Background on Government and Portfolio Processes - Ministerial Briefing - Volume VI

This volume provides background and contextual information on governmentwide and Portfolio processes. Government processes include the Cabinet process, parliamentary process, legislative process, regulatory development process and financial management. This binder also covers how approvals and oversight work for key products; Canada's food safety system; Canada's health care system (including for Aboriginal Canadians); public health; risk communications; and Portfolio operations.

Table of Contents

Government-wide Processes

• A. Government-wide Decision-Making (Cabinet Process) Description of the Cabinet process (Cabinet Committees, Memoranda to Cabinet, Records of Decision, etc.)
• B. Parliamentary Process Description of the legislative and parliamentary process (Question Period, Parliamentary Committees, etc.)
• C. Overview of Legislative Instruments Description of the types of legislative instruments that a Minister has at his/her disposal to make policy changes and their intended objectives
• D. Overview of Regulatory Development Process Description of the steps in the highly-structured federal regulatory process (e.g., consultations, drafting, Treasury Board decisions, publications in Canada Gazette)
• E. Financial Management Description of the steps in the government expenditure cycle, the Minister's role (i.e., Main Estimates appearance) and how funding flows to departments

Portfolio Processes

The tabs in the section below provide an overview of how key areas under the Health Portfolio's responsibility operate in practice

• F. How approvals & oversight work for key products Overview of how Health Canada's regulatory review and approvals process works for the product lines below
  • 1. Drugs
  • 2. Medical Devices
  • 3. Natural Health Products
  • 4. Over the Counter drugs
  • 5. Vaccines
  • 6. Consumer Products
  • 7. Pesticides
• G. Canada's Food Safety System Overview of Canada's food safety system and how the CFIA manages the food recall process
• H. Risk Communications Description of risk communications for health advisories and warnings, along with a description of the process within the department
• I. Canada's Health Care System
  • 8. Canada's health care system: Description of Canada's health care system and the role of the federal government vis-à-vis provinces and territories
  • 9. Administration of the Canada Health Act Description of Health Canada's role in administering the Canada Health Act and the ways that a Minister can intervene when there are violations
  • 10. How the Canada Health Transfer system works Description of the Canada Health Transfer payment structure and how payments are made as well as the role of Health Canada vis-à-vis Finance
• J. Health System for Aboriginal Canadians Overview of how health delivery is managed for Aboriginal Canadians (i.e., role of federal government vis-à-vis the provinces and territories)
• K. Public Health
  • 11. Public health system Description of Canada's public health system (i.e., role of the federal government vis-à-vis the provinces and territories, and other stakeholders)
  • 12. Emergency Preparedness and Response (infectious disease and food-borne illness outbreaks) Overview of what PHAC does when there is an infectious disease or food-borne illness outbreak
• L. Health Portfolio Operations
  • 13. Access to Information (ATI) Description of the government's ATI process - specifically for the Health Portfolio
  • 14. Grants and Contributions (G&Cs) Description of the process for initiating and approving G&Cs programs, as well as reviewing and making decisions about submission

A. Government-Wide Decision-Making: The Cabinet Process

1. What is Cabinet?

Cabinet is the body of advisors that sets the federal government's policies and priorities for the country. Members of Cabinet (Ministers) are appointed by the Governor General on the advice of the Prime Minister. Cabinet Ministers are usually selected from the House of Commons but can also be appointed from the Senate.

2. What is Cabinet's role?

The cabinet system performs several key functions, including:

• securing agreement among Ministers on Government priorities and on the Government's parliamentary actions;
• providing a forum of debate; and
• ensuring Ministers and the Prime Minister have the necessary information they need to carry out their responsibilities.

3. How does the Cabinet system work?

The Cabinet system is formed by Cabinet committees. Ministers are members of the Cabinet committees, and while they may be members of more than one committee, not all Ministers sit on all committees.

While it is the Prime Minister's prerogative to organize Cabinet and the Cabinet committee decision-making system, in the recent past there have been two types of Cabinet committees: policy committees and executive committees. Generally, policy committees consider proposals aimed at implementing the government's agenda, parliamentary business, and any other matter of general concern to Canadians or the government. Issues are normally brought forth by a Minister in the form of a Memorandum to Cabinet which is tendered to the appropriate Cabinet committee after it has been circulated to all member Ministers. In past Parliaments, policy committees have been established to examine issues such as social affairs, the economy, foreign affairs, security, Aboriginal affairs, Canada-U.S. relations, and unity.

Once an item has been discussed at a policy committee and consensus has been reached, a Cabinet Committee Recommendation (CR) is issued. The decision is subject to confirmation by an executive committee chaired by the Prime Minister, normally a committee known as the Priorities and Planning committee. Once a decision has been reached by the executive committee, it is recorded and communicated throughout the government in the form of a Record of Decision.

Besides their role in confirming decisions made by policy committees, executive committees generally consider items of special urgency, political issues and the review of senior appointments. Treasury Board is also considered an executive committee as its decisions are not normally subject to further approval. Typically chaired by the President of the Treasury Board, this committee has historically been responsible for financial, personnel and administrative management, comptrollership, and approving regulations and most Orders-in-Council.

4. What items are considered by Cabinet?

Generally, any new policy direction or position must be approved by Cabinet. While the scope of the responsibility can vary, examples of issues on which Ministers were instructed to have Cabinet approval can include:

• new or major policy changes: to seek funding and/or policy authority for an initiative and/or propose a new or modified policy/program.
• Government Responses (GR): to respond to a Standing House of Commons or Senate Committee Report.
• Government Positions on Private Members' Business (PMB): to propose the Government's position on Private Members' Bills or Motions before debate in Parliament.
• legislation: to propose new legislation or amendments to existing legislation in advance of it being introduced.
• high-level consultation/issues management: to seek authority or agreement for the Minister to consult or negotiate with other governments or sectors (e.g.provinces/territories, foreign governments, organizations, and/or stakeholders).

5. What documents are used to support Cabinet decision making?

A Memorandum to Cabinet (MC) is prepared by the Department in consultation with the Minister. An MC sets out the background, rationale and recommended policy approach. It also notes the other options that were considered and why they are not the preferred recommendation, and outlines various considerations of the proposed approach, including legal and constitutional considerations, the impact on federal/provincial relations, and expected stakeholder views. The MC also includes drafting instructions for legislation, an implementation plan for policy, a communications plan to manage communications and a parliamentary plan which sets out the strategy for managing the issue in Parliament.

MCs are signed by the Minister responsible for the proposal. If the proposal affects the mandates of more than one department, all of the impacted Ministers may be asked to sign the document. Once approved by the Minister, the MC is shared with other Ministers who are members of the Cabinet committee that will consider the issue. (This distribution is managed by the Privy Council Office, which acts as the secretariat for all Cabinet committees.)

If a Minister is presenting an item to a committee, they are often asked to use a PowerPoint presentation that summarizes the key information in the MC in order to help guide the discussion.

6. Besides presenting items, what is the Minister's responsibility as part of Cabinet?

The Minister is expected to attend Cabinet meetings and participate in discussion. As a member of Cabinet, the Minister must adhere to the principle of cabinet solidarity. This allows Ministers to be frank when they are in private in Cabinet, but requires them to support the Government's decisions in public.

Ministers are also expected to follow the principle of Cabinet confidence, which means that Cabinet discussions and related material is not to be publicly disclosed. The protection of the confidentiality of Cabinet proceedings is a longstanding constitutional convention that protects the collective decision-making process and solidarity of Ministers, enabling them to support government decisions despite any differing views. Consistent with this principle, the Government's new policy direction is only discussed after it receives Cabinet approval and in accordance with the communications strategy approved by Cabinet.

7. Who supports the Minister in meeting their Cabinet responsibilities?

The Minister is supported by the Department through the Cabinet Affairs Office, which prepares the necessary information for the Minister (e.g., briefing notes, MCs, presentations), in consultation with the Minister. The Cabinet Affairs Office is the Centre of Expertise for Cabinet and Cabinet documents, including MCs, and is responsible for:

• managing the Health Portfolio Cabinet agenda and regularly briefing senior management on the proposed Cabinet agenda;
• liaising regularly with the Privy Council Office on strategy and timing for Cabinet submissions;
• managing the development of Health Canada-led Cabinet submissions and supporting materials on behalf of the Minister;
• supporting the Minister's participating in Cabinet committee meetings by preparing weekly briefing packages on all items to be discussed at the Cabinet committee meetings the Minister is expected to attend.

8. What is the process for how Cabinet decisions are made, recorded and communicated?

In most cases, items are first considered at a policy committee, where the item can be approved in principle. If this is the case, a Committee Recommendation (CR) is issued by the Privy Council Office (PCO). That said, a policy committee is not required to approve the Minister's recommendation and can ask for changes to the proposal and request that the sponsoring Minister return to Cabinet with a revised MC.

Once an item is approved in principle by a policy committee, it must be considered and ratified by an executive committee (such as, in past governments, the Priorities and Planning committee) or by the full cabinet. Once the decision is ratified, the decision becomes official and a Record of Decision (RD) is issued by PCO. However, an executive committee is not required to ratify the decision. The committee can ask for changes to the proposal and request that the sponsoring Minister return to either the policy committee or the executive committee (e.g. Priorities and Planning, the full Cabinet) with a revised MC. Even if a decision is ratified, Ministers may also be asked to return to Cabinet at a later date with an update, evaluation, or more detailed proposal. The Minister may also have to return to Cabinet if there is a decision to modify the initiative from what was originally approved by Cabinet.

An announcement related to the decision can only be made once the item is ratified and all approvals are in place.

9. What does ad referendum to the Prime Minister mean?

On occasion, an executive committee (such as the Priorities and Planning committee) may approve an item with the proviso that it is "ad referendum" to the Prime Minister. Ad referendum means that the final decision rests with the Prime Minister. Although he or she may take advice from Cabinet, the final decision rests solely with the Prime Minister. Issues that are ad referendum to the Prime Minister generally include Machinery of Government changes such as the structure and organization of government portfolios.

B. Parliamentary Process

1. What are the key elements of the parliamentary system?

Canada's parliamentary system stems from the British, or "Westminster", tradition. This system consists of three parts: the Monarch (our Head of State); the Senate; and the House of Commons. Laws are enacted once they are agreed to by all three parts. The Monarch is represented in Canada by the Governor General who acts on behalf of the Queen.

2. What is the Speech from the Throne?

The Speech from the Throne is delivered by the Governor General in the Senate chamber and opens a new session of Parliament. The Speech sets out the Government's agenda, including the policies and bills it plans to introduce.

3. How does a bill become law?

Considering legislation is one of the key elements of parliamentary debate. Much of the time in the House of Commons and Senate revolves around debating proposed laws.

In order to become law, a bill must be agreed to in the same form by both the House of Commons and the Senate. A bill can be introduced in the House of Commons or the Senate, but a bill that spends public funds or imposes a tax must be introduced in the House of Commons.

The process for the passage of a bill is similar in both the House of Commons and the Senate. Normally the procedure is as follows:

• Introduction and First Reading: the bill is introduced.
• Second Reading: at this stage, the underlying principles and policy objectives (scope) of the bill are debated. All parties have the opportunity to voice their opinions during this debate. At the end of the debate a vote is called to adopt or reject the proposed bill and to refer it to a Standing Committee for detailed study and possible amendment. Although it is still possible to amend the legislation, any changes must remain within the scope of the original bill. In the House of Commons, it is possible to refer a bill to committee before second reading. Referral before second reading provides for more flexibility regarding amendments during the committee stage of the process. In the Senate, it is possible for a committee to study the subject matter of a bill introduced in the House of Commons prior to the bill being debated in the Senate.
• Committee stage: at this stage the bill is studied in detail by the committee, which will often hear witnesses and conduct a clause by clause examination of the bill. When the committee studies government legislation, the responsible Minister is normally called as a witness. The committee can make amendments to a bill as long as the amendments are in line with the scope of the bill. Once the study is concluded, the committee must report the bill back to the originating Chamber with or without amendments. The committee can also recommend that the bill not proceed any further.
• Report stage: at this stage the bill as passed by the committee is considered and an opportunity is provided for Members who were not members of the Committee to propose further amendments to the bill.
• Third Reading: the bill is debated a final time. Once the bill has been "read a third time" it is deemed to have been passed by the House of Commons or Senate.

Once the bill has been passed by one house of Parliament, it is sent to the other house where it follows the same process. If either the Senate or the House of Commons amends a bill already passed by the other house, the amendments must be considered and agreed to by the other house as well. The bill must be passed in the same form in both houses before it can be presented for Royal Assent.

Royal Assent is the point at which the bill becomes law or an Act of Parliament. Royal Assent is granted by the Governor General or one of his or her deputies.

Bills can be introduced by either the Government or by Members of Parliament or Senators who are not part of Cabinet. These types of bills are known as Private Member's Bills (MPs) or Private Senator's Public bills (Senators). All bills must follow the same process to become law, although the rules for Private Members Business are complex and vary in both the House of Commons and the Senate. Although Private Members Business is an important aspect of the daily Parliamentary agenda, it is important to note that the majority of time allocated in Parliament for debate is reserved for consideration of Government-proposed legislation.

4. How is the Minister supported in the legislative process?

Legislation itself is drafted by legislative drafters at the Department of Justice, in consultation with officials from the Health Portfolio, based on drafting instructions provided for in the Memorandum to Cabinet.

Once legislation is ready for introduction in the House of Commons, the Minister is supported by the Portfolio. The Health Portfolio, through the Parliamentary Affairs Office, prepares the necessary information as the bill moves through the legislative process. This includes documents such as:

• speeches for debate at all stages of the legislative process in both the House of Commons and the Senate;
• briefing binders, including background information, questions and answers and other briefing material, to support the Minister before introduction of the bill and as necessary throughout the legislative process; and
• briefing material for government and opposition committee members, if required.

5. What is the Order Paper and Notice Paper?

The Order Paper and Notice Paper is a two-part document published each sitting day in both the House of Commons and the Senate. The Order Paper is the complete and authoritative agenda of all items of business that may be considered by both houses of Parliament. The Notice Paper contains all items for which notice has been given. This means that the items are put on notice to be added to the Parliamentary agenda. Together, these documents contain virtually all items of business that are before the House or Senate or that may be brought before the House or Senate. Printed copies are distributed in the morning in the Chamber. The electronic version is usually made available on the Parliament of Canada web site the previous evening.

