Health Canada
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About Health Canada

HPFB Policy on
Voluntary Statement of Information
for Public Involvement

February 2005

The policy is being piloted in 2005-06. For further information, visit http://ocapi.hc-sc.gc.ca

Office of Consumer and Public Involvement
Health Products and Food Branch
Health Canada

Table of Contents

1. Overview

1.1 Background
1.2 Other Related Policies
1.3 Scope of the Policy
1.4 Roles and Responsibilities

2. HPFB Policy on Voluntary Statement of Information for Public Involvement

2.1 Policy Statement
2.2 Purpose of the Policy
2.3 Application of the Policy
2.4 Type of Information Collected
2.5 Process for Collecting Information
2.6 Use of the Participant Voluntary Information Form

Annex 1: Participant Voluntary Information Form

Annex 2: Participant Voluntary Information Summary

Annex 3: Branch Public Involvement Methods

Annex 4: Definitions

Overview

This document outlines the Policy on Voluntary Statement of Information for Public Involvement for the Health Products and Food Branch (HPFB) and explains the policy development process. The policy will apply to HPFB public involvement activities and will provide an opportunity to participants who wish to do so, prior to such activities, to provide basic information about themselves or their organization such as organizational mandate, roles and relationships, interests and affiliations, and financial interests and funding sources. The information collected by the HPFB for a specific public involvement activity will be made available to all participants involved in that activity, and will be included in any publicly available reports resulting from an activity. Fostering transparency is key to the Branch's strategic directions for 2004-2007 (see Strategy 4), and a policy on voluntary statement of information for HPFB public involvement activities will help to achieve this goal.

This policy was initiated when Health Canada's Assistant Deputy Minister (ADM), HPFB, asked the Office of Consumer and Public Involvement (OCAPI) to assess the issues of competing interests and stakeholder representation in public involvement activities, and lead the development of a Branch response, as appropriate.

HPFB Definitions

Transparency is facilitating access to, and understanding of, the information and processes HPFB uses to conduct its business.

Openness is inviting, hearing, considering and sharing of information in the conduct of HPFB's business.

1.1 Background

Several issues converged in the development of this policy. The HPFB has identified the goals of improving openness and transparency in its Strategic Plan for 2004-2007. Two key deliverables for achieving these goals and thereby strengthening public trust and stakeholder relationships are:

  • developing and implementing a public involvement framework that will optimize public understanding of, and input into, the Branch's decision-making processes
  • making the regulatory process more accessible to stakeholders, including patient and consumer groups.

The HPFB has developed a public involvement framework. It states that the key to strengthening the HPFB's relationships with its constituencies is improving the mutual understanding of the roles, responsibilities and perspectives of all those involved in public involvement activities. A policy on voluntary statement of information will encourage such mutual understanding and add greater transparency to the Branch's activities.

Second, it is important to note that within Health Canada, the HPFB has a unique role as a regulatory body. In December 2003, the Privy Council Office (PCO) held a government-wide workshop to discuss the principles behind regulatory consultations. The resulting report from this workshop notes that because amendments to regulations have the force of law, public consultations (such as some of the HPFB's public involvement activities) can have significant outcomes with respect to regulatory decisions. Therefore, a higher burden of care and due diligence is placed on public servants in ensuring thorough and inclusive consultations. The report further notes that "regulatory bodies must deploy systematic efforts in ensuring that the views of Canadians are indeed considered in the development of regulations." 1

HPFB Strategic Plan 2004-2005

Notably, health-related regulatory bodies in other jurisdictions (e.g. the United States and Australia) face similar challenges with respect to regulatory issues and public involvement activities. The United States Food and Drug Administration is currently drafting a voluntary financial disclosure policy for its open public hearings.

The third issue that provided impetus to developing a policy on voluntary statement of information began as one of conflict of interest. In the fall of 2003, public involvement participants brought the issue of disclosure of information to the HPFB's attention.2 The issue was raised in the context of a concern over perceived conflict of interest from participants attending multi-stakeholder consultations.3

HPFB Terminology

"Consultation" is a commonly used term that, in general, refers to a traditional process in which government seeks feedback from the public on particular policy directions.

"Public involvement" is an evolving concept and term which carries a different meaning than that of "consultation." Public involvement is used throughout this document to refer to a broader approach for the sharing and exchange of information between the government and the public, and including instances where the government facilitates an exchange of information between different groups or members of the public. There are also various types of public involvement activities that can occur (e.g. town halls, workshops, focus groups, posting notices on Web sites). Public involvement activities are used to solicit input at all stages of the policy and/or program development process.

