Regulations Amending Certain Regulations Relating to Restricted Drugs (Special Access Program): SOR/2021-271

Canada Gazette, Part II, Volume 156, Number 1

Registration
SOR/2021-271 December 21, 2021

CONTROLLED DRUGS AND SUBSTANCES ACT

FOOD AND DRUGS ACT

P.C. 2021-1029 December 17, 2021

Her Excellency the Governor General in Council, on the recommendation of the Minister of Health, makes the annexed Regulations Amending Certain Regulations Relating to Restricted Drugs (Special Access Program) pursuant to

Regulations Amending Certain Regulations Relating to Restricted Drugs (Special Access Program)

Controlled Drugs and Substances Act

Food and Drug Regulations

1 (1) The definitions pharmacist and prescription in section J.01.001 of the Food and Drug Regulations footnote 1 are repealed.

(2) The definition restricted drug in section J.01.001 of the Regulations is replaced by the following:

restricted drug
means a controlled substance that is set out in the schedule to this Part. (drogue d’usage restreint)

2 (1) The portion of subsection J.01.004(1) of the Regulations before paragraph (a) is replaced by the following:

Authorized persons

J.01.004 (1) The following persons are authorized to possess a restricted drug listed in Part I of the schedule to this Part:

(2) Subsection J.01.004(2) of the Regulations is replaced by the following:

Agent or mandatary

(2) A person is authorized to possess a restricted drug listed in Part I of the schedule to this Part if they are acting as the agent or mandatary of a person referred to in paragraph (1)(a), (b), (d) or (e).

(3) The portion of subsection J.01.004(3) of the Regulations before paragraph (a) is replaced by the following:

Agent or mandatary — person referred to in paragraph (1)(c)

(3) A person is authorized to possess a restricted drug listed in Part I of the schedule to this Part if they

Narcotic Control Regulations

3 (1) The portion of the definition narcotic in subsection 2(1) of the Narcotic Control Regulations footnote 2 before paragraph (a) is replaced by the following:

narcotic means

(2) Subsection 2(2) of the Regulations is repealed.

Food and Drugs Act

Food and Drug Regulations

4 Subsection C.08.010(3) of the Food and Drug Regulations footnote 1 is repealed.

5 Subsection C.08.011.1(2) of the Regulations is repealed.

Coming into Force

6 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

Drugs that have not been approved for sale in Canada can generally be requested through Health Canada’s Special Access Program in instances where conventional therapies have failed, are unsuitable, or unavailable. As a result of regulatory amendments made to Part C of the Food and Drug Regulations in 2013, restricted drugs became the only category of controlled substances that could not be requested through the Special Access Program.

Restricted drugs are controlled substances that are listed in the Schedule to Part J of the Food and Drug Regulations. footnote 3 Restricted drugs generally do not have approved medical uses. Since the regulatory changes were made in 2013, the science pertaining to the efficacy and safety of certain restricted drugs has continued to advance, with some now demonstrating potential therapeutic uses, including in Phase II and Phase III clinical trials. footnote 4

As a result of the 2013 regulatory amendments, under the Food and Drugs Act, clinical trials became the only mechanism by which the sale of a restricted drug could be authorized for the treatment of patients. While clinical trials remain the best mechanism to authorize the sale of restricted drugs (or any other unapproved drug) for the treatment of patients, there may be situations where a patient is unable to participate in one. For example, there may not be any clinical trials currently recruiting for a specific drug or in a specific area of the country. Given the growing scientific interest in certain restricted drugs, it is expected that Health Canada will encounter a situation where scientific evidence supports the therapeutic use of a restricted drug within the context of the Special Access Program.

The amendments made in 2013 also amended the definition of restricted drug in Part J of the Food and Drug Regulations to include any unauthorized products containing cocaine (i.e. cocaine products that have not undergone Health Canada’s drug review and approval process and been assigned a drug identification number, footnote 5 products containing cocaine that have not been authorized through an approved clinical trial, or that have not been compounded by a pharmacist pursuant to a prescription). At the same time, amendments were made to the Narcotics Control Regulations so that only approved prescription drugs containing cocaine remained subject to its requirements. As a result of these amendments, cocaine became the only controlled substance to be subject to two different sets of regulations. The dual regulation of cocaine resulted in additional complexity for parties applying to conduct or conducting activities with cocaine, such as researchers and licensed dealers, as they must determine which of the two sets of regulations apply to various products containing cocaine.

