CAF submits requests to the SAP for either immediate use or for stockpiling purposes in anticipation of an imminent or potential emergency. There are approximately 70 requests submitted annually.

While the PHAC and the CAF are currently the main users of the existing medical emergency provisions, public health officials at the federal, provincial and territorial levels may use Division 10 of Part C of the FDR, currently entitled “Access to Drugs in Exceptional Circumstances,” footnote 4 to access drugs otherwise unauthorized for sale in Canada for immediate use to address an urgent public health need. To access a drug through this pathway, public health officials 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, at the discretion of the Minister. Drugs on the list may only be imported and sold in the requesting jurisdiction. Access to drugs which may be requested through this pathway is limited to those that have been authorized for the same use in the United States, European Union or Switzerland. Drugs remain on the List for one year, after which they are removed unless Health Canada receives a new notification from the public health official for continued access to the drug to address an urgent or immediate public health need.

Challenges with the current regulatory framework for medical emergencies (sections C.08.010 and C.08.011 of the FDR)

The current medical emergency provisions of the FDR were not designed to respond to, or prepare for a public health emergency: The current medical emergency provisions were designed for a practitioner-patient relationship, where appropriate monitoring of the patient using the drug is done by the practitioner. In the case of public health emergencies, it is a public health official, acting as practitioner to a population, who determines which drug is the best treatment to use in a particular public or military health emergency. There is a need for the FDR to clearly address the stockpiling of drugs by public health officials and requests for immediate use in a public or military health context. The proposed amendments would provide clarity on the application requirements for public health officials, as well as reporting, record keeping and drug labelling requirements.

Objective

The objective of this proposal is to facilitate access to drugs for Canadians by

Description

I. Sale of a new drug for emergency treatment

The proposed amendments would revise the current emergency provisions of the FDR (Part C, Division 8, sections C.08.010 and C.08.011) to: (i) provide a less burdensome process for a practitioner requesting a drug previously authorized through the SAP or the EDR program for use in the emergency treatment of a human or animal patient; (ii) establish a regulatory mechanism for situations when manufacturers wish to import drugs in Canada in anticipation of a request from a practitioner (“pre-position”); and (iii) provide required additional amendments.

(i) Requesting a drug previously authorized through the SAP or the EDR program

The proposed amendments would create new requirements that would allow a practitioner to submit a request for access to an unauthorized drug without submitting data on the use, safety and efficacy of the drug in certain circumstances — data that is currently required in all circumstances. Specifically, this process would be available when the following criteria, outlined in the proposed amendments, are met:

The following information, currently required to be submitted by the SAP or the EDR program, would still be required:

(ii) Pre-positioning

New sections are being proposed for inclusion in the FDR to permit the “pre-positioning” of a drug in Canada by manufacturers in advance of a request for the drug by a practitioner and authorization by the SAP or the EDR program. Through these provisions, a manufacturer will be able to submit a request to the SAP or the EDR program for a letter of authorization allowing for the importation of a given drug by a Canadian drug establishment licence (DEL) holder. footnote 5 The drug would be stored in Canada by the DEL holder, who is prohibited from distributing the drug to a practitioner until a letter of authorization by the SAP or the EDR program is issued allowing the sale of the drug to a practitioner. Pre-positioning allows for a more logistically efficient way for SAP and EDR program drugs to be imported to Canada for potential human or animal use, as they can physically be present in a warehouse in Canada well before a practitioner actually makes a request and an authorization is issued.

Divisions 2 to 4 of the FDR footnote 6 would not apply to the importation of the drug, except for certain provisions relating to good manufacturing practices. For example, a drug would need to be stored in a way that prevents the product from becoming unstable or inactive. The DEL holder would also need to ensure that there is a system of control in place to allow a rapid recall of the drug.

(iii) Additional amendments
(a) Copies of reports submitted to foreign regulatory authorities would need to be submitted to Health Canada upon request

The proposed regulations include a provision that would allow the Minister to request, from the manufacturer of a drug authorized under the SAP or the EDR program, a copy of any report that was submitted to a foreign regulatory authority for the purpose of evaluating the safety, efficacy and quality of the drug. This information would help to inform the SAP and the EDR program’s decision-making on whether or not a drug should be authorized, or may provide information that would be important to share with the practitioner of the request, such as safety information. The information would also allow the program to ensure there are no new terms or conditions on the use of the drug, and to determine if changes to the drug’s safety profile require the SAP or the EDR program to obtain additional information about the drug for the requested use when considering an authorization.

