Supervised consumption site: Guidance for Application Form
Section 56.1 Exemption for Medical Purposes under the Controlled Drugs and Substances Act for Activities at a Supervised Consumption Site
Healthy Environments and Consumer Safety Branch - Office of Controlled Substances - May 2017
The Controlled Drugs and Substances Act (CDSA) is the federal drug control statute. It provides for the control of substances that can alter mental processes and that may cause harm to health, safety and to society if diverted or misused. Its purpose is to protect public health and maintain public safety. It also establishes a framework that provides access to controlled substances for legitimate purposes.
Applying for an Exemption
Section 56 of the CDSA allows the Minister to issue exemptions for a medical or scientific purpose, or if otherwise in the public interest. Section 56.1 allows the Minister to issue an exemption for activities at a supervised consumption site for a medical purpose and sets out criteria to be considered.
Supervised consumption sites provide a location where people can bring their own illicit substances (substances obtained in an unauthorized manner) to consume under hygienic conditions with the supervision of trained workers thereby reducing health risks such as overdose, infections and increasing access to other health and social services including treatment.
The medical model of supervised injection services has been widely studied. This application form is intended for an exemption for a supervised consumption site for a medical purpose. If a novel form of supervised consumption site is proposed, additional information may be required and the Office of Controlled Substances should be contacted.
This guide provides detailed instructions for completing the Application Form for a Section 56.1 Exemption for Medical Purposes under the Controlled Drugs and Substances Act for Activities at a Supervised Consumption Site.
As per the CDSA, section 56.1 requires an application for an exemption to operate a supervised consumption site for medical purposes and requires that the applicant provide information regarding the intended public health benefits of the site and any available information related to:
- local conditions indicating a need for the site;
- impact on crime rates;
- administrative structure in place to support the facility;
- resources available to support its maintenance; and
- expressions of community support or opposition.
Required Information and Review Process
Health Canada conducts an initial screening of an application to determine if it contains sufficient information to begin a review. While not all information needs to be submitted before the Department can begin its review, the following sections must be completed prior to submission:
- Applicant information (Section 1 & 2 of application)
- Policies & procedures (Section 5 of application)
- Report of community consultations (Section 7 of application)
- Financial information (Section 8 of application)
- Applicant information (Section 1 of application)
- Renewal information (Section 9 of application)
If the application does not contain sufficient information, the applicant will be notified.
Once the application has sufficient information to move to the review stage, Health Canada will notify the applicant. A detailed assessment of the application will begin and, if necessary, additional information or clarification will be sought.
Once all information is received, the application is considered complete and moves to the decision stage. At this stage, Health Canada will take a decision and either:
- issue an exemption with appropriate terms and conditions; or
- issue an intent to refuse containing the reason for refusal.
If an exemption application is approved, an exemption document will be issued containing any required terms and conditions, including data collection requirements. Failure to comply with the terms and conditions could result in compliance and enforcement action by Health Canada, up to and including revocation of an exemption.
If Health Canada intends to refuse an application, the applicant will be notified of the intent to refuse with the reasons for refusal. The applicants will be provided an opportunity to submit additional information or reasons that the refusal may be unfounded. Final refusal and reasons for the refusal will be posted on Health Canada’s website.
Health Canada will always conduct an inspection before the site offers services to the public. However, the Department may issue an exemption before an inspection takes place if a supervised consumption site is not fully constructed, thereby removing any uncertainty surrounding the applicant’s investment of funds in the renovation process.
Should you have any questions at any point in the application process, please contact us at 613-954-8287 or firstname.lastname@example.org.
Guidance for the application form
The application must demonstrate that the proposed site will be established and maintained in a manner that will achieve its intended public health benefits. The information requested below provides guidance to applicants for completing the application form, including examples of the type of information that could be provided. Where information is not available, it is important for applicants to indicate this in the application.
1. Applicant Statement
This section of the application form requires the applicant to certify that the information provided in the application and the attached documents is complete and accurate.
2. Applicant Information
In this section, please provide contact information for the individual who would be responsible for the exemption and for ensuring that all the terms and conditions of the exemption continue to be met. This person will also be the main point of contact for Health Canada should additional information for the application be required. Alternate contacts for the applicant may also be identified in this section.
