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SOP#1: Issue Analysis in TPD/BGTD

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Standard Operating Procedure
TPD SOP Template WP Version 1: Effective Date 2006-04-01
Title
Issue Analysis in TPD/BGTD
Doc. Number
GGP SOP #1
Version
2.0
Bureau / Office / Area
Good Guidance Practices WG
Status
Final
Effective Date
August 2007
Approved for external consultation by
TPD Management Committee
BGTD Management Committee
Date
July 27, 2007 (TPD-MC)
August 1, 2007 (BGTD-MC)

Table of Contents

1. Purpose

The purpose of this procedure is to provide the Therapeutic Products Directorate (TPD) and the Biologics and Genetic Therapies Directorate (BGTD) with an overview of the issue analysis process. The output of the issue analysis process will be the development of an Issue Analysis Summary (IAS) articulating TPD and/or BGTD's current position on an issue, and a plan for the next phase of the project, namely implementation of the recommended option.

Guiding Principles applicable to issue analysis are outlined in Chapter 1 of the Good Guidance Practices (GGP) Manual.

2. Scope

This procedure applies to the identification, analysis and management of TPD/BGTD issues. It applies to issues that are complex or cross-cutting (i.e. affecting more than one area of expertise), those that impact the regulations, and those that are narrow in scope (e.g. specific scientific or technical issues).

Issues that will be developed through the full process should follow Section 5.1, while issues that are urgent and critical, relating to a serious health or safety risk, will be developed through the expedited process described in Section 5.2.

Health or safety issues that may trigger the issuance of a health professional communication are not included in the scope of this procedure. However, if after the issuance of a health professional communication, there are issues remaining that may, for example, lead to the development of a guidance document, this procedure may be followed.

All TPD and BGTD staff must adhere to this procedure, including employees and contractors working for the Directorate(s).

This document supercedes A Reference Guide to Policy Development in the Biologics and Genetic Therapies Directorate, dated January 2003, and Policy Development in the Therapeutic Products Programme: A Reference Guide, dated May 1998.

3. Definitions

Definitions applicable to the issue analysis process are outlined in Chapter 2 of the GGP Manual.

4. Responsibilities

Roles and responsibilities of those involved in the issue analysis process are outlined in Chapter 3 of the GGP Manual.


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5. Instructions

This procedure provides an overview of the steps involved in the issue analysis process. This document is intended to accompany, not replace, the Federal Regulatory Process Management Standards Compliance Guide, the Health Canada Decision-Making Framework for Identifying, Assessing, and Managing Health Risks, TPD's Regulations, Legislation, and Standards - A Recipe for Success, and BGTD's draft A Reference Guide to Legislative Instruments.

Included within this procedure are the steps appropriate to the analysis of complex, cross-cutting issues. The process map attached as Appendix 1 describes the steps outlined in this procedure. The process is flexible in that one may move back and forth between steps or revisit steps based on available information.

It is recognized that the circumstances of each issue will be different and therefore this procedure allows for tailoring, depending on the nature and/or complexity of the issue being considered. Judgement will need to be exercised in deciding on the appropriate level of effort for each step in the process. Appendix 2 describes one possible way the process can be tailored to address issues with narrow scope.

Although this procedure identifies key milestones where management should be involved, it is highly recommended that management be updated regularly on the progress of the issue.

Consultations play a central role in issue analysis and there are opportunities to involve staff and stakeholders in the process. Consultations should be effective, timely, open and transparent, and participants should have a clear understanding of their role and how their input will be considered. Included in this procedure are key steps at which formal consultations are recommended; however, consultation is an iterative process and there are opportunities to involve staff and stakeholders throughout the issue analysis process. It is important that all consultations, whether they are considered formal or informal, are documented within the file.

In the following pages, each step of the process is described and detailed with respect to inputs, consultation, outputs, desired outcomes, references and templates. Questions to consider are also included, to establish minimum standards for how each step is approached and assist in tailoring a step to a particular issue.

Issues will normally be analysed in accordance with the full process outlined in Section 5.1. However, urgent issues related to a critical health and safety matter will arise and Directorates must have the ability to analyse the issue and take action quickly. Issues related to an urgent health and safety matter may be developed using the expedited process outlined in Section 5.2, upon approval of the Management Committee(s) of the relevant Directorate(s) (DMC). The decision to proceed according to the expedited process should be made as early as possible in the process; however, during the course of the analysis the urgency of the issue may change and at this point, the Management Committee(s) of the relevant Directorate(s) may decide to proceed in an expedited fashion.

This procedure may be terminated at any time, as a result of new information or changes in TPD/BGTD priorities or resource availability. In order for a project to be terminated, the Project Lead must obtain DMC approval to do so; once obtained, the Project Lead must document the reasons for termination (and the discussions at DMC) for the file.

5.1 Issue Analysis Process

Step 1 Identify Potential Problem and Assign Project Lead

A problem or issue that requires analysis may arise from a variety of sources (refer to Inputs below). Issues may be identified proactively or reactively and may have varying levels of urgency and importance.

The DMC is responsible for ensuring that a Project Lead is identified. DMC should be aware if similar work is ongoing in another area of the Directorate; if so, the issue will be referred to the Project Lead of the ongoing work.

If work is not already ongoing, the choice of Project Lead may be clear in some situations; in this case the need for issue analysis will be discussed with the proposed Project Lead's Unit/Division Manager and/or the Lead Director/Senior Manager, who will approve the development of an Action Plan. Alternatively, the DMC may assign the Project Lead with regards to a problem or issue brought to its attention.

The Project Lead will manage the project and will have overall responsibility and accountability (refer to Chapter 3 of this Manual for more information on roles and responsibilities). The Project Lead will not necessarily complete all steps his/herself, but will be responsible for ensuring each task is completed. The Project Lead is also responsible for record keeping throughout the issue analysis process, in accordance with the Health Canada Records Management Policy(Reference #10).

Questions To Consider:

  • Is the issue within the authority of TPD/BGTD? Is it related to the TPD/BGTD Mandate?
  • How was this issue brought to the Directorate's attention?
  • Who is affected by this issue?
  • Is the choice of Project Lead clear?
  • Has there been previous work done on this issue? If so, what Bureau/Centre/Office was the Lead for the earlier work?

Inputs: Minutes from management or staff meetings; correspondence from or meetings with stakeholders; instructions received from senior management; submission/ application or review documents; work with international partners. Any documentation or data available relating to the identification of the issue or problem.

Consultation: Staff or management familiar with the issue.

Outputs: Issue Identification Statement.

Desired Outcomes: Issues are assigned quickly, to minimize confusion, duplication and delays.

References: Reference #5 (Section 2.1), #8, #10.


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Step 2 Scan for Ongoing or Previous Work

The Project Lead will consult with the International Programs Division (IPD), TPD or the Business Integration Office (BIO), BGTD to determine whether similar work has been undertaken, or is ongoing, internationally. This is intended as a brief check and is not intended to replace the full environmental scan that is part of Steps 7a and 7b of this procedure. If similar work is ongoing internationally, IPD/BIO may become more actively involved or may assume the Project Lead. A procedure for ICH guideline development and implementation is in progress; for more information, contact IPD. Issue analysis will likely not stop here; the objectives of the international document may not address Canadian needs, especially if the issue has not been defined (Step 3 of this procedure) in the Canadian context.