6. What is Question Period?

Question Period, formally called "oral questions", is a 45 minute period held each day in the House of Commons which gives Opposition and Government "backbench" Members of Parliament (i.e., those that are not Ministers) the opportunity to ask the Government questions and hold it to account.

A "late show" is a follow up to Question Period that occurs during the end of a House of Commons sitting day during adjournment proceedings. A member who wishes to receive more information following a response given to his or her question during Question Period can ask for the matter to be raised again during the adjournment proceedings. A "late show" can happen daily, although requests for questions related to the Health Portfolio are less frequent. If the matter is selected, debate can last no longer than ten minutes.

7. How is the Minister supported for Question Period?

The Minister is supported by the Health Portfolio. The Portfolio, through the Parliamentary Affairs Office, prepares "QP cards" which contain a proposed response to an anticipated question as well as background information for the Minister. The background information is publicly available material and does not contain any information that cannot be released to the public.

Typically, at the beginning of a Parliamentary session, the Health Portfolio prepares a comprehensive binder for the Minister of anticipated health-related issues that may be raised during Question Period. This binder is then updated periodically during the session. The Minister may also request a QP card at any time to respond to any health-related issue that may arise during Question Period. Each day that Parliament is sitting, the Portfolio helps to identify whether or not QP cards are needed for that day.

8. How does the parliamentary committee system work?

Parliamentary committees are important elements of the parliamentary process. Both the House of Commons and the Senate have committees that help support parliament's work.

Although the rules and organization of committees differ slightly between the House and Senate, committees serve the same basic function in enabling detailed examination of complex matters more easily completed in committees, rather than in the full assembly of the House or Senate. This includes detailed study of legislation, examination of the estimates, or of a subject matter related to the committee's mandate. The committee structure allows for more direct engagement with Canadians during the examination of issues and helps Members of Parliament and Senators develop expertise on various subject areas.

Committees are made of all members from all parties. Party representation on committees is roughly proportional to the party standings in the House or Senate.

The primary committees related to the work of the Health portfolio are the House of Commons Standing Committee on Health (HESA) and the Standing Senate Committee on Social Affairs, Science and Technology (SOCI). In addition to health-related legislation, in the last Parliament, HESA studied a range of issues relating to the portfolio including medical marijuana, mental health and e-cigarettes, while SOCI completed a multi-year study on prescription pharmaceuticals in Canada. Occasionally health-related issues will also be examined by other committees in the House of Commons or the Senate.

9. How is the Minister supported in parliamentary committees?

The Portfolio, through the Parliamentary Affairs Office, monitors all committee activity and provides updates and information on health-related business.

Parliamentary Affairs also works closely with the Portfolio and the Minister to ensure that the Minister is well supported for any committee appearances (for example on legislation or on the Estimates) by providing the necessary briefing material on the subject matter the Minister is expected to discuss, as well as strategic and procedural advice on committee procedures and rules.

10. What are written questions?

Members of Parliament and senators may pose written questions to the Government seeking detailed or technical information on any matter of interest to them. The Government is required to provide a response to a written question. Members of Parliament can request that a response be tabled within 45 calendar days. There is no deadline for providing a response to questions from Senators. In the House of Commons, if a response is not provided within 45 days, the Minister may be deemed to be in contempt of Parliament and the issue may be referred to the appropriate committee.

11. What are petitions?

Petitions are formal requests made to Parliament by Canadians, which are tabled in the House of Commons by a Member of Parliament. As with written questions, the Government is required to provide a response to any petition tabled in the House of Commons within 45 days. Failure to do so can result in the Minister being deemed to be in contempt of Parliament and the issue may be referred to the appropriate committee.

12. How is the Minister supported in responding to written questions and petitions?

The Portfolio, through the Parliamentary Affairs Office, prepares a response to all written questions and petitions directed to the Minister of Health. Once a response has been prepared, it is sent for the Minister's approval and signature.

C. Overview of Legislative Instruments

1. What are legislative instruments?

There are a range of legislative mechanisms that the Government can use to meet its desired objectives. Legislative tools that can be used at the Government's discretion include:

• Acts;
• Regulations; and
• Orders in Council.

2. What is an Act?

An Act is a law enacted by Parliament. An Act originates as a bill and must be approved in the same form by both the House of Commons and the Senate to become law. Once a bill is passed by both houses of Parliament, the final stage in the enactment of a bill by Parliament is Royal Assent. The timing of Royal Assent is arranged by the Leader of the Government in the House of Commons and the Leader of the Government in the Senate at which time the Governor General (the Queen's representative in Canada) signs the bill. An Act can take effect, generally referred to as "coming into force," on the day it receives Royal Assent, on a specific date noted in the legislation or on a date or dates to be fixed by the Government at a later date.

An Act usually contains fundamental policy. Generally, an Act deals with the elements of a government program that have the greatest impact on the public. Matters that are usually dealt with in Acts include:

• provisions that affect personal rights and liberties;
• provisions for establishing the structure of public bodies or providing for senior appointments;
• controversial matters that should be addressed by Parliament; and
• amendments or additions to the enabling Act or other Acts.

3. What is a regulation

A regulation is also a form of law that, like an Act, has binding legal effect. Regulations are often used to further elaborate on the provisions set out in an Act. Normally, the power to make regulations is conferred by Parliament to the Governor in Council (i.e., Cabinet), a Minister or a head of an agency. The power to make regulations must be expressly provided for in a piece of legislation known as an "enabling Act". Regulations have legal effect on the date of coming into force which can be the day of registration or on a date indicated in the regulation.

4. What is incorporation by reference?

"Incorporation by Reference" is not a stand-alone law like an Act or regulation. Rather it is a drafting technique that is used in the body of a statute or a regulation when it is more efficient to refer to an external document rather than repeating it in the statute or regulation. Acts and regulations do not have to spell out all the details of what is required or provided. Acts and regulations can instead refer to other laws or documents and incorporate their contents without reproducing them. An example of such an incorporation by reference can be found in the Tobacco Products Labelling Regulations (Cigarettes and Little Cigars) which requires manufacturers to display a health warning message on the packaging of certain tobacco products. The health warning message must be taken from a technical document published by Health Canada titled "Labelling Elements for Tobacco Products". Thus, Health Canada avoids having to reproduce graphic health warnings in the body of the Regulations.

5. What is an Order in Council?

An Order in Council is a legal instrument. Orders in Council are made on the recommendation of the responsible Minister. They are formal decisions of Cabinet that are signed by the Governor General. An Order in Council has legal effect on the date of coming into force which can be the day of registration or on a date indicated in the order. Orders in Council address a wide range of administrative and legislative matters.

D. Overview of the Regulatory Development Process

1. What is a regulation?

A regulation is a form of law that, like an Act, has binding legal effect and usually states rules that apply generally rather than to specific persons or situations. Normally, the power to make regulations is conferred by Parliament to the Governor in Council (i.e., Cabinet), a Minister or a head of an agency. The powers to make regulations must be expressly provided for in the Act for which the regulations are to be made (known as the enabling Act).

2. What is the framework for making a regulation?

Regulations must stay within the scope of the authority that the enabling Act grants and must not conflict with it or restrict or extend the scope of its application. Regulations must also follow a specific process which is guided by legal constraints, including the Constitution and other generally applicable laws such as the Statutory Instruments Act Additionally, the Cabinet Directive on Regulatory Management confirms a "life cycle" approach to regulation making. The life cycle approach recognizes that attention must be given not only to regulatory development and analysis but also to the implementation, evaluation, and review of regulations.

3. What is the Statutory Instruments Act?

The Statutory Instruments Act establishes a process designed to ensure that regulations are made on a legally secure foundation, are registered and are published in the Canada Gazette. The Canada Gazette is the official newspaper of the Government of Canada. Published within the Canada Gazette are new statutes and regulations, proposed regulations, decisions of administrative boards and an assortment of government notices.

4. What is the Cabinet Directive on Regulatory Management?

The Cabinet Directive on Regulatory Management sets out requirements governing regulation-making in Canada. Federal departments and agencies are to comply with the Directive and its operational requirements and guidance; develop regulatory plans for the coming year(s); and report publicly on plans, priorities, performance, and regulatory reviews in accordance with Treasury Board reporting requirements.

5. What factors are taken into consideration as part of the regulation making process?

Proposed draft regulations are subject to analysis prior to their approval, which examines the expected impact of the regulatory proposal. This assessment considers factors such as:

• the impact on health, safety, security, the environment, and the social and economic well-being of Canadians;
• cost or savings to the government, business or Canadians, and impact on the economy;
• impact on other departments or agencies, or other governments in Canada or on Canada's foreign affairs;
• degree of interest, contention and support among the affected parties and among Canadians; and
• overall expected impact.

6. What is the process for developing a regulation?

Proposed regulations are drafted by the Department of Justice based on instructions from the sponsoring department or agency, and sent to Treasury Board, a committee of Cabinet, for approval to be published in the Canada Gazette. Publication in the Canada Gazette ensures that Canadians are consulted on the proposed regulation.

Following consultation, the regulatory proposal may be adjusted to reflect comments received. The proposal is reviewed by the Department of Justice. Once a final draft is prepared, the proposal, signed by the responsible Minister, is submitted to Treasury Board for approval. Once approved, the regulatory proposal is submitted to the Clerk of the Privy Council for registration.

The final regulatory package is then published in the Canada Gazette, Part II. Regulations have legal effect on the date of coming into force which can be the day of registration or on a date indicated in the regulation.

7. How are Canadians consulted?

Once approved by Treasury Board, the draft regulation along with a Regulatory Impact Analysis Statement (RIAS) is published in the Canada Gazette, Part I. The RIAS summarizes the analysis undertaken to design the regulatory proposal.

Publication in the Canada Gazette allows any Canadian to comment on the draft proposal. The standard comment period is 30 days, but it can vary based on legislation requirements, international obligations and other considerations. For proposals that may affect international trade, the minimum consultation period is 75 days.

In additional to publishing draft regulatory proposals, departments and agencies also consult with stakeholders and other interested parties on a regular basis.

8. Is Parliament involved in the regulatory process?

Some enabling Acts require that their regulations be tabled in the House of Commons and/or the Senate, and some require certain regulations to be referred to parliamentary committees (e.g., Tobacco Act, User Fees Act, Quarantine Act, Human Pathogens and Toxins Act, Assisted Human Reproduction Act, and Canada Consumer Product Safety Act). The timing of tabling may vary, either before or after the proposal is finalized.

Parliament is also involved in reviewing regulations once made to ensure that they meet certain criteria such as conformity with the Canadian Charter of Rights and Freedoms, and compliance with the Statutory Instruments Act. This review is conducted by the Standing Joint Committee for the Scrutiny of Regulations (SJCSR), a committee composed of Senators and Members of the House of Commons.

The Committee can review any statutory instrument made on or after December 31, 1971. Should the Committee conclude that a regulation is not in keeping with the intentions of an Act as passed by Parliament, it may make a report to Parliament on the matter. Such a report contains a resolution which, if agreed to by Parliament, results in an Order to the government to revoke an offending regulation.

E. Financial Management

1. What is the Budget?

The Budget, prepared by the Minister of Finance, outlines the government's revenue projections and spending obligations. It sets out the Government's fiscal, social and economic policies and priorities. The Budget, usually tabled early in the calendar year, does not authorize the Government to spend money. Following the Budget, Parliament will pass legislation to implement funding initiatives announced in the Budget (known as the Budget Implementation Act).

2. What is the Minister's role in the Budget process?

Typically, each Minister is responsible for preparing a Budget letter which is sent to the Minister of Finance and includes the items that the Minister would like funded for their department or portfolio. This can include incremental funding for existing programs or funding for new programs.

The Department supports the Minister by preparing recommendations, in consultation with the Portfolio, on what could be included in the letter to the Minister of Finance. While the Budget is not usually presented until late February (or sometimes later), the letter to the Minister of Finance is usually submitted in the fall. This allows the Minister and the Department of Finance sufficient time to coordinate the Government's spending and policy priorities and prepare the Budget.

3. What are the Estimates? How are they different from the Budget?

The Estimates, which are voted on by Parliament, set out the Government's detailed projected expenditures for the upcoming fiscal year. They specify the amounts and purposes for which departments and agencies can spend appropriated funds. The Estimates process is the means by which departments receive supply - i.e. funds to operate. The Estimates document family has three parts:

• Part I (Government Expenditure Plan) provides an overview of federal spending.
• Part II (Main Estimates) lists the financial resources required by individual departments, agencies and Crown corporations for the upcoming fiscal year. Under the Standing Orders of the House of Commons Main Estimates must be tabled by March 1.
• Part III (Departmental Expenditure Plans) consists of two documents:
  • Reports on Plans and Priorities (RPPs), normally tabled in early March, are expenditure plans that describe departmental priorities, strategic outcomes, programs, expected results and associated resource requirements, covering a three-year period beginning with the year indicated in the title of the report.
  • Departmental Performance Reports (DPRs), normally tabled in early November, are individual department and agency accounts of actual performance, for the most recently completed fiscal year, against the plans, priorities and expected results set out in their respective RPPs.

Additionally, Supplementary Estimates are part of the normal parliamentary approval process to ensure that previously planned government initiatives receive the necessary funding to move them forward. They present information to Parliament on the Government of Canada's spending requirements that were not sufficiently developed in time for inclusion in the Main Estimates, and will from time to time include urgent but unforeseen expenditures, such as natural disasters (an ice storm, HlNl, etc.). Supplementary Estimates directly support an appropriation act.

Supplementary Estimates are published throughout the year; each release is identified alphabetically (A, B, C, etc.). Supplementary Estimates (A) are generally tabled in May. These provide federal organizations with the funding they need early in the year. Supplementary Estimates (B) are generally tabled in late October or early November. Supplementary Estimates (C) are generally tabled in February.

