Page 3: Health Canada – 2014–15 – Departmental Performance Report - Section I

Priority I - Promote Health System Innovation

SO1
1.1 Canadian Health System Policy

The health care system is vital to addressing the health needs of Canadians. Although health care delivery is primarily under provincial jurisdiction, the federal government has an ongoing role in providing financial support for provincial and territorial health insurance plans, maintaining the core principles of the Canada Health Act, and supporting health care innovation and collaboration across jurisdictions. Health Canada can contribute to improving the quality and sustainability of health care as the system continues to evolve in a context of technological change, demographic shifts and fiscal pressures.

In 2014-15, Health Canada worked with provinces, territories and other health care partners on health system renewal, innovation and sustainability. The Department supported the Minister's engagement with the public and stakeholders on opportunities and challenges for Canada's health care system through speeches, roundtables, and outreach, and pursued discussions with the provinces and territories on health care innovation. On June 2014, the Advisory Panel on Healthcare Innovation was launched to take a focused look at creative ideas and approaches that exist in Canada and abroad, and to identify those that hold the greatest promise for Canada. The Panel consulted widely with governments, stakeholders and Canadians and will be completing its work in 2015.

Health Canada addressed priority health issues through collaboration with key pan-Canadian and other organizations under its Gs&Cs program. Highlights for 2014-15 include support to:

• Canada Health Infoway to advance electronic health systems, as important components of innovation in health care.
• Canadian Institute for Health Information to improve and report on national health information.
• Canadian Partnership against Cancer (CPAC) which has accelerated uptake of new knowledge and coordinated approaches to advance cancer control in Canada.
• Canadian Agency for Drugs and Technologies in Health (CADTH) to inform health care decision-makers about the effectiveness and efficiency of health technologies.
• Mental Health Commission of Canada and its stakeholders to promote changes to the mental health system innovation.
• Brain Canada Foundation in support of the Canada Brain Research Fund, an organization dedicated to advancing cutting-edge brain research.
• Canadian Patient Safety Institute to accelerate the pace of improvement in patient safety.

Health Canada coordinated its approach to health systems research, consulted across the Health Portfolio and academia, and strengthened in-house research capacity focused on health care system trends and impacts. Highlights for 2014-15 include:

• Analyzing the emerging landscape of health care technology policy to identify potential areas for collaboration.
• Launching a series of projects, such as continuing care needs of an aging population, a policy research project on Social Health Insurance to contribute to the evidence base on the use of and affordability of home care and facility-based long-term care needs and costs in Canada, and a project to better understand the role of non-drug health technologies as a health system cost driver.

Priority II - Modernize Health Protection Legislation and Programs

SO2
2.1 Health Products
2.2 Food Safety and Nutrition
2.3 Environmental Risks to Health
2.4 Consumer Product and Workplace
Chemical Safety
2.5 Substance Use and Abuse
2.6 Radiation Protection
2.7 Pesticides

Health Canada is responsible for a regulatory regime for products in the everyday lives of Canadians, including consumer products, food, pharmaceuticals, medical devices, natural health products, chemicals, radiation emitting devices, cosmetics, pesticides, tobacco products and controlled substances. As well, Health Canada helps to manage the risks posed by environmental factors, and the health implications of air quality, water quality, radiation, and environmental contaminants. Rapid technological change, the advent of products that blur traditional definitions, and incorporate innovative components, challenge Health Canada's ability to carry out its health and safety mandate. To address this challenge, Health Canada continues to modernize its regulatory programs.

Health Canada continued to implement a risk-based approach in the interest of consumer product safety in Canada. Highlights for 2014-15 include:

