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Online Consultation: Blueprint for Renewing Canada's Health Products and Food Regulatory System: Final Report
March, 2007
Prepared for the Health Products and Food Branch by Ascentum.
Help on accessing alternative formats, such as Portable Document Format (PDF), Microsoft Word and PowerPoint (PPT) files, can be obtained in the alternate format help section.
(PDF Version - 358 K)Table of Contents
- Executive Summary
- 1. Background
- 2. Current Regulatory Challenges
- 3. The Blueprint for Renewal
- 4. Critical Success Factors
- 5. Evaluation of the Online Consultation Process
- 6. Conclusion
Executive Summary
Blueprint for Renewal
Health Canada's Health Products and Food Branch (HPFB) has developed the Blueprint for Renewal, a document (available on Health Canada's website) that proposes a path forward to modernize Canada's approach to regulating health products and food.
This document has provided the basis for discussions with citizens and stakeholders. The objective is to collect input on which the continued development and implementation of the Blueprint will be based.
HPFB's consultation approach includes both in-person and online techniques. Seven regional discussion sessions on the Blueprint were held in November 2006 with key Branch stakeholders (a summary report is available on Health Canada's website). The online consultation was developed to complement the in-person sessions and expand the scope of input and insight collected. This report presents the findings from the online consultation. In addition, a series of consultations on specific Blueprint initiatives were conducted during the second half of 2006.
The Blueprint for Renewal is Health Canada's plan for modernizing Canada's approach to regulating health products and food.
Participation
The online consultation was "live" for a total of six weeks, ending December 6th, 2006. Participants had the opportunity to complete a workbook, share a story or idea related to regulatory modernization, or do both. During this period, 296 participants started the online workbook, with 226 completed and 70 partially completed workbooks. The online consultation also collected 35 stories and ideas from participants. The stories and ideas supplemented almost 200 written comments submitted within the workbooks.
The two largest respondent groups were health professionals (29%) and industry stakeholders (27%). These groups were followed by concerned citizens (11%), federal government officials (10%) and public interest groups (9%). The remaining participants identified themselves as academics/researchers (6%), provincial government officials (5%) and patients (4%). A majority of the respondents (60%) answered that they frequently deal with the regulatory system, while about 20% indicated they did not deal with the regulatory system.
Participants had the opportunity to complete a workbook, share a story or idea, or do both.
Section 1 - Current Regulatory Challenges
The first section of the workbook discussed the following key challenges facing the health products and food regulatory system:
- Limited and inflexible tools for regulators
- An imbalance between before and after market activities
- The impact of social, scientific and technological change
Based on their responses, participants clearly felt that something should be done to address the current challenges facing the regulatory system.
Overall a large majority of participants (over 80%) strongly agreed or agreed that each of the three challenges presented:
- Were real;
- Represented priority areas for Health Canada; and
- If addressed, would have a positive impact on the regulatory system and health of Canadians.
This would appear to represent an endorsement for the modernization of the regulatory system.
Participants clearly felt that something should be done to address the current challenges facing the regulatory system.
Section 2 - Elements for Renewal
The workbook's second section outlined the following eight ways the regulatory system could be strengthened:
- A product life cycle approach to regulation
- A risk-based approach to regulatory intervention
- A modern approach to food safety and nutrition
- A pro-active and enabling regulatory system
- Making the best use of all types of evidence
- Special emphasis on specific populations
- Increased transparency, openness and accountability
- Moving to an integrated system
All eight elements received strong support from participants and generally agreed that they would have a positive impact on Canada's regulatory system and the health and safety of Canadians. Similar to the support demonstrated around the key challenges, respondents would also appear to support the overall Blueprint and in particular the eight elements presented.
"Increased transparency, openness and accountability" received the strongest overall support (87% of participants strongly agreed or agreed this should be a priority for Health Canada). Element 3 - "A modern approach to food safety and nutrition" followed closely as the second highest priority. While all elements received strong support overall, element 6 - "Special emphasis on specific populations" was ranked the lowest priority by participants.
When examining the impact each element would have on the regulatory system, most participants felt it would be positive. Element 4 - "A pro-active and enabling regulatory system" and Element 5 - "Making the best use of all types of evidence" received the highest support. Almost 80% of participants agreed or strongly agreed addressing these areas would have a positive impact on the regulatory system.
In terms of the health and safety of Canadians, most participants strongly agreed or agreed that implementing each of the elements would have a positive impact. Element 3 - "A modern approach to food safety and nutrition" received the strongest support with 80% of participants strongly agreeing or agreeing that addressing this area would have a positive impact on the health and safety of Canadians. Element 2 - "A risk-based approach to regulatory intervention" received the lowest level of support of the eight elements, with 11% of participants strongly disagreeing or disagreeing that implementing this element would have a positive impact on the health and safety of Canadians.
All eight elements received strong support when participants were asked whether or not they would have a positive impact on Canada's regulatory system and the health and safety of Canadians.
When examining the impact each element would have on the regulatory system, most participants felt it would be positive.
In terms of the health and safety of Canadians, most participants strongly agreed or agreed that implementing each of the elements would have a positive impact.
Top of PageSection 3 - Critical Success Factors
Health Canada identified five critical success factors to support HPFB in achieving the Blueprint's main objectives:
- A 21st century toolkit - legislation, regulatory frameworks and instruments;
- Internationally benchmarked regulatory practices, processes and risk management;
- A sustainable, high performance, science-based organization - continued investments in staff and infrastructure;
- Strategic international regulatory cooperation;
- Enhanced partnership and stakeholder involvement
Based on the responses, "A sustainable, high performance, science-based organization - continued investments in staff and infrastructure" received the greatest support with over three quarters (76%) of participants ranking it "high" or "highest" in terms of priority. "A 21st century toolkit - legislation, regulatory frameworks and instruments" received the second highest level of support with just under three-quarters (73%) of participants ranking it "high" or "highest" in terms of priority. The remaining three success factors also received strong overall support, however at a lower level relative to the two success factors listed above.
Health Canada identified five critical success factors to support HPFB in achieving the Blueprint's main objectives.
1. Background
1.1 About the Blueprint for Renewal
Health Canada's Health Products and Food Branch (HPFB) has developed the Blueprint for Renewal: Transforming Canada's Approach to Regulating Health Products and Food - a discussion document that proposes a plan for modernizing the regulatory system for health products and food.
