Deputy Minister Briefing Material – September 2019

Overview of Department
Governance and Operations
1. Departmental governance
  1. Overview of Health Canada governance structure and Executive Committee membership
  2. Terms of Reference - Executive Committees

**Health Portfolio Organizational Chart**

Health Canada Organizational Chart

Deputy Minister

Stephen Lucas
Deputy Minister of Health
(effective September 3, 2019)

Vacant
Associate Deputy Minister

Assistant Deputy Minister

Strategic Policy Branch (SPB)
ADM and Associate ADM
Abby Hoffman and Marcel Saulnier

Chief Financial Officer Branch (CFOB)
ADM & Chief Financial Officer
Randy Larkin

Health Products and Food Branch (HPFB)
ADM and Associate ADM
Pierre Sabourin and Kendal Weber

Corporate Services Branch (CSB)
ADM
Debbie Beresford-Green

Healthy Environments and Consumer Safety Branch (HECS)
ADM
Robert Ianiro

Communications and Public Affairs Branch (CPAB)
ADM
Jennifer Hollington

Controlled Substances and Cannabis Branch (CSCB)
ADM and Associate ADM
Jacqueline Bogden and Eric Costen

Legal Services
Executive Director and Senior General Counsel
Samantha Maislin Dickson
(effective September 3, 2019)

Pest Management Regulatory Agency (PMRA)
Executive Director
Richard Aucoin

Regulatory Operations and Enforcement Branch (ROEB)
ADM
Stefania Trombetti

Office of International Affairs (OIA)
Director General ^{Footnote 1}
Michael Pearson

Office of Evaluation & Audit (OAE)
Director General ^{Footnote 1}
Shelley Borys

Strategic Policy Branch (SPB) Background Deck

September 2019

Organizational structure of the Strategic Policy Branch (SPB). — **Strategic Policy Branch (SPB) Organizational Structure**

SPB - Key Functions

SPB has three main functions:

Federal focal point for health care policy, with leadership and oversight responsibilities for health care on a pan-Canadian scale.
Delivery of broad array of grants and contributions programs, including transfers to P/Ts, in support of federal health care policy objectives.
Coordination and delivery of cross-cutting corporate functions for HC (and, in some cases, the Health Portfolio) and leadership on targeted horizontal policy files.

While SPB provides services similar to those of OGD strategic policy shops, it is more like a program branch than a typical corporate policy shop:

Similar in that SPB houses Cabinet and Parliamentary Affairs, handles portfolio affairs, oversees annual submissions to the federal Budget process, supports departmental governance, reports on results and delivery, oversees integration of gender-based analysis and Indigenous perspectives and does early work ups on 'orphan' files.
However, because the Portfolio and Health Canada branches tend to operate on a decentralized basis, SPB does not do policy development for all of HC or Health Portfolio (i.e., SPB does some quality control and central agency/MO liaison, but there is no centralized Memoranda to Cabinet function, nor challenge function on non-SPB policy files).
Level of staff effort and resources devoted to policy and programs closer to what is done in a "line" branch in OGDs, with primary responsibility in SPB for a wide range of health care policy issues and programs.
SPB has the largest G and C budget in the Health Portfolio, used to advance pan-Canadian health care policies and partnerships needed for a strong publicly-funded health care system.
Legislative and regulatory role, once minimal, has been growing, in support of key policy files.

1 - Federal Focal Point for Health Care Policy

SPB provides policy leadership, analysis and advice on federal strategy for health care system issues and the federal stewardship and oversight role in health care.
Interprets and administers the Canada Health Act (CHA) and supports the Minister as steward of Canada's universal publicly-funded health care system.
Negotiates and oversees federal/provincial/territorial (F/P/T) accords/agreements (e.g., 2017 F/P/T Common Statement of Principles - or CSOP - on Shared Health Priorities, accompanied by bilateral funding agreements with P/Ts).
Responsible for the full scope of activities (including health research and analysis functions) associated with development and implementation of health care policy initiatives in priority areas. E.g.:
- Pharmaceutical and medical technology policy (including pharmacare, price regulation, intellectual property, trade)
- Health care innovation
- Health information and digital health
- Mental health and addictions
- Home, palliative care and end of life care (including Medical Assistance in Dying)
- Health workforce issues
- Organ Donation and Transplantation
Provides secretariat support for federal panels and task forces, including advising prominent panel members, on significant health sector issues (e.g., 2018-19 Advisory Council on the Implementation of National Pharmacare, 2018 expert panel on blood plasma, 2015 Advisory Panel on Healthcare Innovation; 2015 Panel on Physician Assisted Dying).

Health Care Policy - 2019-20 Priorities

Improve access to pharmaceuticals by lowering drug prices: modernize PMPRB regulations; leverage buying power of existing public drug plans; develop federal game plan for national pharmacare in consultation with Finance Canada; work with P/Ts and other key partners to implement Budget 2019 commitments to a Canadian Drug Agency, a national formulary, and a national strategy for high-cost drugs for rare diseases.
Advance work on F/P/T shared health priorities set out in the 2017 CSOP (home and community care, mental health and addiction services, health care innovation, and pharmaceuticals), including work with Canadian Institute for Health Information on common indicator reporting and with P/Ts to strengthen linkages between their bilateral agreement work plans and HC funding programs.
Address CHA compliance issues through oversight in existing and new areas, and proceeding with new federal policy initiatives on reimbursement, reporting and diagnostic services; oversee P/T Action Plans under Reimbursement Policy where required; support litigation process on Cambie Charter challenge.
Lead reforms of the PCHO suite aimed at improving the coherence of their work and their contributions to federal and F/P/T health care system priorities.
Undertake a comprehensive suite of policy reviews in areas of SPB responsibility in support of HC medium-term planning process; develop health diagnostique for SPB and Health Portfolio.
Work with P/Ts to support the delivery of medical assistance in dying (MAID) services; support the mandatory review of the 2016 MAID legislation (starting June 2020).
Strengthen outreach and policy capacity on mental health and addictions issues; work toward integrated Health Portfolio approach.
Oversee implementation of the federal framework and action plan for palliative care.
Advance Canadian Health Information Forum (CHIF); support efforts to accelerate adoption of digital health and virtual approaches to health care delivery.

2 - Grants and Contributions Programs

SPB manages a wide array of grants and contributions programs in support of health care objectives and acts as HC centre of expertise (~$1.5B in 2019-20; see Appendix A for full breakdown).
Largest part of SPB's budget is now targeted transfers to P/Ts, reflecting recent shift away from the Canada Health Transfer as the sole vehicle to support shared health priorities; federal funding is complemented by SPB work in related policy areas.
- Bilateral agreements with P/Ts on home and community care and mental health and addiction services ($11B/10 years to 2026-27)
- Territorial Health Investment Fund ($108M/4 years ending in 2020-21 for Territorial innovation and medical travel)
Considerable resources dedicated to managing funding to (and relationships with) suite of federally created pan-Canadian health organizations known as the PCHOs (~$285M in 2019-20).
- Canadian Institute for Health Information
- Canada Health Infoway
- Canadian Partnership Against Cancer
- Canadian Agency for Drugs and Technologies in Health
- Canadian Foundation for Healthcare Improvement
- Mental Health Commission of Canada
- Canadian Centre on Substance Use and Addiction
- Canadian Patient Safety Institute
Also responsible for programs designed to support specific federal interests (~$140M in 2019-20):
- Official Languages Health Program (for Minority OL communities)
- Health Care Policy Contribution Program - covers broad range of health care policy priorities
- Research funding to Canadian Blood Services for blood research and development of an organ and tissue donation and transplantation system for Canada
- Canadian Thalidomide Survivors Support Program

Grants and contributions - 2019-20 priorities

Advance priorities for health care modernization through the eight pan-Canadian health organizations (PCHOs) funded by Health Canada, and complete the review of the organizations begun in 2017 (process improvements from the review are underway but structural decisions related to their future function and composition paused pending further consideration of options post-election).
Implement Budget 2019 funding commitments for: expanded federal role in data/performance initiative for organ donation and transplantation; Brain Canada; Terry Fox Foundation; support for ovarian cancer. Includes related policy development, [REDACTED], and new and/or revised funding agreements with recipients.
Consider approach to flowing next 5 years of 10-year targeted funding to P/Ts for home and community care and mental health and addictions in advance of expiration of current agreements in 2021-22, and examine possibility of renewal of Territorial Health Investment Fund in advance of 2020-21 sunset (currently on fourth continuous iteration of initiative).
Oversee implementation ofthenew Canadian Thalidomide Survivors Support Program and manage on-going litigation related to former program.
Continue efforts to reduce blood donor deferral times for men who have sex with men (MSM) through work with Canadian Blood Services.
Reset Health Care Policy Contribution Program priorities to align with current federal and F/P/T agenda and make process improvements to streamline and speed up solicitation, decision-making, and oversight/monitoring processes (including modifications for delivery to Indigenous organizations).

3 - Coordination of Cross-cutting Corporate Functions & Leadership on Horizontal Policy Files

SPB provides strategic oversight and coordination for cross-cutting corporate functions:
- Provides advice to Minister and Deputy Minister on Cabinet and parliamentary business.
- Prepares HC annual submission to federal Budget process, supports Minister for Mains and Supplementary Estimates processes (with CFOB), reports on Results to PCO.
- Coordinates HC governance structures (e.g., Executive Committees, DG Policy committee, Medium-Term Planning and Transition exercises).
- Manages departmental briefing functions (e.g., Ministerial Briefing Unit).
- Coordinates Governor in Council appointments.
SPB also provides leadership and plays integration role on key horizontal functions and files:
- Focal point for HC's federal/provincial/territorial (F/P/T) relations (with some Health Portfolio-wide coordination)
- HC focal point for engagement on Indigenous health matters and inter-departmental work.
- Develops and administers a framework of policies for the conduct of science in HC (research ethics, scientific integrity, Open Science, scientific publications), coordinates science policy issues within HC and with other government departments, supports new Departmental Science Advisor.
SPB plays these roles for the broader Health Portfolio when an integrated approach is needed for the Minister (e.g., Cabinet and parliamentary business, federal Budget submissions, preparation for F/P/T Ministerial meetings).

Cross-cutting Corporate Functions and Horizontal Policy Files - 2019-20 Priorities

Design and lead the HC medium-term planning and transition processes and co-ordinate roll-out of Health Portfolio transition activities; support DM's HC Transition Advice and Planning (TAP) Committee of regulatory and program/policy ADMs; liaise with PCO and support HC contributions to Deputy-level and whole-of-Government process (e.g., MTP-oriented DMCs); be ready for immediate post-election roll-out.
Co-ordinate Health Portfolio Budget 2020 proposals, reflecting platform commitments, priorities of next Government and Mandate Letter commitments.
Support F/P/T dimensions of SPB's files (with an emphasis on supporting engagement on national pharmacare and implementation of the PCHO review); lead Health Portfolio preparation for F/P/T Health Ministers Meeting (HMM) early in mandate of next Government.
Support recently appointed inaugural Departmental Science Advisor as part of priority to strengthen HC role in science policy.
Following recent shift of First Nations and Inuit Health Branch from HC to ISC, develop HC/Health Portfolio game plan to support Indigenous health policy; advance F/P/T and ISC-HC-Indigenous providers/stakeholder process on cultural safety.

Emerging function: regulatory, legislative and litigation activities

SPB is, fundamentally, not a regulatory or legislative branch but approach to addressing recent priorities has significantly increased SPB's role in (and resources dedicated to) regulatory, legislative and legal activities.
- Lead role in developing regulations in support of broader health objectives under SPB's remit (e.g., developing, and implementing the MAID Reporting Regulations, modernization of the PMPRB's drug price regulatory regime);
- Directly engaged in Criminal Code Amendments for MAID and amendments to the Federal-Provincial Fiscal Arrangements Act (related to the Canada Health Act reimbursement policy); and
- Growing engagement in litigation related to health care issues and SPB files (e.g., Hepatitis C compensation, legal challenges to the Thalidomide Support Program, federal role in Cambie (CHA) Charter Challenge).
Role anticipated to continue, with legal decisions on MAID and the Cambie Charter challenge expected in coming year, and new litigation on the horizon (e.g., pharmaceutical companies challenge to the PMPRB regulatory changes).

SPB Financial Overview - 2019-20

The pie chart shows a break-down of Strategic Policy Branch's expenditures for 2019-2020. — **Strategic Policy Branch Expenditures**

Summary of Strategic Policy Branch Grants and Contributions, 2019-20
Grants / Contributions	2019-20 Amount ($000)
Funding to Provinces and Territories	1,127,000
Funding to the Pan-Canadian Health Organizations	285,568
Multi-project targeted funding	106,853
Funding for health research	21,755
Canadian Thalidomide Survivors Support Program	13,419
Total	1,554,595

Total SPB 2019-20 budget is $1.586 B.
SPB's $30M salary budget supports an average head count of approximately 270 employees.

