Health Products and Food Branch Towards a Strategic Science Plan Discussion document

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Table of Contents

• Message from the Assistant Deputy Minister
• Executive Summary
• Introduction
  • About the Health Products and Food Branch
  • Science at HPFB
  • Role of HPFB Scientific Personnel
  • The Need for a Strategic Science Plan
    • External challenges and opportunities
    • Aligning with federal science and technology priorities
    • Aligning with international partners
• Recent Accomplishments by our Scientific Personnel
  • Developing the Plan
    • Internal consultations
    • Purpose of the Plan
• Overview of the Strategic Science Plan
  • Strategic Science Framework
  • Scientific objectives, key strategies, and clusters of science activities
  • Objective 1: Improve the transparency and accountability
    • Strategy 1 - Science, society, and the citizen
    • Strategy 2 - Sustainable development
  • Objective 2: Gain insight into disease and promote healthy choices
    • Strategy 3 - Develop new paradigms for evidence
    • Strategy 4 - Promote healthy living and wellness
    • Strategy 5 - Understand disease and apply new models of pathogenesis
  • Objective 3: Encourage responsible key technologies
    • Strategy 6 - Maximize the benefits of existing and in horizon technologies
    • Strategy 7 - Advance safe manufacturing, quality, and hazard control
  • Objective 4: Strengthen science capacity
• Expected Outputs and Outcomes of the Plan
  • Our expected outputs
  • Our measured outputs
  • Evaluating the benefit outcomes
• Putting the Plan into Action
  • Prioritizing our resources
  • Producing results
    • Strengthening our science capacity
    • Establishing and leveraging scientific partnerships
    • Articulating our science to Canadians
  • Capitalizing on opportunities
• Annexes
  1. Clusters of science activities (Detail)
  2. Glossary
  3. Acronyms
  4. Related Branch, Department, and Federal Government Strategic Plans
  5. Science is at the core of HPFB's activities

Message from the Assistant Deputy Minister
Meena Ballantyne, Assistant Deputy Minister, Health Products Food Branch, Health Canada

I am pleased to present the Health Products and Food Branch (HPFB) Towards a Strategic Science Plan.

HPFB is a science-based organization. This means that all of the evaluation and monitoring activities we conduct and all of the nutritional policies and guidelines we develop are solidly grounded in current and accepted scientific standards.

A range of factors, from demographic shifts to environmental stressors, will impact the health and well-being of Canadians in the coming years. The current pace of technology advancement signals that science will play an increasingly central role in the daily lives of Canadians -- and in the ensuing public policy and debate associated with these emerging products. The challenge for us will be to optimize how science and scientific advice are used in the creation of public policy and in support of the public interest. To respond effectively to these challenges, it is imperative that HPFB has clear objectives and a roadmap for the way ahead in its scientific endeavors.

The HPFB Towards a Strategic Science Plan builds on several Branch initiatives: our 2007-12 Strategic Plan, Blueprint for Renewal II, and Product Life Cycle Approach. Its purpose is to address the science strategies that support the work of the Branch in greater depth. Based on extensive consultation and input from staff, stakeholders, and partners, the Science Plan:

• identifies food, nutrition, and health product science and technology developments on the horizon;
• outlines the Branch's strategic science agenda for the next five years,
• helps us to recognize and act on science opportunities,
• serves as a basis for scientific engagement and partnership, and
• communicates HPFB science priorities to a wider audience.

The Science Plan provides a framework for engaging in and enhancing our science. It identifies seven science strategies along with science activities that address a range of key issues. These strategies provide a clear approach for HPFB to carry forward its standard of science excellence and will support its mission to help Canadians maintain and improve their health.

Science is the cornerstone of HPFB's credibility as a regulator and ability to accomplish its mission. We are very excited about the launch of this new framework, as we expect it to help create new opportunities for science partnerships, and allow us to adapt quickly to the rapidly evolving science challenges for HPFB. It is also an excellent way of sharing our science more comprehensively with all Canadians. Through the Science Plan, we will be inviting Canadians to participate in the science that affects their daily lives. I look forward to your involvement.

Executive Summary

The Health Products and Food Branch (HPFB) places a high priority on a strong science foundation to support its role as a scientific and regulatory authority for health products and food.

Towards a Strategic Science Plan will guide our scientific efforts and help to address our scientific needs over the next five years, and will provide clarity, depth, and precision for the Branch's other key strategies such as the 2007-12 Strategic Plan and Blueprint for Renewal II.

We have defined five critical objectives to achieve the Branch's vision and to most effectively fulfill our mission. These critical objectives are

1. to improve the transparency and accountability of our science;
2. to gain insight into disease and promote healthy choices;
3. to encourage responsible development of key technologies; and
4. to strengthen our science capacity.

Towards a Strategic Science Plan identifies the following seven key strategies that will set our course for the future:

1. Strengthen the link between our science and the needs of Canadians as related to our mandate.
2. Reinforce our responsibilities towards sustainable development by implementing stewardship for chemicals management, the environmental impacts of products, and avoidance of antimicrobial resistance.
3. Build new kinds of evidence, such as the validation of new biomarkers of safety, which helps HPFB to implement better food safety regulation, as well as to oversee the entire life cycle of health products, from discovery to disposal.
4. Incorporate the most advanced concepts of health, diet, and nutrition into policy, guidelines, and standards to promote healthy living and wellness.
5. Understand the processes of disease in order to better assay the effectiveness of products and technologies that promise to alleviate human suffering and disease.
6. Use our accumulated knowledge and expertise to encourage and protect innovators and creators of new science and technology through responsible oversight.
7. Engage with industry experts in food, drug and medical device manufacturing so that health risks can be diminished through design in the earliest stages of product development.

We will implement these strategies and achieve our objectives by strengthening our science capacity, leveraging scientific partnerships, articulating what our science needs are to a wider public and to stakeholders, and capitalizing on opportunities.

Through a skilled workforce and well-built infrastructure, HPFB is a world leader in the regulation of food, nutrition, and health product science and technology. Towards a Strategic Science Plan is our call for partnerships in the national science enterprise, and for international alliances with our peers in other countries. We are reaching out to citizens, academic centres, and industrial science in Canada to increase and share our scientific knowledge, promote health and well-being, work together, and strengthen the capabilities and value of science nationwide.

Introduction

About the Health Products and Food Branch

Each day, Canadians from all walks of life in every part of the country are affected by the work of the Health Products and Food Branch (HPFB). HPFB plays a critical role in promoting healthy living and safeguarding the health and wellness of all Canadians through its comprehensive system of science, policy, and health communication.

HPFB Vision
To play a vital role in protecting and promoting the health and safety of all Canadians by excelling as a trusted scientific and regulatory authority for health products and food in Canada and internationally.

HPFB is Health Canada's authority responsible for regulating health products and food through the Food and Drugs Act. The Branch evaluates and monitors the safety, quality, and effectiveness of the thousands of human and veterinary drugs, vaccines, blood and blood products, medical devices, natural health products, radiopharmaceuticals, biologics and genetic therapies, and other health products available to Canadians, as well as the safety and quality of the foods they eat.

HPFB takes an integrated approach to managing the risks and benefits to health that are related to health products and food by minimizing health risk factors for Canadians while maximizing safety provided by the regulatory system. HPFB also promotes conditions that enable Canadians to make healthy choices and provides information so that they can make informed decisions about their health.

Science at HPFB

Science is at the core of HPFB's activities and decisions -- from policy development to scientific evaluation of health products and food, from risk assessments and compliance testing to nutrition surveillance and research on food pathogens and pharmacogenomics. In all these activities, HPFB is committed to sound, evidence-based decisions anchored in science.

Excellence in science
As a science-based organization, excellence in science is the foundation of HPFB's credibility and ability to fulfill its mission.

Our science encompasses laboratory and non-laboratory activities in natural sciences and social sciences:

• Laboratory science. Our laboratories conduct research and development, along with a variety of activities that support Branch programs, such as compliance testing, reference services and surveillance testing.
• Non-laboratory science. Our non-laboratory science includes regulatory sciences, benefit-risk assessment, and science-based services.

Product Life Cycle Approach
Health Canada is developing a regulatory approach that recognizes health products have a life cycle. Instead of discrete interventions at rigidly defined points (e.g., clinical trials or market authorization), a life cycle approach will encompass all stages of product development and use.

Role of HPFB Scientific Personnel

Currently, almost three quarters of HPFB's total workforce plays a direct or supporting role in HPFB's science.

Researchers: Conducts research in laboratories; for example, detecting chemical residues in food in support of new testing methods, and protocols. This research informs and supports the Branch's policy and regulatory activities.

Reviewers: Evaluate the submissions that Health Canada receives for health products and novel food products. This complex and highly technical process contributes to the safety, efficacy, and integrity of products before and after they enter the market. The majority of HPFB scientific personnel are reviewers.

Inspectors and Analysts: Testing Industry compliance with the Canadian Food and Drug Regulations by periodically reviewing and conducting laboratory and non-laboratory analysis of health products.

Policy Analysts: Research and analyze new and existing science and technology and translate them into policies, standards, operational procedures, and protocols to support our regulatory mandate.

Science Advisor: Provides a focus for coordination and development of science within the Branch, as well as advice on international, federal, and departmental science and technology issues of concern to the Branch.

The Need for a Strategic Science Plan

Our scientific personnel continually work to improve and promote the health and safety of all Canadians, and have had many successes over the years (see page 8 for more details). Towards a Strategic Science Plan will help us be more efficient and effective in an environment of both rapidly advancing, highly complex science and practical, finite resources. Many of the following factors contribute to HPFB's need for a strategic science plan.

