ARCHIVED - RPP 2007-2008
Health Canada

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Section 2: Analysis of Program Activities by Strategic Outcome

Strategic Outcome: Strengthened Knowledge Base to address health and health care priorities

Program Activity - Health Policy, Planning and Information
Planned Spending and Full-Time Equivalents (FTEs)
($ millions)	Forecast Spending 2006-2007	Planned Spending 2007-2008	PlannedSpending 2008-2009	PlannedSpending 2009-2010
Net Expenditures	281.9	263.7	259.9	254.8
FTEs	635	588	570	571
Notes: The decrease in forecast/planned expenditures from 2006-2007 to 2007-2008 is mainly due to the sunset of the Primary Health Care Transition Fund. This decrease is partially offset by an increase in funding for the Canadian Strategy for Cancer Control. The decrease in planned expenditures from 2007-2008 to 2008-2009 is mainly due to a decrease in the level of funding for the Implementation of the Therapeutic Access Strategy, and the Assisted Human Reproduction regulatory regime. The decrease in planned expenditures from 2008-2009 to 2009-2010 is mainly due to a decrease in the level of funding for the National Wait Times Initiative. Figures include an amount for departmental and regional infrastructure costs supporting program delivery.

Program Activity Description

Under this program activity, we strive to develop effective policy responses to a range of priority, emerging, and cross-cutting issues that impact the health of Canadians. There are many governmental and non-governmental organizations working towards improved health outcomes in Canada, including provincial and territorial ministries of health, professional organizations, research organizations, the program branches of Health Canada, and the agencies within the federal Health Portfolio. Our objective is to promote national coordination and development of a strong, shared knowledge base to address health and health care priorities for all Canadians. We also aim to facilitate successful health system adaptation to changes in technology, society, industry and the environment, such that Canadians will continue to be protected from health risks, have access to quality health care, and gain positive health benefits from information and innovation.

We engage in a variety of policy activities to achieve our objectives. This includes managing targeted funding programs to stimulate health system research and renewal, administering the Canada Health Act, drafting new health protection legislation and regulations, developing and distributing federal position papers on emerging issues, and setting up new agencies. We also take a leadership role for the Department in strategic planning, intergovernmental and international affairs, Cabinet and parliamentary relations, and providing policy advice and support to the Minister of Health.

During 2007-2008, reduction in health care wait times will remain one of our key priorities. Our work in this area is focussed on health human resources (i.e., ensuring there are adequate numbers of qualified health professionals to provide the health care Canadians need), promoting the use of electronic health records, facilitating federal/provincial collaboration, and supporting research that will help identify more efficient and effective ways to manage health care. Another continuing priority will be pandemic influenza preparedness and response. Here, we will focus on coordinating our efforts with the provinces and territories and the Public Health Agency of Canada (PHAC), the lead federal agency responsible for responding to public health emergencies and infectious disease outbreaks. Our role is to promote equitable access to needed vaccines and antivirals, to represent Canada in international initiatives, and to provide advice on the broader social and economic implications of a pandemic influenza outbreak. Renewal of health protection legislation and modernization of the Canadian regulatory system also remain priorities. We are aiming to provide enhanced protection for Canadians as consumers, patients and workers, while encouraging commercial innovation and a competitive economy.

Effective policy development in the area of health draws on expertise and knowledge in the health sciences and medicine as well as the social sciences. We work with many partner organizations in health research and health data collection. The Canadian Institutes for Health Research (CIHR), Statistics Canada, the Canadian Institute for Health Information (CIHI), professional organizations, and non-governmental organizations work with the federal Health Portfolio to generate the extensive knowledge base needed for effective health policy, and to ensure its availability to the decision-makers who need it. We also share information internationally through partnerships such as the Organization for Economic Cooperation and Development (OECD) Health Committee, the Global Health Research Initiative (GHRI), and the Canada-Australia Dialogue. Our priority at Health Canada is to promote collaboration and knowledge-sharing in health care research, to address knowledge gaps in what the federal Health Portfolio has identified as priority issues, and to ensure research addresses the health needs of all Canadians. In some areas, we have our own expertise. For example, we conduct economic analyses of what affects supply and demand in health care, and we conduct gender-based analyses (i.e., to determine how men and women may be affected differently by policies and programs).

The impact of the Health Policy Research Program cancellation (as part of the spending restraint announced in September 2006) has been generally on university-based researchers, graduate students and institutions interested in providing evidence for health policy decision-making. Departmental staff scanned other funding organizations to recommend alternate sources of funding for projects terminated or about to begin, but were unable to find appropriate sources. The implication of the program cut for future plans and priorities is that the Department, PHAC, and the broader health community have lost a source of medium- to long-term health policy research on priority issues, which could be/has been used in the development of policies and programs.

Performance Measurement Strategy

Under the Health Policy, Planning and Information Program Activity, Health Canada's role is one of facilitation and coordination as well as promotion of federal standards and policy directions to improve health outcomes for all Canadians. In many areas, we are working collaboratively across jurisdictions, sectors, and agency mandates. Our performance measures and indicators reflect this. For example, our expected results include facilitating strengthened global health security and health system improvements through establishing pan-Canadian as well as international strategies and commitments, and through effectively managing targeted funding programs. To ensure accountability to Canadians, we conduct periodic evaluations of these programs. We also support agencies such as the Health Council to report on progress in joint initiatives such as health care renewal. We have identified expected results and performance indicators for each key program and service below.

Key Programs and Services

Health Care Policy (Ongoing)
Description: Health Canada works in close collaboration with the provinces and territories, health professionals, health care administrators and other key stakeholders to develop strategic policy on health care. Our aim is to improve access, quality, and integration of health services to better meet the health needs of all Canadians. We strive to ensure that health care policy decisions are based on strong evidence and are aligned with the principles of equity, sustainability, and affordability. Further, we aim to facilitate effective health system adaptation to the changing needs of the population. Our policy activities in this area address issues related to broader health care system renewal, such as fiscal transfers, health care financing, governance and accountability, and the roles and interface of the public and private sectors. We also work with the provinces and territories and other stakeholders to address specific health care issues, such as health human resource strategies, electronic health records, home care, continuing care and palliative care.
Expected Results				Performance Indicators
Facilitate improved access, quality and integration of health care services for all Canadians				Establishment of joint federal/provincial/territorial strategies and commitments Interim and summative evaluations of funding programs (ex­pected results and indicators are specific to each initiative) Progress reports on health care renewal from the Health Council Performance indicators and targets are under development for new policy directions

2007-2008			2008-2009		2009-2010
$ (in millions)		FTEs	$ (in millions)	FTEs	$ (in millions)	FTEs
132.8		112	132.6	112	127.8	112

Key Initiatives

Wait Times Management and Health Care Renewal

An important area of focus for 2007-2008 is continuing work on the government's key health priority of Patient Wait Times Guarantees (PWTGs) and the National Wait Times Initiative (NWTI) fund.