4. What are the Public Accounts of Canada?

The Public Accounts of Canada, normally tabled in the fall, is the report of the Government of Canada prepared annually by the Receiver General for the recently completed fiscal year. (In additional to preparing the Public Accounts, the Receiver General (RG) for Canada also manages the operations of the federal treasury and ensures the integrity of the Consolidated Revenue Fund. The RG for Canada is the Minister of Public Works and Government Services Canada.)

The information contained in the report summarizes financial transactions presented in the Accounts of Canada, maintained by the Receiver General, and detailed records, maintained by departments and agencies.

Each department and agency is responsible for reconciling its accounts to the control accounts of the Receiver General, and for maintaining detailed records of the transactions in their accounts. The Minister is accountable for the Department's spending reported in the Public Accounts of Canada.

5. What is Parliament's responsibility regarding management of government funds?

Expenditures made by Government require the authority of Parliament. Authority is provided in two ways:

• Appropriation acts (or Supply Bill) are the vehicles through which expenditures from the Consolidated Revenue Fund are authorized in order to pay for government programs and services. They specify the amounts and broad purposes for which funds can be spent.
• other specific statutes that authorize payments and set out the amounts and time periods for those payments (statutory payments).

The amounts approved in appropriation acts are referred to as voted amounts, and the expenditure authorities provided through other statutes are called statutory authorities. Statutory authorities refer to spending that has been authorized by previous legislation and is listed in the Estimates for information only. An example of statutory spending is contributions to employment insurance for Government of Canada employees.

Approximately two thirds of Government spending is statutory. The rest is subject to annual approval by Parliament through the Estimates process.

6. What happens once the Estimates are tabled in Parliament?

Once tabled, the Estimates are referred to the appropriate House of Commons Standing Committee for review. The Standing Senate Committee on National Finance may review the Estimates, but does not vote on them. In the case of the Health Portfolio, the Estimates are referred to the House of Commons Standing Committee on Health (HESA). The Committee reviews the Estimates documents and votes on the proposed expenditures. Committees can vote to approve, reject or reduce the amount of money allocated to a certain program but they cannot vote to increase spending. Committees typically report back to the House of Commons on how they voted on the Estimates, although they are not required to do so. If a committee does not report back, those Estimates are "deemed" to have been reported by the committee.

Following Committee study, the Estimates must be agreed to by the House of Commons. Approval of the Estimates allows the Government to introduce legislation, known as a Supply Bill, to spend the money outlined in the Estimates. The Supply Bill must follow the normal legislative process (approval in the same form by the House of Commons and the Senate).

7. What is the Minister's role in the Estimates process?

The Minister is responsible for his or her portfolio Estimates and is often asked to appear before the Parliamentary Committee studying the Estimates of the department.

The Minister of Health is usually asked to appear once on the Main Estimates (in the spring) and on the Supplementary Estimates B (in the fall), although the Minister is only required to attend if invited by the Committee.

Although the Committee members will ask specific questions related to the information contained in the Estimates documents, it is also an opportunity for the Committee to question the Minister about any range of issues related to the departmental or portfolio mandate. The department prepares briefing materials to support the Minister's appearance.

8. How is the Minister supported when appearing on the Estimates?

The Minister is supported by the Department through the Parliamentary Affairs Office, which works closely with the Minister to ensure that briefing materials are in line with the Minister's needs. This includes providing briefing material and remarks for the introductory statement before the Committee.

9. Once funding is received, how is it allocated within the Health Portfolio?

Funding for each Portfolio organization is received and allocated as per their approved Estimates documents. Funding is then further broken down organizationally, by program, within each Portfolio organization to achieve the goals and priorities developed to support the delivery of each organization's mandate.

Throughout the fiscal year, funding can only be moved between portfolio partners by way of an Estimates process.

10. Who has authority to spend money allocated to the Health Portfolio?

For the Health Portfolio, the Minister of Health is given the authority to spend allocated funds in accordance with approved Estimates documents. The Minister in turn delegates this authority through each organization's Delegation of Financial Signing Authorities instrument. All Deputy Heads and Branch Heads within the Health Portfolio are responsible for allocating and spending funds, with prudence and probity, in order to reach their respective mandates and objectives. Branch Heads may delegate their spending authority to managers within their respective organizations.

A new delegation instrument must be prepared and authorized by a Minister within 90 days of their appointment.

F. How Approvals and Oversight Work for Key Products

Drugs

1. What is a drug?

The Food and Drugs Ad defines a drug as "any substance or mixture of substances manufactured, sold or represented for use in:

• the diagnosis, treatment, mitigation or prevention of a disease, disorder, abnormal physical state, or its symptoms, in human beings or animals;
• restoring, correcting or modifying organic functions in human beings or animals; or
• disinfection in premises in which food is manufactured, prepared or kept."

Drugs include both prescription and non-prescription pharmaceuticals, biologicallyderived products such as vaccines, blood derived products, and products produced through biotechnology, tissues and organs, disinfectants, and radiopharmaceuticals.

2. Who regulates drugs for use in Canada?

Drugs are regulated by the federal government through the Health Products and Food Branch (HPFB) of Health Canada.

• Therapeutic Products Directorate (TPD): prescription drugs; professional use products; generics; product and site licensing; clinical trials.
• Biologics and Genetic Therapies Directorate (BGTD): vaccines; blood derived products; biotechnology products; tissues and organs; radiopharmaceuticals; product and site licensing; clinical trials.
• The Natural and Non-Prescription Health Products Directorate (NNHPD): self-care products; product and site licensing; clinical trials for self-care indications.
• Marketed Health Products Directorate (MHPD): post-market surveillance, including adverse reaction reporting, signal assessment; risk communications.
• HPFB Inspectorate (HPFBI): compliance and enforcement.

3. How are drugs reviewed and approved in Canada?

Drugs are authorized for sale in Canada once they have successfully gone through the drug review process. This process is the means by which a drug application is reviewed by scientists in HPFB, to assess the safety, efficacy and quality of a drug. Throughout the process, the safety and well-being of Canadians is the paramount concern.

When a manufacturer wishes to market a drug in Canada, they must file a New Drug Submission (NDS) with Health Canada which contains scientific information and data about the drug's safety, efficacy and quality. A NDS includes the results of preclinical and clinical studies, details regarding the production of the drug, packaging and labelling details, and information regarding therapeutic claims and side effects.

Health Canada evaluates the safety, efficacy and quality data to assess the potential benefits and risks of the drug, as well as information about the product that the sponsor proposes to provide to health care practitioners and consumers about the drug (e.g. the label, product brochure). The product information (referred to as a product monograph) explains how and when a drug should be used, as well as the possible side effects that a patient might experience. The product monograph is also the basis upon which advertising for the drug is regulated.

If, at the completion of the review, the conclusion is that the benefits outweigh the risks and that the risks can be mitigated, the drug is issued a Notice of Compliance (NOC), as well as a Drug Identification Number (DIN) which permits the sponsor to market the drug in canada and indicates the drug's official approval in Canada. If there is insufficient evidence to support the safety, efficacy or quality claims, Health Canada will not grant a marketing authorization for the drug.

Some drugs with market authorization (for example, narcotics) are further controlled under the Controlled Drugs and Substances Act, which is administered by Health Canada's Healthy Environments and Consumer Safety Branch.

4. Which laws govern the drug review, surveillance and monitoring process?

Drugs are subject to the Food and Drugs Act and the Food and Drug Regulations. A drug must meet the requirements of the Food and Drugs Act and the Food and Drug Regulations before it can be imported, advertised or sold in Canada.

5. How long does the review process take?

HPFB has set internationally competitive performance targets for its conduct of reviews. The length of time for review depends on the product being submitted and the size and quality of the submission, and is influenced by HPFB's workload and human resources.

Service standards for New Drug Submissions (NDSs) and Supplements to NDSs are 300 calendar days whereas services standards for generic drugs are 180 calendar days.

Health Canada has several policy and regulatory mechanisms to expedite access to drugs that treat serious, life-threatening or severely debilitating diseases such as the Priority Review Policy, and Notice of Compliance with Conditions Policy.

6. What happens when a drug is not approved?

If Health Canada decides not to grant a marketing authorization, the sponsor has the opportunity to supply additional information, to re-submit its submission at a later date with additional supporting data, or to appeal Health Canada's decision.

Reconsiderations are a formal dispute resolution process afforded to sponsors of human drug submissions after the issuance of a negative decision.

7. Can a drug be used or accessed by Canadians if it has not yet been approved?

The Special Access Programme (SAP) provides access to non-marketed drugs for practitioners treating patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The SAP authorizes a manufacturer to sell a drug that cannot otherwise be sold or distributed in Canada.

A decision to authorize or deny a SAP request is made on a case-by-case basis by taking into consideration the nature of the medical emergency, the availability of marketed alternatives and the information provided in support of the request regarding the use, safety and efficacy of the drug. If access is granted, the practitioner agrees to report on the use of the drug including any adverse events encountered with such use and, upon request, account for all quantities received.

B. Is the Minister involved in the review process?

Generally speaking, the Minister is not involved in the drug review process. Decisions are made by specialists after lengthy scrutiny of the associated data.

9. Once a drug has been approved, how is it monitored?

Once a drug is on the market, regulatory controls continue. Some safety risks only emerge after a drug is used more broadly by Canadians so the distributor of the product must report any new information received concerning serious side effects. Some of the information that HPFB looks for once a product is on the market includes: serious side effects that are occurring more often than expected; new side effects that were not expected; side effects in vulnerable groups like children, pregnant women or the elderly; and interactions with other health products.

Health Canada is also responsible for evaluating health product advertising complaints and taking actions to achieve compliance when a contravention has been identified.

In addition, Health Canada licenses most drug production sites and conducts regular inspections as a condition for licensing including whether the drug has been fabricated, packaged/labelled, tested and stored in accordance with Good Manufacturing Practices (GMP). If a foreign site is conducting the licensable activities of fabrication, packaging/ labelling, testing, it must be GMP compliant and listed on the importer's Establishment License (El).

10. What happens if a drug already on the market is found to be unsafe?

If a potential safety issue is identified through surveillance, Health Canada assesses all available information by conducting a safety review to determine if the risk of a product or ingredient exceeds the benefit of the intended condition of use. For vaccines, this is done in consultation with the Public Health Agency of Canada due to the role they play in vaccine surveillance. When a serious risk is identified a tailored risk mitigation approach will be developed. Health Canada may use a combination of risk mitigation tools that are proportionate to the risk and that will result in an effective strategy to reduce it.

Examples of risk mitigation activities include product labelling changes (including addition of contraindications, warnings, precautions), dissemination of information through risk communication and educational materials to health care professionals and consumers about the risks.

In rare cases, a product's license (Notice of Compliance) may need to be suspended or the Drug Identification Number (DIN) cancelled if the risks continue to outweigh the benefits, and the product poses an unacceptable risk to the health of Canadians.

When Health Canada identifies or is notified of potential non-compliance with the Food and Drugs Ad and/or its Regulations, it takes steps to verify that non-compliance has occurred. Incidents of non-compliance are prioritized and action is taken based on the risk they may pose to the general public. Compliance is normally achieved through a cooperative approach between Health Canada and the regulated party. However, a number of compliance and enforcement options are available, if necessary, to correct non-compliance or mitigate a risk to Canadians including, for example, on-site visits, recalls, public communications, or product seizures. The primary objective of Health Canada's compliance and enforcement approach is to manage the risks to Canadians using the most appropriate level of intervention.

Further to the changes made by the Protecting canadians from Unsafe Drugs Ad (Vanessa's Law), the Minister (or a designate) has the power under the Food and Drugs Act to order the recall of a health product (excluding natural health products) if it presents a "serious or imminent risk of injury to health". The Act similarly enables orders for corrective action, and orders to have a product sent to a specified place. Industry is responsible for product recalls, whether they are undertaken voluntarily, or following a mandatory order.

Health Canada monitors the effectiveness of recalls and any necessary preventative and corrective actions. Compliance and enforcement actions, including risk communications to Canadians, are taken proportional to the risk to health.

How Approvals and Oversight Work for Key Products

Medical Devices

1. What is a medical device?

The term "medical device" covers a wide range of products used in the treatment, mitigation, diagnosis or prevention of a disease or abnormal physical condition. Some examples include pacemakers, artificial heart valves, hip implants, synthetic skin, medical laboratory diagnostic instruments, test kits for diagnosis and contraceptive devices.

Medical devices are divided into four risk classes, with Class I being lower risk and Class IV being highest risk. The evidence requirements and the regulatory oversight are aligned to the risk class of the device.

2. Who regulates medical devices for use in Canada?

Medical Devices are regulated by the Health Products and Food Branch (HPFB) and the Regions and Programs Bureau (RAPS) of Health Canada.

• Medical Devices Bureau (MDB) of the Therapeutic Products Directorate (TPD): licensing; quality manufacturing system certification.
• Marketed Health Products Directorate (MHPD): post market surveillance; risk communications.
• HPFB Inspectorate (HPFBI): establishment licensing; compliance and enforcement.
• Regions and Programs Bureau (RAPB): field inspection.

3. How are medical devices reviewed and approved in Canada?

When a company decides that it would like to market a medical device in Canada, it submits a Medical Device License Application. The amount of information which must be submitted varies depending on the class of the device.

MOB reviews the application. If the information provided meets the requirements of the Medical Devices Regulations, a license is issued. Either an Establishment License or a Quality Management System Certificate is also required to sell the product in Canada.

A medical device license application may not be approved if the company has not provided sufficient evidence of safety and effectiveness for that specific type of device.

4. Which laws govern the medical device review process?

The license review process and specific data requirements for the medical devices license application review is governed by the Food and Drugs Act and the Medical Devices Regulations.

5. How long does the review process take?

Although the length of the review varies depending on the class of the device, Class III & IV license applications have a target review time of 60 days and 75 days respectively and Class II license applications have a 15 calendar day target.

6. What happens when a medical device is not approved?

The industry sponsor will be notified that a license application has not been approved, and of the nature of the deficiencies in their submission. The sponsor has the opportunity to supply additional information, or to re-submit its submission at a later date with additional supporting data. A sponsor can also appeal a decision to refuse or reject a medical device license application.

7. Can a medical device be used or accessed by Canadians if it has not yet been approved?

The Special Access Programme (SAP) can be used by a physician to request an unlicensed medical device for a specific patient where there is no suitable Canadian licensed device available.

