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Health Canada


Organization

Audit and Accountability Bureau
The Audit and Accountability Bureau (AAB) is responsible for ensuring that the departmental Internal Audit plan attains the government's priorities for the use of Internal Audit as a key to strengthening public service governance and accountability.

The mandate of the AAB is to provide independent advice and assurance to the Associate Deputy Minister, and Departmental Audit Committee on the effectiveness and efficiency of risk management, controls and governance processes. This is achieved by: ensuring the Deputy Minister has independent, objective advice, guidance and assurance on the adequacy of the Department's control and accountability processes; including assessing the adequacy of controls over financial management, financial reporting and the delivery of programs and activities with due regard to efficiency, effectiveness and economy; directing the implementation of the new Internal Audit policy of the Government of Canada; directing the development of a specialized framework for the conduct of forensic audits and investigations relating to losses of money, illegal acts and other improprieties against the Crown; and leading the program to receive and act on disclosures of wrongdoing and report to the Deputy Minister.

The Bureau is organised as follows: Professional Practices and Development Directorate; Continuous Auditing and Special Examination Directorate; Internal Audit Operations Directorate; Departmental Liaison Activities and Internal Disclosure Office.

Chief Financial Officer Branch
The Chief Financial Officer Branch (CFOB) is the departmental focal point of accountability to ensure rigorous stewardship of resources and managing for results. The CFOB provides strategic advice to the Minister, Deputy Ministers and the Departmental Executive with respect to financial and material management, program evaluation and operational planning and reporting, as well as anticipating and promoting future trends. The Chief Financial Officer (CFO) reports directly to the Deputy Minister and is a key member of Health Canada's Departmental Executive Team. The CFO is also the lead executive with central agencies for overall financial management and has a functional reporting relationship to the Comptroller General of Canada.

In particular, the CFOB is responsible to provide the necessary enabling frameworks, policies, systems, and best practices and tools to support financial management and operations; ensure prudence and probity in compliance with government financial policies and regulations; strengthen risk management practices; enhance performance measurement and reporting; promote efficient administrative shared services; and, monitor and report on the overall implementation of the government's Management Accountability Framework (MAF).

Departmental Performance Measurement and Evaluation Directorate (DPMED)
DPMED provides functional direction and services for performance measurement and evaluation services. DPMED is responsible for providing objective and independent information on the performance of Health Canada's policies, programs, initiatives and functions and to promote performance measurement, to help increase Health Canada's effectiveness and efficiency.

Key activities include evaluation studies and developing evaluation and performance measurement frameworks; providing expert advice on the development and implementation of results-based management and accountability frameworks; developing tools and delivering training to increase Health Canada's capacity in performance management and measurement; coordinating, planning and monitoring Health Canada's performance measurement and evaluation functions (functional stewardship), including developing and implementing performance measurement and evaluation standards, processes and tools; and, advising the Deputy Minister, Associate Deputy Minister and the Departmental Audit and Evaluation Committee on evaluation and related issues and activities in Health Canada.

Departmental Resource Management and Operational Planning Directorate (DRMOPD)
The Departmental Resource Management and Operational Planning Directorate is responsible for managing financial resources and developing and monitoring the operational plan at the department level. It supports the Chief Financial Officer, the Deputy Minister, and the Minister to ensure efficient, effective, and prudent management of resources in pursuit of government and departmental priorities. A core function of the Directorate is to ensure the linking of resources to program activities and outcomes in planning, to monitor departmental operations against the plan, and to report on results internally as well as externally for management and accountability purposes.

The key activities of the Directorate include: providing strategic resource management advice to departmental senior management as well as to program managers, planners, and financial officers; developing the Main and Supplementary Estimates, the Interim Supply, the Annual Reference Level Update, and the Departmental Performance Report; directing the strategic financial component of the departmental strategic plan; directing the departmental operational planning and resource management frameworks, including the development of the Departmental Operational Plan and monitoring its implementation; and providing professional support and coordinate functional reviews in the development / approval of the Treasury Board Submissions and Memoranda to Cabinet for the department and the health portfolio organizations.

Financial Operations Directorate
The Financial Operations Directorate is responsible for the management of departmental resources and its role is to continuously strengthen financial management and accountability practices within the Department. This is done through the provision of high quality financial support and advice to departmental senior management, increased transparency, and effective relations with Central Agencies and Portfolio members.

The Directorate activities include the provision of direct services such as financial management and development of internal policies, functional and advisory assistance to managers, and financial systems development and training to all branches.

Materiel and Assets Management Directorate (MAMD)
MAMD provides leadership, management services and functional direction to Health Canada's procurement community in support of program activities. Services provided by the Directorate include: acquisition of goods and services, fleet management, assets management and inventory control, long term capital planning, and materiel policy development. MAMD is responsible for proactive disclosure of contracts over $10,000. It also provides departmental leadership on shared services initiatives, such as E-Procurement and Government of Canada Marketplace.

Planning and Corporate Management Practices Directorate (PCMPD)
The PCMPD provides leadership and coordination to Health Canada in the development and implementation of a range of department-wide or government-wide projects. The Directorate is the Department's focal point for addressing the Treasury Board Secretariat reporting requirements on the Management Accountability Framework (MAF).

The PCMPD is the departmental lead for Integrated Risk Management (IRM), houses the Department's Office of IRM and develops the departmental Corporate Risk Profile. It provides full secretariat services to the Departmental Executive Sub-Committee on Finance, Evaluation and Accountability (DECFEA), including maintaining a database for documentation and forward agenda.

The PCMPD provides strategic advice for the design, management and oversight of internal controls over financial reporting and financial processes at Health Canada.

Corporate Services Branch
The Branch provides corporate support and services in the following areas: human resources management; official languages, assets, real property and facilities management, occupational health, safety, emergency and security management; information technology and information management; executive correspondence; and access to information and privacy requests/issues.