• Continued implementation of a risk-based Review of Regulations process through a five-year forward plan. The Review of Regulations process will ensure that Health Canada's suite of regulations remains effective in addressing risks posed by consumer products and is aligned with requirements under the Cabinet Directive on Regulatory Management.
• A work plan under the Cooperative Engagement Framework (Canada, United States (U.S.) and Mexico) has led to the establishment of four joint project teams with the three countries sharing technical and import information, as well as joint outreach campaigns on sports safety (June 2014), baby safety (September 2014) and industry requirements on strollers and toys (September 2014 and February 2015).
• All three countries also participated in an Organisation for Economic Co-operation and Development (OECD) international outreach campaign on button batteries and laundry detergent packets.
• Health Canada continued to strengthen its surveillance reports and ad hoc analytical activity requests to inform its outreach and compliance and enforcement activities.
• Using a risk-based approach, 13 Cyclical Enforcement Plan (CEP) projects were initiated for a number of product categories for which regulations exist under the Canada Consumer Product Safety Act. To date, these CEP projects have led to enforcement actions for non-compliant products, including 29 recalls. In total, approximately 250 recalls of non-compliant products were posted in 2014-15.
• In addition, Health Canada published the first Quarterly Consumer Product Safety Incident Report Summary and the first Consumer Product Enforcement Summary Report in March 2015.

The implementation of the Globally Harmonized System (GHS) of Classification and Labelling of Chemicals was advanced in 2014-15. On February 11, 2015, the Government of Canada published in the Canada Gazette, Part II the Hazardous Products Regulations, which in addition to the amendments made to the Hazardous Products Act under the Economic Action Plan 2014 Act, No.1, modified the Workplace Hazardous Materials Information System (WHMIS) 1988 to incorporate the GHS for workplace chemicals. By adopting the GHS, Canada has achieved the Regulatory Cooperation Council (RCC) Joint Action Plan objective of reducing trade barriers and providing benefits for all stakeholders by reducing costs for suppliers, and ensuring employers and workers have access to consistent and coherent hazard information.

Health Canada continued to protect the health and safety of Canadians while reviewing and updating our regulatory frameworks based on sound science and research. Highlights for 2014-15 include:

• The Protecting Canadians from Unsafe Drugs Act (Vanessa's Law) received Royal Assent in November. It amended the Food and Drugs Act to improve Health Canada's ability to collect post-market safety information, and take appropriate action when a serious risk to health is identified. It includes a new requirement for certain healthcare institutions to provide Health Canada with information on serious adverse drug reactions and medical device incidents.
• The Regulations Amending the Food and Drug Regulations (Labelling, Packaging and Brand Names of Drugs for Human Use) were published which will improve the safe use of drugs by making drug labels and safety information easier to read and understand.
• The Department consulted on a new Consumer Health Products Framework aimed at providing a consistent approach to products of similar risk (natural health products, cosmetics, non-prescription drugs, disinfectants) whereby requirements are proportional to the benefit, harm, uncertainty profile of the products.

Health Canada contributed to the Government of Canada's efforts to reduce regulatory compliance burden and support co-operation with major trading partners. Highlights for 2014-15 include:

• Playing a leadership role in international collaborative activities in the review of generic drugs. These activities facilitated the efficient use of resources through information and work sharing with foreign regulatory counterparts.
• Working closely with the U.S., Australia, and Brazil on the Medical Device Single Audit Program, an effort to provide a single efficient audit of medical device manufacturers.
• Under the RCC initiative, Canada and the U.S. had one simultaneous veterinary drug approval, and nine drugs submitted for parallel review.

Health Canada provided citizens and stakeholders with the information they need to make informed decisions, and fostered an effective and transparent regulatory system for health protection as outlined in Health Canada's Regulatory Transparency and Openness Framework. Highlights for 2014-15 include:

• Publishing 20 prescription and one non-prescription summary safety reviews in plain language for Canadians.
• The first plain language summary of a Novel Food Decision Document was published for the Arctic Apple approval.
• Developing the next phase of the Nutrition Facts Education campaign focusing on Serving Size and the Percent Daily Value.

Health Canada continued to deliver a pesticide regulatory program that is protective of human health and the environment, in a timely, transparent and accountable manner. The Department continued to meet regulatory, timeline and performance requirements of the Pest Control Products Act, including pesticide evaluation and re-evaluation, compliance and enforcement, and outreach and risk reduction strategies, in the face of evolving workload pressures and priorities.