8. Is the Minister involved in the review process?

Generally speaking, the Minister is not involved in the review of medical devices. Decisions are made by specialists after lengthy scrutiny of the associated data.

9. Once a medical device has been approved, how is it monitored?

It is the responsibility of the license holder to monitor the ongoing safe use of the medical device which they sell. In addition, the license holder must submit reports of adverse events (called Mandatory Problem reports). Any member of the public or health care professionals could submit a voluntary adverse reaction report. The department also has a sentinel monitoring network, which relies on a group of dedicated representatives at various health care facilities across the country, to report high quality data to the regulator about adverse events associated with medical devices.

10. What happens if a medical device already on the market is found to be unsafe?

If a potential safety issue is identified through surveillance, Health Canada assesses all available information by conducting a safety review to determine if the risk of a product or its components exceeds the benefit of the intended condition of use. When a serious risk is identified a tailored risk mitigation approach will be developed. Health Canada may use a combination of risk mitigation tools that are proportionate to the risk and that will result in an effective strategy to reduce it.

Examples of risk mitigation activities include product labelling changes (including addition of contraindications, warnings, precautions), dissemination of information through risk communication and educational materials to health care professionals and consumers about the risks.

In rare cases, a product's authorization may need to be suspended or cancelled if the risks continue to outweigh the benefits, and the product poses an unacceptable risk to the health of Canadians.

When Health Canada identifies or is notified of potential non-compliance with the Food and Drugs Act and/or its Regulations, it takes steps to verify that non-compliance has occurred. Incidents of non-compliance are prioritised and action is taken based on the risk they may pose to the general public. Compliance is normally achieved through a cooperative approach between Health Canada and the regulated party. However, a number of compliance and enforcement options are available, if necessary, to correct non-compliance or mitigate a risk to Canadians including, for example, on-site visits, recalls, public communications, or product seizures. The primary objective of Health Canada's compliance and enforcement approach is to manage the risks to Canadians using the most appropriate level of intervention.

Further to the changes made by the Protecting Canadians from Unsafe Drugs Act (Vanessa's Law), the Minister (or a designate) has the power under the Food and Drugs Act to order the recall of a health product (excluding natural health products) if it presents a "serious or imminent risk of injury to health". The Act similarly enables orders for corrective action, and orders to have a product sent to a specified place. Industry is responsible for product recalls, whether they are undertaken voluntarily, or following a mandatory order. Health Canada monitors the effectiveness of recalls and any necessary preventative and corrective actions. Compliance and enforcement actions, including risk communications to Canadians, are taken proportional to the risk to health, with an emphasis on openness and transparency.

How Approvals and Oversight Work for Key Products

Natural Health Products

1. What is a natural health product?

Natural health products (NHPs) are naturally occurring substances that are used to restore or maintain good health. They are often made from plants, but can also be made from animals, microorganisms and marine sources. They come in a wide variety of forms such as tablets, capsules, tinctures, solutions, creams, ointments and drops.

NHPs, often called "complementary" or "alternative" medicines, include vitamins and minerals, herbal remedies, homeopathic medicines, traditional medicines such as traditional Chinese and Ayurvedic (East Indian) medicines, probiotics, and other products like amino acids and essential fatty acids.

Many everyday consumer products, such as certain toothpastes, antiperspirants, shampoos, facial products and mouthwashes are also classified as NHPs in Canada.

NHPs are used and marketed for a number of health reasons, such as the prevention or treatment of an illness or condition, the reduction of health risks, or the maintenance of good health. They must be safe to be used as over-the-counter products. Products needing a prescription are regulated as drugs.

2. Who regulates natural health products for use in Canada?

NHPs are regulated by the federal government through the Natural Health Products Program (NHPP) of the Health Products and Food Branch (HPFB) of Health Canada.

• Natural and Non-Prescription Health Products Directorate (NNHPD): product and site licensing; clinical trials*.
• Marketed Health Products Directorate (MHPD): post-market surveillance, including adverse reaction reporting, signal assessment; risk communications.
• HPFB Inspectorate (HPFBI): compliance and enforcement.

* Clinical trials for non-self-care conditions are authorized by the Therapeutic Products Directorate.

3. How are natural health products reviewed and approved in Canada?

All NHPs must have a product license before they can be sold in canada. To get a license, applicants must give detailed information about the product to Health Canada, including: medicinal ingredients, source, dose, potency, non-medicinal ingredients and recommended use(s).

Once Health Canada has assessed a product and determined it is safe, it issues a product license along with an eight-digit Natural Product Number (NPN) or Homeopathic Medicine Number (DIN-HM), which must appear on the label.

Not all NHPs are authorized for sale. Reasons include: deficient applications, concerns around safety as an over-the-counter product, and requirements of the Food and Drugs Act and Natural Health Products Regulations are not met.

4. Which laws govern the natural health products review process?

The Natural Health Products Regulations (NHPR) outline the NHP product license application process. The NHPR are a sub-set of the Food and Drugs Act, which also governs the licensing of NHPs - for example, claims made for an NHP cannot be false or misleading.

5. How long does the review process take?

Health Canada has a three-tiered system to review NHP applications that varies in target review time based on application type:

• Class I (products that comply with all parameters of an existing Health Canada monograph to support safety and efficacy): 10 days
• Class II (products that use a combination of monographs to support safety and efficacy): 30 days
• Class III (products requiring full review of safety and efficacy): 180 days

The three tiered system reflects the various considerations that may impact review times such as the inherent risks associated with the medicinal ingredients of the product and/or the conditions for which use of the product is intended as well as the breadth of supporting evidence required/provided.

6. What happens when a natural health product is not approved?

When a NHP is not approved, the applicant receives either a Rejection Notice or a Refusal Letter. A Rejection Notice is issued to applications that have administrative content deficiencies. A Refusal Letter is issued if the application does not comply with the Class I, II or III requirements (i.e. failure to meet the requirements of the NHPR or FDA), or if there is a failure to submit the requested information in response to an Information Request Notice (IRN) within the specified timelines, or submission of an incomplete or deficient response to an IRN.

The Refusal Letter will contain specific reasons or key deficiencies that resulted in the decision to refuse issuance or amendment of a product license. All decisions to refuse an application are without prejudice to re-filing. If an applicant wishes to resubmit an application at a future time, it will be processed as a new application.

An applicant may request a reconsideration of the decision to refuse their application in accordance with a standard reconsideration process.

7. Can a natural health product be used or accessed by Canadians if it has not yet been approved?

A NHP cannot be sold in Canada unless it has received a product license. However, individuals are permitted to import a single course of treatment or a 90-day supply of a NHP for personal use.

8. Is the Minister involved in the review process?

Generally speaking, the Minister is not involved in the natural health product review process. Decisions are made by specialists after scrutiny of the associated data.

9. Once a natural health product has been approved, how is it monitored?

Once a natural health product is on the market, regulatory controls continue. Some safety risks only emerge after a health product is used more broadly by Canadians so the distributor of the product must report any new information received concerning serious side effects. Some of the information that Health Canada looks for once a product is on the market includes: serious side effects that are occurring more often than expected; new side effects that were not expected; side effects in vulnerable groups like children, pregnant women or the elderly; and interactions with other health products. Health Canada is also responsible for evaluating health product advertising complaints and taking actions to achieve compliance when a contravention has been identified.

10. What happens if a natural health product already on the market is found to be unsafe?

If a potential safety issue is identified through surveillance, Health Canada assesses all available information by conducting a safety review to determine if the risk of a product or ingredient exceeds the benefit of the intended conditions of use. When a serious risk is identified a tailored risk mitigation approach will be developed. Health Canada may use a combination of risk mitigation tools that are proportionate to the risk and that will result in an effective strategy to reduce it.

Examples of risk mitigation activities include product labelling changes (including addition of contraindications, warnings, precautions), dissemination of information through risk communication and educational materials to health care professionals and consumers about the risks.

In rare cases, a product's licence may need to be suspended or cancelled if the risks continue to outweigh the benefits, and the product poses an unacceptable risk to the health of Canadians.

When Health Canada identifies or is notified of potential non-compliance with the Food and Drugs Act and/or its Regulations, it takes steps to verify that non-compliance has occurred. Incidents of non-compliance are prioritised and action is taken based on the risk they may pose to the general public. Compliance is normally achieved through a cooperative approach between Health Canada and the regulated party. However, a number of compliance and enforcement options are available, if necessary, to correct non-compliance or mitigate a risk to Canadians including, for example, on-site visits, recalls, public communications, or product seizures. The primary objective of Health Canada's compliance and enforcement approach is to manage the risks to Canadians using the most appropriate level of intervention.

Industry is responsible for the recall of Natural Health Products on a voluntary basis. While there is no ability for the Minister to order a mandatory recall, the Minister can direct a stop sale for a Natural Health Product.

Health Canada monitors the effectiveness of recalls and any necessary preventative and corrective actions. Compliance and enforcement actions, including risk communications to Canadians, are taken proportional to the risk to health, with an emphasis on openness and transparency.

How Approvals and Oversight Work for Key Products

Over-the-Counter Drugs

1. What is an over-the-counter drug?

An over-the-counter (OTC) drug is a drug that does not require a prescription from a health care practitioner - these are self-selected products sold to the public.

A few examples include: pain killers, sunscreens, wart removers, cough medicines, some household disinfectants.

2. Who regulates over-the-counter drugs for use in Canada?

OTC drugs are regulated by the federal government through the Health Products and Food Branch (HPFB) of Health Canada.

• The Natural and Non-Prescription Health Products Directorate (NNHPD): self-care products; product and site licensing; clinical trials.
• Therapeutic Products Directorate (TPD): professional use products and generics; clinical trials for self-care indications.
• Marketed Health Products Directorate (MHPD): post-market surveillance, including adverse reaction reporting, signal assessment; risk communications.
• HPFB Inspectorate (HPFBI): compliance and enforcement.

3. How are over-the-counter drugs reviewed and approved in Canada?

Before OTC drugs are authorized for sale in Canada, Health Canada reviews them to assess their safety, efficacy and quality. Prior to being given market authorization in the form of a Drug Identification Number (DIN), a manufacturer must present substantive scientific evidence of a product's safety, efficacy and quality as required by the Food and Drugs Act and Food and Drug Regulations.

In some cases, the sponsor is not required to submit new scientific evidence to support their product submission, but can cross reference previously approved information (i.e. a monograph) to support the safety and efficacy of a drug.

4. Which laws govern the over-the-counter drug review process?

Drugs including OTCs are subject to the Food and Drugs Act and the Food and Drug Regulations. A drug must meet the requirements of the Food and Drugs Act and the Food and Drug Regulations before it can be imported, advertised or sold in Canada.

5. How long does the review process take?

Review timelines range from 45 days to 345 days depending on status of active ingredients, complexity of submission and the data submitted.

6. What happens when an over-the-counter drug is not approved?

Notices are issued to applicants when Health Canada requests deficient information and the applicant fails to submit the solicited information within the assigned timeframe.

After the comprehensive review of a submission is complete, a notice will be issued if the submission is deficient or incomplete in complying with the requirements outlined in the Food and Drugs Act and the Food and Drug Regulations.

An applicant may request a reconsideration of Health Canada's decision to refuse their application.

7. Can an over-the-counter drug be used or accessed by Canadians if it has not yet been approved?

An OTC drug cannot be sold in Canada unless it has received market authorization.

8. Is the Minister involved in the review process?

Generally speaking, the Minister is not involved in the OTC drug review process. Decisions are made by specialists after lengthy scrutiny of the associated data.

9. Once an over-the-counter drug has been approved, how is it monitored?

Once a drug is on the market, regulatory controls continue. Some safety risks only emerge after a health product is used more broadly by Canadians so the distributor of the product must report any new information received concerning serious side effects. Some of the information that Health Canada looks for once a product is on the market includes: serious side effects that are occurring more often than expected; new side effects that were not expected; side effects in vulnerable groups like children, pregnant women or the elderly; and interactions with other health products.

Health Canada is also responsible for evaluating health product advertising complaints and taking actions to achieve compliance when a contravention has been identified.

10. What happens if an over-the-counter drug already on the market is found to be unsafe?

If a potential safety issue is identified through surveillance, Health Canada assesses all available information by conducting a safety review to determine if the risk of a product or ingredient exceeds the benefit of the intended use. When a serious risk is identified a tailored risk mitigation approach will be developed. Health Canada may use a combination of risk mitigation tools that are proportionate to the risk and that will result in an effective strategy to reduce it.

Examples of risk mitigation activities include product labelling changes (including addition of contraindications, warnings, precautions), dissemination of information through risk communication and educational materials to health care professionals and consumers about the risks.

In rare cases, a product's authorization may need to be suspended or cancelled if the risks continue to outweigh the benefits, and the product poses an unacceptable risk to the health of Canadians.

When Health Canada identifies or is notified of potential non-compliance with the Food and Drugs Act and/or its Regulations, it takes steps to verify that non-compliance has occurred. Incidents of non-compliance are prioritised and action is taken based on the risk they may pose to the general public. Compliance is normally achieved through a cooperative approach between Health Canada and the regulated party. However, a number of compliance and enforcement options are available, if necessary, to correct non-compliance or mitigate a risk to Canadians including, for example, on-site visits, recalls, public communications, or product seizures. The primary objective of Health Canada's compliance and enforcement approach is to manage the risks to Canadians using the most appropriate level of intervention.

Further to the changes made by the Protecting Canadians from Unsafe Drugs Act (Vanessa's Law), the Minister (or a designate) has the power under the Food and Drugs Act to order the recall of a health product (excluding natural health products) if it presents a "serious or imminent risk of injury to health". The Act similarly enables orders for corrective action, and orders to have a product sent to a specified place. Industry is responsible for product recalls, whether they are undertaken voluntarily, or following a mandatory order.

Health Canada monitors the effectiveness of recalls and any necessary preventative and corrective actions. Compliance and enforcement actions, including risk communications to Canadians, are taken proportional to the risk to health, with an emphasis on openness and transparency.

