Blueprint for Renewal - Regional Consultation Sessions, November 2006 - Summary Report

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Table of Contents

• Background
• Summary of the regional consultation sessions
  • Introduction
  • General comments and perspectives
  • Specific comments on various themes
    • Roles and responsibilities
    • Post-market surveillance and risk communication
    • Compliance and enforcement
    • Openness and transparency
    • Consumer/provider information and education
    • Special Access Programme, Clinical trials, orphan drugs
    • International regulatory cooperation
    • Product categorization, review of the Natural Health Products regulations
    • Observations on product lines other than human drugs
• Conclusion and next steps
• Annex 1
• Annex 2 - Participant Organizations
  • Toronto
  • Halifax
  • Winnipeg
  • Montréal
  • Ottawa
  • Vancouver
  • Edmonton

Background

In October 2006, the Health Products and Food Branch (HPFB) released the discussion document Blueprint for Renewal: Transforming Canada's Approach to Regulating Health Products and Food to communicate our current thinking with respect to the modernization of the regulatory system for health products and food.

The discussion document articulates the case for renewal, as well as the vision and objectives of our Blueprint plan. A snapshot of the plan is presented in Annex 1. The full discussion document is available on the Health Canada Web site at www.healthcanada.gc.ca/hpfb-blueprint.

In October 2006, HPFB launched a series of consultations related to the Blueprint to seek the views of our stakeholders. Seven regional consultation sessions were held with stakeholders over the month of November 2006. These sessions took place in Toronto, Halifax, Winnipeg, Montreal, Ottawa, Vancouver and Edmonton (see Annex 2 for a list of participants for each session). At the same time, an electronic consultation on the Blueprint took place from October 26 to December 6, 2006.

In addition, HPFB conducted a series of consultations on specific Blueprint initiatives over the second half of 2006-registration and disclosure of clinical trial information, review of the clinical trials regulatory framework, a policy on public input into the review of health products, and a proposed progressive licensing framework for pharmaceuticals and biologics. Additional consultations are planned for 2007, including external charging; the review of the Natural Health Products regulations; a regulatory modernization strategy for food; and a proposed regulatory framework for food-related health claims. We invite you to consult our Web site for more details.

The input we receive from these various consultations will help inform the further development and implementation of the Blueprint plan and its various components.

This report presents an overview of the key findings and observations we heard during these regional consultation sessions. A detailed report of the electronic consultation will also be made available on the Blueprint's Web site.

Summary of the regional consultation sessions

Introduction

Seven regional consultation sessions with key stakeholder groups took place in November 2006 to seek stakeholders' views on the Health Products and Food Branch (HPFB) Blueprint for Renewal initiative. The sessions were held in Toronto, Halifax, Winnipeg, Montréal, Ottawa, Vancouver and Edmonton.

The participants at the sessions represented a broad range of key Branch stakeholders, including industry representatives, health care professionals, academics, and patient and consumer groups (provinces and territories are being consulted separately).

The sessions were chaired by HPFB's Assistant Deputy Minister, Mr. Neil Yeates, and facilitated by Health Canada staff. Each session began with an overview presentation of the Blueprint by Mr. Yeates. Participants then had an opportunity to seek clarifications on the presentation and to provide their organization's views and perspectives (the Blueprint discussion document and the overview presentation are available on the Blueprint Web site at www.healthcanada.gc.ca/hpfb-blueprint). The session then closed with a facilitated discussion between participants and Health Canada representatives.

The following summarizes the main observations, suggestions and discussion points. More detailed reports of the individual sessions will be made available on the Blueprint web site.

General comments and perspectives

Generally, participants at the sessions agreed with the diagnosis and the case for renewal presented in the Blueprint, as well as with its broad vision and objectives. In addition, many indicated that they are ready to do their part to contribute to the success of the initiative.

Some, although supportive of the overall direction, reserve final judgment until they see the implementation details and roll-out of specific Blueprint initiatives.

Many participants noted that the fundamental role of Health Canada in protecting the health and safety of Canadians is not adequately reflected in the Blueprint. It was suggested that this role should be clarified and articulated, possibly in a new section on values and principles. Some suggested a small workshop could be a useful way of developing a comprehensive set of values and principles that should underpin Blueprint initiatives.