An individual may apply for an exemption on behalf of an organization. In that case, this section also requests a description of the organization, including a description of any services the organization may already offer. There are separate boxes to identify the individual as the applicant and the name of the organization they represent.
3. Proposed site description
In this section, please describe the proposed site location and facility, including the services that will be offered. This should also include a description of any services currently provided at this site.
This information assists Health Canada in understanding the context in which the site will be located as well as the scope of services to be provided.
4. Local Conditions
In this section, please provide information to support the chosen location of the proposed site. This information will help Health Canada understand the local conditions supporting a need for the site and the intended public health benefits of the proposed site for the community in question. Examples of information that could be submitted as part of this section of the application include, but are not limited to, the following:
- a description of the target population to be served by the site;
- estimates of the number of persons who use illicit substances and/or who may use the service;
- rates of infectious diseases that may be related to the use of illicit substances;
- number of drug-related overdoses and deaths in the local area relevant to the types of services to be provided at the site;
- other social services in the area;
- other factors that may impact public health and safety (e.g., local crime rates); and,
- the intended health and safety impact of the site on the target population and local area.
5. Policies & Procedures
In this section, please provide information related to operating procedures and security at the site. This information helps Health Canada determine whether appropriate procedures are in place to protect the health, safety and security of persons at the site, including processes to appropriately manage illicit substances present at the site. This section is also used to determine the activities to include in the final exemption (if granted).
Part A – Policies & Procedures
Provide operating procedures describing the manner in which the site will function, including measures that will be taken to minimize risks to the health, safety and security of people at the site, including staff members. At a minimum, operating procedures should describe the following:
- Responsibilities of staff members with regards to supervised consumption activities;
- Site operational procedures (e.g., how the client enters and moves through the site, conflict management protocols);
- Disposal procedures for anything left behind by clients such as illicit substances, including how to transfer them to a police officer when necessary;
- Information about site security, including:
- how access to the site will be controlled (e.g., fobs, check-in, reception, etc.);
- how the loss, theft, or trafficking of illicit substances will be prevented; and,
- the measures for securing the facility, including how and where controlled substances that may be on-site will be stored (either medications kept in stock within the site or unidentified substances left behind).
- Information on record keeping and reporting, including:
- record keeping procedures for the disposal, loss, theft, and transfer of illicit substances and used equipment left at the site; and,
- reporting procedures for any loss or theft of illicit substances at the supervised consumption site to the local police department and to Health Canada.
Part B – Physical Site Plan
Please attach a site floor-plan to this section of the application. This does not need to be an architectural rendering, however, it should provide a visual representation of the entire location in which activities involving illicit substances will be undertaken. This plan will help Health Canada better understand the operating procedures and security measures described in Part A. The floor plan should include the specific location of the following:
- the room(s) in which activities involving illicit substances will take place;
- the room(s) used for the storage of illicit substances, and any used equipment; and
- the placement of security cameras, motion detectors and any other security devices.
If a proposed site is part of a larger structure (e.g. a multi-unit commercial building, a community health centre, etc.), a description of the other services or tenants at the site, as well a diagram that illustrates the location of the proposed site within the larger structure should be provided.
Part C- Provincial or Territorial Guidance
Some provincial or territorial governments have published guidance documents intended for use by organizations seeking to establish a supervised consumption site. Typically these documents provide recommendations, such as appropriate operating and staffing procedures, that they believe best support the establishment of such facilities.
If such a document exists in your province or territory, please attach it to your application. If it does not exist, please note this in your application. Any provincial or territorial guidance will assist Health Canada in understanding how the proposed site will fit into the broader health system in your community.
In this section, please identify the proposed Responsible Person in Charge (RPIC), and each of their proposed Alternate Responsible Persons in Charge (A/RPIC). Either the RPIC or an A/RPIC must be present at the site at all times during hours where supervised consumption activities are occurring.
The RPIC or A/RPIC(s) may or may not be the same person identified in Section 2 of this application.