External challenges and opportunities

Canada's changing demographic, globalization, the environment, new technologies, the threat of terrorism, and the emergence of new threats, such as the changing patterns of disease, counterfeit products, and product tampering are driving the need to maintain, leverage, and focus the scientific needs of HPFB. Today's increasingly complex world is producing many health challenges, but there are also many untapped research opportunities. For example, advances in scientific knowledge and technology, novel regulatory systems, and new scientists entering the workforce are providing new capabilities and fresh approaches to problems.

Aligning with federal science and technology priorities

There are a number of strategic initiatives that support the development of a Branch science plan. The importance of science to Canada is recognized by the federal government's 2007 Science and Technology Strategy, Mobilizing Science and Technology to Canada's Advantage. Health Canada also has a number of recent strategic initiatives, such as the Health Canada Science and Technology Strategy (October 2008), the HPFB 2007-12 Strategic Plan; Protecting the Health and Safety of Canadians, the HPFB Product Life Cycle Approach, the Food and Consumer Safety Action Plan, and the Blueprint for Renewal II; Modernizing Canada's Regulatory System for Health Products and Food (see Annex C for more details) which place an emphasis on science as the basis for effective regulation.

Towards a Strategic Science Plan builds on HPFB's 2003 report, Our Science, Our Health. It responds to and strengthens, internally and externally, the science and priority areas identified in the Branch's key strategic documents. It also reflects the strategies of each directorate within the Branch and aligns with the broader policies and guidelines they propose.

Did you know?
One of the 2007 Science and Technology Strategy's policy commitments: "Canada's federal government will make Canada a world leader though stronger domestic and international partnerships by...strengthening Canada's ties to the global supply of ideas, talent, and technology."

Aligning with international partners

HPFB is respected internationally as a modern regulator; however, there is a need for greater harmonization among international and domestic regulatory partners to provide a coordinated and comprehensive response to rapidly emerging challenges, such as pandemic planning. To remain on par with international partners, HPFB needs to review how it regulates and monitors health products and the direction of our science investments.

Our counterparts at the U.S. Food and Drug Administration (FDA) have also published their 2007 Strategic Action Plan. This document outlines the FDA's goals and objectives in order to focus agency efforts to achieve the FDA's public health mission and to fulfill its role in supporting the larger mission and strategic goals of the U.S. Department of Health and Human Services.

Our document, Towards a Strategic Science Plan addresses some of the same global challenges, although it is tailored to enhance and guide HPFB science capacity, partly by building on lessons garnered through the experiences of our international partners.

Recent Accomplishments by our Scientific Personnel

Despite the highly specialized nature of the work of the Branch, our scientific personnel continually strive to better protect and promote the health and safety of all Canadians.

Some of our most recent accomplishments:

• We made substantial improvements in our product reviews. We eliminated the backlog in the review of drug and biologic submissions and now meet our established review times.
• We established maximum residue limits of veterinary drugs to ensure that food-producing animals are healthy and safe to eat.
• We made additional investments in our post-market surveillance system and compliance enforcement capacity, improving oversight of the safety and effectiveness of products available on the market.
• We put in place a number of measures to enhance the transparency, openness and accountability of Branch science-based activities, such as public forums on the safety and efficacy of regulated products and the development of a policy on public input in the review of regulated products.
• We launched the revised Canada's Food Guide after extensive consultations with stakeholders and the public.
• We developed a new regulatory framework for cells, tissues, and organs, based on national safety standards.
• We implemented nutrition labeling regulations in December 2005 with supporting Web-based tools for consumers.
• We launched the MedEffect Web site to provide Canadians with safety information about health products on the market.
• We established the Office of Science and Risk Management, led by a Branch Science Advisor.

Developing the Plan

Given the variety and breadth of our science activities, the challenge in developing the Strategic Science Plan was to focus on our most critical science needs. HPFB scientific activities are conducted to help achieve the Branch's strategic mandate in a cost-effective manner, but we certainly cannot accomplish every possible science activity alone. The Science Plan helps us to outline and prioritize science activities that are very complex, and are usually undertaken with other groups, both internal and external to the branch. Furthermore, this plan does not attempt to address every kind of science need or activity of interest, but instead focuses on those scientific activities that will provide support to HPFB's overall mandate.

Internal consultations

To identify the strategic science needs of the Branch, we circulated a discussion paper for comment and invited staff to participate in workshops with the Branch's Science Advisor. The workshops were designed to provide information on the science strategies, identify the science needs of staff, and identify criteria for setting priorities.

Towards a Strategic Science Plan: The Plan will aim to provide clear and detailed guidance on the Branch's future scientific direction and strategic areas of interest to HPFB staff and its stakeholders.

Purpose of the Plan

Based on the results of staff workshops, a review of related internal documents, and further workshops and discussions with the Branch Science Committee, HPFB proposed five purposes for the Plan:

• For HPFB to continue to be made aware of food, nutrition, and health product science and technology developments on the horizon;
• To provide clarity, depth, and precision for Branch strategies outlined in the HPFB 2007-12 Strategic Plan: Protecting the Health and Safety of Canadians;
• To enable the Branch to recognize and act on science opportunities by articulating clear, strategic priorities in science;
• To serve as a basis for engagement and partnership in science allowing the Branch to leverage external capabilities; and
• To communicate our science to a broad audience of lay and expert publics, as well as stakeholders.

Towards a Strategic Science Plan is intended to engage a variety of audiences who play a part in Branch science and are affected by science activities. They include

• senior decision makers, because science is integral to the decision-making process in HPFB;
• our scientists, because they must make science ideas and ideals a reality;
• our clients and partners, with whom we share our expertise to help share, translate and develop new evidence for improved health; and
• the Canadian public, because their health and well-being is our primary focus.

Overview of the Strategic Science Plan

Towards a Strategic Science Plan provides a framework for defining HPFB's many science needs. The plan will allow us to harmonize and link these science needs with other science efforts in Canada and internationally in order to provide more effective collaborations and result in more focused, relevant science that supports the health and welfare of Canadians. An integrated, well-coordinated science body will help HPFB attract and retain a world-class scientific workforce. It will also encourage new opportunities for collaboration and information-sharing from other governmental departments, the public sector and our international counterparts.

Towards a Strategic Science Plan lists clear science objectives, strategies and clusters of activities, and describes how they strengthen HPFB's science foundation. They make up the framework on which we build our credibility and reputation as a world leader in health protection. Our mission is to support scientists and science as it supports us in our decisions to improve the lives of Canadians.

HPFB's Strategic Science Framework

Vision: To provide a strong science foundation that mobilizes and supports our science workforce and attracts new scientists to work in the service of Canadians.

Mission: Promotes, enriches and reinforces HPFB's science mandate in order to improve and safeguard the health of Canadians.

Strategies and Clusters of Science Activities

Objectives	Strategies
1 - Improve transparency and accountability	Integrate science, society, and the citizen
	Promote sustainable development
2 - Gain insight into disease and promote healthy choices	Develop new paradigms for evidence
	Promote healthy living and wellness
	Understand disease and apply new models of pathogenesis
3 - Encourage responsible key technologies	Maximize the benefits of existing and new technologies
	Advance safe manufacturing, quality, and hazard control
4 - Strengthen science capacity	Strengthen our key science enablers

Results: This strategic plan will result in a tangible increase in new science partnerships, opportunities, activities and capacities for HPFB.

Outcomes: This strategy will be evaluated for impacts on the health and safety of Canadians, the advance of government science, and the strength of our organization.

Scientific objectives, key strategies, and clusters of science activities

HPFB's scientific objectives apply to all the potential science activities that fall under the Branch's mandate and responsibilities, including research and development, evaluation of science, science-based compliance and enforcement, risk communication, and science policy.

Under the first three objectives, there are seven strategies that will guide the science we need to do and have access to. The final objective describes how we will conduct our own science capacity and improve our engagement on all levels.

Each of the seven strategies includes clusters of science activities that reflect both areas of our scientific efforts and areas of our science needs. These clusters can also be areas where HPFB sees a future scientific need to support our mandate.

Overview of objectives, key strategies, and clusters of science activities

Objectives	Key Strategies		Clusters of Science Activities
1 Improve Transparency and Accountability	1	Science, Society and the Citizen	1A Science Policy	1B Decision Sciences	1C Public Input and Consumer Outreach	1D Risk Communications and Behavioural Sciences	1E Emergency Preparedness
	2	Sustainable Development	2A Environmental Impact Assessment	2B Chemicals Management	2C Anti-microbial Resistance
2 Gain Insight into Disease and Promote Healthy Choices	3	New Paradigms for Evidence	3A Safety Biomarkers and Surrogate Endpoints of Benefit	3B Clinical Trials, Investigational Testing	3C Real-world Safety and Effectiveness	3D Epidemiology and Population Studies	3E Vulnerable Populations
	4	Healthy Living and Wellness	4A Diet, Nutrients, and Health	4B Nutrition and Genetics	4C Sole Source Foods	4D Dietary Guidance and Standards	4E Quality of Life and Patient-Reported Outcomes
	5	Understand Disease and Apply New Models of Pathogenesis	5A Dietary Patterns and Chronic Disease	5B Food Risks and Consumer Safety	5C Characterization of Pathogens	5D Validating Alternative Models of Disease
3 Encourage Responsible Key Technologies	6	Existing and Horizon Technologies	6A Tissue Engineering	6B Nanotechnology	6C Biotechnology and Genomics	6D Emerging Health Technologies and Biosystematics	6E Synthetic Biology
	7	Advance Safe Manufacturing, Quality, and Hazard Control	7A Manufacturing and Quality Systems	7B Non-medicinal Ingredients, and Materials Sciences	7C Contamination	7D Counterfeit Products and Tampering
4 Strengthening Science Capacity

Objective 1: Improve transparency and accountability

Objective 1
For HPFB: Making informed, ethical decisions that benefit individuals, the organization, and our society as a whole.

