ARCHIVED - HPFB Public Involvement Framework
The HPFB Public Involvement Framework is an overarching framework intended to guide public involvement activities within the Branch, for all stakeholder groups, across the full spectrum of HPFB's responsibilities.
Prepared by: Office of Consumer and Public Involvement
The Health Products and Food Branch (the Branch) of Health Canada has developed a Public Involvement Framework (the Framework). This Framework is intended to guide public involvement activities across the full spectrum of the Branch's responsibilities. The development of the Public Involvement Framework has followed the inter-connected steps of Health Canada's Decision-Making Framework (see Appendix A). It is the product of extensive analysis of public involvement activities within the Branch and of best practices in public involvement within Canada and internationally. The analysis included review of documents from the International Association for Public Participation (IAP2) and the Organisation for Economic Co-operation and Development (OECD). In addition, members of the Branch Public Involvement Network (PIN) and Public Involvement Framework Working Group, the Departmental Public Involvement Network Committee (PINC) and the Branch Executive Committee (BEC) were consulted throughout the development of the Framework (see Appendix B for descriptions of these internal groups). The Framework reflects the ongoing involvement of interested and affected parties throughout the process. It was also reviewed through consultation with the following categories of external stakeholders:
- current Branch advisory committees
- industry associations
- patient and consumer networks
- health professionals' associations
- organizations with public involvement expertise
A separate document, Branch Public Involvement Framework Action Plan, will be developed and is meant to be a companion document to this Framework. This action plan will be updated regularly to achieve the Branch's vision for public involvement.
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.
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.
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 public, patients, consumers, professionals, academia and industry.
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.
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.
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.
Health Canada's mission: to help the people of Canada maintain and improve their health
HPFB's vision for public involvement:
The Health Products and Food Branch will have mutually beneficial relationships with the public. While respecting our regulatory responsibilities, the Branch will be open, transparent and accountable in our work, and integrate stakeholder input into our decisions. The Branch will improve stakeholder trust and confidence in the regulatory system.
To deliver more strategic, coherent and effective public involvement activities, the Health Products and Food Branch will:
- Make public involvement an integral part of Branch strategic and operational planning so that resource can be identified and invested early on in the decision-making process.
- Consult the public early in and throughout the decision-making process, to understand and incorporate the public's expectations, interests and concerns when establishing priorities, developing policies and planning programs and services.
- Foster inclusiveness of all types of stakeholders and ensure that public involvement opportunities are as open, transparent and accessible as possible.
- Enhance the stakeholders' ability to participate effectively in public involvement activities.
- Develop a customized public involvement plan for all significant policy and program initiatives that will:
- determine public involvement objectives
- identify opportunities for collaboration at all levels
- select appropriate methods (exploring new technologies as well as using traditional methods)
- identify key types of stakeholders, and
- communicate how stakeholders' input will be used
- Evaluate the effectiveness of the public involvement initiatives from both the Branch's and the public's perspectives, in order to improve and strengthen public involvement activities.
- Provide timely feedback to all participants, reflecting how public input influenced the decisions made.
- Improve public awareness, through better exposure to and delivery of clear and understandable information about the Branch.
5.0 Guiding Principles
These principles will guide the public involvement activities of the Branch, and will ensure that decisions are made based on the best available information and evidence.
Transparency is facilitating access to and understanding of the information and processes HPFB uses to conduct its business. Transparency is shaped by these principles:
- Equal opportunity to access information: As much as possible, all parties who are affected by an outcome, or those who express interest on an issue, have equal access to unbiased and complete information. Access is provided through various methods including, but not limited to, making information available on the Internet
- Relevance: The public receives useful and practical information that meets their needs.
- Clarity: Communication with the public is in clear, objective language. Whenever possible, Branch documents are written in plain language, so that the information can be understood by as many individuals as possible.
- Accountability: Decisions, including a rationale on how and why the decision was made, are communicated widely and promptly
- Timeliness: The public receives information early enough to be aware of public involvement processes
Openness is inviting, hearing, considering and sharing of information in the conduct of HPFB's business. Openness is shaped by these principles:
- Equal opportunity for participation: As much as possible, all parties who express an interest in an issue, or who are affected by an outcome, have an equal opportunity to influence decisions.