Appendix A - Grants and Contributions, By Program
Grant/Contribution	Funding Authority	2019-20 Amount ($000)
Provinces and Territories
Bilateral agreements with P/Ts (home and community care and mental health and addictions services)	10-year commitment (2017-18 to 2026-27)	1,100,000
Territorial Health Investment Fund	Four-year commitment (2017-18 to 2020-21)	27,000
Pan-Canadian health organizations
Canadian Institute for Health Information	Ongoing	87,659
Canada Health Infoway	Five-year commitment (2017-18 to 2021-22)	75,000
Canadian Partnership Against Cancer	Five-year commitment (2017-18 to 2021-22)	51,000
Canadian Agency for Drugs and Technologies in Health	Ongoing	23,059
Canadian Foundation for Healthcare Improvement	Ongoing	17,000
Mental Health Commission of Canada (MHCC)	Four-year commitment (2017-2021)	14,250
Canadian Centre on Substance Use and Addiction (CCSA)	Ongoing	10,000
Canadian Patient Safety Institute	Ongoing	7,600
Multi-project targeted funding
Health Care Policy Contribution Program (e.g., Heart & Stroke Foundation, Choosing Wisely, Pallium Canada, Canadian Virtual Hospice, Institute for Safe Medication Practices, Centre for Addiction and Mental Health)	Ongoing	26,874
Official Languages Health Program	Five-year commitment (2018-19 to 2022-23)	37,380
Substance Use and Addictions Program Funds transferred to the Controlled Substances and Cannabis Branch (CSCB)	Ongoing	38,828
Cannabis-related funding to CCSA	Five-year commitment (2018-19 to 2022-23)	2,405
Cannabis-related funding to MHCC	Five-year commitment (2018-19 to 2022-23)	1,366
Health Research
Canadian Blood Services Blood Research and Development Program	Ongoing	5,000
Organ and Tissue Donation and Transplantation	Ongoing	3,580
Canada Brain Research Fund Program (Brain Canada)	Ending in 2019-20; being renewed following Budget 2019 announcement	13,175
Canadian Thalidomide Survivors Support Program	Ongoing	13,419
Total (may not add up due to rounding)	-	1,554,595

In addition, a 3-year funding commitment (2019-20 to 2021-22) for Innovative Solutions Canada ($1.4 million in 2019-20) is in approvals.
Note: Substance Use and Addictions Program funds transferred to CSCB may also be included in the financial overview slide of the CSCB presentation.

Health Products and Food Branch (HPFB)

Background Deck

September 2019

Mission

Minimizing health risk factors to Canadians while maximizing the safety provided by the regulatory system for health products and food.
Providing information to Canadians so they can make healthy, informed decisions about their health.

Health Products and Foods Branch senior management organizational structure — **Current Branch Organizational Structure**

Domestic and International Roles

Areas of responsibilities

Food (including the food guide)
Prescription drugs
Non-prescription drugs
Natural health products
Medical devices
Veterinary drugs
Blood
Assisted human reproduction

International collaboration

Build and maintain working relationships with key partners: US, EU, UK, Japan and Australia
Increase multilateral engagement in targeted areas on advanced technologies and medical devices

Legislative framework

Food and Drugs Act and its Regulations
Assisted Human Reproduction Act and its Regulations

Key Stakeholders

Food Industry
Health Products Industry
Canadian Blood Services (CBS)/ Héma-Québec
Provincial/Territorial health partners
Canadian Agency For Drugs And Technologies In Health (CADTH)/ Institut national d'excellence en santé et en services sociaux (INESSS)
Healthcare professional and Patient organizations
Academia

Core Business Lines

Food

Develop evidence-based dietary guidance (e.g. Canada's Food Guide).
Establish regulations for all foods sold in Canada and provide pre-market assessment and authorization of food additives, novel foods, and infant formula.
Provide health risk assessments to support CFIA's food safety investigations.

Health Products

Clinical Trials
- Regulate, review application
Product Submission Review and Market Authorization
- Assess health product submissions for scientific evidence and potential risks.
- Authorize products for sale if the benefits outweigh the risks.
Post-Market Surveillance
- Monitor health product safety, and communicate emergent risks to Canadians.
- Collect adverse event reports, address advertising complaints and conduct post-market safety reviews.

Blood

Regulate the safety of blood and blood components collected for transfusion and for manufacture into therapeutic products.
Review and authorize submissions filed under the Blood Regulations to ensure the safety of the blood establishments' operational procedures.

Assisted Human Reproduction

Establish regulations to protect Canadians making use of third party assisted human reproduction technology.

Significant accomplishments over the last four years

Over the last four years, HPFB has delivered on an unprecedented number of high profile initiatives. This volume of activity was unique, as was the amount of funding the Branch received. We published 23 regulatory package and some major accomplishments included:

New Canada Food Guide

Canada's new Food Guide was launched in 2019.

Opioids

New pathway to permit the Minister to add/amend terms and conditions to an authorization, require patient information handout and warning stickers, and restrict marketing of opioids.

Implementing Vanessa's Law - Protecting Canadians from Unsafe Drugs Act

Implementing changes to the Food and Drug Act to improve the ability to collect post-market safety information, take appropriate actions when a serious risk to health is identified (e.g. recall), and promote greater confidence in the oversight by increasing transparency.

Improving the regulations of drugs and devices

Parallel review with CADTH and INESSS, scientific capacity investments (i.e., digital health).

Cost Recovery Renewal

Increased fees for regulatory activities related to human drugs, veterinary drugs, and medical devices to help sustain programs and provide the Branch with a source of funds to address existing and emerging gaps. The revised fees will be implemented April 1, 2020.

Strengthening the Assisted Human Reproduction Act

Regulations published to reduce the risks to human health and safety and make clear what expenses may be reimbursed to donors and surrogates.
Will come in force in 2020.

Blood

Reduce MSM deferral to 3 months.

Priorities

New healthy eating initiatives to reduce the burden of chronic disease

Canada is facing a growing burden of chronic disease. Two in five Canadian adults live with at least one of the ten most common chronic diseases, including heart disease, stroke, diabetes and cancer.
The economic burden of chronic diseases is estimated at $26.7 billion annually. By 2025, it will cost Canada over $34 billion annually to treat chronic disease.
Poor diets are a primary cause of chronic disease in Canada. Initiatives to improve diet and enhance information to help Canadians make better choices could help Canada create a more sustainable healthcare system: [REDACTED].

Regulatory Reviews (led by TBS)

Health and Biosciences: advanced therapeutics, use of foreign reviews, modernized clinical trial regulations, and risk based approval pathways.
Agri-food led by CFIA: supplemental foods, use of foreign reviews, human milk fortifiers, food labelling coordination, and biotechnology products approval pathways.

Determining whether to establish a pathway for cannabis health products that do not require physician oversight

Exploring whether to establish a pathway for cannabis-based products which do not require the oversight of a health practitioner (natural health products, over the counter drugs).
Analysis of the results of the Summer 2019 consultation are underway and we will provide advice on next steps, including the launch of an external scientific advisory panel.

Priorities

Enhancing post-market authorities for natural health products (NHPs)

Health Canada does not currently have the same post-market tools for NHPs as it does for other products like drugs, devices or consumer products. [REDACTED].
[REDACTED].
Office of the Auditor General audit is taking place in 2019-20 to review Health Canada's oversight and enforcement of responsibilities as they relate to NHP programs and NHPs.

Medical Devices Action Plan

Recent safety issues with medical implants have resulted in significant domestic and international media attention regarding the evidence required to approve a medical device, post-market oversight of devices, and the transparency of medical device regulations. Industry, clinicians and patients began calling for more openness and increased transparency concerning the approval, oversight and performance of medical devices.
In response, Health Canada introduced the Action Plan on Medical Devices, which includes concrete actions to continuously improve the safety, effectiveness and quality of medical devices in Canada. Work is underway and needs to continue in order to meet our commitments to Canadians.

Prevent antimicrobial resistance (led by PHAC)

Antimicrobial resistant (AMR) infections are a growing public health threat in Canada and around the world. The misuse and over use of antimicrobials in humans and animals is a major contributor to the emergence and spread of AMR, threatening our ability to treat infections.
[REDACTED].

Overview of Substance Use in Canada and the Controlled Substances and Cannabis Branch

Background Deck
September, 2019

Purpose

Provide an overview of substance use in Canada, and the approach being taken to address it
Discuss short and longer term substance use issues, and key forthcoming decisions
Provide a snapshot of Health Canada's Controlled Substances and Cannabis Branch

Substance Use in Canada

Rates of substance use (2017)

Alcohol - 78% (23.3 million ^{Footnote 2})
Tobacco - 18% (5.3 million ^{Footnote 3})
Cannabis - 15% (4.4 million ^{Footnote 4})
Illegal Drugs^{Footnote 5} - 3% (987,000 ^{Footnote 6})
Vaping Products - 3% (863,000 ^{Footnote 7})
Problematic Prescription Drug Use - 1% (336,000 ^{Footnote 8})

Key Substance Use Trends

Generally speaking, overall rates of substance use tend to be higher in one's youth than in later years.
- Riskier/more harmful forms of use (e.g. binge use) also tend to be undertaken more by youth than adults
- Men tend to use substances more than women
Many people will use multiple substances at once (poly-substance use)
Overall, only a small percentage of people who use substances will develop a substance use disorder
- Estimates range from 4% to over 10% in any given year, depending on the substance and age of the person
- Over one's lifetime, it's estimated that more than 1 in 5 (21.6%) Canadians will meet the criteria for a substance use disorder
- Underlying factors often include experience with trauma, poverty, mental health issues, physical and emotional pain, and other socio-economic factors
Problematic substance use causes significant health harms and associated costs
- Opioids crisis - over 4,400 deaths in 2019 (1 life lost every two hours)
- Tobacco and alcohol claim tens of thousands of deaths each year (over 47,500 and 14,800 respectively)
- Each day, over 400 Canadians are hospitalized because of alcohol or drug-related harms
- In 2017, 4% (820,000) of Canadians aged 15 years and older reported experiencing at least one harm in the past year due to their illegal drug use

Rates of Cannabis Use ^{Footnote 9} (2019, Q2)

Men: 21%
Women: 12 %
Aged 15-24: 27.4 %
Aged 25-44: 24.2 %
Aged 45-64: 12.2 %

Patterns of Substance Use

Generally speaking, substance use occurs across a spectrum
Understanding patterns of use and associated risks/harms helps to better design policies and programs
Federal focus is on minimizing use (youth) or reducing the harms of use (adults), preventing problematic use patterns before they begin, and supporting treatment and recovery
- Problematic substance use: the use of any drug or substance in a manner, situation, amount, or frequency that is harmful to the individual or to society
- For those with substance use disorder, the focus shifts to harm reduction, treatment and recovery

The continuum of increasing levels of risks, harms and costs to individuals, families and communities associated with drug use. — **Continuum of substance use**

Harms Related to Substance Use

A number of factors contribute to the overall level of harm related to substance use:
- the nature of the substance itself (lower risk substances such as cannabis, vs. higher risk substances such as tobacco, cocaine, opioids, etc.)
- the method by which the substance is consumed (e.g. ingestion tends to be less harmful than injection; vaping less harmful than smoking, etc.)
- the manner in which the substance is used (infrequently vs frequently, in small amounts vs "binge" use, alone vs. with others who can provide help in case of emergency, etc.)
- the total number of people in society using a substance
See Appendix A for further details on the costs and harms of specific substances in Canada

Associated harms of specific substances in canada
Associated Harms (2014 Data)	Alcohol	Tobacco ^{Footnote 1}	Cannabis	Opioids
Deaths	14,826	47,562	850 ^{Footnote 2}	2,395 Note: 4460 deaths in 2018.
Emergency Dept. Visits	649,412	239,512	27,761	31,686
Hospitalizations	87,911	145,801	3,835	6,981
Unintentional Injuries	42,774	113	98	2,204
Lost Productivity ^{Footnote 3}	110,048	74,622	6,892	49,533
Counts of Policing	252,227	-	126,492	99,052
Footnote 1 All tobacco products, including cigarettes. Return to footnote 1 referrer Footnote 2 There are no known deaths directly attributable to cannabis consumption, however there are related harms, namely 638 deaths from lung cancer and 212 deaths from car accidents Return to footnote 2 referrer Footnote 3 Unit in years Return to footnote 3 referrer

Sources: Canadian Substance Use Costs and Harms, 2018 (data from 2014); Canadian Tobacco, Alcohol and Drugs Survey 2017.

Costs of Substance Use in Canada

Apart from deaths, other costs in Canada are increasing. The estimated cost of substance use in Canada (for 2014) is approximately $38.4 billion per year ^{Footnote 10}.

Substance use-attributable overall costs in Canada 2007 - 2014 — **Substance use-attributable overall costs, Canada 2007-2014**

Costs of substance use in Canada in 2014 — **Costs of substance use in Canada (2014)**

Most costs are associated with alcohol and tobacco
Considerable regional variations (highest total costs in ON and QC; highest per capita costs in the Territories)
These numbers are from 2014 and so do not reflect the recent increases in costs related to the ongoing opioids crisis

Addressing Substance Use

Substance use is a multifaceted, and often complex, problem:

A significant number of Canadians use substances
People use substances in different ways (experimental, occasional, repeated/habitual) and for different reasons (for enjoyment, curiosity, to "fit in", to reduce stress, to deal with physical/emotional pain, life events or trauma)
- In the case of people with a substance use disorder, they may have a uncontrollable compulsion to use substances, or a need to use them to ward off the painful effects of withdrawal
Patterns of substance use often vary by region, requiring close collaboration with P/Ts and local organizations/stakeholders
No one level of government, nor one specific action or intervention, can solve the problem
Actions need to be taken at all levels: population level, targeted interventions (e.g. youth, at-risk populations) and at the individual level
Reducing rates and patterns of harmful substance use can be done, but it takes time and effort (e.g. reducing rates of tobacco use has taken decades of action at all levels)

Key Federal Directions in Addressing Substance Use

Prevention: Reducing rates of use and preventing problematic use, especially for youth and at-risk populations
Treatment: Supporting evidence-based treatment and recovery services
Reducing harms and improving health outcomes for people who currently use substances
Enforcement and regulatory measures that address organized drug crime and support authorized uses of controlled substances (e.g. the manufacture and distribution of some prescription medications)

A u-shaped image presents visually how a health-focused approach to drugs control (illegal and legal substances) can reduce harms and costs to individuals, families and communities. — **Our Goal**

Roles and Responsibilities

Substance use cannot be addressed through federal action alone. Collaboration and coordination with provincial and territorial governments is essential, as is engagement with a range of key non-governmental players.