As an internationally recognized regulatory leader, Health Canada's vision is for a regulatory system that:
- Helps Canadians improve their health outcomes through timely access to safe, effective and high-quality health products and food;
- Strengthens safety oversight through a product lifecycle approach;
- Sustains and improves regulatory efficiency and predictability, while maintaining Health Canada's high standards for safety;
- Is accountable, open and transparent to stakeholders and the public; and
- Contributes to better aligned regulatory and reimbursement decision-making.1
A dialogue on the Blueprint with stakeholders and citizens is essential in order to guide the modernization of Canada's regulatory system. The results of all consultation activities will help inform the continued development and implementation of the Blueprint for Renewal.
The Blueprint for Renewal is a discussion document that explores the modernization of the regulatory system for health products and food.
1.2 About The Online Consultation
HPFB's Blueprint consultation approach includes both in-person and online techniques. Seven regional discussion sessions on the Blueprint were conducted with key Branch stakeholders in November 2006.
The online consultation was developed to complement the in-person sessions and expand the scope of input and insight collected. Participants were asked to provide feedback on some of the key challenges facing Health Canada's regulatory system, the elements that make up the Blueprint, as well as the critical success factors for implementation.
In this chapter, we will discuss the online consultation participation profile, including:
- Participation levels
- Workbook respondents profile
- Stories and ideas contributors profile
HPFB's consultation approach includes both in-person and online techniques.
1.3 Participation Levels
The HPFB Blueprint for Renewal online consultation was "live" for a total of six weeks, from October 26th to December 6th, 2006. In terms of online consultation tools, participants had the opportunity to complete a workbook, share a story or idea related to regulatory modernization, or do both.
During the live period 296 participants started the online workbook, with 226 completed and 70 partially completed workbooks. This translates into a 76.4% completion rate that is high in comparison to traditional survey completion rates, which typically fall between 10 and 25%. This demonstrates a high level of commitment on behalf of participants, particularly based on the fact that the workbook took approximately 40 minutes to complete.
The online consultation also collected 35 stories and ideas from participants. The stories and ideas supplemented almost 200 written comments submitted within the workbooks. These comments provided feedback on the challenges facing today's regulatory system, the eight elements of the Blueprint and the critical success factors to support HPFB in achieving the Blueprint's main objectives.
Participants had the option to register or participate anonymously. Over three quarters (77.4%) of the participants registered for the online consultation.
The following table summarizes some of the key participation figures from the Blueprint for Renewal online consultation:
| Participation levels | Results |
|---|---|
| Workbooks* | |
| Total workbooks started** | 296 |
| Total workbooks completed*** | 226 |
| Workbook registered participant rate | 77.4% |
| Workbook anonymous participant rate | 22.6% |
| Workbook completion rate | 76.3% |
| Stories/Ideas | |
| Total stories/ideas | 35 |
* "Workbooks" refers to both the online and paper workbooks.
** "Workbooks started" refers to the number of people who initiated a workbook, responding to more than 3 questions.
*** "Workbooks completed" refers to the number of people who reached the last question of the workbook.
Given the high level of participation, the online consultation proved to be an effective complement to the in-person sessions, having extended the opportunity to provide input to a larger group of stakeholders.
1.4 Profile Of Workbook Participants
The "About You" section of the workbook collected basic demographic and contextual information for analysis purposes.
Perspective
Participants were asked to identify which category best described their perspective. The two largest groups of respondents were health professionals (29%) and industry stakeholders (27%). These groups were followed by concerned citizens (11%), federal government officials (10%) and public interest groups (9%). The remaining participants identified their perspective as academics/researchers (6%), provincial government officials (5%) and patients (4%).
Health Canada Participants
Federal Government officials working for Health Canada were asked to identify the group they were part of; 20 of the 27 federal government officials responded to this question. A quarter of them stated they were part of the Therapeutic Products Directorate. The remaining participants were spread fairly evenly across the other groups (Biologics and Genetics Therapies Directorate; Inspectorate; Food Directorate; Veterinary Drugs Directorate; Marketed Health Products Directorate; Policy, Planning and International Affairs Directorate; Office of Management and Program Services; Assistant Deputy Minister's Office; Regional offices). The only groups not represented were the Natural Health Products Directorate and the Office of Consumer and Public Involvement.
Health Canada Area of Work
The same group was also asked to state the area they were working in. The largest group (30%) was in the policy and regulatory development area and 20% were in corporate support. The remaining groups identified themselves as part of science and research (15%), regulatory review (10%) and public involvement (5%). Twenty percent also responded they worked in 'other' areas, including revision of drug submissions, records assistant and regulatory compliance.
Dealing With The Regulatory System
A majority of all respondents (60%) answered that they frequently deal with the regulatory system. Specifically, 42% indicated that they deal with the system on a weekly basis while 18% deal with it monthly. Eighteen percent of the participants answered that they rarely deal with the system and 22% thought the question did not apply to them, likely meaning they do not deal with the regulatory system.
Organizations' Areas Of Interest
Out of the participants who checked an area of interest for their organization, one quarter said their organization's main area of interest was food (25%). Pharmaceuticals ranked second with 23% and natural health products came in third position with 22%. Thirteen percent and 12% of the participants checked 'medical devices and biologics' and 'genetic therapies' respectively. Finally, 5% of the participants checked veterinary drugs as their organization's area of interest.
Province Of Residence
The largest number of participants came from Ontario (44%). Quebec and British Columbia each accounted for 13.4% of the total participation with Manitoba contributing 11%.
Alberta and Saskatchewan each had approximately 5% of the participants with Nova Scotia (3.4%), New Brunswick (2.4%), Newfoundland and Labrador (2.1%) and Prince Edward Island (1.7%) accounting for the remaining participants. Also noteworthy was the absence of participants from the Yukon, Northwest Territories and Nunavut. The chart below summarizes the distribution of workbook respondents by province:
Education
The majority of participants reported high formal education levels. Almost three quarters had a Bachelor's degree (35%) or a post-graduate degree (38%).2. Current Regulatory Challenges
The first section of the workbook presented participants with an overview of the key regulatory challenges. These included:
- Limited and inflexible tools for regulators
- An imbalance between before and after market activities
- The impact of social, scientific and technological changes
Participants had the opportunity to learn about each of the challenges before providing their input.