Health Canada's Policy Guide for the Management of Advisory Committees addresses the issue of conflict of interest as it applies to all situations where external advice on a scientific or technical issue is obtained. However, advisory committees are only one mechanism for involving the public in program and policy decisions. The policy for these committees does not extend beyond the advisory committee mechanism, nor does Health Canada currently provide the oppportunity to participants in public involvement activities, who wish to do so, to provide information related to conflicts of interest. The lack of a policy is increasingly raising concerns as it is not viewed as fostering transparency.

In response to participants' concerns and the ADM's request to enhance transparency in public involvement activities, the OCAPI brought together, in March 2004, internal (Health Canada) and external participants to generate solutions and help shape an appropriate approach for dealing with stakeholder representation in the Branch's public involvement activities.4 Together, participants identified voluntary statement of information as a priority area for action. Notably, the potential for participants' conflict of interest is not isolated to interests that may lead to financial gain, but extends to a range of interests or influential ties that may reflect voluntary, professional and personal affiliations. In seeking broad stakeholder representation, the Branch actually seeks to bring together various members of competing groups, and to have a variety of interests represented when discussing Branch programs, policies and regulations. Transparency is key, and fostering it means providing participants, who wish to do so, the opportunity to inform others on their organizational mandate, roles and relationships, interests and affiliations in advance of scheduled HPFB public involvement activities.

In drafting the Policy on Voluntary Statement of Information for Public Involvement, the OCAPI has stressed that the voluntary provision of information related to roles and relationships, interests and affiliations will not preclude participants from attending public involvement activities or expressing their opinions. Likewise, choosing not to provide information will not limit participation or the expression of opinions.

The OCAPI examined three models of voluntary statement of information. Each model asks participants to provide information about their relationships and affiliations that may suggest potential conflicts of interest or competing interests. Some of the models examined presented best practices and the OCAPI has considered elements of them in the development of its own policy for voluntary statement of information.

1Workshop Report on Principles of Regulatory Consultations, Privy Council Office, Regulatory Affairs and Orders in Council Secretariat, released March 2004.

2The issue was raised during a Public Policy Forum deliberation on regulatory system improvement through stakeholder engagement and during thematic consultations on the advertising of health products as part of the legislative renewal related to the new Canada Health Protection Act.

3Throughout this document, the OCAPI has modeled its definition of "conflict of interest" on the one used by the International Committee of Medical Journal Editors (ICMJE).

4The meeting was part of a three-session issue-framing exercise held on the broader issue of stakeholder representation in HPFB public involvement activities.

1.2 Other Related Policies

In preparation for developing a new policy, the OCAPI reviewed other federal government policies related to public involvement. Of the policies it reviewed, none addressed the issue of provision of information and all were limited in providing any direction for increasing transparency in public involvement processes.

  • Health Canada practices and policies - As noted in the previous section, Health Canada has a Policy Guide for the Management of Advisory Committees, but does not have a department-wide policy that addresses voluntary statement of information or conflict of interest with respect to public involvement activities.

    Health Canada has a Policy Toolkit for Public Involvement in Decision Making. The objective of the toolkit is to enhance the Department's culture and capacity for public involvement in developing policy. The toolkit provides a policy framework and practical guidance for all Health Canada officials conducting public involvement activities. It outlines and defines five levels of public involvement between and among the government and public participants. It is the purpose of the public involvement exercise that determines of level of engagement.
  • Level 1: Inform/Educate participants
  • Level 2: Gather information from participants
  • Level 3: Discuss issues with participants
  • Level 4: Engage participants to share information among themselves and with government
  • Level 5: Encourage partnering between participants and with government

The toolkit provides a good foundation upon which to base public involvement activities but does not provide guidelines as to how to deal with transparency, especially in situations where stakeholder representation may include competing interests.

The Accord Between the Government of Canada and the Voluntary Sector - This agreement between the federal government and the voluntary sector is a framework document that guides the relationship between these two parties. It represents a public commitment to more open, transparent, consistent and collaborative ways for the voluntary sector and the Government of Canada to work together.