Federal Government

Drug control legislation (Controlled Drugs and Substances Act, Tobacco and Vaping Products Act, Cannabis Act, Food and Drugs Act), and enforcement of regulations (through Health Canada's Regulatory Operations and Enforcement Branch)
National leadership and collaboration through the Canadian Drugs and Substances Strategy (CDSS) and Canada's Tobacco Strategy (CTS) - see Appendix B
Grants and contributions funding programs (e.g. Substance Use and Addictions Program)
Data collection, surveillance and research
Drug risk education/health promotion activities (e.g. public education campaigns)
Services provided to federal populations (Indigenous peoples, members of armed forces and veterans, federal inmates)
International engagement on tobacco and drug control/policy issues

Provincial/Territorial Governments

Responsible for the delivery of health services to Canadians, including treatment and harm reduction services
Undertake targeted education/ prevention campaigns
Responsible for local law enforcement
Set regulations for sale and access to certain substances (e.g. age restrictions on alcohol, tobacco and cannabis)
Collection of provincial data (e.g. drug use trends, hospitalization data, overdose data).

Key Stakeholders ^{Footnote 11}

People with lived/living experience

Patient organizations, organizations representing people who use/have used drugs and their family members,

Medical community (doctors, nurses, medical regulatory colleges)

Responsible for the practice of medicine, including delivery of treatment programs and related medical/operational protocols.

Other key stakeholders

Drug policy advocacy organizations, public health associations, Indigenous leadership and communities, professional associations, researchers/academics, etc.

Industry

Compliance with laws and regulations on regulated substances (alcohol, tobacco, vaping products, cannabis, prescription drugs)
Engagement with some national industry associations (cannabis, alcohol)

Moving Forward: Priority Areas and Challenges

While a wide range of substance use issues are currently being addressed by Health Canada and federal partners, there are a number of key priority issues causing significant harms and costs to individuals and communities:

The opioid overdose crisis is one of the most serious public health crises and continues to claim thousands of Canadian lives each year
- While illegal drugs have always posed a risk of overdose, the illegal market is now increasingly toxic as a result of the introduction of more potent or lethal and difficult to detect synthetic substances, such as fentanyl. This may be a permanent change to the composition of the illegal drug market, leading to a higher risk overdose death for thousands of Canadians each year.
Methamphetamine use is rising at alarming rates in some provinces, particularly in the Prairies
- Presents unique health risks to people who use it, public safety challenges to first responders and communities, and is challenging to treat
Alcohol is the most costly substance to Canadian society, and causes nearly 15,000 deaths a year
- Alcohol use is normalized in Canada, including some forms of problematic use, such as binge drinking
- Our approach to alcohol lags behind actions taken on tobacco and opioids, and also lags behind those of other like-minded countries
Tobacco use is the leading cause of premature death and disease in Canada
- Vaping holds promise as a less harmful alternative to smoking cigarettes, and may help further reduce the number of Canadians who smoke. However, youth vaping has risen rapidly and poses risks, including nicotine addiction that could lead to future tobacco use
Cannabis legalization and regulation is still in its early days - need to continue to monitor use rates for cannabis, especially for youth

The organizational chart for the Controlled Substances and Cannabis Branch at Health Canada — **Controlled Substances and Cannabis Branch: Organizational Structure**

Cannabis Directorates

Mandate: To support the government's commitment to legalize and strictly regulate cannabis

Core business lines include:
- Setting cannabis policy direction and regulations, supported by a coordinated approach to research and data collection, in collaboration with stakeholders
- Granting licences and other authorizations (cultivation, processing, research, import/export permits and personal production registration certificates)
- Promoting, monitoring and verifying compliance with the regulations
Cannabis directorates provide support to:
- the Minister of Border Security and Organized Crime Reduction as the Minister responsible for the administration of the Cannabis Act, and
- the Minister of Health for public education relating to the health effects of cannabis and research and surveillance (the review and approval of prescription drugs containing cannabis is supported by the Health Products and Food Branch)
The Program works with other Branches and federal departments in the design of the legal framework, in implementing the program, and monitoring and enforcing compliance with the regulations
- e.g., ROEB which leads cannabis inspection activities in support of compliance and enforcement
- e.g., Justice and Public Safety in the design and implementation of the cannabis framework

Tobacco Control Directorate

Mandate: To lead and implement Canada's Tobacco Strategy in collaboration with federal partners, provinces and territories, the health community, and other stakeholders

Core business lines include:
- Setting tobacco and vaping policy direction and regulations, supported by a coordinated approach for research and data collection, in collaboration with stakeholders
- Administering and monitoring compliance with the Tobacco and Vaping Products Act and its regulations (with ROEB)
- Providing public education resources, information and programming on smoking prevention/cessation, health effects, and youth vaping
The directorate liaises with several other federal departments who play a critical role in the area of tobacco control, including:
- The Public Safety portfolio and the Canada Revenue Agency, which administer programs related to the excise duty and combatting contraband tobacco
- Indigenous Services Canada, which engages with and funds Indigenous organizations in tobacco programming
- The Public Health Agency of Canada, which funds targeted projects for populations with high tobacco use prevalence

Controlled Substances Directorate

Mandate: To regulate controlled substances and promote initiatives that reduce or prevent harm associated with substance use, including alcohol

Core business lines include:
- Setting drug and substance policy direction and regulations, supported by a coordinated approach to research and data collection, in collaboration with partners and stakeholders through the Canadian Drugs and Substances Strategy
- Providing guidance and leadership on harm reduction activities such as supervised consumption sites (SCS) and urgent public health need sites (UPHNS) also known as overdose prevention sites (OPS) as entry points to treatment and saving lives by preventing and reversing overdose deaths related to substance use
- With ROEB, administering and monitoring compliance of the Controlled Drugs and Substances Act and its regulations (authorization of licences, exemptions, and a compliance program)
- Acting as the competent authority with respect to the United Nations Drug Control Conventions
The Canadian Drugs and Substances Strategy sets out the overall federal approach to drug and substance use policy, and takes a comprehensive, collaborative, compassionate and evidence-based approach under the pillars of prevention, treatment, harm reduction and enforcement

Key Initiatives Directorate

Mandate: To deliver opioid-related programs and support federal/provincial/territorial (FPT) relations on matters related to drug and substance use issues

Core business lines include:
- [REDACTED]
- Fostering and maintaining intergovernmental collaboration on opioid issues and initiatives, including the Emergency Treatment Fund, through bilateral and multilateral engagements and via the FPT Committee on Problematic Substance Use and Harms
- Administering and overseeing the Substance Use and Addictions Program (SUAP), which provides contribution funding to other levels of government, community-based and not-for-profit organizations to respond to drug and substance use issues
The SUAP has an annual budget of approximately $50 million to fund projects that support federal priorities related to cannabis, tobacco, and controlled drugs and substances

Opioid Response Team

Mandate: To act as the central coordinating hub for the federal response to the opioid crisis

Core business lines include:
- Developing strategic advice and recommendations pertaining to the various factors guiding the federal opioid response
- Synthesizing and integrating research and analysis on the opioid crisis and problematic substance use to promote an accurate understanding of the opioid crisis
- Providing a focal point for engagement with partners and stakeholders related to the opioid crisis in Canada, including other federal departments and levels of government, health professionals and organizations, substance use experts, and people with lived and living experience with drug use
- Addressing attitudes and behaviors that can interfere with recovery and delivery of substance use services

Pain Task Force

Task Force Mandate: Work with members of the chronic pain community, FPT governments, professional associations, and other stakeholders to:

assess how chronic pain is currently addressed in Canada (March to July 2019);
identify best practices and elements of an improved approach to prevent and manage chronic pain in Canada (July 2019 to June 2020); and
disseminate information about best practices to facilitate their uptake across the country (July 2020 to December 2021)

The opioid crisis has drawn attention to longstanding challenges faced by the 1 in 5 Canadians living with chronic pain and stakeholder calls for a national pain strategy to better address pain in Canada.

The Task Force will provide advice and information to increase Canadians' access to the range of pharmacological, psychological and physical therapies needed to effectively manage pain.

Appendix A: Costs and Impacts by Substance
Costs and Impacts by Substance
Substance	% Past-year use by Canadians aged 15 and up (CTADS 2017)	Impact
Substance	% Past-year use by Canadians aged 15 and up (CTADS 2017)	Costs (CCSA, 2018)	Annual Deaths ^{Footnote 1}	Emergency Department Visits
Alcohol	78%	$14.6B annually	14,827	649,412
Tobacco (all tobacco products)	18%	$12.0B annually	47,562	239,512
Cannabis	15%	$2.8M annually	No known deaths (850 deaths where cannabis was a known factor ^{Footnote 2})	3,835
Cocaine	2%	$2.2M annually	No national figures	No national figures
Hallucinogens (e.g., LSD, magic mushrooms)	1%	Unknown	No national figures	No national figures
Opioids	>1% ^{Footnote 3}	$3.5B annually	4,460 (2018)	31,686 opioid-related visits
Amphetamine	>1%	$1.1M annually (includes other stimulants like ecstasy)	No national figures (346 meth-related deaths in BC in 2017)	No national figures
Footnote 1 Data on death rates are not nationally representative. Include all of ON, AB and YK; partial data on PEI, NS, MB, SK and BC; and no data on NL, NB, NWT or NU. Return to footnote 1 referrer Footnote 2 638 deaths due to lung cancer and 212 for car accidents. Return to footnote 2 referrer Footnote 3 Opioids not reported as a category. Heroin is not reportable due to small sample size and ~100,000 Canadians reported problematic use of opioid pain relievers. Return to footnote 3 referrer

Appendix B: Federal Strategies

Canadian Drugs and Substances Strategy (CDSS)

A comprehensive, collaborative, compassionate and evidence-based approach to drug policy
Four pillar approach (prevention, treatment, harm reduction, enforcement)
Encompasses a wide range of legal and illegal substances and guides the federal approach to opioids, cannabis, and other drugs and substances

An image of the Canadian Drugs and Substances Strategy depicting the four pillars of the strategy (prevention, treatment, harm reduction and enforcement) and the foundation on which it is based (strong evidence-base). — **Canadian drugs and substances strategy**

Canadian Tobacco Strategy (CTS)

Outlines the federal approach to reaching the goal of less than 5% tobacco use in Canada by 2035
Aims to:
- help Canadians quit tobacco
- protect youth and non-tobacco users from nicotine addiction
- work with Indigenous groups to create specific plans for Indigenous people
- strengthen our science, surveillance and partnerships

Appendix C: Key Stakeholder Groups

Drug Policy/Research Organizations

Canadian Centre on Substance Use and Addiction (CCSA): funded by Health Canada, research based organization with a focus on substance use and addiction, health and public safety, people and communities, and data trends.
Canadian Institute for Health Information (CIHI): focus on health data and information to accelerate improvements in health care, health system performance and population health across the continuum of care. Includes the Canadian Research Institute on Substance Misuse (CRISM), a 5-year initiative with a focus on clinical and community-based interventions for substance use disorders, evidence regarding prevention and treatment services, and supporting improvement in the quality of care and quality of life for Canadians living with substance use.
British Columbia Centre on Substance Use (BCCSU): provides provincial leadership in substance use and addiction research, education and clinical care guidance.
Canadian Institute for Substance Use Research (CISUR): network of individuals and groups dedicated to the study of substance use and addiction in support of community-wide efforts to promote health and reduce harm. Located in Victoria, BC.
Centre for Addiction and Mental Health (CAMH): Canada's largest mental health teaching hospital and one of the world's leading research centres. Offers both clinical care to patients and engages in research, training, and development of promotion and prevention strategies related to mental health and addictions.
Canadian Drug Policy Coalition (CDPC): research and advocacy organization that works to advance and realize drug policies grounded in compassion and guided by science, and shift the public narrative on substance use and people who use drugs.

People with Lived/Living Experience with Substance Use

Canadian Association of People Who Use Drugs (CAPUD): national advocacy organization formed by and representing the interests of people who use drugs.
Moms Stop the Harm (MSTH): network of mothers and families whose loved ones use drugs or who have died due to substance use. They call for new approaches based on reducing harm, where people who use drugs are treated with respect, compassion and support.
Community Addictions Peer Support Association (CAPSA): Provides opportunities for people affected by addiction to connect with their local community through collective volunteerism and community participation.

Health Professional and Regulatory Bodies

College of Family Physicians of Canada (CFPC): leads family medicine to improve the health of all people in Canada by setting standards for education, certification and support of family physicians, championing advocacy and research, and honouring the patient-physician relationship.
National Association of Pharmacy Regulatory Authorities (NAPRA): Provides leadership to enhance patient care by regulating the practice of pharmacy and operation of pharmacies in their respective jurisdictions in Canada.
Federation of Medical Regulatory Authorities of Canada (FMRAC): FMRAC's mission is to advance medical regulation on behalf of the public through collaboration, common standards and best practices.
A wide range of professional medical associations (e.g. Canadian Medical Association, Canadian Nurses Association, Canadian Pharmacists Association, etc.)