It may be possible to work collaboratively on an issue with one or more foreign or international regulatory agencies or organizations; if so, this procedure should still be followed to the extent possible (e.g. consultation will still take place within TPD/BGTD and with TPD/BGTD stakeholders). This will require active involvement from IPD/BIO.

Questions To Consider:

  • Could the issue be included in any current issue, guidance or regulatory development activity?
  • Is there anything on this issue being developed internationally? Does the international document address the issue(s) identified? How applicable is it to Canadians?
  • Is there an opportunity for TPD/BGTD to collaborate with another regulatory agency or organization (in Canada or in other jurisdictions)?

Inputs: Issue Identification statement from Step 1.

Consultation: IPD, TPD or BIO, BGTD; other domestic, foreign or international regulatory agencies or organizations as needed; other areas of the Directorate(s) or the Branch.

Outputs: Confirmation about work ongoing domestically or internationally.

Desired Outcomes: Duplication is avoided, actions are integrated across organizational bodies. Approaches taken in published documents should be harmonized or aligned with those of other jurisdictions where possible.


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Step 3 Confirm and Scope Problem

In this step, the Project Lead will define the problem ("current state"), begin to characterize it and its associated risks, and set it into an appropriate context. The Project Lead will scope the issue, determining exactly what problem needs to be solved, defining its parameters, and which areas are involved. This will lead to a definition of the issue that will carry forward through the analysis process.

An accurate definition of the issue is a prerequisite to effective analysis; a frequent cause of failure is the analysis and solving of the wrong problem. The definition of the issue will determine whether it falls within the Directorate(s)'s mandate and whether it needs to be addressed according to the expedited process described in Section 5.2, or whether there is time to move through the full process in this Section.

Within BGTD, if the issue is identified as risk related, refer to the Model Process for Managing Risk Issues in the Biologics and Genetic Therapies Directorate (reference #8) for more information.

For very large, high-level, cross-cutting issues, the Project Lead may draft an Issue Identification Paper. This will assist in identifying each aspect or sub-project associated with the issue, each of which would likely have its own Action Plan.

Under the Canadian Environmental Assessment Act, the potential environmental impact of all government projects must be assessed. If it appears that the issue could have environmental consequences, a detailed assessment will be needed. Consult with Legal Services regarding applicable environmental legislation.

The issue definition resulting from this step will feed into the Action Plan and contribute to the IAS.

Questions To Consider:

  • Is the problem real or a matter of perception? Could the problem be a symptom of a deeper issue?
  • Is the issue sufficiently limited in scope?
  • Is this an urgent health or safety matter that should be addressed using the expedited process described in Section 5.2?
  • Who is affected by this issue?
  • What is the current state, i.e. what problem needs to be addressed?
  • Is the issue related to risk?
  • Would consultation (internally/externally) assist with defining the issue?
  • Could the issue have environmental consequences? Is a detailed environmental assessment required?

Inputs: Minutes from management or staff meetings; correspondence from or meetings with stakeholders; instructions received from senior management; submission/ application or review documents; work with international partners. Any documentation or data available relating to the definition of the issue or problem.

Consultation: Staff or management familiar with the issue. External stakeholders may be consulted to help define the issue.

Outputs: A definition of the issue including "current state". For larger, cross-cutting issues, possibly an Issue Identification Paper.

Desired Outcomes: Issues are clearly defined and limited in scope.

References: Reference #1, #4, #5 (Section 2.1), #7, #8, #9, #11, #12, #13 (Part 1), #16 (Part II).


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Step 4 Prepare Action Plan

The Project Lead is responsible for the development of the Action Plan. The Action Plan initiated in this step is used to describe how the issue analysis process will be applied, managed and tracked. It also outlines all the sub-projects that may feed into the process. Sub-projects can include, but are not limited to: Compliance and Enforcement, Legal Authority and Tools, Cost-Benefit Analysis, Communications/Consultations and/or Public Involvement Plans, and Evaluation. These sub-projects may also help to divide the work between various areas of expertise; for a large project, an Action Plan may be drafted for each sub-project and presented to DMC with the Action Plan for the over-arching project.

In developing a Communications/Consultations Plan, attention should be paid to choosing the right mechanism for informal and formal consultation, timing, selecting the right participants, and budgeting accurately. For assistance with Communications/Consultations and/or Public Involvement Plans, consult the Promotion and Consultation Unit (BGTD) or the Public Involvement Network representatives (TPD). Documents to assist with public involvement are available on the HPFB Intranet.

The Action Plan is used to describe and obtain agreement up-front on the resources (internal and external) required to investigate the issue further. The Action Plan will also provide the Project Lead with the rationale to request participation from other Bureaux/Centres/Offices, Directorates, Branches and/or Departments, depending on the scope of the issue and the expertise required.

The Action Plan will clearly outline the roles and responsibilities of those involved in the project. For example, if the Project Lead is a content expert but may require assistance with process, a policy resource should be identified, or, if the Project Lead is a process expert the Action Plan should identify needed content expertise. The expertise may be provided as part of a working group formed, or be available for assistance as needed.

The Action Plan will include the definition of the issue from Step 3 of this procedure. It may be necessary to revise the Issue Definition (and the Issue Identification Paper if drafted) and the Action Plan as the exercise proceeds and the issue(s) becomes clearer; however, the Project Lead is responsible for ensuring 'project creep' does not occur.

The Project Lead should revisit the Action Plan regularly throughout issue analysis, to ensure no steps have been missed and verify whether the project is proceeding according to the timeframes predicted. Significant changes may require review and approval by DMC.

Note that for issues with narrow scope, it may not be necessary to draft an Action Plan for issue analysis and present it to DMC for approval. Instead, the Project Lead (with the approval of the Lead Director/Senior Manager) may choose to proceed directly to Step 6 (Optional) or Step 7. Refer to Appendix 2 for one possible way the process can be tailored to address an issue with narrow scope.

Questions To Consider:

  • Why should the analysis of this issue be considered a priority? What triggered the issue and what are the consequences if it is not addressed?
  • What needs to be done to address the issue?
  • Who needs to be involved internally and what are their roles in the process?
  • Is a working group needed? What areas of expertise should be represented on the working group and what will each member contribute?
  • What time commitment will be required from working group members?
  • What sub-projects should feed into the plan for issue analysis?
  • Will external contractors be hired?
  • What are the resources needed (money, FTE, internal/external)?
  • At what points will DMC be informed/updated? At what points will DMC approval be sought?
  • Who are the stakeholders? Who will be consulted and at what stages? Has a Communications/Consultations Plan been prepared?
  • Is a Public Involvement Plan needed?
  • Has the Promotion and Consultation Unit (BGTD) or the Public Involvement Network representatives (TPD) been notified of proposed consultation activities, and/or involved in the development of a Public Involvement Plan?

Inputs: Definition of the Issue from Step 3.