(b) Veterinary drugs accessed through the EDR program with certain antimicrobials would have to be reported

In 2017, requirements for reporting related to certain antimicrobial active pharmaceutical ingredients in veterinary drugs were introduced to the FDR footnote 7 as part of comprehensive efforts to improve stewardship and prudent use of antimicrobials. Specifically, a requirement was introduced that manufacturers or importers of drugs for veterinary use that contain an active pharmaceutical ingredient on the List of Certain Antimicrobial Active Pharmaceutical Ingredients (List A) are required to provide an annual report for each drug that lists the total quantity sold and an estimate of the quantity sold for each intended animal species. As part of the proposed amendments, Health Canada is proposing to expand the antimicrobial reporting requirement to veterinary drugs authorized under the emergency provisions by the EDR program, which are currently otherwise exempt from all requirements of the FDR.

(c) Drugs may be shipped to community pharmacies

In addition, the proposed amendments would also remove the requirement from the practitioner to submit the names of all institutions in which the drug is to be used, and instead would only require information on the location where the drug is to be shipped (the “civic address”). This would allow for the shipment of SAP drugs to community pharmacies. In turn, this would mean that patients could have access to SAP drugs even outside of an institution such as a hospital or practitioner’s office. This would facilitate access to drugs for patients, particularly in rural communities, and could help to ensure any delay in the treatment of patients is avoided.

(d) Patient’s identity does not need to be known at time of request

The proposed amendments would specify that it is permissible that the patient’s identity (human or animal) is not known to the practitioner that has submitted a request to the SAP or the EDR program. This provision would capture future use situations where a drug is needed for administration in an emergency by a first responder or in the hospital, such as in an emergency room setting, where the patient may not be known in advance of the emergency. In this scenario, the practitioner would still need to submit the same information to Health Canada to receive a letter of authorization through the SAP or the EDR program as he or she currently does. However, the patient’s identity could be unknown at the time that the request is made.

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

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

A new division is being proposed that would provide a regulatory framework for access to drugs 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.

The proposed Division 11 would provide the authority for the Minister to issue a letter of authorization permitting the sale of a drug to a public health official in order to address a potential, imminent or actual emergency, event or incident affecting public health or the health of members of the CAF. The sale of the drug may be for immediate use to address the emergency, event or incident, or for stockpiling the drug in anticipation of a future emergency, event or incident. The Minister would have 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 are the main users of the existing medical emergency provisions, the proposed Division 11 would allow for requests to be submitted by public health officials at other levels of government (federal, provincial, territorial or municipal, or the Surgeon General of the CAF) to respond to, or prepare for, a public health emergency. The definition of “public health official” in the FDR, with respect to this Division only, would account for municipal-level public health officials. This would be in line with the current governance structure for emergency preparedness activities, where municipal governments have the primary responsibility in their jurisdiction and can initiate a request. Since drugs authorized under the proposed public or military health emergency framework are to treat a population, the proposed new requirements would place certain labelling, reporting and monitoring obligations on the public health official to ensure safe use and handling of the drug, specifically

Stockpiling drugs that would otherwise be unavailable for distribution for use in an emergency would allow rapid procurement and distribution of the drugs, thereby enabling an effective coordination of the supply of drugs in an emergency. Public health officials responsible for emergency preparedness and response would benefit from a regulatory mechanism that provides clarity for requesting access to otherwise unauthorized drugs for use in an emergency.

Requirements for reporting on the results of the use of a drug in a public or military health emergency, event or incident would contribute to further understanding of the use of the drug in situations where limited information may be known. The requirement for appropriate labelling of a drug intended for stockpiling is there to ensure that anyone in possession of the drug is aware of the relevant information related to the safe use and administration of the drug as well as the appropriate storage conditions.

(ii) Additional amendments related to Division 11
(a) Change in title to Division 10

It is proposed that the title of Division 10 of the FDR be amended from “Access to Drugs in Exceptional Circumstances” to “Urgent Public Health Need — Foreign Approved Drugs” to better reflect the intent of the Division 10 provisions, as set against the Division 11 provisions. The definition of “public health official” in Division 10 would also be amended to reflect the new Department of Indigenous Services Canada.

(b) 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.