Health Canada has been working collaboratively with the provinces and territories and other stakeholders to develop and share innovative initiatives and best practices in wait times management and reduction; develop and implement pilot projects to test and evaluate PWTGs; establish evidence-based benchmarks for medically acceptable wait times; produce regular reports to Canadians on progress on wait times; support and disseminate research on wait times; and, monitor national and international developments in quality and patient safety. A number of initiatives to stimulate health care renewal were initiated in response to the 2004 Health Accord, and Health Canada is continuing to monitor the implementation of those initiatives. We will also continue to support the Health Council of Canada with a grant of up to $10 million annually until March 2008 to monitor and report on the progress of health care renewal in Canada. With regard to patient safety, Health Canada oversees a grant of up to $8 million annually (until March 2008) to the Canadian Patient Safety Institute (CPSI) to improve national collaboration.

At the time of writing of this document, workplans for wait times reduction initiatives were being developed to reflect the direction of the new government in this area in collaboration with the provinces and territories.

Health Human Resources Strategies

Health Canada will continue the implementation of the Pan-Canadian Health Human Resource (HHR) Strategy, established in 2003 to provide financial support (up to a total of $20 million annually) for activities that promote appropriate planning and management of HHR to help ensure Canadians have access to the health providers they need. Under the Strategy, Health Canada manages three broad funding initiatives: Pan-Canadian Health Human Resource Planning, Interprofessional Education for Collaborative Patient-Centred Practice, and Recruitment and Retention. Projects underway include the development of nationwide databases for HHR planning, and projects to stimulate interest in health careers in areas of shortage such as rural medical practice. (See also the Nursing Policy section for a description of activities under these initiatives.) Evaluations of the funding initiatives under the Strategy will be conducted in 2007-2008.

In partnership with federal, provincial and territorial governments, regulatory bodies, academic organizations and others, Health Canada will also continue to implement the Internationally Educated Health Professionals Initiative (IEHPI), for which the federal government committed $75 million, beginning in 2005-2006. The goal of this initiative is to facilitate integration of health professionals educated in other countries into the Canadian workforce.

As part of the Pan-Canadian HHR Strategy, Health Canada has been working with the provinces and territories, stakeholders, and other federal departments to develop and implement a pan-Canadian HHR Planning Framework. The framework is intended to act as a guide for HHR planning in Canada and for the future research and activity agenda of the Pan-Canadian HHR Strategy. Between the Spring and Fall of 2006, key stakeholders, including representatives from ministries of education, research entities, national Aboriginal groups, health sector organizations, health professional associations, and professional regulatory bodies were consulted on the framework and its action plan. Federal funding for 2008-2013 of the Pan-Canadian HHR Strategy will largely be based on the framework.

The Canada Manitoba Health Policy Dialogue is a partnership between Health Canada's Manitoba Region and Manitoba Health to provide continuous learning opportunities for staff and to foster new networks and collaborations across programs. To be held quarterly, it is a forum for senior managers at Health Canada and Manitoba Health to discuss strategic health issues with broad involvement of staff from both organizations.

Home and Continuing Care, Chronic Disease Management, E-Health

Health promotion and prevention of disease, screening, diagnosis, treatment, home and continuing care, and palliative and end of life care are all important elements of a quality health system. The new government is committed to emphasizing health promotion, chronic disease management (in particular, cancer), and the health of seniors and children. Federal initiatives related to these priorities will be the shared responsibility of Health Canada, the Public Health Agency and the Canadian Institutes for Health Research. Health Canada will focus on the role of the health care delivery sector and coordination across the federal Health Portfolio and the provinces and territories.

In early 2007-2008, the summative evaluation of initiatives under the Primary Health Care Transition Fund (PHCTF) will be available. The Fund (2000-2006) aimed to support provinces, territories and other health care system stakeholders in improving access, quality of care, accountability, and integration of services in primary care (i.e., the broad spectrum of services involved in health promotion, illness and injury prevention, and the diagnosis and treatment of illness and injury).

Moving forward, Health Canada's priority policy development issues in the area of primary and continuing care include coordination of care, self-managed home care, and data development related to palliative care. Health Canada will also enhance attention to emerging portfolio issues such as chronic disease management and e-health, and we will provide Portfolio leadership in relation to government policy and commitments regarding autism.

Health Canada is the federal government's liaison with the Canadian Partnership Against Cancer Corporation (CPACC) and will be responsible for managing the $50 million per year grant agreement with the Corporation (April 2007 to March 2012). CPACC is currently in its start-up phase and is developing its workplan for the upcoming fiscal year. Its mandate will be to provide a leadership role with respect to cancer control through the management of knowledge and the coordination of efforts among provinces and territories, cancer experts, stakeholder groups, and Aboriginal organizations to champion change, improve health outcomes related to cancer, and leverage existing investments.

Addressing Mental Health and Mental Illness

The Government of Canada recognizes the importance of pursuing action on mental health, and is committed to advancing pan-Canadian efforts with the provinces, territories, and other stakeholders, including various organizations and Aboriginal groups. Health Canada, along with PHAC, is reviewing the recommendations of the Senate Committee report released in May 2006, including the proposal to set up a Commission as a focal point in Canada for mental health.

Pharmaceuticals Management Strategy (Ongoing)
Description: The Pharmaceuticals Management Strategy activity area focusses on the overall coordination of federal pharmaceutical policy and collaborative work with provincial and territorial partners on pharmaceuticals management. Our objective is to better integrate pharmaceuticals into a seamless, robust health care system in order to improve health out­comes for Canadians and reduce costs in other health care sectors, such as hospitals. To achieve this, we seek to optimize policy interventions in areas such as post-market drug safety and effectiveness, appropriate drug-prescribing and use, and drug pricing and research. Our work in this area is closely linked with the Department's initiatives under the Blueprint for Renewal (the Health Products and Food Branch's comprehensive plan for regulatory modernization) and with the activities of the Patented Medicine Prices Review Board.
Expected Results				Performance Indicators
Facilitate better integration of pharmaceuticals into the health care system				Under the second phase of the National Pharmaceutical Strategy, workplans are being established in consultation with the provinces and territories

2007-2008			2008-2009		2009-2010
$ (in millions)		FTEs	$ (in millions)	FTEs	$ (in millions)	FTEs
9.9		25	8.5	22	8.5	22

We will continue to work with the provinces and territories on pharmaceutical activities initiated as part of the 2004 Health Accord under the National Pharmaceuticals Strategy (NPS), an integrated, collaborative, multi-pronged approach to addressing pharmaceutical challenges that builds on governments' shared roles in the pharmaceuticals sector. The NPS Progress Report, published in September 2006 by the F/P/T Ministerial Task Force on the NPS, highlighted major achievements to date and set out key next steps for future work. The Report sets the stage for development and implementation of a second phase of the NPS work.