Chief Information Officer (CIO)
The CIO is responsible for leading the Department's strategic information management/information technology (IM/IT) planning process, establishing a common departmental enterprise architecture (including policies and standards); being a champion of the Computer Science (CS) in fostering excellence and a shared management regime; and leading colleagues in the implementation of best practices for IM/IT project management, procurement and performance measurement.

Facilities and Security Directorate (FSD)
The FSD supports and provides services for the effective management of the Department's real property assets and the occupational health, safety and security of Health Canada employees. The range of services provided in support of departmental programs includes: custodial and leased property acquisition; maintenance and disposal; real property and facilities planning and management; accommodation services; occupational health and safety; and environmental management. The FSD also develops and maintains policies, systems, and procedures governing the management of these services within Health Canada.

Human Resources Services Directorate (HRSD)
The HRSD contributes to the effective management of human resources within Health Canada by providing strategic advice and guidance on a wide variety of Human Resources Management issues. This includes working with our partners to develop plans and strategies to recruit, develop and retain employees. The HRSD is responsible for developing policies, tools and related training to help managers and employees at all levels to achieve their business goals. It also provides advice and delivers services in such areas as: staffing, classification, organizational design, healthy workplaces, labour relations, conflict resolution, mediation, and compensation, workforce planning including official languages, diversity, continuous learning and recognition of achievements.

Information Management Services Directorate (IMSD)
Under the direction of the Chief Information Officer (CIO), IMSD provides the strategy, policies, infrastructure, tools and competent personnel necessary for Health Canada to make effective use of information management, information technology and knowledge management (IM/IT/KM) in the delivery of departmental programs and services. This includes coordination of a departmental planning process for information and knowledge management, development and management of a diversified enterprise architecture, and design and implementation of informatics initiatives, strategies, technologies and policies in the Department.

Planning, Integration and Management Services Directorate (PIMSD)
The Directorate is responsible for: administering the Access to Information Act and the Privacy Act on behalf of the Department; effectively managing the Department's executive correspondence; developing and coordinating branch strategic and business plans, including performance measures and input to departmental planning documents; providing secretariat support services in relation to various departmental governance committees led by the Branch; and providing various management and administrative services to the Branch, including those related to human resources and facilities management, occupational safety and health, information management, security and internal communications.

The Directorate acts as the departmental focal point to foster a greater sensitivity to openness and transparency and the protection of personal information within the Department; provides training to promote consistency in access and privacy practices across Health Canada; develops corporate access and privacy policies and guidelines; facilitates the development and maintenance of Privacy Impact Assessments; and provides liaison and coordination with federal partners, provincial/territorial ministries of health and other key stakeholders to facilitate two-way information and knowledge sharing in support of collaborative work on common issues and concerns, and strengthening the protection of personal health information across Canada's health-care sector. The Directorate is also responsible for liaising with other departments and central agencies on planning and operational issues, on behalf of the Branch; developing Branch policies and procedures in relation to good management practices, and providing advice and leadership in the application of such practices; and coordinating audit and evaluation activities affecting the Branch.

First Nations and Inuit Health Branch (FNIHB)
The First Nations and Inuit Health Branch (FNIHB) works with First Nations and Inuit to maintain and improve their health, support their access to quality health services and to facilitate greater First Nations and Inuit control over health programs. The health system for First Nations and Inuit is a shared responsibility between provincial governments and the federal government. FNIHB provides a range of primary care and public health services and programs on-reserve, supplementary health benefits through the Non-Insured Health Benefits program (NIHB) to all eligible First Nations and Inuit and targeted disease prevention and health promotion programs for all Aboriginal peoples. Many programs and services are delivered through community-based nursing stations, health centres, and other health facilities, particularly in isolated and remote areas. A number of First Nations manage their own health programs and services through Contribution Agreements with FNIHB. FNIHB maintains a regional presence through the regional offices of the Public Affairs, Consultation and Regions Branch (PACRB) of Health Canada. The delivery and management of Health Canada's community-based wellness programs in the territories are carried out by the Northern Secretariat of PACRB.

Business Planning and Management Directorate (BPMD)
The Business Planning and Management Directorate provides planning and management frameworks, processes, and strategies that strengthen and support First Nations and Inuit Health Branch's (FNIHB) capacity in the delivery of health care services and programs through strong partnerships with key stakeholders. Key responsibilities include: information management frameworks and processes to ensure that FNIHB's information is maintained and safeguarded appropriately; performance management and evaluation strategies; audit and quality assurance frameworks; operational and human resources planning; business continuity, emergency preparedness and risk assessment strategies; continuous learning, internal communications, and procurement services to the Branch; and, management of a contribution funding arrangements framework.

Senior Medical Officer, First Nations and Inuit Health
Senior Medical Officer, First Nations and Inuit Health, provides professional advice on medicine, and provides leadership on professional issues related to Aboriginal medical services; represents the Assistant Deputy Minister, FNIHB, at meetings, negotiation sessions, conferences and other national/international forums and serves as the point of consultation/collaboration and liaison between the branch and aboriginal health organizations and aboriginal professional health organizations. Representational and liaison activities are aimed at providing advice on approaches to complex problems, elaborating new concepts/approaches or medical interventions, promoting the medical aspects of new policies and governance, fostering acceptance to policies and policy positions having a bearing on improving the health and health conditions for First Nations and Inuit.

Community Programs Directorate
The Community Programs Directorate promotes health and prevents disease through the healthy development of pregnant women, children and youth, and by strengthening existing and developing new approaches to mental health, addictions and chronic disease prevention.

Non-Insured Health Benefits Program
The Non-Insured Health Benefits Program provides medically necessary health-related goods and services not covered by other federal, provincial, territorial or third-party health insurance plans to about 792,000 eligible registered Indians and recognized Inuit. These benefits complement provincial/territorial insured health-care programs and include pharmaceuticals, medical transportation, dental care, vision care, medical supplies and equipment and payment of provincial health-care premiums (British Columbia and Alberta), and short-term crisis intervention mental health counselling.