2.1 Challenges
Challenge 1: Limited And Inflexible Tools For Regulators
Challenge 1 explored the issues facing Canada's regulatory system around the limited and inflexible tools currently available to regulators. When asked to provide their input, participants responded in the following manner:
| Strongly Agree | Agree | Neither | Disagree | Strongly Disagree | I Don't Know | N= | |
|---|---|---|---|---|---|---|---|
| Limited and inflexible tools for regulators is a real challenge for Canada's health products and food regulatory system | 36.2% | 47.1% | 8.2% | 3.5% | 1.2% | 3.9% | 257 |
| Health Canada should make it a priority to broaden and strengthen its tools to evaluate and monitor health products and food, both pre- and post-market | 51.0% | 35.8% | 7.4% | 3.5% | 0.8% | 1.6% | 257 |
| Addressing this challenge will have a positive impact on Canada's regulatory system and the health and safety of Canadians | 44.4% | 36.6% | 7.4% | 3.9% | 0.4% | 7.4% | 257 |
- Over a third of the participants strongly agreed (36%) and close to half agreed (47%) that limited and inflexible tools for regulators were a real challenge for the regulatory system.
- Over half of the participants strongly agreed (51%) and 36% agreed with making it a priority to broaden and strengthen Health Canada's tools to evaluate and monitor health products and food, both before and after they reach the market.
- Forty-four percent of the participants strongly agreed and 37% agreed that addressing this challenge would have a positive impact on Canada's regulatory system and the safety of Canadians.
Challenge 2: An Imbalance Between Before and After Market Activities
Most of the regulator's resources are now focused on evaluating a therapeutic product before it is approved, rather than after it reaches the market. The second challenge examined this imbalance. Participants provided the following input:
| Strongly Agree | Agree | Neither | Disagree | Strongly Disagree | I Don't Know | N= | |
|---|---|---|---|---|---|---|---|
| The imbalance between pre-market and post-market activities is a real challenge for Canada's health products and food regulatory system | 37.7% | 46.4% | 8.3% | 3.6% | 0.8% | 3.2% | 252 |
| Health Canada should increase its efforts to assess post market product safety and effectiveness | 47.0% | 41.1% | 3.2% | 4.7% | 2.4% | 1.6% | 253 |
| Addressing this challenge will have a positive impact on Canada's regulatory system and the health and safety of Canadians | 41.1% | 41.1% | 6.7% | 4.3% | 2.0% | 4.7% | 253 |
- Thirty-eight percent and 46% of the participants strongly agreed or agreed that the imbalance is a real challenge.
- A large majority strongly agreed (47%) or agreed (41%) that Health Canada should increase its efforts in the area of after market assessment.
- Forty-one percent of participants strongly agreed and 41% agreed that addressing this challenge would have a positive impact on the regulatory system and Canadians' health and safety.
Challenge 3: The Impact Of Social, Scientific And Technological Change
| Strongly Agree | Agree | Neither | Disagree | Strongly Disagree | I Don't Know | N= | |
|---|---|---|---|---|---|---|---|
| The impact of social, scientific and technological changes is a real challenge for Canada's health products and food regulatory system | 48.0% | 41.0% | 7.4% | 2.0% | 0.4% | 1.2% | 244 |
| Health Canada should make it a priority to improve its ability to respond to emerging social, scientific and technological changes | 48.4% | 42.6% | 6.6% | 1.2% | - | 1.2% | 244 |
| Addressing this challenge will have a positive impact on Canada's regulatory system and the health and safety of Canadians | 41.8% | 43.0% | 6.6% | 2.5% | - | 6.1% | 244 |
- Forty-eight percent strongly agreed and 41% agreed that it is a real challenge for the regulatory system.
- Forty-eight percent of the participants strongly agreed and 43% agreed that Health Canada should make this challenge a priority.
- The positive impact of addressing this challenge on both the regulatory system and the health and safety of Canadians was acknowledged by 85% of the participants (42% strongly agreed and 43% agreed).
2.2 Comparison Across Challenges and Perspectives
Overall a large majority of participants (over 80%) strongly agreed or agreed that each of the three challenges presented:
- Were real;
- Represented priority areas for Health Canada; and
- If addressed, would have a positive impact on the regulatory system and health of Canadians
In comparing results across each challenge, the third challenge - the impact of social, scientific and technological changes - received the strongest support. The first two challenges ranked almost identically, and only slightly lower than Challenge 3.
For the most part participants across all perspectives agreed that each of the areas explored represented challenges for Health Canada. One exception to this observation was noted. When asked whether Health Canada should increase its efforts to assess after market product safety and effectiveness, support from industry respondents was lower in comparison to the results from the other perspectives. Similarly, industry support was lower when asked if addressing this challenge would have a positive impact on Canada's regulatory system and the health and safety of Canadians.
In comparing across each challenge, the third challenge - the impact of social, scientific and technological change - received the strongest support.
In terms of responses by perspective, for the most part participants agreed that each of the areas explored represented challenges for Health Canada.
Summary remarks
Based on the responses to the questions asked for each of the three challenges presented in the online workbook, participants clearly felt that something should be done to address the challenges facing the current regulatory system.
Participants felt strongly that addressing the challenges would have both a positive impact on the regulatory system and the health of Canadians. This would appear to represent an endorsement for the modernization of the regulatory system.
Overall, the sentiments expressed by all participants were consistent across each group, except for industry's lower support for enhanced assessment of post-market safety and effectiveness.
3. The Blueprint for Renewal
3.1 The Eight Elements
Health Canada's Blueprint for Renewal has been developed to guide government efforts to modernize how health products and food are regulated.
The Blueprint outlines eight ways in which the regulatory system could be strengthened. In the workbook's second section, participants were introduced to each of these eight elements and asked to provide their input.
Element 1: A product life cycle approach to regulation
Element 1 explored the topic of a product lifecycle approach to regulation. This approach would mark a major shift in regulatory practices. Instead of discrete regulatory interventions at specific points, a life cycle approach would encompass all stages of product development and use. When asked to provide their input around this element, participants responded in the following manner:
| Strongly Agree | Agree | Neither | Disagree | Strongly Disagree | I Don't Know | N= | |
|---|---|---|---|---|---|---|---|
| Health Canada should make adopting a life cycle approach a priority | 40.1% | 39.7% | 12.2% | 3.4% | 0.8% | 3.8% | 237 |
| Implementing this element will have a positive impact on Canada's regulatory system | 29.1% | 42.2% | 13.9% | 3.4% | 1.3% | 10.1% | 237 |
| Implementing this element will have a positive impact on the health and safety of Canadians | 31.2% | 40.5% | 13.5% | 3.4% | 1.3% | 10.1% | 237 |
- Eighty percent strongly agreed or agreed (40% each) that Health Canada should make this element a priority.
- Seventy-two percent indicated its implementation would have a positive impact on Canada's regulatory system.
- Seventy-two percent responded that implementing this element would have a positive impact on the health and safety of Canadians.