Consultation: Staff or management familiar with the issue, Legal Services, staff from the Bureau of Policy, Science and International Programs, TPD or the Policy and Promotion Division, BGTD to provide advice on process. For advice on Communications/Consultations and/or Public Involvement Plans, consult the Promotion and Consultation Unit (BGTD) or the Public Involvement Network representatives (TPD).

Outputs: Action Plan.

Desired Outcomes: Management has the information needed to make a decision on the path forward.

References: Reference #1, #5 (Section 2.1), #7, #8, #9, #12. HPFB Intranet (Public Involvement tools).

Templates (Chapter 5 of GGP Manual): Action Plan, Communications/Consultations Plan, Public Involvement Plan.

Step 5 Obtain Lead Director/Senior Manager and DMC Approval of Action Plan

The Lead Director/Senior Manager will review the Action Plan and may suggest revisions. Once he/she has approved the Action Plan, it will proceed to DMC for approval. BGTD employees should refer to the Lotus Notes BGTD DMC workbook for DMC templates.

The approval of Action Plans will be a standing item on the agendas of the Management Committees of both TPD and BGTD, and approval is intended to be as efficient a process as possible. DMCs should ensure that this remains a standing item (i.e. is not "bumped" from the agenda) so that issue analysis is not delayed.

The Action Plan must be sent to the DMC(s) one week prior to the Management Committee meeting, along with any other documents (e.g. Agenda Item Summary, presentation slide deck). The Project Lead and the Director will present an overview of the issue and the Action Plan to DMC. DMC will decide whether to approve the Action Plan; in doing so, DMC is making a decision on the priority of the issue and the allocation of resources for its analysis.

The DMC decision will be reflected in the minutes of the meeting. If approval is granted, it is the responsibility of DMC members to communicate to their Bureau/Centre/Office that work on this issue is ongoing.

If this is a cross-Directorate issue, a similar presentation should be made to the Management Committee of each affected Directorate. In each case, the DMC will decide whether and how their Directorate will participate in the process.

Questions To Consider:

  • Does everyone have a common understanding of the issue?
  • Has the Action Plan template been used?
  • Is the Action Plan as complete as possible for what is known about the issue at this stage of the process?
  • Have all of the questions of Step 4 been considered?
  • What are the impacts of this issue analysis on the Directorate?
  • What are the implications if DMC decides not to approve the Action Plan?
  • If this is a cross-Directorate issue, what will happen if the DMCs make different decisions re: approval of the Action Plan?

Inputs: Action Plan from Step 4.

Outputs: Approved Action Plan; OR Decision to stop issue analysis at this point.

Desired Outcomes: Management decision on issue analysis is expedited.

Templates: BGTD employees should refer to the Lotus Notes BGTD DMC workbook.


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Step 6 (Optional) Form Working Group

The Project Lead may choose to form a working group to assist with the development of the IAS. A working group will often be formed when an issue touches on several areas within a Directorate, or several Directorates; it will provide a mechanism to obtain input from various areas within the affected Directorate(s) and will facilitate internal communication. The Project Lead will normally chair the working group and will be responsible for its effective management. The intention to form a working group will have been identified in the Action Plan drafted in Step 4 and approved by DMC in Step 5 of this procedure.

For cross-Directorate issues, the level of participation decided by the affected DMC(s) in Step 5 of this procedure will determine whether a request for working group representatives should be sent to that Directorate.

If it is anticipated that significant issues will arise during the course of the working group activity, it may be useful to request a representative from Health Canada Legal Services. This representative will normally be a full working group member and provide Legal Services input as needed throughout the issue analysis process.

The working group Chair will draft the Terms of Reference for the working group; among the group's first tasks should be a review and endorsement of the Terms of Reference and Action Plan. The Terms of Reference will outline the roles and responsibilities of the working group members, including various tasks that may be delegated to members by the Chair. Roles and responsibilities must also be defined with regards to the role of working group members as liaisons with their respective areas (Bureau/Office/Centre, Directorate, Branch, etc.). For example, working group members are normally responsible for updating the management within their Bureau/Office/Centre (or Directorate), obtaining management approvals from their area as needed, and bringing any management concerns back to the working group table.

Questions To Consider:

  • What will be the mandate of the working group?
  • What kind(s) of expertise is/are needed? What level of representation is needed on the working group? What time commitment will be required from working group members?
  • Should a representative from Health Canada Legal Services be requested?
  • How will the working group be managed? How will key decisions be made (e.g. consensus, majority, etc.)?
  • What are the responsibilities of working group members?

Inputs: Action Plan from Step 4.

Outputs: Terms of Reference of working group and Action Plan.

Desired Outcomes: Issue analysis is inclusive and internal communication is facilitated. The issue analysis process is open and transparent.

Templates (Chapter 5 of GGP Manual):Terms of Reference, Agenda, Meeting Notes


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Step 7 Draft IAS

In the remaining sections of this procedure, the term Project Lead refers to the Project Lead with the input of the working group if one is formed.

The IAS includes a complete summary of the information and analysis gleaned from the issue analysis process. It includes sections for issue identification and analysis, options analysis, recommendations, and results of internal and external consultations. Note that the depth and breadth of analysis will vary depending on the nature and/or complexity of the issue, and that an IAS for an issue with narrow scope will likely be less detailed than one for a complex, cross-cutting issue. Sample IASs for various issues are included in Chapter 5 of this Manual.

Consultations play a central role in collecting data, identifying the cause(s) of the issue, identifying and analysing options, and selecting a recommended option. The degree of internal and external consultations to be undertaken on the issue will have been outlined in the Action Plan drafted in Step 4 and approved by DMC in Step 5 of this procedure. A Communications/Consultations Plan and/or Public Involvement Plan may have been drafted at Step 4 and may be revisited throughout this step as the issue develops.

The Project Lead should consult with areas directly affected by the issue, and with areas potentially impacted by the various options identified, throughout this step.

The consultation effort should be proportional to the magnitude and/or complexity of the issue and should generally occur as soon as possible into the analysis of the problem. Formal consultations held only after key decisions are made are not likely to be effective in achieving commitment and 'buy-in' from staff or stakeholders. Although formal consultations are often very valuable to properly analyse the issue, informal consultations are also important and there are opportunities to involve staff and stakeholders in all stages of the issue analysis process. All consultations, whether they are considered informal or formal, must be documented within the file. For assistance with Communications/Consultations and/or Public Involvement Plans, consult the Promotion and Consultation Unit (BGTD) or the Public Involvement Network representatives (TPD). Documents to assist with public involvement are available on the HPFB Intranet.

At any time during the development of the IAS, the Project Lead may consult with Directorate-, Branch- or Department-level committees, to seek their opinion on scientific issues encountered in the issue analysis process. External parties (including Scientific Advisory Committees) may also be consulted. The Project Lead may also seek input on associated socio-economic or ethical issues when they seem pertinent to the selection of options or if they are an important component of the underlying cause. It may be advisable for the Project Lead to discuss this matter with the working group and Lead Director/Senior Manager first. Further, the Project Lead should communicate with the Lead Director/Senior Manager if it becomes clear during the research that the question is not fully clear or that an alternative framing of the issue becomes apparent.

