Health Products and Food Branch 2005-06 Business Plan - Highlights

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the health and well-being of Canadians through the development of evidence-based guidelines, policies and standards.

sound science and effective risk management;

a strong national approach supported by offices in every region of the country ;

strong partnerships with other governments, health care providers, non-governmental organizations, industry, academia; and

international cooperative relationships to share information, collaborate on regulatory standards and processes, minimize duplication and leverage efforts .

Regulation

Transforming our efficiency, effectiveness and responsiveness as a regulator.

Transformed regulatory processes.

A regulatory platform for the 21st century.

Expanded collaboration with international regulatory authorities.

Leveraged national partnerships.

Enhanced health innovation.

Monitoring and Surveillance

Increasing responsiveness to public health issues and greater vigilance of safety and therapeutic effectiveness in real world use.

Improved risk management and communications as a shared responsibility with stakeholders.

Improved assessments based on research and surveillance.

Enhanced post-market surveillance of safety and therapeutic effectiveness.

Effective compliance and enforcement.

Integrated role in health system.

Authoritative Information

Providing authoritative info rmation for healthy choices and info rmed decisions by Canadians.

Useful and credible evidence-based information.

Improved public awareness and healthy choices.

Supportive conditions to enable Canadians to make informed and healthy choices.

Strategic and coordinated communications.

Public and Stakeholder Involvement

Improving transparency, openness and accountability to strengthen public trust and stakeholder relationships.

Increased public accountability.

Enhanced transparency.

Improved openness.

A Strong Organization

Building a nationally-based organization with the capacity and flexibility to fulfill its mandate in an ever-changing environment.

We invest in our workforce and strengthen the quality assurance and management tools, systems and processes that are vital to our continuing stability and effectiveness as an organization.

Strengthened nationally-based capacity for sustainable performance.

Improved management tools and systems.

Strategic management of corporate commitments and obligations.

Leveraged technology to support a high-performing organization.

Strengthened responses to emergencies.

Key Performance Indicators (KPIs)

1. Pre-market submissions reviewed within performance targets.
   
   
2. Modernized legislative tools, policies and regulatory approaches.

• Meet or exceed our performance targets for the review of new pharmaceutical drug submissions 90% of the time.
  
  
• Make substantial progress in clearing the backlog for biologics drug submissions, enabling us to meet performance targets in 2007.
  
  
• Continue to improve submission review performance for veterinary drugs and natural health products.

• Develop a Good Guidance Practices Framework to enhance guidance to industry for improved quality and consistency of submissions.

• Introduce new processes and systems that allow for the receipt, processing and review of submissions in an electronic environment and improve overall project management.

• Introduce new regulations to ensure donor and patient safety with respect to plasmapheresis (i.e., the process of extracting plasma from donated blood and returning remaining components to the donor).

• Introduce new national standards-based regulations for cells, tissues and organs.

• Develop a new biotechnology stewardship framework to assure the responsible introduction of new discoveries.

• Ensure that all large manufacturers meet new mandatory labelling requirements of Nutrition Facts Table, by December 2005.

• Continue working with a multi-stakeholder task force to develop recommendations for reducing trans-fats in Canadian foods to the lowest levels possible, while ensuring that alternatives are safe.

• Work with federal partners, provinces and territories to enhance national decision-making on food safety and nutrition issues. We will begin development of a strategy including public health outcomes that will demonstrate achievements to Canadians and international partners.

• Continue work on policy and standard setting projects launched in 2004-05 under the Agricultural Policy Framework to effectively address public health hazards at the farm and industry level.

• Further prohibit the personal importing of drugs intended for use in food-producing animals and continue to add to the regulatory list of safe residue limits for veterinary drugs in foods.

• Update policies and regulations to address issues of antimicrobial resistance² and the addition of vitamins and minerals to foods through policy and regulatory development.
  
  
• Update how we conduct safety assessments of novel foods (e.g., genetically-modified animals and plants) to minimize risks to Canadians.

• Collaborate with the U.S. and Mexico in the areas of drugs, biologics, medical devices, food safety and nutrition.³ We will lead the development of a performance management framework and take over leadership of working groups on laboratories and health fraud.