Office of Community Medicine
The Office of Community Medicine (OCM) provides professional leadership and support to the Branch public health physicians/medical officers through sponsorship and coordination of forum of communications of the Branch Council of Medical Officers in Public Health (CMOPH) to advance the best practice in public health. OCM also works collaboratively with key partners and stakeholders in other directorates, branches, departments and outside the Government of Canada and takes steps to improve the horizontal linkage of OCM with others to promote the philosophy of public health/population health and the determinants of health, and contribute in program and policy development. In addition, OCM provides ongoing technical expertise and advice to the Assistant Deputy Minister and the Deputy Minister of Health on public health issues relevant to First Nations people.

Office of Nursing Services
The Office of Nursing Services provides professional strategic leadership for nurses employed in First Nations and Inuit communities and strategic policy advice to Senior Management from a nursing perspective. The Office of Nursing Services, in partnership with Regional Nursing Services, provides nursing leadership, support and consultation to nurses working in First Nations and Inuit Health communities. The Office of Nursing Services supports comprehensive nursing practice across the continuum of health care through the development of clinical standards, educational supports, and practice supports for nurses providing Community Health (Public Health and Home Health Care) and in some instances, Primary care.

Office of the Chief Dental Officer
The Office of the Chief Dental Officer (OCDO) was established in 2004 in recognition of the link between oral and general health and to improve Government's capacity to address oral health issues in the general Canadian population. The Office of the Chief Dental Officer provides evidence-based oral health perspectives on a wide range of health policy and program development issues and assists in gathering epidemiological information for program planning. The Office of the Chief Dental Officer is the point of contact/liaison for professional associations, provinces, academic institutions and other non-government organizations on oral health issues.

Primary Health Care and Public Health Directorate
The Primary Health Care and Public Health Directorate is responsible for the delivery of primary health-care services, as well as disease prevention and health promotion programs, in partnership with First Nations and Inuit health organizations and authorities. Activities support knowledge and capacity building among First Nations and Inuit. Key services delivered by the Primary Health Care and Public Health Directorate include home and community care, health info structure (such as telehealth services and electronic health records management), health human resources (including bursary and scholarship programs), accreditation and quality improvement, communicable disease control, environmental health programming, oral health programming, environmental contaminants research and expert advice on pharmacy issues.

Strategic Policy, Planning and Analysis Directorate
The Strategic Policy, Planning and Analysis Directorate (SPPAD) provides advice and analysis to senior management and regional offices on Branch policy, planning and health service initiatives. SPPAD is also responsible for managing partnerships with National Aboriginal Organizations (NAOs), the federal health portfolio, and other federal departments. SPPAD carries out these responsibilities through horizontal, cross-Branch policy analysis, identification of current and near-term policy challenges, targeted economic and health program analysis, health research, support for health surveillance and information and the preparation of Cabinet documents. SPPAD also plays a critical role in the development and management of First Nation and Inuit health systems between federal, provincial and territorial (F/P/T) governments, and the coordination of the Aboriginal Health Transition Fund, designed to improve the adaptation and integration of F/P/T health services for all Aboriginal peoples. SPPAD coordinates activities regarding international Aboriginal health commitments. SPPAD also houses the Office of Inuit Health to provide a focussed Inuit health lens on all policy and program issues for the Branch and to liaise with key internal and external partners on Inuit health issues.

Health Policy Branch (HPB)
The HPB provides advice and support to the Minister, the departmental executive and to program branches in the areas of policy development, intergovernmental and international affairs, strategic planning and review, and the administration of the Canada Health Act.

Applied Research and Analysis Directorate (ARAD)
ARAD helps to build the analytical foundation for Health Canada's policy decision making and performance measurement and reporting. ARAD conducts economic analysis of health policy issues and publishes the Health Policy Research Bulletin. ARAD develops the quantitative information base to support the Department's and the Government of Canada's health system performance reporting commitments. ARAD develops, in collaboration with data providers, federal policy on investments in Canada's health statistics system and coordinates departmental core data requirements with data providers. ARAD has also developed a data dissemination system to give Health Canada and the Public Health Agency of Canada analysts single-tool access to core data from a wide variety of sources. ARAD actively supports HPB, other branches, and regions through capacity building, partnerships, and the provision of analytical and performance information and tools.

Health Care Policy Directorate
The Health Care Policy Directorate provides strategic advice and programs and helps shape policy related to health care issues, such as improved access, quality and integration of health services to better meet the health needs of Canadians wherever they live or whatever their financial circumstances. The objective is pursued mindful of long term equity, sustainability and affordability considerations and in close collaboration with provinces and territories, health professionals, administrators, other key stakeholders and citizens.

Intergovernmental Affairs Directorate
The Intergovernmental Affairs Directorate is responsible for the administration of the Canada Health Act. It monitors provincial/territorial compliance with the criteria and conditions of the Act, informs the Minister of possible non-compliance and recommends appropriate action. The Directorate also provides policy advice concerning the Act, develops interpretations under it, provides an annual report to Parliament on the Act, and provides support to legal counsel in court cases in which the Act is involved.

The Directorate also provides strategic advice and coordination on the full range of federal/provincial/territorial issues in order to maintain effective relationships with provinces and territories while preserving the federal government interest in order to advance Health Canada's mandate. It supports the branches with respect to the federal/provincial/territorial aspects of their policies, programs and activities. The Directorate is also in charge of the organization of federal/provincial/territorial Deputy Ministers and Ministers meetings.

International Affairs Directorate
The International Affairs Directorate initiates, coordinates and monitors departmental policies, strategies and activities in the international field. It provides advice on the Department's strategic approach to international affairs, ensures the Department's international activities are internally coherent and consistent with government-wide policies and recommends departmental representation at international meetings.