For more information on the NPS Progress report, see:
http://www.hc-sc.gc.ca/hcs-sss/pubs/care-soins/2006-nps-snpp/index-eng.html

In 2007-2008, Health Canada will continue to seek to advance work on all elements of the NPS. Specific collaborative work on the priority areas with provincial and territorial partners is expected to include:

• Catastrophic Drug Coverage (CDC): Officials will review and validate CDC costing methodologies, update related costs, and analyse issues related to the private insurer role.
• Expensive Drugs for Rare Diseases (EDRD): Officials will focus on developing federal/provincial/territorial consensus on the parameters of an EDRD framework and validate it with experts and external stakeholders.
• Common Drug Formulary: Officials will continue work to expand the Common Drug Review to all drugs and identify improvements to drug plan formulary management processes.
• Drug Pricing and Purchasing Strategies: Officials will develop a business case and implementation plan to address generic and other non-patented drug prices, and will examine the issue of the price of patented drugs for which there are expanded indications.
• Real-World Drug Safety and Effectiveness: Officials will complete a business plan to develop a national research network and centres of excellence under the guidance of a national oversight body, and engage "front-line" providers and patients on knowledge exchange related to drug safety and effectiveness in day-to-day use.

Nursing Policy (Ongoing)
Description: Under this activity, policy advice from a nursing perspective is provided to the Minister, his office and senior staff within the Department. The aim is to work in close collaboration with the nursing community to optimize the contribution of nursing knowledge and practice to improved health care for Canadians. To support policy development in this area, we fund activities related to knowledge generation as well as knowledge transfer and uptake (through publications, presentations, internet postings, sharing at meetings, workshops, etc.) These activities are targeted at decision-makers in governments and non-government organizations, both nationally and internationally.
Expected Results				Performance Indicators
Optimize the contribution of nursing knowledge and practice to improved health care for Canadians				Specified in workplans and funding agreements

2007-2008			2008-2009		2009-2010
$ (in millions)		FTEs	$ (in millions)	FTEs	$ (in millions)	FTEs
1.5		10	1.5	10	1.5	10

In support of efforts to improve Canadians' access to health care services, reduce wait times and support care guarantees, we will continue to be engaged in policy development and knowledge generation, sharing and uptake. To facilitate an increase in the supply of nurses and improvements in the stability of the nursing workforce, we fund projects related to increasing domestic production, enhancing recruitment and retention, and integrating internationally educated nurses into the Canadian system. These activities are funded through the Pan-Canadian HHR Strategy (under Recruitment and Retention), and through the Internationally Educated Health Professional Initiative.

Under the Healthy Workplace Initiative (HWI) component of the Pan-Canadian HHR Strategy, we have been working to enhance the uptake and utilization of healthy workplace practices to improve the retention of health care providers. To achieve this, we are providing funding to projects that will increase knowledge about best practices in health workplaces, and funding for a national project that will facilitate the exchange of best practices across the country. In 2007-2008, we will complete an evaluation of the Healthy Workplace Initiative to establish if its objectives are being met. Expected results include policies that enhance the workplace, thereby improving provision of quality health care; improved health and well-being of health care workers; decreased absenteeism, turnover and overtime of health care workers; and an inventory of innovative practices that enhance the health practice setting.

In 2007-2008, we will also provide ongoing funding to 20 research/learning projects that will increase knowledge about best practices in encouraging health care professionals to learn and work together in collaborative, patient-centred practice. In addition, we will provide ongoing and new funding for complementary projects that address issues at the health system level to improve the uptake of these collaborative practices in all jurisdictions. These projects are funded under the Interprofessional Education for Collaborative Patient-Centred Practice (IECPCP) component of the Pan-Canadian HHR Strategy and will be completed by June 2008. Further, we will develop an evaluation plan and interim evaluation to determine how well IECPCP objectives are being met.

Assisted Human Reproduction Canada Implementation (Ongoing)
Description: Under this activity, Health Canada works towards the set up of Assisted Human Reproduction Canada (AHRC), the implementation of the Assisted Human Reproduction Act, and the development of related regulations. The aim of AHRC is to promote and protect the health and safety of Canadians who are using Assisted Human Reproduction technologies.
Expected Results				Performance Indicators
Implementation of Assisted Human Reproduction Act and development of related regulations Set up of Assisted Human Reproduction Canada (AHRC)				Milestones towards completion specified in yearly workplans Ultimately, AHRC will report on success in promoting the health and safety of Canadians who are using these technologies

2007-2008			2008-2009		2009-2010
$ (in millions)		FTEs	$ (in millions)	FTEs	$ (in millions)	FTEs
3.1		25	1.5	9	1.5	9

With the appointments of the President and board of directors of AHRC completed in December 2006, Health Canada will now concentrate its resources on completing the elements of the regulatory framework.

It is anticipated that in 2007-2008, draft regulations will be published for areas such as licencing, health reporting information, and clinical and laboratory requirements dealing with in-vitro fertilization procedures using the patients' own gametes. We will continue to gather input from stakeholders, including the provinces, to ensure a pan-Canadian approach and to develop further regulations for controlled activities, such as the use of third-party gametes and pre-implantation genetic diagnosis. In 2007-2008, we expect to complete the issue identification phase of these consultations.

The Personal Health Information Registry will be ready for transfer to AHRC by the end of 2007-2008. Steps will be taken to develop a workplan to begin the process to remake, under the AHR Act, the Processing and Distribution of Semen for Assisted Conception Regulations under the Food and Drugs Act.

The Quebec Government filed a reference with the Quebec Court of Appeal challenging the constitutionality of sections of the AHR Act. The Department will continue to defend the constitutional validity of the Act.