Other Key Stakeholder Groups:

Indigenous organizations - Assembly of First Nations, Inuit Tapiriit Kanatami, Metis National Council, Native Women's Association of Canada. Thunderbird Partnership Foundation

Pain groups - organizations representing the interests of pain patients (e.g. Canadian Pain Society, Chronic Pain Association of Canada)

Cannabis - Cannabis Council of Canada, Canadian Hemp Trade Alliance, Canadians for Fair Access to Medical Marijuana

Alcohol - Mother's Against Drunk Driving, Post-Secondary Education Partnership on Alcohol Harms

Location of Supervised Consumption Sites, Drug Checking Sites and Substance use and Addictions Program Funding Recipients across Canada and in major cities. — **Appendix D: Location of Supervised Consumption Sites, Drug Checking Sites, and Substance Use and Addictions Program Funding Recipients**

Map of location of cannabis licence holders — **Appendix E: Location of Cannabis Licence Holders**

As of August 2019, there are 211 cannabis license holders (cultivators, processors and sellers) in Canada

Healthy Environments and Consumer Safety Branch

Background Deck

September 2019

Mission of the Healthy Environments and Consumer Safety Branch (HECSB)

HECSB helps to maintain and improve the health of all Canadians by:
- promoting healthy living, working and recreational environments
- minimizing the harm caused by environmental factors, workplace hazardous materials, and unsafe consumer products and cosmetics
HECSB works with Canadians, and other partners, to help prevent problems before they occur, target the highest risk areas to maximize our impact, and respond quickly when necessary to protect Canadians

HECSB organizational structure — **HECSB Organizational Structure**

HECSB Core Business Lines

Safe Environments

Assesses and manages potential risks to human health posed by new and existing chemicals under the Chemicals Management Plan (CMP), with Environment and Climate Change Canada (ECCC)
Works with P/Ts to develop guidelines for Canadian drinking and recreational water quality, and national standards and guidelines for indoor and outdoor air quality
Provides expert advice for Impact Assessments of major resource projects (e.g., pipelines, mines) and federal contaminated sites on the health effects related to air quality, drinking water, noise and radiation, and traditional foods
Undertakes activities under the Canadian Environmental Protection Act, 1999, the Canadian Environmental Assessment Act and the Impact Assessment Act
Helps Canadians and health authorities understand the impacts of climate change on health, and inform adaptation strategies to minimize the health effects

Environmental and Radiation Health Sciences

Conducts research, monitoring and surveillance on the health impacts of environmental factors, chemicals, and radiation
Leads the Federal Nuclear Emergency Plan, Canada's plan for coordinating the federal government response to a radiological or nuclear emergency, and contributes to fulfilling the requirement of the Comprehensive Nuclear Test-Ban Treaty Implementation Act through the operation of a laboratory and radiation monitoring stations
Maintains 24/7 readiness and capacity to respond to nuclear and chemical emergencies
Manages the National Dosimetry Service to provide radiation exposure measurement services for workers
Administers the Radiation Emitting Devices Act and Regulations, which support regulation of devices that emit electromagnetic or acoustical energy including industrial/commercial/security products (e.g. airport security screening equipment, smart meters); consumer products (e.g. cellphones, laser pointers); and medical devices (e.g. medical x-ray and ultrasounds)
Manages horizontal science and science policy issues for the Branch including open science, research governance, and science promotion

Consumer and Hazardous Products Safety

Protect Canadians from hazards associated with consumer products, including toys, appliances, mobile phones, and cosmetics, using a post-market, risk-based system
Relies on authorities in the Canada Consumer Product Safety Act (CCPSA), the Food and Drugs Act (FDA), and various specific regulations (e.g. Cosmetics, Toys, Consumer Chemicals, Lead)
Ensures workers are warned about the hazards, appropriate precautions, and first aid treatment associated with dangerous workplace chemicals using authorities under the Hazardous Products Act and the Hazardous Materials Information Review Act (HMIRA)

Policy, Planning and Integration

Coordinates planning, accountability, horizontal policy and business functions for HECSB
Provides leadership to fulfill Health Canada's responsibilities under the Federal Sustainable Development Act (e.g. input to the Federal Sustainable Development Strategy, development of a departmental strategy, contributions to 'green' departmental operations), and supports the Department's compliance with Strategic Environmental Assessment requirements

HECSB Science

Science is foundational to HECSB's policy, programmatic, legislative and regulatory work

Monitoring and Surveillance:
- Biomonitoring through longitudinal Maternal-Infant Research and Environmental Chemicals Study and Canadian Health Measures Survey, as examples, are used to risk assessments and risk management actions
- Gathering and distributing poison centre data through the Pan-Canadian Poison Surveillance System to provide near real-time safety signals, high quality surveillance data and ready access to medical toxicology expertise
Research:
- Investigating emerging issues of concern related to chemicals, plastics, vaping, air, water and radiation (with partners - domestic and/or international)
Informing Risk Communication:
- Using our science to communicate risk, such as helping people reduce their exposure to air pollutants through the Air Quality Health Index, raising awareness of risks from chemicals and other pollutants around the home through the Healthy Home Campaign, and providing information on radon risks through National Radon Action Month
Laboratories:
- HECSB laboratories support compliance and enforcement work, test and methodology development and research on products, cosmetics and radiation
- HECSB laboratories are part of the TerraCanada cluster of the Laboratories Canada initiative

HECSB Priorities

Advance current CMP work to reduce the risks posed by chemicals, including:

Assessing and managing the risks of chemical substances, toward the goal of addressing 4,300 priority substances by 2020, and addressing new substances entering Canada
Engaging internationally on global chemical issues and providing leadership for the development of a global framework on chemicals and waste beyond 2020, the future of the Strategic Approach to International Chemicals Management. [REDACTED].

Protecting Canadians from the health impacts of climate change through:

[REDACTED].
Coordinating federal efforts on health under the Pan-Canadian Framework on Clean Growth and Climate Change to ensure health adaptation is a core component of federal action on climate change.
Building the capacity of 10 pilot health authorities (PT and local) across Canada to understand climate change risks to health and the health system and develop adaptations through the HealthADAPT Gs & Cs program ($3M)

[REDACTED]

Continuing Regulatory Review initiatives including modernizing the Hazardous Materials Information Review Act (HMIRA) and optimizing choice of instruments for consumer products.

Key Files

[REDACTED]
Memorandum of Understanding between Health Canada and the Impact Assessment Agency of Canada to support the Impact Assessment Act
[REDACTED]
[REDACTED]
[REDACTED]

Regulatory Operations and Enforcement Branch (ROEB)

Background Deck

September 2019

Branch Mandate

The Regulatory Operations and Enforcement Branch (ROEB) is Health Canada's dedicated compliance and enforcement (C&E) branch.
ROEB was established to strengthen oversight of the Department's acts and regulations, modernize C&E activities to be more risk-based, strengthen inspection capacity and enhance the ability to respond to emerging issues.

Our vision

To be a world class compliance and enforcement organization

Our mission

To be a compliance and enforcement leader that informs and protects Canadians from health risks associated with products, substances, and their environment

Who We Are

ROEB was created in April 2016 as a dedicated compliance and enforcement (C&E) branch, bringing together all of Health Canada's C&E functions under one accountable ADM.
ROEB delivers its core business through a national program delivery model.
ROEB is one of the largest federal C&E organizations, with more than 1,300 employees in 26 locations across Canada.

Map showing ROEB employees across Canada. ROEB has employees in 26 locations across Canada. — **Roeb employees across canada**

What We Do

ROEB carries out the following C&E actions:
- Compliance promotion - educating and promoting compliance with the law;
- Compliance monitoring - monitoring and verifying that products, processes and activities comply with the law; and
- Enforcement - bringing regulated parties into compliance with the law and preventing future non-compliance.
ROEB provides strategic policy advice and support for the department's regulatory agenda, as well as legislative and regulatory changes.
ROEB delivers complementary scientific programs, such as laboratory services and environmental health expert advice, and delivers the Internationally Protected Persons Program for international dignitaries and international summits.
ROEB works closely with partner branches across Health Canada to deliver its mandate (see Annex A for roles and responsibilities)

Core Business

Compliance and Enforcement
- Cannabis and controlled substances
- Consumer product safety and cosmetics, pest control products, and tobacco/ vaping
- Health products (prescription drugs, non-prescription drugs, natural health products, veterinary drugs)
- Medical devices and biological products (blood, donor sperm and ova, cells/tissues/organs), clinical trials and border operations

Laboratories and Scientific Analysis
- Illegal drugs and substances, cannabis, health products, food, pesticides and microbiology analysis
- Air quality, chemical assessments and human health risk assessments for contaminated sites

Health Promotion, Protection and Outreach
- Environmental health
- Internationally protected persons
- Domestic and international collaboration

Policy and Operations
- Border integrity and surveillance
- Establishment licensing
- Regulatory policy development as well as internal operations and services

Operating Context

ROEB operates in a complex and rapidly evolving environment. The following drivers inform the way ROEB conducts its business.

Globalization:
- The evolving global supply chain requires increased harmonization and collaboration

Innovation:
- The rapid pace of innovation requires the development of new regulatory frameworks and state-of-the-art laboratory equipment

Technological Advancement:
- Innovative products require establishing new compliance and enforcement measures

Credibility as a Regulator:
- The protection of Canadians requires providing risk-based oversight and information on health and safety risks

Strategic Direction

Comprehensive Review (2017)
The department conducted a comprehensive review of its programs in 2017. Compliance and enforcement was identified as an area for improvement.
As a result, ROEB is implementing a plan to stabilize, modernize and transform its compliance and enforcement function. This includes increasing inspections, strengthening oversight and modernizing tools and training.

ROEB 2019-2022 Strategic Plan
- The branch released its Strategic Plan in April 2019. The plan outlines three strategic priorities for the branch:
  - Modern Program Delivery - strengthen partnerships, invest in technology and ensure national consistency.
  - Compliance and Enforcement Transformation - leverage data, target resources and increase foreign and domestic C&E capacity, and modernize statutory frameworks.
  - People and Workplace Excellence - create an innovative workplace, develop talent, foster employee engagement, and support a healthy and productive workplace.
  - The plan will be monitored through the branch operational planning exercise and the development of a performance framework.

Key Priorities

Core Business Activities

Inspections: Conduct over 14,000 inspections annually across product lines.
Management of Non-Compliance: Proactive monitoring activities and collecting risk intelligence.
Provide Information: Recalls, product seizures, stop sales, adverse events, shortages, etc.
Scientific and Technical Services: Analysis of Illicit drugs, pesticides, food products and health products.
Environmental Health: Identify and assess health risks posed by environmental factors.

Compliance and Enforcement Modernization

Transformation of Compliance and Enforcement Activities:

Increase domestic and foreign surveillance.
Establish a national training program for inspectors.
Develop an investigation capacity.
Leverage data to be more proactive and risk-based.
Implement the revised C&E Policy 001.
Implement the C&E transformation framework.

Regulatory Frameworks and Modernization

The Regulatory Agenda: Facilitate the management of the department's regulatory agenda.
Regulatory Roadmaps: Coordinate the implementation of the Regulatory Roadmaps developed through TBS-led Regulatory Review.
Compliance and Enforcement Approaches: Modernize legislative, regulatory and policy frameworks to keep pace with the changing operating context.

Key Issues - First 30 Days

Bulk Importation

Stakeholder and media attention has increased because of recent developments in the United States regarding the bulk importation of drugs and the potential impact on Canadian drug prices and supply.

New Cannabis Classes

New compliance and enforcement measures are required for the legislative and regulatory changes to legalize cannabis edibles, extracts, beverages and topicals (e.g., skin creams).

Drug Shortages

There is significant advocacy from stakeholders as drug shortages frequently occur and can be disruptive to Canadians.

Cabinet Directive on Regulation Implementation

Cabinet Directive on Regulation regulatory transparency administrative burden baseline reporting requirement needs to be posted by September 30, 2019. The Health Canada Regulatory Stock Review will also be posted in September.

ROEB organizational structure. — **Organizational Structure**

ROEB - Financial Overview

Annual Reference Level Update (in millions)

Salaries and Wages represent 85% of ROEB's overall budget
Operating represents 13% of ROEB's budget
23% of the budget is related to the collection of revenues, which adds to the Salary and Operating budget
ROEB has a small capital budget of $3M

Financial Snapshot ($ millions)

Salary - $ 113.4

O&M - $ 16.7

Capital - $ 3.0

TOTAL - $ 133.1

# of FTEs - 1,285

ROEB Budget - Text Equivalent

ROEB Budget pie chart. ROEB's budget is comprised of Salaries and Wages which represents 85% of the Branch's budget, Operating which represents 13%, and Capital which represents 2% of the overall budget.