Priority III - Strengthen First Nations and Inuit Health Programming

SO3
3.1 First Nations and Inuit Primary Health Care
3.2 Supplementary Health Benefits for First
Nations and Inuit
3.3 Health Infrastructure Support for First
Nations and Inuit
Internal Services (CFOB - IM/IT)

First Nations and Inuit continue to experience serious health challenges. Health Canada plays an important role in supporting the delivery of, and access to, health programs and services for First Nations and Inuit. Health Canada works with partners on innovative approaches to strengthening access to, and better integration of health services, as well as encourages greater control of health care delivery by First Nations and Inuit. Many departmental strategies evolved to correspond to the health needs of First Nations and Inuit. In addition, Health Canada also continues to work with partners to further the implementation of a Strategic Plan which is intended to provide a stronger sense of coherence and direction for Health Canada's activities in this area, and demonstrate how the Department collectively contributes to improving health outcomes for First Nations and Inuit.

Health Canada strengthened primary care and public health service models and strengthened access, quality and safety across the continuum of health services. Highlights for 2014-15 include:

• Enhancing the use of inter-professional teams and examining new models of care in remote and isolated communities.
• Modernizing Clinical Practice Guidelines for nurses in primary care.
• Launching a new marketing campaign as part of Health Canada's Nursing Recruitment and Retention Strategy.

Health Canada advanced collaborative effort with provinces/territories and First Nations and Inuit to ensure quality health services. Highlights for 2014-15 include:

• Continuing support for the implementation of the British Columbia Tripartite Framework Agreement on First Nation Health Governance.
• Investing in innovative approaches to integrate federal/provincial/territorial health services and improve access to quality health services for First Nations and Inuit.
• Working with the Assembly of First Nations (AFN) on an Engagement Protocol and with the Inuit Tapiriit Kanatami (ITK) on an Inuit Health Approach, to support a mutually acceptable standard of engagement for FNIHB policy and program initiatives.
• Finalizing a Joint Action Plan to enhance collaboration between First Nations, Health Canada, Alberta Health and Alberta Health Services, which was approved by the federal and Alberta Ministers of Health.

Health Canada improved the quality and availability of comprehensive mental health and addictions services, including defining service levels, standards and indicators. Key highlights for 2014-15 include:

• Finalizing the First Nations Mental Wellness Continuum Framework.
• Developing suicide prevention modules to support Mental Wellness Teams.
• Enhancing the Prescription Drug Abuse Strategy and client safety through the monitoring and surveillance of prescription drug utilization and prescribing patterns.
• Investing in training crisis teams in Manitoba and Saskatchewan as part of the Prescription Drug Abuse Strategy.

Health Canada emphasized collaborative/horizontal work with Aboriginal Affairs and Northern Development Canada, the Health Portfolio and other key partners. In 2014-15, Health Canada fully implemented AANDC's risk management tool (the General Assessment) using the Grants and Contributions Information Management System (GCIMS).

Health Canada ensured access to Non-Insured Health Benefits (NIHB) to First Nations and Inuit. Key highlights for 2014-15 included:

• Developing an interim five-year management plan for supplementary health benefits as part of ongoing efforts to increase efficiencies.
• Continuing work with the AFN and ITK on the Joint Review of the NIHB Program.

Health Canada improved the availability of and access to high quality data to better inform decision making and performance measurement and reporting. Key highlights for 2014-15 included:

• Developing a monitoring and performance framework for tuberculosis programs as part of the early implementation of Health Canada's Strategy Against Tuberculosis for First Nations On-Reserve.
• Completing regional assessments to inform the development of a surveillance and information framework relevant for communities and aligned with First Nations/ Inuit/ provincial/territorial surveillance and information strategies.
• Training approximately one thousand workers in the correct use of enhanced personal protective equipment in response to the Ebola crisis.

Priority IV - Continue to build an efficient, interconnected and adaptable organization with improved processes, structures and systems

Internal Services

The success of Health Canada depends on having processes, structures and systems that support its programs to excel in meeting their objectives. These foundations are critical to assist the Department to adapt to changing pressures, devise innovative approaches to problems, work collaboratively to address common issues, and provide efficient and cost-effective services to internal and external clients. Cutting edge public communications and engagement services and systems are vital to promote public health and provide relevant, accessible public health information. In 2014-15 the Department is focused on improving business approaches and streamlining services independently and in partnership with Government of Canada organizations.

Through the Shared Services Partnership advances were made on government-wide modernization and transformation initiatives such as e-mail transformation initiative, the Windows 7 project completion, the IM maturity initiative, cost effective telephone services and Workplace 2.0.