• Participate in a food-related emergency exercise and co-host, with the Canadian Food Inspection Agency, the meeting of a tri-national task force charged with conducting the assessment and identification of food safety coordinating mechanisms.⁴

• Continue to implement the agreement with Australia's Therapeutic Goods Administration (TGA), which provides for information-sharing on new technologies and methods, as well as safety, efficacy and quality standards.
  
  
• Identify an appropriate biologics submission to conduct a parallel review between ourselves and the TGA. This pilot review project is one mechanism to share information on current review and decision-making practices.
  
  
• Implement the work plan arising from a 2005 Memorandum of Understanding with the Australian Pesticide and Veterinary Medicines Authority to increase international cooperation and information-sharing.

• Contribute to the international consultation on the United Kingdom 's National Institute for Biological Standards and Control's proposed reorganization.

• Further the development of a regulatory framework to support new legislation for the provision of low-cost medicines to developing countries suffering from infectious diseases such as HIV/AIDS.

Key Performance Indicators (KPIs)

1. More and better tools available to all partners responsible for risk management and risk communications capacity in the regulatory system.
   
   
2. Use of therapeutic effectiveness evidence to support formulary listing decisions for health products.
   
   
3. Significant number of MedEffect portal users with increases over time.
   
   
4. Increased number of adverse drug reactions reported to the new regional centres.
   
   
5. Compliance of industry stakeholders with departmental regulations and standards.

• Collaborate with and provide guidance to industry on requirements for the development and approval of a vaccine to address the risks of pandemic influenza.
  
  
• Conduct Bovine Spongiform Encephalopathy (BSE)-related research and enhance risk assessments to human health of bovine-derived health products and food.

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• Invest in research and monitoring of chemical contaminants, microbial hazards and pathogens in Canada 's food supply.

• Build upon the Canadian Laboratory Information Network (CANLINE) to create a repository of data on levels of contaminants in foods consumed by Aboriginals.

• Further the development of detection and analytical methodologies for Canadian Food Inspection Agency (CFIA) laboratories and conduct assessments of the effectiveness of CFIA's food safety activities and programs.

• Broaden the use of the Canadian Nutrient File (CNF), the high-quality standard reference on nutrients in foods commonly consumed in Canada .

• Develop and disseminate a user's guide to assist nutrition stakeholders in interpretation of the findings of the Canadian Community Health Survey (CCHS) 2.2, nutrition focus.
  
  
• Develop a themed report on Household Food Security following the release of the CCHS 2.2 wave 1 data.

• Continue work with health care professionals, consumers and patient groups on MedEffectCanada, a new system that gathers and provides info rmation on adverse drug reactions (ADRs), medication problems and safe product use.

• Examine new mechanisms for identifying ADRs in children, including the completion of a two-year study⁵ to determine the feasibility of active surveillance of ADRs in children and development of a publicly accessible information database on drug safety issues related to children.

• Expand our capacity to monitor and evaluate clinical trial ADRs and safety information.
  
  
• Begin testing a handheld wireless tool designed to support the timely reporting of adverse reaction information by health care professionals.

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• Identify and implement options for minimizing the risks associated with single-use medical devices.

• Carry out compliance inspections of establishments with respect to human drugs, veterinary drugs, natural health products, medical devices and blood, tissues, organs and xenografts.
  
  
• Continue the development and implementation of compliance mechanisms for cells, tissues and organs.
  
  
• Implement recommended changes to the medical devices program made by the Office of the Auditor General⁶.

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Key Performance Indicators (KPIs)

1. Increased awareness and knowledge among consumers and patients of health products, food and nutrition issues.
   
   
2. Informed choices made by consumers and patients demonstrating more safe and healthy behaviours relating to health products, food and nutrition.

• Complete the revision of Canada's Food Guide to Healthy Eating to ensure it continues to promote a pattern of eating that meets nutrient needs, promotes health and minimizes the risk of nutrition-related chronic disease.
  
  
• Launch an interactive feature on the Health Canada website to provide information on the Nutrition Facts table found on food labels and help consumers make more informed food choices.

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• Ensure that nutrition considerations and labelling information are integrated into key national and international campaigns and strategies.
  
  
• Distribute nutrition guidance information and the results of the Total Diet Study.