- Relationship building: The public has ongoing involvement through which it can contribute its experience, expertise, knowledge and ideas for developing better public policies and for improving the design and delivery of programs.
- Timeliness: Whenever possible, the public is involved early enough in the decision-making process to be able to influence issues.
- Planning: Participants have enough time to prepare and to contribute effectively to public involvement.
- Support and Capacity: Recognizing that stakeholders have differing capacities to participate in public involvement processes, measures are in place to ensure effective participation.
- Clarity: The purpose and objectives of public involvement activities are clearly identified. Clear roles and expectations are established, known and understood by all.
- Shared responsibility: All those who participate share responsibility for successfully meeting public participation objectives and for evaluating results.
- Accountability: Commitments are met and outcomes are communicated.
- Innovation: New approaches and techniques are incorporated to encourage public participation in decision making.
Canadians expect their governments to be responsive, open, transparent and accountable. The Canadian public has increased its awareness of health issues and it demands for more consumer information, more choice in health products and food, and more say in regulatory processes. At the same time, Canadians rely on the government to provide basic protection such as access to safe and affordable drugs and to a safe and nutritious food supply.1
Stakeholders want effective mechanisms to ensure that they are appropriately informed, that their views are heard and that governments are held accountable for how public expertise and advice are used. This is particularly true in a regulatory context, where the actions and decisions taken by governments have real effect on the lives of Canadians and on their ability to manage their health. This means that regulators must recognize the fundamental importance of public involvement and engagement and build government knowledge and capacity to support it.2
The Government of Canada Regulatory Policy imposes a clear requirement on regulators, when developing regulations, that "Canadians [be] consulted, and that they have an opportunity to participate in developing or modifying regulations and regulatory programs."3
The pace of scientific discovery continues to accelerate dramatically. Advances in biotechnology, genomics, information technology and nanotechnology have become powerful new platforms for scientific discovery and product development. The Branch needs to be able to address these new technologies in terms of both regulatory approaches and ensuring access to knowledge and expertise. This can be done only with a greater emphasis on engaging and working with the diverse interests of many stakeholders.4 The Branch Public Involvement Working Group has reviewed best practices in public involvement and recommends, as a core principle rooted in fairness, that there should be consistency in our basic approach to all stakeholders, and that all Canadians should have equal access to provide meaningful input into our decision-making process.
This does not imply, however, that relationships with various stakeholder communities are uniformly the same or that their needs are the same. On the contrary, while the Framework sets out a basic approach and principles that should guide all public involvement activities in the Branch, it does not preclude developing public involvement strategies and activities that can accommodate the varied complexities of the issues dealt with by the Branch, and that can address the unique needs of individual stakeholder communities.
We must recognize that the Branch cannot regulate overall with a "one size fits all" approach to stakeholder engagement, but must address different needs, goals and opportunities with innovative approaches to public involvement.5
And, while progress has been made by creating the Office of Consumer and Public Involvement (OCAPI) in 1999, and by conducting an ever increasing number of public involvement activities, the Branch needs to position itself to deliver even more strategic, coherent and efficient public involvement initiatives. The Framework will allow the Branch to build on its strengths as a regulator, to increase stakeholder awareness of its mandate, and to enrich its relationships with its constituencies (individuals, groups or organizations that are affected by or interested in a Branch issue or policy).
The Framework's goals are directly linked to the Branch's planning process through the Branch's commitment to Strategy 4 (Improved Transparency, Openness and Accountability to Strengthen Public Trust and Stakeholder Relationships) of its Strategic Plan 2004-07.