The Accord's Code of Good Practice on Policy Dialogue is of particular interest because it encourages the inclusion of the diverse voices of many societal groups at the policy table. It states that "engaging more people, collecting more ideas, and integrating a broader range of views into the policy process will contribute to policies that are more reflective of Canada's diversity, and more responsive to the needs of Canadians."5

The focus of this Code is on the relationship between the government and the voluntary sector, and how the principles of their joint Accord apply to policy dialogue. The Code presents good practices for deepening policy dialogue at the various stages of the policy process to encourage the exchange of knowledge and experience. The government and the voluntary sector both recognize that their relationship is only part of the broad public policy process and that the government has a responsibility to consider many sources of input when developing policy. While the Accord and Code speak to transparency and accountability, they do not provide guidance for specific public involvement activities to foster transparency and understanding of viewpoints.

Communications Policy of the Government of Canada - The objective of the policy is to ensure that communications across the government are well coordinated, effectively managed and responsive to the diverse information needs of the public.

The policy provides guidance to all federal government staff involved in communications activities and outlines requirements for open, inclusive, clear and accessible communications with respect to public consultations and involvement.

The policy does not address conflict of interest situations or whether related information should be provided. Although the policy requirements encourage transparency in public involvement processes, they do not specifically address the practice of providing an opportunity for participants to exchange basic information about themselves and/or the organizations they represent as a means of increasing transparency in public involvement processes.

Value and Ethics Code for the Public Service - Health Canada employees are obligated to comply with the Conflict of Interest Measures (Chapter 2) and the Post-Employment Measures (Chapter 3) of the Values and Ethics Code for the Public Service. The Code requires that employees submit a Confidential Report form if they are involved in any activity which could result in a real, potential or apparent conflict of interest.

Privacy Act - Another federal legislative instrument that has an impact on the voluntary statement of information is the Privacy Act. Its intent is to protect the privacy of individuals with respect to their personal information that is held by any government institution. Section 5 of the Act stipulates that where there is a need to collect personal information, an individual will be told why the information is being collected and to what use it will be put. Section 7 requires that government acquire the individual's consent to use the personal information for the purpose it was collected or for use consistent with the original use. Therefore, as part of this policy development, the OCAPI will ensure that forms and practices (such as those proposed in Annexes 1 and 2) used to collect and summarize information from public involvement participants comply with the requirements of the Privacy Act. For example, the preambular statement on the first page of Annex 1, explains the purpose for collecting the information and invites participant to complete all or part of the attached Participant Voluntary Information Form (the Form), at their sole option. The Form also explains the purpose and explicitly asks participants for their consent to use the information for the stated purpose.

5Visit Next link will take you to another Web site http://www.vsi-isbc.ca/eng/relationship/accord.cfm for more information on the Accord.

1.3 Scope of the Policy

The Policy on Voluntary Statement of Information for Public Involvement will be administered by all HPFB directorates and offices that undertake public involvement activities. It is in respect of public involvement activities and information that may be voluntarily provided by participants in those activities where the objectives correspond to Levels 2 to 5 (gather information, discuss, engage, partner), as defined in the Health Canada Policy Toolkit for Public Involvement (see pages 6-7). The policy would not apply to public involvement activities designed only to inform and educate the participants (Level 1) because this level does not require an exchange of information between participants. Essentially, applying a policy of voluntary statement of information is appropriate whenever public information exchange occurs among participants.

1.4 Roles and Responsibilities

The OCAPI will:

  • promote and support the application of the policy by directorates and offices in the Branch to increase transparency in its public involvement strategies and activities
  • monitor and evaluate the application and the impact of the policy across the Branch. Method for doing so will be further developed.
  • report, internally and to the public, on the frequency and the merit of the application of the policy by directorates and offices.

HPFB programs conducting a public involvement activity will:

  • provide invited participants with a Participant Voluntary Information Form
  • collect completed forms, prior to or during each public involvement activity, from those participants who have chosen to voluntarily provide that information
  • provide participants with a Participant Voluntary Information Summary prior to, or at the beginning of, the public involvement event. HPFB will also append this summary to any reports resulting from this activity that are made publicly available, and will post it on the Branch website. See Annex 2 for a form and example.

Participants (organizational representatives and individuals) attending consultations may:

  • at their sole option, voluntarily provide basic information about themselves (if participating as individuals) or the organization they represent with respect to mandate, roles, relationships, interests and affiliations with regards to the subject of the public involvement activity
  • share responsibility for successfully meeting HPFB's public involvement objectives and for evaluating results.