The CSP Regulations define “authorization for sale” as 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; an experimental studies certificate for use in animals issued under section C.08.015 of the FDR; an exemption for an urgent public health need permitting the sale of a drug under subsection C.10.002(1) of the FDR; or an authorization for a clinical trial or an authorization through the SAP or the EDR program (under section C.05.006, C.05.008 or C.08.010 of the FDR or section 67 or 71 of the Natural Health Products Regulations).

In order to ensure that an authorization issued under the new proposed Division 11 is not considered a previous “authorization for sale,” this definition in the CSP Regulations would need to be amended. This amendment would ensure that drugs brought into Canada under the proposed Division 11 provisions would be considered for a certificate of supplementary protection at a later time if and when a manufacturer seeks market authorization for the drug in Canada and receives a notice of compliance. The proposed amendment to the definition of “authorization for sale” would add the Division 11 authorization to the list of exclusions from the definition.

Regulatory development

Consultations

I.Sale of a new drug for emergency treatment

Targeted consultations with key stakeholders on the proposed changes to the regulatory provisions related to emergency treatment took place beginning in December 2017 and ending in early 2018. Over 130 individuals from across the country participated in the sessions, representing the following groups: physicians, veterinarians, patients, pharmacists, pharmacy technicians, health associations, professional regulatory bodies, drug industry representatives and safety advocates. Additional consultations on the EDR program with key stakeholder groups began in November 2018 and ended in February 2019. Considerable feedback was received through these consultations, including suggestions for areas where improvements could be made to better meet the needs of patients.

For example, respondents commented that the FDR should allow the practitioner to choose a preferred shipment location for a drug accessed through the SAP. In response to this comment, the proposed amendments allow drugs to be shipped to an address supplied by the practitioner. In general, respondents supported Health Canada’s proposals to reduce the burden associated with certain requests to the program. Other comments focused on operational improvements that could be made, such as more direct communication with requestors and increased openness about decisions with requestors. Health Canada has taken these comments under advisement as it considers operational improvements to the program; however, these improvements are outside of this regulatory proposal. Veterinary stakeholders were generally supportive of the proposed approach, including pre-positioning.

A document titled Feedback from the Consultation: Renewal of Health Canada’s Special Access Program (SAP) was shared electronically with participants of the consultation. footnote 8

II. Public or Canadian Armed Forces health emergencies — Drugs for immediate use or stockpiling

Consultations have been undertaken with the CAF and the PHAC. Both the CAF and the PHAC have been engaged throughout the development of the proposed Regulations over the past several years via face-to-face and teleconference meetings and are supportive of the proposal.

Modern treaty obligations and Indigenous engagement and consultations

This proposal is intended to facilitate access to drugs not authorized in Canada for all Canadians, including Indigenous peoples. Accordingly, specific consultations with Indigenous peoples were not undertaken. It is anticipated that this proposal would not have an impact on the Government’s modern treaty obligations.

However, in general, Indigenous peoples could be positively impacted by aspects of this proposal, specifically, the portion of the proposal that provides access to drugs for public health emergencies. The Chief Medical Officer of Health (CMOH) for the Department 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 CMOH has accessed drugs not authorized in Canada that are on the current List of Drugs for an Urgent Public Health Need (UPHN) footnote 9 to treat tuberculosis in Indigenous populations. This proposal will provide the CMOH with an additional mechanism to access unauthorized drugs, as the CMOH would not only have access to drugs on the UPHN list but would also have access to drugs for stockpiling purposes or immediate use in health emergencies.

Instrument choice

Health Canada considered regulatory and non-regulatory options.

1. Status quo

In the status quo option, Health Canada would continue to administer the current emergency provisions in the FDR. While they have served their purpose, they do not accurately reflect the most efficient way to administer the SAP or the EDR program. For example, this option would not allow Health Canada to reduce the burden that practitioners currently face with respect to the information that they need to provide to Health Canada when they request drugs though the SAP or the EDR program. In addition, it would not create any exemptions to the prohibitions currently operating against the pre-positioning of drugs by manufacturers.

Furthermore, maintaining the current emergency provisions would not allow for the creation of a separate regulatory framework for drugs for public and military health emergencies. Drugs for these incidents would therefore have to rely on the SAP or the EDR program rules, which places a burden on these programs as they were not designed to respond to, or prepare for, a public or military health emergency. Health Canada is of the view that specific frameworks 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 of the FDR. The Department would establish processes to fix certain limitations of the current emergency provisions.

