10. (Mental Health and Addictions) Controlled Drugs and Substances Act – Division 44

Questions & Answers

Part 4
Division 44 – Controlled Drugs and Substances Act

Q. What is the key objective of the proposed legislative amendments?

A. As the number of supervised consumption and drug checking services has grown across Canada. It is time to move away from authorizing these services using a discretionary exemptions framework, and instead start authorizing these life-saving services through a standardized regulatory scheme.

The objective of these amendments is to replace the existing exemptions framework in the Controlled Drugs and Substances Act (CDSA) with a new regulatory scheme that would give service providers more clarity, stability and predictability, while maintaining strict controls that are consistent with the public health and public safety objectives of the CDSA.

Q. What activities does the Government of Canada conduct to address the overdose crisis?

A. The Government of Canada’s response to substance use-related harms, including the overdose crisis, is guided by our federal drug strategy – the Canadian Drugs and Substances Strategy (CDSS). Canada’s model takes a holistic approach to the overdose crisis, with actions to support both public health and public safety by focusing on several related priorities, including:

Q. Don’t we already have a framework in place to authorize supervised consumption and drug checking services?

A. Since there are currently no regulations for supervised consumption or drug checking services, supervised consumption sites (SCS) legally operate pursuant to a ministerial exemption issued under section 56.1 of the CDSA. Some shorter-term supervised consumption services (also known as urgent public health needs sites or overdose prevention sites) and most drug checking services operate pursuant to an exemption issued under subsection 56(1) of the CDSA.

The proposed legislative amendments would introduce new regulation-making authorities that would allow for the creation of a new regulatory scheme to authorize and regulate supervised consumption and drug checking services in a clear and predictable manner, while maintaining strict controls that are consistent with the public health and public safety objectives of the Controlled Drugs and Substances Act.

Q. How will the new authorization framework for supervised consumption and drug checking services compare to the current exemption framework?

A. If the proposed legislative amendments are adopted, they would provide the regulation-making authorities to allow the government to create a new regulatory scheme to authorize and regulate supervised consumption and drug checking services.

The proposed new regulations would create system with clear and predictable requirements and procedures, which would provide more stability and predictability for service providers, clients, communities and the regulator. At the same time, the new regulations would maintain strict controls that are consistent with the public health and public safety objectives of the CDSA.

Under the new regulations, it is proposed that services would be placed into classes based on:

  1. the length of time the service will be operating, with short-term services subject to fewer requirements than longer-term services, and
  2. the activities that are proposed to take place at the site (i.e. supervised consumption or drug checking services or some combination of the two).

For example, a short-term standalone drug checking only service would be categorized differently from a long-term supervised consumption service, as the length of time the drug checking service would be operating is very short, and because no consumption of illegal drugs would be taking place at the site.

Like the existing exemption framework, the proposed regulations would accommodate a wide variety of service delivery models (including all models of SCS, overdose prevention sites and drug checking that are currently in operation) and allow service providers to adapt their services to address the overdose crisis as it evolves over time. At the same time, the new regulations would maintain strict controls that are consistent with the public health and public safety objectives of the CDSA

Q. Will all existing SCS, UPHNS and drug checking services be included in the proposed authorization framework?

A. These regulation-making authorities will be used to develop a new authorization structure for supervised consumption and drug checking services. The legislative amendments include transitional provisions to ensure that all existing supervised consumption and drug checking services can continue to operate until their exemptions expire, at which time the operators would apply for an authorization under the new regulatory scheme.

Q. How will the proposed amendments affect the P/Ts?

A. Given their jurisdiction over health care service delivery and their role in funding many of these services, the provinces and territories currently play a large role in oversight of supervised consumption and drug checking services.

Authorization of these services by the federal Minister of Mental Health and Addictions and Associate Minister of Health would not impact provinces and territories’ ability to regulate matters that fall under their authority.

Health Canada will consult extensively with the provinces and territories during the development of the authorization framework.

Q. What will happen to the P/T class exemptions?

A. The existing class exemptions are currently set to expire on September 30, 2025. Health Canada will be consulting with provinces and territories on this subject over the coming months, and their views will be taken into consideration before deciding whether to extend the class exemptions.

Q. Will the proposed amendments include decriminalization or safer supply initiatives?

A. The new regulations would not authorize any activities related to prescribed alternatives, nor would they address the issue of the decriminalization of illegal drugs for personal possession.

The sale of illegal drugs for consumption at supervised consumption and drug checking services would remain strictly prohibited.

Supervised consumption services could continue to offer clients legal pharmaceutical drug therapies, such as methadone, to help treat substance use disorders, and allow them to refer clients to treatment services.

Q. Will the legislative amendments provide funding for SCS, UPHNS and/or drug checking?

A. The proposed amendments do not provide any funding for SCS, UPHNS or drug checking services.

Q. Will the proposed new authorization scheme for supervised consumption and drug checking services increase the number of SCS and UPHNS operating in Canada, and if so, by how many/year?