Health Canada also conducted successful testing of all systems related to a multi-departmental initiative (led by the Canada Border Services Agency) to implement a single window through which importers can electronically submit information necessary to comply with government import regulations.

Health Canada undertook several initiatives that served to improve internal processes and provide better services to Canadians and clients. Highlights for 2014-15 include:

• Successfully transitioning Public Health Agency of Canada (PHAC) to the new GCIMS in partnership with Aboriginal Affairs and Northern Development Canada (AANDC). All 2014-15 payments were processed using GCIMS payment module.
• Implementing the on-going risk-based monitoring strategy for Internal Controls over Financial Reporting for Health Canada's and PHAC's common key controls related to financial statements.
• Initiating the Planning for Enterprise Performance (PEP) project which will result in high degree of alignment between financial and non-financial planning and reporting activities and priorities in Health Canada and partner departments.
• Successfully rolled out to both Health Canada and PHAC, in support of the Shared Services Partnership, the new Shared Travel Services products and tools such as Government Travel Card, Online Booking Tool, Travel Expense Management Tool and Travel Agency Services.

1. Risks exist with the ability to reform legislative and regulatory systems:

• Need to leverage international cooperation and alignment.
• Meeting demand for openness and transparency.

Health Canada leveraged and exchanged information with foreign regulators by means of quarterly planned multilateral Cluster Meetings. In addition, ad-hoc bilateral teleconferences with other regulators were held to discuss common submissions. When appropriate, the program used foreign review reports as a further source of information.

In order to build on international efforts to assess and manage chemicals, assessments of existing substances in Canada continued to take into consideration regulatory information and activities in other countries, as appropriate.

Health Canada continued to work with key regulatory partners at the World Health Organization to share best practices on product regulation for tobacco products.

Health Canada also worked collaboratively with international partners to effectively harmonize regulatory processes by participating as:

• Member and Chair of the International Coalition of Medicines Regulatory Authorities.
• Member of harmonization initiatives such as International Conference on Harmonisation.
• On-going exchange of regulatory information.

Health Canada launched the Regulatory Transparency and Openness Framework in April 2014 in order to improve access to timely, useful and relevant health and safety information available to Canadians. The first year of the Framework produced significant achievements, including: the launch of the Drug and Health Product Register, a new resource for Canadians looking for information on prescription drugs; and consultation with Canadians to determine how to improve nutritional information on food labels.

• PA: 2.1, 2.2, 2.3, 2.4, 2.5, 2.7
• OP: II, IV

2. Risks exist with First Nations and Inuit Health System Innovation:

• Differing regional circumstances and contextual environments.
• Varying capacity of partners.
• Alignment between Health Canada and local health needs.

In 2014-15, Health Canada supported over 300 communities to design, deliver and manage health programs and services through Flexible or Block funding arrangements. 518 communities across all provinces and territories were involved in Health Services Integration Fund projects that supported innovative approaches to integrate federal and provincial health services.

In addition, the department supported the development of the First Nations Mental Wellness Continuum Framework in partnership with key stakeholders, which provides guidance on adapting and realigning programs and services to be more flexible and responsive to community needs.

• PA: 3.1, 3.2, 3.3
• OP: III

3. Risks exist with the ability to deliver high quality health services to First Nations and Inuit:

• Sustainability of primary care.
• Variable capacity of partners.
• Lack of program data.

Health Canada continued to enhance new models of care by reorienting service delivery toward inter-professional teams and establishing a Relief Nursing Coordination Unit to introduce standardization and manage nursing relief service contracts in three regions. In addition, a 10-year Home and Community Care Program Plan was finalized to assist program staff to anticipate and respond to evolving health needs and trends associated with home care for First Nation and Inuit clients.

Health Canada undertook monitoring and surveillance of prescription drug utilization and prescribing patterns as part of its strategy to address prescription drug abuse. Additionally, Health Canada continued to work with AANDC and First Nations communities on data linkages between the Indian Registry System and provincial data sets.

• PA: 3.1, 3.2, 3.3
• OP: III

4. Risks exist with implementing innovations in Grants & Contributions (Gs&Cs) delivery to Canadians:

• Pressure to reduce administrative burden on clients.
• Meeting demand for openness and transparency.
• Transitioning to new GCIMS.