Throughout Step 7, the Project Lead should consider the need for an evaluation to determine whether the objectives set at the early stages of issue analysis have been met. To prepare for the evaluation, criteria should be identified throughout the process and formalized into an Evaluation Plan, to be carried out following implementation of the recommended option.

Step 7a Analyse Issue

The Project Lead will analyse the key cause(s) of the issue and assess risks and benefits. Tasks associated with this step include:

  • identifying potential causes;
  • collecting, displaying and interpreting data in order to identify key causes;
  • understanding social, cultural, political, economic, international, ethical and legal implications of the issue, as well as the public view of associated risk and values; and
  • drafting components of the IAS and revising both the Issue Definition and the Action Plan as needed.

Input from external sources, including scientific or non-scientific experts, may be useful in some circumstances. The Project Lead should identify these cases, conduct consultations accordingly and consider this information in the issue analysis.

The analysis of the issue will be included within the IAS. Depending on the information and data collected, it may be necessary to revisit the Issue Definition in Step 3. The Project Lead should revisit the Action Plan to ensure no steps have been missed and verify whether the project is proceeding according to the timeframes predicted. Note that significant changes may require review and approval by DMC.

Questions To Consider:

  • What are the magnitude and probability of the issue?
  • Are there any quantitative facts to define, or assist with analysing, the issue?
  • What data are available and what are not? Are the data of sufficient quality to contribute to the risk/benefit assessment? Have the data been effectively documented and displayed?
  • What are the key causes of the issue and are they supported by data analysis?
  • Does data analysis verify the issue definition? Has the definition been revised/refined?
  • What is the 'desired state' of the issue?
  • What risk does the issue pose to public safety? What are the potential benefits to addressing the issue? Are risks and benefits distributed equally throughout the population, or is there 'differential harm'?
  • Does the public (broadly defined) need to be consulted in analysing the issue?
  • Are there social, cultural, political, economic, international, ethical or legal implications of the issue?
  • Are there health, safety and/or environmental risks involved, that require a scientific risk assessment?
  • Has information been collected on all aspects of the situation (e.g. context, risks, benefits, magnitude, dimension)?
  • What are the domestic Legislation, Regulations and/or domestic guidances that may be relevant to the issue? Are there relevant documents from other jurisdictions?
  • Has the Promotion and Consultation Unit (BGTD) or the Public Involvement Network representatives (TPD) been notified of proposed consultation activities and/or involved in the development of a Public Involvement Plan?
  • Has the IAS template been used?

Scientific Risk Assessment:

  • Have possible exposures to hazards and possible benefits to health been developed using risk scenarios (e.g. using epidemiological studies or laboratory toxicological investigations)?
  • Have the risk and benefit scenarios been described in terms of their timing and the breadth of their impacts?
  • Has the population(s) at risk been identified?
  • Have the chance of occurrence and the consequences of each risk scenario been estimated?
  • Has the analyst avoided imposing his/her own risk preferences on the analysis?
  • Have the assumptions been documented?
  • Have the findings of the analysis been summarized?

Inputs: Action Plan from Step 4; any documentation or data available relating to the identification, definition and analysis of the issue.

Consultation: Staff or management familiar with the issue. External stakeholders may be consulted to help analyse the issue. In BGTD, the Promotion and Consultation Unit, Policy and Promotion Division (PPD), will develop a Public Involvement Plan in collaboration with the Project Lead for approval by the PPD Manager and allocation of resource requirements.

Outputs: IAS: Background and Issue Analysis (Section 3) completed. Communications/Consultations and/or Public Involvement Plans as needed.

Desired Outcomes: The issue analysis process is open and transparent. All aspects of the issue have been analysed and are thoroughly understood.

References: Reference #1, #4, #5 (Section 2.2), #6, #7, #9, #11, #12, #13 (Part 1, Part 2), #16 (Part II), #17. HPFB Intranet (Public Involvement tools).

Templates (Chapter 5 of GGP Manual): Issue Analysis Summary, Communications/Consultations Plan, Public Involvement Plan.


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Step 7b Identify and Analyse Options

The analysis will result in the development of various options for addressing the issue. (See Step 13 for examples of options.) Regulatory options rely on the government's authority to enforce compliance with legislation, and may include direct regulations, self-regulation and the issuing of permits or approvals. Non-regulatory options include the use of advisory, economic and technological measures, and can include taking no action when none is required.

A combination of regulatory and non-regulatory options should also be considered, e.g. a regulatory change plus an accompanying guidance document.

The Health Canada Decision-Making Framework (Reference #5) identifies some of these options and also outlines key considerations in the analysis of the proposed options. For further information, refer to section 2.3 of the Framework.

In generating potential options, the Project Lead should examine the regulatory practices and guidelines of other regulatory authorities or organizations (in Canada or in other jurisdictions) with a view to moving to greater compatibility. As described in the Guiding Principles (Chapter 1 of this Manual), TPD/BGTD's approach to issue analysis should be harmonized or aligned with that of other jurisdictions where possible. The Project Lead may wish to consider the possibility of adopting the approach of another jurisdiction, in whole or in part. The Project Lead should document in the IAS the analysis and rationale behind the recommendation to either follow an approach of another organization or pursue a TPD/BGTD-specific approach.

The Project Lead will analyse each option to determine its expected probability and efficiency in achieving the "desired state", its limitations and key considerations such as feasibility and resource implications. If one or more regulatory options are being considered, the Project Lead must refer to the Federal Regulatory Process Management Standards Compliance Guide (Reference #16) to ensure that the proper analysis is undertaken.

It may be useful for the Project Lead to perform a triage of the options to identify the most viable ones. Options may be ranked by overall net benefit, cost (assuming a certain degree of issue resolution is achieved), speed of issue resolution, risk, etc., based on the analysis of the options. The Project Lead should also consider the principles of Smart Regulation and the precautionary principle in the analysis.

Options analysis should be based on sound science. The safety of Canadians must be taken into account in the analysis, even if it results in the consideration of options that are not the most cost-effective.

The Project Lead will contact Legal Services to discuss whether an in-depth Legal Opinion is needed. Prior to this, there must be a clear understanding of what the issue is, why it is being analysed and proposed options for addressing it. It is crucial to ask the 'right' question: one that explains the options considered and outcomes sought, as well as the need to know how to achieve these outcomes within the constraints of the applicable legislative framework. If a representative from Legal Services is on the working group formed in Step 6 of this procedure, it would be his/her role to provide this information.

Cost-benefit analysis is a useful technique for ranking the identified options. It is required by Treasury Board if a regulatory option is proposed and it is also a useful tool for issue analysis. However, it can be time-consuming and so it may be advisable to first perform an initial triage of the options to identify the most viable ones. For more information, refer to the Federal Regulatory Process Management Standards Compliance Guide (Reference #16).

The cost-benefit analysis may be done at either a qualitative or quantitative level, depending on the significance of the issue and the time and resources available for the analysis. The ability to perform a quantitative analysis may be constrained by the lack of accurate, high quality data. Even where an in-depth quantitative analysis is appropriate, it can be more efficient to perform the analysis at a general level of detail initially - it may be found that only a general analysis is necessary to locate the most cost-beneficial option. The distribution of costs and benefits should also be considered.