How Approvals and Oversight Work for Key Products

Vaccines

1. What is a vaccine?

Vaccines are biologic drugs that contain immunogenic substances (antigens) capable of inducing specific, active and protective host immunity when administered to humans. The majority of vaccines are used prophylactically to prevent disease. Some examples include Measles, Mumps, Rubella (MMR) vaccines, Hepatitis A and B vaccines, and seasonal influenza vaccines.

2. Who regulates vaccines for use in Canada?

Vaccines for human use are regulated by the federal government through the Health Products and Food Branch (HPFB) of Health Canada.

• Biologics and Genetic Therapies Directorate (BGTD): products and site licensing; clinical trials.
• Marketed Health Products Directorate (MHPD): post market surveillance; risk communications.
• HPFB Inspectorate (HPFBI): compliance and enforcement.
• Public Health Agency of Canada (PHAC): monitoring vaccine safety; oversight of immunization.

3. How are vaccines reviewed and approved in Canada?

Vaccines are reviewed and approved in Canada similar to other drugs for human use. Vaccines are subject to strict regulatory oversight because they are often administered to large groups of healthy individuals, including children.

When a manufacturer wishes to market a vaccine in Canada, they must file a New Drug Submission (NDS) to Health Canada. The submission must contain data that demonstrates the safety, quality, and efficacy of the vaccine. This scientific evidence includes results from human clinical trials. In addition, information regarding the manufacturing facility, the method of manufacture and quality control of the vaccine is included in the submission.

Prior to market authorization, an on-site evaluation may be conducted to assess the quality of the manufacturing process and to determine that the manufacturer is able to carry out the necessary quality controls for the vaccine. Clinical studies are reviewed to ascertain that no significant safety concerns have been identified and that the vaccine is able to elicit an adequate immune response in vaccinated subjects.

If, after completion of the review, the conclusion is that the benefits of the vaccine outweigh any risks, then the vaccine is issued a Notice of Compliance (NOC) and a Drug Identification Number (DIN) indicating that it is authorized for sale in Canada.

Seasonal Flu Vaccines: There are unique challenges associated with the development and regulatory evaluation of influenza vaccines. The influenza virus strains circulating the globe change on a regular basis and the composition of the vaccine must be modified each year to include new circulating strain(s). Every February, World Health Organization (WHO) experts select influenza virus isolates which form the basis for influenza vaccine production for the following fall and winter flu season.

Given the short timeframe between the identification of the strains and the need to use the vaccine to protect Canadians, an abbreviated market authorization process with expedited review timelines is used to regulate these vaccines. The seasonal influenza vaccines are authorized each year via the filing of manufacturing and quality data and revised labelling material.

In certain situations, such as public health emergencies (e.g. influenza pandemics), special authorizations may be used to provide emergency access to a vaccine.

If there is insufficient evidence to support safety, efficacy or quality claims, Health Canada will not authorize the vaccine, and the product cannot be sold in Canada.

4. Which laws govern the vaccine review process?

Drugs including vaccines are subject to the Food and Drugs Act and the Food and Drug Regulations. Vaccines are regulated under a specific set of regulations for a subset of drugs known as biologic drugs.

5. How long does the review process take?

There are established target performance standards for drug submission review. These are communicated in Health Canada's Management of Drug Submissions Guidance Document. The performance standard for review of a New Drug Submission for a new vaccine is 300 calendar days.

6. What happens when a vaccine is not approved?

If Health Canada decides not to grant a marketing authorization, the sponsor has the opportunity to supply additional information, or to re-submit its submission at a later date with additional supporting data.

A sponsor can also request reconsideration of a final submission decision. Reconsiderations are a formal dispute resolution process, which can be used only under specific circumstances when informal processes have failed to resolve a submission issue. This includes: issues relating to the interpretation of data, applied methodology and the weights given to data impacting the risk/benefit assessment of a particular submission.

7. Can a vaccine be used or accessed by Canadians if it has not yet been approved?

The Special Access Programme (SAP) provides access to non-marketed drugs for practitioners treating patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The SAP authorizes a manufacturer to sell a drug that cannot otherwise be sold or distributed in Canada.

A decision to authorize or deny a SAP request is made on a case-by-case basis by taking into consideration the nature of the medical emergency, the availability of marketed alternatives and the information provided in support of the request regarding the use, safety and efficacy of the drug. If access is granted, the practitioner agrees to report on the use of the drug including any adverse events encountered with such use and, upon request, account for all quantities received.

8. Is the Minister involved in the review process?

Generally speaking, the Minister is not involved in the vaccine review process. Decisions are made by specialists after lengthy scrutiny of the associated data.

9. Once a vaccine has been approved, how is it monitored?

As done by other major national regulatory authorities, vaccines are subject to an ongoing risk-based lot release evaluation after approval which enables Health Canada and the manufacturer to monitor consistency in the vaccine manufacturing process. In the majority of cases, for each lot of vaccine to be sold in Canada, the manufacturer must submit the results of its own testing as well as samples for independent evaluation by Health Canada. If a vaccine lot meets specifications, a formal Release Letter is issued which approves the sale of that lot in Canada.

Manufacturers of biologic drugs, including vaccines, are also required to submit a Yearly Biologic Product Report (YBPR). This annual report is used to assess the ongoing quality of the vaccine, and to highlight any trends.

After a new vaccine has been authorized for sale, it is not uncommon for sponsors to make changes to its manufacturing process or to its indication for use. Any proposed changes that may have an impact on the quality, safety, efficacy or effective use of the vaccine are reviewed by Health Canada before they can be implemented by the manufacturer.

Surveillance systems are used to monitor any potential adverse events following immunization. A combination of mandatory and voluntary reporting is used in Canada. The Food and Drug Regulations require manufacturers of all drugs, including vaccines, to report serious adverse events that occur in Canada as well as serious unexpected adverse events that occur internationally within 15 days of receiving the information via the Canada. Vigilance Program. Manufacturers also develop annual safety summary reports.

The Public Health Agency of Canada is responsible for the Canadian Adverse Events Following Immunization Surveillance System (CAEFISS), a reporting system in which health care providers (mainly public health nurses and physicians) report adverse events following immunization to local public health authorities. The Public Health Agency of Canada also funds active, pediatric-hospital-based surveillance that closely monitors and reports admissions for selected adverse events of particular importance.

In collaboration with provincial and territorial public health authorities who receive the reports from their local jurisdictions, and the active pediatric hospital-based surveillance, CAEFISS collates the reports into its national database and conducts analyses, reviewing the routine data and any findings with Health Canada.

Health Canada performs compliance verifications as well as investigations of potential health hazards and other violations. In addition, regular inspections of manufacturers, packagers/labellers, testing laboratories, importers, distributors and wholesalers of vaccines are conducted to ensure that they comply with Good Manufacturing Practices (GMP). When deemed necessary, enforcement action may be taken by Health Canada in accordance with compliance and enforcement policies.

10. What happens if a vaccine already on the market is found to be unsafe?

If a potential safety issue is identified through surveillance, Health Canada assesses all available information by conducting a safety review to determine if the risk of a product or ingredient exceeds the benefit of the intended condition of use. For vaccines, this is done in consultation with PHAC due to the role they play in vaccine surveillance. When a serious risk is identified a tailored risk mitigation approach will be developed. Health Canada may use a combination of risk mitigation tools that are proportionate to the risk and that will result in an effective strategy to reduce it.

Examples of risk mitigation activities include product labelling changes (including addition of contraindications, warnings, precautions), dissemination of information through risk communication and educational materials to health care professionals and consumers about the risks. These actions may be done by Health Canada or the manufacturer or both parties. In rare cases, a product's licence (Notice of Compliance) may need to be suspended or the Drug Identification Number (DIN) cancelled if the risks continue to outweigh the benefits, and the product poses an unacceptable risk to the health of Canadians.

When Health Canada identifies or is notified of potential non-compliance with the Food and Drugs Act and/or its Regulations, it takes steps to verify that non-compliance has occurred. Incidents of non-compliance are prioritised and action is taken based on the risk they may pose to the general public. Compliance is normally achieved through a cooperative approach between Health Canada and the regulated party. However, a number of compliance and enforcement options are available, if necessary, to correct non-compliance or mitigate a risk to Canadians including, for example, on-site visits, recalls, public communications, or product seizures. The primary objective of Health Canada's compliance and enforcement approach is to manage the risks to Canadians using the most appropriate level of intervention.

Further to the changes made by the Protecting Canadians from Unsafe Drugs Act (Vanessa's Law), the Minister (or a designate) has the power under the Food and Drugs Act to order the recall of a health product (excluding natural health products) if it presents a "serious or imminent risk of injury to health". The Act similarly enables orders for corrective action, and orders to have a product sent to a specified place. Industry is responsible for product recalls, whether they are undertaken voluntarily, or following a mandatory order.

Health Canada monitors the effectiveness of recalls and any necessary preventative and corrective actions. Compliance and enforcement actions, including risk communications to Canadians, are taken proportional to the risk to health.

How Approvals and Oversight Work for Key Products

Consumer Products

1. What is/isn't a consumer product?

Under the Canada Consumer Product Safety Act (CCPSA) a "consumer product" is defined as a product, including its components, parts or accessories that may reasonably be expected to be obtained by an individual to be used for non-commercial purposes, including for domestic, recreational and sports purposes, and includes its packaging.

Consumer products include virtually all goods manufactured, imported, advertised or sold to the consumer such as children's products (e.g., toys, strollers, cribs), clothing and accessories (e.g., sleepwear, clothing, jewellery), home furnishings and household items (e.g., window coverings, electronics, appliances, furniture, carpets, mattresses) and sporting goods (e.g., hockey helmets, face protectors).

The Act also lists a range of exclusions. These include products that are covered under other legislation such as food, cosmetics, drugs, medical devices, natural health products, pest control products, fertilizers, vehicles and others. Tobacco products are also excluded, except with respect to their ignition propensity (i.e., their flammability properties).

2. How are consumer products regulated in Canada?

In canada, consumer products are regulated at the federal level under the CCPSA and its regulations. The CCPSA came into force in June 2011, giving Canada a modern product safety framework that aligns with the safety regimes of major trading partners, such as the United States and the European Union. The Act regulates products that are in the marketplace (post market). There are no certification requirements or pre-market approval requirements under the CCPSA. The CCPSA includes a general prohibition which places the responsibility on industry to ensure that all products they bring to market do not pose a danger to human health or safety.

The Department administers 35 regulations under the Act which address risks from specific products, such as toys and cribs. The Act also outlines that a person cannot manufacture, import, advertise or sell a product if the product meets any of the following criteria:

• it is found on the prohibited list found in Schedule 2 of the CCPSA (e.g., jequirity beans and baby walkers);
• is packaged or labelled in a misleading or deceptive manner as to their safety;
• is part of a recall in Canada;
• is a danger to human health or safety.

3. How are consumer product issues monitored?

The purpose of the CCPSA is to protect the public by addressing or preventing dangers to human health or safety that are posed by consumer products in Canada. The CCPSA contains provisions that require manufacturers, importers and retailers to report to Health canada and their supplier(s) any safety-related incident or product defect they become aware of that involves their product. This reporting is mandatory and must occur within two days of the regulated party becoming aware of an incident.

Product safety issues are also monitored regularly through a cyclical enforcement program which targets specific products for closer examination for compliance with the CCPSA regulatory framework. Health canada also gathers information about potential product hazards from other sources:

• voluntary incident reporting by consumers;
• international regulatory partners;
• provincial and territorial partners, such as poison control centres and hospital networks;
• academic research; and
• media monitoring.

Since the CCPSA came into force (2011), Health Canada has received more than 7,000 incident reports from both consumers and industry, providing the Department with valuable information about products on the market. During that time, the Department has posted over 1,000 recall notices, getting unsafe products off of store shelves, and published almost 70 advisories and alerts to provide Canadians with information to help them safely choose and use consumer products.

4. What actions can or does Health Canada take to address unsafe products found on the market?

Consumer products already on the market that are identified as "unsafe" or non-compliant with the CCPSA's regulations and prohibitions are subject to a compliance action. When non-compliance is identified, industry may choose to address it through a corrective measure or remove the product from the market through a voluntary recall. When a recall is initiated, the Department posts the information related to the recall on the Healthy Canadians website to assist in the distribution of the recall messaging to all Canadians.

In the absence of voluntary agreement, Health Canada may order a company to conduct a recall when the consumer product presents a danger to human health or safety.

The enforcement measures enabled by the Act include ministerial authorities to:

• order companies to recall products considered to be a danger to human health or safety when they do not respond voluntarily; and
• issue compliance orders and administer monetary penalties.

As of September 2015, the Department has used its new powers under the Act to issue seven orders to recall or take measures where companies have not done so voluntarily.

5. What is the Minister's role in the enforcement of consumer product requirements?

The CCPSA authorizes the Minister to issue orders, including orders to recall consumer products (under section 31) and orders to take other measures (under section 32), including stopping the manufacturing, advertising or selling of a consumer product, or any other measures necessary to remedy non-compliance with the Act or the regulations. These powers have been designated to the Director of the Risk Management Bureau in the Consumer Product Safety Directorate of the Healthy Environments and Consumer Safety Branch (HECSB).

How Approvals and Oversight Work for Key Products

Pesticides

1. What is a pesticide?

The terms 'pesticide' and 'pest control product' are used interchangeably to refer to a multitude of pest control methods that include herbicides for weed control; fungicides for the control of plant diseases; insecticides and repellents to control insects; rodenticides to control rodents; electronic devices to control insects or rodents; sanitation products to control bacteria and viruses in pools and spas; special preservatives for wood, structural materials and other products; biochemical; and non-conventional products.

The term "pest control product" is used in the Pest Control Products Act (PCPA) and is defined as:

• a product, an organism or a substance, including a product, an organism or a substance derived through biotechnology, that consists of its active ingredient, formulants and contaminants, and that is manufactured, represented, distributed or used as a means for directly or indirectly controlling, destroying, attracting or repelling a pest or for mitigating or preventing its injurious, noxious or troublesome effects;
• an active ingredient that is used to manufacture anything described above; or,
• any other thing that is prescribed to be a pest control product.