In examining the results by perspective, industry respondents, while still in support of this element, were less likely to agree in comparison to the other perspectives.
What we Heard - Ideas, stories and comments on Element 1
The majority of ideas submitted concerning Element 1 came from industry stakeholders. In general, the introduction of a product "life cycle" approach was received positively by these and other participants.
"We consider a "Life Cycle" approach rather than interventions at definite point...a very positive component of this Blueprint."
- An Industry Stakeholder -
A number of participants suggested that an effective life cycle approach would need improved after-market surveillance, supported by reliable data on safety and efficacy. One commented that more rigorous surveillance could be supported by information provided by physicians, pharmacists and patients. This would be especially important in monitoring physicians' use of particular health products and evidence of any off-label use.
Several industry stakeholders expressed concerns about the implementation of a life cycle approach. They observed that Health Canada already has access to after market data and, as a result, questioned the benefits. They also expressed unease about the potential costs and "red tape" that could be generated under a life cycle approach.
One participant sought clarification on the Canadian Food Inspection Agency's (CFIA) role in food safety under a life cycle approach. This individual queried why the consultation had not included reference to CFIA's mandate in this area.
A federal public servant suggested that the life cycle approach be used to respond not only to products that have lower-than-expected risks when issued in the marketplace, but also to those that may have higher-than-expected risks.
Finally, a provincial government participant requested information on "real life" examples to gain a more thorough understanding of how a life cycle approach would work for health products and food.
A number of participants suggested that an effective life cycle approach would need improved after-market surveillance, supported by reliable data on safety and efficacy.
Element 2: A risk-based approach to regulatory intervention
Element 2 looked at risk-based approaches to regulatory intervention. Health Canada plans to move toward a more transparent and predictable system of categorizing both food and health products, assessing their risk, and making interventions proportional to the risk. Participants provided the following responses to the questions presented for this element:
| Strongly Agree | Agree | Neither | Disagree | Strongly Disagree | I Don't Know | N= | |
|---|---|---|---|---|---|---|---|
| Health Canada should make implementing risk-based regulatory interventions a priority | 41.0% | 41.5% | 8.7% | 4.4% | 0.9% | 3.5% | 229 |
| Implementing this element will have a positive impact on Canada's regulatory system | 35.1% | 41.7% | 8.8% | 4.8% | 0.9% | 8.8% | 228 |
| Implementing this element will have a positive impact on the health and safety of Canadians | 32.5% | 37.7% | 7.9% | 7.9% | 2.6% | 11.4% | 228 |
- Forty-one percent strongly agreed and 42% agreed with the fact that Health Canada should make implementing this element a priority.
- Over three quarters of the participants acknowledged its positive impact on the regulatory system (35% strongly agreed and 42% agreed).
- A third of the participants strongly agreed and 38% agreed that implementing this element would have a positive impact on the health and safety of Canadians.
In examining the responses provided by each of the different perspectives, the concerned citizens' view varied from the other perspectives. Specifically, the concerned citizens were less likely to agree that:
- Health Canada should make implementing risk-based regulatory interventions a priority;
- Implementing a risk-based approach to regulatory intervention would have a positive impact on Canada's regulatory system; and
- Implementing a risk-based approach to regulatory intervention would have a positive impact on the health and safety of Canadians.
What we Heard - Ideas, stories and comments on Element 2
Comments from participants were strongly supportive of adopting risk-based approaches to regulation. These views came predominantly from industry stakeholders, but also from several provincial governments, health professionals and an interested citizen.
Several organizations remarked that a more targeted approach to risk categorization would have a positive impact on their business operations and ability to innovate.
"Lack of clarity and sophistication in product categorization has tended to move novel food products and ingredients into a regulatory paradigm more appropriate to higher risk health products, with serious consequences for product innovation, market development and consumer choice."
- An Industry Stakeholder -
Other industry stakeholders supported a risk-based approach, but with caveats. One suggested that efforts should be made to ensure that a flexible framework was applied consistently to all products of similar risk. Another commented that decisions should still be evidence-based.
A provincial government participant expressed support but requested more information on how Health Canada would determine the risk levels of products and how "low-risk" products would be regulated under the new approach.
In addition to these views, there was a strong call from a number of industry stakeholders for a more coherent approach to the regulation of self-care health products, including over-the-counter (OTC) and natural health products (NHPs).
"Remove the regulation of non-prescription drugs from Part C of the Food and Drug Regulations and develop a new set of risk-based regulations that would apply to all self-care health products."
- An Industry Stakeholder -
One organization expressed the difficulty of having prescription therapy policies applied to half their products (OCTs) and a self-care policy applied to the other half (NHPs).
Several organizations remarked that a more targeted approach to risk categorization would have a positive impact on their business operations and ability to innovate.
There was a strong call from a number of industry stakeholders for a more coherent approach to the regulation of self-care health products.
Element 3: A modern approach to food safety and nutrition
Element 3 addressed a modern approach to food safety and nutrition. As part of the Blueprint, Health Canada plans to develop and implement a Regulatory Modernization Strategy for Food and Nutrition in order to respond to emerging food safety and nutrition challenges, nationally and internationally. When asked to provide their input around this element, participants responded in the following manner:
| Strongly Agree | Agree | Neither | Disagree | Strongly Disagree | I Don't Know | N= | |
|---|---|---|---|---|---|---|---|
| Health Canada should make implementing a modern approach to food safety and nutrition a priority | 44.9% | 41.0% | 5.7% | 3.5% | 0.9% | 4.0% | 227 |
| Implementing this element will have a positive impact on Canada's regulatory system | 35.2% | 41.9% | 9.7% | 1.8% | 1.3% | 10.1% | 227 |
| Implementing this element will have a positive impact on the health and safety of Canadians | 41.2% | 38.5% | 8.4% | 1.8% | 1.3% | 8.8% | 226 |
- Almost half of the participants strongly agreed (45%) while 41% agreed this element should be a priority for Health Canada.
- Over three quarters of the participants strongly agreed (35%) or agreed (42%) that implementing this element would have a positive impact on the regulatory system.
- Approximately 80% agreed (41% strongly agreed and 39% agreed) that implementing this element would have a positive impact on the health and safety of Canadians.
Of note, a sizeable number of participants (19% and 18% respectively), responded "neither" or "I don't know" in relation to the impact that implementing this element would have on the regulatory system or on the health and safety of Canadians. Also of note was the fact there were no noticeable differences across the different perspectives.