Incorporating the views of citizens and stakeholders is a critical success factor for regulating effectively in the public interest. An engaged citizenry has implications for governance, ethics, transparency, openness and accountability. Maintaining and strengthening public confidence is especially important because the accelerating rate of scientific and technological advances carries both benefits and risks. Canadians must have confidence in the regulatory system, particularly when it regulates health-related products and services, if they are to have access to and use beneficial health innovations.6
Government and industry, as well as patient and consumer organizations, are coming to understand their respective roles in making the regulatory system work for all Canadians. Improving transparency, openness and accountability in health product regulation, and encouraging all stakeholders to share responsibility for achieving this, are key objectives of the Branch and the Therapeutics Access Strategy7. The 2003 Public Policy Forum consultations with stakeholders on Health Canada's therapeutics review process underscored that the Branch should fully integrate transparency, openness and accountability into its business.8
The Branch's Framework is also closely aligned with Departmental and other Federal regulatory and public involvement guidelines, such as Health Canada's Policy Toolkit for Public Involvement in Decision Making9 and the Privy Council Office's Workshop Report on Principles of Regulatory Consultations10.
7.0 Public Involvement Framework: The Current Situation
7.1 Framework Context
The Framework is set in the context of the Branch's current level of public involvement activities. The Branch uses a mixture of ongoing and/or permanent mechanisms and ad hoc or topic-specific activities. Some of the ongoing mechanisms include advisory committees and regular meetings with organizations (also called association or bilateral meetings). A variety of public involvement mechanisms, including workshops and public hearings, are used to address the ad hoc issues.
The Branch receives advice from two permanent advisory committees with broad mandates. The Public Advisory Committee (PAC) is composed of members of the public and the Advisory Committee on Management (ACM) is composed of various stakeholder representatives. The ACM has recently expanded its mandate to provide advice for the entire Branch. There is also a Science Advisory Board, which provides independent scientific advice to the Minister of Health.
The Branch also has 23 subject-specific advisory committees with a technical or scientific focus. The members of these committees are primarily health professionals and academics. However, patients are now being included as committee members.
Another three committees have a broader mandate and include representation from different stakeholders such as patient groups, the general public, industry and/or government. Most committees meet regularly three or four times a year.
Other Directorates conduct ad hoc (not regularly scheduled) bilateral meetings with various organizations to establish contacts, develop relationships with particular groups and/or conduct information sessions on specific issues, such as Legislative Renewal. There is very limited information about these meetings.
Table 1 illustrates the number and method of Branch public involvement activities reported to OCAPI since 2001 (see Appendix C for a description of the different levels of public involvement). These are public involvement activities on specific topics.
|fiscal year||number of issues addressed||total number of PI activities||paper/web-based method (% of total)||in person method (% of total)|
It is important to note that the total number of public involvement activities recorded in each year reflects only the number that was reported to OCAPI. Clearly, the reporting system implemented by OCAPI (PI Calendar) has improved since 2001 and can now generate a much more accurate and detailed picture of public involvement activities across the Branch.
During the 2003-04 fiscal year, most of the in-person consultation activities were workshops (56.7 %). Face-to-face meetings (including workshops, dialogues and working groups) involved a variety of patient, consumer and community groups.
The data also indicate that most of the public involvement activities actually combine several approaches, typically face-to-face meetings with electronic distribution and review of documents. The Framework will help the Branch continue to develop and implement innovative ways to encourage stakeholder involvement. For a comprehensive list of the methods of public involvement that have been used in the Branch, see Appendix D.
Table 2 summarizes the types of interactions that take place between categories of stakeholders and the Branch.
|Stakeholders||Interaction with Branch|
|members of the general public||
|patient and consumer groups;||
7.2 Framework Benefits
The Framework encompasses all of the ongoing public involvement activities of the Branch, as well as any new initiatives developed to provide the tools and infrastructure needed to improve public involvement with the Branch, as indicated in the chart below:
The Framework offers stakeholders a mechanism for increasing openness and transparency in the Branch decision-making processes. Implementing the Framework will increase the availability of timely, relevant and accessible information to Canadians. It will also demonstrate that stakeholder interests and concerns are taken into consideration when the Branch establishes priorities, develops policies and plans programs and services. In addition, stakeholders will be represented more meaningfully throughout the Branch. This will result in improved Branch and stakeholder relations through increased opportunities for stakeholders to engage in Branch initiatives, and in turn, for the Branch to participate in stakeholder activities.
