Regulations Amending Part J of the Food and Drug Regulations (Temporary Accelerated Scheduling): SOR/2018-85

Canada Gazette, Part II, Volume 152, Number 9

Registration

April 23, 2018

CONTROLLED DRUGS AND SUBSTANCES ACT

P.C. 2018-439 April 20, 2018

Her Excellency the Governor General in Council, on the recommendation of the Minister of Health, pursuant to paragraph 55(1)^footnotea of the Controlled Drugs and Substances Act ^footnoteb, makes the annexed Regulations Amending Part J of the Food and Drug Regulations (Temporary Accelerated Scheduling).

Regulations Amending Part J of the Food and Drug Regulations (Temporary Accelerated Scheduling)

Amendments

1 Section J.01.002 of the Food and Drug Regulations ^footnote1 is replaced by the following:

J.01.002 (1) The following persons are authorized to possess a restricted drug listed in Part I of the schedule to this Part or referred to in paragraph (b) of the definition restricted drug in section J.01.001:

• (a) a licensed dealer;
• (b) a qualified investigator, if they possess the drug for the purpose of and in connection with research in an institution;
• (c) an analyst, inspector, member of the Royal Canadian Mounted Police, constable, peace officer, member of the staff of the Department of Health or officer of a court, if they possess the drug for the purpose of and in connection with their employment; and
• (d) a person exempted under section 56 of the Act with respect to the drug.
  

(2) A person is authorized to possess a restricted drug listed in Part I of the schedule to this Part or referred to in paragraph (b) of the definition restricted drug in section J.01.001 if they are acting as the agent or mandatary of a person referred to in paragraph (1)(a), (b) or (d).

(2.1) A person is authorized to possess a restricted drug listed in Part I of the schedule to this Part or referred to in paragraph (b) of the definition restricted drug in section J.01.001 if they

• (a) are acting as the agent or mandatary of a person that they have reasonable grounds to believe is a person referred to in paragraph (1)(c); and
• (b) possess the restricted drug for the purpose of assisting a person referred to in paragraph (a) in the enforcement or administration of an Act or regulation.
  

2 The portion of section J.01.028 of the Regulations before paragraph (a) is replaced by the following:

J.01.028 Every licensed dealer who possesses a restricted drug, every qualified investigator who possesses a restricted drug for the purpose of and in connection with research in an institution, every person exempted under section 56 of the Act with respect to a restricted drug and every institution to which the sale of a restricted drug has been authorized by the Minister must

3 The Regulations are amended by adding the following after section J.01.036:

Temporary Accelerated Scheduling

J.01.037 (1) The Minister may, by order, add to column 1 to Part III of the schedule to this Part any item or portion of an item listed in Schedule V to the Act for a period referred to in column 2 that is the same as that listed in Schedule V for that item.

(2) The Minister may, by order, delete any item or portion of an item from column 1 to Part III of the schedule to this Part.

(3) An item or portion of an item listed in Part III of the schedule to this Part is deemed to be deleted on the day on which it is no longer listed in Schedule V to the Act.

4 The schedule to Part J of the Regulations is amended by adding the following after Part II:

PART III

Item	Column 1 Substance	Column 2 Period

Coming into Force

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

REGULATORY IMPACT ANALYSIS STATEMENT

(This statement is not part of the Regulations.)

Issues

The Minister of Health (the Minister) has the authority to add substances to Schedule V to the Controlled Drugs and Substances Act (CDSA) for a period of one year, with the possibility of a one-year extension. While a substance is temporarily controlled under the CDSA, activities such as importation, exportation, production, and distribution of the substance would be prohibited. However, while a substance is subject to temporary control, there may be a need to permit access to it for research. The CDSA also includes an authority allowing the Governor in Council to make regulations authorizing the Minister to add or delete Schedule V substances to the schedule to Part J of the Food and Drug Regulations (FDR). As such, corresponding regulations are needed in order for the Minister to be able to allow access to temporarily controlled substances for research.

In the absence of such regulatory amendments, there would be no mechanism in place to facilitate access to Schedule V substances for research other than exemptions under Section 56 of the CDSA, which are meant to be used in exceptional cases.