What we Heard - Ideas, stories and comments on Element 3
Participants expressed a range of perspectives on Canada's regulatory strategy for food and how this could be strengthened. Broad patterns emerged across the groups of stakeholders: industry associations expressed concern about the speed of regulatory amendments, health professionals urged greater use of a precautionary approach to regulatory decision-making and government officials called for greater coherence in regulatory oversight.
"The Canada Gazette process required for most regulatory changes means that the food/beverage industry currently faces a complex, cumbersome and lengthy process (anywhere between 1 and 5+ years) for even simple things as requesting the use of a different food additive in a product"
- An Industry Stakeholder -
Several stakeholders expressed similar views and suggested that regulatory change should allow for faster approvals, especially in cases where there was demonstrated low-risk. Furthermore, one group commented that the legislative and regulatory authority in the Food and Drugs Act is inadequate and that there is a need for a dedicated "Food Act" to focus on the needs of the food and beverage industry.
Despite wide agreement among industry associations on the need for more efficient regulatory approvals, there were some differences of opinion on the approval process for different kinds of health products. Food that is considered a 'natural health product' has different considerations. Some stakeholders argued that natural health products should not be evaluated against the same "double-blind" standard as pharmaceutical products because "natural health products do not behave in the same manner as a foreign substance such as a pharmaceutical product." However, other industries suggested it would be unfair to assess pharmaceutical products differently from natural health or food products.
Several health professionals expressed concern over the proposed shift to a "risk-based" approach for food regulation. One, who described himself or herself as a dietician, reported feeling unease about the safety of food products imported from Asia and South East Asia. Another suggested that the main approach should be based on prevention, not on perceived levels of risk, which could be inaccurate.
Finally, a number of government officials called for greater regulatory alignment between governmental organizations.
Several stakeholders expressed similar views and suggested that regulatory change should allow for faster approvals, especially in cases where there was demonstrated low-risk.
Several health professionals expressed concern over the proposed shift to a "risk-based" approach.
Element 4: A pro-active and enabling regulatory system
Element 4 looked at the issue of a pro-active and enabling regulatory system. As part of the Blueprint, Health Canada plans to establish a regulatory foresight program to proactively develop or adapt regulatory guidance to support new product development and regulatory review. Participants responded in the following manner to the questions presented:
| Strongly Agree | Agree | Neither | Disagree | Strongly Disagree | I Don't Know | N= | |
|---|---|---|---|---|---|---|---|
| Health Canada should make developing a pro-active regulatory system a priority | 39.0% | 46.1% | 9.6% | 3.1% | - | 2.2% | 228 |
| Implementing this element will have a positive impact on Canada's regulatory system | 33.3% | 45.2% | 11.8% | 3.5% | - | 6.1% | 228 |
| Implementing this element will have a positive impact on the health and safety of Canadians | 30.4% | 39.6% | 14.1% | 4.8% | 0.4% | 10.6% | 227 |
- Eighty-five percent strongly agreed or agreed (39% and 46% respectively) with making this element a priority.
- Seventy-eight percent strongly agreed or agreed (33% and 45% respectively) that implementing this element would have a positive impact on Canada's regulatory system.
- Seventy percent strongly agreed or agreed (30% and 40% respectively) that implementing this element would have a positive impact on the health and safety of Canadians.
In examining the results by perspective, the 'academics/researchers' view varied from the other perspectives. Specifically, the academics/researchers were less likely to agree that:
- Health Canada should make developing a pro-active regulatory system a priority;
- Implementing a pro-active and enabling regulatory system would have a positive impact on Canada's regulatory system; and
- Implementing a pro-active and enabling regulatory system would have a positive impact on the health and safety of Canadians.
What we Heard - Ideas, stories and comments on Element 4
The online consultation received fewer written comments on Element 4 than on other components of the Blueprint. The majority of views received was from industry and were supportive of a pro-active approach to regulation.
"We are in full agreement with element 4, this blends very well with the life-cycle approach discussed in element 1."
- An Industry Stakeholder -
Nevertheless, one industry stakeholder commented that, while the Blueprint lays out a process for dialogue on new technologies with manufacturers of health products, a similar approach was not described for engaging the agri-food industry on similar issues related to food. This respondent suggested that Health Canada should plan a regulatory foresight program specific to agri-food.
A health professional suggested that instead of helping to develop new and novel health or food products, the central objective of the regulatory system is to protect the safety of Canadians.
The online consultation received fewer written comments on Element 4 than on other components of the Blueprint.
Element 5: Making the best use of all types of evidence
Element 5 explored the topic of making the best use of all types of evidence. As part of the Blueprint, Health Canada wants to improve how it collects, generates, disseminates and responds to safety and effectiveness data for health products. Participants provided the following responses to the questions posed for this element:
| Strongly Agree | Agree | Neither | Disagree | Strongly Disagree | I Don't Know | N= | |
|---|---|---|---|---|---|---|---|
| Health Canada should make improvements to its collection and use of data a priority | 49.8% | 35.6% | 8.0% | 4.0% | 1.3% | 1.3% | 225 |
| Implementing this element will have a positive impact on Canada's regulatory system | 38.2% | 40.4% | 12.0% | 4.9% | 0.9% | 3.6% | 225 |
| Implementing this element will have a positive impact on the health and safety of Canadians | 38.4% | 37.5% | 14.7% | 4.0% | 1.3% | 4.0% | 224 |
- Half of the participants strongly agreed and 36% agreed that making improvements to Health Canada's collection of data should be a priority.
- Seventy-eight percent strongly agreed or agreed (38% and 40% respectively) that implementing this element would have a positive impact on the regulatory system.
- Over three quarters strongly agreed or agreed (both 38%) that implementing this element would have a positive impact on the health and safety of Canadians.
Of note, when asked whether or not implementing this element would have a positive impact on the regulatory system and the health and safety of Canadians, 12% and 15% of the participants respectively replied "Neither".
In examining the results by perspective, industry respondents were less likely to agree in comparison to the results from the other participant groups. Specifically they were less supportive that making the best use of all types of evidence would have a positive impact on Canada's regulatory system and implementing this element would have a positive impact on the health and safety of Canadians.
What we Heard - Ideas, stories and comments on Element 5
Stakeholders who provided additional information supported element 5 and the proposed use of a greater range of evidence in regulatory decision-making. Several industry stakeholders urged against the Government of Canada requiring sponsors to only undertake "Canadian only" after market studies. They suggested that, due to Canada's limited patient base, allowing greater use of studies in global populations would allow for more accurate assessments.