Annex A: Variability in Implementing C&E Across Regulated Product Lines
-	Regulated Products
-	Health Products					-
-	Therapeutic & Non-Prescription Drugs	Veterinary Drugs	Blood, Semen/Ova, Cell, Tissues & Organs	Natural Health Products	Clinical Trials	Medical Devices	Cannabis ^{Footnote 1}	Controlled Substances	Tobacco	Vaping	Consumer Products Safety & Cosmetics	Pest Control Products
Compliance Generation
C&E Legislative & Regulatory Development	^{Footnote R}	^{Footnote R}	^{Footnote R}	^{Footnote O}	^{Footnote R}	^{Footnote R}	^{Footnote O}	^{Footnote O}	^{Footnote O}	^{Footnote O}	^{Footnote S}	^{Footnote O}
Legislative & Regulatory Development	^{Footnote O}	^{Footnote O}	^{Footnote O}	^{Footnote O}	^{Footnote O}	^{Footnote O}	^{Footnote O}	^{Footnote O}	^{Footnote O}	^{Footnote O}	^{Footnote O}	^{Footnote O}
C&E Policy, Guidance, Plans & Procedures	^{Footnote R}	^{Footnote R}	^{Footnote R}	^{Footnote R}	^{Footnote S}	^{Footnote R}	^{Footnote S}	^{Footnote S}	^{Footnote S}	^{Footnote S}	^{Footnote S}	^{Footnote S}
C&E Performance Measurement & Service Standard	^{Footnote R}	^{Footnote R}	^{Footnote R}	^{Footnote R}	^{Footnote S}	^{Footnote R}	^{Footnote R}	^{Footnote S}	^{Footnote S}	^{Footnote S}	^{Footnote S}	^{Footnote S}
C&E Core Activities
Compliance Promotion & Regulated Party Outreach	^{Footnote S}	^{Footnote S}	^{Footnote S}	^{Footnote S}	^{Footnote S}	^{Footnote S}	^{Footnote O}	^{Footnote S}	^{Footnote S}	^{Footnote S}	^{Footnote S}	^{Footnote S}
Conduct Inspections / Investigations	^{Footnote R}	^{Footnote R}	^{Footnote R}	^{Footnote R}	^{Footnote R}	^{Footnote R}	^{Footnote TBD}	^{Footnote R}	^{Footnote R}	^{Footnote R}	^{Footnote R}	^{Footnote R}
Conduct Industry Audits	N/A	^{Footnote R}	^{Footnote R}	N/A	N/A	^{Footnote O}	N/A	N/A	N/A	N/A	^{Footnote R}	N/A
Compliance Review and Verification	^{Footnote R}	^{Footnote R}	^{Footnote R}	^{Footnote S}	^{Footnote R}	^{Footnote R}	^{Footnote S}	^{Footnote R}	^{Footnote R}	^{Footnote R}	N/A	^{Footnote S}
Issuance of C&E Actions	^{Footnote R}	^{Footnote R}	^{Footnote R}	^{Footnote S}	^{Footnote S}	^{Footnote R}	^{Footnote TBD}	^{Footnote S}	^{Footnote S}	^{Footnote S}	^{Footnote S}	^{Footnote S}
C&E Enforcement
Quality Management Systems	^{Footnote R}	^{Footnote R}	^{Footnote R}	^{Footnote R}	^{Footnote R}	^{Footnote R}	N/A	^{Footnote S}	N/A	^{Footnote O}	^{Footnote O}	^{Footnote O}
Training for Inspectors	^{Footnote S}	^{Footnote S}	^{Footnote S}	^{Footnote S}	^{Footnote S}	^{Footnote S}	^{Footnote R}	^{Footnote R}	^{Footnote S}	^{Footnote S}	^{Footnote S}	^{Footnote S}
IT to Support C&E Strategy	^{Footnote R}	^{Footnote R}	^{Footnote R}	^{Footnote R}	^{Footnote R}	^{Footnote R}	^{Footnote S}	^{Footnote S}	^{Footnote O}	^{Footnote S}	^{Footnote O}	^{Footnote S}
Lab Testing	^{Footnote R}	^{Footnote R}	^{Footnote R}	^{Footnote R}	^{Footnote R}	^{Footnote R}	^{Footnote R}	^{Footnote R}	^{Footnote O}	^{Footnote S}	^{Footnote O}	^{Footnote O}
Partner Relationships	^{Footnote S}	^{Footnote S}	^{Footnote S}	^{Footnote S}	^{Footnote S}	^{Footnote S}	^{Footnote S}	^{Footnote S}	^{Footnote S}	^{Footnote S}	^{Footnote S}	^{Footnote S}
Occupational Health & Safety	^{Footnote R}	^{Footnote R}	^{Footnote R}	^{Footnote R}	^{Footnote R}	^{Footnote R}	^{Footnote R}	^{Footnote R}	^{Footnote R}	^{Footnote R}	^{Footnote R}	^{Footnote R}
Inspector Recruitment	^{Footnote R}	^{Footnote R}	^{Footnote R}	^{Footnote R}	^{Footnote R}	^{Footnote R}	^{Footnote R}	^{Footnote R}	^{Footnote R}	^{Footnote R}	^{Footnote R}	^{Footnote R}
Accountability = Lead/Responsible ("Holds the Pen"/Approves) Footnote 1 Based on the most recent draft RACI (responsibility assignment matrix). Return to footnote 1 referrer Footnote TBD Accountability to be determined Return to footnote TBD referrer Footnote O Product Branches are accountable Return to footnote O referrer Footnote S Accountability is shared between ROEB and Product Branches Return to footnote S referrer Footnote R ROEB is accountable Return to footnote R referrer

Pest Management Regulatory Agency (PMRA) Background Deck

September 2019

PMRA Mandate

As the federal regulator of pesticides:

PMRA's primary objective is to prevent unacceptable risks to Canadians and the environment from the use of pesticides. This is accomplished through pre- and post-market regulatory activities and the establishment of food safety standards (i.e., pesticide maximum residue limits).
- PMRA's legislative mandate stems from its administration of the Pest Control Products Act (PCPA) and its regulations.
- PMRA's mission is to protect the health and environment of Canadians by using modern evidence-based scientific approaches to pesticide regulation, in an open and transparent manner.

About Pesticides:

Pesticides are, for the most part, inherently hazardous chemicals designed to eliminate a specific pest and released purposefully into the environment.
Regulated pesticides include: agricultural chemicals such as herbicides, insecticides and fungicides; industrial chemicals such as wood preservatives and anti-fouling paints for boats; and, consumer products such as personal insect repellents, sanitizers and swimming pool disinfectants.
Agriculture accounts for 60% of pesticide use by volume.

Organizational Structure of the Pest Management Regulatory Agency — **PMRA Organizational Structure**

Core Business Lines

New Product Evaluation (Pre-Market)

Prior to registering a product for use, PMRA conducts a scientific assessment to ensure that any risks to the health of Canadians and the environment are acceptable and that the product has value (e.g., will meet a need to control a pest problem).
PMRA regulates pesticide products under the PCPA. Pesticides must be registered or otherwise authorized before they can be sold or used in Canada.

Registered Product Evaluation (Post-market)

To ensure that pesticides meet modern standards for protection of health and the environment, all pesticides must be re-evaluated on a 15 year cycle.
Special reviews must be initiated if there are reasonable grounds to believe that the health and environmental risks posed by the product may no longer be acceptable. Monitoring activities such as incident reporting and collection of sales data are included under this business line.

Science and Business Innovation

PMRA develops innovative science policy and IM/IT solutions to: address emerging technologies; keep pace with scientific developments; improve information sharing with federal and international regulators; improve the timeliness, predictability and transparency of regulatory processes; and, support the global alignment of regulatory science policies and approaches.

PMRA Key files/priorities/issues

1. Review of the Pesticide Post-Market Review Program:

PMRA's workload for the re-evaluation of pesticides is compromising the integrity of the program
- The PCPA requires re-evaluation of every pesticide on a 15-year cycle.
- The Commissioner of the Environment and Sustainable Development, and Environmental Non-Governmental Organizations (ENGOs), have been critical of PMRA's ability to make and implement timely regulatory decisions to protect Canadians health and the environment.
- While workload has doubled since the new PCPA came into force in 2006, funding for the program has not kept pace resulting in a growing backlog.
Stakeholders want increased engagement and time to provide data and information
- Pesticide regulatory decisions can have serious economic implications for agriculture and other use sectors.
- Industry stakeholders expect: a high level of engagement prior to publication of proposed and final decisions; the opportunity to generate new data to avoid negative decisions; and, when required, long phase-out periods for economically important chemicals.
- All stakeholders expect science-based decisions that reflect key information/data such as real-world use and environmental monitoring, although such information is no longer collected by Federal departments with relevant mandates.
Through extensive consultations PMRA is exploring ways to transform the pesticide post-market review program including:
- Examining new approaches to re-evaluation (including international comparisons);
- Legislative and regulatory modernization through Parliamentary review of the PCPA, as early as Fall 2020;
- Changes to appropriations and the cost recovery regime for pesticides; and
- Enhanced linkages with Other Government Departments (OGDs).
PMRA will propose a path forward early in the new mandate.

2. Neonicotinoids (Neonics):

Neonics are insecticides used extensively in agriculture.
Neonics have received worldwide attention due to their potential risks to bees.
There are three neonic pesticides approved in Canada currently being re-evaluated.
- Imidacloprid, thiamethoxam and clothianidin.
In April of 2019, Health Canada published the final pollinator re-evaluations for the three neonic pesticides. To protect pollinators some uses were cancelled with restrictions applied to other uses.
Neonics were also being measured at levels in some aquatic environments that would pose risks to certain insect populations.
In 2016, PMRA proposed a 3 to 5 year phase-out of all agricultural uses of imidacloprid to protect aquatic insects. The Special Review of clothianidin and thiamethoxam in August of 2018 also proposed to cancel all outdoor uses due to this same risk.
Final decisions related to aquatic organisms are expected in January 2020.

3. Glyphosate:

Public interest in glyphosate remains high due to political level (European) decisions, high profile court cases in the United States and recent initiation of class action cases in Canada linking glyphosate exposure and presence of Non-Hodgkins lymphoma.
In April 2017, PMRA published the final re-evaluation decision for glyphosate, concluding that it does not pose unacceptable risks to human health or the environment.
Health Canada's finding with respect to carcinogenicity is consistent with other countries, as no pesticide regulatory authority in the world considers glyphosate to be a cancer risk to humans.
Health Canada continues to monitor for new information related to glyphosate, including regulatory actions from other governments, and will take appropriate action if risks of concern to human health or the environment are identified

4. International Regulatory Cooperation (IRC)

PMRA works with international counterparts (e.g., US EPA) to align science and policy approaches, which has allowed us to participate in international joint reviews of pesticides.
Other key IRC activities include:
- Chairing or participating in a number OECD steering & expert groups
- Leadership at CODEX, a multilateral body that develops international food standards (e.g. Maximum Residue Limits - MRLs).
- Participate in the negotiation and implementation of multi-lateral environmental and trade agreements (e.g., Stockholm, Rotterdam Conventions, CUSMA, CPTPP, CETA).
- Continuing working relationship within the CUSMA framework in relation to Pesticides (continuing from the NAFTA Working Group on Pesticides).
- Regulatory Cooperation Council plan for crop protection products.
- Support for federal partners by providing scientific regulatory support on trade-related files

Total budget and total full time equivalents

Total Budget (Main Estimates 2019-2020): $37,390,000
Total Full Time Equivalents: 396

Gross budget (in millions of dollars)
Financement	Business Line 1 - New Product Evaluation	Business Line 2 - Registered Product Evaluation	Branch Support - Science and Innovation,	Total
A- Base	$15.7	$1.7	$6.8	$24.3
B-Base - Chemicals Management Plan - expires March 2021	N/A	$4.9	N/A	$4.9
B-Base - Canadian Agricultural Partnership - expires March 2023	$3.3	N/A	N/A	$3.3
Departmental Pressure Funding S&W(incl. EBP): 89%, O&M: 11%- expires March 2020	N/A	$4.8	N/A	$4.8
Respendable Revenue	$5.1	$7.7	N/A	$12.9
Total	$24.2	$19.2	$6.8	N/A
Gross Budget	-	-	-	$50.3

Communications and Public Affairs Background Deck

September 2019

CPAB Mission

The Communications and Public Affairs Branch (CPAB) is a full-service communications branch that directly supports Health Canada and the Public Health Agency of Canada (PHAC) in their missions, through a Shared Services Partnership
CPAB provides a broad range of communications services, including strategic communications and issues management, risk communications, marketing and advertising, digital communications, public opinion research and consultations, internal communications and executive correspondence
CPAB is the primary liaison with Privy Council Office (PCO) Communications and with Communications in the Minister's Office
Our work contributes to ensuring that Canadians have access to the information they need to take action on their health

The Communications and Public Affairs Branch organizational structure — **CPAB Organizational Structure**

CPAB Services

Strategic and Ministerial Communications

Provide strategic communications advice, planning and issues management to support the Minister of Health ^{Footnote 12} and Health Canada, including:
- Ministerial announcements, including speechwriting
- Communications plans and products
- Media relations
- Media monitoring and analysis
- Regional communications

Risk Communications

Communicate important health and safety information to Canadians, including advisories about health and consumer products

Marketing, Advertising, Partnerships and Creative Services

Develop and deliver marketing and advertising campaigns and partnerships to advance program objectives
Provide design, publishing, video, copyright, printing and distribution services to all branches, and manage the Service Canada contract for the Health Canada general enquiries line

Digital Communications

Manage Health Canada's digital presence on Canada.ca
Manage Health Canada social media accounts as well as the official Minister of Health Twitter account

