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Health Products and Food Branch
2005-07 Public Involvement Performance Report
Our 2005-07 Performance
Public involvement on specific issues
The Health Products and Food Branch conducted 99 public involvement activities that focused on 48 specific issues in 2005 - 06 and 102 public involvement activities that focused on 67 specific issues in 2006 - 07, compared with 84 public involvement activities in 2004 - 05. The majority of the issues involved policy development and the regulatory process.
Why we consulted
In 2005 - 07, the Branch sought the involvement of the public and stakeholders for many reasons, including to
- seek comments on proposed changes to policy and regulations;
- obtain expert opinion in relation to product reviews;
- gather input on draft guidance, directives, policies, and other documents;
- gain a better understanding of the views and behaviours of consumers;
- communicate progress, discuss issues, or identify barriers to implementing Branch initiatives;
- support stakeholders in learning more about the Branch and in participating meaningfully in our decision-making processes; and
- clarify Branch expectations and build stakeholder capacity.
How we involved stakeholders and the public in the decision-making process
When the Branch collects input from the public on specific issues, it ensures that the most appropriate method is selected based on the purpose of the activity, the desired outcome, and the availability of resources. In some cases, the Branch uses a combination of methods to collect meaningful feedback and enhance stakeholder participation.
Did you know?
The number of public involvement activities on specific issues at HPFB over the last three years.
2004-05: 84 activities
2005-06: 99 activities
2006-07: 102 activities
In 2005 - 06 and in 2006 - 07, the Branch strengthened the level of public participation by increasing the total number of public involvement activities and the level of engagement.
The Branch used a range of methods to conduct its public involvement activities.
In 2005 - 06, the number of face-to-face activities increased from 21 to 54, while the number of other activities, like mail-outs and Web postings, declined from 63 to 45. In 2006 - 07, the number of face-to-face activities further increased from 54 to 60, while the number of other activities decreased marginally from 45 to 42.
The methods selected to conduct Branch public involvement activities were chosen based on HPFB's objectives and what level of engagement was required for each issue. As innovative methods for public involvement are developed, changes appear in the methods selected over time, for example, electronic consultation was not available to the Branch in 2004 - 05.
In 2005 - 07, the Branch used a variety of methods to consult on many issues (refer to Annexes for a list of issues).
Definitions for each method are provided in the Glossary.
At what stage in the decision-making process did we consult?
During policy and regulatory development, the Branch involves the public in various stages of its decision-making process - identifying issues, assessing health risks and benefits, identifying and analyzing options, selecting a strategy, implementing the strategy, and evaluating result.
In 2005-06 a significant percentage of public involvement activities helped the Branch in implementing a strategy, whereas, in 2006 - 07, a significant percentage of public involvement activities helped the Branch in selecting a strategy. In 2004 - 05, a majority of the activities were used in identifying and analyzing options and selecting a strategy.
Who participated in our activities
The Branch generally targets specific groups of participants based on the nature of the topic, the type of input needed, and the level of engagement at which the public is able and willing to contribute. Some issues require highly specialized or technical input, while others benefit most from the perspective of a wide range of participants. In selection processes, the Branch aims to ensure that interested or affected groups are represented in one or more of the six steps of the decision-making framework.
- Involve those affected by the issue
- Involve those who are interested in the issue
- Understand stakeholder concerns
- Achieve a balanced representation
- Obtain expert opinion
- Increase transparency
- Contribute to effective decision and policy making
HPFB consultations were held across Canada
The Branch continues to improve its ability to hold public involvement activities in various locations across Canada. Options for participants to connect remotely with the Branch are growing beyond basic teleconferencing, Web postings for feedback, and mail-outs, into innovative technologies such as moderated electronic dialogues or electronic workbooks.