Strategy 1 - Science, society, and the citizen

Scientific endeavors have enormous potential to benefit society; however, public mistrust and poor understanding or awareness of science have sometimes resulted in a disparity between science and citizens that hinders beneficial progress.

The relationship between scientific facts and societal values is strongly influenced by

• the quality of scientific policies and regulations;
• information dissemination and risk communications; and
• the level of public outreach and receptiveness to consumer feedback.

By focusing on and improving these processes, HPFB will strengthen the links between science and society. The following clusters of science activities fall under Strategy 1:

• Science policy (1A): Developing effective science policy and supporting the relationship between science policy and research.
• Decision sciences (1B): Effectively using decision sciences to put scientific discoveries to work -- translating research results to concrete applications.
• Public input and consumer outreach (1C): Taking public input into consideration as evidence in our decision-making and, as a result, strengthening regulatory and policy decisions, fostering public trust, openness, and promoting accountability.
• Risk communication and behavioural sciences (1D): Communicating with the public and other stakeholders on issues related to risk involving food, drugs, and other health products.
• Emergency preparedness (1E): Mitigating and responding to risks and threats on behalf of Canadians.

Behavioural sciences essentially investigates the decision processes and communication strategies within and between organisms in a social system

Strategy 2 - Sustainable development

The Branch's responsibilities in this regard encompass social, economic, and environmental dimensions of sustainability. For example, HPFB is responsible to help curb emerging antimicrobial resistance, while at the same time promoting the development of and access to new antibiotic drugs.

HPFB will continue to focus on balancing the fulfillment of human needs with the protection of the natural environment, so that these needs can be met not only in the present, but also in the future. The following clusters of science activities fall under Strategy 2; however, sustainable development is an underlying principle of all HPFB activities:

• Environmental impact assessment (2A): Responding to growing scientific evidence that substances found in products regulated under the Food and Drugs Act are being found in the environment.
• Chemicals management (2B): Implementing the food borne contaminants initiative for the Government's Chemical Management Plan, which includes, as part of the pre-market evaluation programs, the evaluation of submissions of food additives, flavouring.
• Anti-microbial resistance (2C): Establishing a clear hierarchy of drug use and development that will help to mitigate the rise and spread of anti-microbial resistance.

Objective 2: Gain insight into disease and promote healthy choices

Objective 2
For HFPB: Using science to increase the health outcomes of Canadians, to make better clinical decisions, and to do so in a more efficient, cost-effective manner

Strategy 3 - New paradigms for evidence

The scientific method is the hub of all empirical knowledge, but putting it into practice is an evolving challenge that has a direct impact on the quality of the evidence used to make regulatory and policy decisions. This includes investigating how technologies provide novel ways to collect data, and how changing demographics affect study outcomes and safety boundaries which work to enhance patient safety. HPFB recognizes that improving the methods and practices for gathering scientific evidence will improve the quality, efficacy, and safety of the health products and food available to Canadians.

HPFB will support the development of new paradigms for evidence. This involves focusing scientific efforts on studying and enhancing the assumptions, concepts, values, and practices that guide how we collect or use research evidence and developing practices and guidelines based on that evidence. The following clusters of science activities have been identified as priorities for Strategy 3:

• Safety biomarkers and surrogate endpoints of benefit (3A): Validating new biomarkers that can be used during non-clinical and clinical drug safety evaluations; and developing new, more reliable surrogate markers for determining drug safety, food safety and clinical effectiveness.
• Clinical trials and investigational testing (3B): Supporting adequate and appropriate clinical trial or investigational testing to decrease risk and delays in regulatory approval. Continuing to evaluate clinical research design, especially of submissions for regulatory approval.
• Real-world safety and effectiveness (3C): Factoring observational evidence of the real-world safety and effectiveness of drugs, drug-like foods and natural health products into decision making.
• Epidemiology and population studies (3D): Applying new knowledge on how genetic and environmental factors combine to influence disease occurrence.
• Vulnerable populations (3E): Understanding the impacts of health products and food on vulnerable populations.

Strategy 4 - Healthy living and wellness

Healthy living refers to the behaviours that individuals or populations engage in to maintain or improve their health. For health products and food, the Branch recognizes a need for scientific activities that further our understanding of the impact of behavioural choices on health. Understanding the impact of food choices, as well as the role of various vitamins, minerals, and supplements on health status, is important in the development of policy and guidelines for holistic health promotion. HPFB recognizes that well-developed guidance enables citizens to make lifestyle choices that will improve their health and well-being. Evaluating the impact of guidelines on public behaviours and health will help gauge their effectiveness. Additionally, it is important to continually evaluate guidelines to make certain that they reflect the needs of Canada's changing demographic groups. Therapeutic products such as natural health products and medical devices contribute to healthy living and wellness, for example, by maintaining as many quality of life factors as possible for persons suffering from chronic disease. These life quality factors may influence risk tolerance factors in the usage of a therapeutic drug. There is a need to focus efforts on developing and promoting such products. HPFB must also address the novel challenge of regulating how food can be used and marketed for therapeutic purposes, in both quality of life, as well as having a direct pharmacological effect.

Quality of life is how well someone feels physically and psychologically. The physical aspect includes things such as health, diet, and protection against pain and disease. The psychological aspect includes stress, worry, pleasure and other positive or negative emotional states.

Understanding how lifestyle choices affect health status is important in developing policy and guidelines for health promotion. HPFB will promote greater understanding in this field by providing clear guidance to Canadians so they can make informed choices that will improve their health and well-being. The following clusters of science activities have been identified as priorities for Strategy 4:

• Diet, nutrients, and health (4A): Understanding the interaction between diet, nutrients, and health.
• Nutrition and genetics (4B): Applying the knowledge of complex nutrition and genetic factors and how they influence each other in the development of better nutritional advice to Canadians.
• Sole source foods (4C): Applying new science in the novel nutritional challenges posed by long-term use of sole source foods such as infant formula, feeding tube nutrition and other such diets.
• Dietary guidance and standards (4D): Improving and promoting dietary guidelines.
• Quality of life and patient-reported outcomes (4E): To recognize the concept of quality of life of patients in order to help them access safe and effective health products that are intended to mitigate symptoms of disease rather than treat the disease directly.

Strategy 5 - Understand disease and apply new models of pathogenesis

Our understanding of disease is always changing, but one fact remains certain: health and disease are significantly affected by lifestyle choices, whether it is through the nutritional quality of foods that people consume, the presence of disease-causing organisms within those foods, or the protection afforded by vaccines and other therapeutic drugs. Disease models are essential to advance our understanding of these interactions. HPFB recognizes the need to engage with the academic community, partners and stakeholders to help validate new disease models that will aid in studying the effects of drugs on disease, spanning both infectious and chronic disease. HPFB also recognizes the need to engage with partners to further explore the relationship between diet and disease, and apply disease models that identify contributing and preventative factors, especially as they relate to chronic disease.

Additionally, as new technologies are adopted, there is a need to assess the quality and safety of health products and food products derived through these novel methods. Research and policy development are critical elements in minimizing exposure of Canadians to hazardous substances and pathogens through food consumption.

The following clusters of science activities have been identified as priorities for Strategy 5:

• Dietary patterns and chronic disease (5A): Understanding the possible impacts of dietary patterns in relation to chronic diseases.
• Food risks and consumer safety (5B): Investigating and mitigating possible chemical and microbial threats in the food supply.
• Characterization of pathogens (5C): Studying emerging bacterial, viral, parasitic, and prion food pathogens and their impacts on human health.
• Validation of alternative models of disease (5D): Validating new in vitro, in vivo and in silico models of disease to facilitate the transition of new therapeutic products to the clinical trial stage. This is in keeping with modern trends away from compulsory animal testing and towards substitute methods, while still maximizing consumer safety.

Objective 3: Encourage responsible key technologies

Objective 3
For HFPB: Understanding new and upcoming science and technology before they arrive in the regulatory pipeline. This is in order to more accurately assess research, policy and regulatory implications at the branch, departmental, federal, and public level.

Strategy 6 - Maximize the benefits of existing and horizon technologies

HPFB regulators have a responsibility to use the appropriate evaluation tools to monitor the responsible application of cutting-edge technology, especially when future impacts are mostly unknown. Current technologies now entering into the drug and drug regulatory stream include tissue engineering, nanotechnology, biotechnology, and genomics, while emerging technologies such as synthetic biology are on the horizon. Evaluators also need access to new technologies to measure safety in products and devices. HPFB must be able to access the expertise and skilled staff necessary to fulfill its mandate in these areas. HPFB needs to maximize its influence on the responsible application of technologies to avoid harmful effects, while encouraging the development of beneficial technologies. The following clusters of science activities are highlighted under Strategy 6:

• Tissue engineering (6A): Understanding the unique properties and regulatory challenges posed by tissue-engineered products and research, such as stem cells and their role in regenerative medicine.
• Nanotechnology (6B): Recognizing the unique regulatory and health risk assessment challenges in the assessement of nanotechnology in most aspects of food and drug composition and/or delivery.
• Biotechnology and genomics (6C): Understanding the function and structure of genes, proteins, and cellular metabolites, and how these technologies are being incorporated into new drugs and foods.
• Emerging health technologies and biosystematics (6D): Capitalizing on technological advances, such as the statistical analysis of data obtained from genetic, biochemical, and other studies to determine the taxonomic relationships of organisms and populations.
• Synthetic biology (6E): This is an example of a horizon technology which could appear in the next 10 years. HPFB needs to be able to understand synthetic biology's positive outcomes in order to mitigate any potential harmful effects if and when these sorts of technological applications are in the Canadian marketplace.