An academic/researcher suggested that regulatory agencies make greater use of their internal expertise and knowledge. This could include the know-how of technical and non-science experts, as well as practitioners with experience in the field.
A health professional suggested that decisions should be "evidence-informed" but not necessarily "evidence-based". He/she suggested that scientific evidence plays a useful and important role in decision-making, but that other factors should shape these decisions.
"The definition of "evidence" is best defined without fixed paradigm bias and with the embracement of ALL types of evidence (from RCTs to meta-analyses, from case reports to historical use data). Although the strength of each type of evidence must be considered, the strengths of other parameters must be considered as well to facilitate decision-making by Health Canada. The strength of the evidence alone shall not be the only guiding light in decision-making, but be used wisely in the context of these parameters."
- A Health Professional -
Stakeholders supported element 5 and the proposed use of a greater range of evidence in regulatory decision-making.
Decisions should be "evidence-informed" but not necessarily "evidence-based".
Element 6: Special emphasis on specific populations
Element 6 explored the issue of special emphasis in the regulatory system on specific populations. As part of the Blueprint, Health Canada wants to build on its capacity to consider the special needs of specific populations in its regulatory decisions. Participants provided the following responses to the questions around this element:
| Strongly Agree | Agree | Neither | Disagree | Strongly Disagree | I Don't Know | N= | |
|---|---|---|---|---|---|---|---|
| Health Canada should make special emphasis on the needs and vulnerabilities of specific populations a priority | 45.3% | 34.5% | 7.6% | 9.0% | 2.2% | 1.3% | 223 |
| Implementing this element will have a positive impact on Canada's regulatory system | 32.3% | 35.9% | 13.0% | 10.8% | 1.8% | 6.3% | 223 |
| Implementing this element will have a positive impact on the health and safety of Canadians | 39.0% | 32.7% | 12.6% | 6.3% | 2.7% | 6.7% | 223 |
- Forty-five percent strongly agreed and 35% agreed with Health Canada making special emphasis on the needs and vulnerabilities of specific populations a priority.
- Sixty-eight percent strongly agreed or agreed (32% and 36% respectively) that implementing this element would have a positive impact on the regulatory system.
- A little less than three quarters of the participants strongly agreed (39%) or agreed (33%) that implementing this element would have a positive impact on the health and safety of Canadians.
Of note, approximately 20% of participants responded either "Neither" or "I don't know" when asked about the positive impacts of this element.
When examining responses by perspective, almost all responses were consistent across the different groups. However, concerned citizens were less likely to agree that placing a special emphasis on specific populations would have a positive impact on the regulatory system.
What we Heard - Ideas, stories and comments on Element 6
Among participants who commented, there was widespread support for element 6's proposed emphasis on vulnerable populations. Support came from government officials, public interest groups, health professionals and industry stakeholders.
"I agree that it is important to have focus on special populations, but beyond paediatrics. Must include pregnant women, geriatric populations and include interactions with other pre-existing technologies/medications that that population is likely to encounter.
- A Provincial Government Official -
Participants suggested other vulnerable groups that should be considered for inclusion in the Blueprint, including those with diabetes. A health professional suggested that age and gender should be included, as well as social factors such as culture and religion.
"[Stakeholder] supports a risk/benefit approach to decision-making that considers and properly balances the potential benefits for the balance of the population from the introduction of a particular food product or products as well as what special population(s) may be at risk and to what degree. Management of risk to the special population(s) should not always mean that a product cannot come to market."
- An Industry Stakeholder -
While supporting an emphasis on protecting vulnerable populations, one industry stakeholder called for a cost-benefit analysis in which the needs of these groups were balanced against the potential benefits to the larger population.
Among participants, there was widespread support for element 6's proposed emphasis on specific populations.
Element 7: Increased transparency, openness and accountability
Element 7 proposed increased transparency, openness and accountability in the regulatory system. As part of the Blueprint, Health Canada plans to promote a more open and transparent regulatory system that more frequently and consistently involves a broader range of patients, consumers, health professionals, industry and researchers to improve the overall quality of regulatory decision-making. Participants provided the following responses to the questions around this element:
| Strongly Agree | Agree | Neither | Disagree | Strongly Disagree | I Don't Know | N= | |
|---|---|---|---|---|---|---|---|
| Health Canada should make transparency, openness and accountability a priority | 52.0% | 34.7% | 8.9% | 3.1% | 0.9% | 0.4% | 225 |
| Implementing this element will have a positive impact on Canada's regulatory system | 37.8% | 36.9% | 12.4% | 8.4% | 1.3% | 3.1% | 225 |
| Implementing this element will have a positive impact on the health and safety of Canadians | 34.2% | 34.2% | 18.7% | 4.9% | 0.9% | 7.1% | 225 |
- Over half of the participants strongly agreed (52%) and over a third agreed (35%) that Health Canada should make this element a priority.
- Three quarters strongly agreed (38%) or agreed (37%) that implementing this element would have a positive impact on the regulatory system.
- Sixty-eight percent strongly agreed or agreed (both 34%) that implementing this element would have a positive impact on the health and safety of Canadians.
Of note, a higher number of participants disagreed or strongly disagreed that implementing this element would have a positive impact on Canada's regulatory system (10%) in comparison to a positive impact on the health and safety of Canadians (6%).
Further, concerned citizens were less supportive than other perspectives when asked if increased transparency, openness and accountability would have a positive impact on the regulatory system.
What we Heard - Ideas, stories and comments on Element 7
"Public input and access to information about regulatory decisions on the safety of approved products is a step in the positive direction that would lead to informed choice and greater public health protection."
- A Provincial Government Official -
Most stakeholders who commented felt that greater transparency, openness and accountability in regulatory decisions were a positive development.
Some industry groups suggested that, in addition to greater transparency towards citizens, greater transparency in the regulatory system is important to all stakeholders including industry, health professionals and provincial governments.
Nevertheless, some participants were skeptical about citizens' ability to use more technical information about health products and food to inform their decisions. A health professional was concerned that patients would be unable to adequately interpret scientific data and suggested that doctors should play an important role in helping patients understand this technical information.
Several industry participants saw a potential conflict between transparency and the protection of private, commercial information about products. They expressed concerns that the risks inherent in a new open and transparent approach of compromising valuable commercial information could act as a disincentive for research and innovation. Some of these participants also argued that greater transparency would place further burdens and constraints on the regulatory system.
"This transparency and openness should include making clear how evidence submitted by various stakeholders during consultations is weighed or considered in the decision-making process. For example, how were the views of experts balanced against those of lay commentators? What criteria were given prominence in decision-making?"