Health Sciences Policy (Ongoing)
Description: Health Canada monitors new and emerging health science technologies, such as nanotechnology and human genetics, to determine potential risks and benefits to the health system and the health of Canadians, as well as to address wider economic, social, ethical and/or legal implications. We develop policy options to address these potential impacts. For example, we work collaboratively to develop standards for research ethics, best practices for biobanking, and quality guidelines for genetic testing. We also aim to ensure that Canadians will be in a position to make informed decisions on health care or participation in research involving new health technologies. By conducting policy research in this area, we aim to incorporate the perspectives of affected stakeholders, the knowledge of experts, and the experience of other jurisdictions. Our work involves collaboration with other Health Portfolio agencies, other departments, and international organizations, such as the Organization for Economic Cooperation and Development (OECD) and the United Nations Educational, Scientific and Cultural Organization (UNESCO).
Expected Results				Performance Indicators
Contribute to health science areas such as: - promotion of innovation in preventative, diagnostic and therapeutic technologies - interventions for infectious diseases, such development of and access to safe and effective vaccines - strengthened human research participant protection - quality assurance guidelines for genetic testing				Reflection of ethical, legal, social, economic and health system considerations in international and domestic partnerships and policy advice in health science areas Progress on a system for human research protection in Canada; milestones specified in the workplan and project agreement

2007-2008			2008-2009		2009-2010
$ (in millions)		FTEs	$ (in millions)	FTEs	$ (in millions)	FTEs
3.7		33	3.4	33	3.5	33

Under this activity area, Health Canada will continue to provide strategic policy analysis, advice and oversight on economic, social, legal, and ethical issues on pandemic influenza and other infectious disease issues. Activities include the following: liaising with officials across the Health Portfolio and other government departments on broad policy issues related to pandemic influenza (e.g., potential social and economic impacts); advancing dialogue on equitable access to vaccines and antivirals; assessing policy and market levers to stimulate health research and innovation to address unmet health needs related to infectious diseases domestically and abroad; and providing input to government-wide initiatives on infectious disease-related issues, including pandemic influenza, vaccines, etc. For example, we are providing input to the North American Plan for Avian and Pandemic Influenza, the G7 Advance Market Commitment pilot vaccine project for pneumococcal vaccine, and Government of Canada positioning within the OECD high-level forum on neglected and emerging infectious diseases.

We will also continue working with domestic stakeholders (i.e., clinical researchers, research ethics board members and administrators, sponsors of clinical trials such as pharmaceutical companies, the National Council on Ethics in Human Research, the Canadian Institutes of Health Research, the Inter-Agency Panel on Research Ethics, and other experts involved in research ethics) to develop standards for research ethics boards and solutions to the issue of protecting human research participants. Health Canada's role in developing the standards is to engage these stakeholders as well as the industry sector through a consensus-based approach. Work on this project involves collaboration with the Health Products and Food Branch to ensure consistency with clinical trial regulations. In 2007-2008, Health Canada will work with the Canadian General Standards Board to establish the technical committee made up of experts and stakeholders who will draft the standards, and will play a central role in coordinating the project and communicating more broadly. This work aims to achieve improved consistency in the operation of research ethics boards that review clinical trial applications, contributing to improved protection for research participants. Funding for the project for 2007-2008 is $1 million, and will be $0.7 million per year from 2008-2009 onward.

Legislative and Regulatory Affairs (Ongoing)
Description: Health Canada is preparing a new framework to update, strengthen and integrate federal health protection legislation to be more responsive to present and future social and technological realities and to provide the tools needed to better protect the health and safety of Canadians. A new legislative framework will modernize and reinforce key existing legislation, including the Food and Drugs Act, Radiation Emitting Devices Act and Hazardous Products Act. With respect to regulations, Health Canada continues to actively work to modernize the Canadian regulatory system to respond to current and emerging challenges from rapid scientific developments, globalization and cross-boundary health risks. The goal is to build a robust and flexible regulatory system that maximizes health, safety and environmental protection and also promotes an innovative and competitive economy.
Expected Results				Performance Indicators
Better protection for the health and safety of Canadians as consumers, workers, and patients				Progress towards regulatory policy coherence across the Health Portfolio Achievement of milestones towards completion of a new framework set in annual workplans (see text below for 2007-2008) Ultimately, the success of the new framework in achieving improved health protection for Canadians will be reported on by the Health Canada program branches and the Health Portfolio organizations responsible for specific sectors (i.e., food safety, consumer safety, etc.)

2007-2008			2008-2009		2009-2010
$ (in millions)		FTEs	$ (in millions)	FTEs	$ (in millions)	FTEs
1.1		0	1.1	0	1.1	0

Health Canada will continue in 2007-2008 with a phased approach to legislative renewal. Over the next fiscal year, efforts will be focussed on the following areas: protection of personal health information, re-design of enforcement and compliance authorities and the treatment of confidential commercial information. We will review current legal authorities and instruments, and develop policy options for greater, modernized health protection that are aligned with Charter, legal and international considerations. Research and policy work, along with stakeholder engagement, will continue on the other aspects of the renewal exercise to advance a comprehensive framework of consumer health protection laws. In addition, we will further the work already undertaken on direct-to-consumer advertising (DTCA). Specifically, we will review the latest approaches by other countries, review scientific evidence, conduct consultations within the Health Portfolio to determine implications of various options, and make a recommendation on a policy on DTCA.

We will continue to work on a renewed modern approach to regulation, which builds on existing federal regulatory policy by promoting increased regulatory transparency, the alignment of legislative and regulatory planning and increased departmental efficiencies through improved coordination.

International Affairs (Ongoing)
Description: Health Canada contributes to enhancing health security and to protecting the health of Canadians by anticipating and responding to international health developments. International Affairs is Health Canada's focal point to initiate, coordinate, and monitor departmental policies, strategies and activities that help promote Canadian priorities and values on the international health agenda. We provide strategic policy advice on international health issues to the Minister of Health, senior management and the Health Portfolio. We ensure Canada's health priorities are advanced by appropriate representation at international fora, and we ensure that the Department's international activities are consistent with government-wide policies. We collaborate and exchange ideas and knowledge with key multilateral health agencies, including the World Health Organization (WHO) and the Pan American Health Organisation (PAHO) on global issues such as pandemic influenza preparedness, HIV/AIDS strategies, and global health security initiatives. We also share Canada's best policies and practices with other countries, and negotiate bilateral agreements with numerous countries on important health issues.
Expected Results				Performance Indicators
Contribute to enhancing global health security and protecting the health of Canadians				Participation in and outcomes of conferences and meetings; establishment of joint strategies and frameworks Expected results and performance measurements relating to specific sectors will be reported on by the organizations responsible (e.g., PHAC will report on pandemic preparedness)

2007-2008			2008-2009		2009-2010
$ (in millions)		FTEs	$ (in millions)	FTEs	$ (in millions)	FTEs
22.9		30	23.3	30	23.3	30

Avian influenza and the possibility of a pandemic human influenza outbreak are considered a global threat. Health Canada will continue to provide policy coordination, advice and analysis on international avian and pandemic influenza planning and preparedness. By participating in interdepartmental policy development (for example, with Department of Foreign Affairs, PHAC, Public Safety and Emergency Preparedness Canada, Agriculture/CFIA and Industry Canada), we will contribute to a coherent cross-government approach to advancing global pandemic preparedness. Health Canada will continue to provide policy coordination/coherence for the Health Portfolio and to act as the lead/key interlocutor for Canada with organizations such as the WHO, OECD, APEC, etc. We will work closely with PHAC, which serves as the substantive lead on pandemic influenza.