It also represents the Department in international organizations, promotes the Department's corporate interests abroad and ensures that Canadian health policy and priorities are reflected in the Department's international activities. The Directorate administers exchange agreements with other countries, manages the international components of the Tobacco and AIDS strategies, arranges visits for foreign delegates interested in health affairs, and responds to health-related information requests both from domestic and foreign clients.

Office of the Chief Scientist
Created in 2001, the Office of the Chief Scientist (OCS) provides leadership for, and promotes awareness of, Health Canada's science and research. It also encourages and supports the science community within and outside Health Canada. This helps to make sure the department has the scientific information that it needs to make health-related policy and regulatory decisions. The OCS is led by the Chief Scientist, who reports to the Associate Deputy Minister and is a key member of Health Canada's Departmental Executive Team.

The OCS is comprised of three divisions (in addition to the Chief Scientist's Office): Policy Planning and Partnerships; Health Research Secretariat; and Science Activity Valorization and Development.

The OCS undertakes activities along three lines of business, described below along with key priorities:

Science promotion: raising awareness and understanding of science conducted at Health Canada and its contribution to the health and safety of Canadians; communicating science; and recognizing science excellence;

Science advice: promoting the effective use of sound science advice in policy and regulatory decisions; promoting the responsible conduct of research; and providing science advice to the Minister and Deputy Ministers;

Science management: enhancing science capacity and quality, to help ensure that Health Canada has the science capacity it needs to meet current and emerging challenges; building and enabling strategic relationships; supporting the recruitment, retention and development of scientific expertise; managing intellectual property; and promoting horizontal science management.

Among these priorities, the OCS is responsible for several corporate functions such as the Science Advisory Board (SAB), which provides a valued source of expert, independent advice to the Minister of Health on the science performed and used by Health Canada, the Research Ethics Board which provides an independent, complete review to help make sure Health Canada's research involving humans is ethical.

Office of Nursing Policy
This Office was created in 1999 to strengthen the focus on nursing policy issues within Health Canada. It is responsible for advising Health Canada on the nursing perspectives on various policy issues and programs, representing that perspective in various fora, contributing to health policy formulation and program development, and working closely with the nursing community in developing advice to the Minister and the department.

The Office of Nursing Policy remains committed to advancing Health Canada's mandate and mission by optimizing the contributions of nurses in improving the health of Canadians. We continue to focus on what needs to occur in the nursing workforce to ensure that all Canadians have access to health services when and where they need them, that the quality of those services is continually improved, and that the system can provide the necessary care for today and has the capacity to identify and adapt to the emerging needs and challenges of tomorrow.

Policy Coordination and Planning Directorate
The Policy Coordination and Planning Directorate provides analysis and strategic advice to ensure that Health Canada's policy agenda is integrated and consistent with the government's overall social and economic agendas, ensures coherence of policies across Health Portfolio organizations, provides leadership and coordination on broad departmental strategic planning endeavours, provides policy advice and builds departmental capacity on gender-based analysis, provides support across the department and across the Portfolio in preparing for parliamentary activities and statutory obligations, focal point for Cabinet business and is responsible for the coordination and preparation of Health Canada's Cabinet material.

Policy Development Directorate
The Directorate leads on policy research, development and consultation in order to create regulatory frameworks that enable implementation of the provisions of the Assisted Human Reproduction Act. The Directorate is responsible for strengthening and modernizing the Portfolio's legislative health protection base. The Directorate provides expert health science policy advice and responsive strategies/coordination on a wide range of issues, ranging from social, ethical and legal considerations relating to research involving humans to genetics, intellectual property issues, bio-banking, nanotechnology, pandemic and vaccines.

Health Products and Food Branch
The Health Products and Food Branch (HPFB) plays a vital role in protecting and promoting the health and safety of Canadians by providing timely access to safe, effective, and high-quality health products and food, and the information they need to allow healthy and informed decisions.

As Health Canada's federal authority for regulating health products and food through the Food and Drugs Act, HPFB 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 therapeutic products available to Canadians, as well as the safety and quality of the foods they eat.

The Branch's responsibilities include ensuring that veterinary drugs sold in Canada are safe and effective for animals and that the foods derived from animals treated with those drugs are safe. HPFB also promotes the health and well-being of Canadians through a broad range of activities on health products and food, including developing nutrition policies and standards such as "Canada's Food Guide".

HPFB strives to ensure that the potential benefits of all health products outweigh their risks. Our highest priority is public safety. Before any health product or veterinary drug is authorized for sale in Canada, the manufacturer must provide HPFB with substantive scientific evidence of its safety, efficacy, and quality. Highly skilled HPFB scientists review this evidence carefully to determine whether the potential risks from the health product are acceptable when balanced against its positive effects. HPFB takes a similar approach to food. HPFB also establishes policies, sets standards, and provides advice and information on the safety and nutritional value of food.

High safety and quality standards also apply to health products that have reached the Canadian market. HPFB: monitors all health products available for sale in Canada for compliance with manufacturing, advertising, and labelling regulations and guidelines; monitors expected and unexpected health risks such as adverse reactions do drugs; enforces the Food and Drugs Act and associated regulations, when necessary; and assesses the effectiveness of the activities of the Canadian Food inspection Agency that are related to food safety.

HPFB is committed to being transparent, open, and accountable to Canadians. Performance targets, safety measures, and results are documented in its "2007-12 Strategic Plan" and annual performance report. A variety of public involvement activities offer Canadians opportunities to contribute to regulatory decisions about the health products they use and the food they consume every day.

Biologics and Genetic Therapies Directorate (BGTD)
The BGTD is the Canadian federal authority that regulates biological drugs (products derived from living sources) and radiopharmaceuticals (pharmaceutical or biological drugs that contain a radioactive entity) for human use.