Another tool is cost-effectiveness analysis, which is similar to, but simpler than, cost-benefit analysis and may be a more appropriate tool for certain issues. It involves the time-discounted estimation of the costs of various alternatives for achieving a goal, such as a given amount of health risk reduction. It does not involve an attempt to measure the benefits of the goal itself.

Questions To Consider:

  • What are the goals of TPD/BGTD regarding the issue?
  • Have all viable options been identified?
  • Are the options identified grounded in and consistent with the applicable Legislation, Regulations and/or guidance documents?
  • Are the options identified within the TPD/BGTD mandate and authorities?
  • Would external consultation assist with identifying and analysing options to address the issue?
  • Has the status quo been included as an option and analysed?
  • What data are available to contribute to the analysis of options and what are not? Are the data of sufficient quality to contribute to the risk/benefit assessment?
  • What are the constraints to action, e.g. of a technological, social, political, environmental, legislative/ regulatory, policy, ethical or fiscal nature?
  • Is each of the identified options feasible, i.e. there are no unreasonable health, economic, social, ethical, political or legal implications?
  • What is the statutory authority for a proposed regulation?
  • Have non-regulatory options been generated (e.g. information provision, self-regulation, guidance development) in the event that regulation is not a plausible option?
  • What are the risks associated with the various options (risk of non-effectiveness, risk of unintended effects, political, reputation or business risks)?
  • Has Legal Services been consulted?
  • Have the assumptions made during the analysis been documented in the IAS?
  • Has the IAS template been used?

International Considerations:

  • What lessons can be learned from the experience of other regulatory authorities or organizations (in Canada or in other jurisdictions)?
  • Has the possibility of adopting an approach (e.g. a guidance), in whole or in part, from another regulatory authority or organization (in Canada or in other jurisdictions), been considered? If so, is the approach consistent with applicable legislation, regulations, and Health Canada objectives and mandate? Does the approach contradict existing guidance documents?
  • Have options been analysed with a view to moving to greater compatibility with approaches or practices of other regulatory authorities or organizations (in Canada or in other jurisdictions), while meeting Canadian goals?
  • Have options been analysed in a way that considers Canada's competitive position with respect to other countries?

Cost-Benefit Analysis:

  • What are the constraints caused by the costs involved for outside stakeholders or for TPD/BGTD?
  • Have the benefits of each alternative been estimated in quantitative terms (unless a cost-effectiveness analysis is being performed)?
  • Have the costs of each alternative been estimated in quantitative terms?
  • Have the costs and benefits been used to compute the net present value (NPV) of each alternative using the approved rate (10%)?

Burden on Stakeholders:

  • Has the burden on regulatees, including that imposed by information and administrative requirements, been considered in the analysis?
  • Has the cost-benefit analysis assessed the potential effects on business (the Business Impact Test must be undertaken for major regulatory proposals), workers, the environment, consumers and other sectors of society?

Evaluation:

  • Have the objectives of each option been stated clearly enough so that a post-implementation evaluation will be able to determine the degree of success achieved?
  • Has the feasibility of a post-implementation evaluation of the effectiveness of each option been considered?

Inputs: IAS from Step 7a. Information on practices used by other regulatory authorities or organizations (in Canada or in other jurisdictions).

Consultation: Staff or management familiar with the issue, including Legal Services. External stakeholders and other regulatory authorities or organizations (in Canada or in other jurisdictions) may be consulted to help generate and analyse options.

Outputs: IAS: Options Analysis (Section 4) completed.

Desired Outcomes: The drafting of recommendations is facilitated by full consideration of the options available.

References: Reference #1, #2, #3, #4, #5 (Section 2.3), #6, #7, #9, #11, #12, #13 (Part 1, Part 3, Part 4), #14, #15, #16 (Part II).

Templates (Chapter 5 of GGP Manual): Issue Analysis Summary


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Step 7c Select Recommended Option

Based on the analysis above, the Project Lead will choose one option to recommend to senior management. All information required for the IAS, including information from all sub-projects, will have been collected and factored into the analysis and recommendation.

Based on the recommended option, the Project Lead will develop a proposed Action Plan for the next phase of the project, namely the implementation of the recommended option (e.g. Action Plan for guidance development). This will give management an idea of the resources required to implement the recommended option and timeframes associated with implementation, but will likely not accompany the IAS through consultations.

Consideration should also be given to developing an Evaluation Plan, to determine how and when the selected option will be evaluated to ascertain whether the objectives set in the early stages of issue analysis have been met.

Once completed, the Project Lead will forward the IAS and Action Plan for the next phase of the project to the Lead Director/Senior Manager for review.

The Project Lead should revisit the Action Plan to ensure no steps have been missed and verify whether the project is proceeding according to the timeframes predicted. Note that significant changes may require review and approval by DMC.

Questions To Consider:

  • Is the selected option grounded in (and consistent with) applicable Legislation and Regulations?
  • Has the least burdensome but effective alternative for business been recommended?
  • Will the recommended option achieve the greatest net benefit?
  • What is being compromised by choosing the recommended option? Does this impact the safety of Canadians and is this an acceptable risk?
  • How will compliance of the recommended option be secured?
  • What is the cost of compliance and government administration for the recommended option?
  • What will be needed to implement the recommended option?
  • Why should the implementation of the recommended option be considered a priority? What are the consequences if the recommended option is not implemented?
  • What are appropriate time frames for implementation?
  • Will a working group be needed to assist with implementation? What areas of expertise should be represented and what will each member contribute? What time commitment will be required from working group members?
  • What are the resources needed for implementation (money, FTE, internal/external)?
  • At what points will DMC be informed/updated? At what points will DMC approval be sought?
  • Have the IAS and Action Plan templates been used?

Inputs: IAS from Steps 7a and 7b.

Consultation: Staff or management familiar with the issue, external stakeholders.

Outputs: IAS and Action Plan for implementation of recommended option.

Desired Outcomes: Recommendations for the path forward are clearly outlined.

References: Reference #1, #4, #5 (Sections 2.4, 2.5), #6, #7, #9, #11, #12, #13 (Parts 3, 4), #14, #15.

Templates (Chapter 5 of GGP Manual): Issue Analysis Summary, Action Plan

Step 8 Review and Approve IAS for Internal Consultation

Management approvals will be based on the IAS, which will include the recommended option, and the proposed Action Plan for the next phase of the project.

The Lead Director/Senior Manager will review the IAS and decide whether to approve the implementation of the recommended option based on the evidence provided. Note that Lead Director/Senior Manager approval is sign-off of both process and content. The Director may request that the Project Lead revise the IAS; significant revisions to the recommended option may require detailed analysis and documentation within the IAS itself.

In some situations it may be necessary to obtain DMC approval prior to consulting internally, particularly for issues with significant impact. This will have been included in the discussion and decision by DMC at Step 5. If DMC approval is required, the Project Lead should follow the process outlined in Step 5 of this procedure.

Note that for issues with narrow scope, the Lead Director/Senior Manager may determine that extensive and formal consultations (internal or external) on the IAS and Action Plan are not necessary. In this case, the Project Lead may proceed directly to the final portion of Step 11 of this procedure. Refer to Appendix 2 for one possible way the process can be tailored to address issues with narrow scope.