Health Canada will continue to chair the APEC Health Task Force (HTF) (2006-2008). As Chair, Canada provides key policy guidance on current priorities of the HTF, including enhancing avian and human pandemic influenza preparedness and response; fighting against AIDS in APEC; and improving health outcomes through advances in health information technology. Our partners in the working group on APEC HTF are PHAC, DFAIT, and the Canadian Food Inspection Agency (CFIA).

Official Languages Minority Community Development (ongoing)
Description: Health Canada manages funding programs to support projects that will help improve access to health services for official language minority communities.
Expected Results				Performance Indicators
Improved access to health services for official language minority communities				Evaluations of funding programs (expected results and indicators are specified in the funding agreements for projects)

2007-2008			2008-2009		2009-2010
$ (in millions)		FTEs	$ (in millions)	FTEs	$ (in millions)	FTEs
24.4		11	24.4	11	24.4	11

In 2007-2008, Health Canada will conduct an evaluation of the Contribution Program to Improve Access to Health Services for Official Language Minority Communities (launched in June 2003). The Program has had an ongoing funding base of $23 million per year as of 2006-2007. Funds support initiatives for community networking and training and retention of health professionals among official languages minority communities. The evaluation will assess the program for its success in achieving the following: increased awareness among health professionals and policy makers of health needs of official language minority communities; increased recruitment and enrolment of students in training to offer services for official language minorities; increased level of satisfaction of health professionals and patients; increased health service access for official language minority groups; increased number of health professionals providing health services to official language communities; and, improved health status of target population groups.

The following programs and initiatives contribute to the balance of the program activity total:

Applied Research and Analysis
Canada Health Act
Federal Provincial Relations
Policy Coordination
Policy Priorities and Analysis
Portfolio Affairs
Women's Health and Gender Analysis

The planned spending for 2007-2008 for these programs and initiatives is $64.3 million.

Strategic Outcome: Access to Safe and Effective Health Products and Food and Information for Healthy Choices

Program Activity - Health Products and Food
Planned Spending and Full-Time Equivalents (FTEs)
($ millions)	Forecast Spending 2006-2007	Planned Spending 2007-2008	Planned Spending 2008-2009	Planned Spending 2009-2010
Gross Expenditures Less: Expected respendable revenues	345.0 41.2	298.6	293.7 41.2	287.9 41.2
Net Expenditures	303.8	257.4	246.3	246.7
FTEs	2,591	2,668	2,656	2,650
Notes: The decrease in forecast/planned expenditures from 2006-2007 to 2007-2008 is due in part to the sunset of the Phase II Response to Bovine Spongiform Encephalopathy (BSE) in the areas of Risk Management and Targeted Research, the effect of one-year interim funding the Department received for 2006-2007 for Natural Health Products and Litigation Management as well as other Funding from the Department's operational budget carry-forward. The decrease in planned expenditures from 2007-2008 to 2008-2009 is primarily due to a decrease in funding for the Therapeutic Access Strategy and the sunsetting of funding for the Agriculture Policy Framework and the augmentation of Health Canada's Phase I response to Bovine Spongiform Encephalopathy (BSE). This is partially offset by an increase in Therapeutic Products Safety (TPS) Initiative funding. The decrease in planned expenditures from 2008-2009 to 2009-2010 is primarily due to the sunsetting of funding for the Access to Medicines Program and the Phase II response to BSE in the areas of Risk Management and Targeted Research. This is partially offset by an increase in the TPS Initiative funding. Figures include an amount for departmental and regional infrastructure costs supporting program delivery.

Program Activity Description

Health Canada is Canada's federal authority responsible for the regulation of health products and food. Under this Program Activity, Health Canada evaluates and monitors the safety, quality and efficacy of health products such as drugs, vaccines, medical devices, natural health products and other therapeutic products available to Canadians, as well as the safety and nutritional quality of the foods they eat. In addition, the Department protects human and animal health and the safety of Canada's food supply by evaluating and monitoring the safety, quality and effectiveness of veterinary drugs by setting standards and promoting the prudent use of veterinary drugs administered to food-producing animals and companion animals. Finally, we promote the health and well-being of Canadians through a broad range of activities related to health products and food, including developing nutrition policies and standards such as Canada's Food Guide to Healthy Eating.¹

Health Canada has identified five major challenges that must be addressed to help ensure continued, timely access by Canadians to safe and effective health products and a safe and nutritious food supply:

• an outdated regulatory toolkit that is increasingly limited and inflexible in responding to today's health products and food environment;
• the regulatory system's current incapacity to consider a given product through its entire life cycle, from discovery through examining the "real-world" benefits and risks of a health product and a food on the market;
• the impact of social and economic changes, such as accelerating scientific and technological advances, the rise of trans-border health and environmental threats, and a more informed and engaged citizenry;
• a regulatory system that currently is not sufficiently interconnected with the research and development, and health care systems; and
• the need to sustain and improve regulatory performance and capacity.

Health Canada will continue to renew the regulatory system for health products and food. This requires strengthening our regulatory tools and promoting innovative solutions to new population and public health challenges; improving the efficiency of our regulatory system, and more fully integrating evidence-based decision-making; influencing and adopting internationally respected scientific advice and internationally recognized regulatory best practices; pursuing international regulatory cooperation opportunities; meeting high standards of vigilance in our responsibility to monitor "real-world" product safety and effectiveness; and promoting a culture of openness and transparency.²

Therefore, Health Canada needs to continue to modernize its legislative and regulatory frameworks to keep pace with the challenges affecting Canada's regulatory environment. The Department recently launched its Blueprint for Renewal plan, which aims to modernize Canada's regulatory system for health products and food.³ The Blueprint underpins many of the activities described under the Key Programs and Services section below.

In response to the Auditor General report regarding the funding of regulatory programs, Health Canada is reviewing its resource requirements and updating its cost recovery regime as complementary activities to the Blueprint for Renewal.⁴ The Department has recently approved a new cost recovery strategy and framework for all its user fees programs, including drugs and medical devices, to align it to the Treasury Board Policy on Service Standards for External Fees and to develop a full costing model. The work on cost recovery is expected to be completed by March 31, 2008.

The Department will continue to work in collaboration with all the key players who influence or provide access to health products on the Canadian market. These players include provincial and territorial governments, the Patented Medicine Price Review Board, the Canadian Agency for Drugs and Technologies in Health, health professionals and practitioners, patients and consumers, and industry. In particular, Health Canada will foster partnerships and information sharing arrangements with the Canadian Institutes of Health Research (CIHR) and the Canadian Agency for Drugs and Technologies in Health.