Continuing to address the limitations of these provisions through policy-based decisions is not recommended. For example, without a change to the regulations, practitioners would still need to submit data with respect to the use, safety and efficacy of a drug, even if the drug had been previously authorized in the past for the same medical emergency. Health Canada could continue, through policy, to permit the import for sale of small individual shipments of drugs in advance of a request from a practitioner and an authorization by the SAP. As this would be permitted through an exercise of enforcement discretion, regulations rather than policy are required to enable Health Canada to apply certain conditions on the pre-positioning of products in Canada.

In relation to drugs for use in a public or military health emergency, regulatory changes are required to create oversight and reporting requirements for stockpiled drugs and to allow the Minister to cancel an authorization if a drug that could potentially harm a large population is deemed unsafe.

3. Regulatory option

Amending the FDR is the recommended option. There is a need for the FDR to specifically address the pre-positioning of a drug in Canada in advance of a practitioner request, reduce the administrative burden for practitioners and address how drugs are used 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 public health emergency). The proposed amendments support current activities and would provide the appropriate authorities to drug manufacturers and public health officials, and reduce the administrative burden on practitioners.

Regulatory analysis

Costs and benefits

I. Sale of a new drug for emergency treatment
Costs

The proposed provisions would allow the Minister to request a copy of any report submitted to a foreign regulatory authority for the purpose of ensuring there are no new safety, efficacy or quality issues with the drug. These would add negligible costs to the manufacturer, as this report is a requirement in the foreign jurisdiction and would already be in the possession of the manufacturer. Further, because the proposed requirement to submit a report would only be upon request of the Minister, it would not be required of all manufacturers selling a drug accessed through the SAP or the EDR program. Based on past experience, Health Canada anticipates making few requests for these reports using the proposed provisions. To date, manufacturers have always complied voluntarily with any requests by Health Canada for additional safety-related information. In the event that a manufacturer does not wish to comply and the proposed regulatory power is used, the only cost would be related to the transmission of the data, which could be done electronically. The incremental cost would therefore be zero.

As part of the Regulatory Impact Analysis Statement published in the Canada Gazette, Part II, on May 17, 2017, which accompanied the amendments to the FDR regarding Veterinary Drugs — Antimicrobial Resistance, costs were established for the reporting of sales of most veterinary antimicrobials. Based on the results of a 2015 stakeholder costing survey, it was estimated that the reporting activities would take approximately 10 hours and have a resource cost per hour of $112. The proposed amendments relating to the sale of emergency drugs would expand antimicrobial reporting requirements to include veterinary drugs authorized by the EDR program.

These costs are expected to be limited. In the last two years, the EDR program has processed authorizations for two drugs containing an active pharmaceutical ingredient on the list of antimicrobial active pharmaceutical ingredients, which are supplied by two manufacturers. Based on an estimated one additional drug reported through the EDR program per year, this would result in a total annual cost of $1,120 to manufacturers, importers or practitioners collectively. This estimate is based on costing data collected in 2015 and at that time, manufacturers, importers and compounders had to enter data using an Excel spreadsheet. Health Canada has since launched a new web application for concerned parties to report sales data in an efficient user-friendly way. It is anticipated that the costs will thus be reduced when this web application is used. Since the web-based system was not costed by industry at the time, Health Canada is using the $1,120 figure as a conservative estimate of the cost impact for industry.

The proposed pre-positioning provisions would be voluntary and would not result in any costs to manufacturers, as the proposed amendments would clarify the requirements for drugs to be imported into Canada by the holder of an establishment licence. Allowing the manufacturer to pre-position a drug in Canada would reduce the time it takes to ship a drug to a practitioner and the costs for the manufacturer to ship small amounts of a drug each time there is an authorization by the SAP or the EDR program.

Benefits

There are expected to be benefits associated with the proposed amendments for practitioners who submit requests for access to drugs that have been previously authorized through the SAP or the EDR program. For drugs that meet the criteria set out in the proposed amendments, the practitioner would no longer be required to submit use, safety and efficacy data in respect of drugs that have been previously authorized by the SAP or the EDR program, as is currently done under the existing regulations. Not submitting this data would reduce the administrative burden on practitioners for a drug that has been previously authorized by the SAP or the EDR program. It is estimated that 30–40% of the drugs submitted to the SAP could be subject to the reduced information requirements. However, these benefits are minimized by the need for the practitioner to contact Health Canada in order to find out if the drug has been previously authorized, until such a time as an electronic system for the SAP is created to help with the application process. For veterinary drugs, Health Canada is developing options for how the list of drugs will be made available in order to facilitate the application process and the completion of forms that can be downloaded from the EDR program web page.