• Work with the U.S. Institutes of Medicine to produce and widely disseminate a report of the Dietary Reference Intakes to Canadian practitioners to help guide nutrition policies and programs.

• Distribute the Canadian Adverse Reaction Newsletter to more than 64,000 physicians across Canada and around the world.

• Continue to develop research networks on herbal medicines and natural health products in collaboration with the Canadian Institutes of Health Research and the Institute of Aboriginal People 's Health.

• Distribute fact sheets on new topics such as the safe disposal of pharmaceutical products.

• Publish the Summary Basis of Decisions that outline the rationale and scientific basis of our regulatory decisions concerning market authorization of new drugs and medical devices for human use.
  
  
• Launch a Notice of Compliance database which will allow Canadians to search information about all drugs since 1994.
  
  
• Distribute fact sheets about HPFB's regulatory role and activities.

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Key Performance Indicators (KPIs)

1. Improved public and stakeholder opinion about the Branch's accountability for results, and the timeliness and transparency of its regulatory process.
   
   
2. Sustained public confidence and trust in health products, food and the regulatory system.
   
   
3. Increased stakeholder awareness of the Branch's business and decision-making processes.
   
   
4. More individuals accessing info rmation online.
   
   
5. Increased public involvement in Branch program and policy development, implementation and decision-making.

• Implement a new public involvement framework to ensure our public involvement activities are efficient and effective.
  
  
• Increase our use of online consultation tools to solicit more immediate and valuable information from Canadians and health stakeholders on many aspects of our business, such as the revision of Canada's Food Guide to Healthy Eating.

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• Engage the public, industry and other stakeholders to solicit policy and regulation input in areas such as blood and blood components, new drug delivery methods and the development of a regulatory framework for environmental assessments.

• Begin operations of a new Office of the Public Ombudsman to handle complaints, concerns and feedback from individuals and organizations about our work.

• Hold public fora on COX-2 inhibitors and breast implants. We will establish leading edge practices in public engagement that will include use of an extensive online site for public submissions, and public access to industry information in an earlier timeframe and more accessible format than other regulators.

• Create a permanent health products safety board, which will include external members and incorporate principles of openness and transparency in its terms of reference and operations.

• Conclude national consultations on the registration and disclosure of clinical trial information as well as a national survey of users.

• Launch a national consultation on mandatory reporting of Adverse Drug reactions.

• Collect and consider feedback on the draft joint industry guidance for inhalation and nasal products developed with the European Medicines Agency, and finalize the guidance.

Key Performance Indicators (KPIs)

1. Sustainable and flexible workforce.
   
   
2. Improved science capacity.
   
   
3. Reduced number of workplace health and safety incidents.
   
   
4. Use of resource tracking systems linked to performance.
   
   
5. Meeting immediate and ongoing info rmation management and technology needs.
   
   
6. Implemented emergency preparedness plans and guidelines.

HPFB will continue to implement employee succession, staffing, orientation, training and development plans that support Health Canada's Workplace Health and Human Resource Management Strategy.

HPFB will continue to invest in staff training to ensure we have the right knowledge and tools to do our work and engage stakeholders successfully.

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HPFB will continue to enhance our database systems and infrastructure to better manage information for our changing needs. This will strengthen our capacity to track information on ingredients contained in therapeutic products to ensure they are sourced from BSE-free animals as well as track products that have been approved under the Access to Medicines Program for developing countries.

We will also continue work to achieve efficiencies by consolidating our information technology functions, equipment and infrastructure.

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HPFB will continue to develop plans and performance frameworks that better position us to successfully meet our goals. For example, we will:

• Initiate the development of a new program activity architecture, an updated strategic plan and improved performance frameworks.
  
  
• Develop an external charging regime for therapeutic products, as part of a longer term, sustainable funding strategy.

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HPFB will strengthen its audit and evaluation capacity to continually monitor and shape efficiency and effectiveness improvements. For example, we will:

• Develop an evaluation framework for BSE Initiatives and a performance framework for the Access to Medicines Program.
  
  
• We will carry out formative evaluations of BSE and Therapeutics Access Strategy, as well as a summative review of the Canadian Regulatory System for Biotechnology.

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