Health Canada will continue to seek the views of citizens and stakeholders in reviewing and strengthening our regulatory system. We are working with federal science and technology partners to promote and protect the health and safety of Canadians. Some of our work includes collaborating directly with Agriculture and Agri-Food Canada (AAFC), Environment Canada (EC), the Canadian Food Inspection Agency (CFIA), the Public Health Agency of Canada (PHAC), and other federal partners. Also we are collaborating with CFIA to promote food safety as a science priority for Canada.

Science underpins the work of Health Canada's Health Products and Food Branch (HPFB). It informs our regulatory, policy and research activities pertaining to food and nutrition, drugs, medical devices and, natural health products. This requires the expertise of many - from the laboratory researchers to the scientists reviewing new health product submissions, and from the inspectors in the regions to the researchers generating the evidence base to create appropriate policies. Health Canada also supports the Community of Federal Regulators (CFR) Initiative, which works to build the capacity of the federal regulatory community through learning, the sharing of best practices and horizontal collaboration.⁵

Health Canada's regional offices develop and deliver key programs and services, including monitoring the risks of health products and the safety of food, and the investigation and inspection associated with the import, sale and manufacture of health products. They work with regional stakeholders and provincial and municipal governments to promote collaboration, participate in the monitoring of adverse reactions and assist in developing policy responses in areas including: food safety, nutrition, natural health products, antimicrobial resistance, and the efficacy of health products. As part of the national laboratory network, Health Canada's regional laboratories are key contributors to our work to develop and manage food safety research and surveillance projects on natural toxins, genetically modified food, food allergen detection, method development and nutrition.

Performance Measurement Strategy

The Performance Measurement Strategy for this Strategic Outcome will help us measure our results over time, and determine if our current program activity is working to ensure Canadians have access to safe and effective health products and food, and safe and nutritious food, as well as useful information for healthy choices.

Expected Results	Performance Indicators
Access to safe and effective health products and food Access to information for healthy choices	Level of satisfaction of Canadians, health professionals and other stakeholders with the information disseminated for healthy choices and informed decision-making

Key Programs and Services

Pre-Market Evaluation and Regulatory Process Improvement (Ongoing)
Description: A modernized Regulatory System: making regulatory functions more efficient, effective, flexible and responsive to Canadians by streamlining processes and collaborating more closely with other organizations to ensure Canada continues to have a world class regulatory environment.
Expected Results				Performance Indicators*
Timely product assessment for health products and food A modern regulatory system for health products and food that meets the needs of Canadians				Percentage of decisions made within performance target by type for submission related to: - pharmaceuticals - medical devices - biologics - veterinary drugs - natural health products Percentage of pre-market submissions backlog reduced for: - veterinary drugs - natural health products - food Percentage of Blueprint for Renewal initiatives completed on schedule

2007-2008		2008-2009		2009-2010
$ (in millions)	FTEs	$ (in millions)	FTEs	$ (in millions)	FTEs
106.5	1,273	97.8	1,264	95.6	1,254
*Data is collected and reported quarterly and annually.

Health Canada is responsible for assessing the efficacy, safety, and quality of drugs before they are marketed. However, there is a need to monitor drugs after they reach the market and are being used in the real world. To address this need, Health Canada will develop a regulatory approach that recognizes that health products have a life-cycle. A life-cycle approach will encompass all stages of product development and use, both before and after it reaches the market. For example, Health Canada will establish a progressive licensing framework based on sound science and risk assessment principles, that supports: continuous monitoring of safety, quality, efficacy and effectiveness of information, evaluation of benefits and risks throughout the product's life-cycle, and access to promising new pharmaceuticals and biologics. As well, Health Canada plans to implement new safety reporting policies, which will take into account risk-benefit assessment, risk management, risk communication and market intervention.

Health Canada will improve the review processes for the following food-related submissions: those for which a pre-market review is mandated under the Food and Drugs Regulations (food additives, novel foods and infant formulae); submissions for which a pre-market review is conducted in support of legislation or certification programs outside of Health Canada (packaging materials, incidental food additives and processing aids); or those for which specific amendments to the Food and Drugs Regulations are sought (i.e., with respect to the addition of vitamins and minerals to foods, requests for approval of novel fibre sources, requests for acceptability of nutrition and health claim). This initiative aims to improve the transparency and predictability of the submission management process and define the respective roles and responsibilities of all parties involved (i.e., petitioners and Health Canada officials).

In 2007-2008, Health Canada will continue working on a regulatory framework for food-related health claims that support informed consumer choice and that are truthful, substantiated and not likely to lead to harm to consumers.⁶ The health claims initiative, along with other initiatives related to novel foods and food fortification, will aim to promote conditions that enable innovative food products to be marketed. As well, we will improve guidance for industry regarding what is required for pre-market submissions.

The Department will continue its efforts to establish and meet internationally-benchmarked performance targets for all regulated products, building on recent performance improvements in the review of pharmaceuticals, biologics and medical devices.⁷ Health Canada will institute efficiencies and management strategies to maintain the current standard of service and meet performance targets for pharmaceuticals, biologics and medical devices and continue working towards eliminating the backlog for submissions of natural health products and veterinary drugs.

In 2007-2008, Health Canada will continue to implement new regulatory frameworks for blood, cells, tissues and organs, which balance the need for safe cells, tissues and organs and blood of high quality with the need to ensure their availability.⁸ The Department will also develop a new regulatory framework for vaccines. As well, Health Canada will continue to work with other departments and stakeholders to ensure that new products and procedures derived from bio, nano and other health related emerging technologies have been adequately evaluated for their safety to humans, animals and to the environment.

In the Quebec Region, the Health Products and Food Branch is working to promote the establishment of good co-ordination with Quebec's Ministère de la Santé et des Services sociaux [health and social services department] in connection with implementation of the federal regulations concerning bloods, cells, tissues and organs. These regulations are designed to ensure that Canadians have access to these products and that the products are safe and effective.

Health Canada is committed to establishing a more transparent and consistent system of categorizing products and assessing their risks. This will help product sponsors understand how decisions are made and anticipate the approach that will be taken by Health Canada to review their products. Health Canada's overall review of the Natural Health Product Regulations will contribute to these efforts. In addition to work completed through the International Conference on Harmonization (ICH), Health Canada will continue to work on the reviews of the Special Access Programme and the Clinical Trial Regulations, which have already been initiated.^{9, 10}

Health Canada is actively engaged in International Regulatory Cooperation (IRC) initiatives with regulators around the world. In 2007-2008, our efforts will focus on refining these activities to maximize their strategic value and ensure they are resource efficient.

For example, Health Canada and US Food and Drug Administration (FDA) will hold a Strategic Policy Forum to map out policy directions related to medical devices, food and drugs under the HPFB-FDA Memorandum of Understanding. In addition, through the Security and Prosperity Partnership (SPP), Canada, US and Mexico will collaborate on human and avian influenza pandemic planning. Internally, the Department will continue to implement the HPFB IRC Strategic Framework and advance work and information sharing that further domestic regulatory performance.