Of the 54 face-to-face activities held in 2005 - 06, 10 were held in more than one city across Canada:
- Bilateral meetings on the development of the National Food Safety trategy and Public Health Outcomes Performance Framework - Winnipeg, Victoria, Regina, Edmundston (New Brunswick), Québec, Halifax, and Moncton
- Focus groups on the draft content for the revised Canada's Food Guide to Healthy Eating - Vancouver, Calgary, Winnipeg, St. John's, Montréal, and Iqaluit
- Focus groups on the usability of the Food Guide Web site mock-ups - Québec and Ottawa
- Stakeholder consultations on the draft content for the revised Canada's Food Guide to Healthy Eating - Ottawa, Burnaby, Winnipeg, Toronto, Moncton, St. John's, Yellowknife, Charlottetown, Montréal, and Regina
- Stakeholder focus groups on the Natural Health Product Directorate's public education and outreach program - Toronto, Montréal, Saskatoon, and Vancouver
- Workshop on animal models for whole food testing for use in the evaluation of safety and nutritional quality of novel foods - Ottawa and Toronto
- Workshops on the Dietary Guidance - St. John's, Halifax, Moncton, Charlottetown, Vancouver, Edmundston (New Brunswick), Regina, Winnipeg, Ottawa, Longueuil, Toronto, and Yellowknife
- Workshops on the Registration and Disclosure of Clinical Trials - Halifax, Ottawa, and Vancouver
- Workshop on measures to help ensure Canadians' continued access to an adequate supply of safe and affordable drugs - Ottawa and Calgary
- Workshops with the food industry on improvement of allergen prevention practices - Ottawa and Toronto
Of the 60 face-to-face activities held in 2006-07, 8 were held in more than one city across Canada:
- Animal Biotechnology - Edmonton, Toronto, and Montréal
- Assistant Deputy Minister regional tour on the Blueprint for Renewal - Ottawa, Edmonton, Burnaby, Winnipeg, Toronto, Halifax, and Longueuil
- Awareness and educational sessions for medical device industry on Health Canada's Inspection Program - Moncton, St. John's, and Halifax
- Food Guide Regional meetings (post launch) - Edmonton, Burnaby, Moncton, St. John's, Halifax, and Charlottetown
- Meetings on the Regulatory Framework for Blood and Blood Components - Edmonton, Vancouver, Winnipeg, Toronto, Halifax (including Newfoundland, New Brunswick, and Prince Edward Island stakeholders), Québec, and Regina
- Qualitative research on Food Guide consumer resource - Vancouver, Winnipeg, Toronto, Richibucto, and Montréal
- Qualitative research on layout, comprehensiveness and understanding of content in a draft Food Guide resource for intermediaries - Toronto and Montréal
- Usability testing of Food Guide Web site mock-ups - Toronto and Montréal
Performance stories
Each public involvement activity provides the Branch with valuable input and opportunities for learning.
As examples, they demonstrate the diversity of activities conducted by the Branch, the opportunities for learning inherent in our activities, and the impact that public involvement can have on our work. Each highlights a different level of involvement - from gathering information and opinions, to engaging stakeholders in the policy and regulatory decision-making process.
In 2005-07 several public involvement activities stood out - the COX-2 and breast implant public forums; the MedEffect consultation; consultations on the registration and disclosure of clinical trial information; the Symposium on Drugs, Food and Natural Health Products Interactions; Blueprint for Renewal; Canada's Food Guide; Consumer Advertising Guidelines for Marketed Health Products, and the Review of Regulated Products: Policy on Public Input.
Public forums: Broadening our perspective in product review
Why a public forum? To promote transparency and broad public awareness of an issue as well as reach a greater number of Canadians.
The piloted 2005 public forums on selective COX-2 inhibitor NSAIDS (Non-Steroidal Anti-Inflammatory Drugs) and silicone gel-filled breast implants set a number of precedents for Health Canada, for example, in the disclosure of affiliations and interests of advisory panel members, and the disclosure of some health product submission information. The practical experience in implementing the public forums laid the foundations for a transformative change in the way the Health Products and Food Branch involves the public in its review of decision making.
The public forums were designed to give Canadians multiple ways to learn about the review process and the issues under consideration, as well as the opportunity to provide input. Health Canada's public forum model is distinguished from those of other international regulators by its accessibility, with multiple input mechanisms offered to the public, including a dedicated Web site, and the fact that it adheres more closely to best practices in public involvement processes, for instance by making information available ahead of time and by building in lead time for participants to prepare and participate.
In an independent evaluation of the forums, the majority of informants saw them as a positive step toward increasing openness, transparency, and accountability in the regulatory review process. In terms of accessibility, most public participants agreed that the online mechanism for receiving public input, over and above in-person presentations, made the process more transparent and open, and constituted an innovative and forward-thinking mechanism to solicit broader public input on key health issues.