Background

Regulatory Framework for Controlled Substances and Restricted Drugs in Canada

The Controlled Drugs and Substances Act is the federal statute that provides a framework for the control of substances that can alter mental processes and may produce harm to health or society when diverted to an illegal market or misused. These substances are defined as controlled substances and are listed in the Schedules I to V to the Controlled Drugs and Substances Act. Various offences and punishments for conducting prohibited activities with controlled substances are also set out in that Act.

Regulations made under the Controlled Drugs and Substances Act provide a framework within which legitimate activities, such as the possession, production, sale, importation and exportation of controlled substances, are permitted. Under the Controlled Drugs and Substances Act, there are four different categories of controlled substances: narcotics, targeted substances, controlled drugs and restricted drugs. Each drug category is regulated under a different regulation under the Controlled Drugs and Substances Act.

Restricted drugs are controlled substances regulated under Part J of the Food and Drug Regulations. They generally have no approved medical uses and can only be used for scientific or research purposes, such as clinical trials. Given that restricted drugs generally do not have approved medical uses, the regulations do not allow practitioners, pharmacists or patients to conduct any activities with restricted drugs. The regulations also do not allow a licensed dealer to sell a restricted drug to a practitioner. In order to legally conduct activities with restricted drugs that are not authorized under Part J of the Food and Drug Regulations, an exemption issued under subsection 56(1) of the Controlled Drugs and Substances Act is required.

Because of their pharmacological effects, controlled substances also meet the definition of “drug” under the Food and Drugs Act and are therefore also subject to that Act and its regulations. Under the Food and Drug Regulations, the importation and sale of any drug is prohibited unless, subsequent to Health Canada’s established drug review and approval process, a Notice of Compliance has been issued or a Drug Identification Number has been assigned. Access to drugs that have not been approved for sale in Canada can be provided through an authorized clinical trial or through Health Canada’s Special Access Program.

Special Access Program

Part C of the Food and Drug Regulations allow the Minister of Health to issue a letter of authorization to allow the sale of an unapproved drug from a manufacturer to a practitioner for the emergency treatment of a patient under certain circumstances. Through the Special Access Program, practitioners may request access to drugs that are not available in Canada for treating their patients with serious or life-threatening conditions when conventional treatments have failed, are unsuitable or unavailable.

Requests to the Special Access Program are assessed on a case-by-case basis taking into consideration the level of scientific evidence, including evidence pertaining to safety and efficacy, to support the use of the drug for the treatment of the patient’s specific condition. Requests to the Special Access Program are normally only considered when positive results of Phase II or Phase III clinical trials are already available.

When the Special Access Program authorizes the sale of a specified quantity of an unapproved drug, the requesting practitioner must provide the name and the civic address of the facility to which the drug will be shipped. The person who receives the shipment of the drug must be a practitioner or a pharmacist.

Practitioners initiating requests on behalf of their patients are responsible for ensuring that their patients are informed of the possible risks and benefits of the drug being requested and its development status.

Restricted drugs

In 2013, regulatory amendments were made to the Narcotic Control Regulations and Parts C and J of the Food and Drug Regulations to prevent restricted drugs, diacetylmorphine (i.e. heroin) and unauthorized products containing cocaine from being authorized through the Special Access Program. At the time that the 2013 regulatory amendments were made, Health Canada had never received a request from a practitioner to access a restricted drug through the Special Access Program, although prior to the 2013 amendments that would have theoretically been possible.

In September 2016, diacetylmorphine was removed from the Schedule to Part J of the Food and Drug Regulations and added to the Schedule to the Narcotic Control Regulations, thereby restoring the ability for practitioners to request access to this drug through the Special Access Program. However, the remaining 2013 amendments stayed in place.