Questions To Consider:

  • Have the main stages and decision points of the process been documented?
  • Are the criteria used to rank the options documented?
  • If the Director has recommended significant changes to the analysis or the recommended option, have the changes and the rationale been documented in the IAS?
  • Have the IAS and Action Plan templates been used?

Inputs: IAS and Action Plan for the next phase of the project.

Outputs: Approved IAS and Action Plan.

Desired Outcomes: Decisions on issue analysis are expedited and well informed.

Step 9 Consult Internally and Revise Documents

The Project Lead will distribute the IAS internally for comment via e-mail to affected staff and DMC members (of each affected Directorate). DMC members are responsible for forwarding the document to those people or unit(s) within their area who should provide input. The e-mail will include contact information for the Project Lead, to whom comments and questions should be addressed, as well as a deadline for providing comments. The standard internal comment period is 30 days, however a longer comment period may be needed where the impact of the issue and/or the recommended option is expected to be high.

The Project Lead may consider conducting discussion sessions or presentations to staff to more actively solicit feedback on the document.

The Project Lead will review all comments received, analysing each to determine whether a change will be made to the IAS. Comments that are not relevant to this issue will be referred to the relevant area for possible action.

A key guiding principle, outlined in Chapter 1 of this Manual, is that all comments received during the consultative process should be addressed in a document available to those who were consulted. Therefore, the Project Lead will complete section 5.1 of the IAS, Internal Consultations, summarizing the comments received and the rationale for acceptance or non-acceptance.

The summary of consultations should be provided, along with the IAS to those who provided comments on the draft (at a minimum).

Note that if extensive comments are received, necessitating significant revisions to the documents, an additional round of internal consultations may be required.

The Project Lead will make changes to the IAS as appropriate and will forward the IAS to the Publications Unit (TPD) or the Website Coordinator (BGTD). The Publications Unit/Website Coordinator will perform a quality check of the IAS (including formatting, consistency, compliance with Treasury Board and Health Canada policies related to publications, etc.) and prepare the document for posting. The Publications Unit/Website Coordinator will return the IAS to the Project Lead for approval; once approved, the Project Lead will forward the IAS to the Lead Director/Senior Manager.

The Project Lead should revisit the Action Plan to ensure no steps have been missed and verify whether the project is proceeding according to the timeframes predicted. Note that significant changes may require review and approval by DMC.

Questions To Consider:

  • Have all affected staff had the opportunity to comment?
  • Have all comments been addressed in the IAS?
  • Has the IAS been revised appropriately as a result of comments received?
  • Have any comments that do not relate directly to this issue been forwarded to the relevant area for possible action?
  • Is the level of consultation proportional with the expected degree of impact of the issue?

Inputs: Comments received from internal consultation.

Consultation: Documents will normally be sent to affected staff and DMC members of each affected Directorate for comment.

Outputs: Revised IAS, including section 5.1 - Internal Consultations.

Desired Outcomes: Issue analysis is improved by input from affected areas. Comments received during the consultative process are addressed in a document available to those who were consulted.

Templates (Chapter 5 of GGP Manual): Issue Analysis Summary, Summary of consultation comments received


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Step 10 Review and Approve Revised IAS for External Consultation

As in Step 8 of this procedure, the Lead Director/Senior Manager will review the completed IAS and Action Plan for the next phase of the project, and may suggest revisions to the Project Lead. When the Lead Director/Senior Manager is satisfied with the document, he/she will sponsor the item to DMC.

A formal request should also be placed to have the IAS and Action Plan presented to the Management Committee of every other affected Directorate (if a working group was formed in Step 6, the representative(s) from the other Directorates will normally sponsor the item).

The DMC(s) must be sent the IAS, Action Plan and any other documents (e.g. Agenda Item Summary, presentation slide deck) one week prior to the Management Committee meeting. The Publications Unit (TPD) or Website Coordinator (BGTD) must be copied on the documents, as must the Manager of IPD (TPD) or of BIO (BGTD) to ensure consistency with ongoing international initiatives.

The Project Lead and the Director will present an overview of the IAS, including options considered and the recommended option, to DMC; DMC will be asked to approve the IAS for external consultation. The Project Lead is responsible for incorporating suggested changes into the document.

When DMC(s) has approved the document, the date of the last Management Committee approval becomes the Approval Date indicated on the IAS and recorded in the Management Committee meeting notes.

Questions To Consider:

  • Have the Management Committees provided input on the recommended option selected?
  • If the Lead Director/Senior Manager or DMC has recommended significant changes to the analysis or the recommended option, have the changes and the rationale been documented in the IAS?
  • Has DMC decided to formally consult externally at this time?

Inputs: Completed IAS and Action Plan from Step 9.

Outputs: Approved IAS to be distributed externally for comment and approved Action Plan.

Desired Outcomes: Decisions on issue analysis are expedited and well informed.

Step 11 Consult Externally, Revise Documents, Approve Implementation

The Communications/Consultations Plan, developed in Step 4 (and possibly modified in Step 7) will outline the consultation mechanisms; in addition, the Public Involvement Plan may outline other methods of interacting with, or informing, stakeholders about the issue.

External consultations will normally be conducted via webposting of the IAS. The Project Lead will arrange for the IAS to be translated and will ensure that the translated version is verified and matches the original. The Project Lead will complete any additional documents needed (as identified by the Publications Unit (TPD) or Website Coordinator (BGTD)) and forward them to the Publications Unit/Website Coordinator.

The Publications Unit/Website Coordinator will coordinate the posting of documents with the webmaster; it is the Project Lead's responsibility to coordinate the distribution of announcements to stakeholders, either through the Director General's Office of each affected Directorate or another unit or area as appropriate. On occasion, other regulatory authorities or organizations (in Canada or in other jurisdictions) may be encouraged to provide comments.

A template for the submission of comments by stakeholders is included in Chapter 5 of this Manual and may accompany the published documents.

The standard external comment period is 60 days. A longer comment period may be appropriate if the recommended option is anticipated to have significant impact on stakeholders, or a number of documents are being posted for comment from the same stakeholders. A shorter comment period may be warranted if the issue is urgent or the impact on stakeholders is not expected to be significant. Rationale for a shorter comment period should be explained in the Notice to Stakeholders that accompanies the published document(s).

The Project Lead may wish to present the issue to meetings or workshops with stakeholders, to more actively solicit feedback on the IAS. In addition, as appropriate the Project Lead may meet with stakeholders to discuss aspects of the documents, particularly in response to specific concerns or divergent views or upon request.

The Project Lead will review all comments received, analysing each to determine whether a change will be made to the IAS. Comments that are not relevant to this issue will be referred to the relevant area for possible action.

A key guiding principle, outlined in Chapter 1 of this Manual, is that all comments received during the consultative process should be addressed in a document available to those who were consulted. Therefore, the Project Lead will complete section 5.2 of the IAS, External Consultations, summarizing the comments received and the rationale for acceptance or non-acceptance.

Comments may be published, in detail or in summary, unless they contain confidential information and the person commenting has specifically objected to the disclosure of this confidential information.

