Chapter 2: Definitions

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Act

A law passed by a legislature (Parliament or provincial legislature). (Health Canada. Regulations, Legislation, and Standards - A Recipe for Success, 2002.) (Loi)

Action Plan

A document detailing the process (including project management steps) for issue analysis and/or guidance development. (Plan d'action)

An Action Plan template is included in Chapter 5 of this Manual.

Corporate Memory

Information holdings which meet operational needs as well as the requirements of legislation and policy. (Treasury Board Secretariat of Canada. Management of Government Information Holdings (Review Guide), 1995.) (Mémoire institutionnelle)

Corporate memory information documents the delivery of Departmental programs and services, is a record of why or how decisions and actions were taken, may involve financial and legal matters, has policy, program and procedure implications, and may be needed to account to Parliament. Corporate memory information is not to be destroyed without a National Archives of Canada disposition authority.

Cross-Directorate Issue

An issue requiring analysis that affects more than one Directorate. (Question interdirections)

Date Adopted

The date on which Directorate (pl.) management approval is given on a final issue, guidance document, or regulatory position. For cross-Directorate issues, the date of adoption will be the day the last Directorate Management Committee approved the final document. (Date d'adoption)

Directive

A document issued by BGTD, advising a target audience of a policy decision or regulatory requirement that requires immediate action to address a specific risk issue. Directives are often issued as an interim measure pending the development of regulations. A directive may include guidance for implementation. Directives will be developed in accordance with Good Guidance Practices. (Directive)

Draft Date

The date on which Directorate (pl.) management approval is given on a draft guidance document or regulatory position. For cross-Directorate issues, the draft date will be the day the last Directorate Management Committee approved the draft document. (Date de l'ébauche)

Effective Date

The date on which a guidance document comes into effect, as agreed upon by Directorate (pl.) management. For a guidance document this will normally be three to four months from the Date Adopted to allow stakeholders the opportunity to transition accordingly, but may vary depending on the issue and its expected impact. For a final document both the Date Adopted and Effective Date are required. (Date d'entrée en vigueur)

Evaluation Plan

A document detailing the outcomes expected from the implemented option on a short term and long term basis, the outcome measures that will be used to evaluate those outcomes, how the data relative to those measures will be collected, and when the evaluation of those data will be conducted. (Plan d'évaluation)

Form

A document completed by external stakeholders and filed with TPD/BGTD. (Formulaire)

Frequently Asked Questions (FAQ) Document

A document that supplements a guidance document, and is used to clarify portions of the guidance document, or as a quick reference for issues that commonly arise. It may accompany, but should not replace, a guidance document. (Foire aux questions)

Guidance Document

An official record providing information to assist external stakeholders in complying with governing statutes and regulations. Guidance documents also provide assistance to staff on how Health Canada's mandate and objectives should be implemented in a manner that is fair, consistent and effective. (Ligne directrice)

Guidance documents are administrative instruments not having force of law and, as such, allow for flexibility in approach. Alternate approaches to the principles and practices described in guidance documents may be acceptable provided they are supported by adequate justification. Alternate approaches should be discussed in advance with the relevant program area to avoid the possible finding that applicable statutory or regulatory requirements have not been met.

The term 'guidance document' includes the documents for external implementation historically called: Directives (except for BGTD), Guidance, Guidelines, Policies, and Policy Issues. It also includes documents developed by another regulatory authority or organization (in Canada or in other jurisdictions), once they have been officially adopted by TPD or BGTD. The term 'guidance document' does not include Health Professional Communications (e.g. Dear Healthcare Professional Letters, Notices to Hospitals), Health Product Consumer Updates, Public Advisories, Procedures, Directorate reports, media interviews, Memoranda of Understanding, or communications directed to individuals or firms. It also does not include government policies intended for internal use (for example, policies related to Human Resources).

A Guidance Document template is included in Chapter 5 of this Manual.