Prior to being issued a Notice of Compliance (NOC), a manufacturer must present substantive scientific evidence of a product's safety, efficacy and quality as required under the Food and Drugs Act and Regulations. Some of the products regulated by BGTD include, blood and blood products, viral and bacterial vaccines, gene therapy products, cells, tissues, organs and xenografts, which are manufactured in Canada or elsewhere. Biologic products also include hormones and allergenic products, and therapeutic products produced through recombinant DNA technologies.

Biologics require different regulatory oversight than drugs made from chemicals. An important safeguard for Canadians is that we test batches (called "lots") of biologics, before they are "released" for sale in Canada. Tests are done in both pre- and post-market stages of the product life cycle. We also test products to ensure the consistency of manufacturing as part of the approval process for new products; and engage in collaborative studies with other national and international organizations to establish methodology and standards to support testing activities internationally.

Food Directorate
The Food Directorate is responsible for establishing policies, setting standards, and providing guidance and information on the safety and nutritional value of food. It also administers the provisions of the Food and Drugs Act that relate to public health, safety, and nutrition. The Canadian Food Inspection Agency (CFIA) provides all federal inspection services related to food safety, and enforces the food safety and nutritional quality standards established by Health Canada. Health Canada is responsible for assessing the effectiveness of the CFIA's activities related to food safety.

With a network of modern laboratories across the country, the Food Directorate works in close cooperation with officials from other levels of government. Key activities include: conducting scientific research, as well as health risk and benefit assessments; developing policies, standards, and guidelines; evaluating submissions from the food industry; and providing information to support Canadians in their decisions about food and diet.

Inspectorate
The mandate of the Inspectorate is to deliver a national compliance monitoring and enforcement program for all health products that fall within the mandate of the Health Products and Food Branch, with the exception of food. It is responsible for compliance monitoring and enforcement to assess the compliance of regulatees with the requirements under the Food and Drugs Act and its regulations. The Inspectorate fulfills its responsibility through a number of core functions which include compliance monitoring, compliance verification and investigation, establishment licensing and laboratory analyses.

Products for which the Inspectorate is responsible include medical devices, disinfectants, medical gases, biologics such as vaccines, pharmaceuticals, radiopharmaceuticals, veterinary drugs, natural health products, blood products and human cells, tissues and organs for transplantation. Food products and cosmetics are not covered by the Inspectorate but by the Canadian Food Inspection Agency and by Health Canada's Healthy Environment and Consumer Safety (HECS) Branch, respectively. The Inspectorate also conducts inspections of drug clinical trials to assess compliance with Good Clinical Practices and of drug companies to determine whether sites comply with Good Manufacturing Practices.

Marketed Health Products Directorate (MHPD)
The MHPD works to monitor the safety and quality of health products after they have reached the marketplace. This post-market surveillance is essential to maintaining the balance between the health benefits and risks posed by all health products.

MHPD reviews health-product safety data, conducts risk assessments and evaluates therapeutic effectiveness of marketed health products. It also communicates, in partnership with stakeholders, product related risks and benefits to health care professionals and the public.

Natural Health Products Directorate (NHPD)
The NHPD is the regulator of natural health products in Canada. The mission of the NHPD is to ensure that all Canadians have ready access to natural health products that are safe, effective, and of high quality, while respecting freedom of choice and philosophical and cultural diversity.

The Natural Health Products Regulations came into effect on January 1, 2004. These Regulations set out requirements for the manufacture, packaging, labelling, storage, importation, distribution and sale of natural health products in Canada, as well as clinical trials involving human subjects. Persons wishing to market a natural health product in Canada must provide the NHPD with scientific evidence of a product's safety, efficacy and quality as required by the Regulations.

Office of Consumer and Public Involvement (OCAPI)
The OCAPI supports the work of the Health Products and Food Branch by providing information and opportunities to Canadians to become meaningfully involved in the decision-making processes. OCAPI helps the Branch involve the public in its business, leading to better decisions for and by Canadians.

As a centre of expertise for public involvement, OCAPI: Provides advice to Branch directorates on the development of policies and programs; collaborates in strategic planning based on its knowledge of the public environment; partners with directorates and collaborates with stakeholders to deliver public involvement activities; and increases public awareness and understanding of the Branch by Canadians.

Every year, OCAPI supports the Branch in over 100 public involvement activities that touch a broad variety of issues, using, for example, electronic consultations, surveys, roundtable discussions, and forums.

Office of Management and Program Services (OMPS)
The OMPS develops frameworks, strategies, guidelines and management solutions to support Health Products and Food Branch (HPFB) managers in carrying out their programs and activities. OMPS also delivers programs such as Continuous Learning and Human Resources Development, Information and Records Management, Scientific Libraries, and provides planning and management services to all HPFB managers and employees.

Office of Nutrition Policy and Promotion (ONPP)
The Office of Nutrition Policy and Promotion (ONPP) was created in 2001 to provide a focal point for nutrition and healthy eating in Canada. The ONPP promotes and supports the nutritional health and well-being of all Canadians by collaboratively: (i) Anticipating and responding to public health issues associated with nutrition; (ii) Defining, promoting and implementing evidence-based nutrition policies and standards; (iii) Providing timely and authoritative information to support and influence decisions; and (iv) Generating and disseminating knowledge through research, surveillance and evaluation activities.

The ONPP is comprised of three divisions: Research, Monitoring and Evaluation (RME); Policy and Standard Setting (PSS); and Planning, Dissemination and Outreach (PDO).

Policy Planning and International Affairs Directorate (PPIAD)
PPIAD is a corporate services organization providing Health Products and Food Branch a centre of excellence in planning and performance management; audit and evaluation; policy and regulation; Cabinet and Parliamentary relations; and in international, federal/provincial/territorial (F/P/T) and Health Portfolio affairs.

Specifically, PPIAD: Leads the development of HPFB's policy, legislative and regulatory agenda, planning, reporting and performance management, and key evaluation activities; coordinating Branch audits, and Cabinet and Parliamentary affairs; and inputting to Health Canada's planning initiatives; and,

Through cooperation with partners, PPIAD leads and facilitates effective integration of horizontal regulatory policy, international, F/P/T and Health Portfolio affairs through the full life-cycle of health products and food.