Public Opinion Research and Consultations

Provide full-service public opinion research contracted through external firms or using survey software managed internally
Support external consultations and the establishment of external advisory bodies
Manage Health Canada's Consultation and Stakeholder Information Management System (CSIMS), and provide stakeholder intelligence and mapping services

Internal Communications

Lead internal communications to all Health Canada employees, including providing advice to branches
Support the Deputy Minister in employee engagement

Blueprint and Beyond 2020

Support Health Canada's efforts to modernize and transform the workplace through a range of initiatives
Manage the Health Canada Solutions Fund, which supports employee-led experimentation
Develop and coordinate implementation of Health Canada's Beyond 2020 plan

Executive Correspondence

Manage correspondence for the Minister and the Deputy Minister

Food and Drugs Act Liaison Office (FDALO)

Provide dispute-resolution services through an impartial, confidential office to improve relations between external stakeholders and representatives of Health Canada, as well as to increase openness and transparency in the regulatory process

Financial Profile

For FY 2019-20, CPAB has an opening reference level of $44.5M (including EBP) ^{Footnote 13}
CPAB's total salary budget covers 306 FTEs, 72 of which are funded through PHAC's contribution to the
Shared Service Partnership (SSP)
Funding from PHAC represents 24% of CPAB's reference-level budget
CPAB also receives in-year funding from TB submissions, advertising campaigns and Branch Transfer Agreements. The following is anticipated for the 2019-20 fiscal year:
- HC: $2.0M salary / $7.0M O&M
- PHAC: $0.3M salary / $1.2M O&M

2019-20 Opening Reference Level
(Includes EBP)
Funding source	Full-time equivalents (FTEs)	Funds
HC Salary & Operating (Vote 1)	-	$30.6M
EBP	-	$2.8M
FTEs	234	-
PHAC Shared Services Partnership	-	$9.4M
EBP	-	$1.7M
FTEs	72	-
Total Salary & Operating	-	$44.5M

The 2019-20 Fiscal Year Communications and Public Affairs Branch opening reference level (Chart does not include the Employee Benefit Plan) — 2019-20 Opening Reference Level
(Does not include EBP)

Corporate Services Branch (CSB) Overview

Background Deck

September 2019

Mandate

The Corporate Services Branch (CSB) provides support/services to Health Canada (HC) in
- Human Resources
- Information Management/Information Technology
- Real Property and Security
- Access to Information and Privacy
- Enterprise Architecture and Data
These services are also provided to the Public Health Agency of Canada pursuant to a Shared Services Partnership Agreement established in 2012.
Some services also continue to be provided to HC's former First Nations and Inuit Health Branch that transferred to Indigenous Services Canada through a MOU established in 2017.
CSB also provides Specialized Health services (Occupational Health, Employee Assistance) to various Government of Canada institutions through cost recovery and other arrangements.

Core Business/Key Files

Human Resources Services Directorate

Scope: Provides human resource services, strategic advice and policy guidance; supports a healthy, respectful, inclusive, safe and productive workplace; engages Public Services and Procurement Canada (PSPC) to provide compensation advice and support; and manages executive recruitment, staffing, organizational design and classification as well as performance/talent management.

Key Files:

Pay

Implement PSPC's Pod Model to better support employees and adjust tools and processes to meet new HR-to-Pay Timeliness requirements from Treasury Board Secretariat (TBS).
In-house pay team of 65 employees working on pay issues under MOU with PSPC.

Workplace Wellness Service Centre

Continue efforts to implement 'one-stop access' for Disability Management, Duty to Accommodate and Occupational Health and Safety Services (best practice as per GoC/Clerk's Annual Report).
Risk-based Conflict of Interest regime implemented for the cannabis program.

Information Management Services Directorate

Scope: Manages, develops and delivers information management and information technology (IM/IT) strategies, policies, software/solutions and services; engages Shared Services Canada (SSC) to advance departmental IM/IT priorities; supports the implementation of TBS/SSC-driven enterprise initiatives; and protects information and systems from cyber attacks.

IT Key Files:

Enterprise initiatives

Complete implementation of Wi-Fi, Windows 10 and migration of applications/servers running Windows 2008 and in data centres' scheduled closures; these initiatives have varying timelines, with the earliest coming up in December 2019 (Windows 2008).

IT Planning

Lead annual planning process (Fall start) and engage SSC on priority IT projects. Includes HC's evolving 'science IT' needs, as well as Aging IT and Mission Critical Applications.

IM Key Files:

Implementing GCDocs across HC and PHAC (replace current shared drive and RDIMS repositories).

Real Property and Security Directorate

Scope: Manages custodial and office space nationally; partners with PSPC to deliver real property and accommodations services; leads GCworkplace office modernization projects; develops and maintains policies, systems and procedures for managing buildings; keeps personnel, assets and information safe and secure; manages plans to ensure preparedness and business continuity in the event of emergencies; and facilitates security clearances, awareness, contracting and travel briefings.

Key Files:

Security

Developing a new three-year strategic Integrated Departmental Security Plan (including security and cybersecurity) and update policies and practices, consistent with new TBS policy.

Laboratory Renewal

Developing a national Laboratory Infrastructure Renewal Strategy for HC custodial laboratories.

Laboratories Canada Initiative

Lead for HC which is part of two clusters (Terra Canada + Regulatory Science and Security).

Planning, Integration and Management Services Directorate

Access to Information and Privacy

Scope: Manages compliance under the Access to Information Act, Privacy Act and related TBS policies. The volume/scientific nature of ATI requests present unique challenges relative to most other federal institutions (in 2018-2019, HC received 1,942 ATI requests, representing an increase of 7.5% compared to 2017-18). While steps taken in recent years to improve performance (demand management, program accountability and increased investments) enabled HC to close 2,255 ATI requests last FY (20%+ than previous year), a significant backlog of requests remain.

Key Files:

A permanent investment was made at the beginning of 2016-17 to significantly increase time performance on the management of new files.

Backlog reduction: using in-year investments to eliminate the backlog (consultants) and continue to work with programs to explore ways to reduce incoming levels through proactive disclosure (e.g. adverse drug reactions).

Business Renewal and Enterprise Architecture Directorate

Scope: Collaborates with branches to bring a broad, enterprise-wide view to investment decisions; leads the development of a collaborative data strategy for HC; and fosters innovation through a network of virtual and physical workspaces designed for collaboration.

Key Files:

Enterprise Architecture

Representing HC & PHAC on GC Enterprise Architecture Review Board

Data Strategy

Leading the development of the HC Data Strategy (a key part of the Government of Canada's broader digital agenda).
Developing an integrated data strategy/roadmap for HC & collaborate with PHAC in developing its data strategy.

Specialized Health Services Directorate

Scope: Public Service Occupational Health Program (PSOHP) - delegated to HC by Treasury Board in 1984, this program supports Deputy Heads in meeting their obligations under the Canada Labour Code by ensuring that public servants, especially those in high risk and safety-sensitive positions, are physically and psychologically fit to perform their duties, and that they will not pose any danger to their colleagues or the citizens they serve. PSOHP also provides domestic and overseas occupational health advice and leadership in response to emerging issues and hazards e.g. lead, asbestos, legionella, air quality, noise levels, and exposure to toxins such as fentanyl and beryllium.

Employee Assistance Program, which provides 24/7/365 confidential bilingual services to support employees and their families in identifying and resolving personal and work-related problems. Services are provided on a cost-recovery basis to 85+ federal institutions, including RCMP, Canadian Air Force and Veterans. Also includes Specialized Organizational Services, which provides counselling for grief and loss, mental health training, workplace wellness and mental health supports, and Psycho-social emergency response.

Key Files:

PSOHP Sustainability

Continue TBS engagement to ensure implementation of a sustainable funding model that keeps pace with Public Service growth/renewal, rising costs and evolving/complex client needs.

HC-PHAC Shared Services Partnership (SSP)

In June 2012, a Shared Services Partnership (SSP) agreement was signed by Deputy Heads of HC and PHAC to consolidate resources in selected areas; under this agreement, each organization retains responsibility for a different set of internal services and corporate functions, however, each service/function is accountable to both Deputy Heads.

HC responsibility

Communications and Public Affairs
Corporate Services (Human Resources, IM/IT, Real Property and Security, ATIP and Enterprise Architecture)
Financial Operations/Procurement
Ombudsman, Values and Ethics, Informal Conflict Management

PHAC responsibility

Audit and Evaluation
Emergency Preparedness and Response
International Affairs

The SSP is overseen by the Partnership Executive Committee (PEC), which consists of: you and the President, PHAC as co-chairs, the Associate DM (HC) and the Chief Public Health Officer of Canada (PHAC) as members, and the ADM, CSB as Secretary.

There have been no formal meetings of the PEC in recent years owing to the evolution/maturing of SSP and reliance on existing HC/PHAC governance mechanisms

The SSP Agreement (Appended) ^{Footnote 14}, which was last revised in August 2016, is being updated and also the subject of an internal audit.

CSB Financial Overview
2019-20 Initial Budget ($M)^{Footnote 1}
Salary & Operating (Vote 1)	127.3
Revenue	30.9
Capital (Vote 5)	4.3
Sub-Total	162.5
Shared Services Partnership Funding	33.0
Total	195.5
2019-20 FTEs^{Footnote 1}	1,156
Footnote 1 Source of data: Main Estimates Return to footnote 1 referrer

Revenue sources:

Employee Assistance Program (cost recovered)
MOU with Indigenous Services Canada
Internal Services revenue received from the Health Products and Food Branch, Regulatory Operations and Enforcement Branch, Specialized Health Services Directorate and the Pest Management Regulatory Agency.

CSB Initial Budge by Function ($195.5M) — **CSB Initial Budget by Function ($195.5M)**

Chief Financial Officer Branch (CFOB)

Background Deck

September 2019

Purpose

To provide an initial overview of the Chief Financial Officer Branch, including its mandate and key activities
To flag a number of files that will require your attention in the near-term

Mandate

The Chief Financial Officer Branch (CFOB) is the Departmental focal point for accountability to ensure rigorous stewardship of resources and managing for results.

Key Activities:

Resource Management: Strategic advice, monitoring and oversight of the departmental financial situation and coordination of TB subs
Financial Operations: Core financial services including accounting services, financial systems, travel, and financial policies
Procurement and Asset Management: Providing procurement and asset management services in accordance with government contracting policies
Planning and Performance Reporting: Departmental results reporting including the DRF and publication of the DP/DRR

Organizational Structure

The Chief Financial Officer (CFO) provides the Minister, Deputy Minister and Departmental executives with strategic advice on all financial matters.

The CFO is the lead executive with Central Agencies for overall financial management, and has a functional reporting relationship to the Comptroller General of Canada.
CFOB has a budget of $27.2M and 353 FTEs

Organizational structure of the Chief Financial Officer Branch — **Organizational structure**

CFOB's Shared Services

HC and the Public Health Agency of Canada (PHAC) share a number of internal services and functions
- CFOB provides financial operations, systems, procurement, asset and materiel management services to PHAC
- However PHAC retains its own CFO
CFOB also hosts a number of other Departments on its financial system
- Indigenous Services Canada (ISC)
- Crown-Indigenous Relations and Northern Affairs Canada (CIRNA)
- Patented Medicine Price Review Board (PMPRB)
- Canadian Northern Economic Development Agency (CanNor)

These Departments are hosted through a series of MOUs and buy-back agreements

Table depicting the Chief Financial Officer Branch's shared functions and services — **Cfob shared functions and services**

Files requiring attention in the near-term

Financial signing authorities

Minister and DM sign-off of the financial delegation matrix following the election
- Separate briefing to be scheduled for your DM-level authority

Upcoming approvals / tablings

A number of public documents will require sign-off and tabling:
- Financial Statements, Departmental Results Report, Fees Report, Supplementary Estimates

Treasury board submissions

Several submissions targeting early fall/winter approval:
- [REDACTED]

Proactive disclosure

Requirement to disclose various expenditures on a regular basis:
- Contracts over $10K
- Gs&Cs over $25K
- Travel and Hospitality

A more detailed presentation on the Department's financial situation will be provided upon your arrival

Next Steps

Following your arrival at HC we will provide you with the necessary internal briefings to authorize your financial delegation
- However Ministerial sign-off is required to activate your DM-level signing authorities
Presentation on the departmental financial situation

[REDACTED]

Office of Audit and Evaluation

Background Deck

September 2019

Office of Audit and Evaluation (OAE) Core Business Lines

The Office of Audit and Evaluation (OAE) provides independent and objective advice and assurance to Health Canada (HC) and the Public Health Agency of Canada (PHAC) senior management on the effectiveness of risk management, controls, and governance, as well as the relevance and performance of programs.

Internal Audit and Special Examinations (IASE)

Audits currently scheduled focus on a combination of program activities, primarily regulatory, and corporate services. Audits of internal services which are on the HC-PHAC shared services platform are taken to the Departmental Audit Committees of both HC and PHAC.
IASE also conducts special examinations related to losses of money, fraudulent activities, or other illegal actions against the Crown. These examinations are conducted on an ad-hoc basis when allegations are made.

Evaluation

Almost half of the planned evaluations over the next five years touch on Health Canada's regulatory responsibilities, while the rest cover the Department's grants and contributions agreements, and other functional work. We are also heavily engaged in horizontal evaluations, specifically with Environment Canada on its climate change agenda.

Performance Measurement Planning and Integration

The Performance Measurement team is continuing to advance the culture of performance measurement to ensure useful information is collected for program and senior management decision-making and reporting, to support robust evaluations by providing advice and guidance on performance measurement, and to carry out evaluation readiness assessments.