2. Who regulates pesticides for use in Canada?

Officials of Health Canada's Pest Management Regulatory Agency (PMRA) are responsible for administering the PCPA on behalf of the Minister of Health. With some exceptions, pesticides must be approved (i.e., registered) by PMRA before they are allowed on the Canadian market. Registration of a pesticide under the PCPA requires a thorough scientific evaluation to determine if risks to human health and the environment are acceptable and if the product has value. PMRA officials are also responsible for regulating products already on the Canadian market, including re-evaluations to ensure that risks remain acceptable according to modern standards, monitoring activities, and compliance and enforcement activities.

The Canadian Food Inspection Agency (CFIA) also plays a role in regulating pesticides. They monitor pesticide residues in food imported into and grown in Canada.

Provincial governments have the authority to place conditions on the use and sale of pesticides that are more restrictive that those established by Health Canada. Municipal governments can also place further conditions on the use of a registered pesticide if they have been granted the authority under provincial regulation.

3. How are pesticides reviewed and approved in Canada?

Before a pesticide is registered for use or sale in Canada, it must undergo a rigorous scientific assessment process which provides reasonable certainty that no harm will occur when pesticides are used according to label directions.

The evaluation of a new pesticide is a multi-year process that involves an applicant (usually a pesticide manufacturer) submitting an application to register along with the required scientific data to support the registration of its pesticide to the PMRA.

During the evaluation process, results from more than 200 types of scientific studies must be reviewed by the PMRA to determine if the pesticide would cause any unacceptable risks to people, animals, birds, insects, plants, as well as on the soil and in the water.

During the risk assessment process, special consideration is given to sensitive sub-groups, such as pregnant and nursing women, infants, children and seniors. PMRA scientists then assess this data to ensure that health, environmental and other standards are met. They examine the entire data package, identify any risks to human health or the environment, and ensure the pesticide has value.

4. Is the pesticide review process governed by law?

Yes. The registration process for pesticides is regulated by the Pest Control Products Act and its regulations.

5. How long does the review process take?

The time period incurred for the review of a pesticide submission in Canada can range from a few months to two years, depending on the category of submission. For the review of a new active ingredient, the process typically takes 12 to 18 months and represents the majority of time spent on a submission. The process may take longer if the PMRA requires additional studies to be conducted in order to better understand the potential health or environmental impact of a pesticide.

Performance standards for review time are provided in the Management of Submissions Policy. Generally speaking, submission types that require less data have shorter review times. However, during the science review and assessments, risks may be identified that would need to be addressed before proceeding with granting a registration. The applicant would be asked to submit, and is some cases generate, additional data requiring timelines to be renegotiated.

6. Are all pesticides that are reviewed approved?

No. Pesticides will only be registered by the PMRA if the requirements for assessing safety have been adequately addressed, the evaluation indicates that the pesticide has value, and the human health and environmental risks associated with its proposed use are acceptable.

7. What happens when a pesticide is not approved?

During the review process, if it is determined that the use of the pesticide would present unacceptable risks to human health or the environment, or it does not have value, the pesticide would not be registered and the application would be rejected by the PMRA or withdrawn by the applicant. If the application is rejected, the applicant would be informed of the reasons. If the risks to human health or the environment can be mitigated, the applicant may choose to resubmit the application with the required information.

8. Can a pesticide be used or accessed by Canadians if it has not yet been approved?

Generally, all pesticides must be registered with the PMRA before they can be sold, used, manufactured or imported into Canada. There are a few exceptions where Canadians can use an unregistered pesticide, including:

• pesticides not registered in Canada may be imported for personal use by an individual only, subject to size and value restrictions; and
• through PMRA's Grower Requested Own Use Import Program (GROU Program), Canadian farmers can import American pesticides that have been approved by the PMRA provided they have an import permit issued by the PMRA.

9. Is the Minister involved in the review process?

The PMRA is responsible for administering the PCPA and its regulations on behalf of the Minister of Health. Due to the specialist qualifications required to make decisions regarding risks associated with pesticide use, the Minister does not play an active role in the review process.

10. Once a pesticide has been approved, how is it monitored?

Although PMRA staff carefully review all scientific data prior to a registration certificate for a pesticide, adverse effects may not become known until the pesticide is used. Incident reports help Health Canada to identify any potential risks to health or the environment from the use of pesticides and to take corrective actions when necessary.

As of April 2007, registrants of pesticides are legally required to report information about incidents related to the use of, or exposure to, their pesticides to the PMRA. Registrants have timelines by which they must report specific information about effects that occurred in Canada and the United States. An incident includes an effect on a human, domestic animal or the environment.

The PMRA has established a re-evaluation program which uses current scientific approaches to examine the continued acceptability of older active ingredients and their associated end-use products. Under the PMRA's re-evaluation program, pest control products must be reviewed on a 15-year cycle.

Furthermore, special reviews may be initiated to investigate a particular aspect of a registration, and can be considered based on information from the public, other OECD countries, or identified within PMRA (e.g., after a review of scientific literature).

Every year, PMRA and Health Canada's Regions and Programs Bureau implement planned inspections across the country, to monitor compliance with the PCPA. When noncompliance is detected, the PMRA takes appropriate action to address the violation commensurate with the level of risk which includes any potential health and environmental risks (harm). The PMRA also considers the knowledge of the violator that they are contravening the PCPA (intent), and the violator's history of non-compliance. Each violation is assessed independently and may require the involvement of scientific evaluators at the PMRA to ascertain exposure or environmental risk.

MRLs are acceptable levels of pesticide residues in or on foods, set by the PMRA for each pesticide and food type combination (food safety standards). The CFIA is responsible for monitoring of pesticide residues in food, including imported food and foods grown domestically in Canada.

11. What happens if a pesticide already on the market is found to be unsafe?

At any time during the registration period, the registration of a pesticide may be amended or cancelled if the pesticide is found to present an unacceptable risk of harm to human health or the environment, or if it no longer meets the criteria of merit or value for its intended uses. The PMRA will take appropriate measures to communicate the amendment or cancellation of the registration to the registrant and other affected parties. Where necessary, PMRA will also communicate to the general public situations presenting imminent human or environmental risk.

G. Canada's Food Safety System

1. Who is responsible for keeping Canada's food supply safe?

The responsibility for food safety and the prevention of food-borne illness is shared by federal, provincial and territorial governments, industry and consumers.

• Within the Health Portfolio, the Canadian Food Inspection Agency (CFIA), the Public Health Agency of Canada (PHAC), and Health Canada (HC) all play an important role in keeping canada's food supply safe.
• The CFIA has strong food safety rules in place to minimize risk to the Canadian population. CFIA is responsible for enforcing policies and standards set by HC and for verifying industry compliance with food safety regulations. In the event of a food recall, the CFIA manages and communicates the risks to canadians.
• PHAC is responsible for food borne illness surveillance and outbreak investigation, and is generally the first point of contact for actual or potential food-borne illness outbreaks. PHAC also coordinates multi-jurisdictional outbreaks, training in outbreak response and expert advice.
• HC is responsible for establishing policies and regulations related to the safety and nutritional quality of food as well as evaluating the safety of pesticides and veterinary drugs used in food-producing animals. HC also has a number of food safety responsibilities with respect to First Nations communities south of 60 degrees parallel. Finally, HC (and in particular the Health Products and Food Branch), provides assistance with investigations of food-borne illness outbreaks, upon request, including scientific advice and analytical surge capacity, diagnostic services for food borne viruses and bacteria, risk management advice and more.
• Provincial and territorial governments also maintain jurisdiction under their own authorities for establishing regulatory requirements and conducting the inspection of foods that are produced and sold exclusively intra-provincially.
• Industry is responsible for the production of safe food, including ensuring that all relevant regulatory requirements are met. The food industry has many controls and procedures in place to protect the safety of their products.
• Consumers and food service providers are responsible for safe food handling and preparation in order to protect themselves and others from food-borne illness.

2. What safeguards are in place to ensure our food is safe?

Canada has all the safeguards of a world-class food safety system. These include:

• enforceable laws and regulations aligned with internationally recommended standards;
• capacity to trace products and issue recalls;
• a professional and well-trained inspection service; and
• a science-based approach to assessing risks and establishing appropriate requirements, monitoring and testing of food-borne hazards, and investigating potentially unsafe food products.

Canada's food safety system also includes a strong surveillance and outbreak response capacity. While Canada has strong food safety rules in place to minimize food-borne hazards, it is not possible to eliminate risk altogether.

3. How is the food safety system regulated?

Under the Canadian Food Inspection Agency Act, CFIA is responsible for the administration and/or enforcement of the following Acts:

• Canada Agricultural Products Act (including associated regulations on dairy, fresh fruit and vegetables, eggs, processed products, etc.)
• Consumer Packaging and Labelling Act (as it relates to food)
• Fish Inspection Act
• Food and Drugs Act (as it relates to food)
• Meat Inspection Act

Note: The Safe Food for Canadians Act (SCFA), which is supported by all parties, would amend or repeal a number of the Acts as they relate to food when it comes into force.

4. What happens if a food is thought to be unsafe?

Various triggers can initiate a food safety investigation of the suspected product, including consumer or industry complaints, food-borne illness outbreaks, CFIA inspection activities (e.g., food test results), and surveillance information from other government departments, or provincial/territorial or international partners.

If a potential health risk has been identified by the food safety investigation or by an outbreak investigation, a formal written request for a health risk assessment is submitted to HC. The purpose of the health risk assessment is to determine what level of risk a specific food presents for the Canadian population.

The health risk assessment is the basis for CFIA's risk management decisions. The CFIA has a range of tools under its authority to address unsafe food. This includes seizure and detention, as well as suspending or cancelling the license to operate when the risk is at the production level. If the food product is on the market, requests to companies to conduct food recalls, and issuing public warnings, serves to minimize consumer exposureto unsafe food.

5. What is a food safety investigation?

A food safety investigation is an activity to gather information related to a potential food safety incident, which could involve food safety, nutrition, tampering, quality or noncompliance with regulatory requirements.

The objective of a food safety investigation is to determine whether a food product poses a health risk, the extent of the problem and the required actions.

A food safety investigation is a routine part of an outbreak investigation when a food product is suspected as a source of illness.

During a food safety investigation, the CFIA collects information on the production and handling of the product; reviews procedures and records; and undertakes sampling, as necessary, to identify the source and extent of the problem.

Food safety investigation findings are provided to HC so that a health risk assessment can be conducted, in order to determine the health risk posed by the product and the appropriate risk management action required from the CFIA.

6. When is a food safety investigation conducted?

A food safety investigation is conducted when the CFIA determines a need for one through its inspection activities, or obtains information suggesting that a food product may pose a health risk to Canadian consumers.

7. Who decides if an investigation is needed?

The decision to initiate a food safety investigation is shared among various CFIA staff and depends on the trigger involved. Triggers could include consumer or industry complaints, illness outbreak, laboratory results, inspector findings, information from other countries or organizations. CFIA staff involved in a food safety investigation includes inspectors, area managers, and the Office of Food Safety and Recall, which is part of CFIA's Operations Branch.

On average, CFIA conducts 3,000 food safety investigations each year. Less than 10 percent of investigations result in a food recall.

8. Who is involved in a food safety investigation?

CFIA works in collaboration with its federal, provincial and international partners in food safety in its investigation of events, and verifies that the firm has successfully removed the product from the marketplace.

HC conducts health risk assessments associated with food safety incidents, which provides the critical characterization of the risk presented by the incident and informs CFIA decisions on the appropriate risk mitigating actions.

PHAC investigates whether illnesses are linked to specific product(s) and leads responses to food-borne illness outbreaks when they affect more than one province or territory.

The firm cooperates with the CFIA to provide information necessary for the food safety investigation, such as brand name, code, label, package, expiry/best before date, and/or date of purchase. The firm also assists in tracing the suspect product throughout the production and distribution chain.

9. What are the steps involved in a food safety investigation?

Investigation: Confirming hazards, investigating suspected root cause, and identifying affected products to confirm whether possible health risk or regulatory violations exist.

Decision-making: A health risk assessment determines whether physical, chemical, biological or allergen issues are present, and the CFIA determines the appropriate risk management strategy.

Implementation of recall: If a recall is required, the CFIA requests the firm initiate a voluntary recall and issues a public warning when needed. If no recall is required as part of the risk management strategy, the CFIA conducts follow up activities such as further inspection, sampling, a letter of non-compliance, meeting, public advisory, detention and/or prosecution.

Verification: The CFIA verifies the clarity of the firm's recall notice, reviews the firm's data on recall effectiveness and conducts recall effectiveness checks. The firm controls the affected product and its return, monitors the effectiveness of the recall and assesses the effectiveness of the recall.

Follow-up: The CFIA monitors the firm's actions on returns and warehouse stock, supervises the disposition of the recalled product, and issues corrective action on current and future production. The firm disposes of the recalled product, controls warehouse stock, conducts corrective action, and monitors future production. HC develops or revises regulatory requirements as required.

10. What is a food recall?

A food recall is an action taken to remove unsafe food products from the market and is one of the tools CFIA employs to manage risk.

The majority of recalls in Canada are conducted voluntarily by the responsible company.

On average, there are 300 recall incidents per year. There may be multiple recalls and recall warnings related to one recall incident. Recalls are an indicator that the system is working and that risks to Canadians are being managed.

There are three classes of recalls:

• Class I (high risk): Initiated when there is reasonable probability that the consumption of, or exposure to, a food product will cause serious health problems or death.
• Class II (moderate risk): Initiated when the consumption of, or exposure to, a food product may cause temporary adverse health consequences or where the probability of serious adverse health consequences is remote.
• Class III (low to no risk): Initiated when the consumption of, or exposure to, a food product is not likely to cause any adverse health consequences.

11. When is a food recall conducted?

The CFIA requests a food recall when a food safety investigation and a health risk assessment conclude that products represent an unacceptable risk to the population.

12. Who decides if a recall is needed?

The CFIA's Vice President of Operations holds the authority to request a company conduct a voluntary recall.

The Minister of Health holds the authority to order a mandatory recall, if a firm is unknown, unavailable or unwilling to conduct a voluntary recall.

13. Is the Minister involved in the food investigation and recall process?

The CFIA provides regular briefings to the Minister on any recalls of significance.

A Minister is rarely involved in ordering a food recall. On average, there are 300 recall incidents each year, with the majority being conducted voluntarily by the responsible company.