Strategy 7 - Advance safe manufacturing, quality, and hazard control

As next-generation technologies such as direct digital manufacturing, rapid prototyping, stereolithography, and solid freeform fabrication become a reality, new opportunities for innovation become available. New manufacturing practices have potential to create novel products, higher quality therapeutics, accelerate the convergence of drug and device technologies, increase yields, and lower costs. Increased demand for higher quality and lower cost products is being fueled by the entrance of new world manufacturing facilities in places such as China and India, and the increase in global trade poses challenges not only to the Canadian socio-economic sector, but to consumer safety. Recent problems with toothpaste -- where inspectors found that shipments of toothpaste from China contained diethylene glycol -- exemplify the need for more effective regulation. To address these issues in food and drug regulation, HPFB needs to oversee effective industry hazard control. This includes investigating and monitoring the safety of desirable materials in drugs (such as useful non-medicinal ingredients), while reducing the risk of unintended, undesirable or harmful materials being included in final products. Science-based inspections help HPFB learn about and monitor industry best practices and determine industry adherence to Good Practice (GxP) quality guideline systems so that health products are made in a consistent and responsible manner.

As traditional manufacturing techniques evolve into more complex manufacturing and as global trade increases, there is a need for regulation to ensure that quality and safety standards are upheld.

To ensure the safety of Canadians, HPFB needs to maintain effective hazard control. The following clusters of science activities are highlighted under Strategy 7:

• Manufacturing and quality systems (7A): Ensuring product quality by taking into account the complete product life cycle from concept through manufacturing to consumer satisfaction.
• Non-medicinal ingredients and materials science (7B): Developing more accurate classification for non-medicinal ingredients and other materials patients may come in contact with.
• Contamination (7C): Limiting the exposure of people to harmful compounds and microbial agents found in their diets and health products.
• Counterfeit products and tampering (7D): Learning about and using new tracking and detection systems.

Objective 4: Strengthen science capacity

Objective 4
For HPFB: Building intellectual capital, infrastructure, and laboratories and adapting to environmental changes.

Our vision -- to develop a strong science foundation that will mobilize and support our science workforce and attract a new generation of scientists to work in the service of Canadians -- supports strengthening our science capacity.

From a strategic perspective, however, strengthening science capacity underlies most of the clusters' activities. There are several potential ways to strengthen this capacity, including

• recruiting, retaining, and supporting scientists who have the skills and knowledge required to meet the objectives of the Branch;
• redeveloping our science information base, such as Health Canada's Science Library Network, and facilitating access to important data so that scientists, evaluators, and regulators can make informed decisions and work effectively;
• improving and making more accountable our laboratory infrastructure to provide a robust, more predictable level of engagement; strengtening laboratory capacity for natural health products and post-market work related to medical devices, increasing capacity for our regulatory-based science laboratories, and putting processes and procedures in place to meet specific laboratory accreditation standards;
• linking our major capital plans for science equipment into a more cohesive plan of science strategies for the future; and
• providing our scientists with the specialized tools and training they need, such as bioinformatics (including new databases to support inspections, investigations, and trend analysis), and statistical services.

Expected Outputs and Outcomes of the Plan

The following presents an outline of expected and measured outputs of the Plan. These will eventually lead to evaluated benefit outcomes. As the Plan is further developed and implemented over the coming years, we will be able to concretely measure and evaluate our contribution to the advancement of government science as we capitalize on science opportunities. Most importantly, it aims to define the science we will need to do and access in order to advance our mandate to help Canadians maintain and improve their health.

Our expected outputs:

Consistent with the key science drivers for Health Canada's Report on Plans and Priorities, as well as the Department's Science Strategy, the HPFB is expecting the following outputs:

• An integrated, advanced approach to health assessment and protection;
• An increased promotion of health and disease prevention;
• An increase in our ability to effectively anticipate and evaluate new science;
• A dedicated, motivated and highly-trained scientific workforce; and
• An enriched Canadian market environment which encourages and develops new products and technologies.

Our measured outputs will be determined by:

• The number of new partnerships with academics, industry and granting councils;
• The number of new science opportunities;
• The assessed quality of these selected science activities; and
• Annual tracking of indices of science capacity.

Evaluating the benefit outcomes:

• The direct impacts on the health and safety of Canadians;
• The further advance of our government science, policies, regulations, and decision making; and
• The strength of our organization and our science culture.

Putting the Plan into Action

The objectives and strategies laid out for the Science Plan are ambitious; however, they are essential for HPFB to remain at the forefront of food, nutrition, and health product science and technology.

That said, however, implementation of the Science Plan will not be done at the cost of our core regulatory duties. The Branch continually faces the difficult task of developing and implementing timelines and resource allocations for prioritized areas.

Although the Science Plan will help us to identify and modify cluster activities, the actual implementation of the Plan will give us valuable insight into how this prioritization can be done from both a policy and operational standpoint. Future revisions of the Science Plan will contain these new policies and procedures so that they can be refined over time.

Prioritizing our resources

In prioritizing the scientific strategies in order to best allocate Branch resources and investment, HPFB must consider operational needs and balance these against research and policy pressures, as well as the needs of evaluators and inspectors. The Branch must continue to achieve its performance targets, fulfill functional requirements, and take into account the explosion of technologies in our day-to-day activities.

Balancing these varying demands, the Branch will utilize our Strategic and Operational Planning and Review cycles to prioritize science initiatives and activities. Whether we conduct the science internally, or apply sound scientific knowledge generated outside of the Branch, the ultimate goal is to reduce the uncertainty of product performance throughout its life cycle, using scientific research. The priority for research will be placed on those areas where Canadians face the highest level of risk.

The process of prioritization and risk assessment will involve looking at an inventory of all priorities in science and research, which can be identified from the following non-exclusive sources:

• A review of the strategies of component organizations of the Branch;
• Staff-level surveys and workshops;
• Comprehensive review and operational planning;
• The logic of Directorate operations (for example, enforcement/compliance, surveillance, policy development, testing, risk communications) where an identified strategic science priority might need to be pursued; and
• Environmental scans, such as the annual Health Canada environmental scan, prepared each year by the Strategic Policy Branch.

The inventory of science activities includes items that are currently being pursued and items that represent projected, future science needs or proposals. Investments will be prioritized based on strategic and operational needs. Our commitment in these clusters will be measured using the science strategy matrix (see Appendix A) as a scorecard. Each box in the matrix will be assigned a score number based on Branch priorities and external influences.

Producing results

The successful implementation of this Plan will allow HPFB to deliver the science that underpins the Branch's Roadmap and the HPFB 2007-12 Strategic Plan, Blueprint for Renewal II, Product Life Cycle Framework, and Canada's Food and Consumer Safety Action Plan. It will require a multifaceted approach. Not only will the Branch need to strengthen its own science capacity, it will need to strengthen scientific partnerships to leverage the expertise and resources available in Canada and abroad. The Branch will also have to successfully communicate its science to the public and stakeholders, and at all times be ready to capitalize on opportunities.

Strengthening our science capacity

Identifying and providing HPFB scientists with the resources they need is essential to the Branch's success. This includes improving laboratories; increasing access to scientific literature, bioinformatics, and statistics services; and providing scientists with necessary equipment and training. Improving the science information infrastructure to include enhancing services is essential. For example, librarians have specialized knowledge and expertise in searching through scientific literature, both on paper and online. In addition, it would ensure that required research information is complete. This saves researchers considerable amounts of time and effort, maximizing their efficiency.

Also, as HPFB continues to evolve as a science-based organization, it will be of paramount importance to recruit and maintain our intellectual capital. We must ensure that scientists with the necessary expertise and training -- whether they be researchers working in a laboratory environment, reviewers at the operational level, or science-based policy analysts -- are available to carry out the Branch's mission. Supporting the Branch's intellectual capital will require providing training programs to new scientists, in particular, improving the comprehensiveness and availability of training necessary for science staff to become science-based policy makers.

Establishing and leveraging scientific partnerships

The successful implementation of the Plan will depend on a collaborative cross-sector effort between government, industry, and academia, both in Canada and abroad. HPFB will need to identify and tap into new channels as well as strengthen present partnerships.

One of the first priorities in this effort should be to develop a formal process for collaborations in external science and research opportunities. This will involve developing an inventory of potential partnerships and clearly defining levels of engagement. This would provide the Branch with a transparent and balanced approach to assessing potential collaborations using clear criteria. It would also provide the Branch with a transparent methodology to evaluate the resource implications of proposed initiatives.

Moving forward, HPFB must also continue to work with its international partners to address challenges as well as to leverage scientific opportunities that continue to emerge in the context of globalization. We need to look inward at our own organization and outward to the experiences of other modern regulators globally in order to improve the flow and exchange of novel regulatory approaches and scientific information. We also need to continue to ensure that our scientific activities are open and shared with the global scientific community, and that our approaches to regulatory activities reflect international best practices. Efforts will also focus on improving the transfer of knowledge from HPFB program areas to partners at both the provincial and federal level.

Articulating our science to Canadians

HPFB is committed to a more open and transparent regulatory system in which the involvement of patients, consumers, health professionals, industry, and researchers contribute to better overall quality of decision making. As such, the importance of communicating HPFB's science to its stakeholders and the public cannot be overstated.

Effective science communication is crucial to ensure that knowledge is passed on, results are understood, and instructions are followed (for example, for drug dosing). To ensure transparency, the Branch must articulate its scientific activities in a way that a lay audience can understand. Effective science communication will result in increased partnerships and support and may even inspire a young generation of scientists or students in scientific disciplines. Of paramount importance is the need to influence academia to teach regulatory science -- articulating the Branch's science can help make this possible.