2. HPFB Policy on Voluntary Statement of Information for Public Involvement

2.1 Policy Statement

Consultative processes, and by extension, Canadian public policy should be appropriately open and transparent. HPFB has committed to increasing transparency in its public involvement activities as supported by Strategy 4 of the Branch's Strategic Directions for 2004-2007 (refer to page 4). It is the policy of the Branch to provide the opportunity to participants to voluntarily provide basic information about themselves or their organization at the onset of a public involvement activity (refer to Annex 1: Participant Voluntary Information Form). The HPFB will make no efforts to evaluate the information voluntarily provided, or to use the information to limit attendance or preclude the expression of opinions. In the interest of transparency, information will be made available to all participants in advance, or at the beginning of each public involvement activity (refer to Annex 2: Participant Voluntary Information Summary). Additionally, the Summary will be available on the Branch website and will be appended to any publicly available reports or documents resulting from the public involvement activity. In this way, participants will be better informed about the broad range of views and diverse societal voices that are contributing to the public discussion of Branch issues.

In support of this policy, the HPFB will:

  • comply with the requirements of the federal Privacy Act6
  • ensure the policy is aligned with other policies and frameworks within the Branch
  • monitor, evaluate and report on the application and impact of the policy
  • amend the policy, as necessary.

2.2 Purpose of the Policy

The purpose of the policy is to support the Branch's efforts to foster transparency in its public involvement activities and decision-making processes by providing participants the opportunity to share basic information about themselves (if participating as individuals) or the organization they represent with respect to mandate, financial interest, funding sources and/or relationships, memberships and affiliations. This policy is in direct response to requests from participants to know who is participating in each Branch public involvement activities and who they represent when doing so (priority area identified for Stakeholder Representation). The participants' provision or lack of provision of information will not limit their participation, nor will the Branch evaluate the information provided or preclude anyone from expressing their opinion.

6The Privacy Act stipulates that the information provided cannot be used for any purpose other than that to which the participant consented and the information cannot be used unless the participant completes all or part of the information form and signs the consent portion

2.3 Application of the Policy

The policy does not need to be applied to all public involvement activities. For activities such as bilateral meetings, focus groups or surveys, it is not necessary for the Branch to make available the basic participant information as participants are not being asked to share their respective viewpoints with each other. However, in a dialogue session or workshop, where an exchange of perspectives and opinions is encouraged for the benefit of sound understanding of all aspects of an issue, the policy will apply. As well, in cases where Internet technology (e.g. e-dialogue) is used to share information, opinions and/or seek feedback between respondents, electronic forms for voluntary statement of information would be integrated into the Web site design.

2.4 Type of Information Collected

Participants, whether as individuals or members of organizations, are provided the opportunity, if they wish to do so, to provide basic information about themselves (if participating as individuals) or the organization they represent with respect to mandate, financial interests, funding sources and/or relationships, memberships and affiliations. Categories of information sought include:

  • identification of participant (name of individual, title, name of organization represented)
  • type of organization (e.g. academic, industry, community or consumer group)
  • scope of an organization's membership (e.g. national, local)
  • provision of information related to organizational roles and relationships, interests and affiliations (within the past year), which may be affected by the outcome of the public involvement activity
  • identification of the type of relationship, interest or affiliation, if any
  • amount of funding received related to the subject of the public involvement activity, if any
  • acknowledgement of organization's adherence to funding guidelines and/or sponsorship agreements, if any
  • signature of participant
  • date of signature.

See the Participant Voluntary Information Form in Annex 1.

2.5 Process for Collecting Information

When the HPFB organizes a public involvement activity of Levels 2 to 5 (refer to page 7) and sends an invitation to potential participants, a Participant Voluntary Information Form (paper or electronic) will be attached. Upon confirmation of attendance, invited participants may choose to complete, all or part of the form, and return it to the HPFB official receiving the confirmations of attendance. There is no requirement for participants to complete the form in order to attend the activity.

Alternatively, where registration packages are provided in advance to confirmed participants of a public involvement event, the form may be included in the package (paper or electronic) and completed and returned to the appropriate HPFB official.

2.6 Use of the Participant Voluntary Information Form

Upon submission of the Participant Voluntary Information Form, Branch officials will complete a Participant Voluntary Information Summary (Annex 2) and provide a copy to each participant in advance or at the beginning of the public involvement activity. A copy of the Summary will also be appended to any publicly available reports resulting from the activity and will be posted on the Branch website.