MedEffect: Working to improve health product safety
Why interviews, focus groups, and a survey? To allow the development of MedEffect to be a collaborative undertaking, where future users worked with site developers to finalize the site.
The new Health Canada Web site, MedEffect, is making it easier for patients, consumers, and health care professionals to find the latest safety information on regulated products-like prescription drugs, natural health products, and therapeutic vaccines - marketed for sale or use in Canada.
To ensure that MedEffect is user-friendly, potential users were consulted on the site design before it was launched in August 2005. Health, patient, and consumer associations, individuals, and health care professionals were given an opportunity to look at a prototype of the site and provide their comments to the Health Products and Food Branch. A combination of face-to-face interviews, focus groups, and a Web survey was used to solicit feedback, which was then incorporated in the final MedEffect design.
Access to information on clinical trials: Enhancing transparency
Why an online questionnaire and workshops? To allow for a wide range of stakeholders to discuss issues surrounding the registration and disclosure of clinical trial information.
The transparency of clinical trials has become an important issue in Canada and abroad. Patients, prescribers, researchers, and regulators want greater access to information on clinical trials to help them make more informed decisions. Failure to publicly disclose information on clinical trials can reduce efficiency in research, result in the suppression of negative results, prevent prospective participants from becoming involved, and prevent the public from accessing safety and effectiveness information.
In June 2005, the Branch consulted with a wide range of stakeholders to identify the needs and requirements for clinical trial registration. Public input was gathered through an online questionnaire and face-to-face workshops.
Feedback from the consultations provided valuable insight for policy development and led to the establishment of an external working group. In 2006, the working group presented to the Branch options for improving public access to clinical trial information of health products in Canada while respecting the need for patient privacy and commercial confidentiality. The Health Products and Food Branch will consider the results of the public consultations and recommendations before making a final decision on how to proceed with the registration and disclosure of clinical trial information in Canada.
International symposium to increase awareness of drug, food, and natural health product interactions
Why a symposium? To promote open time frames for deliberation and discussions on complex issues with international participants.
Participants from around the world took part in a two-day symposium in Gatineau, Quebec, in February 2006. The goal of the Symposium on Drugs, Food, and Natural Health Products Interactions was to increase awareness of drug, food, and natural health product interactions and to assist the Health Products and Food Branch in developing effective risk management strategies related to the health effects of these interactions.
Organized by the Health Products and Food Branch and the University of Ottawa's Faculty of Science, the event attracted health care professionals, academics, representatives from industry and non-governmental organizations, and government staff. The three scientific sessions focused on risk of interactions, ways to evaluate the potential risks, and surveillance issues. The final session with three panelists dealt with how consumers can avoid the risks of these interactions.
Blueprint for Renewal
Why an electronic consultation and bilateral meetings? The electronic consultation allowed a range of stakeholders to provide input on policy and program decisions that affect the future direction of HPFB. The bilateral meetings allowed the Branch to meet key stakeholders, listen to their views, share information on the direction of HPFB, and build strategic relationships.
In October 2006, the Health Products and Food Branch released its Blueprint for Renewal plan, a major initiative aimed at modernizing Canada's regulatory system for health products and food. The Blueprint presented the vision and objectives for the renewal of HPFB's regulatory system, as well as proposed actions for moving forward.
From October to December 2006, HPFB consulted stakeholders and the general public on the Blueprint plan. This included a series of discussion sessions across Canada, as well as an electronic consultation, where over 300 stakeholders provided their views on the Blueprint's vision and objectives. The Branch received strong support from Canadians on the case for renewal and orientations in the Blueprint. Constructive feedback from the consultations helped inform the development and implementation of the plan and was incorporated into a revised version of the Blueprint. Blueprint for Renewal II offers a more comprehensive articulation of the Branch's action plan and how it will concretely move forward to design a regulatory system that will further protect the health and safety of Canadians.
The Branch also held a number of consultations on various Blueprint initiatives key to its renewal. The initiatives included a progressive licensing framework for pharmaceuticals and biologics; a renewed external charging framework that will stabilize the Branch's resources and cover the regulation, licensing, and post-market surveillance of health products; and a regulatory modernization strategy for food and nutrition.