Capitalizing on opportunities

The most critical component of the Science Plan is not the objectives, nor the key strategies, nor even the science activity clusters. The essential factor that will determine the success of the Plan depends almost entirely on the ability of HPFB to remain flexible enough to capitalize on opportunities as they arise in the scientific environment, throughout all levels of government, and through its collaborators. The Plan highlights some of the tremendous science opportunities that exist or are on the horizon that can help HPFB develop, enhance, and strengthen its science foundation. To exploit these opportunities and to turn these innovations into reliable applied sciences, HPFB scientists will need to stay current with the latest discoveries and policies. HPFB will need to be aware of new scientific programs, whether they provide opportunities to train employees or to engage in unique collaborations. Capitalizing on opportunities will also allow HPFB to take advantage of financial opportunities to ensure that resources are available to realize the Branch's mission. This involves not only fostering an awareness of current developments to monitor for emerging opportunities, but also proactively seeking connections and engagements.

Annexes

Annex A: Clusters of science activities (Detail)

Key Strategy 1 - Integrating Science, Society, and the Citizen

1A - Science Policy

The development of effective science policies, whether regulatory or non-regulatory, requires high-quality science research delivered to policy makers and effectively communicated to the public. The relationship between science policy and research is two-fold: research discoveries can fuel policy development, and policy needs can fuel research initiatives. To achieve a stronger science-policy interface, HPFB will work to develop stronger links with key stakeholders both inside and outside the Branch to ensure the connections between scientists and policy makers are made. Scientists will also investigate how to effectively manage science issues and controversies, as well as determine how to best communicate the science behind policy to the public by conducting social science research.

1B - Decision Sciences

Decision sciences put scientific discoveries to work, translating research results to concrete applications. However, to ensure effective decision making, HPFB needs to apply a rigorous method and precautionary principle. HPFB needs to develop new tools and approaches that are specific to its operational environment, such as guidelines to help classify products that fall within several regulatory regimes. The Branch will also benefit from a weight-of-evidence approach - a method that balances the credibility of proof on one side relative to another - that can be applied to fields such as veterinary medicine and natural health products. For example, the development of a weight-of-evidence approach can aid regulators in making a decision when presented with the risks and benefits of a new health product. HPFB also requires an enhanced tool to help reviewers evaluate the methodological quality of published research papers. Knowing which research is of greater quality is vital to making informed decisions based on the available research.

1C - Public Input and Consumer Outreach

Regulatory and policy development decisions, such as those concerning therapeutic agents, are outside the scope of decisions that citizens can make; nonetheless, citizens want to play a more active role. Feedback from the public and from consumers using a particular product can be useful in assessing the effectiveness and safety of a product, especially when scientific evidence is lacking. To make the best use of public input, HPFB needs defined methods to reach the public, obtain comments, and to integrate and assess a range of perspectives and evidence. A rigorous process will ensure that the feedback obtained is valid and that it is actually used. Under its Blueprint for Renewal II, HPFB is updating and modernizing its regulatory approach to make it more transparent and to allow for the integration of public input, including that of a qualitative nature. The goal is to develop a process that takes public input into consideration and, as a result, strengthens regulatory and policy decisions, fosters public trust, and promotes accountability. To achieve this, HPFB will continue to develop and implement instruments and tools to support the incorporation of input from external stakeholders into regulatory safety reviews.

1D - Risk Communication and Behavioural Sciences

HPFB is responsible for communicating with the public and other stakeholders on issues related to risk involving food, drugs, and other health products. Effective risk communication enhances public trust and prevents the public from making ineffective or even damaging decisions. For example, when the risks of eating unhealthy foods are communicated clearly and accurately, consumers may modify their behaviour. While considerable progress has been made in communicating information relating to food, communications relating to health products lag behind. Also, while doctor's offices feature posters and brochures with health messages from many organizations, messages from Health Canada are often absent. To improve risk communications of all kinds, scientists must work to answer key knowledge-translation questions about how risk communication is conducted and its impact on the receiver. For example, determining which types of media communications are most effective for alerting the public to health risks. Behaviour modification is not the only potential outcome; research in this area can also lead to better policy and product development. For example, investigations on how consumers understand nutritional labelling can aid in the development of support resources.

1E - Emergency Preparedness

Emergency preparedness is most effective when informed by multiple disciplines, especially as it pertains to food security and food defence. HPFB has specific expertise in product labelling, tampering, analysis, and traceability that can be applied to civil emergency preparedness, which may include an accidental or intentional biological, chemical, or radionuclear event. Through the development of partnerships, HPFB can help protect supply chains for food and health products that are vulnerable to becoming vehicles for bioterrorism agents such as biological contaminants. This will be accomplished through the development of plans, procedures, exercises, special resources, science projects, and technology to effectively mitigate and respond to these risks in cooperation with other government departments and agencies, industry, and civil authorities. For example, HPFB can work in partnership with the Canadian Border Services Agency (CBSA) and other regulators to support monitoring and surveillance of shipments of health products into Canada.

Key Strategy 2 - Promoting Sustainable Development

2A - Environmental Impact Assessment

International monitoring has established that certain substances contained in products regulated under the Food and Drugs Act are present at detectable levels in the environment. To this end, HPFB scientists are currently investigating the prevalence and persistence of drug contamination of the environment, in addition to our traditional role in the investigation of bacterial, viral, and parasitic pathogens. Not only will HPFB be responsible for the investigation of drug and health product impacts on disease, but consideration must be paid to the impacts of drugs and health products on the environment. HPFB is partnering with Environment Canada and the New Substances Division of HECSB to develop a science and research agenda to contribute to the overall risk assessemnet and risk management actions for both new and existing substances in FDA products. The research agenda includes analytical methodology development, toxicology properties, evaluation, monitoring, surveillance and furthering the understanding of the biological effects of single substances, mixtures and the underlying chemical pathways that are affected.

2B - Chemicals Management

In addition to biological contaminants, HPFB is responsible for investigating, evaluating, and regulating emergent chemical contaminants from food and health products that could ultimately pose threats to human health. This includes persistent organic pollutants, pesticides, food additives, and volatile organic contaminants. For example, bisphenol A (BPA) is a chemical monomer used in the production of polycarbonate and epoxy-phenolic resins. Polycarbonate (PC) is widely used in the manufacture of food containers (e.g., milk, water and infant bottles) and epoxy resins are used as an interior protective lining for food and beverage cans. As a result of these food contact uses, minute quantities of BPA can potentially leach out into the water or food and consumers may be exposed to BPA through the diet. BPA has been found to mimic the activity of hormones in humans and as such has potential for negative effects. HPFB researchers have investigated the probable daily intake of BPA for the general population from food packaging uses and more recently has focused on studies measuring the levels of BPA in canned liquid infant formulas from the Canadian market. HPFB is committed to continuing research on BPAs and other chemical contaminants that could threaten human health and the environment. To ensure that decisions are made using the most up-to-date knowledge and policies, it is necessary to improve harmonization with international experts in this area.

2C - Antimicrobial Resistance

To enable the sustainable use of life-saving drugs for humans, a clear hierarchy of drug use and development needs to be established that will prevent the rise and spread of antimicrobial resistance. Antimicrobial resistance (the ability of a microorganism to withstand the effects of an antimicrobial agent such as a drug) can be intrinsic or it can arise over time. There is a concern that important life-saving drugs for humans may lose their effects once the targeted microbe develops resistance due to widespread use of the drug (e.g., to prevent disease or promote growth in animal husbandry practices). Studies are needed to detect the prevalence of antimicrobial resistant bacteria in food sources, including seafood and aquatic environments in the eastern and western costal areas of Canada. Antimicrobial resistance risk assessment is in its infancy and there is an urgent need to develop appropriate methodologies that take into account the multifaceted pathways of exposure to resistant bacteria or resistance genes and to be able to characterize the health risks. It is critical that scientists understand the mechanisms of direct and indirect resistance transfer among species (e.g., transfer of resistance between humans and animals). A greater understanding is also needed of how antimicrobial sanitizers and disinfectants contribute to antimicrobial resistance to therapeutic drugs.

Key Strategy 3 - Developing New Paradigms for Evidence

3A - Safety Biomarkers and Surrogate Endpoints of Benefit

While new technologies and investigative techniques are allowing for a more accurate evaluation of the risk versus benefit profile for therapeutic drugs and treatments, changing societal practices are introducing new challenges. For example, evaluating the benefits and risks of taking a specific prescription drug has been made easier with technological advances that have increased the number of biomarkers to monitor the progression of specific diseases and disorders. On the other hand, the number of drugs taken concurrently by patients continues to expand, and the effects of multiple drug therapies, or drug therapies combined with diet and lifestyle changes, are not easily predictable. This complexity is further increased as the evaluation of benefit versus risk is expanded to take into account the impact of drug use and medical device use, as well as the interaction of non-traditional treatments, such as traditional Chinese medicines, with traditional therapeutic treatments and drug metabolism. Rapid technological development in this field has also increased the complexity of pharmaceutical and medical device licensing submissions. Areas of interest to HPFB scientists include the validation of new biomarkers that can be used during pre-clinical and clinical drug safety evaluations; the development of new, more reliable surrogate markers for determination of drug safety and clinical effectiveness; the use of biomarkers as predictors of an increased risk of serious adverse effects; the ability to evaluate generic copies of complex drugs; and the application of risk versus benefit profiles to functional foods and other products that are accompanied by health claims but have little data on possible risks.