Annex 1: Participant Voluntary Information Form

The Health Products and Food Branch (the Branch) of Health Canada and its stakeholders recognize the importance and value of openness and transparency in public involvement activities and decision-making processes. The Branch's commitment to transparency is supported in its Strategic Directions for 2004-2007 under Strategy # 4.

The Branch encourages the participation of diverse voices and promotes the inclusion of a broad range of views in its public involvement activities. The Branch provides participants of public involvement activities the opportunity to complete all or part of the attached Participant Voluntary Information Form (the Form).

Participants are not obliged to complete any part of the Form nor to consent to its use by the Branch. The decision by participants to complete, or to decline to complete and sign, all or part of the Form is voluntary. Neither the participant's decision nor the information, if any, that is provided, will be used by the Branch to limit the participant's attendance or expression of opinions in the public involvement activity. The information provided by participants should be in regards to the subject of the public involvement activity only.

The Branch will use information provided in the Form to prepare a Participant Voluntary Information Summary (the Summary) based on information voluntarily provided by participants who complete all or part of the Form. In support of creating a transparent process, the Summary will be distributed by Branch officials to all of the participants in this public involvement activity. The Summary will also be appended to any reports or documents resulting from this public involvement activity and will be available on the Branch's website. The Branch will not make use of the information provided in the Form or the Summary for any other purpose.

Should you wish to complete all or any part of the attached Participant Voluntary Information Form, please submit the completed and signed form when registering for this public involvement activity.

Annex 2: Participant Voluntary Information Summary

Name of public involvement activity :

Date and location of public involvement activity:

The following summarizes the information provided by those participants to this public involvement activity who voluntarily completed the Participant Voluntary Information Form and who consented to: 1) distribution of this summary by the Health Products and Food Branch to participants in this public involvement activity; 2) inclusion of this summary in the Branch's public reports arising from this public involvement activity; and 3) posting of this summary on the Branch's website. The information reported by participants pertaining to relationships, interests or affiliations is limited to the past year and to organizations likely to be affected by the outcome of this public involvement activity.

Information about the Health Products and Food Branch Policy on Voluntary Statement of Information for Public Involvement can be found at: Next link will take you to another Web site http://ocapi.hc-sc.gc.ca

No. Name of Representative and Organization
or
Name of Individual
Scope of Org. Membership Type of Organization Mandate of Organization Relationships, Interests and Affiliations [Yes/No] Relationship (with whom, type, amount ($)) Funding Guidelines, Sponsorship Agreement [Yes / No]
               
               
               

Example of a Participant Voluntary Information Summary

No. Name of Representative and Organization
or
Name of Individual
Scope of Org. Membership Type of Organization Mandate of Organization Relationships, Interests and Affiliations [Yes/No] Relationship
(with whom, type, amount ($))
Funding Guidelines, Sponsorship Agreement [Yes / No]
1 The Disease Society of XYZ National Voluntary Org. Patient Group. The mandate of the organization is to represent patients' interests. Yes ABC Pharma: travel and accommodations to attend this activity ($4000) Yes
2 College of XYZ of Canada National Association: health professional The mandate is... No n/a yes
3 Environmental Organization XYZ provincial Community The mandate is... Yes University of XYZ: research grant ($50,000) No
4 Jane or John Doe n/a General Public n/a No n/a n/a

Annex 3: Branch Public Involvement Methods

The following is a list of public involvement methods used by the Health Products and Food Branch, Health Canada.

Advisory Committee - group of representatives from a particular community or with differing interests, who are selected by government bodies to advise, comment, review or make recommendations for action on any given issue. Terms of reference outline the responsibilities of Advisory Committees. (Level 3 or 4)

Bilateral Meetings - formal meetings usually between government and a stakeholder organization (public or private) mainly used to identify, define or clarify issues and increase knowledge base on the issues. This category is part of a public involvement plan or strategy and excludes intermittent (meaning periodic or everyday) business meetings with stakeholders. (Level 2 or 3)

Dialogue - a structured, usually moderated, process to discuss and deliberate on issues allowing participants with differing values and priorities to build a common understanding of the problems and opportunities. This allows interactions and influence amongst participants, eg. E-dialogues, Appreciative Inquiry, Deliberative Dialogue. (Level 4)

Focus Groups - structured process where specifically selected individuals are brought together to provide reactions to a specific topic, policy, project or issue. (Level 2)