Regulating cocaine

Prior to the 2013 regulatory amendments, all forms of cocaine were regulated under the Narcotic Control Regulations. Following the 2013 amendments, cocaine products that were assigned a drug identification number, were authorized for sale through a clinical trial or were compounded by a pharmacist pursuant to a prescription, were regulated as narcotics under the Narcotic Control Regulations whereas, all other cocaine products were regulated as restricted drugs under Part J of the Food and Drug Regulations. Effectively, cocaine became regulated under two different regulations under the Controlled Drugs and Substances Act: the Narcotic Control Regulations and Part J of the Food and Drug Regulations. Apart from cocaine, there are no other controlled substances that are subject to two different sets of regulations under the Controlled Drugs and Substances Act.

Objective

The objective of the regulatory amendments is to restore the possibility for practitioners to request access to restricted drugs through the Special Access Program. In practice, this means that practitioners will, on behalf of patients with serious or life-threatening conditions, be able to request restricted drugs through the Special Access Program in instances where other therapies have failed, are unsuitable, or are not available in Canada.

These amendments would also remove cocaine from the definition of “restricted drug,” so that all cocaine products are regulated as narcotics under the Narcotic Control Regulations. Regulating all cocaine products under the Narcotic Control Regulations will remove complexity for stakeholders applying to conduct or conducting activities with cocaine.

Description

Restoring potential access to restricted drugs through the Special Access Program

The amendments repeal the provisions in Part C of the Food and Drug Regulations that prohibit the authorization of the sale or importation of a restricted drug for the purposes of the Special Access Program. These amendments allow Health Canada the discretion to authorize the sale of restricted drugs for the purposes of emergency treatment through the Special Access Program, provided the application submitted by the practitioner meets all applicable requirements. footnote 6

Making all forms of cocaine subject to the Narcotic Control Regulations

The definition of “restricted drug” in Part J of the Food and Drug Regulations is amended by removing any mention of cocaine. To reflect this change in the definition, certain additional provisions in Part J of the Food and Drug Regulations are also amended to remove reference to cocaine. The Narcotic Control Regulations are also amended by removing the provision which excludes unapproved forms of cocaine from the Schedule to the Narcotic Control Regulations. The net effect of these changes is to remove cocaine from the definition of “restricted drug” and to thereby make all forms of cocaine subject exclusively to requirements under the Narcotic Control Regulations.

In addition, the definitions of “pharmacist” and “prescription” are repealed from Part J of the Food and Drug Regulations, as they were only included to support the addition of cocaine to the definition of “restricted drug” in 2013.

Regulatory development

Consultation

On December 12, 2020, Health Canada published a Notice of Intent in the Canada Gazette, Part I, signalling Health Canada’s intent to amend the Food and Drug Regulations and the Narcotic Control Regulations to restore potential access to restricted drugs through the Special Access Program. Publication of this notice initiated a 60-day comment period during which the Department received written feedback from 392 unique respondents. The consultation targeted health care professionals and organizations, researchers and academics, licensed dealers, as well as the general public.

The vast majority of the responses were submitted by individual members of the public, while 25 responses were submitted on behalf of organizations. Notably, one organization’s submission was supported by 922 individuals, who signed their name or provided written support to accompany the submission. Responses from organizations have been grouped into the following categories:

As part of the public comment period, Health Canada received submissions from four letter-writing campaigns. In total, submissions from letter-writing campaigns made up approximately 14% of all responses. In some cases, respondents added unique testimonies to the form letters.

Many submissions received in response to the Notice of Intent were beyond the scope of this regulatory initiative, including general feedback on the Special Access Program as well as the administration of the Special Access Program as it relates specifically to psychedelic restricted drugs. While the Department has taken these submissions into consideration, comments of this nature have not been included in the consultation summary, as they do not pertain specifically to this regulatory initiative.

Overall, nearly all comments were supportive of the proposed regulatory amendments and/or increasing access to psychedelic substances more broadly. The Department received very little opposition to the proposal, making up less than 2% of all responses.