Under its Environmental Impact Initiative, Health Canada will conduct a review of current New Substance Notification Regulations (NSNR), which are used to assess the environmental and human health impact of new substances, contained in products regulated under the Food and Drug Act.¹¹ Activities under this initiative will include the completion of needs analyses for Cosmetics, Pharmaceuticals, Medical Devices, Veterinary Drugs, Novel Foods, Food Additives, Radiopharmaceuticals, Natural Health Products, and Biologics.

Information, Education and Outreach on Health Products, Food and Nutrition (Ongoing)
Description: Responding to increased consumer interest in health issues by disseminating more information, and improving access to information that enables consumers to make appropriate decisions about health products and food safety, and nutrition
Expected Results				Performance Indicators*
Public and stakeholders are aware of and have access to information that enables them to make informed decisions regarding the safety of health products, food and nutrition				Number of information products disseminated related to: - health products - food - nutrition Percentage target population reached

2007-2008		2008-2009		2009-2010
$ (in millions)	FTEs	$ (in millions)	FTEs	$ (in millions)	FTEs
119.2	1,072	117.9	1,070	12.3	135
*Data is collected and reported annually

In 2007-2008, Health Canada will undertake activities to further develop, promote and disseminate healthy eating advice and information. A revised Canada's Food Guide was launched in February 2007. A Food Guide tailored to First Nations, Inuit and Métis is scheduled to be launched in 2007 in partnership with the First Nations and Inuit Health Branch. Based on findings from the Canadian Community Health Survey and other sources, work will also be undertaken to identify additional information that could be developed for specific segments of the population. Health Canada will also update key recommendations from its national pregnancy guidelines, Nutrition for a Healthy Pregnancy.¹²

Health Canada will continue to promote consumers' understanding and awareness of the information available on food labels to assist them to make informed choices. For example, the Nutrition Facts panel will be profiled on the revised Canada's Food Guide and through related public information initiatives that promote the importance of healthy eating to overall health and wellness.

Health Canada will deliver effective and timely communications to the public and vulnerable groups regarding food safety and nutrition issues and educate consumers on risk avoidance practices in order to maximize safety and minimize risks associated with food choices. Specifically, the Department plans to disseminate updated advice about fish consumption, safe handling of raw meat and poultry and consumption of unpasteurized juice, and updated consumer information as a result of amendments to the 2002 Nutritional Labelling regulations, which will be published in Canada Gazette Part II by December 2007.

As the applications of new technologies become numerous and more complex, Health Canada will continue to promote a comprehensive stewardship approach (i.e., responsible management of economic, environmental and social interest, while maintaining and improving high standards for product safety). As an integral part of this, Health Canada will continue to ensure that the public has access to objective information about and understand the benefits and risks associated with products of bio, nano and other health related emerging technologies.

As part of Health Products and Food Branch's Consumer Information Strategy, we will continue to: find new and effective ways to improve the way we communicate information to the public; improve and expand the tools and practices through which we communicate information; turn raw information about health products and food into practical knowledge that consumers can use to make personal decisions about their health and healthcare treatments; and provide this information to consumers when they need it in a form that allows them to more easily and effectively use it.

Monitoring Safety and Therapeutic Effectiveness and Risk Management (Ongoing)
Description: Increasing the responsiveness to specific public health issues and the ability to manage risks through the development of sustainable research, monitoring and surveillance systems and stronger compliance and enforcement activities. Increased ability to manage risks associated with the food supply, including food safety emergencies, in order to provide safer food to Canadians.
Expected Results				Performance Indicators*
Strengthened safety of health products available to Canadians Compliance with the Food and Drugs Act and its regulations				Percentage of health product recalls addressed within legislated timelines (15 days from receipt of information) Percentage annual increase of adverse reaction reports received Number of inspections Percentage of compliance based on total number of inspections (of establishments) completed

2007-2008		2008-2009		2009-2010
$ (in millions)	FTEs	$ (in millions)	FTEs	$ (in millions)	FTEs
120.4	1,076	119.1	1,074	122.5	1,076
*Data is collected and reported annually

Current regulatory resources and tools are primarily focussed on pre-market assessments of health products. However, Health Canada has a key responsibility for monitoring the real-world safety and therapeutic effectiveness of health products and the safety of food, and surveillance and monitoring of the Canadian food supply, once it is on the market. In particular, there are many new challenges and threats related to food: unapproved residues and chemicals in imported food;
the pace and scale of technological innovations; new consumption trends such as organic food; and unforeseeable threats such as new animal or plant diseases and bio-terrorism. Recognizing this, Health Canada will use the regulatory system to better generate and disseminate data, and respond to safety and effectiveness issues affecting health products and food. We will move towards a more proactive, post-market surveillance and monitoring strategy.

The Department plans to continue its efforts towards a robust, sustainable research and surveillance system to increase our ability to manage risks associated with the food supply for Canadians. Key activities include addressing priority gaps in scientific knowledge in order to better characterize risks associated with priority food-borne pathogens (e.g., E.coli 0157, Salmonella, C. Botulinum) and chemical contaminants in food (e.g., Persistent Organic Pollutants, flame retardants, water repellents) working with departmental partners to develop a sustainability plan for bio-monitoring; and working with CFIA and other federal, provincial and territorial partners to ensure that there is a consistent "national" approach to the enforcement and compliance of Health Canada policies and standards for the safety and nutritional quality of all food sold in Canada.¹³

Health Canada will co-chair the Nova Scotia Food and Health Products Safety Network with the Nova Scotia Department of Agriculture and Fisheries in 2007-2008. The Network is comprised of experts in the areas of food, water, health products, and animal health issues who work together to promote proactive and preventative strategies, and conduct post incident reviews of significant investigations in order to improve the efficiency and effectiveness of the regulatory systems. Also, the Network provides a forum for federal, provincial and municipal governments to exchange information on best practices, policy development, roles and responsibilities, and to conduct joint training exercises.

Adverse reaction reports are used by Health Canada to identify potential health product safety issues. Health Canada has launched the development of a new computerized system, which will replace the current Canadian Adverse Drug Reaction Information System (CADRIS) and strengthen Health Canada's ability to detect potential safety issues and to analyse adverse report data.¹⁴ In addition to being able to monitor adverse reactions over the entire life cycle of a product - an option not available under CADRIS - the new system will also allow more efficient electronic reporting by all manufacturers in the future. In 2007-2008, the new system will initially focus on post-market adverse reactions to pharmaceuticals, biologics and natural health products, and later be expanded to include pre-market adverse reaction reports from clinical trials. Implementation will be completed in 2007-2008.