Strong support has been expressed for many of the orientations outlined in the Blueprint, such as

• adopting life-cycle approaches in the regulation of therapeutic products, as opposed to the current point-in-time approach;
• strengthening post-market surveillance and risk communication;
• addressing product categorization issues and irritants - for example, some low risk products that are regulated under the Natural Health Product regulations;
• continued progress to enhance the transparency and openness of our activities, as well as our accountability to Canadians; and
• better synchronization of research and development, regulatory and health system objectives.

Mixed views have been expressed on other topics, such as on the concept of regulatory interventions proportional to risk, as well as on the precautionary principle versus risk management of health products. Some participants felt that the latter two concepts are incompatible and that a move toward more risk-based regulatory interventions for health products would indicate a diminished focus on protecting the safety of Canadians.

A number of gaps in the Blueprint were identified by participants. Two gaps in particular were mentioned in all the consultation sessions:

• much more needs to be done in the area of compliance and enforcement, both at the levels of authorities and capacity; and
• there was a strong message that the Blueprint should include a greater focus on consumer information and the role that Health Canada could play in this area.

Participants also felt in order for the Blueprint implementation to be successful, it will be critical for the Health Products and Food Branch to secure adequate and sustainable resources (including a renewed external charging regime), as well as new legislative tools.

Some participants expressed concerns that the Blueprint is very ambitious and will require setting priorities. The inclusion of an implementation plan with timelines in relation to the various initiatives was recommended.

Specific comments on various themes

Roles and responsibilities

Many participants felt that the roles and responsibilities of the various players throughout the regulatory process should be better aligned to improve timely access to safe and effective health products.

Health Canada was encouraged to play a role in working with and informing certain sectors about how they can contribute to an effective regulatory system - for example, physicians want to better understand the expectation for reporting of adverse events as part of the post-market surveillance system.

Many participants encouraged better coordination between Health Canada and the provinces and territories in general, and with the Common Drug Review (CDR) in particular. Participants expressed concern that products approved by Health Canada (guided by considerations of safety, quality and efficacy) are essentially inaccessible when they are not recommended for reimbursement on public drug plans by the CDR (guided by considerations of therapeutic and cost-effectiveness). This is an area of particular concern for drugs targeted at rare disorders and unmet health needs.

It was expressed that an effective and modern regulatory regime will require active stakeholder participation in decision-making processes. It was noted that Health Canada should more systematically seek input from stakeholders on regulatory activities that have a direct impact on them and that resources should be made available for smaller organizations that have limited capacity to participate in stakeholder engagement activities.

Post-market surveillance and risk communication

A strong post-market surveillance system was considered essential by most participants, especially in the context of a progressive licensing framework. The difference between, and the need for both, proactive and reactive surveillance was highlighted.

One common area of discussion and concern was the under-reporting of adverse drug reactions (ADR). Some participants continued to advocate for mandatory reporting by health professionals while others indicated that implementing strategies to address under-reporting would be more efficient and effective. Improved ADR reporting is an area that will need to be strengthened in the post-market surveillance regime.

Interest was expressed around an electronic adverse drug reaction reporting system and around the implementation of mandatory registration and disclosure of Phase IV clinical trial information by industry as a way of generating improved data on safety and effectiveness in a "real world" setting. There was also support for the creation of a network of national centres of excellence as part of the National Pharmaceuticals Strategy to improve the collection, analysis and dissemination of information on post-market safety and effectiveness.

Some participants recommended the development of better tools to communicate risk to the public. It was also suggested that Health Canada's post-market surveillance program could consider tracking health products in order to more easily contact affected patients when a problem arises.

Compliance and enforcement

Many participants mentioned that the Blueprint did not adequately address current gaps in Health Canada's capacity and authorities around the compliance and enforcement of the current regulatory frameworks for health products. It was suggested that strengthened compliance and enforcement be a distinct objective in the Blueprint. Securing new legislative authorities in this area was deemed critical for the successful implementation of the Blueprint.

Openness and transparency

Openness and transparency were identified by many participants as values that should underlie the entire regulatory process, although many recognized the challenges in doing so effectively. Information on both products and product reviews should be readily available, as should information on the regulatory system itself. At the same time, transparency and openness should be values that are well integrated into all public involvement activities, such as advisory committees, with accountability mechanisms in place to ensure that these principles are respected. Integrating this kind of openness throughout the regulatory process will help all Canadians, from health care providers to consumers, to better understand how to access health product and food-related information, as well as how to become involved in the decision-making process when appropriate.