3B - Clinical Trials and Investigational Testing

The results of both clinical trials (controlled studies on humans that compare a drug treatment to a placebo) and investigational testing (the study of the safety therapeutic effectiveness of a medical device) are critical to the evaluation of and regulation of therapeutics and medical devices. Adequate and appropriate clinical trial or investigational testing can result in decreased risk and delays in regulatory approval. HPFB scientists continue to evaluate clinical research design, especially as it relates to submissions for regulatory approval. In particular, scientists have identified that clinical trials for type 2 diabetic drugs, which are the fastest growing group for new submissions, are failing to capture the true risk versus benefit profile of drugs in comparison to lifestyle interventions. HPFB has identified a need for well-defined "healthy lifestyle" reference groups for clinical evaluations of new drugs in type 2 diabetes. Poor clinical trial design is also a concern for biologics as is the need for increased clinical trials for new natural health products. HPFB has also identified a need for a way to better determine the type of studies required for treatments of potentially self-resolving conditions and for radiopharmaceuticals used in diagnostic imaging.

3C - Real-world Safety and Effectiveness

Clinical trials and the resulting experimental evidence they generate lead to the approval of pharmaceutical drugs for specific uses. However, it is common practice for pharmaceutical drugs to be used for indications, durations, in additional populations, and at doses they were not originally approved for. Known as off-label clinical use, the risk versus benefit profile of pharmaceutical drugs under such conditions is poorly understood or unknown. Scientists at HPFB will continue to collect data on the incidence and nature of such off-label use as an input factor when conducting risk assessments. However, observational evidence of the real-world safety and effectiveness of drugs will be difficult to incorporate into decision making; a more proactive approach is needed in this area. A more proactive approach is also needed in the area of pharmagenomics, which is allowing scientists to study the therapeutic effectiveness of pharmaceuticals through genetic testing. Because pharmaceuticals are often taken in tandem with natural health products, research should be undertaken to identify those combinations of therapeutics that could cause the gravest of adverse reactions. There is also an interest in investigating the effectiveness of patient registries. Finally, HPFB should investigate the possibility for adverse reactions in humans from veterinary drugs.

3D - Epidemiology and Population Studies

In developing new paradigms for evidence, HPFB has identified epidemiology as a specific area to focus on. Results from epidemiological studies can be used to better control the spread of disease and to treat patients more effectively. Genetic epidemiology is an emerging discipline that considers the role of genetic factors in the occurrence of diseases in populations. It attempts to determine how genetic and environmental factors combine to influence disease occurrence. For example, environmental conditions such as high exposure to radiation can cause genetic mutations in individuals, making them or their offspring more susceptible to conditions or diseases such as cancer. By taking such novel approaches to epidemiology and population studies, HPFB scientists will gain a broader understanding of how often diseases occur in different groups of people and why.

3E - Vulnerable Populations

Vulnerable populations are made up of groups such as infants, the unborn, older adults, the mentally ill, transplant recipients, and other groups of people who are more susceptible to ill health because of their prevailing life conditions. Studies within this area seek to determine how diet and therapeutic products uniquely affect the health of these populations. HPFB recognizes a need for more studies within this area, including how food choices, natural health products, pharmaceutical drugs, and dosage levels affect the health of specific vulnerable populations, such as pediatric populations. Socioeconomic drug utilization studies may also be used to determine which populations are at greater risk. In addition, there is a need to establish standardized definitions of vulnerable populations to clarify risk communications and information dissemination to these groups. In terms of applying the research findings, it is important to advance an awareness of the rights of these individuals and how these rights may clash with health guidelines (for example, rights to work versus exposure to harmful chemicals in the workplace).

Key Strategy 4 - Promoting Healthy Living and Wellness

4A - Diet, Nutrients, and Health

HPFB works to promote the message that good diet leads to good health and prevents disease; it is a message supported by years of evaluations performed by countless HPFB scientists. Assessing the human health impacts, safety, and nutritional quality of food is one of HPFB's main priorities. Moving forward, scientists at HPFB will continue to collaborate on the Canadian Total Diet Study, which has monitored how toxins in foods (for example, mercury in fish, meat, and dairy) accumulate in Canadians of different age or sex groups for more than 35 years. Ultimately, the findings can be applied to risk assessment and management of these substances in foods. There is also a need to assess the effects of consuming soy, omega-3 fatty acids, sodium and potassium, selenium, and multiple single-dose vitamins and multi-vitamins. Additionally, HPFB scientists will examine the interactions between various nutrients and effects of consuming minerals, vitamins, and antioxidants. Ongoing health surveys, such as the Canadian Community Health Survey, provide information on how dietary guidance impacts the dietary patterns and health of Canadians. The survey highlights major food sources of nutrients in Canadian diets, while estimating the prevalence of food insecurity and inadequate nutrient intake among Canadians. Similarly, surveys to follow up on earlier survey research, such as the Baseline Natural Health Products Survey Among Consumers conducted in March 2005, may provide the Branch with valuable insights regarding natural health product use as well as areas of concern that may involve further collaboration among the Natural Health Product Directorate (NHPD), Health Products and Food Branch Inspectorate, and Marketed Health Products Directorate (MHPD).

4B - Nutrition and Genetics

Nutrition and genetic factors both play a role in influencing the development of certain diseases such as cancer and diabetes. Scientists are also discovering that diet can induce heritable changes - not by altering genes themselves, but by altering gene activity. Called epigenetics, it is area of research that holds much promise in producing knowledge mothers can use to choose a diet that will prevent future disease in their unborn children. Another important field in this strategic area is nutriomics. Nutriomics deals with the availability of nutrients in food sources, and the effects that complex mixtures of nutrients can exert on physiological functions. For example, complex mixtures of nutrients can be characterized and related to biological responses such as anti-inflammatory activity by microarray data. This field is currently being exploited through the development of functional foods.

4C - Sole Source Foods

The development and use of sole source foods presents a unique challenge to HPFB because it is positioned on the boundary line of using foods like a drug. Sole source foods, which are often liquids, are used in hospitals and clinics (but increasingly in the home), for individuals who are unable to eat normal foods or who have special dietary requirements that cannot be met by modifying their diets alone. Sole source foods such as infant formulas, and feeding techniques such as tube feeding, are designed to meet daily nutritional requirements or supplement an inadequate dietary intake. HPFB has identified a need to further expand research in this area.

4D - Dietary Guidance and Standards

HPFB strives to improve dietary guidelines to ensure that they reflect the most up-to-date research and provide accurate nutrition standards. Developed and recently updated by HPFB, Canada's Food Guide translates the science of nutrition and health into healthy eating patterns and emphasizes the importance of combining healthy eating and physical activity. By following Canada's Food Guide, Canadians will be able to meet their nutrient needs and reduce their risk of obesity and chronic diseases. HPFB scientists will evaluate the compliance of Canadians to the new version of the Guide by comparing nutrition survey results to the advice provided by the Guide. This will inform our response to changing eating patterns and the changing environment within which Canadians are making food choices. In addition to Canada's Food Guide, the Branch is committed to supporting and improving the use of the Dietary Reference Intakes (DRIs), a comprehensive set of nutrient reference values for healthy populations that can be used for assessing and planning diets. They are established by Canadian and U.S. scientists through a review process overseen by the United States' National Academies, which is an independent, nongovernmental body. The DRIs are based on scientifically grounded relationships between nutrient intakes and indicators of adequacy as well as prevention of chronic diseases. Health Canada uses the DRIs in policies and programs that benefit the health and safety of Canadians. HPFB will continue to work with the Institute of Medicine (IOM) to identify research needs and knowledge gaps in developing and advancing the DRIs.

4E - Quality of Life and Patient-Reported Outcomes

The area of health products and quality of life focuses on improving the quality of life for Canadians through access to safe, effective, and high-grade health products. These health products consist of natural health products, foods, prescription drugs (including restorative and regenerative medicine), medical devices, and over-the-counter products. The quality of life of patients is an important consideration when developing and regulating new therapeutic products, as it is something that is highly valued. For example, many Parkinson's patients are trading off the risk of drug complications to uphold their quality of life. Veterinary therapeutic products also fit into this category, as it can be argued that vet products that make pets and agricultural animals healthier also contribute to human well-being.

Key Strategy 5 - Understanding Disease and New Models of Pathogenesis

5A - Dietary Patterns and Chronic Disease

Understanding the possible impacts of nutrition on chronic diseases is essential for HPFB to inform programs and policies related to nutrition. Numerous studies are currently underway, for example, to study the effect of vitamin E on prostate cancer, which will advance understanding in this strategic area. There is also a need for HPFB to assist in the development of a probabilistic approach to the synthesis of scientific literature in support of the development of nutrition policy, particularly as it relates to chronic disease prevention.

5B - Food Risks and Consumer Safety

Protecting Canadians from possible dangers in the food supply is a critical pillar of HPFB's mandate. Research in this domain includes assessing potential health risks associated with the consumption of novel foods such as genetically modified organisms (GMOs) designed to have different nutritional properties than the original food. Other important areas of research include safety evaluations of trans fat, non-digestible fat products such as Olestra, and risk assessment of using fortified foods as disease-based interventions. Looking forward, scientists will also investigate the development of nutritional status biomarkers and development of animal models to improve testing methodologies associated with the evaluation of novel foods. This research can lead improved food labelling, standard setting, and regulatory practices.

5C - Characterizing Pathogens

Recent years have shown a dramatic increase in illnesses associated with emerging bacterial, viral, parasitic, and prion pathogens and their impacts on human health and the economy. As a result, one of HPFB's key areas of activity is determining the risks that such pathogens pose to Canada's food supply and the Canadian consumer. To this end, scientists will continue to work on developing rapid detection methods (for example, DNA microarray chips), intervention strategies, guidelines, and standards to respond to and control microbial pathogens such as Campylobacter jejuni, Listeria monocytogenes, verotoxigenic Escherichia coli, noroviruses, and prions. Antimicrobial drugs and vaccines play a key role in controlling microbial pathogens, and there is a need to sponsor and support the development of novel drugs and vaccines. Scientists will also focus on improving traceability to isolate the source of contamination and to guide food recalls and investigating, monitoring, and improving animal slaughtering and processing practices.