Building on international best practices, Health Canada will develop a pharmacovigilance toolkit to strengthen our post-market surveillance capacity. The toolkit will allow easy access to guidance documents, information management and prioritization strategies, as well as additional information sources such as Periodic Safety Update Reports (PSURs) and the analysis of foreign adverse reaction data.¹⁵

Post-market surveillance, compliance and enforcement are essential in helping to ensure that Canadians have access to safe and effective medical devices. In 2007-2008, the Therapeutic Product Safety Initiative along with other sources of funding will increase funding for Health Canada's inspection program for medical device establishment licence holders to $1.8 million. These resources will allow Health Canada to conduct an estimated 205 Medical Devices Establishment inspections and associated follow-up activities.

Clinical trials require periodic compliance inspections to protect the trials' subjects as well as the integrity and accuracy of the data that supports the application for new drugs bound for market. As a component of the Therapeutic Product Safety Initiative, in 2007-2008 the number of clinical trial inspections will be increased to 85, which meets the international benchmark of 2% of all clinical trials inspected annually.

In order to reduce the number of drugs and natural health products on the market that are making unapproved health claims, Health Canada is carrying out two surveys of the health food stores, fitness facilities, pharmacies and other retail establishments to search for products making these unapproved claims and following up with the manufacturers to correct the situation.

A strong, flexible compliance and enforcement strategy is necessary for Health Canada to fulfil its mandate in today's complex regulatory environment. To reflect this change the Department will develop a new compliance and enforcement strategy as part of the Blueprint for Renewal of the health products and food regulatory system initiative

Health Canada is responsible for the development of a pandemic emergency implementation plan that outlines the roles and responsibilities of the regulatory authority if a pandemic is officially declared. Health Canada will continue to work with PHAC to implement the Canadian Pandemic Influenza Plan and to support the WHO's Global Agenda for Influenza Surveillance and Control. The Department will spend $6.2 million over five years, as well as $1.2 million ongoing, on planning and preparedness activities, providing regulatory guidance during the development of a prototype vaccine, developing a regulator's emergency implementation plan and designing an accelerated approval process. These measures will help to ensure that Canada is ready in the event of an influenza pandemic and will limit the impact of a pandemic on the Canadian population. It will also enable Canada to fulfill its role as a WHO laboratory for release of vaccines for WHO member countries in the event of a pandemic.

Transparency, Public Accountability and Stakeholder Relationships (Ongoing)
Description: Bringing more transparency to our decision-making processes by providing more accessible information about the evidence, processes and rationale underpinning our decisions. Health Canada is also strengthening its capacity to involve the public more meaningfully and inclusively in regulatory decision-making.
Expected Results				Performance Indicators*
Transparency accountability and openness are integrated into Health Canada's daily business				Number and nature of new tools and approaches implemented to better integrate transparency and openness into HPFB's daily business

2007-2008		2008-2009		2009-2010
$ (in millions)	FTEs	$ (in millions)	FTEs	$ (in millions)	FTEs
18.5	188	17.7	187	16.3	185
*Data will be collected and reported annually.

In the spring or summer of 2007, Health Canada will begin to implement measures for the registration and disclosure of clinical trial information on health products. In response to stakeholder requests for additional information, the Department will also begin providing web-based access to Health Canada-authorized Product Monographs in 2007 thereby providing Canadians with quick access to the most recently-approved information supporting safe and effective use of drug products. In addition, Health Canada will continue to provide access to information regarding the basis for regulatory decisions on some of its newly approved products (i.e, Summary Basis of Decision document) and will undertake an evaluation to explore the feasibility of expanding the initiative.¹⁶

In 2007-2008, Health Canada's Office of Consumer and Public Involvement (OCAPI) will also develop an implementation strategy for the Policy on Public Input in the Review of Health Products. This policy builds on the Health Products and Food Branch's commitment to improved transparency, openness, and accountability made in the "2004-2007 Strategic Plan, Serving Canadians Now and Into the Future" and further developed in the Public Involvement Framework.

Health Canada will continue to use a variety of methods to engage stakeholders early and throughout the decision-making process. In 2007-2008, Health Canada will launch a number of thematic consultations on such initiatives as the proposed Progressive Licensing Framework for pharmaceuticals and biologics; its cost recovery regime, the review of Natural Health Product Regulations and regulatory regime, and the Special Access Program (SAP), as well as the regulatory framework for food-related health claims.

Endnotes

1. http://www.hc-sc.gc.ca/fn-an/food-guide-aliment/fg_rainbow-arc_en_ciel_ga-eng.html

2. Once therapeutic products are on the market, Health Canada monitors them for safety, efficacy and quality. For further information, visit the HC web site: http://www.hc-sc.gc.ca/hcs-sss/pharma/nps-snpp/securit/index-eng.html

3. http://www.hc-sc.gc.ca/ahc-asc/branch-dirgen/hpfb-dgpsa/blueprint-plan/index-eng.html

4. http://www.hc-sc.gc.ca/ahc-asc/finance/frais-charg/index-eng.html

5. www.cfr-crf.gc.ca

6. http://www.hc-sc.gc.ca/fn-an/label-etiquet/nutrition/claims-reclam/final_proposal-proposition_final01-eng.html

7. http://www.hc-sc.gc.ca/ahc-asc/pubs/hpfb-dgpsa/performance_rendement_2005-eng.html

8. http://www.hc-sc.gc.ca/dhp-mps/brgtherap/reg-init/index-eng.html

9. http://www.hc-sc.gc.ca/dhp-mps/acces/drugs-drogues/index-eng.html

10. http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/consultation/clini-rev-exam/index-eng.html

11. http://www.hc-sc.gc.ca/ahc-asc/activit/strateg/environ/index-eng.html

12. http://www.hc-sc.gc.ca/fn-an/nutrition/prenatal/national_guidelines-lignes_directrices_nationales-06-eng.html

13. The measurement of people's exposure to toxic substances in the environment by measuring the substances of their metabolites (blood or urine) in human specimens.

14. http://www.hc-sc.gc.ca/dhp-mps/medeff/advers-react-neg/fs-if/cadris-2-eng.html

15. A clinical science whose objectives are the surveillance, evaluation and signaling of the undesirable effects of pharmaceutical products used for medical therapy and whose major sources of new information are spontaneous notification and reporting of such effects. Pharmacovigilance also includes the diffusion of this information and the regulatory measures taken to prevent future adverse drug reactions, to ensure safer use of drug products as well as an improvement in the risk-benefit ratio.

16. A public document that outlines in technical language the risk-benefit analysis and scientific considerations that have factored into Health Canada's Health Products and Food Branch's decision to grant market authorization for a drug or medical device. The document provides regulatory, quality (chemistry and manufacturing), efficacy and safety information.

 

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