The anticipated benefits, if using the current paper-based application process, would only be a couple of minutes; however, once the electronic system for the SAP is operationalized, practitioners would gain additional benefit from being able to quickly see if a drug has been previously authorized by Health Canada. Health Canada estimates this may save 15 minutes per application. Although the practitioner would no longer have to submit use, safety and efficacy data for a drug that has been previously authorized, he or she would still have to ensure the safety and efficacy data supports prescribing the drug to a patient for the medical emergency. While the regulatory changes will facilitate the less burdensome use of the electronic system, they do not require its use. As the savings are administrative in nature, the details of the savings are outlined below in the “One-for-one rule” section.

Removing the requirement for the practitioner to provide the names of the institutions where the drug is to be used would allow the shipping of the drug to other locations, such as community pharmacies, which would facilitate patient access to the drug, particularly in rural communities, and could ensure any delay in the treatment of patients is avoided.

The portion of the proposal that deals with pre-positioning would provide a more logistically efficient way to get a drug to a practitioner by allowing manufacturers to distribute the drug to a Canadian establishment licence holder, in advance of a request from a practitioner for the drug and subsequent authorization by the SAP or the EDR program. This could improve the time it takes for a drug to reach a practitioner once the practitioner receives a letter of authorization from Health Canada.

II. Public or Canadian Armed Forces health emergencies — drugs for immediate use or stockpiling

Costs

The SAP currently administers the existing emergency provisions in the FDR to respond to requests for drugs for public or military health emergencies. Since activities related to drugs for public health emergencies are already occurring, there would be no additional costs to businesses, consumers or Canadians expected as a result of this proposal, as it codifies an existing process. The proposed reporting requirements for public health officials are not expected to result in additional costs, as public health officials are already reporting on the use of the drug in the emergency treatment in accordance with the existing emergency provisions in the FDR.

Further, public health officials already have mechanisms in place for monitoring and reporting, including keeping records, on the use of drugs in emergencies. Even if there were incremental costs, they would be very small. For example, during the H1N1 pandemic in 2009, PHAC received 41 reports concerning adverse events following immunization. Taking into account that the estimated cost of reporting adverse reactions to drugs in a hospital setting is around $100, this places the estimated cost of reporting of such adverse events in 2009 at approximately $4,000. The assumption is that public health officials are currently incurring similar costs for monitoring and reporting.

The proposed requirement for the public health official to ensure that information be made available concerning the appropriate use and other safety-related information regarding the product would impose a new burden on the public health official. It is likely that this activity is already being done by public health officials as part of their standard medical practice given their responsibility for public health emergencies and given the nature of the products being stockpiled and used. Most leaflets providing information on the safe use of the product (for example, information as what is found in Part III of a Canadian product monograph) are approximately 4 to 10 pages and would cost between $300 and $1,000 to translate into French or English. These figures would effectively double if the information was in a language other than English or French and the product required labelling in both official languages. Therefore, the cost to a public health official using this path could be estimated to be around $5,000 per drug added to the stockpile. Health Canada estimates that approximately 10 drugs could be added to the stockpile per year. This would represent a cost of $50,000 to public health officials responsible for making the information available and ensuring the proper labelling of products stockpiled.

Benefits

The proposed amendments would provide a benefit to public health officials by clarifying the requirements for stockpiling drugs in anticipation of an emergency, event or incident affecting the public or military health or for requesting a drug for immediate use in an emergency. The proposed Division 11 sets out an appropriate framework to provide greater transparency and predictability for the use of unauthorized drugs for public or military health emergencies and is meant to reflect current operations. This framework would allow public health officials to ensure that necessary drugs are available for use in an emergency setting that may require a rapid response, while also providing certain requirements to appropriately address stockpiling of an unauthorized drug in Canada, such as reporting and the ability to conduct inspections or track a drug in the distribution chain should there be a safety-related issue with use of the drug.

In addition to the public health benefits, the proposed amendments (both parts) would also result in an overall net reduction in administrative burden over 10 years valued at $48,759 (2012 dollars, 7% discount rate), or an annualized benefit of $6,942. These benefits and associated costs are discussed in more detail in the “One-for-one rule” section.