The Framework will allow the Branch to be aware of and to monitor the full stakeholder environment: patient and consumer groups, health professionals, academia, industry and the general public. It entrenches public involvement activity as a Branch business function, ensuring that stakeholder involvement is linked to the strategic plan and that appropriate resources are allocated. The Framework reflects an appropriate balance between public involvement obligations and regulatory responsibilities (such as the priority on safety; the legal and ethical obligations to protect information; and the requirement for efficient and timely decision making), while ensuring that input from the broad spectrum of stakeholders allows for fully informed decision making. In addition, the Framework creates a vehicle for packaging and promoting public involvement activities and allows the Branch to demonstrate that there is a strategic plan for public involvement.
8.0 Public Involvement Framework: Roles and Responsibilities
8.1 Lead Accountability
The Office of Consumer and Public Involvement coordinates the development of the tools and infrastructure needed to improve public involvement in the Branch.
The Director General, OCAPI, will demonstrate lead accountability by providing leadership, oversight and strategic advice for the design and implementation of the Public Involvement Framework. The Director General, OCAPI, will ensure that the Framework remains relevant and meets its key objectives, and will track and report on horizontal initiatives. The Director General, OCAPI, will seek Branch Executive Committee (BEC) endorsement on horizontal initiatives and keep BEC apprised of progress. In addition, the Director General will liaise with and co-ordinate the Directorates on directorate-led initiatives, and the Policy and Strategic Planning Directorate (PSPD) on planning and performance reporting.
8.2 Branch Executive Committee Members' Accountability
The Directors General are responsible and accountable for the public involvement activities in support of policy and regulatory development within their offices and directorates. As such, they ensure that the Branch Public Involvement Framework-in particular, the vision, objectives, principles and commitments-is implemented for the core business under their responsibility. They provide leadership, oversight and strategic advice to their staff and they oversee resource allocation, expenditures and performance reporting on public involvement activities.
Regional Directors support the development of and provide regional perspective for policies and programs in the Branch, and coordinate implementation of Departmental initiatives in the Regions. As such, they are responsible for implementing the Branch Public Involvement Framework for certain activities, in collaboration with others. Where necessary, they will also provide advice on the design and application of the process to meet and consult Regional stakeholders when the public involvement plan includes a Regional component.
Directors General and Regional Directors have a responsibility to collaborate on the implementation of the horizontal initiatives in support of the Framework. As such they support participation of their staff in the Working Group and in other related initiatives and they provide information that is necessary for the monitoring and performance reporting on the Framework.
8.3 Project Managers
The Director, Public Involvement, OCAPI and the Director, Strategic Partnerships and Outreach, ADMO will co-chair an ongoing, Branch-level working group to coordinate Directorate participation in developing and implementing the Framework. They will support the OCAPI Director General in resource allocation, planning, reporting, liaison and coordination.
8.4 Public Involvement Working Group Members
Working Group members will represent the viewpoints and interests of their Directorates or Regions and will provide input and advice to the Working Group Co-chairs on Framework implementation. In collaboration with their direct supervisors and/or the Directorate Management Committee, they will identify issues of concern (for example, capacity issues) and bring these to the Working Group for discussion and resolution. They will report back to their Directorates on the progress and implications of Framework implementation.
Working Group members will provide leadership and support for developing and implementing specific Framework initiatives or activities.
- Strategic Plan 2004-07: Your Health and Safety-Our Priority. Health Products and Food Branch, April 2004: p.3.
- Government of Canada Regulatory Policy. Privy Council Office, November 1999: p. 3.
- Transparency and Openness in the Regulatory Process-International Perspectives. Speech given by Dr. Julia Hill, Health Products and Food Branch, January 2004.
- Strategic Plan 2004-07: Your Health and Safety-Our Priority. Health Products and Food Branch, April 2004: p. 15.
- Therapeutics Access Strategy. Priority Areas: Biologics & Genetic Therapies Directorate. Presentation given by Dr. Julia Hill, Health Products and Food Branch, November 2003.
- Corporate Consultation Secretariat, Health Canada, 2000.
- Regulatory Affairs and Orders-in-Council Secretariat, Privy Council Office, March 2004.
