Framework for Designating Additional Classes of Practitioners Under the New Classes of Practitioners Regulations

November 2012                                             

1. Purpose

The purpose of this document is to complement the New Classes of Practitioners Regulations (NCPR) by outlining the process by which Health Canada will consider amending the NCPR in order to designate additional classes of health professionals as practitioners in the future.

2. Background

The Controlled Drugs and Substances Act (CDSA) provides for the control of substances that can alter mental processes and that may produce harm to health and to society when diverted or misused.  Except as authorized under its related regulations, activities, i.e. possession, possession for the purposes of trafficking, trafficking, importation, exportation, possession for the purposes of exportation and production of controlled substances is prohibited under the CDSA.  Through the administration of the CDSA and its regulations, Health Canada is responsible for ensuring that controlled substances are handled effectively and remain in legal distribution channels, while not interfering with legitimate medical, scientific and commercial activities.

As the federal statute for drug control, the CDSA prohibits activities with controlled substances and precursor chemicals listed in its Schedules unless authorized by regulation. Within this framework, only authorized persons as set out in regulations made under the CDSA may conduct activities with controlled substances such as prescribing, administering, providing and transporting. The conduct of these activities is usually subject to certain conditions relating to record keeping, security and reporting.

In the CDSA, the term "practitioner" is defined as "a person who is registered and entitled under the laws of a province to practice in that province the profession of medicine, dentistry or veterinary medicine and includes any other person or class of persons prescribed as a practitioner". In this definition, "prescribed" means "prescribed by regulation". By including this clause, the CDSA permits the authorization of other health professionals that may have a requirement, within their respective scopes of practice set in provincial/territorial (P/T) legislation, regulation or policy to conduct activities with controlled substances in a manner similar to those of dentists, doctors of medicine or doctors of veterinary medicine.

In this regard, while the NCPR were originally designed to extend the definition of practitioner in the CDSA to include nurse practitioners, podiatrists and midwives, they can be amended to designate additional classes of health professionals as practitioners under the CDSA where they have been authorized to conduct activities with controlled substances within their scope of practice as set out in P/T legislation, regulation or policy.

 3. Definitions

All relevant definitions in the CDSA and its regulations are applicable to this designation framework. Definitions specified below are for the purpose of this document only.

"Regulated health professional" means a person who is registered and entitled under the laws of a province to practice his or her profession in that province and who is authorized, via their scope of practice as set out under that same legislation or related regulation/policy to prescribe and administer drugs containing controlled substances.

"P/T legislation" means the legislation of a province or territory in which a health profession is regulated with respect to registration, education/training/competency, scope of practice, and compliance assurance.  Note that in some provinces, a scope of practice may be specified in a regulation or policy.

4.  Principles for Including a Health Profession as a New Class of Practitioner in the NCPR

In order for a class of health professional to be considered for inclusion in the NCPR, it must be demonstrated that the following principles have been met:

• the health profession in question must be regulated by an authority established under P/T legislation;
• a mechanism must be in place to ensure compliance of the health profession in question with P/T legislation; and
• a mechanism must be in place to ensure that practitioners meet the security, record-keeping, and loss and theft reporting provisions of the relevant regulations under the CDSA.

5. Roles and Responsibilities

Within this framework, each party involved will assume the following roles and responsibilities:

Health Canada is the federal department that administers the CDSA and its regulations.  When appropriate, Health Canada will initiate the federal regulatory process to amend the NCPR to include a new class of health professionals.

P/T ministries of health are responsible for establishing legislation or policy to regulate health professionals with respect to conducting activities with controlled substances within the context of their scope of practice.  A P/T ministry of health can propose the inclusion of a class of health professionals in the NCPR with sufficient supporting information.  P/T ministries of health are also expected to provide input on the inclusion of a particular class of health professionals in the NCPR when consulted by Health Canada.

6. Designation Procedure

6.1     Submission of a Proposal

A sponsoring P/T ministry of health, or group of collaborating ministries of health, should initiate the process by submitting a proposal to Health Canada containing the following information:

• copies of related P/T legislation; and
• supporting information demonstrating that the principles stated in Section 4 of this framework have been met.

In preparing a proposal for the inclusion of an additional class of health professionals in the NCPR, P/T ministries of health should consult other P/T ministries of health.  They may also choose to consult various organizations including:

• P/T licensing authorities (to provide input on a particular health profession with respect to registration and compliance); and 
• National and P/T health professional associations (to provide input on a particular health profession with respect to education and competencies). 

6.2 Review by Health Canada

Health Canada will review all proposals received. During this review process, Health Canada may:

6.2.1   request additional information from the sponsoring P/T ministries of health; and

6.2.2   consult and request information from relevant national health professional associations in collaboration with relevant P/T ministries of health.

6.3 Initiation of the Federal Regulatory Process

If Health Canada has no concerns with the proposal, it will initiate the federal regulatory process to amend the NCPR so as to designate the relevant class of health professional as a practitioner under the CDSA.

7. Transparency

Health Canada will engage the sponsoring P/T ministry of health and/or other P/T ministries of health as required throughout its review process.  It will also ensure that necessary communications with affected stakeholders take place in a timely manner.

8. Submissions

All proposals under this framework should be submitted to:

Director
Office of Legislative and Regulatory Affairs
Controlled Substances Directorate
Controlled Substances and Cannabis Branch
Health Canada
150 Tunney’s Pasture Driveway, AL0302A
Ottawa, Ontario
K1A 0K9
Email: hc.csd.regulatory.policy-politique.reglementaire.dsc.sc@canada.ca