The Department successfully adopted GCIMS in a phased approach to ensure that the support capacity can meet program requirements. Health Canada and AANDC continue to collaborate on the new functions in GCIMS such as Debt Management and Multi-Year functions. These new functions will benefit both AANDC and Health Canada portfolio users.

Health Canada also adopted a general assessment module in GCIMS along with the common process and e-learning training material and piloted an automated performance measurement system for Gs&Cs to support improved recipient reporting and program management.

• PA: 1.1, IS.1.1
• OP: I, IV

3,657,312,088

3,658,912,088

3,909,808,102

3,814,473,966

155,561,878

9,081

8,756

-325

242,633,254

244,186,030

260,390,118

279,235,095

359,916,645

334,273,289

353,877,280

405,697,982

18,728,166

18,728,166

19,133,053

18,594,271

15,315,788

13,650,940

16,475,781

19,926,803

37,527,825

37,527,825

37,528,856

38,090,836

37,412,211

36,653,712

25,830,789

39,011,188

298,889,245

300,442,021

317,052,027

335,920,202

412,644,644

384,577,941

396,183,850

464,635,973

152,060,884

152,060,884

148,110,784

144,368,697

167,240,719

166,617,222

179,564,797

164,654,898

59,175,139

59,175,139

67,838,730

63,411,776

66,393,020

66,365,087

71,238,491

69,655,161

102,849,859

102,849,859

100,282,109

32,895,947

107,392,104

97,967,114

101,141,190

103,655,546

37,725,014

37,725,014

37,689,337

32,920,119

37,697,458

34,325,605

35,535,627

28,148,044

82,748,939

82,748,939

86,731,215

87,710,622

74,460,754

69,339,368

88,591,578

115,533,278

20,522,668

20,522,668

20,282,587

13,097,382

21,345,176

20,709,033

21,420,658

15,303,974

40,651,125

40,651,125

40,190,336

35,248,559

45,426,812

44,319,169

46,299,835

42,148,137

495,733,628

495,733,628

501,125,098

409,653,102

519,956,043

499,642,598

543,792,176

539,099,038

853,702,552

853,702,552

809,838,696

746,688,679

884,879,027

870,774,016

927,125,272

945,580,413

1,133,324,859

1,133,324,859

1,128,474,836

1,077,480,363

1,104,008,776

1,075,694,038

1,071,034,484

1,140,213,493

604,177,779

604,177,779

635,463,846

664,358,695

640,557,440

640,190,204

525,066,806

356,715,000

2,591,205,190

2,591,205,190

2,573,777,378

2,488,527,737

2,629,445,243

2,586,658,258

2,523,226,562

2,442,508,906

271,484,025

271,531,249

266,815,846

252,973,346

347,762,172

343,595,169

364,976,909

374,914,169

3,657,312,088

3,658,912,088

3,658,770,349

3,487,074,387

3,909,808,102

3,814,473,966

3,828,179,497

3,821,158,086

1.1 Canadian Health System Policy

Social Affairs

Healthy Canadians

334,273,289

1.2 Specialized Health Services

Social Affairs

Healthy Canadians

13,650,940

1.3 Official Language Minority Community Development

Social Affairs

Healthy Canadians

36,653,712

2.1 Health Products

Social Affairs

Healthy Canadians

166,617,222

2.2 Food Safety and Nutrition

Social Affairs

Healthy Canadians

66,365,087

2.3 Environmental Risks to Health

Social Affairs

Healthy Canadians

97,967,114

2.4 Consumer Product and Workplace Chemical Safety

Social Affairs

Healthy Canadians

34,325,605

2.5 Substance Use and Abuse

Social Affairs

Healthy Canadians

69,339,368

2.6 Radiation Protection

Social Affairs

Healthy Canadians

20,709,033

2.7 Pesticides

Social Affairs

Healthy Canadians

44,319,169

3.1 First Nations and Inuit Primary Health Care

Social Affairs

Healthy Canadians

870,774,016

3.2 Supplementary Health Benefits for First Nations and Inuit

Social Affairs

Healthy Canadians

1,075,694,038

3.3 Health Infrastructure Support for First Nations and Inuit

Social Affairs

Healthy Canadians

640,190,204

Economic Affairs

Social Affairs

3,387,380,839

3,470,878,797

International Affairs

Government Affairs