Guidance for Implementation

A section in each guidance document, describing the operational details regarding the implementation of policy objectives and policy statements. For example, a process to be followed by a sponsor, submission requirements, performance targets, etc. (Conseils sur la mise en oeuvre)

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Implementation Plan

A document detailing the process (including project management steps) for implementation of a guidance document. (Plan de mise en oeuvre)

An Implementation Plan template is included in Chapter 5 of this Manual.

Input

Information required to commence each step in the issue analysis and guidance development processes (often the output from the previous step). (Intrant)

Issue Analysis Summary (IAS)

A complete summary of the information and analysis gleaned from all steps in the issue analysis and/or guidance development process. This document may be audited to ensure compliance with the relevant procedure, and with the Federal Regulatory Process Management Standards Compliance Guide as appropriate. (Résumé analytique de la question)

An Issue Analysis Summary template is included in Chapter 5 of this Manual.

Issue Identification Paper

Produced to document the process of identifying key issues related to both the assessment of the risk and the development of risk management strategies and policies. Can also serve as an initial background document on the subject. (Document sur la détermination de la question)

An Issue Identification Paper template is included in Chapter 5 of this Manual.

Legislation

A law made through a legislative process. Sometimes the phrase primary legislation is used to refer to an Act, while secondary or subordinate legislation refers to a Regulation. (Health Canada.Regulations, Legislation, and Standards - A Recipe for Success, 2002.) (Législation)

Output

A document or information produced as a result of each step in the issue analysis and guidance development processes (this will often identify the input(s) to the next step).(Extrant)

Policy Objectives

A section in each guidance document, outlining clearly and concisely what the government is seeking to achieve, i.e. the larger aim or goal. They should be linked both to the relevant Acts and Regulations, and to Health Canada's mandate and objectives. This is not a statement of the purpose of the document. (Objéctifs stratégiques)

Policy Statements

A section in a guidance document, stating the policy (or position) that will achieve the policy objectives, and general principles to guide decisions on the issue. The policy statements will serve as the underpinning for the remaining text of the document, i.e. the guidance for implementation, which will describe how the policy statements will be applied. (Énoncés de politique)

Procedure

An informative record outlining the steps to be taken by TPD or BGTD staff to accomplish one or more specific tasks. Although intended as internal documents (vs. guidance documents, which are intended to provide information to external stakeholders as well as staff), they may be made publicly available in the interests of transparency. Also called Standard Operating Procedure (SOP).(Procédure)

Questions to Consider

Questions included in each step in the issue analysis and guidance development processes to provide the Project Lead with a minimum checklist for consideration in completing the step. The questions establish minimum standards for how each step is approached and assist with tailoring a step to a particular issue. (Questions à examiner)

Regulation

A statutory instrument (a) made in the exercise of a legislative power conferred by or under an Act of Parliament, or (b) for the contravention of which a penalty, fine or imprisonment is prescribed by or under an Act of Parliament.(Statutory Instruments Act) For the purposes of this Procedure, the expression of guidance having the force of law, normally issued under the authority of the Food and Drugs Act. This may include a revocation of an existing regulation, the amendment of an existing regulation, or a new regulation. (Règlement)

References

Reference material that may be accessed for further information for a particular step in the issue analysis and guidance development processes. (Renvois)

Stakeholder

An individual, group, or organization that is affected by or interested in an issue. (Health Canada. Health Products and Food Branch Public Involvement Framework.) (Intervenant)

Standard Operating Procedure (SOP)

Refer to definition for Procedure. (Procédure opératoire normalisée)

Template

A document with a preset format. (Modèle)

Backgrounder: Acts v. Regulations vs. Guidance Documents

(Excerpted in part from: A Reference Guide to Legislative Instruments - Biologics and Genetic Therapies Directorate, Draft 2005)

Legislative Instruments

Acts / Statutes

A Bill, which is an Act proposed to Parliament, is legislation that must be accepted by both the House of Commons and Senate. After receiving royal assent it is considered an Act or a Statute of Canada. Acts, or sections of Acts, may be repealed in their entirety only by another Act.