The summary of consultations may be published along with the final IAS; alternatively, it should be provided to those who commented and available upon request for other interested parties (this should be indicated in the Notice to Stakeholders accompanying the final IAS).

Note that if extensive comments are received, necessitating significant revisions to the documents, an additional round of internal and/or external consultations may be required.

The Project Lead will make changes to the IAS and Action Plan as appropriate and will forward the documents to the Lead Director/Senior Manager for review. Step 10 (review of the document and approval for implementation) will be repeated before proceeding to Step 12. The presentation(s) to DMC(s) will likely focus on changes to the documents as a result of external consultations. DMC will be asked to make a decision on whether to approve the next phase of the project, namely implementation of the recommended option; in doing so, DMC is making a decision on the priority of the issue and the allocation of resources to its implementation.

The Project Lead should revisit the Action Plan to ensure no steps have been missed and verify whether the project is proceeding according to the timeframes predicted. Note that significant changes may require review and approval by DMC.

Note that for issues with narrow scope, the Lead Director/Senior Manager may determine that extensive and formal consultations (internal or external) on the IAS and Action Plan are not necessary. In this case, the Project Lead would proceed directly from Step 8 to the final portion of Step 11, and present the IAS and Action Plan to DMC for approval to implement the recommended option. Refer to Appendix 2 for one possible way the process can be tailored to address issues with narrow scope.

Questions To Consider:

  • Is the level of consultation proportional to the expected impact of the issue? Is the comment period appropriate?
  • Has the scope of the subject under consultation been defined? Are the expectations of all parties clear?
  • Have all affected stakeholders had the opportunity to comment?
  • Have all comments been addressed in the IAS?
  • Has the document been revised appropriately as a result of comments received?
  • Have any comments that do not relate directly to this issue been forwarded to the relevant area for possible action?

Inputs: IAS. Communications/Consultations Plan and/or Public Involvement Plan as needed.

Consultations: Publications Unit, TPD or Website Coordinator, BGTD

Outputs: Revised Action Plan and IAS, including section 5.2 - External Consultation.

Desired Outcomes: Issue analysis is improved by input from affected areas. The issue analysis process is open and transparent. Comments received during the consultative process are addressed in a document available to those who were consulted.

References: Reference #1, #4, #7, #9, #11, #12, #16 (Part II).

Templates (Chapter 5 of GGP Manual): Issue Analysis Summary, Table for submission of comments, Summary of consultation comments received.


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Step 12 (Optional) Publish IAS

The affected Directorate(s) may wish to publish the IAS on the Health Canada website at this stage, to inform stakeholders of the recommended option and next steps. This may be particularly valuable where no further action is to be taken: the IAS would then serve as the position paper on this issue. The IAS will be published according to the process outlined by the Publications Unit (TPD) or Website Coordinator (BGTD). As with every document posted, the Publications Unit/Website Coordinator will set up a standard review cycle of the IAS, normally two years from publication. The Project Lead will ensure a Contact is identified for the document, to whom comments will be directed; in addition, a generic e-mail address should be identified for posting. The Publications Unit/Website Coordinator will enter this information into the Metatag Database.

The Contact is responsible for receiving, reviewing and responding to comments and questions regarding the IAS. The Contact must keep a record of comments received; if there are significant concerns with the option selected for implementation, the Contact may decide to review and possibly revise the document. The standard review period is two years; at the end of this time, the Contact will decide whether the IAS is still relevant and necessary, and if so, will review it to determine whether any revisions are needed. The nature of the revision (administrative or significant) will determine the process to be followed. Timing of the revision will depend on TPD/BGTD priorities and available resources. Alternately, if significant new issues arise, it may be necessary to re-analyse the issue and selected option, and therefore to revise the document, outside of the normal review schedule. Refer to Standard Operating Procedure (SOP) #3, Revisions to Published Documents in TPD and BGTD, for more information on revising published documents.

If the IAS is no longer relevant and necessary and is to be removed from the website, a Notice to Stakeholders will be drafted to provide the rationale for the removal of the document. This will be posted in place of the IAS for at least six months.

Questions To Consider:

  • Is the Contact aware of the responsibilities for document maintenance?
  • Is the document still relevant and current?
  • Does the document need to be revised?

Inputs: Final IAS. Any comments or questions received pertaining to the documents.

Consultations: Publications Unit, TPD or Website Coordinator, BGTD

Outputs: Published IAS (if applicable).

Desired Outcomes: Staff and stakeholders continue to provide input on TPD/BGTD documents. Published documents are subject to periodic review to determine whether they are still relevant and necessary, and whether revisions are needed.

Step 13 Implement Recommended Option

The following is not an exhaustive list, but is meant to illustrate some of the possible actions that may be taken following issue analysis.

Step 13a Regulatory Option

If the decision is made to revoke, amend or draft a new regulation(s), the IAS will be referred to the Bureau of Policy, Science and International Programs (TPD) or the Centre for Policy and Regulatory Affairs (BGTD) for processing in accordance with the Federal Regulatory Process. A memorandum should accompany the IAS with the date on which the recommendation was approved by the Management Committee of each affected Directorate.

The IAS will likely form the basis for the Regulatory Impact Analysis Statement (RIAS).

Refer to the Federal Regulatory Process Management Standards Compliance Guide (Reference #16) for more information.

Step 13b Non-Regulatory Option: Development of a Guidance Document

If the decision is made to develop a guidance document or adopt (in whole or in part) a document from another regulatory authority or organization (in Canada or in another jurisdiction), SOP #2, Guidance Development in TPD and BGTD, will be followed. Each guidance document must include policy objectives (normally these will be formed as a direct result of the issue analysis and may be accompanied by policy statements) and guidance for implementation (normally developed via SOP #2, Guidance Development in TPD and BGTD). The guidance document may be accompanied by a template, form, or Frequently Asked Questions document, which should be developed concurrently with the guidance document, according to the same procedure.

Note that in some situations, particularly for issues that represent a significant change to TPD or BGTD's objectives or the way in which the Directorate(s) does business, it may be useful to consult on the policy objectives portion of the guidance document separately, before developing the operational portions. In this situation, those portions of the guidance document may accompany the IAS and undergo internal and external consultation prior to the development of the operational components of the guidance document in SOP #2, Guidance Development in TPD and BGTD.

Step 13c Non-Regulatory Option: Development of a Procedure

If instructions to staff are needed (e.g. to accompany a guidance document or regulatory change), a procedure will be developed using the TPD/BGTD template.

Step 13d Non-Regulatory Option: Development of a Directive (BGTD only)

A Directive is normally developed to advise 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, and will normally be recommended after an expedited issue analysis process (see Section 5.2). Directives include policy objectives and may include policy statements and guidance for implementation.

Templates (Chapter 5 of GGP Manual): Procedure.

Step 13e Other Non-Regulatory Options

Other non-regulatory options include the development of a form, a Notice to Stakeholders, a standard, a Fact Sheet or other communication tool, etc. Although the full Guidance development procedure does not need to be followed for these situations, the documents must be published in accordance with the processes outlined by the Publications Unit (TPD) or Website Coordinator (BGTD).