Practice Management

The Practice Management team is responsible for quality assurance, annual audit and evaluation planning, governance of audit and evaluation committees, liaising and coordinating with external assurance providers, and following up on action plans to respond to recommendations.

More about OAE

OAE is part of the Shared Services Platform which has enabled the audit and evaluation functions to integrate and transfer knowledge and lessons learned from both organizations.
As of today, we have 71 indeterminate employees within OAE not including casuals (3), students (8) and contractors (3). Our target end state is 76 FTEs.
OAE places importance on professional development and supports team members in the pursuit of credentials, as well as the specialized training needed to maintain them. Official languages capacity has also been enhanced through ensuring a culture that recognizes and supports development in this area.
A concerted focus on workplace wellness has had a positive impact on the environment within OAE. This was validated in the 2018 PSES results.

OAE Organizational Structure — **Organizational Structure**

OAE Key Files for 2019-20
Health Canada Engagements
2019-20	Type of Engagement	Branches and Other Government Departments
Natural Health Products (September 2019 - November 2020)	External Audit by the Office of the Auditor General	Health Products and Food Branch Regulatory Operations and Enforcement Branch Healthy Environments and Consumer Safety Branch
Management of Grants and Contributions (Phase II) (April 2018 - October 2019)	Audit	Strategic Policy Branch
Controlled Substances (October 2018 - December 2019)	Audit	Controlled Substances and Cannabis Branch
Inspection Activities (April 2018 - March 2020)	Audit	Regulatory Operations and Enforcement Branch
Program Implementation of the Cannabis Act (April 2019 - March 2020)	Audit Consulting Engagement	Controlled Substances and Cannabis Branch
Medical Devices (March 2019 - March 2020)	Joint Audit and Evaluation	Regulatory Operations and Enforcement Branch Health Products and Food Branch
Chemicals Management Plan (August 2018 - October 2019)	Evaluation	Environment and Climate Change Canada Healthy Environments and Consumer Safety Branch Health Products and Food Branch Pest Management and Regulatory Agency Regulatory Operations and Enforcement Branch Communications and Public Affairs Branch
Thalidomide Survivors Contribution Program (September 2019 - December 2019)	Evaluation (FAA Deadline: March 2020)	Strategic Policy Branch
Drug Safety and Effectiveness Network (DSEN) (December 2018 - December 2019)	Evaluation (FAA Deadline: March 2020)	Strategic Policy Branch Health Products and Food Branch Canadian Institutes of Health Research
Workplace Hazardous Products (April 2019 - March 2020)	Evaluation	Healthy Environments and Consumer Safety Branch
Tobacco Control (January 2019 - October 2019)	Evaluation Readiness Assessment	Healthy Environments and Consumer Safety Branch Regulatory Operations and Enforcement Branch Communications and Public Affairs Branch Controlled Substances and Cannabis Branch
Consumer Product Safety (February 2019 - December 2019)	Evaluation Readiness Assessment	Healthy Environments and Consumer Safety Branch Regulatory Operations and Enforcement Branch

Shared Services Partnership Engagements
Health Canada Engagements
2019-20	Type of Engagement	Branches and Other Government Departments
IT Systems Development (August 2018 - November 2019)	Audit	Corporate Services Branch (HC and PHAC)
Procurement and Contracting (November 2018 - December 2019)	Audit	Chief Financial Officer Branch Office of the Chief Financial Officer (PHAC)
Shared Services Partnership Agreement (May 2019 - December 2019)	Audit	Communications and Public Affairs Branch (HC and PHAC) Chief Financial Officer Branch Corporate Services Branch (HC and PHAC)
IT Asset Management (December 2018 - January 2020)	Audit	Chief Financial Officer Branch Corporate Services Branch (HC and PHAC)
Management of Privacy Practices (January 2019 - February 2020)	Audit	Corporate Services Branch (HC and PHAC)

OAE is also responsible for conducting ten projects that focus strictly on PHAC activities over the current fiscal year (two audits, one joint audit and evaluation, four evaluations and three evaluation readiness assessments).

Departmental Audit Committee

The Departmental Audit Committee (DAC) is comprised of four external members: Jim Mitchell (Chair); Vicki Harnish; John McWhinnie; and Lorraine Maheu (appointed in May 2019).
Our DAC members have an excellent rapport with Health Canada's senior management. This positive relationship allows for authentic discussions resulting in sound advice for the department.
The Deputy Minister is an internal member and the Chief Financial Officer and the Chief Audit Executive are ex-officio members.
The DAC meets three times a year. A meeting was held on July 9, 2019, and there are meetings scheduled for November 7, 2019 and March 19, 2020.
An orientation/refresher session is planned for this Fall, which will include a visit to a laboratory. Branches will present an overview of their activities and priorities.

Performance Measurement, Evaluation and Results Committee (focused on Evaluation)

The Performance Measurement, Evaluation and Results Committee (PMERC) is comprised of Executive Committee (EC) members and meets four times a year on evaluation topics (the Head of Performance Measurement schedules other PMERC meetings that focus on performance measurement).
Each evaluation is discussed at three stages: scoping; preliminary findings; and final report and management response and action plan (MRAP). The forward agenda for 2019-20 is as follows:
- October 21, 2019:
  - Final Report and MRAP for the Evaluation of Health Canada's Chemicals Management Plan
  - Preliminary Findings for the Drug Safety Effectiveness Network (DSEN)
  - Evaluation Readiness Assessment for Tobacco Control
- December 16, 2019:
  - Final Report and MRAP for the Evaluation of DSEN
  - Preliminary Findings for the Audit and Evaluation of Medical Devices
  - Preliminary Findings for the Evaluation of Workplace Hazardous Products
  - Scoping Discussion on the Evaluation of the Pesticides Program
  - Consultation on the draft schedule for the Five Year Departmental Evaluation Plan (DEP)
  - Evaluation Readiness Assessment for Consumer Product Safety
- March 9, 2020:
  - Final Report and MRAP for the Audit and Evaluation of the Medical Devices Program
  - Final Report and MRAP for the Evaluation of Workplace Hazardous Products
  - Scoping Discussion on the HC component for the Evaluation on Climate Change
  - Final consultation on the DEP

OAE Financial Overview - Budget 2019-20 by Category — **OAE Financial Overview**

Budget and Full Time Equivalents

Total Budget (Main Estimates 2019-2020): $9.94M
Total Full Time Equivalents: 76

Key financial considerations

OAE is jointly funded by Health Canada and PHAC. In 2019-2020, Health Canada's contribution was 55% of the total budget.

Upcoming Priorities

The OAG audit of Natural Health Products will begin the first week of September, 2019.
A DAC teleconference will be held on September 12, 2019, to seek recommendation for your approval of the MRAP for the Audit of Procurement and Contracting.
Consistent with Treasury Board guidance, data collection for two projects is ongoing until mid-October. The previous Deputy Minister was comfortable with this approach and your confirmation will be sought. This includes:
- A survey with 80 Provincial and Territorial inspectors (accredited by Health Canada to conduct inspections under the Hazardous Products Act) for the Evaluation of the Workplace Hazardous Products Program; and
- Interviews (n=25) with academics, community organizations, members of the public and industry for the Audit and Evaluation of the Medical Devices Program.
A PMERC meeting will occur on October 21, 2019.
A DAC Orientation session to welcome the new member followed by a regular DAC meeting are scheduled to take place in early November, 2019.
A review exercise to support future OAG audits was initiated by the former DM, to be completed by late Fall, 2019, concentrating on assessing the realistic or aspirational nature of performance measurement targets. The review will also ensure that the rationale for aspirational targets is clearly articulated.

Key International Priorities and Engagement Opportunities

Office of International Affairs

September 2019

Purpose

To provide the global health landscape overview, as well as why and how we engage internationally on health.
To highlight key global health issues and international engagement opportunities over the next 12 months.
To consider how these opportunities could be best leveraged to advance Canadian interests.

Context: The Global Health Landscape

Health issues are increasingly complex (e.g. multiple sectors and actors; proliferation of new fora)
Geopolitical tensions and instability threaten recent gains; impact on the global community's ability to respond to key issues
Obligation to meeting global commitments
- Binding: International Health Regulations, Tobacco
- Political Endorsement: Sustainable Development Goals; G7/G20 Statements (e.g. UHC)
Opportunity to make a difference/influence international health agenda
- Areas where global action is required - WHO 10 Threats to Global Health
- Fill gaps in global leadership

Context: Why Should Canada Engage in Global Health?

Strategic engagement provides opportunities to:

Protect the health and safety of Canadians
Establish and share expertise and success stories
Advance Canada's interests through global leadership on issues where we can make a difference
Use health as a "soft diplomacy tool" to advance Canada's broader foreign policy objectives
- Feminist International Assistance Policy (FIAP)
- UN Security Council Campaign (UNSC)
- Trade negotiations and economic interests
- Canada's international reputation

OIA's Role ^{Footnote 15} in the Health Portfolio/Government of Canada

Lead Canada's engagement in global health governance (with GAC)
Focal point to coordinate global health issues across the HP and GoC (shared service)
Single window for PM, Ministerial and senior official engagement
- Coordinate Canada's policy positions
- Provide protocol, international event and official visit logistics support
Collaborate with domestic partners to:
- leverage Canadian expertise/experiences; and
- position Canada's engagement priorities on the global stage
Manage the International Health Grants Program (base $1M per year)

Overview of the Health Portfolio and Government of Canada's roles in global health including Health Portfolio and Government departments that collectively contribute to the Federal Government's role in global health, including examples of issues and technical-level activities. — **Overview: HP/GoC Roles in Global Health**

Key Issues on the Global Health Landscape (2019-2020)
Issue	Int'l Pressures	Domestic Priorities
Issue	WHO 10 Threats to GH in 2019	MoH Mandate Letter	[REDACTED]
Immunization (e.g. Access; Vaccine Confidence)	yes	yes	[REDACTED]
Non-communicable diseases (NCDs) Mental Health^{Footnote 1} Aging and Dementia^{Footnote 1} Healthy Eating and Obesity	yes	yes	[REDACTED]
(Global) Health Security (e.g. pandemic influenza, and other emergencies)	yes	yes	[REDACTED]
Antimicrobial Resistance (AMR)	yes	no	[REDACTED]
Problematic Substance Use (e.g. Opioids)	no	yes	[REDACTED]
Sexually Transmitted Blood Borne Infections (STBBIs) (e.g. HIV/AIDs)	yes	no	[REDACTED]
Universal Health Coverage (UHC) Access to Medicines	yes^{Footnote 2}	yes	[REDACTED]
Health Impacts of Climate Change	Yes	no	[REDACTED]
Footnote 1 Not specifically considered NCDs on list Return to footnote 1 referrer Footnote 2 Primary health care on list Return to footnote 2 referrer

Key Players - International Fora

Key Fora

Multilateral Fora: Focus on UN System

UN General Assembly (UNGA)
UN Special Procedures (UN Special Rapporteur visits)
World Health Organization (WHO)
- International Agency for Research on Cancer (IARC)
- Framework Convention on Tobacco Control (FCTC)
Pan American Health Organization (PAHO)

Political / Economic Fora:

G7 / G20
Organisation for Economic Co-operation and Development (OECD)
World Bank

Engagement:

Represent Canada at meetings and events
Provide oversight on governance and administration (e.g. budget review)
Negotiate Canadian positions, political declarations
Fund priority projects and Canada's membership to FCTC
Support work of health working groups/ committees

Key Players - Bilateral / Regional Partners

Strategic bilateral engagement occurs directly with key countries or on the margins of international events, participation in regional bodies (e.g. APEC) and in international fora (e.g. G7, OECD)
Bilateral engagement supported by formal mechanisms (e.g. Memoranda of Understanding and policy dialogues) and informal technical cooperation

[REDACTED]

Key Players - Stakeholders

Stakeholder / Partners

International

Gates Foundation, GAVI
Wellcome Trust
Alliances/coalitions of willing partners
International Civil Society
World Economic Forum

Domestic

NGOs (Canadian Society for International Health, MDSC, MHCC)
Professional Associations (CMA, CPHA)
Academia (Global Health Schools - McGill, Dalla Lana)
Youth and People with Lived/Living Experience
Provinces/Territories (P/Ts)
Industry (arm's length)

Engagement

Strategic and meaningful engagement to formulate policy positions is key.