- An Industry Stakeholder -
Several industry stakeholders suggested that there should be greater transparency around how regulatory decisions are made and the rationale for these decisions.
Most stakeholders commented that greater transparency, openness and accountability in regulatory decisions were a positive development.
Several industry participants saw a potential conflict between transparency and the protection of private, commercial information about products.
Element 8: Moving to an integrated system
Element 8 addresses the issue of moving to an integrated system. As part of the Blueprint, Health Canada plans to develop stronger partnerships with a number of organizations so that the regulatory system is better aligned with the objectives, policies and practices of the health care and innovation systems. Participants provided the following responses to the questions posed on this element:
| Strongly Agree | Agree | Neither | Disagree | Strongly Disagree | I Don't Know | N= | |
|---|---|---|---|---|---|---|---|
| Health Canada should make a more integrated system a priority | 39.7% | 44.2% | 9.4% | 2.7% | 0.9% | 3.1% | 224 |
| Implementing this element will have a positive impact on Canada's regulatory system | 33.0% | 45.1% | 12.5% | 2.2% | 0.9% | 6.3% | 224 |
| Implementing this element will have a positive impact on the health and safety of Canadians | 29.0% | 39.7% | 17.9% | 4.0% | 0.4% | 8.9% | 224 |
- Eighty-four percent strongly agreed or agreed (40% and 44% respectively) that Health Canada should make a more integrated system a priority.
- A third of the participants strongly agreed and 45% agreed that implementing this element would have a positive impact on Canada's regulatory system.
- Twenty-nine percent of participants strongly agreed and 40% agreed that implementing this element would have a positive impact on the health and safety of Canadians.
A look at the results across perspectives reveals the following:
- Industry respondents were less likely to agree that making a more integrated system should be a priority for Health Canada in comparison to the overall results.
- Concerned citizen respondents were less likely to agree that implementing this element would have a positive impact on the health and safety of Canadians
What we Heard - Ideas, stories and comments on Element 8
Participants who provided comments generally agreed with the proposal for greater partnership in a more integrated system.
"In an environment of scarce professional resources, it will be important for Health Canada to partner effectively with industry, academia, and other jurisdictions to access the expertise to make informed decisions."
- A Health Professional -
Several industry groups echoed this view, particularly the call for greater partnership across jurisdictions. They suggested that federal government agencies work more closely and collaboratively with those of provincial governments and in other countries, especially the US. Indeed, some industry stakeholders urged greater harmonization between regulatory decisions and provincial drug schedules.
Participants generally agreed with the proposal for greater partnership in a more integrated system.
3.2 Comparison Of The Elements: Priorities
All eight elements received strong support in terms of whether or not they should be priorities for Health Canada. "Increased transparency, openness and accountability" received the strongest overall support (87% of participants strongly agreed or agreed this should be a priority). Of note, this element also received the highest number of participants who strongly agreed this element should be a priority (52%), followed closely by Element 3 - A modern approach to food safety and nutrition.
"Special emphasis on specific populations" (Element 6) received the lowest amount of support from participants, with 9% of participants disagreeing and 2% strongly disagreeing with making this element a priority. However it is important to note that this element still received strong support overall. Following Element 6, Element 1 - A product life cycle approach to regulation, received the second lowest support of the eight elements. Once again, it is important to note that this element also received strong support overall.
Summary remarks
All eight elements were strongly perceived by respondents as having a positive impact on Canada's regulatory system and the health and safety of Canadians. This is consistent with participant's support of the challenges presented in the previous section of the workbook. Similarly, it would also appear to demonstrate support for the Blueprint overall and in particular the elements presented.
When looking specifically at which elements would have the most positive impact on the regulatory system, Element 4 - "A pro-active and enabling regulatory system" and Element 5 - "Making the best use of all types of evidence" received the highest support with almost 80% of participants who agreed or strongly agreed.
In the area of health and safety of Canadians, most participants strongly agreed or agreed that implementing each of the elements would have a positive impact. Element 3 - A modern approach to food safety and nutrition - received the strongest support with 80% of participants who strongly agreed or agreed.
Element 2 - A risk-based approach to product categories, received the lowest level of support with 11% of participants who strongly disagreed or disagreed that implementing this element would have a positive impact on the health and safety of Canadians.
4. Critical Success Factors
Health Canada identified five critical success factors to support HPFB in achieving the Blueprint's main objectives:
- A 21st century toolkit - legislation, regulatory frameworks and instruments;
- Internationally benchmarked regulatory practices, processes and risk management;
- A sustainable, high performance, science-based organization - continued investments in staff and infrastructure;
- Strategic international regulatory cooperation; and
- Enhanced partnership and stakeholder involvement
Based on the response, two of the five key success factors received a higher level of support:
- A sustainable, high performance, science-based organization - continued investments in staff and infrastructure received the greatest support with 76% of participants ranking it "high" or "highest" in terms of priority.
- A 21st century toolkit - legislation, regulatory frameworks and instruments received the second highest level of support with 73% of participants ranking it "high" or "highest" in terms of priority.
The remaining three success factors also received support, however at a lower level relative to the factors listed above.
"Enhanced partnership and stakeholder involvement" and "Strategic international regulatory cooperation" ranked as the lowest priorities.
| Lowest | Low | Medium | High | Highest | N= | |
|---|---|---|---|---|---|---|
| A 21st century toolkit - legislation, regulatory frameworks and instruments | 4.9% | 2.7% | 19.7% | 34.5% | 38.1% | 223 |
| Internationally benchmarked regulatory practices, processes and risk management | 3.2% | 9.9% | 30.2% | 39.6% | 17.1% | 222 |
| A sustainable, high performance, science-based organization - continued investments in staff and infrastructure | 3.1% | 3.1% | 17.9% | 35.0% | 40.8% | 223 |
| Strategic international regulatory cooperation | 5.8% | 15.2% | 35.4% | 31.4% | 12.1% | 223 |
| Enhanced partnership and stakeholder involvement | 13.1% | 6.3% | 29.7% | 31.3% | 19.8% | 222 |
4.1 Comparison Across Perspectives
When examining the results by perspective there are a few variations amongst the different groups that are worth noting. Specifically:
- Concerned citizens were less likely to agree with the overall group that Internationally benchmarked regulatory practices, processes and risk management was a critical success factor to support HPFB in achieving the Blueprint's main objectives.
- Concerned citizens and patients were less likely to agree with the overall group that Strategic international regulatory cooperation was a critical success factor to support HPFB in achieving the Blueprint's main objectives.