5D - Validating Alternative Models of Disease

Researchers have been using tissue cultures and animals such as rats or fruit flies in laboratories for years as common models to study the progression of diseases. Presently, emerging infectious diseases or re-emerging diseases are driving the need to develop new models of disease that have greater applicability, ease of use, and provide greater accuracy. Disease models are also needed to study chronic diseases. The development of new disease models will facilitate the transition of new therapeutic products to the clinical trial stage, because the safety of a product can be preliminarily assessed through the model.

Key Strategy 6 - Maximizing the Benefits of Existing and Horizon Technologies

6A - Tissue Engineering

Tissue engineering - combining engineering with medicine to induce cells to grow within a recipient organism's body or in a laboratory to replace missing tissue or support the function of defective body parts - and nanotechnology are expected to contribute to a new generation of medical devices. In some cases, such as skin grafts and bone-filling material, tissue-engineered devices are already on the market. It is therefore imperative that scientists continue to work towards understanding the dynamics of the behaviour of tissue-engineered products in the human body (for example, the interaction of human cells with engineered tissue scaffolds), as well as the fundamental issues related to tissue engineering research. With this knowledge, scientists in the Medical Devices Bureau can develop the appropriate criteria to use for pre-market and post-market evaluations, including licence applications. HFPB also needs to be fully aware of the results of internationally produced stem cell research to prepare for and regulate possible human applications in the future.

6B - Nanotechnology

Although nanotechnology (the design and manufacture of functional systems at the molecular scale) holds much promise in revolutionizing the field of medicine, there are substantial knowledge gaps concerning nanotechnology's implications for health, safety, and the environment. In addition, future second- and third-generation products that may have significantly different and novel applications than those currently available may raise unseen social and ethical issues. To address these issues, scientists will need to focus their research efforts on understanding the biocompatibility of nano materials, developing adequate risk assessment methodologies for evaluating future nano-based veterinary drugs and medical devices, and determining how nanotechnology differs from clinical trial, pharmacokinetic and pharmacodynamics (PK-PD), and targeted drug delivery.

6C - Biotechnology and Genomics

Cutting-edge research on the function and structure of genes, proteins, and cellular metabolites could generate a wide range of biotechnology applications of interest to HPFB, including transgenic plant-derived materials, vaccines, oncotherapeutics, and next generation recombinant proteins. The regulatory process for licensing of these products is still unfolding, and as a result, regulatory uncertainties are limiting human clinical trials. There is, therefore, a need for scientists to establish required dosages, timing of delivery, and to evaluate possible adverse effects. Additional research and development of DNA microarray, and microelectrode array technologies will also be of great value in identifying virulent genes, factors, and mechanisms that contribute to pathogen virulence, which will allow scientists to develop strategies to counteract these elements. Such systems are also useful for investigating physiological mechanisms and responses to pharmaceuticals, environmental pollutants, or other toxicants. HPFB has also identified a need to augment the Branch's expertise and knowledge of potential biotechnology applications for aquaculture.

6D - Emerging Health Technologies and Biosystematics

Mandated to evaluate and monitor the safety, quality, and effectiveness of emerging technologies, HPFB scientists need to keep pace with technological advances in medical devices, such as cardiovascular devices, musculoskeletal devices, and diagnostic devices, as well as software for devices and technology platforms, and new drug delivery methods to take full advantage of new therapeutic molecules. There is a pressing need to study the safety of food irradiation technology, nanotechnology food applications, and foods that have been genetically modified for commercial benefit (for example, Roundup Ready crops designed to simplify farming practices and increase production). Biosystematics, which involves the statistical analysis of data obtained from genetic, biochemical, and other studies to determine the taxonomic relationships of organisms and populations, is being used as a high-throughput technology for drug development. High-throughput dataset analysis forms a basis to understand the operation of complex biological systems, to develop predictive models of human disease, and to predict drug response. Key examples are the mapping of protein-protein interactions in human cells and gene expression profiles. The health benefits of gene expression could include a predictable treatment response and reduction of risk related to adverse drug reactions for Canadians. Currently, there is a lack of relevant policies, guidelines, and regulation pertaining to this issue for the industry, drug evaluators, and regulatory staff. There is, therefore, a need for scientists to investigate these deficiencies and provide guidance for industry and reviewers to evaluate the data generated using these techniques in both animals and humans.

6E - Synthetic Biology

This is an example of a horizon technology which is still in the conceptual stage. Synthetic biology - designing and building natural biological systems from the ground up using engineering techniques - is a relatively new field on the horizon. Based on its current momentum, however, scientists predict that it will radically change biotechnology as the capacity to write genetic sequences by fully synthetic assembly is doubling every 18 months. If the forecast holds true, it will be possible to synthesize a string of DNA the size of a human genome in a single day by the year 2016. The filing of the first patent for a minimal bacterial genome in October 2005 by Synthetic Genomics, Inc., provides evidence of the quiet rush underway to harness this power and commercialize fully synthetic, living organisms. The implication of this technology is enormous for the manufacture of a whole range of regulated products, as well as drug development and regulation. HPFB scientists need to be fully engaged in all aspects of this research to maximize its positive outcomes and prevent any potential harmful effects. The first applications of this technology are likely to be in the synthesis of complex drug molecules that will alter sources in manufacturing, extend the power of generic copying of molecules, and make possible fully synthetic biological products with enhanced functionality.

Key Strategy 7 - Advancing Safe Manufacturing, Quality, and Hazard Control

7A - Manufacturing and Quality Systems

Total Quality Management is a management approach that ensures product quality by taking into account the complete product life cycle from concept through manufacturing to consumer satisfaction. Additionally, this approach encompasses quality assurance and quality control practices. For health products and food, this is reflected in the development of new technologies (for example, biotechnology, nanotechnology) for application in manufacturing processes and the establishment of product quality standards and regulations, as well as the setting of standards for the health claims made by manufacturers. Key research focuses for HPFB scientists in this area include investigating science issues related to the reprocessing of single-use devices; making reference materials available for product validation and authentication; improving the ability to identify herbs present in natural health products; and studying the health effects of food allergens, which will lead to better standard setting and food labeling. Another key element will be the development of a method to monitor the implementation of Good Laboratory Practices and Good Manufacturing Practices in Canada, as well as ensuring compliance with adopted regulatory measures in this area. Additionally, HPFB has identified organic products and the health claims regarding functional foods containing probiotics and phytoestrogens as areas for regulation development. A key focus in this area is monitoring health products and food to ensure nutritional value and safety, while meeting the needs of consumers. The overall goal is to achieve quality in the design of manufacturing processes to ensure active fault prevention and avoidance.

7B - Materials Science and Non-medicinal Ingredients

Materials science is an interdisciplinary field encompassing the study of relationships between the structure of materials and their properties and how materials can be applied to science and engineering. From an HPFB perspective, this includes the study of non-medicinal ingredients, which are added to natural health products, pharmaceutical drugs, and veterinary drugs as stabilizers, thickeners, or flavouring agents to improve the quality of the physical drug. The equivalent for food products would be food-contact materials such as food packaging. Looking to the future, scientists need to develop more accurate classification for non-medicinal ingredients and other materials patients may come in contact with. They also need to enhance the methods of analysis and reporting on their concentrations and effects.

7C - Contamination

Canadians are concerned about being exposed to harmful compounds and microbial agents through their diets and health products, and it is HPFB's responsibility to improve on the safety of the food supply. HPFB is committed to developing more powerful contaminant detection and quantification methods, monitoring and establishing accurate safety limits. They are also performing more research into the effects of dietary exposure to contaminants such as foodborne pathogens, persistent organic pollutants, veterinary drug residues, perfluorinated compounds used in water- and grease-repellent coatings, and mutagenic furan compounds that are formed in food during cooking or heating. HPFB will also be investigating the appropriate tolerance levels for impurities (for example, metals, mycotoxins, adulterants) in natural health products.

7D - Counterfeit Products and Tampering

When it comes to therapeutic agents, counterfeit products and product tampering pose serious health risks. Therefore, there is a continuous need to enhance tracking and detection systems, to be aware of new developments, and to adopt these rapidly evolving technologies. Examples of recent advances include new imaging and spectroscopy technologies that can provide unique "fingerprints" to the structure of tablet coatings, allowing scientists to differentiate genuine approved drugs from counterfeit products. The development of radio-frequency identification systems (RFID) could provide a new capability to serialize products and link labels electronically to the point of sale (cash register) for instant, real-time distribution of safety messages. Scientists and regulators will work to gain knowledge of anti-counterfeiting technologies and will support the development of product-pedigree systems that record the distribution history of products and ingredients. In addition, more resources will be devoted to intelligence gathering on illegal importations of health products into Canada.

Annex B - Glossary

Bioinformatics: A field concerned with the use of mathematical tools to extract useful information from data produced by science such as high-throughput biological techniques (for example, genome sequencing).

Biotechnology: The industrial use of living organisms or biological substances, such as enzymes, to make products or aid in research. These products include transgenic plant-derived materials, vaccines, oncotherapeutics, and next generation recombinant proteins.

Compliance testing: A science activity enforcing an act or regulation (for example, pharmaceutical product testing).

Decision sciences: These encompass social sciences (for example, regulatory/policy science and behavioural sciences), as well as a number of HPFB related science activities such as compliance testing, reference services, and surveillance.

Epidemiology: The study of how often diseases occur in different groups of people and why. Results from epidemiological studies can be used to better control the spread of disease and to better treat patients.

High throughput: Refers to a high processing rate.

In vivo, in vitro, in silico: Scientific terms describing tests occurring "in the body" (ie: using whole organisms), "in glass" (ie: using cell cultures or extracts rather than whole organisms), and "in silicone" (ie: modeling research conducted with computers only), respectively.