Appendix A: The PI Framework in Relation to Health Canada's Decision-Making Framework
The development of the Public Involvement Framework has followed the inter-connected steps of Health Canada's decision-making Framework and reflects the ongoing involvement of interested and affected parties throughout the process, including members of the Branch Public Involvement Network (PIN) and Public Involvement Framework Working Group, the Departmental Public Involvement Network Committee (PINC) and the Branch Executive Committee (BEC). External stakeholders have been involved since the initial stages of the decision-making process. In addition, the Framework was validated through consultation with stakeholders.
- Identify the issue and its context: OCAPI undertook a detailed analysis of the Branch's public involvement activities, websites, bilateral stakeholder meetings and advisory committee structure from April 2001 to December 2003. This analysis demonstrated the need for an overarching public involvement framework.
- Assess risks and benefits: OCAPI's analysis included an assessment of strengths and gaps in public involvement that exist in HPFB.
- Identify and analyze options: The HPFB Public Involvement Framework Working Group was created in January 2004 to identify key issue areas, risks and benefits and to generate a framework to address them.
- Select a strategy: A draft PI Framework was presented to the Branch Executive Committee (BEC) in April 2004.
- Implement the strategy: Activities identified in Year 1 of the Framework are now underway.
- Monitor and evaluate results: A monitoring/evaluation plan is a critical component of the Framework. The Framework consultation plan provided for several consultations to validate the Framework (regional consultations in British Columbia, Alberta, Saskatchewan, Manitoba, Ontario, Quebec and Atlantic, and one in Ottawa).
Appendix B: Description of Internal Groups
Public Involvement Framework Working Group is composed of representatives of each Directorate and region of the Health Products and Food Branch. This working group is responsible for the creation of the Public Involvement Framework as well as the subsequent implementation of the Framework within the Directorates, including specific initiatives or activities.
Branch Executive Committee (BEC) is responsible for day-to-day management of the Branch, which includes both operational and policy issues. It is composed of the Director Generals of each Directorate and the Regional Directors, and is chaired by the Associate Deputy Minister.
Branch Public Involvement Network (PIN) is composed of key representatives from all directorates and regions of the Health Products and Food Branch, as well as other staff interested in public involvement, to increase networking and to build public involvement capacity across the Branch.
Departmental Public Involvement Network Committee (PINC) is composed of representatives from all Branches and regions of Health Canada, as well as other staff with an interest in public involvement, to facilitate information sharing, to strengthen the Department's network of public involvement expertise and to implement Health Canada's Policy on Public Involvement in Decision Making.
Appendix C: Health Canada's Public Involvement Continuum
This public involvement continuum has been provided by the Office for Public and Consumer Involvement, Health Products and Food Branch, Health Canada. It has five levels:
- Level 1: Inform or Educate Level 1 provides members of the public with balanced and objective information to help them understand the issues, the options, the process and the solutions. Examples include posting public advisories or other information documents on web sites, conducting public awareness campaigns, etc.
- Level 2: Gather Information Level 2 collects public concerns and information about the affect of the developing policy. Examples include surveys, focus groups, mailing or web posting discussion documents for feedback, etc.
- Level 3: Discuss Level 3 allows the public to discuss the policy. At this stage the policy is not set, so the public has an opportunity to influence its final form. The exchange of information is usually between one individual or group and the decision maker. Examples include bilateral meetings, public or town hall meetings, etc.
- Level 4: Engage Level 4 offers a more thorough and in-depth deliberation about the issues. Parties can hear other perspectives and influence each other. The focus is usually on the underlying values and principles, and the goal is to seek common ground among all participants. Examples include deliberative dialogue, study circles, citizen juries or panels, advisory committees, etc.
- Level 5: Partner Level 5 involves partners sharing responsibility for implementing aspects of policy or program decisions. It usually involves joint decision making.
In this continuum, consultation refers to levels 2, 3 and 4 (that is, levels through which Health Canada seeks input for its decisions).
Using this continuum helps align public involvement methods with the objectives and level of influence appropriate to a situation. For example, in a crisis situation, the government is expected to make decisions and inform the public (level 1) about these decisions and their rationale. In another situation, the objective might be to achieve a shared understanding of an issue among stakeholders, making a dialogue (level 4) appropriate. No one level is "best"; usually a variety of involvement methods, started early in the decision-making process, produce the "best" outcome.
Appendix D: Branch Public Involvement Methods
This 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)
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