The Canadian Food Inspection Agency Act gives the Minister of Health the power to order a recall, if a company is unable or refuses to voluntarily do so. However, only seven recalls in the history of the CFIA required the order of a mandatory recall.

In the unlikely event that a mandatory recall order is required, the Office of Food Safety and Recall within the CFIA initiates the process, which is then drafted by CFIA Legal Services, forwarded to the Minister for signature, and then 'served/delivered' by CFIA inspection staff to the company, distributors and/or retailers.

14. Who is involved in the recall process?

CFIA conducts food safety investigations, provides scientific, technical and operational guidance, coordinates the relationships among relevant partners, and monitors the implementation of the recommended risk management strategy by the responsible firm. The firm is responsible for ensuring the product that is sold is safe, assisting CFIA in the food safety investigation and recalling the product effectively from the marketplace.

Several foreign country governments have agreements in place with the CFIA for the exchange of information related to food safety issues and recalls. For countries where an agreement is absent, the CFIA's Office of Food Safety and Recall will notify the receiving country's officials of a food recall when necessary.

Other external partners are involved on an as-needed basis, and may include HC, PHAC, as well as provincial, territorial and municipal governments.

15. What are the steps in the food recall process?

Following a food safety investigation, the CFIA may determine that conducting a food recall is a necessary risk management action.

There are two types of recalls: voluntary and mandatory. If a firm is unknown, unavailable or unwilling to conduct a voluntary recall, the Canadian Food Inspection Agency Act provides the Minister of Health with the authority to order a recall.

There are two key steps in the food recall process:

• Communication of decision and recall process: The CFIA requests the responsible firm to conduct a voluntary recall, completes and issues public warnings when needed, and coordinates the recall effectiveness verification strategy.
• Verification of the firm's recall activities: The CFIA ensures all necessary components are included, such as the delivery of the notice of recall to all of the firm's accounts, the firm's plans for conducting effectiveness checks, and for correcting or disposing of the affected products.

16. How and when is the public notified of a possible food safety issue?

Depending on the nature of the recall, the CFIA will notify the public through the media, as well as through the CFIA website, social media accounts and subscriber e-mail list. All recalls are posted on the CFIA website.

In instances where the food safety investigation identifies that additional products need to be removed from the market, CFIA will request additional recalls and issue updated food recall warnings. In the presence of illness, PHAC may issue a Public Health Notice to alert the public to illness linked to a specific food source.

H. Risk Communications

1. What are risk communications?

Health Canada has a mandate to manage and communicate the risks to Canadians from products they use every day, including drugs, medical devices, natural health products, consumer products (e.g. fridges, TVs, toys, cribs), pesticides, and marijuana used for medical purposes. Health Canada issues risk communications when it becomes aware that a product may pose a risk to the health or safety of Canadians and their families. In the event of a food recall, Canadian Food Inspection Agency (CFIA) manages and communicates the risks to Canadians.

2. What sort of information is included in a risk communication?

In general, Health Canada risk communications will inform Canadians of:

• What the product risk is;
• What Health Canada and the product maker are doing to help reduce the risk (recalling a product from the market, changing instructions for safe use, etc.); and,
• What they can do to protect themselves from the risk.

3. When does Health Canada issue a risk communication product?

Product makers have the primary responsibility for informing Canadians about product safety risks. They issue the vast majority of public risk communications in consultation with Health Canada. The Department posts and disseminates company-issued risk communications to help ensure that they reach as wide an audience as possible. Health Canada may issue its own risk communication when the Department's risk assessors determine it is warranted. Health Canada has established criteria that help determine whether a given product risk may warrant a public communication. These include:

• death, illness or injury that may be related to the use of a product;
• a large number of safety incidents suggesting a trend;
• exposure of vulnerable populations to potentially unsafe products, e.g., women of child-bearing years, children, seniors and those with weakened immune systems;
• where the profile of the product is such that a risk may be of broad public interest, e.g., contraceptives, smoking cessation aids, pain relievers, toys, diapers, cough and cold medicines;
• actions taken by international regulators on products that are also available in Canada; and
• special circumstances where a statement from Health Canada is needed to warn Canadians about health risks from the use of approved drugs (e.g. fentanyl overdoses).

4. What tools does Health Canada use to communicate risk?

When communicating risk, Health Canada's goal is to ensure that the appropriate message is delivered to the right person at the right time. The tools Health Canada uses are based on the level of risk identified to the public.

• The most urgent and serious potential risks to the public are communicated using Public Advisories for health products and Consumer Product Alerts for consumer products.
• Lesser risks are communicated using Information Updates (health products), Recall Alerts, and Consumer Product Updates.
• Health risks identified for products that are only used in clinical settings, like a hospital or doctor's office, are dealt with using a risk communication targeted specifically to health professionals working in these settings. These types of communications can also be led by the company.
• The monthly Health Product InfoWatch publication is issued to health professionals to inform them of certain adverse drug reactions being reported to the Department and to increase awareness of new safety information.
• Foreign Product Alerts are issued when other jurisdictions take safety action on health products that are not authorized in Canada, but that Canadians may buy over the Internet or when they travel.

5. How are risk communications disseminated?

Health Canada disseminates risk communications according to the intended target audience. Traditional and digital media channels are used.

• Risk communications targetted at the public are disseminated most broadly: newswire, the Recalls and Safety Alerts Database on healthycanadians.ca, the Recalls and Safety Alerts Widget and Mobile App, Twitter, RSS Feed, MedEffect e-Notice (subscriber-based).
• Health professional communications are posted to the Recalls and Safety Alerts Database and sent by MedEffect e-Notice.
• All company-issued product recall notices are reposted in the Recalls and Safety Alerts Database, and are available through the mobile app as well.

In addition to the channels normally used, the Communications and Public Affairs Branch works to enhance the dissemination to the target audience of specific risk communications that may be sensitive (for example, products used by pregnant women) or high-profile (hockey helmets), or that may be of broad interest (general food safety reminders). For example, information can be put on Departmental Facebook pages that target families (Healthy Canadians) and First Nations, and supported with regional outreach activities.

I. Canada's Health Care System

1. How much is spent on health in Canada?

Total health spending was $2158 in 2014, 11 % of Gross Domestic Product (GDP). Of that spending, 71 % was publicly funded ($1528), which is slightly below the Organisation for Economic Co-operation and Development (OECD) average of 73%. The remainder is covered through out-of-pocket payments by individuals (14%) and private health insurance (12%).

The latest internationally comparable data from the OECD show that Canada ranked tenth highest among OECD countries in terms of GDP spent on health in 2013.

2. What are the federal roles in health care?

The federal government has a number of key roles in Canada's health care system:

• It sets out the legislative framework for the publicly funded health care system through the Canada Health Act:
• It assists in the funding of provincial/territorial health care services through the Canada Health Transfer (CHT). The CHT amounts to $348 in 2015-16, and currently represents 23% of provincial/territorial health care expenditures.
• Some provinces also receive Equalization payments that enable these governments to provide reasonably comparable levels of public services (including health care) at reasonably comparable levels of taxation.
• In addition to the CHT, the three territories receive additional federal funds through Territorial Formula Financing to assist them in providing public services.
• The federal government also funds and delivers some health care services to specific groups (First Nations on reserve and Inuit, members of the Canadian Forces, veterans, some refugee claimants, and federal inmates).
• Additional federal health activities include programs to protect and promote health (e.g., regulation of drugs and medical devices, consumer safety and public health), and the regulation of patented drug prices through the Patented Medicine Prices Review Board.

3. What are the provincial/territorial roles in health care?

Provinces and territories are responsible for the day-to-day management and delivery of health care services. These responsibilities include:

• Administering the publicly funded health insurance plans and other health care programs (e.g., prescription drugs, home care, and long-term care);
• Regulation of health care facilities (e.g., hospitals and long-term care facilities) and health professionals (e.g., physicians, nurses);
• Determining the organization and governance of the system; and
• Managing capital investments (e.g., building new health care facilities and equipment).

4. What is health care coverage like in Canada?

Unlike most countries with universal coverage, Canada's publicly funded health insurance is narrow and deep, consisting of full coverage but only for medically necessary hospital and physician services. There is generally uniform coverage across the country for these services.

As a result of provincial/territorial management and delivery of health care services, large variations exist between jurisdictions on the eligibility, scope of coverage, and level of benefits for services outside of medically necessary hospital and physician services. Public funding for prescription drugs, home and long-term care, and other services such as vision and dental care is provided by a patchwork of programs whose scope of coverage and level of benefits vary by province/territory. In many cases, eligibility for these programs is based on age, income, and/or disease status, which vary by province/territory.

5. How are health care services financed in Canada?

In total, 71% of Canada's health expenditures are paid through public funds; the remaining 29% is private - split fairly evenly between out-of-pocket expenses incurred by individuals and families and those covered by private health insurance (usually provided as an employment benefit).

Revenues for the publicly funded portion (i.e., the 71 %) come from general tax revenues of the federal and provincial/territorial governments. These sources include personal income taxes, sales taxes, and corporate taxes.

In addition, Ontario, British Columbia and Quebec impose government health insurance premiums payable by individuals that are nominally targeted for health care. (Note that Quebec plans to gradually eliminate its income-based health care charge introduced in 2010.)

6. How are hospitals, doctors, and other services funded in Canada's health system?

Hospitals are generally funded through global budgets based on historical expenditures, although there are initiatives in some provinces towards funding based on the number of cases treated (e.g., activity-based funding in Ontario).

The majority of canada's physicians, even those working in a hospital setting, consider themselves to be private, self-employed professionals. About 71 % of total payments to physicians were made on a fee-for-service basis in 2013-14. Other forms of payment include capitation payments based on the number of patients enrolled with the physician, and various salary arrangements. Physician fees and types of compensation are bargained collectively by provincial/territorial governments and medical associations.

Other health care professionals (e.g., dentists and pharmacists) are paid in a variety of ways (e.g., fee-for-service and salaried).

7. What is the extent of public versus private delivery of health care?

Health care services are delivered by a broad range of providers, some of which are owned by government, and others of which are privately-owned.

Depending on the jurisdiction, hospitals are either public or not-for-profit institutions operated by a health authority, or by boards selected from the community. In all cases, the provincial/territorial government sets the key operational and financial directions for hospitals.

Depending on the jurisdiction, other health care organizations, such as those operating long-term care facilities and providing home care services, are a mix of private for-profit, private not-for-profit, and public organizations.

8. How is health care governance organized at the provincial level?

Provincial/territorial governments are responsible for the management and delivery of health care services. Most jurisdictions have established provincial-level or regional health authorities (RHAs) to plan the delivery of publicly funded health care services on a local basis. These health authorities generally manage the day-to-day delivery of many health care services, such as hospital care, rehabilitation, long-term care, and home care. However, they also fund other organizations (which have their own boards for governance) for some services, particularly community services, such as mental health.

• Currently, RHAs operate in all provinces except Ontario, Alberta, Nova Scotia, and Prince Edward Island.
• A province-wide health authority organizes the delivery of health care services in Alberta, Nova Scotia, and Prince Edward Island and a territory-wide authority will soon be established in the Northwest Territories.
• In Ontario, Local Health integration Networks plan and fund services delivered by separate organizations.

In all jurisdictions, physician services and drug coverage (to the extent offered) remain the direct responsibility of provincial/territorial governments.

Provincial governments also regulate the quality of care delivered by health care providers. Health professionals have been granted a degree of autonomy in the regulation of their practices, and provincial laws have established self-regulatory colleges for health professions that regulate practice standards.

Canada's Health Care System

Administration of the Canada Health Act

1. What is the Canada Health Act?

The Canada Health Act (the Act) is Canada's federal legislation for publicly funded health care insurance and defines the national principles that govern the Canadian health insurance system, namely, public administration, comprehensiveness, universality, portability and accessibility. The Act sets out the primary objective of Canadian health care policy, which is "to protect, promote and restore the physical and mental well-being of residents of Canada and to facilitate reasonable access to health services without financial or other barriers."

2. What does the Canada Health Act do?

The Act establishes criteria and conditions related to insured health services (medically necessary physician and hospital services) and extended health care services (e.g., nursing home care) that the provinces and territories must fulfill to receive the full federal cash contribution under the Canada Health Transfer (CHT).

The aim of the Act is to ensure that all eligible residents of Canadian provinces and territories have reasonable access to medically necessary hospital and physician services on a prepaid basis, without charges related to the provision of insured health services.

3. Who administers the Canada Health Act?

The federal Minister of Health administers the Act with the assistance of Health Canada staff. The Department of Justice provides legal advice as required and representation when litigation implicating the Act requires federal government intervention.

The Canada Health Act Division of the Strategic Policy Branch at Health Canada is responsible for administering the Act. Members of the Division located in Ottawa and their colleagues in regional Health Canada offices fulfill ongoing functions such as:

• monitoring and analysing provincial and territorial health insurance plans for compliance with the criteria, conditions and extra-billing and user charges provisions of the Act;
• producing the Canada Health Act Annual Report on the administration and operation of the Act; and
• informing the federal Minister of Health of possible non-compliance and recommending appropriate action to resolve the issue.

4. What are the Minister's roles and responsibilities with respect to the Canada Health Act?

The federal Minister of Health is responsible for the interpretation and enforcement of the Act. Furthermore, the Minister is required to annually report to Parliament on the Act's administration and operation, as set out in section 23 of the Act. The Canada Health Act Annual Report (CHAAR) fulfills this reporting requirement.

The CHAAR is a public document that offers a comprehensive description of each province and territory's health insurance plan and describes non-compliance issues that occur within a reporting period.

5. What are the requirements of the Canada Health Act?

The Act contains the following nine requirements that the provinces and territories must fulfill in order to qualify for the full amount of their cash entitlement under the CHT:

• five program criteria (public administration, comprehensiveness, universality, portability and accessibility) that apply only to insured health services;
• two conditions: to provide information to the federal Minister of Health as prescribed by regulations under the Act; and, to recognize the federal financial contributions toward both insured and extended health care services, that apply to insured and extended health care services;
• extra-billing and user charges prohibitions that apply only to insured health services.
  • Extra-billing is billing of an insured person for an insured health service provided by a medical practitioner or a dentist (i.e., a dentist providing insured surgicaldental services in a hospital setting) in addition to any amount paid or to be paid for that service by the health care insurance plan of a province or territory.
  • User charges are any charges for an insured health service, other than extrabilling. For example, if a patient is charged a facility fee for the non-physician (i.e., hospital) services provided in conjunction with a physician service that is insured under the provincial health insurance plan at a clinic.

