Regulatory Operations and Enforcement Branch Strategic Plan 2019-2022

ADM Message

In April 2016, Health Canada introduced a dedicated compliance and enforcement branch. This was a critical step to strengthen oversight of the department’s acts and regulations, and improve national consistency of program delivery. Much progress has been made since 2016. As the dynamic environment within which our work evolves, so too must our branch.

This strategic plan is the culmination of a comprehensive review that was conducted in 2017, and engagement with employees across the country. The plan outlines a three year vision of how we will modernize our compliance and enforcement approach, laboratories, and scientific programs, strengthen our infrastructure, equip our workforce with needed tools, and foster a healthy, inclusive, and respectful workplace.

I want to sincerely thank all members of our team for your contribution to the development of this plan. Whether it is by enforcing one of our many regulations, conducting scientific analysis, or developing and administering policies and programs, the work we do has a meaningful impact on the overall wellbeing of our country. Together, we will continue to protect and improve the health and safety of Canadians by remaining committed to regulatory excellence.

Tina Green
Assistant Deputy Minister
Regulatory Operations and Enforcement Branch

Regulatory Operations and Enforcement Branch

We are Health Canada’s dedicated compliance and enforcement branch. We inform and protect Canadians from health risks through regulatory oversight, outreach, laboratories, and scientific analysis. With more than 1000 employees across Canada, the branch is well positioned to understand the risks faced by Canadians, the context in which Health Canada delivers its programs and services, and to contribute to regulatory policy and program development at a national level.

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

What We Do

The Regulatory Operations and Enforcement Branch (ROEB) delivers its compliance and enforcement programs, and conducts its laboratory and scientific analysis in collaboration with internal and external partners and stakeholders.

Compliance and enforcement

Cannabis, drugs and natural health products, pest control products, controlled substances, and tobacco/vaping; Consumer product safety; Medical devices, clinical trials, and biologics; Manufacturing practices

Laboratories and scientific analysis

Drug analysis, health products, food and microbiology laboratories; Air quality and chemical assessments

Health promotion, protection, and outreach

Environmental health; Internationally protected persons; Domestic and international collaboration

Policy and operations

Border integrity and surveillance; Establishment licensing; Internal operations and services

Our Guiding Principles

Our branch is guided by the following five principles:

• Excellence
• Respect
• Consistency
• Transparency
• Agility

They are essential to how we conduct our work and the environment in which we operate. These principles reflect how we treat our partners, stakeholders, and employees, and how we expect to be treated in return. This is core to ROEB’s strategic foundation and guides our conduct, activities, and the goals we work towards every day.

Our Strategic Priorities

• Modern Program Delivery
• Compliance and Enforcement Transformation
• People and Workplace Excellence

Modern Program Delivery

We are strengthening our strategic partnerships and operational infrastructure to modernize our regulatory programs and scientific services. We are investing in mobile tools and integrated processes to be more efficient and effective. Our goal is to protect the health and safety of Canadians and be a more agile and responsible regulator and partner.

Objectives

• Strengthen partnerships by clarifying accountabilities and aligning with industry and international practices
• Invest in technology by developing modern and interoperable systems and tools
• Ensure national consistency by developing standardized and streamlined business practices

Key Initiatives

• Enhance engagement and improve effectiveness of outreach and scientific advice to industry, stakeholders and partners
• Improve reporting of non-compliance and the management of drug shortages in collaboration with our partners
• Expand and enhance international partnerships and respect our international Mutual Recognition Agreements (MRA)
• Ensure that the ROEB Laboratories have the capacity necessary to conduct analyses of samples, as well as develop and maintain its laboratory equipment and services, and scientific expertise
• Implement a new IM/IT strategy, including modernizing tools for inspectors, analysts and specialists such as upgrading our licensing databases
• Support department-wide modernization initiatives, such as GCWiFi and GCDocs
• Invest in our skills and assets, including project management, scientific analysis, and fleet management
• Develop an occupational health and safety program

Compliance and Enforcement Transformation

We are enhancing oversight to continuously improve how we conduct our regulatory activities and responsibilities. Our goal is to be a truly dynamic organization that is proactive and intelligence-driven so that we are at the forefront of existing and emerging risks.

Objectives

• Become more proactive by leveraging data to better identify and manage risks
• Strengthen oversight of regulated parties by better targeting resources and increasing foreign and domestic inspection and investigation capacity
• Improve programs by establishing new, innovative, and transparent regulatory frameworks

Key Initiatives

• Provide timely analysis and information to law enforcement partners and clients. This includes eliminating sample backlogs, keeping pace with national and international standards, and improving expertise to better react in the face of new and complex legal and illegal drugs
• Leverage data to be more proactive, including targeting regulated parties based on risk and incenting and promoting compliance through online and social media platforms
• Increase domestic and foreign surveillance and inspections, including developing virtual inspection capacity and a compliance and enforcement toolkit
• Strengthen our borders by increasing surveillance and inspections of shipments in collaboration with our partners
• Develop and implement investigative capacity, including establishing formal networks and policies
• Develop clear and consistent policies and guidelines, such as a inspectors’ guide, and designation and oversight policies
• Explore potential legislative and regulatory modifications, including updating and expanding our cost recovery regimes

People and Workplace Excellence

We are delivering our mandate in an environment where our employees will thrive. Our goal is to embrace a healthy, inclusive, and respectful work experience with a modern workplace, mobile workforce, and positive branch culture.

Objectives

• Create an innovative workplace by ensuring we are equipped to achieve our vision
• Strengthen our workforce by attracting, retaining, and developing our talent
• Foster employee engagement by promoting frequent and meaningful interactions
• Support a healthy, productive workforce by ensuring the right tools and resources are in place to support and recognize staff

Key Initiatives

• Implement a people and workplace plan, which includes accommodations and national staffing strategies
• Champion virtual work by promoting consistent practices
• Develop a branch manager’s network, including managers’ forums
• Enhance employee skills by implementing an employee training and development program across ROEB, including targeted training for inspectors and analysts
• Support career development opportunities, including micro-missions and assignments
• Engage staff regularly through virtual cafés, regional management visits, and all-staff town halls
• Implement an official languages strategy, including a language exchange initiative
• Prioritize employee well-being by promoting mental health, workplace wellness, diversity, and linguistic duality

Tracking Our Progress

• This strategic plan will be used to guide ROEB’s operational planning process over the next three years. Progress will be monitored and tracked through existing planning and performance mechanisms and cycles, including branch performance dashboards, the Branch Operational Plan, and performance agreements for staff at all levels.
• An annual results snapshot of the key highlights and achievements will be prepared at the end of each fiscal year and shared with staff and both internal and external stakeholders. Any required modifications to this plan will be dealt with promptly and communicated in a way that is open and transparent.
• Going forward, significant collaboration and effort will be required to implement this plan. It will require the entire ROEB team, across all programs and business lines, to remain dedicated and committed to the delivery of our vision, mission, goals, objectives, and actions necessary to achieve regulatory excellence.