Small business lens

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

Physician offices, pharmacies, and veterinary clinics are all considered to be small businesses. The only costs anticipated for small business would be for veterinary clinics, and these would be very small. Specifically, veterinarians importing certain antimicrobial products through the EDR program would have to report their sales of these drugs by using an electronic system established by Health Canada. On average, in the past, no more than one such product per year has been brought to Canada through the EDR program, with a maximum annual cost of $1,120.

This small potential cost increase would be more than offset by time savings and reduced costs provided under the SAP and the EDR program application and approval process. These benefits would be magnified by the flexibility the proposed amendments provide when an electronic system for human drugs is operationalized for the SAP. These savings are discussed in more detail below.

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 Reductions Act. The proposed amendments are expected to increase reporting costs under the EDR program for the purposes of antimicrobial resistance reporting; however, they would reduce administrative burden under the SAP overall and over time (i.e. when the electronic system mentioned above is in place).

The new reduction in annual administrative burden for the proposed amendments would be $6,942 ($7,905 + $157 − $1,120), as described below. Under the one-for-one rule, this proposal would constitute a net “OUT” in the total annualized amount of $4,323 in administrative costs (2012 dollars, 7% discount rate) footnote 10 or an average saving of $1 per affected stakeholder.

I. Sale of a new drug for emergency treatment

Part of the SAP and the EDR program proposal would be to remove the requirement to provide use, safety and efficacy data for repeat requests of drugs when certain conditions are met. No new requirements would be added. This represents a small reduction in administrative burden for applicants. The creation of an electronic system for SAP that would maximize the benefits of the proposed provision is envisioned; however, the proposed amendments do not specifically require its use. Therefore, any efficiencies the electronic system would realize would not be captured under the one-for-one rule. Using the current process may save physicians only a couple of minutes per application. Health Canada anticipates an electronic system to be in place by the end of 2019. The Department believes such a system should save on average 15 minutes of work per application that meets the criteria, but the Regulations do not require its use.

Health Canada averages 16 000 requests from 5 000 physicians each year. For the purpose of the analysis, it is assumed that these requests are received from individual physicians and not from health care institutions. Of the 500 drugs that on average were approved in any given year through the SAP, 30–40% would meet the criteria allowing for the use of the abbreviated application process. Using the average of 35%, this would represent 175 drugs. Assuming that the ratio between total requests and drugs is the same as the ratio between requests and drugs that meet the criteria set out in the proposed amendments, there would be 5 600 requests that could use the proposed new SAP process (16 000 requests × 0.35 = 5 600 requests).

On a per physician basis, this would average 1.12 requests per doctor who would meet the criteria for using an abbreviated application process.

Using the standard hourly cost for health professionals from Statistics Canada footnote 11 in 2012 dollars, as required for the purposes of the one-for-one rule, and assuming a rate of $42.35 and multiplying by 2 minutes (or 1/30 hours), the savings will be $1.41 per request ($42.35 × 1/30 = $1.41). This would represent a total annual administrative burden reduction of $7,905 ($1.41 × 5 600 requests = $7,905).

There are up to 1 000 requests per year under the EDR program from 400 veterinarians. Of the 45 drugs that on average were approved in any given year through the EDR program, approximately 5 drugs would meet the criteria, representing 11%. Assuming that the ratio between total requests and drugs is the same as the ratio between requests and drugs that meet the criteria set out in the proposed amendments, there would be up to 111 requests that could use the proposed new EDR program process. Using the wage rate for health professionals, this would represent a total annual administrative burden reduction of $156.85 ($1.41 × 111 requests = $156.85).

On a per veterinarian basis, there would be around 0.28 requests.

Additional amendments — The provision, which would allow the Minister to request from the manufacturer a copy of any reports submitted to a foreign regulatory authority, for the purposes of safety, efficacy and quality, would create a negligible administrative burden, as these are reports that manufacturers already keep in their possession and they would only need to submit a copy of the report electronically. Further, when Health Canada has requested additional safety-related data in any form from manufacturers, they have provided all information voluntarily, and this requirement only formalizes already standard industry practices.

The proposal to expand antimicrobial reporting requirements to veterinary drugs authorized under the EDR program would simply treat these drugs like other antimicrobial drugs that are subject to the sales reporting requirement under the FDR. Based on the results of a 2015 stakeholder costing survey, it was estimated that the reporting activities by the importer would take approximately 10 hours and have a total resource cost per hour of $112, in 2012 dollars. Based on one additional drug that would need to be reported through the EDR program per year, this would result in an annual increased administrative burden of $1,120.