Consumer/provider information and education

Participants in all the regional sessions noted the importance of communicating effectively with consumers, including vulnerable populations. Messages to the public, particularly those concerning risks and benefits of health products and food, must be clear, and communicated in consistent and simple language so that people can make informed choices about their health. There were calls for better information to

• physicians and other health care professionals, who need more information on the risks and benefits of products to support optimal prescribing and use;
• patients, who are increasingly calling for greater autonomy to make informed decisions about their health; and
• consumers and the public, who need to be able to understand how the regulatory system works, as well as the risks and benefits of the health products and food they are consuming.

It was noted that the use of the Internet is insufficient to communicate effectively with all consumers. Participants identified the need for unbiased and objective information as well as direction around how to judge the reliability of information. It was also suggested that consumer information should be readily available and communicated in French as well as in English. Health Canada was seen as having a strong mandate to provide authoritative information to consumers and health providers. Participants suggested that Health Canada (including the regional offices) should work more closely with consumer groups, health care providers, and others in the regions to ensure information is effectively communicated.

Special Access Programme, Clinical trials, orphan drugs

Participants welcomed the review of the Special Access Program and of the 2001 clinical trials regulatory framework as opportunities to ensure the appropriate use of these key access mechanisms to drugs not yet licensed in Canada.

It was noted that there have been many positive changes since the new regulatory framework for clinical trials was put in place in 2001 (e.g. improved timeliness of approvals of clinical trial applications) but that the regulations would need to adapt to reflect changes in the clinical trials environment (e.g., move toward adaptive clinical trials).

There were calls for information from clinical trials to be fully disclosed. Some participants hoped that under new legislation, confidential commercial information protections would no longer restrict safety and efficacy data from being available to the public. Some also recommended exploring how the extrapolation of clinical trials results to different populations might be put in place.

Some participants recommended that Health Canada establish an orphan drugs policy, which would put in place incentives for sponsors to develop treatments to address rare disorders and unmet health needs.

International regulatory cooperation

Participants expressed support for exploring options to establish worksharing agreements with other regulators to improve the efficiency and effectiveness of HPFB's regulatory activities. However, it was noted that Canada should retain final regulatory decision-making authority.

International harmonization, collaboration and partnerships are seen as important to strengthen Canada's regulatory regime, enhance competitiveness and thereby facilitate better decisions. Better collaboration would also allow for greater efficiencies and help reduce overlap and duplication of efforts.

Compliance and enforcement and post-market surveillance were mentioned as key areas to further international collaboration, to pool scientific resources, and to harmonize standards where appropriate.

Product categorization, review of the Natural Health Products regulations

There were many calls among meeting participants for clarity related to product categorization, particularly around the categorization of "grey zone" products that do not fit clearly into existing categories of natural health products, food, drugs and/or cosmetics. The lack of clarity was seen as detrimental to both industry and consumers.

Participants supported the review of the Natural Health Products regulations, emphasizing that this review should not "undo" the good work that has already been done. Participants are looking forward to providing input on the categorization of "grey zone" products, clarifications of industry guidelines, and implementing a risk-based regulatory scheme similar to that currently in place for medical devices.

Observations on product lines other than human drugs

Many participants made the observation that the Blueprint is heavily focused on human drugs and that little detail has been provided on how the various Blueprint initiatives will apply to other product lines regulated by the Branch, such as medical devices, veterinary drugs and food.

Interest was expressed in how the Blueprint would apply to food and nutrition. Health Canada staff noted that a separate consultation document on the food regulatory modernization strategy would be available in early 2007.

Some participants were particularly interested in how Health Canada could promote better information to consumers at the point of purchase, and regulatory requirements related to novel foods. There was support to continue with the development of a framework for food-related health claims. It was also suggested that Health Canada and the Canadian Food Inspection Agency need to better define their roles and responsibilities and communicate them to the public in an effort to reinforce public trust in the food system.

Conclusion and next steps

HPFB's regional consultation sessions on the Blueprint for Renewal served to demonstrate that there is strong support for regulatory system renewal priorities articulated in the Blueprint. Many important suggestions for improvement were offered, and will be incorporated in a second version of the Blueprint - planned for release in Spring 2007 with the release of the Health Products and Food Branch's new Strategic Plan.

A detailed report of the electronic consultation will be posted on the Web site in early 2007, as well as regular progress reports on the development and implementation of the Blueprint.

Annex 1

Annex 2