Therapeutic Products Directorate (TPD)
The TPD contributes to the health of Canadians and to the effectiveness of the health-care system by regulating pharmaceuticals and medical devices and by providing Canadians with access to information to make informed choices.

HPFB's Special Access Program (SAP) allows health-care professionals to gain limited access to pharmaceutical, natural health products, biological and radiopharmaceutical products and medical devices that have not yet been approved for sale in Canada. Special access can be requested for emergency use or if conventional therapies have failed, are unavailable or are unsuitable to treat a patient.

Veterinary Drugs Directorate (VDD)
The VDD is responsible for protecting human and animal health and the safety of Canada's food supply through the evaluation and monitoring of the safety, quality and effectiveness of veterinary drugs. The Directorate develops policies relating to the safety and prudent use of veterinary drugs, sets standards to ensure that residues of veterinary drugs in food derived from animals do not pose undue risk to human health and promotes the prudent use of veterinary drugs administered to food-producing and companion animals.

Healthy Environments and Consumer Safety Branch
Healthy Environments and Consumer Safety touches many elements of day-to-day living that have an impact on the health of Canadians. These include drinking water safety, air quality, radiation exposure, substance use and abuse (including alcohol), consumer product safety, tobacco and second-hand smoke, workplace health, and chemicals in the workplace and in the environment. Much of this work is governed through legislation including the Food and Drugs Act, the Controlled Drugs and Substances Act, the Hazardous Products Act, the Radiation Emitting Devices Act, the Canadian Environmental Protection Act, the Tobacco Act, the Quarantine Act, the Potable Water Regulations for Common Carriers, and others. Health Canada is also engaged in other health and safety related activities such as chemical and nuclear emergency preparedness; inspection of food and potable water for the travelling public; and health contingency planning for visiting dignitaries.

The Healthy Environments and Consumer Safety strategic outcome seeks to improve health outcomes by: Reducing health and safety risks associated with tobacco consumption and the abuse of drugs, alcohol, and other controlled substances; and Reducing risks to health and safety, and improving protection against harm associated with workplace and environmental hazards, consumer products (including cosmetics), radiation-emitting devices, new chemical substances, and products of biotechnology.

Drug Strategy and Controlled Substances Program
The Drug Strategy and Controlled Substances Program regulates controlled substances and promotes initiatives that reduce or prevent the harm associated with these substances and alcohol. The Program also provides expert advice and drug analysis services to law enforcement agencies across the country.

The Office of Demand Reduction coordinates the implementation of the National Anti-Drug Strategy initiatives related to prevention and treatment of illicit drug abuse. Activities in this area include: collaborating with other departments, governments and expert bodies; collecting, synthesizing, researching, analyzing and distributing leading‑edge information about prevention and treatment such as: best practices; and, managing funding programs to support health promotion, prevention and treatment initiatives.

The Office of Controlled Substances (OCS) works to ensure that controlled substances and precursor chemicals are not diverted for illegal use. This involves developing legislation, regulations, policies and programs to ensure that these drugs and substances are used only for legitimate purposes. Activities in this area include: licensing manufacturers and distributors of controlled substances and precursor chemicals; issuing import/export permits when necessary, to manage and track the movement of these substances across the Canadian border; licensing individuals and companies to cultivate, process and sell industrial hemp products; authorizing individuals to possess marihuana for medical purposes; authorizing individuals to produce marihuana for a person who is authorized to possess marihuana for medical purposes; managing an exemption process that allows individuals with legitimate scientific or medical reasons to possess a controlled substance; managing the exemption process which allows the physicians to prescribe methadone for the treatment of opioid dependence and as an analgesic; and, working with other groups such as the law enforcement community to address compliance issues.

The Office of Research and Surveillance monitors trends and patterns of alcohol and illicit drug use in Canada as well as emerging trends regarding substance abuse nationally and internationally. The Office maintains networks with government and non-government stakeholders regarding data collection and information needs. The data and information gathered provide an evidence-based platform for the decision and policy making processes and also serve to meet the Program's international reporting obligations.

Drug Analysis Service (DAS) provides drug analysis services including expert advice and analytical support to law enforcement agencies in their drug enforcement responsibilities. Activities in this area include: analyzing the content and determining the quantity of illicit drugs seized by law enforcement agencies across the country ‑ roughly 100,000 drug samples per year ‑ documenting the information for use as evidence in criminal prosecutions; and assisting in the investigation and dismantling of clandestine laboratories, by gathering evidence to determine the type and quantity of drugs produced, as well as providing expert advice and training to police on drug sampling, trends identification and health and safety issues related to shutting down these laboratories. DAS is also responsible for issuing the authorization for the disposal of seized drugs and managing the production and distribution of marihuana for those authorized to possess and use marihuana for medical purposes.

The Office of the Drug Strategy and Strategic Policy (ODSSP) develops comprehensive policy and approaches pertaining to emerging issues to illicit drugs, alcohol and other substances. ODSSP also supports reporting requirements under domestic legislations and international conventions on drug-related issues and provides leadership in the evaluation of program and policy-related performance.

Product Safety Program
The Product Safety Program has the legislative mandate to identify, assess, and manage the health and safety hazards and health risks to Canadians associated with: new chemical substances; products of biotechnology; radiation produced by radiation emitting devices; environmental noise; solar UV radiation; consumer products (incl. cosmetics); workplace chemicals.

Safe Environments Programme
The Safe Environments Programme (SEP) promotes healthy and safe living, working and recreational environments by identifying and assessing health risks posed by environmental factors. In addition to the activities carried out under its legislative mandate, the Programme develops national risk management strategies supported by scientific research to promote healthy environments and reduce the risks to human health from the environment. These strategies directly align with Health Canada's Sustainable Development Strategy.