II. Drugs for public or Canadian Armed Forces health emergencies — Drugs for immediate use or stockpiling

This portion of the proposal would not result in new incremental administrative burden, nor any reductions in administrative burden.

Regulatory cooperation and alignment

I. Sale of a new drug for emergency treatment

The proposed amendments for the sale of drugs for emergency treatment would continue to allow Canada to remain consistent with international regulatory approaches for human drugs, such as those found in the United States, the European Union, Australia, New Zealand and Ireland. In general, these jurisdictions have similar programs in place to provide for expanded access of drugs, which include reporting requirements.

The requirements would be voluntary for manufacturers, who would not be obligated to provide access to a drug requested through the SAP or the EDR program. Further, the proposed amendments would 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 a Canadian medical emergency.

The proposed amendments would allow a practitioner to submit a request for access to an unauthorized drug without submitting data on the use, safety and efficacy of the drug in certain circumstances, including if the drug is authorized for sale without terms and conditions by the European Medicines Agency (EMA) or the U.S. FDA for the same medical emergency for which the drug is requested. These foreign regulatory authorities were chosen as they represent international regulators of reference. Further, drugs requested through the SAP are primarily those that have been authorized in these two jurisdictions. The European Union and the United States have strong, internationally recognized regulatory regimes, and there is a long history of collaboration between Health Canada, the EMA and the U.S. FDA. Health Canada works regularly with these two trusted regulatory counterparts, both bilaterally and through multilateral international organizations, and there is substantial regulatory alignment between them.

II. Public or Canadian Armed Forces health emergencies — Drugs for immediate use or stockpiling

This regulatory proposal would 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 EMA 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.

The requirements in the proposed regulations would be voluntary for manufacturers, who would not be obligated to provide access to address a public health or military health emergency. Further, the proposed amendments would 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 medical 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 this proposal would not result in positive or negative environmental effects; therefore, a strategic environmental assessment is not required.

Gender-based analysis plus

Consideration of gender and other social and cultural-related factors was taken into account during the development of this proposal. By arriving at less burdensome processes for drugs accessed through the SAP, this proposal could create improved access for people with a disease or health condition for which a drug is not otherwise available in Canada but its use as a treatment would improve a patient’s quality of life. This proposal could also positively impact patients in rural communities due to the changes in the emergency provisions governing the SAP that would allow for drugs to be shipped to community pharmacies. This would facilitate access to drugs for patients in rural communities. No other gender-based analysis plus (GBA+) impacts have been identified for this proposal, as these factors do not determine whether a drug is approved for use through the SAP or to address public or military health emergencies; the SAP also is not tailored to serve any one particular socio-economic group (all Canadians may be eligible).

Implementation, compliance and enforcement, and service standards

The regulatory amendments would come into force on the day on which they are registered. Guidance on implementation of the regulatory proposals will be outlined in the following Health Canada guidance documents:

With the regulatory changes related to the emergency provisions, the timing of processing requests through the SAP and the EDR program is anticipated to remain unchanged (i.e. Health Canada works to process requests within 24 hours).

The amendments would not result in any changes to existing compliance and enforcement activities conducted by Health Canada.

Contact

Bruno Rodrigue
Director
Office of Legislative and Regulatory Modernization
Policy, Planning and International Affairs Directorate
Health Products and Food Branch
Department of Health
Holland Cross, Suite 14
11 Holland Avenue
Ottawa, Ontario
K1A 0K9
Address Locator: 3000A
Email: hc.lrm.consultations-mlr.sc@canada.ca

PROPOSED REGULATORY TEXT

Notice is given that the Governor in Council, pursuant to section 30 footnote a of the Food and Drugs Act footnote b, proposes to make the annexed Regulations Amending Certain Regulations Made Under the Food and Drugs Act (Sale of a New Drug for Emergency Treatment).

Interested persons may make representations concerning the proposed Regulations within 70 days after the date of publication of this notice. All such representations must cite the Canada Gazette, Part I, and the date of publication of this notice, and be addressed to Bruno Rodrigue, Office of Legislative and Regulatory Modernization, Health Products and Food Branch, Health Canada, Address Indicator 3000A, 11 Holland Avenue, Suite 14, Ottawa, Ontario hc.lrm.consultations-mlr.sc@canada.ca.