Mail Outs for Feedback - for feedback, letters or information kits mailed to stakeholders and interested parties to provide knowledge on a subject and seek input/comments (including e-mail notification. (Level 2)

Public Awareness - information sessions, web postings for information, social marketing, advertising and promotion of information, attitudes, values and behaviours to create a climate conducive to social and behavioural change. (Level 1)

Public Meetings - meetings open to stakeholders and the public where the government makes a formal presentation on a policy, project or issue and the public is given the opportunity to react with questions and comments. (Level 2 or 3)

Publication in Canada Gazette Part I - posting of all public notices, official appointments and proposed regulations from the Government, as well as miscellaneous public notices from the private sector that are required to be published by a federal statute or regulation. (Level 2)

Round Tables - meetings at which a group of people gather to discuss specific issues in which they have a common interest or expertise. The concept of 'round' table comes simply from the fact that no one is the 'head' of the table. (Level 4)

Surveys - method of primary data collection based on communication with a representative sample of individuals using different information-gathering techniques such as mailouts, questionnaires, in-person or telephone interviews and e-mail and Internet based. (Level 2)

Technical Consultations - selected participants with scientific/technical expertise are invited to provide input and feedback on the development of government guidelines, research programs, etc. (including expert working groups). (Level 3)

Web Postings - posting of an invitation to provide input on a question, issue or document on the world-wide web (including a call for briefs or proposals). (Level 2)

Workshops - interactive meetings at which participants expect to be involved in group discussion on one or more them areas. The intent is usually to identify problems and expectations or to recommend solutions. (Level 3 or 4)

Working Groups (includes working committees) - group of representatives from a particular community or with differing interests who are selected by government bodies to work together on a specific activity or project, towards a specific outcome. Works at strategic and/or operational levels. (Level 3 or 4)

Annex 4: Definitions

The definition of "conflict of interest" is an adaptation of the one used by the International Committee of Medical Journal Editors (ICMJE), Next link will take you to another Web site http://www.icmje.org; November 2003. The definition for "voluntary sector" was taken from A Code of Good Practice on Funding: Building on An Accord Between the Government of Canada and the Voluntary Sector, Voluntary Sector Initiative (Canada), October 2002.

Conflict of Interest exists when an [individual or the individual's organization] has financial or personal relationships that inappropriately (bias) influence his or her actions (such relationships are also known as dual commitments, competing interests, or competing loyalties). These relationships vary from those with negligible potential to those with great potentioal to influence judgment, and not all relationships represent true conflict of interest. The potential for conflict can exist whether or not an individual believes that the relationship affects his or her [ ] judgement. Financial relationships (such as employment, consultancies, stock ownership, honoraria, paid expert testimony) are the most easily identifiable conflicts of interest and the most likely to undermine credibility. However, conflicts can occur for other reasons, such as personal relationships, academic competition, and intellectual passion.

Consumer groups represent users or purchasers of the products or services of the Branch and/or Health Canada and are a segment of the public.

Health professional associations include, but is not restricted to, physicians, nurses, pharmacists, dentists, hospital administrators, natural health practitioners and alternative medicine practitioners. They are also a segment of the public.

Patient groups represent individuals who require or who are under medical care. A patient may also be a consumer. Please note, however, that not all consumers are patients.

Public is defined broadly and inclusively to cover all the individuals or groups who may be interested in or affected by the decision-making body. The definition does not require the certainty that any individual or group has such an interest; just that they may have. Therefore, the public includes consumers, patients, professionals, academia, industry and the groups that represent them.

Public Involvement refers to interactions between the public and the decision-making body (e.g., Health Canada), which include surveys, focus groups, feedback on discussion documents, public consultation, dialogue, workshops, advisory boards and partnerships.

Stakeholders are individuals, groups or organizations that are affected by or interested in an issue or policy. Stakeholders, interested parties and affected parties are segments of the public, which consist of those that the Branch knows are interested in the specific subject matter, mainly based on previous experience with them. The Branch interacts regularly with different types of stakeholders, including the general public1 patients, consumers, professionals, academia and industry.

Voluntary Sector consists of organizations that exist to serve a public benefit, are self-governing, do not distribute any profits to members, and depend to a meaningful degree on volunteers. Organizataions range from small community-based groups to large, national umbrella organizations including neighbourhood associations, service clubs, advocacy coalitions, food banks, shelters, transition houses, symphonies and local sports clubs.