Canada's Food Guide: Providing Canadians with a new tool to help them follow a healthy lifestyle
Why an electronic consultation and regional meetings? To allow a broad number of Canadians, many with important regional perspectives on food and nutrition, to take part in the development of the revised Food Guide.
For 65 years, Canadians have trusted Canada's Food Guide to provide guidance on healthy eating. Canada's first food guide, the Official Food Rules, was introduced to the public in July 1942. Since 1942, the food guide has been transformed many times, including the latest revisions starting in 2005.
More than 7,000 Canadians across the country were consulted, including dietitians, health care professionals, scientists, doctors, and researchers. National consultations were launched in Ottawa in November 2005 and included an online component and a series of regional meetings. The purpose of these meetings was to present some of the key design elements and to provide an opportunity for stakeholders to take part in a dialogue on content issues (presentation of food intake patterns and energy balance), ask questions, and provide feedback on the proposals for Canada's Food Guide. Focus testing with consumers was also done to assess how well the messages were understood. In addition to these consultations, Health Canada received advice and guidance from three expert advisory committees throughout the revision process.
Canada's new Food Guide, released in February 2007, helps Canadians make healthy food choices and describes the amount and type of food recommended for Canadians.
Consumer Advertising Guidelines for Marketed Health Products
Why a technical consultation and roundtable? To allow stakeholders to voice concerns and propose options for updated guidelines.
The Consumer Advertising Guidelines for Marketed Health Products (for non-prescription drugs, including natural health products) replaces the outdated 1990 Consumer Drug Advertising Guidelines. Revised guidelines were developed in collaboration with Advertising Standards Canada and members of the Branch Advertising Working Group. They include a new requirement aimed at providing fair and balanced information on the risks and benefits of non-prescription drugs and natural health products in consumer advertising.
Two rounds of external stakeholder consultation in February 2005 and April-May 2006 resulted in overall support for the draft guidelines; but consensus was not reached on the requirements for the communication of risk information. Consequently, the Health Products and Food Branch invited key stakeholders to Ottawa for a roundtable discussion in June 2006. The event allowed the full range of interested parties to voice concerns and work collaboratively to propose options.
The resulting measures incorporated in the revised guidelines are intended to help Canadians make better informed decisions about their health before purchasing non-prescription products. They are also designed to help advertisers develop advertising messages that meet all the relevant provisions of the Food and Drugs Act and Regulations, the Natural Health Products Regulations, and other related Health Canada policies and guidelines.
Review of Regulated Health Products: Policy on Public Input
Why an electronic consultation? To provide an opportunity for a broad range of stakeholders to take part in reviewing a draft policy and providing feedback.
In June 2005, the Office of Consumer and Public Involvement of the Health Products and Food Branch started developing a policy on public input into the review of regulated products. The Branch developed this policy to promote a more open and transparent system for reviewing the safety and effectiveness of products and food both pre and post market. It recognizes that input from citizens and stakeholders is an important source of evidence in regulatory decision making about benefits and risks.
The Policy sets out standards to follow when the Branch seeks and considers public input. The policy guides the Branch in how to manage information about a regulated product, including confidential business information, to support informed public participation in its decision-making processes.
In July 2006, as part of its ongoing consultations, HPFB posted the draft Policy and an electronic workbook on Health Canada's Web site. The workbook gave participants information about key policy elements and asked focused questions about them.
To encourage response to the workbook, HPFB sent out 125 e-mails to 18 members of Health Canada's Science Advisory Board and 107 organizations, including officials in industry, health professionals, academics, patients, and consumers. In addition, any visitor to the Health Canada Web site could read the draft policy and complete the workbook questions. In all, 65 people completed the online workbook, 62 in English and 3 in French; results are available online. The input received confirmed HPFB's policy approach and helped to structure the final policy.
Public involvement using ongoing mechanisms
The Health Products and Food Branch uses a number of ongoing mechanisms to gather input and advice, including bilateral and advisory committee meetings. With external advisors as members, these meetings are a valuable, independent source of information and allow the Branch to communicate its policies and increase the transparency of its decision-making process.
Did you know?