Stakeholders make-up an important part of Canadian Delegations (e.g. youth, P/Ts for annual WHA)
Funding to NGOs and international partners for priority projects under the IHGP
Gathering intel and sharing of info with NGOs/GH schools

Canada in Global Health: Preparing for the next 12 months

Continue fulfilling core mandate; ongoing engagement throughout transition (keeping in mind potential impact of caretaker role)
Continue progress in fulfilling obligations/commitments, including implementation of Sustainable Development Goals
Prepare strategic recommendations on areas Canada can continue to make a difference, focusing on:
- Advancing legacy issues and initiatives with demonstrated impact
- Strengthening and leveraging key relationships
- Providing strategic advice and bringing policy coherence to key global health issues

ANNEX A: Office of International Affairs - Key Functions

Global Health Policy Analysis, Advice & Support

Global Health policy development, analysis and negotiations
Global Health issues and trends analysis
Connections with foreign policy and trade agendas

International Relations & Engagement

Government-to-government bilateral relations
Lead on governing body multilateral relations (e.g. UN, WHO, PAHO)
Protocol, International Events and Official Visits
Interface with other government departments on Global Health
Stakeholder engagement of Global health issues

Priority-Setting & Strategic Planning

Coordinating and contributing to International priority-setting
Planning, monitoring and reporting on deliverables and commitments
Managing the International Health Grants Program
Portfolio secretariat for international working groups

Health Canada Departmental Budget and Financial Situation Departmental Budget

Per the 2019-20 Main Estimates, Health Canada has a budget of approximately $2.5B. The budget is broken down by branch as follows:

2019-20 Budget
-	FY 2019-20 Budget by Vote
-	FTEs	Vote 1	Vote 5	Vote 10	Total
Strategic Policy Branch	307	52.6	-	1,515.8	1,568.4
Health Products and Food Branch	2,038	234.0	0.5	-	234.5
Healthy Environments and Consumer Safety Branch	1,020	114.1	1.5	1.7	117.3
Controlled Substances and Cannabis Branch	732	80.2	0.2	38.8	119.2
Regulatory Operations and Enforcement Branch	1,285	140.5	1.5	-	142.0
Pest Management Regulatory Agency	394	41.4	0.2	-	41.6
Chief Financial Officer Branch	353	27.1	0.0	-	27.2
Corporate Services Branch	1,156	158.2	4.3	-	162.5
Executive Services	158	43.3	-	-	43.3
Communications and Public Affairs Branch	234	33.1	-	-	33.1
Departmental Reserve	0	18.4	12.2	0.1	30.7
TOTAL	7,677	942.9	20.4	1,556.4	2,519.8

Financial Situation

At P3, the Department is forecasting a surplus of $23.8M across all Votes

Forecasted Surplus / Deficit
-	Vote 1	Vote 5	Vote 10	Total
P3 Forecasted Surplus	13.5	1.7	8.5	23.8

Key Financial Considerations

The department has a number of initiatives scheduled to sunset over the next four years. Programs are working with stakeholders and partner departments to determine the path forward in seeking renewed funding
[REDACTED]

Sunsetting Initiatives
Year of Sunset	Program Description	Total
Year of Sunset	Program Description	(millions)
2019-20	Brain Canada^{Footnote 1}	13.2
2019-20	Program Integrity^{Footnote 1}	35.0
2019-20 Total		48.2
2020-21	Chemicals Management Pan	66.0
	Heart & Stroke	1.2
	Mental Health Commission of Canada	14.3
	Territorial Health Investment Fund	27.0
2020-21 Total		108.4
2021-22	Legalization of Cannabis	109.7
	Canada Health Infoway	80.0
	Regulatory Review for Drugs and Devices^{Footnote 1}	17.3
2021-22 Total		207.0
2022-23	Canadian Agricultural Partnership	4.0
2022-23	Impact Assessment	6.8
2022-23 Total		10.8
2023-24	Bringing Innovation to Regulations^{Footnote 1}	13.9
2023-24	Bovine Spongiform Encephalopathy	1.2
2023-24 Total		15.1
Footnote 1 [REDACTED] Return to footnote 1 referrer

**Health Canada Executive Committee Structure**

Executive Committee Membership
Membership	Executive Committee (EC)	Executive Committee - Look Ahead (EC-LA)	Performance Measurement, Evaluation and Results Committee (PMERC)	Executive Committee on Regulatory Strategies (EC-RS)	Executive Sub-Committee on Finance, Investment Planning and Transformation (EC-FIPT)	Executive Committee on People Management (EC-PM)	Deputy Minister's Policy Committee (DMPC)	Transition Advice and Planning (TAP) (time limited)
BRANCH RESPONSIBLE	SPB/ECS	SPB/ECS	ECS/OAE	HECSB	CFOB	CPAB	SPB/ECS	SPB/ECS
Deputy Minister	Chair	Chair	Chair	Not a member	Not a member	Not a member	Chair	Chair
Associate Deputy Minister	Alternate Chair	Alternate Chair	Alternate Chair	Alternate Chair	Alternate Chair	Not a member	Member	Alternate Chair
Abby Hoffman \| ADM, SPB	Member	Member	Member	Not a member	Not a member	Not a member	Alternate Chair	Member
Marcel Saulnier \| AsADM, SPB	Member	Member	Member	Member	Not a member	Not a member	Member	Member
Pierre Sabourin \| ADM, HPFB	Member	Member	Member	Member	Member	Member	Member	Member
Kendal Weber \| AsADM, HPFB	Member	Member	Member	Not a member	Not a member	Not a member	Member	Member
Stefania Trombetti \| ADM, ROEB	Member	Member	Member	Chair	Member	Member	Member	Member
Debbie Beresford-Green \| ADM, CSB	Member	Member	Member	Not a member	Member	Member	Not a member	Not a member
Robert Ianiro \| ADM, HECSB	Member	Member	Member	Member	Member	Member	Member	Member
Jacqueline Bogden \| ADM, CSCB	Member	Member	Member	Member	Not a member	Not a member	Member	Member
Eric Costen \| AsADM, CSCB	Member	Member	Member	Member	Not a member	Not a member	Member	Member
Jennifer Hollington \| ADM, CPAB	Member	Member	Member	Member	Member	Chair	Member	Member
Randy Larkin \| ADM and CFO, CFOB	Member	Member	Member	Not a member	Chair + DG, Planning and Resource Mgm't & Chief Information Officer	Not a member	-	Not a member
Richard Aucoin \| ED, PMRA	Member	Member	Member	Member	Not a member	Not a member	Not a member	Member
Samantha Maislin Dickson \| Senior General Counsel	Member	Member	Member	Observer Status	Not a member	Not a member	Not a member	Not a member
Shelley Borys \| OAE	Member	Not a member	Member	Not a member	Not a member	Not a member	Not a member	Not a member
Daryl Gauthier \| DG HRSD	Not a member	Not a member	Not a member	Member	Not a member	Not a member	Not a member	Not a member
PHAC \| Vice-President	Not a member	Not a member	Not a member	Member	Not a member	Not a member	Not a member	Not a member
Dr. Supriya Sharma \| Chief Medical Advisor	Not a member	Not a member	Not a member	Member	Not a member	Not a member	Member	Not a member
Karen Shepherd \| Ombudsman	Observer Status	Not a member	Not a member	Not a member	Not a member	Member	-	Not a member

Health Canada Executive Committee
Terms of Reference

1. Authority:

The Executive Committee (EC) functions under the authorities of the Deputy Minister (DM) and the Associate Deputy Minister (AsDM) to set the strategic direction of the department, make key policy and management decisions, and coordinate cross-departmental activities.

2. Role and mandate:

EC is Health Canada's senior decision-making, direction setting and oversight body.

EC convenes at two weekly meetings: Executive Committee and Executive Committee Look Ahead.

At EC meetings, members generally focus on policies, legislation and regulations, as well as emerging issues and trends that have departmental, portfolio or government implications. Members also ensure appropriate management oversight and accountability on progress, activities and performance of the department in financial management, program and service delivery, and human resources management.

At EC Look Ahead meetings, members generally focus on short-term departmental business planning such as upcoming Cabinet business, parliamentary activities, Treasury Board submissions, communications, as well as ongoing business and issues requiring senior management attention.

The Executive Committee also acts as the departmental evaluation and performance measurement committee. In this role, it serves as an advisory body to the deputy head related to the departmental evaluation plan, resourcing, and final evaluation reports and may also serve as the decision-making body on other evaluation and evaluation-related activities of the department. (See Appendix D - Roles and Responsibilities of Departmental Evaluation Committee).

3. Guiding principles

Health Canada's governance structure is based on the following principles:

Leadership - achieving an department-wide commitment to good governance through leadership
Accountability - being answerable for decisions and having meaningful mechanisms in place to ensure the department adheres to all applicable standards
Integrity - acting impartially, ethically and in the interests of the department
Stewardship - using every opportunity to enhance the value of the public assets and institutions that have been entrusted to care
Efficiency - ensuring the best use of resources to further the aims of the department, with a commitment to evidence-based strategies for improvement
Transparency/openness/predictability - having clear roles and responsibilities and clear procedures for making decisions
Engagement - using all opportunities to create a learning organization and to foster staff engagement
Agility - ensuring a flexible, responsive, adaptive organization

EC and its sub-committees commit to operate with due regard to:

Public service values, as described in the Values and Ethics Code for the Public Sector ^{Footnote 16} (i.e. democratic, professional, ethical and people values) and the Health Canada Code of Conduct;
The Treasury Board Secretariat Framework ^{Footnote 17} for the Management of Risk and the Health Canada Decision-Making Framework ^{Footnote 18};
Senior management responsibility to foster a work environment that is conducive to the effective use of both official languages, as stated in the Treasury Board Secretariat Policy on Official Languages and Health Canada's Policy on Language of Work;
Horizontal collaboration within the department and portfolio;
Compliance with laws and regulations; and
Departmental and government priorities.

4. Position with governance structure ^{Footnote 19} :

EC is supported by the following sub-committees:

EC - Finance, Investment Planning and Transformation (EC-FIPT)
EC - People Management (EC-PM)
Executive Committee on Regulatory Strategies (EC-RS)
Performance Measurement, Evaluation and Results Committee (PMERC)

An additional sub-committee made up of Assistant Deputy Ministers, called ADM-DAC, meets quarterly to review audits, progress reports against MRAPs and audit plans being tabled at Departmental Audit Committee (DAC) meetings.

It should be noted that the structure of EC and its sub-committees should not preclude departmental management from creating and dissolving committees based on operational need. However, EC shall remain the most senior horizontal decision-making body in Health Canada.

5. Agenda setting:

The business of EC is captured in the Forward Agenda of EC meetings as well as the fixed agenda of EC Look Ahead meetings.

The Forward Agenda of EC meetings are populated by items:

proposed by the Chairs of the sub-committees and approved by the DM and AsDM;
proposed by Branches and approved by the DM and AsDM; and
requested by the DM and AsDM.

Guidance for Scheduling Items at EC Meetings

The scope of the issue suggests that it would benefit or requires input from multiple Branches; or would require implementation by multiple Branches (corporate policies, changes in internal/external service delivery, etc.).
The issue directly implicates the authority or accountability of multiple ADMs, the DM, the Minister, Cabinet or Treasury Board (e.g. Memoranda to Cabinet, regulatory amendments, compliance with Central Agency policies, etc.).
The issue involves or could involve significant financial materiality (e.g. financial transactions, resource allocations, capital planning, etc.).
The issue has policy implications with potentially significant impact to the department or the health of Canadians.

Branches are encouraged to use the same criteria in proposing items for EC consideration and are encouraged to interact with the EC Services for clarification as needed.

6. Membership

Chair:: Deputy Minister/ Associate Deputy Minister
Alternate Chair:: ADM if designated by DM or AsDM
Members:: All Assistant Deputy Ministers (ADMs) and Associate ADMs
Executive Director, Pest Management and Regulatory Agency Senior General Counsel (Legal Services)
Observers:: Director General of Evaluation and Chief Audit Executive ^{Footnote 20}
Chief of Staff to the Deputy Minister
Advisors to the Associate Deputy Minister
Director General, Policy Coordination and Planning Directorate (PCPD)
Director, Strategic Policy, Priorities and Portfolio Affairs

Members are expected to attend all meetings. Where this is not possible, EC Members may designate a DG-level substitute for EC meetings, subject to the Chair's approval.

Guest presenters or observers may accompany a member for the presentation of an item, subject to the Chair's approval.

EC Members are responsible for the preparation and timely submission of materials to Executive Committee Services (ECS).

7. Frequency of meetings

EC meetings will be held weekly, or at the call of the Chair.

EC - Look Ahead meetings will be held weekly, or at the call of the Chair.

Additional special EC meetings may be organized at the call of the Chair.

8. Secretariat and administration

The Director General of Policy Coordination and Planning Directorate, with support from the Strategic Policy Priorities and Portfolio Affairs Division, and Executive Committee Services are responsible for overall secretariat support for EC meetings, which includes:

maintaining a Forward Agenda;
providing guidance on the development of EC documents to be presented by EC Members as needed;
providing advice to the Deputy and Associate Deputy Minister on EC meeting agenda items;
following up with Branches, post-meeting, as requested by the Chair, to support the further development of the work presented;
taking notes and preparing the Records of Decisions for EC meetings;
coordinating overall logistics and distribution of documents; and records management.

Footnotes

Footnote 1

Reports through PHAC.

Return to footnote 1 referrer

Footnote 2

Past 12-month use (CTADS 2017).

Return to footnote 2 referrer

Footnote 3

Past 30-day use of any tobacco product (CTADS 2017).

Return to footnote 3 referrer

Footnote 4

Past 12-month use (CTADS 2017).

Return to footnote 4 referrer

Footnote 5

Includes: cocaine or crack, ecstasy, speed or methamphetamines, hallucinogens and heroin.

Return to footnote 5 referrer

Footnote 6

Past 12-month use (CTADS 2017).

Return to footnote 6 referrer

Footnote 7

Past 30 day use.

Return to footnote 7 referrer

Footnote 8

Past 12-month use (CTADS 2017).

Return to footnote 8 referrer

Footnote 9

Past 3-month use (NCS 2019).

Return to footnote 9 referrer

Footnote 10

Source: Canadian Institute for Substance use Research/Canadian Centre on Substance Use and Addictions, 2018. Note: "CNS" = central nervous system.

Return to footnote 10 referrer

Footnote 11