The Programme's areas of responsibility include: Assessing and providing expert advice on the health risks and impacts posed by chemical substances in commerce and in federal contaminated sites in Canada, as well as impacts posed by development projects; Developing and implementing strategies to manage risks to human health which are associated with environmental exposure to chemical substances; Leading the development of health risk assessment to protect the health of Canadians from contaminants in drinking and recreational waters and outdoor and indoor air; Conducting environmental health science and research in support of regulatory functions, providing leadership, direction, and cooperation on horizontal and international health policy strategies, issues and initiatives related to environmental contaminants; Providing leadership, responsive services and medical and technical advice to Canadians in connection with environmental and occupational radiation protection; Participating in developing regulations and standards to address risks from air and water contaminants; and Facilitating program delivery within interdepartmental horizontal initiatives (such as the Chemical Management Plan and the Clean Air Agenda) integral to the Government of Canada's Environmental Agenda.

The Programme leads public health initiatives such as Canada's Radon Strategy, coordinates Canada's preparedness for nuclear emergencies, and provides surveillance networks to monitor radiation levels around critical infrastructure and operates the National Dosimetry Service and Worker Dose Registry. SEP also includes the Chemical Emergency Response Unit (CERU) which provides advice on health effects and coordinates the Departmental response to chemical emergencies. Safe Environments Programme staff are located in the national capital region and in regional offices across Canada.

Tobacco Control Program
The goal of the Tobacco Control Program is to reduce death and disease due to tobacco use. The Office of Regulations and Compliance administers the Tobacco Act, which regulates the manufacture, sale, labelling and promotion of tobacco products, in order to protect Canadians, especially young people, from the health consequences of tobacco addiction. The Office of Programs and Knowledge Exchange (OPKE) works with provincial and territorial governments and non governmental organizations to plan, implement and evaluate prevention, cessation and protection initiatives which help to reduce the number of Canadians who smoke and which help to reduce the number of Canadians who are exposed to second-hand tobacco smoke. The Office of Policy develops the policies, strategies and frameworks that are needed to reduce tobacco use in Canada, and also promotes international cooperation for tobacco control. The Office of Research, Evaluation and Surveillance monitors and analyzes knowledge, attitudes and behaviour with respect to smoking; monitors and analyzes tobacco sales, industry practices and consumption; and works to expand knowledge of the health effects of tobacco use.

Workplace Health and Public Safety Program (WHPSP)
The WHPSP is responsible for helping Canadian private and public sector employers maintain and improve the health of their workers by providing leadership and policy development in the areas that affect workplace health. A major component of Workplace Health and Public Safety Programme's main portfolio is the Public Service Health Program (PSHP). Through the PSHP, WHPSP is the principal occupational health and safety advisor to the Treasury Board Secretariat and provides a wide range of occupational health services to federal employees. WHPSP also provides public health services including food, water and sanitation inspections; develops health contingency plans for Internationally Protected Persons on official visit or attending international summits hosted by the Prime Minister in Canada; offers confidential employee assistance programs; wellness and organizational development; counselling services; and physical and psycho-social emergency preparedness and response; and helps Canadian private and public sector employers maintain and improve the health of their workers by providing leadership, policy and tool development in the areas that affect workplace health.

Pest Management Regulatory Agency
The mandate of the Health Canada Pest Management Regulatory Agency (PMRA) is to ensure that pesticides registered in Canada are acceptable for use and do not pose risks to human health or the environment.

Consistent with this mandate, the PMRA supports sustainable development designed to address the needs of the present without compromising the ability of future generations to meet their own. The PMRA seeks to minimize health and environmental risks posed by pesticides and encourage the development and implementation of innovative, sustainable pest management strategies by facilitating access to low-risk pesticides and other appropriate measures. The PMRA encourages public awareness about pesticides by informing the public, facilitating access to relevant information, and, promoting public participation in the decision-making process. The PMRA also ensures that all pesticides submitted for registration are evaluated using modern scientific standards to determine the potential risks posed to human health and the environment, as well as the pesticide's value.

Additionally, the PMRA develops and implements policies and guidelines related to pest management; seeks to improve processing of registration applications through such means as international workshare initiatives, electronic submissions and review of pesticide registration data; enforces compliance with the Pest Control Products Act; and re-evaluates registered products to ensure they meet modern scientific standards.

Public Affairs, Consultation and Regions Branch
The Public Affairs, Consultation and Regions Branch (PACRB) encompasses the Marketing and Consultation Directorate, Strategic Communications Directorate, the Senior Director General, Internal Ombudsman Services, the Food and Drugs Liaison Office, the Strategic Planning and Operations Division, the Office of Emergency Preparedness and seven Regions. With this structure, Health Canada integrates national and regional perspectives into all of its policies and strategies, communications and consultation functions. The Branch plays a key role in delivering Health Canada's commitment to transparency. Through PACRB, Health Canada will continue to improve communications and the flow of information to and from stakeholders, clients, partners, media and the Canadian public.

The Senior Director General is responsible for PACRB's corporate support services, including Strategic Policy and Planning, and Operations, as well as the day-to-day oversight of the Office of the Internal Ombudsman and the Food and Drugs Act Liaison Office.

Strategic Planning and Operations Division is responsible for Human Resources Management, Financial Management, Contracting, Asset Management, Accommodations, Security, Occupational Health & Safety, Strategic Planning, Performance Measurement, Internal Communications and Business Continuity Planning.

The Internal Ombudsman service provides a confidential, neutral and informal resource to facilitate the resolution of work-related concerns, including conflicts. The goal of the Centre for Workplace Ethics is to foster an ethically sound and vibrant culture that best embodies Health Canada and the Public Service values and ethics. The Centre offers workshops, tools and case studies, customized activities, interactive presentations, research results, etc.