Over 80% of all respondents associated Health Canada’s proposal with increasing access to psychedelic restricted drugs (e.g. MDMA, psilocybin, LSD, DMT), often for the treatment of various conditions, most notably mental health disorders. Some individual respondents self-identified as health care professionals (e.g. physicians, clinical counsellors, registered nurses), frontline workers (e.g. social workers), or researchers / scientists. Physicians and therapists often expressed interest in expanding their treatment options to include psychedelic restricted drugs. Other individuals (approximately 22%) described having lived or living experience with a mental health disorder or other health conditions, many of whom indicated a personal interest in seeking treatment with a psychedelic restricted drug. Several individuals also wrote about family members or friends who have struggled with mental health or psychological distress associated with a medical diagnosis, and whom they believed would benefit from therapeutic use of a psychedelic restricted drug. Many submissions described the mental health status of Canadians as being poor, and commented that the existing treatment options for many mental health disorders are limited, relatively ineffective and/or accompanied by negative side effects. In these cases, respondents felt that psychedelic restricted drugs would provide a promising therapeutic option that should be available to patients. The outcomes of this consultation suggested there is strong public interest in the use of psychedelic restricted drugs for therapeutic purposes. The regulatory proposal was commonly misinterpreted to mean that there would be guaranteed access to psychedelic restricted drugs through the Special Access Program, and/or that access would be granted to a large number of individuals. Several respondents, both individuals and organizations, supported or advocated for access to certain restricted drugs that went beyond the scope of the Special Access Program. For example, a few organizations supported the regulatory proposal as a “step in the right direction” but felt that the proposal did not go far enough. Such responses typically aligned more closely with the legalization of psychedelics for medical use.

Notably, the regulatory amendments will not create large-scale access to restricted drugs and they do not signal an intent towards the decriminalization or legalization of restricted drugs. The Special Access Program is for emergency treatment only. Furthermore, reversing the prohibition on accessing restricted drugs does not guarantee that requests for psychedelic restricted drugs, or any other restricted drug, will be authorized through the Special Access Program. All requests will continue to be assessed on a case-by-case basis, taking into consideration the level of evidence regarding the safety and efficacy for the proposed use, as well as the patient’s condition and their clinical status.

Two organizations were opposed to the proposed regulatory amendments due to the changes related to cocaine. More specifically, one organization was concerned that the regulatory changes may encourage physicians to prescribe cocaine as a first-line treatment for individuals with stimulant use disorders, thereby replacing comprehensive addiction treatment and increasing the availability of low-cost cocaine. The second organization associated the proposed changes with increased access to a safer supply of cocaine and felt that such changes would increase rates of addiction. This organization advocated instead for increased access to detoxification, treatment and recovery programs. It is important to note that the Special Access Program assesses requests for emergency treatment on a case-by-case basis. As such, the Special Access Program will not enable cocaine to become widely accessible through a physician’s prescription. No changes were made to the proposal based on these concerns.

Finally, some stakeholders expressed a desire to see these regulatory amendments made as soon as possible. Given that the regulatory amendments reverse the 2013 changes and in light of the overwhelming support for the proposal, further consultations with stakeholders would not be expected to yield any additional views. Furthermore, certain patients may benefit from these amendments being made in an expedited fashion. For these reasons, the regulatory initiative was not prepublished.

It is important to note that this regulatory change will not result in large-scale authorization for access to restricted drugs; each request to the Special Access Program will continue to be assessed on a case-by-case basis.

Modern treaty obligations and Indigenous engagement and consultation

In accordance with the Cabinet Directive on the Federal Approach to Modern Treaty Implementation, an analysis was undertaken to determine whether these amendments are likely to give rise to modern treaty obligations. The assessment found that the amendments are not expected to have any modern treaty implications.

Instrument choice

Status quo

If no amendments are made (“baseline scenario”), potential access to restricted drugs through the Special Access Program would remain prohibited. Under the Food and Drugs Act, clinical trials would remain the only mechanism by which the sale of a restricted drug could be authorized for the treatment of patients.

While clinical trials remain the best mechanism to authorize the sale of unapproved drugs for the treatment of patients, there may be situations where a patient is unable to participate in one. For example, there may not be any clinical trials currently recruiting for a specific drug or in a specific area of the country. In situations such as these, and where conventional therapies have failed, are unsuitable, or unavailable, practitioners would typically have the option of requesting access to these drugs through the Special Access Program. However, restricted drugs would remain the only category of controlled substances that cannot be authorized through the Special Access Program. Maintaining the status quo was therefore rejected as a viable option to achieving the stated objective.