Background

New psychoactive substances

A trend in the illegal drug market involves the growing number of new psychoactive substances (NPS), commonly referred to as “designer” drugs which are sold as allegedly “legal highs” or “safe” alternatives to controlled substances. NPS are substances that have psychoactive effects in humans, either in a pure form or a preparation, which may pose a threat to public health. They can be natural or synthetic substances, often deliberately engineered to circumvent drug control legislation. The number of potential NPS appears limitless, and new substances appear quickly on the market.^footnote2

Temporary accelerated scheduling

In May 2017, Bill C-37, An Act to amend the Controlled Drugs and Substances Act and to make related amendments to other Acts, received royal assent. The Bill was comprehensive and designed to better equip both health and law enforcement officials to reduce the harms associated with drug and substance use in Canada. Among other things, the Bill included a Temporary Accelerated Scheduling scheme, a tool to quickly, and temporarily control potentially dangerous substances, such as NPS.

The CDSA now includes this scheme which grants the Minister the authority to temporarily add a substance to Schedule V of the CDSA through a Ministerial Order, if the Minister has reasonable grounds to believe that the substance

• (a) poses a significant risk to public health or safety; or
• (b) may pose a risk to public health or safety, and
  • (i) is being imported into Canada with no legitimate purpose, or
  • (ii) is being distributed in Canada with no legitimate purpose.

Under the Temporary Accelerated Scheduling scheme, a substance that meets any of the above criteria can be added to Schedule V by a Ministerial Order. Once placed under temporary control, activities such as importing, exporting, producing and distributing of the substance would be prohibited. Simple possession would not be an offence. During this time, Health Canada would determine, through scientific assessment, information gathering and consulting with stakeholders and Canadians more broadly, if the substance merits long-term control. If this is the case, the Department would complete the standard regulatory process to add the substance to the appropriate CDSA schedule before the expiration of the temporary scheduling order.

Objective

The objective of these regulatory amendments is to establish a mechanism that allows researchers access to substances that have been placed under temporary control in Schedule V of the CDSA.

Description

In order to facilitate access to temporarily controlled substances, these regulatory amendments grant the Minister the authority to add, by order, to the schedule to Part J of the FDR, temporarily controlled substances listed in Schedule V to the CDSA. The Minister is also granted the authority to remove, by order, such a substance from the schedule in Part J of the FDR.

These regulatory amendments also create a new part, Part III, in the Schedule to Part J of the FDR to specify those substances that are subject to temporary control but which are allowed for use for research purposes. The period of time a substance is temporarily regulated under Part J of the FDR will also be specified in Part III to provide additional clarity.

Technical changes were made to sections J.01.002 and J.01.028 of Part J to improve the clarity of the regulatory text.

“One-for-One” Rule

The “One-for-One” Rule does not apply to these regulatory amendments. Although modifications are made to Part J of the FDR, there are no impacts as a result of these changes to regulated parties, including businesses. As such, there is no change in administrative costs to businesses.

Small business lens

The small business lens does not apply, as there are no costs associated with the regulatory amendments.

Consultation

On August 26, 2017, Health Canada published a Notice to interested parties in the Canada Gazette, Part I, to notify stakeholders and the general public regarding Health Canada’s proposed regulatory amendments and provided stakeholders with a 30-day comment period. The consultation closed on September 25, 2017. No comments related to this proposal were received.

Rationale

These regulatory amendments provide a framework to authorize access for research to substances subject to temporary controls under the CDSA. Part J of the FDR regulates the use of controlled substances with no recognized therapeutic uses. These substances are defined as “restricted drugs” and can be used for research if authorized by the Minister.

There are no costs to any stakeholders resulting from the regulatory amendments. These amendments only establish Part III to the Schedule to Part J of the FDR and no substances are currently being added to that part. Any cost impacts to stakeholders will be considered in the future as substances are added to the Schedule.

There are no immediate benefits to stakeholders from these regulatory amendments. However, they provide the Minister with the authority to allow for activities with a substance listed in Schedule V to the CDSA under the regulatory framework set out in Part J of the FDR during the time a substance is temporarily controlled.

Implementation, enforcement and service standards

These regulatory amendments come into force on the day they are registered.

As part of the implementation of these amendments, Health Canada will notify stakeholders of the changes and provide additional information on the Department’s website.

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