- Federal government employees and concerned citizens were less likely to agree with the overall group that Enhanced partnership and stakeholder involvement was a critical success factor to support HPFB in achieving the Blueprint's main objectives.
4.2 What We Heard - Ideas, stories and comments on the critical success factors
Critical Success Factor 1 - A 21st century toolkit - legislation, regulatory frameworks and instruments
Some participants who commented were supportive of the proposed amendments to the toolkit for health products and food. At the same time, however, stakeholders recognized that achieving this renewal would require significant resources and time to complete.
"[It] will take a considerable amount of effort and time to change the act/regulations but it could be well worth it."
- A Provincial Government Official -
A number of participants raised a concern that regulatory renewal could result in more rather than less legislative barriers for industry to bring new products to the market. This view came not only from several industry groups, but from health professionals and concerned citizens as well.
An industry stakeholder suggested that a 21st century toolkit, while useful, is not enough to effectively regulate Canada's health product and food industries. In addition, there is room for government officials to be more creative in using existing legislation to bring products to market efficiently.
"Unless and until there is a commitment to enforcement, any regulatory changes will not improve service to industry or increase the trust of Canadians."
- A Business Stakeholder -
Critical Success Factor 2 - Internationally benchmarked regulatory practices, processes and risk management
Participants who provided additional comment expressed two different points-of-view on the importance of adopting internationally benchmarked regulatory practices.
Most participants supported the adoption of international approaches and processes, where appropriate. They commented that an international focus is needed to meet the changing global environment for commerce and regulatory harmonization. While some called for greater harmonization with US approaches, others called for the adoption of those used in the European Union (EU) and Nordic countries. This view was expressed predominantly by industry stakeholders and several academic/researcher participants.
In contrast, a smaller number of participants questioned the value of international benchmarks, arguing instead for "made in Canada" approaches. One academic/researcher suggested that some of the existing international benchmarks had been developed without sufficient consultation with public interest groups or citizens and, instead, had relied on input from industry stakeholders. For others, benchmarks in health product and food regulation involved issues of sovereignty and capacity to implement policy independently.
Critical Success Factor 3 - A sustainable, high performance, science-based organization - continued investments in staff and infrastructure
"It is very important when progressing with regulatory reform that we have the resources at Health Canada to carry out the changes."
- A Federal Government Official -
Participants who commented tended to agree that Health Canada needs to invest resources to ensure that it has the scientific capacity and expertise to continue to be a leader in the regulation of health products and food.
Several participants observed that this capacity currently exists in Health Canada and other federal government agencies, but that staff is facing increased pressures that may harm employees' retention. One participant reported the long hours and stressful deadlines that some of these officials face in the current regulatory environment. Another suggested that greater resources be allocated to the staff's professional development and learning.
An industry stakeholder emphasized the need for Health Canada to remain a science-based organization. They argued that social and other influences should not replace science as the basis for regulatory decisions.
Critical Success Factor 4 - Strategic international regulatory cooperation
"It is important to recognize and utilize good science conducted in other jurisdictions to approve food products. The notion of international cooperation through agreements for data-sharing and standard-setting is a positive feature of the Blueprint."
- A Provincial Government Official -
Stakeholders who submitted views regarding critical success factor 4 were broadly supportive of greater international regulatory cooperation. Nevertheless, several raised concerns about Canada's approach and its reliance on slow-moving and cumbersome multilateral and regional agreements.
Though supportive of greater regulatory cooperation, a provincial government official requested further information on the protocols that would allow external research findings to be used in Canadian regulatory decisions.
Critical Success Factor 5 - Enhanced partnership and stakeholder involvement
There was support among stakeholders who commented for enhanced partnerships and stakeholder involvement. At the same time, a number of respondents suggested that the relationships between regulators and stakeholders should operate under the right governance structures.
"A framework must be established that provides the proper levels of control and collaboration with all stakeholders."
- A Public Interest Group -
A provincial government official commented that federal and provincial governments should partner more effectively. This individual suggested that the federal government can more effectively acknowledge the key role that provincial governments play in health care policy, financing, management and the implementation of regulations.
"My hope is to have representatives from all areas of specialty and expertise, including leading researchers, clinical, community and industrial practitioners in each field such as nutrition, pharmacy, medicine and naturopathic medicine, present at the tables."
- A Health Professional -
Other stakeholders described the value of the role their constituents could play in health product and food regulation. A health professional illustrated the important role that a wide range of practitioners could play in regulatory decisions. A public interest group also suggested that patients could also participate in decision-making as partners.
5. Evaluation of the Online Consultation Process
Before finishing the workbook, participants were asked to share their thoughts about their online consultation experience. Overall the feedback was positive:
- Fifty-eight percent of participants enjoyed completing the workbook, while 32% had no view one way or the other
- Sixty-one percent thought the workbook helped them to better understand regulation issues for health products and food
- Eighty percent of the participants strongly agreed or agreed (22% and 58% respectively) that the information and facts contained in the workbook were easy to understand.
- A majority of the participants (67%) strongly disagreed or disagreed (23% and 44% respectively) that from a technical standpoint, completing the workbook was complex and demanding.
- Over three quarters of the participants (79%) strongly agreed (26%) or agreed (53%) they would consider completing a workbook in the future, based on this experience.
| Strongly Agree | Agree | Neither | Disagree | Strongly Disagree | I Don't Know | N= | |
|---|---|---|---|---|---|---|---|
| I enjoyed completing the workbook | 19.5% | 38.2% | 32.3% | 5.9% | 3.6% | 0.5% | 220 |
| The workbook helped me to better understand regulation issues for health products and food | 16.3% | 44.8% | 18.1% | 12.7% | 6.8% | 1.4% | 221 |
| The information and facts contained in the workbook were easy to understand | 22.0% | 58.3% | 11.9% | 6.0% | 1.4% | 0.5% | 218 |
| From a technical standpoint, I felt completing the workbook was complex and demanding | 9.0% | 6.8% | 15.8% | 44.3% | 23.1% | 0.9% | 221 |
| Based on this experience, I would consider completing a workbook in the future | 26.2% | 52.9% | 11.8% | 2.3% | 4.5% | 2.3% | 221 |
6. Conclusion
The online consultation was successful in extending Health Canada's reach to a broader audience, complementing the in-person consultations. It provided stakeholders and citizens with another means of providing input on the Blueprint for Renewal.
Health Canada has made a commitment to using the input gathered from all the consultation activities to help inform the continued development and implementation of the Blueprint for Renewal. Health Canada is planning to launch a revised version of its Blueprint discussion document in April 2007.