The number of public involvement activities using ongoing mechanisms at HPFB over the last three years.
2004-05: 65 activities
2005-06: 81 activities
2006-07: 65 activities
In 2005-06, the Branch held 38 bilateral meetings and 43 advisory body meetings, and in 2006-07, the Branch held 22 bilateral meetings and 43 advisory body meetings, compared with 31 bilaterals meetings and 34 advisory body meetings in 2004-05.
Why we consulted
Regular meetings with various committees and groups ensure that participants are informed on an ongoing basis of the Branch's activities and that their views are heard. While each meeting is held to meet a specific objective, the Branch generally aims to achieve one or more of the following goals:
- to receive medical, technical, scientific, or other expert advice and recommendations on policy development or regulatory issues related to products regulated by the Branch;
- to request advice and guidance on the planning, development, delivery, and evaluation of Branch programs;
- to ensure that the Branch and participants have the same understanding of relevant issues;
- to discuss issues of mutual interest, including regulatory issues, and share information and expertise;
- to solicit advice from a wide variety of stakeholders, including consumers and the public, on major issues and initiatives; and
- to enhance co-operation and collaboration with consulted groups.
Advisory bodies meetings
The Branch has established a number of standing advisory bodies that provide advice and, in some cases, act as sounding boards to Branch and other Health Canada officials as they carry out their work. These bodies are made up of a wide range of members, and may include health professionals, industry representatives, academics, and patient and consumer representatives. Members are selected, based on their experience and expertise, and according to the purpose of each committee.
In 2005-06, the Branch held 43 meetings with 23 advisory bodies, and in 2006-07, the Branch held 43 meetings with 26 advisory bodies, compared with 34 meetings with 20 advisory bodies in 2004-05 (refer to Annexes for a list of Branch committees).
Advisory body
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.
Advisory Committee on Management
The Branch's Advisory Committee on Management met three times in 2005-06 and one time in 2006-07. It provided a forum for senior Health Canada officials and external stakeholders to exchange ideas, opinions, expertise, and advice on a wide range of issues concerning therapeutic products, such as pharmaceuticals (prescription and over-the-counter), medical devices, biologics and genetic therapies (such as vaccines and blood and blood products), radiopharmaceuticals, and natural health products.
Did you know?
The Advisory Committee on Management's 19 external members include health professionals, as well as representatives from industry associations, patient and consumer groups, academia, and other levels of government.
Advisory panels or working groups
Advisory panels or working groups are often used to provide ongoing medical, technical, and scientific advice and recommendations on regulatory policies, programs, or issues that arise during the review of health products (refer to Annexes for a list of advisory panels or working groups).
Members are chosen through a formal nomination process involving a wide range of stakeholders. Panel members are recruited on the basis of their expertise or experience related to the mandate of the advisory body. The Branch also seeks members with a variety of perspectives to ensure that advice is as balanced and as comprehensive as possible. Broader involvement can be particularly useful in providing alternative perspectives to deal with inherent uncertainty and "imperfect" knowledge, in the scientific context.
Bilateral meetings
The Branch meets with industry and health professional associations to discuss and consult on regulatory issues of mutual interest, share information and expertise, and when appropriate, responsibilities under the Food and Drugs Act and Regulations. Some meetings are held regularly - one to four times a year - while others are conducted as needed to develop relationships or to discuss specific issues. In 2005-06, the Branch held 38 bilateral meetings and in 2006-07, the Branch held 22 bilateral meetings with various organizations (refer to Annexes for a detailed list).
Bilateral meeting
A formal meeting usually between government and a stakeholder organization (public or private) to identify, clarify, or increase the knowledge on issues.
Assistant Deputy Minister stakeholder meetings
In 2006-07, HPFB launched an ADM bilateral meeting program. Through the program, the Assistant Deputy Minister and key Branch officials meet with stakeholders to have open discussions about issues of stakeholder interest. These meetings are initiated by HPFB to help to ensure that stakeholder issues are being addressed at the appropriate level within the Branch, and to provide HPFB with a vehicle to address its issues with stakeholders. Meetings also help to support the Branch's relationships with stakeholders. In 2005-07, the Branch met with 22 stakeholder organizations (refer to Annexes for a list of organizations).