Step 13f No Further Action

If the approved option is to take no further action, the IAS may be published as per Step 12, in order to communicate the Directorate's position on an issue.

5.2 Expedited Issue Analysis Process

In urgent or critical situations, it is imperative that Health Canada take decisive action; this must be balanced with the Directorates' commitment to the principles outlined in Chapter 1 of this Manual.

In order to qualify for the expedited process, issues must be related to a critical health or safety concern and receive DMC approval for the issue to expedited. Other situations where the expedited process may be appropriate include a response to a court decision or report from the Office of the Auditor General. The process for expedited issue analysis is similar to that outlined in Section 5.1, but will move in an expedited manner and may omit certain steps; for example, it will likely not involve the full range of internal or external consultation described in Section 5.1. The justification for the expedited process will be included in the Notice to Stakeholders accompanying published documents.

The decision to proceed via an expedited process will normally be made by DMC when the issue is identified and a Project Lead will be assigned very early (Step 1 of the process outlined in Section 5.1). The Publications Unit (TPD) or Website Coordinator (BGTD) should be contacted as early in the process as possible, to make the necessary preparations to publish documents resulting from the process.

The Project Lead may form an ad-hoc working group (Step 6 of Section 5.1) to assist with expedited issue analysis. Due to the urgent nature of the issue, formal documents such as Terms of Reference are not necessary.

It is recognized that in urgent situations it is important to take fast, decisive action; however, for future reference the Project Lead must make every attempt to document key decisions made and the rationale for those decisions. These will form the basis of an IAS; in the expedited process, a shortened version of the template in Chapter 5 of this Manual may be utilized.

Where possible, the Project Lead will consult internally with affected Directorate(s) in analysing options and making decisions. Directorate-, Branch- or Department-level committees or external Scientific Advisory Committees may be a valuable resource to seek input internally on key scientific issues. Those stakeholders that will be most affected by the decision may also be consulted where appropriate and feasible.

Given the urgency of the situation, it may not be possible to undergo full internal and/or external consultations, and documents may be published for immediate implementation. In this situation, the Project Lead should consider undertaking full internal and external consultations after implementation. As in Section 5.1, the Project Lead is responsible for analysing responses received, making changes to the document as appropriate and documenting rationales, and ensuring the necessary management approvals are obtained.

6. Reference Documents

6.1 References

  1. Communications and Consultations Secretariat. Consultation Guidelines for Managers in the Federal Public Service, 1992. Available on the Privy Council Office website.
  2. Department of Justice Canada. Designing Regulatory Laws That Work, 1994.
  3. Government of Canada. A Framework for Science and Technology Advice: Principles and Guidelines for the Effective use of Science and Technology Advice in Government Decision Making, 2000. Available on the Industry Canada Strategis website.
  4. Health Canada. A Reference Guide to Legislative Instruments - Biologics and Genetic Therapies Directorate, Draft 2005. (Internal document)
  5. Health Canada. Health Canada Decision-Making Framework for Identifying, Assessing, and Managing Health Risks, 2000. Available on the Health Canada website.
  6. Health Canada. Health Canada Policy Toolkit for Public Involvement in Decision Making, 2000. Available on the Health Canada website.
  7. Health Canada. Health Products and Food Branch Public Involvement Framework. Available on the HPFB Intranet.
  8. Health Canada. Model Process for Managing Risk Issues in the Biologics and Genetic Therapies Directorate, 2002. (Internal document)
  9. Health Canada. Public Involvement Framework and Guidelines. Minister of Public Works and Government Services Canada, 2000. (Internal document)
  10. Health Canada. Records Management Policy, 1998. (Internal document)
  11. Health Canada. Regulations, Legislation, and Standards - A Recipe for Success, 2002.
  12. Privy Council Office. Guidelines for Effective Regulatory Consultations. Available on the Government of Canada Regulation website.
  13. Treasury Board of Canada Secretariat. Assessing Regulatory Alternatives, 1994. Available on the Privy Council Office website.
  14. Treasury Board of Canada Secretariat. Benefit-Cost Analysis Guide for Regulatory Programs. Minister of Public Works and Government Services Canada, 1995. Available on the Privy Council Office website.
  15. Treasury Board of Canada Secretariat. Competitiveness and the Design of Regulations, 1992.
  16. Treasury Board of Canada Secretariat. Federal Regulatory Process Management Standards Compliance Guide, 1996. Available on the Privy Council Office website.
  17. Treasury Board of Canada Secretariat. Technical Guide to Regulatory Impact Analysis, 1994.

6.2 Templates

The following templates are located in Chapter 5 of the GGP Manual:

  • Action Plan
  • Agenda
  • Communications/Consultations Plan
  • Issue Analysis Summary
  • Issue Identification Paper
  • Meeting Notes
  • Notice to Stakeholders
  • Procedure (TPD); BGTD should refer to the procedure template in QSI system
  • Public Involvement Plan
  • Table for Submission of Comments
  • Table for Summary of Consultations
  • Terms of Reference

7. Authors

TPD/BGTD Good Guidance Practices Working Group.

8. Document Revision History

Version Change Made Effective
Date
1 Initial issuance of document for internal consultation September 2005
1.1 Revisions after internal consultation. April 2006
1.2 Revisions after DMC discussion. Issuance for external consultation May 2006
1.3 Revisions after external (and internal) consultation. April 2007
2.0 Final version posted. August 2007

Appendix 1: Process Map - Issue Analysis in TPD/BGTD

PROCESS MAP - ISSUE ANALYSIS IN TPD>BGTD

Appendix 2: Sample process for Issues with Narrow Scope

As described in Section 5 of this procedure, the circumstances of each issue are different and the procedure allows for tailoring, depending on the nature of the issue being considered. The following describes one possible way the process can be tailored to be more appropriate for issues with narrow scope.

Issues that are narrow in scope are often specifically scientific or technical, and may include those that are Bureau/Centre/Office-specific. Issues that are scientific or technical are often related to the demonstration of the safety, efficacy or quality of therapeutic products. Specific examples of issues that are narrow in scope may include:

  • specific issues related to the quality portion of a submission/application;
  • issues related to the clinical portion of a drug submission for a specific disease or therapeutic area, e.g. bacterial meningitis; or
  • issues related to the application for a specific type of medical device.

The depth and breadth of analysis will vary depending on the nature and/or complexity of the issue, and an IAS for an issue with narrow scope will likely be less detailed than an IAS for a complex, cross-cutting issue. Sample IASs for various issues are located in Chapter 5 of this Manual.

A significant difference between this tailored process and the longer process outlined in Section 5.1 is the timing of the presentation of an Action Plan to DMC for approval. In this tailored process, the Project Lead may analyse the issue, identify and analyse options, select a recommended option, and draft an Action Plan for the implementation of the option, and then will present the IAS and Action Plan to DMC for approval.

In addition, this tailored process involves fewer approvals and less extensive formal consultation.

The process map on the following page outlines a sample process appropriate for an issue with narrow scope.

Process Map - Analysis of Issue with Narrow Scope

Process Map - Analysis of Issue with Narrow Scope

Date Modified: 2007-10-31

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