Regulatory option

Subsequent to the regulatory amendments made in 2013, stakeholders have increasingly been calling for Health Canada to consider reversing these amendments, thereby restoring potential access to restricted drugs through the Special Access Program. There has been emerging scientific evidence supporting potential therapeutic uses for some restricted drugs, most notably psychedelic restricted drugs such as MDMA and psilocybin that have been granted “breakthrough therapy” designation footnote 7 by the United States Food and Drug Administration for the treatment of post-traumatic stress disorder and treatment-resistant depression, respectively.

Maintaining the 2013 regulatory changes (status quo) would limit the potential therapeutic options available for the emergency treatment of some patients. As the prohibition to access restricted drugs through the Special Access Program was put in place by way of regulations, the only viable option to restore this pathway and to address the dual regulation of cocaine is through regulatory amendments. Reversing the remaining regulatory amendments made in 2013 was the most appropriate course of action to achieve the stated objective.

Regulatory analysis

Benefits and costs

Benefits

Given the growing scientific interest in certain restricted drugs, it is expected that Health Canada would eventually encounter a situation where scientific evidence supports the therapeutic use of a restricted drug within the context of the Special Access Program. The regulatory amendments are therefore expected to benefit patients with serious or life-threatening conditions who may be granted access to restricted drugs through the Special Access Program in instances when other therapies have failed, are unsuitable, or are unavailable in Canada.

Cocaine was the only controlled substance where, depending on the form, the substance was controlled under either the Narcotic Control Regulations or Part J of the Food and Drug Regulations. The amendments create consistency in the regulation of controlled substances by subjecting all forms of cocaine to the requirements of a single regulation. Regulating all forms of cocaine under the Narcotic Control Regulations simplifies the administration of the control regime with respect to cocaine, while maintaining regulatory oversight. The amendments are not expected to increase the risk of diversion or unauthorized activities. As well, some stakeholders applying to conduct or conducting activities with cocaine will benefit from the amendments as they will no longer need to determine which regulations are applicable based on the form of the substance, as all cocaine will be regulated under the Narcotic Control Regulations.

Costs

The amendments do not alter the existing Special Access Program, other than that practitioners will now be able to request access to restricted drugs through the Special Access Program for the emergency treatment of patients with serious or life-threatening illnesses. Practitioners will need to prepare and submit the required applications and maintain records of activities involving any drugs that may be authorized. This could include, for example, documenting and reporting any patient reactions to a restricted drug once administered. These activities will result in incremental costs to practitioners. On an individual basis, on average, the time for a practitioner to complete an application to the Special Access Program is expected to be less than two hours; if an application is approved, the time to meet existing regulatory requirements (e.g. reporting an adverse drug reaction) is estimated at less than an hour. Over the next ten years, it is difficult to reliably estimate the total number of requests to the Special Access Program that might be received for restricted drugs. Based on the significant interest in potential therapeutic uses of psychedelic restricted drugs expressed through the public consultation in response to the Notice of Intent, it is expected that there will be heightened interest in the Special Access Program in the months following the coming into force of these amendments, but that the number of requests will stabilize over time. Overall, the total incremental cost to practitioners over the next ten years is not expected to be significant.

Health Canada is also expected to incur some incremental costs as a result of these amendments. To support the implementation of the amendments, Health Canada will update guidance documents and other materials, including web pages, relevant to the Special Access Program and inform stakeholders of the regulatory changes. The Department will also respond to stakeholder inquiries regarding the amendments.

In addition, Health Canada will see incremental costs related to the processing of requests submitted to the Special Access Program. These costs are associated with the time that will be spent by the Special Access Program reviewing requests associated with restricted drugs. The length of time required to process an application to the Special Access Program is also typically longer for a new drug or for a new indication. As stakeholders expressed strong support for accessing restricted drugs through the Special Access Program in response to the Notice of Intent, Health Canada expects to see a spike in the volume of requests received by the Special Access Program in the months following coming into force of these amendments. However, the incremental volume is expected to normalize and reach a steady state over time. Nevertheless, given the absence of historical data, the number of requests for restricted drugs that may potentially be received by Health Canada through the Special Access Program cannot be reliably estimated.