Responsible Person in Charge (RPIC) of the Site
The RPIC is the person designated by the applicant, who is responsible for ensuring that every person involved in activities with illicit substances complies with the terms and conditions specified in the exemption.
Alternate Responsible Person in Charge (A/RPIC)
The A/RPIC is the person designated by the applicant who is responsible, when the responsible person in charge is absent from the site, for ensuring that every person involved in activities with illicit substances complies with the terms and conditions specified in the exemption. There may be more than one A/RPIC per site.
Along with the information above, the RPIC and each A/RPIC must provide:
- a résumé including relevant education and training;
- a criminal record check issued by a Canadian police force; and,
- a document(s) issued by a police force of another country, if the person has lived outside of Canada within the preceding 10 years.
Criminal Record Checks
- The document issued by a Canadian police force should state whether in the preceding 10 years the person was convicted as an adult of a designated substance offence or a designated criminal offence.
- If any of the persons referred to above has resided in a country other than Canada in the 10 years before the day on which the application is made, the document issued by a police force of that country should state whether in that period that person was convicted as an adult of an offence committed in that country that, if committed in Canada, would have constituted a designated substance offence or a designated criminal offence.
- If the document(s) provided from the other country is in a language other than English or French, a certified translation must be provided.
- This information is only required for the RPIC and any A/RPIC. Criminal record checks are not required for other staff at the site unless determined otherwise by the RPIC.
- Criminal record checks for the RPIC and A/RPIC are standard practice when working with vulnerable populations and will support the proper functioning of the facility.
At the application stage, criminal record checks for the RPIC and A/RPICs are not required if hiring has not been completed. However, a decision on an application cannot be taken until information regarding the RPIC is provided. Criminal record checks for the RPIC and A/RPIC(s) must be submitted to Health Canada prior to the facility providing supervised consumption services to the public.
7. Consultation report and Letter
a. Community Consultation Report
In this subsection, please provide a report of the consultations held with a broad range of stakeholders (such as local government; local police; relevant regulatory authorities; potential clients; businesses; and community groups) in the community, including in the immediate vicinity of the site, which includes:
- a summary of the views of those groups on the proposed activities at the site;
- copies of all written submissions received; and,
- a description of the steps that will be taken to address any relevant concerns that were raised during consultations.
This information assists Health Canada in understanding the context of the community where the site will operate.
b. Letter from Provincial or Territorial Minister Responsible for Health or the Minister Responsible for the Delivery of Supervised Consumption Services
In this subsection, please provide a letter from the Provincial or Territorial Minister responsible for health or for the delivery of supervised consumption services in the province or territory. The letter should:
- outline the Minister’s opinion on the proposed activities at the site;
- describe whether and how those activities are integrated with the provincial or territorial health care system;
- provide information about access to drug treatment services, if any, that are available in the province or territory for persons who would use the site; and,
- confirm the provincial or territorial funding sources, if any, that will be available to support the site.
8. Financial Plan
In this section, please provide a financial plan that demonstrates the feasibility and sustainability of operating the site. This information helps Health Canada understand whether the site has the resources needed to operate safely and effectively.
Examples of information that may be submitted for this section include, but are not limited to, the following:
- financial statements or audits for the organization applying;
- documentation confirming sources of funds (public or private);
- confirmation of funding commitments; and/or,
- budget proposals.
The funding description should confirm the provincial funding sources, if any, that will be available to support the site.
9. Renewal (if applicable)
If this is a renewal application, please provide any updated information since the previous exemption was granted, including any information relating to the public health and safety impacts of the site.
Examples of information that may be submitted for this section include:
- scientific articles;
- scientific data;
- media articles; and/or,
- updated policies, procedures or guidelines.
Details of any new or additional community consultations, or views since the issuance date of the previous exemption should also be provided.
10. Submitting Application
Application can be sent to:
By e-mail: email@example.com
Office of Controlled Substances
Controlled Substances Directorate
Healthy Environments and Consumer Safety Branch
161 Goldenrod Driveway, AL0300B
Ottawa ON K1A 0K9
Health Canada considers all applications on a case-by-case basis. We are committed to processing applications without undue delay and will keep the applicant informed during the process.
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