A. It is not possible to estimate how many more supervised consumption and drug checking services we could expect to see authorized under the new regulations. We do know that the legislative amendments made in 2017, which significantly streamlined application requirements for SCS, were critical in terms of facilitating the significant expansion of SCS across Canada (at the end of 2015, there was one SCS in Canada – now there are approximately 40). It is expected that the further streamlining of application requirements could lower barriers for smaller organizations, including in rural and remote communities, who may wish to operate a supervised consumption or drug checking service.

However, one of the main barriers to establishing or expanding existing supervised consumption and drug checking services is sustainable funding. The proposed amendments do not provide funding for these services.

Q. When will these amendments be implemented?

A. If the legislative amendments are adopted, provincial and territorial partners, service operators, people with lived and living experience, law enforcement, and other interested parties would be consulted as part of regulatory development to make sure their views are considered. Communities and individuals would also have the opportunity to provide their opinion on the proposed regulations during the public consultation period. These steps would take place before the new regulations are implemented.

The legislative amendments introducing new regulation-making authorities to the Controlled Drugs and Substances Act would come into force upon royal assent. The legislative amendments repealing existing provisions related to SCS would only come into force once the new regulations have been consulted upon and finalized. The regulations and repeals would come into force on the same date.

Transitional provisions are included as part of the legislative amendments to ensure that all existing supervised consumption and drug checking services can continue to operate until their exemptions expire, at which time the operators would apply for an authorization under the new regulatory scheme.

Q. What is the consultation and engagement plan?

A. In 2020-21, Health Canada held a consultation on proposed new regulations for supervised consumption sites and services, which concluded that legislative changes were needed prior to regulatory development.

Provincial and territorial partners, service operators, people with lived and living experience, law enforcement, and other interested parties would again be consulted as part of regulatory development to make sure their views are considered. Communities and individuals would also have the opportunity to provide their opinion on the proposed regulations during the public consultation period.

Overview

Part 4
Division 44 – Controlled Drugs and Substances Act

Canada is in the midst of an unrelenting and tragic toxic illegal drug and overdose crisis that has left no community untouched.

Supervised consumption and drug checking services are important evidence-based elements of Canada’s comprehensive public health response to substance use harms and the overdose crisis.

Over the past 20 years, Canadian and international studies have consistently shown that, when properly established, supervised consumption and drug checking services help to save lives and connect people who use drugs to social services and treatment.

Data reported to Health Canada indicates that between January 2017 to October 2023, supervised consumption sites (SCS) in Canada received over 4.4 million visits, responded to over 53,000 non-fatal overdoses and made over 424,000 referrals to health and social services.

SCS reduce public drug use, the spread of diseases, and strain on emergency services. They provide a safe space to consume drugs with clean consumption supplies, access to care and without judgement.

SCS legally operate pursuant to a ministerial exemption issued under section 56.1 of the Controlled Drugs and Substances Act (CDSA). Some shorter-term supervised consumption services, often referred to as overdose prevention sites, and standalone drug checking services operate pursuant to an exemption issued under subsection 56(1) of the Act.

As the number of supervised consumption and drug checking services has grown significantly across Canada since 2016, so has the evidence in support of their positive impacts on reducing overdose harms. It is time to move away from exemptions, and to instead start authorizing these services through a formal regulatory scheme.

The proposed amendments would allow for the creation of a regulatory scheme so that supervised consumption and drug checking services can be authorized through a structured system with requirements and procedures for obtaining an authorization laid out in regulation. This is expected to provide more stability and transparency for service providers by establishing clear and predictable regulatory requirements, while maintaining strict controls that are consistent with the public health and public safety objectives of the CDSA.

To allow this to happen, in the 2024 Budget Implementation Act the Government of Canada announced its intention to amend the CDSA to repeal section 56.1 and other provisions related to SCS and to introduce new regulation-making authorities that would allow for the creation of a new regulatory scheme to authorize supervised consumption and drug checking services.

These regulation-making authorities will be used to develop a new authorization structure for supervised consumption and drug checking services. The legislative amendments include transitional provisions to ensure that all existing supervised consumption and drug checking services can continue to operate until their exemptions expire, at which time the operators would apply for an authorization under the new regulatory scheme.

Under the new regulations, it is proposed that services would be placed into classes based on:

  1. the length of time the service will be operating, with short-term services subject to fewer requirements than longer-term services, and
  2. the activities that are proposed to take place at the site (i.e. supervised consumption or drug checking services or some combination of the two).

Within each class, it is proposed that the regulations would set out:

The new regulations would also set out requirements for losses and theft, record-keeping and reporting, disposal, security and storage, and grounds for refusal, suspension or revocation of an authorization.

The legislative amendments and proposed new regulations would not authorize any activities related to prescribed alternatives, nor would they address the issue of decriminalization of illegal drugs for personal possession.

The sale of illegal drugs for consumption at supervised consumption and drug checking services will continue to remain strictly prohibited.

Supervised consumption services could continue to offer clients legal pharmaceutical drug therapies, such as methadone, to help treat substance use disorders, and allow them to refer clients to treatment services.

Provincial, territorial and Indigenous partners, service operators, people with lived and living experience, law enforcement, and other interested parties would be consulted as part of regulatory development to make sure their views are considered.

Communities and people in Canada would also have the opportunity to provide their opinion on the proposed regulations during the public consultation period.