Ottawa, May 3, 2019

Ima Armani
Acting Assistant Clerk of the Privy Council

Food and Drug Regulations

1 The heading before section C.08.010 of the French version of the Food and Drug Regulations footnote 12 is replaced by the following:

Vente d’une drogue nouvelle pour des soins d’urgence

2 Sections C.08.010 and C.08.011 of the Regulations are replaced by the following:

C.08.010 (1) The Minister may issue to a manufacturer of a new drug a letter of authorization authorizing the sale to a practitioner of a specified quantity of the new drug, for human or veterinary use, for use in the emergency treatment of a patient under the care of that practitioner, if the following conditions are met:

(1.01) The Minister may issue the letter, even if the practitioner has not supplied the information referred to in subparagraph (1)(a)(iii), if the sale of the new drug has been authorized under subsection (1) to address the same medical emergency on at least one previous occasion, and the following conditions are met:

(1.1) The Minister must not issue a letter of authorization under subsection (1) for a new drug that is or that contains a restricted drug as defined in section J.01.001.

(2) The letter of authorization issued under subsection (1) must contain the following information:

(3) For the purposes of this section, the practitioner need not know the identity of the patient at the time the letter of authorization is issued.

C.08.011 (1) Despite section C.08.002, the manufacturer may sell to a practitioner named in a letter of authorization issued under subsection C.08.010(1) a quantity of the new drug named in that letter that does not exceed the quantity specified in the letter.

(2) The Minister may request the manufacturer who sells the new drug to a practitioner under subsection (1) to submit to the Minister a copy of any report that was submitted, for the purpose of evaluating the safety, efficacy and quality of the new drug, to a foreign regulatory authority that has authorized the sale of the drug in its jurisdiction.

(3) In the case of the sale under subsection (1) of a new drug for veterinary use that contains an active pharmaceutical ingredient set out in List A and that was not imported under section C.08.011.2, the following persons must submit to the Minister, in a form established by the Minister, an annual report identifying for the new drug, the total quantity sold and an estimate of the quantity sold for each animal species for which it is intended:

(4) The sale of a new drug made in accordance with subsection (1) is exempt from the provisions of the Act and of these Regulations, other than this section.

C.08.011.1 (1) The Minister may issue to the manufacturer of a new drug a letter of authorization authorizing the importation of a quantity of the new drug, for human or veterinary use, by the holder of an establishment licence, if the following conditions are met:

(2) The Minister must not issue a letter of authorization under subsection (1) for a new drug that is or that contains a restricted drug as defined in section J.01.001.

(3) The letter of authorization issued under subsection (1) must contain the following information:

(4) The Minister may request the manufacturer to whom a letter was issued under subsection (1) to submit to the Minister a copy of any report that was submitted, for the purpose of evaluating the safety, efficacy and quality of the new drug, to a foreign regulatory authority that has authorized the sale of the drug in its jurisdiction.

C.08.011.2 (1) Despite subsection C.01A.004(1), the holder of an establishment licence may import a new drug in accordance with a letter issued under subsection C.08.011.1(1).

(2) Section C.01A.006 and Divisions 2 to 4 do not apply to the importation of a new drug authorized under subsection C.08.011.1(1), except for the following provisions:

C.08.011.3 (1) Despite section C.08.002, the holder of an establishment licence who imports a new drug under section C.08.011.2 may distribute to a practitioner named in a letter of authorization issued under subsection C.08.010(1), a quantity of the new drug named in that letter that does not exceed the quantity specified in the letter.

(2) The holder of an establishment licence who distributes to a practitioner, in accordance with subsection (1), a new drug for veterinary use that contains an active pharmaceutical ingredient set out in List A, must submit to the Minister, in a form established by the Minister, an annual report identifying the total quantity of the new drug that was distributed and an estimate of the quantity distributed in respect of each animal species for which the drug is intended.

(3) The distribution of a new drug made in accordance with subsection (1) is exempt from the provisions of the Act and these Regulations, other than this section.

Natural Health Products Regulations

3 (1) The portion of section 103.1 of the Natural Health Products Regulations footnote 13 before paragraph (a) is replaced by the following:

103.1 Section C.08.010 and subsections C.08.011(1), (2) and (4) of the Food and Drug Regulations apply in respect of natural health products except that

(2) Section 103.1 of these Regulations is amended by striking out “and” at the end of paragraph (a), and by adding the following after paragraph (b):

Coming into Force

4 These Regulations come into force on the day on which they are registered.