Small business lens

Medical clinics that are small businesses will be impacted by the amendments if practitioners affiliated with those clinics request access to restricted drugs for the emergency treatment of patients with serious or life-threatening illnesses. Costs will be incurred for preparing and submitting requests to the Special Access Program on behalf of patients and to meet existing regulatory requirements. As discussed in the Benefits and Costs section above, the related incremental cost to small businesses is not expected to be significant. Given that the cost to small businesses is minimal and that the regulatory amendments do not modify existing requirements under the Special Access Program, providing further flexibilities is not within the scope of these regulatory amendments.

One-for-one rule

The amendments do not impose any requirements that will result in new administrative burden on businesses. Therefore, the one-for-one rule does not apply.

Regulatory cooperation and alignment

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

Health Canada’s Special Access Program, which provides for the sale of unapproved drugs for emergency treatment, allows 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 to drugs that are not otherwise approved (e.g. Australia’s Special Access Scheme, U.S. Food and Drug Administration’s Expanded Access Program).

Strategic environmental assessment

In accordance with the Cabinet Directive on the Environmental Assessment of Policy, Plan and Program Proposals, a preliminary scan concluded that a strategic environmental assessment is not required.

Gender-based analysis plus

Removing the prohibition on access to restricted drugs through the Special Access Program is expected to have a positive impact on Canadians who face serious or life-threatening conditions. The gender-based analysis plus (GBA+) determined that restoring access to restricted drugs through the Special Access Program will not have any disproportionate impacts or potential for diversity-based impacts on any groups or subgroups based on ethnicity, gender/sex, age or any other socioeconomic characteristics.

Implementation, compliance and enforcement, and service standards

Implementation

The regulatory amendments will come into force on the date of publication of these amendments in the Canada Gazette, Part II. Upon publication in the Canada Gazette, Part II, Health Canada will undertake activities to support the implementation of the amended regulations, including notifying stakeholders of the amendments and updating the Special Access Program Guidance document and any other related web pages, as necessary. The Department will also respond to stakeholder inquiries regarding the amendments.

Compliance and enforcement

Apart from notifying stakeholders of the amendments, there are no new compliance and enforcement activities or costs associated with the regulatory amendments.

Pursuant to the Food and Drug Regulations, the Minister may issue a letter of authorization to a manufacturer to authorize the sale of an unapproved drug to the requesting practitioner, so long as the practitioner provides the required information and the request is approved, following assessment. This process will not change as a result of the amendments to the Food and Drug Regulations. However, the Minister will now be able to issue a letter of authorization for a drug that is, or contains, a restricted drug.

Under the Controlled Drugs and Substances Act, domestic manufacturers of controlled substances must hold a valid dealer’s licence. The importation of controlled substances manufactured outside of Canada (for example to support the treatment of a patient through the Special Access Program) requires a valid import permit issued by Health Canada. Import permits can only be issued to licensed dealers. The Canada Border Services Agency supports compliance monitoring for controlled substances at the border.

Practitioners requesting drugs through the Special Access Program are responsible for monitoring their patients and the outcomes of the use of the drug. Pursuant to the Food and Drug Regulations, practitioners must report, to the manufacturer and to Health Canada, the outcome experienced by the patient using the drug and any observed adverse drug reactions.

In accordance with the Food and Drug Regulations, advertising of unauthorized drugs, including those authorized through the Special Access Program, is prohibited. If a message regarding a health product is deemed promotional, it is subject to the advertising provisions of the Food and Drugs Act, and associated regulations.

Service standards

There are no existing service standards issued for the review of requests to the Special Access Program; however, requests are generally processed within 1–2 working days following receipt. As drugs being requested through this program are for emergency treatment purposes, Health Canada aims to respond in a timely fashion, giving priority to the most urgent requests. Requests for drugs that have not previously been authorized through the Special Access Program or for new indications generally take longer to be processed.

Contact

Jennifer Saxe
Director General
Controlled Substances Directorate
Controlled Substances and Cannabis Branch
Health Canada
Main Statistics Canada Building
150 Tunney’s Pasture Driveway
Ottawa, Ontario
K1A 0K9
Email: csd.regulatory.policy-politique.reglementaire.dsc@hc-sc.gc.ca