Federal Acts are the expression of policies established by Parliament. They create standards of general application with binding legal effect on all Canadians and are unlikely to change within the medium term. An Act, as opposed to regulations, embodies provisions that might substantially affect personal rights, describe fundamental requirements or prohibitions, or establish a public body.

Schedules

A schedule is often found at the back of an Act (or a Regulation). Schedules may provide relevant details, such as an international convention enacted in the legislation, or provide lists. The act should contain authorities to amend the schedule, usually by an order of the Governor-in-Council. This permits the schedule to be modified when necessary without having to resort to Parliamentary involvement.

Regulations

Regulations deal with matters of a legislative (as opposed to administrative) nature that are secondary to the main components of an Act. The types of information that will be found in regulations include:

• procedural matters (for example, conditions one must satisfy to obtain a licence);
• matters that are likely to need adjusting in the short to medium term;
• technical requirements or prohibitions;
• rules that would need to be written or changed after some experience in dealing with the Act's broad provisions; and
• user-(pay) fees.

Regulations are laws, made according to the authorities in an Act, that require, prohibit, permit, or provide standards of behaviour, and provides a penalty for noncompliance. Many regulations are standards written directly into law.

Standards (Incorporation by reference)

A regulation need not spell out all of the details. Instead, they can refer to other documents, such as a third-party standard (or voluntary standard), and incorporate their contents without reproducing them. While regulations and standards share many similarities, they differ in one fundamental respect: regulations apply standards through the force of law and provide penalties for non-compliance. Standards alone are not legislative tools; to have the force of law, they must be incorporated into the legislation or regulation.

Non-Legislative Instruments

Many issues can be dealt with administratively through the use of non-legislative instruments, rather than through Acts and/or Regulation.

Guidance documents

Guidance documents are non-legislative instruments used to clarify existing legislative instruments (i.e., regulations). Guidance documents cannot be used to compel a certain behaviour but rather to guide desired behaviour to supplement the regulatory requirements. Bear in mind that guidance documents under no circumstances are part of a legislative instrument. If certain behaviour is required in a certain way, that prescription goes in a legislative instrument.

Guidance documents cannot be used to extend or constrict the meaning of a legislative instrument, but they can be used to help describe the instrument to those impacted. As administrative instruments, guidance documents must be consistent with the law. When there is a conflict between a guidance document and an act, the Act takes precedence.

Guidance documents are administrative instruments not having force of law and, as such, allow for flexibility in approach. They do not legally bind stakeholders or TPD/BGTD. Alternate approaches to the principles and practices described in guidance documents may be acceptable provided they are supported by adequate justification.

Guidance documents cannot not include mandatory language such as "shall", "must", or "requirement", unless a statutory or regulatory requirement is being described. "Should" or "expected" are not mandatory language and may be used in guidance documents.

Voluntary Standards

Voluntary standards do not have the authority of law. They are usually adopted by an organization, such as a trade or professional association or a recognized standards development organization in the self-interest of that group nd members can contract into compliance with the standards. If a member contracts into compliance, it is possible for the organization to enforce the standard.

A standard which does not have the authority of law or legal sanctions (such as court-ordered fines) may still have non-criminal sanctions associated with non compliance (such as expulsion from the group or negative publicity). A standard could have authority of law if it is referenced into regulation.

Health Promotion

Health Promotion initiatives include consultation and public involvement, information dissemination, education and/or tools of personal skill development (e.g., Fact Sheets), building partnerships (e.g., expert advisory committees), re-orienting health services (e.g., new consumer information section in the product monograph) and strengthening community action (e.g., Diabetes strategy).

When it is possible to implement non-legislative tools such as guidance documents and voluntary standards to help ensure compliance from our stakeholders, health promotion is increasingly a tool which is being sought to help Canadians themselves increase control over and improve their health.