"Model of Disease": A pattern or model of disease which is the de facto broadly accepted "correct" mechanism of dysfunction in that particular case.

Mycotoxins: Poisonous substances produced by organisms of the fungus kingdom (which includes mushrooms, molds, and yeasts). Mycotoxins can appear in the food chain as a result of fungal infection of crops. They are greatly resistant to decomposition or break down through digestion, allowing them to pass through the food chain from livestock to humans.

Natural sciences: Disciplines concerned with understanding, exploring, developing or utilizing the natural world. Included are the engineering, mathematical, life and physical sciences.

Oncotherapeutics: Refers to the field of therapies targeted to treating tumors and cancer.

"Paradigm for Evidence": Throroughly-validated and internationally current methods, standards, guidelines and datasets provide the foundation of HPFB's evidence-based decision making regarding the approval and monitoring of therapeutic products in Canada.

Pathogens: Organisms capable of causing infections and disease. Pathogens may be bacterial, viral, parasitic, or prion organisms.

Perfluorinated compounds (PFCs): A family of fluorine-containing chemicals with unique properties to make materials stain- and stick-resistant. PFCs are heat stable and extremely resistant to degradation and environmental breakdown, and have been found to bioaccumulate in humans.

Pharmacodynamics: The study of the biochemical and physiological effects of drugs on humans or pathogens. It includes the study of the mechanisms of drug action, as well as the relationship between drug concentration and effect.

Pharmacokinetics: The study of the action of drugs in the body over a period of time, including the processes of absorption, distribution, localization in tissues, biotransformation, and excretion.

Prions: Proteinaceous infectious particles, believed to cause a number of diseases in mammals such as bovine spongiform encephalopathy (BSE), or "mad cow disease." Although the exact mechanism behind prion diseases is still emerging, the most current scientific evidence indicates that the prion protein alone is the infectious agent.

Radio-frequency identification (RFID): Used to identify or track items by relying on storing and remotely retrieving data using devices called RFID tags or transponders. RFID tags can be incorporated into or attached to a product, animal, or person to allow identification using radiowaves.

Reference services: Scientific activities whose data, services, or products are intended to be used by internal or external clients for identification or confirmation of potential public health risks related to infectious diseases and bacterial toxins.

Related science activities: Activities that are not research-based, but are included in the broader definition of science and technology. They can include scientific data collection, information services related to science, and special science services and studies, such as the establishment of standards and feasibility studies.

Research: Research is the investigative process aimed at discovering, interpreting and revising knowledge on topics of interest. Research is also considered as the process whereby new information and/or knowledge is obtained to address specific science and policy issues of significance to HPFB.

Science policy: The integration of science and public policy with the aim of developing research- and knowledge-based policies and guidelines to help transition scientific results in a way that best serves the public.

Surveillance: Science activity whose data are used by internal or external clients to assess or develop regulations (policy development) or to facilitate decision making regarding public health issues.

Annex C - Acronyms

BSE

bovine spongiform encephalopathy

CBSA

Canadian Border Services Agency

DNA

deoxyribonucleic acid

DRIs

Dietary Reference Intakes

EFSA

European Food Safety Authority

GLP

good laboratory practices

GMOs

genetically modified organisms

GMP

good manufacturing practices

HPFB

Health Products and Food Branch

IOM

Institute of Medicine

MHPD

Marketed Health Products Directorate

NHPD

Natural Health Product Directorate

PBDE

polybromodiphenylether

PFCs

perfluorinated compounds

PK-PD

pharmacokinetics and pharmacodynamics

R&D

research and development

RFID

radio-frequency identification

RSA

related scientific activities

S&T

science and technology

SARS

Severe Acute Respiratory Syndrome

U.S. FDA

United States Food and Drug Administration

WHO

World Health Organization

Annex D - Related Branch, Department, and Federal Government Strategic Plans

Mobilizing Science and Technology to Canada's Advantage is the overarching national Science and Technology (S&T) strategy. It builds on Canada's science and technology strengths while addressing challenges such as health, the environment, and the competitive use of natural resources. Recognizing the important role that the private sector and others play in Canada, the Strategy aims to create a business environment that encourages the private sector to innovate, while making sure that public funds are invested wisely.

Health Canada Science and Technology Strategy (2008): The Health Canada S&T Strategy provides a policy framework for science planning, priority setting and management at the departmental level, and will guide future science planning that is carried out by Health Canada branches. The Health Canada S&T Strategy will also help the Department to position itself more strategically and work more effectively with science partners within Health Canada, other science-based departments and agencies, governments in Canada and other countries, international organizations and other stakeholders. Table 1 provides a crosswalk between the Health Canada S&T Strategy and Towards a Strategic Science Plan.

Table 1: Science and Technology Strategy (2008) and Towards a Strategic Science Plan: A Crosswalk

No	Key objectives from Science and Technology Strategy (2008)	Alignment with Towards a Strategic Science Plan
1	Promoting excellence in science	Science excellence and quality is one of the stated purposes of the Health Products and Food Branch (HFPB) plan and a key prioritization and implementation criteria; the Branch has undertaken a project to catalogue and describe existing science quality systems
2	Linking science to key departmental priorities and the development of policy	Each of the science strategies links to departmental priorities; the Science and Society element has a specific component devoted to science policy
3	Enabling an effective, forward-looking, and responsive regulatory environment that protects the health and safety of Canadians and the environment and promotes a competitive marketplace	Each of the first six science strategies is linked to the regulatory mandate of HPFB; the strategy for Sustainable Development is linked to the regulatory mandate of other parts of the Department, especially the Healthy Environments and Consumer Safety Branch, through the Chemicals Management Programme
4	Improving the ability to access science and science human resources, including focussing on science and technology (S&T) activities that are best delivered by Health Canada	The five components of the element called Critical Science Enablers includes the science workforce, and the infrastructure of science to support those science services which are best delivered by HPFB
5	Maximizing linkages and partnering opportunities to provide access to ideas, information, emerging trends, and technology	This objective is incorporated into the characterization of the activities of the science strategy, and into the methodologies for implementation as the externally oriented Science Opportunities inventory
6	Clearly communicating the department's science needs	Implementation of HPFB's Towards a Strategic Science Plan will include development and implementation of a communications plan and ongoing cycles of consultation with stakeholders
7	Increasing accountability with an effective means to measure and report on S&T expenditures	Implementation of the HPFB Plan will include an ongoing analysis of indices of science expenditures using data gathered in the annual Statistics Canada survey of Federal Science Expenditures and Personnel (FSEP)

Note: Resulting from the Health Canada S&T Strategy, an Health Canada S&T Action Plan is being developed for publication in 2009. This Plan will put into action the objectives discussed in the Table 1. The Science Plan will contain a comprehensive crosswalk and linkages with the Health Canada S&T Action Plan in its next revision.

Our Science, Our Health: A Report from the Health Products and Food Branch - 2003 highlights the wide range and complexity of the science and research activities of the HPFB. As the first report of its kind since the creation of the Branch in 2000, it fosters a better understanding of the work HPFB does and its contribution to the health of Canadians.

HPFB Product Life Cycle Approach enables the Branch to build knowledge about a health product over its lifecycle to maximize is benefits and minimize its risks. The framework includes amendments to current regulations as well as development of new guidance and regulations.

HPFB Blueprint for Renewal II outlines the way ahead for how HPFB will design a regulatory system that will further protect the health and safety of Canadians. The Blueprint for Renewal was developed based on consultations and discussion sessions across Canada, as well as a comprehensive review of the HPFB's approach to regulating health products and food.

HPFB 2007-12 Strategic Plan is a guiding document by which the Branch will base its operations. The Plan identifies the following six strategies that will guide HPFB forward:

1. Adopt a life cycle approach to regulating health products.
2. Promote health through a modernized food regulatory system and proactive approach to nutrition.
3. Advance international cooperation and be an international leader.
4. Establish strategic partnerships to fulfill our mandate.
5. Better integrate transparency, openness and accountability into our day-to-day work.
6. Build a nationally based, flexible organization that can fulfill its mandate and priorities in a changing environment.

Canada's Food and Consumer Safety Action Plan proposes a series of initiatives to modernize and strengthen Canada's safety system for food, health, and consumer products and to better support the collective responsibilities that government, industry, and consumers have for product safety. Released in December 2007, the Action Plan puts forward initiatives that focus on preventing problems, targeting the highest or unknown risks, and delivering rapid response.

Annex E - Science is at the core of HPFB's activities

Pre-market

Biologics and Genetic Therapies

We regulate the safety, quality and efficacy of biologics and biotechnology products, such as vaccines; blood and blood products; cells, tissues, and organs; gene therapies and biotherapeutics.

Food

We establish policies and standards for food safety and nutrition and assess the effectiveness of the activities of the Canadian Food Inspection Agency for food safety.

Natural Health Products

We ensure that Canadians have timely access to natural health products that are safe, effective and of high quality, while respecting freedom of choice and philosophical and cultural diversity.

Nutrition Policy and Promotion

We collaboratively define, promote and implement evidence-based nutrition policies and standards.

Therapeutic Products

We regulate pharmaceutical drugs and medical devices for human use.

Veterinary Drugs

We protect human and animal health and the safety of Canada's food supply by evaluating and monitoring safety, quality, and effectiveness; setting standards; and promoting the prudent use of veterinary drugs administered to food-producing and companion animals.

Post-market

We apply safety and quality standards to health products that have reached the Canadian market. We also

• monitor all health products available for sale in Canada for compliance with manufacturing, advertising, and labelling regulations and guidelines;
• monitor expected and unexpected health risks such as adverse reactions to drugs;
• enforce the Food and Drugs Act and associated regulations, when necessary; and
• assess the effectiveness of the activities of the Canadian Food Inspection Agency that are related to food safety.