The mandate of the Food and Drug Liaison Office is to receive complaints, concerns or enquiries about alleged acts, omissions, improprieties and/or broader systemic problems on matters pertaining to the Food and Drugs Act. We will listen, offer options, facilitate resolution, make recommendations, investigate or otherwise examine issues independently and impartially.

The Strategic Communications Directorate is the departmental focal point for strategic advice, planning and implementation of communications. The Directorate is highly engaged in proactive and reactive issues management and support to the Minister, the Deputy Minister, and the Associate Deputy Minister and to Program Branches. As well, it plays a critical role in the development of communications partnerships with provincial and territorial governments, non-governmental organizations, the private sector, and other federal departments in the United States and abroad.

The Strategic Communications Directorate is comprised of two divisions: Public Affairs Division and Strategic Issues Division.
The Public Affairs Division (PAD) includes media relations, ministerial services, crisis and emergency communications, risk communications, and other special projects. Activities of this unit include: being the first point of contact for the Media; providing media coaching to spokespeople; maintaining the Spokespersons' Policy; conducting crisis and emergency communications; conducting risk communications (developing a departmental Framework, process and Handbook on Strategic Risk Communications); coordinating Ministers' speeches and messages; and planning media events. This Division is also involved in a number of corporate initiatives, including the planning, coordination, design and distribution of "It's Your Health", a publication focused on a variety of health and science topics of interest to health care professionals and Canadians.

The Strategic Issues Division is comprised of Communication Executives and their communications teams who are assigned to serve a specific Branch or area in Health Canada, and are co-located with the Assistant Deputy Ministers (ADMs) of those Branches or areas. These teams provide ADMs and their senior management teams with strategic communications advice and guidance related to national files; are a focal point for communications planning and implementation at the Branch level; and provide horizontal, integrated and coordinated communication for the Branches.

The Strategic Issues Division is also responsible for: coordinating with the central agencies such as the Privy Council Office and the Treasury Board Secretariat; providing communications issues management; coordinating communications presentations to Cabinet committees; leading horizontal corporate issues such as "Communicating Science"; and managing corporate internal communications, including the on-line staff magazine "Intracom".

The Emergency Preparedness Office is responsible for all activities, such as plans, procedures, contact lists and exercises, undertaken in anticipation of a likely emergency. The goal of these preparedness activities is to make sure that the government is ready and able to respond quickly and effectively in the event of an emergency.

The Marketing and Consultation Directorate is the departmental focal point for strategic advice, planning and implementation of social marketing, public opinion research and evaluation, and the policy lead for corporate consultation. The Directorate is comprised of three divisions: Marketing and Corporate Communications Division, Public Opinion Research and Evaluation Division, and the Corporate Consultation Secretariat.

The Marketing and Corporate Communications Division is composed of two units: The Social Marketing Unit develops social marketing campaigns, in collaboration with departmental issue experts to help change attitudes and behaviours to raise awareness and increase knowledge of specific health issues and motivate Canadians to adopt healthier behaviours; develops strategic alliances to help bolster social marketing campaigns; and manages all Health Canada advertising.

The Corporate Communications Unit provides expert guidance, project management and creative services to help departmental clients achieve their communications goals through the web, graphic design and publication management, audio-visual, exhibits, warehousing and distribution. Corporate Communications is also responsible for the public enquiries, 1 866 toll-free line, facilitates the publishing of the Health Canada website and manages Health Canada's Intranet.

The Public Opinion Research and Evaluation Division (PORED) is the central authority for public opinion research (POR) within Health Canada. POR is a key tool that Health Canada uses to understand the needs and expectations of citizens. It ensures our programs, policies and services are tailored to the needs of Canadians. PORED provides advice on methodology, design, and analysis, and ensures the Department meets its accountability on the value and quality of the research it undertakes. PORED manages all POR contracted by Health Canada in cooperation with Public Works and Government Services Canada. The Division also produces and disseminates regular research products, including a quarterly report and in-depth analysis of recent research. The evaluation unit within the Division ensures that our communications activities are effectively evaluated, and implements the performance measurement framework for communications.

The Corporate Consultation Secretariat (CCS) is Health Canada's corporate policy lead for public involvement activities throughout the Department. Health Canada recognizes the importance of meaningful public involvement in health policy development and service delivery. Consultations are one way in which the Government seeks input and feedback from Canadians on a variety of issues. CCS provides strategic advice to Health Canada staff on public involvement; networks and coordinates public involvement activities in the Department; and offers workshops and training for staff; and, is responsible for overseeing the Treasury Board policy on posting consultations on the departmental and Government of Canada sites.

Regions

Northern, British Columbia, Alberta, Saskatchewan and Manitoba, Ontario, Quebec and the Atlantic
Reporting to the Assistant Deputy Minister, Public Affairs, Consultation and Regions Branch, Regional Directors General are Health Canada's senior representatives in the regions. They deliver Health Canada programs and implement Health Canada policies. They play an important role in building relations with partners, stakeholders and Canadians, and cultivate horizontal relationships with other federal departments. Through this engagement process the Regional Directors General are able to provide a regional perspective in the development of policies and programs that impact the health of Canadians.

Close to 40% of Health Canada's employees work in the Regions. The Regional workforce consists of dedicated and highly-trained professionals including laboratory scientists, health products inspectors, community health nurses in First Nations communities, occupational health nurses, product safety inspectors, tobacco enforcement officers, environmental health officers, administrators, program consultants and support staff.

The Northern Region operates somewhat differently from the other Health Canada regions. It is responsible for representing the health portfolio in the Yukon, Nunavut and the Northwest Territories. This ensures that Health Canada's activities and interests in the Territories are managed and represented in an integrated manner. The Northern Region: provides advice on federal health-related policies, research, and planning activities affecting the territories; manages stakeholder relations on behalf of Health Canada in the three territories; and administers a range of health portfolio funding programs through contribution agreements with territorial governments, non-governmental organizations and First Nations and Inuit organizations.