6. When are deductions made to a province or territory's Canada Health Transfer?

If it can be confirmed that either extra-billing or user charges exist in a province or territory, a mandatory deduction from the Canada Health Transfer (CHT) payments to that province or territory is required under the Act. To date, provincial/territorial transfer payment deductions totaling $10 million have been made in respect of the extra-billing and user charges provisions of the Act.

Non-compliance with one of the five criteria or one of the two conditions of the Act is subject to a discretionary penalty. The amount of any deduction from federal transfer payments under the CHT is based on the magnitude of the non-compliance. The Canada Health Act sets out a consultation process that must be undertaken with the province or territory before discretionary penalties can be levied. To date, the discretionary penalty provisions of the Act have not been applied.

7. How are issues of non-compliance with the Canada Health Act resolved?

Health Canada assesses issues of concern and complaints regarding non-compliance on a case-by-case basis. In most instances, issues are successfully resolved through consultation and discussion with a province or territory based on a thorough examination of the facts.

In instances where a Canada Health Act issue has been identified and remains after initial enquiries, Health Canada officials ask the jurisdiction in question to investigate the matter and report back. Health Canada staff discuss the issue and its possible resolution with provincial/territorial officials. Only if the issue is not resolved to the satisfaction of the Department after following the aforementioned steps is it brought to the attention of the federal Minister of Health.

For the most part, provincial and territorial health care insurance plans generally respect the criteria and conditions of the Act and many exceed its requirements. The application of financial penalties through deductions under the CHT is considered as a last resort when all other options to resolve an issue collaboratively have been exhausted.

8. What if there is disagreement between the provinces and federal government? How are disputes over the Canada Health Act resolved?

Disagreements between the provinces and the federal government can be resolved using the Canada Health Act Dispute Avoidance and Resolution process that was formalized in the 2004 Health Accord. The process includes the dispute avoidance activities of government-to-government information exchange; discussions and clarification of issues, as they arise; active participation of governments in ad hoc federal/provincial/territorial committees on Canada Health Act issues; and Canada Health Act advance assessments, upon request.

Where dispute avoidance activities prove unsuccessful, dispute resolution activities may be initiated, beginning with government-to-government fact-finding and negotiations. If these are unsuccessful, either the federal or provincial/territorial Minister of Health involved may refer the issues to a third-party panel to undertake fact-finding and provide advice and recommendations.

The federal Minister of Health has the final authority to interpret and enforce the Canada Health Act In deciding whether to invoke the non-compliance provisions of the Act, the Minister will take the panel's report into consideration.

Canada's Health Care System

How the Canada Health Transfer System Works

1. What is the Canada Health Transfer?

The Canada Health Transfer (CHT) is the key federal vehicle providing funding support to provinces and territories (P/Ts) in their role in administering and delivering healthcare in Canada.

The CHT's legislated purpose is to:

• Maintain the national criteria and conditions in the Canada Health Act (CHA); and
• Contribute to providing the best possible healthcare system for Canadians and to making information about the healthcare system available to Canadians.

In 2015-16, the Government of Canada will provide $34 billion in cash support for Canada's health system through the CHT. This represents approximately 23% of P/T government health spending and is the largest major federal transfer to P/Ts.

2. How is the money transferred to the provinces and territories?

The Department of Finance is the lead on all aspects of the CHT and other federal transfers.

The Federal-Provincial Fiscal Arrangements Act and its associated regulations set out the calculation process including the envelope size and the allocation of annual payments to P/Ts. Under the authority of the Minister of Finance, the CHT is paid out of the Consolidated Revenue Fund. Payments are made to P/Ts on a bi-monthly basis with amounts transferred directly to P(T Consolidated Revenue Funds (not health ministries).

3. What are the rules governing how provinces use the Canada Health Transfer?

P/T health insurance plans must comply with the principles (universality, comprehensiveness, portability, accessibility and public administration) outlined in the Canada Health Act (CHA) in order to qualify for the full federal CHT cash contribution.

Beyond the CHA requirements, the CHT is largely unconditional, meaning P/Ts may spend CHT funds as each government sees fit.

4. How is the Canada Health Transfer calculated?

Under the CHT renewal plan announced in December 2011, the current 6% annual CHT escalator is set to continue through 2016-17. Starting in 2017-18, the CHT is then set to grow in line with a three-year moving average of nominal gross domestic product (GDP) growth, (which is the real rate of growth plus inflation) with funding guaranteed to increase by at least three percent per year. Estimates provided in the 2015 federal Budget forecast the CHT to increase to over $40 billion by the end of the decade.

5. How are provincial and territorial a/locations determined?

Annual allocations to P/Ts are made on an equal-per-capita basis.

• Overall growth of the CHT cash envelope is governed by the legislated escalator (i.e., by 6% until 2016-17).
• As first announced in Budget 2007, the CHT allocation method moved to an equalper- capita cash distribution in 2014-15.
• For any given year, the CHT cash is divided by population, and each P/T is allocated its share according to its population.
• Prior to 2014-15, the CHT cash took into consideration the value of tax points (taxation room) transferred from the federal government to P/Ts, whereby P/Ts with fiscal capacity above the national average received relatively less in per capita CHT cash.

6. What are the Minister's roles and responsibilities with respect to the Canada Health Transfer?

Although the Department of Finance is the lead on all aspects of the CHT and other federal transfers, the federal Minister of Health is frequently called upon to answer questions regarding the CHT, and other issues related to health system financing.

In addition, as part of the federal Minister of Health's responsibility for monitoring P/T compliance with the CHA, the Minister:

• Determines the amounts of any deductions or withholdings of CHT cash pursuant to the conditions and criteria of the CHA; and
• Ensures that these amounts are communicated to the Department of Finance (typically in March). Finance Canada will then alter payments, as needed.

J. Health System for Aboriginal Canadians

1. What is the difference between the terms "Aboriginal", "First Nations", "Inuit" and "Métis"?

"Aboriginal peoples" is a collective name for the original peoples of North America and their descendants. The Canadian Constitution recognizes three groups of Aboriginal peoples: Indians (commonly referred to as First Nations), Métis and Inuit. These are three distinct peoples with unique histories, languages, cultural practices and spiritual beliefs.

• "First Nations people" refers to Status and Non-Status "Indian" peoples in Canada.
  • Status Indians, or Registered First Nations, are those individuals recognized by the federal government as being registered under the Indian Act, and are entitled to a wide range of programs and services offered by federal agencies and provincial governments.
  • Non-Status Indians commonly refers to people who identify themselves as Indians but who are not entitled to registration on the Indian Register pursuant to the Indian Act. Some of them may be members of a First Nation.
• Métis are people of mixed First Nation and European ancestry who identify themselves as Métis, as distinct from First Nations people, Inuit or non-Aboriginal people. Métis are one of the three recognized Aboriginal people in Canada, and are not considered Status Indians.
• Inuit are the Aboriginal people of the Arctic. The word Inuit means "the people" in the Inuit language of Inuktitut. The singular of Inuit is Inuk.
  • Recognized Inuit are identified under Inuit Land Claim organizations.

According to the 2011 National Household Survey, more than 1.4 million people in Canada identify themselves as an Aboriginal person, or four percent of the population. Of the 1.4 million self-identified Aboriginal people:

• 50% are Status Indians;
• 30% are Métis;
• 15% are non-status Indians; and
• 4% are Inuit.

2. What is the difference between the terms "on-reserve" and "off-reserve"?

A reserve, as defined in the Indian Act, is a tract of land (the legal title to which is vested in Her Majesty) that has been set apart for the use and benefit of an Indian band. Much like the term "First Nation" has become more accepted than "Indian", so too has the use of the term "First Nation communities" instead of "Indian reserves". In the context of health care, the federal government provides health promotion programs and public health services in First Nations communities and in Inuit communities. In remote and isolated areas, where provincially or territorially insured services are not readily available, the Government of Canada provides or funds on-reserve primary and emergency care services, primarily in First Nations communities through nursing stations.

Health Canada's First Nations and Inuit Health Branch (FNIHB) provides or funds the following activities:

• to First Nations on reserve only:
  • primary health care in 80 communities, including access to urgent care services 24/7.
  • health protection programs such as communicable disease control, monitoring of drinking water and wastewater, and environmental public health inspections of facilities and housing.
• to First Nations on reserve and Inuit communities:
  • home and community care in over 500 First Nations and Inuit communities.
  • community-based health promotion and disease prevention programs.
• to registered First Nations and recognized Inuit living in Canada:
  • Non-Insured Health Benefits (NIHB) including coverage for prescription drugs, dental services, medical transportation, medical supplies and equipment, vision care, and short-term mental health counselling.

3. Who is responsible for providing health care services to First Nations and Inuit?

The responsibility for providing health care services for First Nations and Inuit is a shared undertaking between provinces and territories, the federal government, and First Nations and Inuit.

There is an expectation that the federal government will provide or fund primary health care and public health programs on-reserve. Over the years, administrative arrangements and treaties have led to devolution of some of the federal programming to First Nations organizations or territorial governments.

4. What services and care are the provinces responsible for providing to First Nations and Inuit?

Provinces and territories provide universal insured health services (physician and hospital services) to all residents, including First Nations, Inuit, and other Aboriginal people.

5. What role does the federal government play in providing health care to First Nations and Inuit?

The federal government, through Health Canada, funds or directly provides health programs and services for First Nations and Inuit that supplement those provided by provinces and territories in the areas of:

• primary health care (nurses, but not physicians);
• Non-Insured Health Benefits; and
• health infrastructure support.

The federal government, through the Canadian Institutes of Health Research (CIHR), supports research on culturally sensitive health and social policies and interventions. For example, through the Pathways to Health Equity for Aboriginal Peoples initiative, CIHR aims to develop the evidence base in how to design, offer and implement programs and policies that promote health and health equity in First Nations, Métis and Inuit communities in four priority areas: suicide prevention, tuberculosis, diabetes and oral health.

The Public Health Agency of Canada (the Agency) promotes and protects the health of all Canadians, working broadly to reduce health inequities within the population by considering the needs of vulnerable groups within its policies, programs, and initiatives. In alignment with this mandate, it focuses on the needs of Aboriginal populations both on and off reserve. Specifically, the Agency fosters collaboration, provides public health expertise and advice to governments providing direct services to Aboriginal populations, and supports community-based organizations serving Aboriginal populations living off-reserve. The Agency's investments in Aboriginal public health are primarily targeted to the health of Aboriginal children to improve health outcomes later in life.

The Health Portfolio also works with other government departments to support Aboriginal public health and to improve the social determinants of health for Aboriginal populations. Federal partners include Aboriginal Affairs and Northern Development Canada, Canadian Heritage, Canadian Northern Economic Development Agency, Canada Mortgage and Housing Corporation, Employment and Social Development Canada, Correctional Services Canada, and Statistics Canada.

6. What legislation and policies outline the jurisdictional responsibilities for First Nations and Inuit health care in Canada?

Health services for First Nations and Inuit are provided by the federal government based on policy, rather than legislation.

The 1979 Indian Health Policy, based on constitutional and statutory provisions, treaties, and customary practice, outlines the jurisdictional responsibilities for First Nations and Inuit health care in Canada. The goal of the Policy is "to achieve an increasing level of health in Indian communities, generated and maintained by the Indian communities themselves." It articulates that responsibility for First Nations and Inuit health may be shared between federal, provincial or municipal governments, Indian Bands, or the private sector due to the integrated nature of the health care system and outlines that the federal role must include public health on reserves, health promotion, and the detection and mitigation of hazards to health in the environment.

7. What is Jordan's Principle?

Jordan's Principle was passed by the House of Commons unanimously in 2007 after the death of Jordan River Anderson, a First Nations child with a rare neuromuscular disorder, who required care from multiple service providers. The Province of Manitoba and the federal government could not agree on who was financially responsible for Jordan's care, causing Jordan to remain in hospital for five years, where his condition deteriorated and he passed away before a resolution was reached.

Jordan's Principle stipulates that in the event of a jurisdictional dispute over funding for a First Nation child, the government of first contact will pay for services and seek cost-sharing later. Jordan's Principle is intended to guarantee that health care services delivered to Aboriginal children will not be delayed due to jurisdictional disputes.

Engagement efforts have resulted in a network of federal and provincial contacts across the country to review all cases brought forward. Formal agreements to implement Jordan's Principle have been reached with Manitoba (in 2012) and Saskatchewan (in 2009). In other provinces, alternative mechanisms are in place to implement Jordan's Principle.

8. In some cases First Nations and Inuit have responsibility for managing community-level health services. In what circumstances is this responsibility transferred?

First Nations and Inuit interested in having more control over their health programs and services have access to various types of funding model approaches based on the demonstration of their eligibility, interests, needs and capacity. When First Nations or Inuit communities demonstrate an interest and capacity to manage community-level health services, Health Canada facilitates the transfer of this responsibility to the community through a variety of mechanisms. In 2013, after a 10 year process, the provision of health services to First Nations in British Columbia was transferred to a First Nations Health Authority. As a result, Health Canada is now a funding partner but does not directly manage programs in British Columbia.

• 76% of First Nations and Inuit communities have assumed greater responsibility for their health care resources.
• 36% of First Nation communities have taken responsibility for clinical and client care services provided in nursing stations in remote and isolated communities.

9. What role does the federal government play in supporting First Nations management of community-level health services?

The federal government supports First Nations management of community-level health services in a number of ways, working with communities to support First Nations design, delivery and management of health programs and services.

Generally, Health Canada:

• Provides ongoing advice and guidance on the health planning tools and process, throughout the different phases of the community health planning process.
• Assesses and undertakes peer review of health plans created at the recipient level to ensure that the plans link directly to reporting requirements and funding models for which the recipient has been approved.
• Works and formally engages with national organizations, such as the Assembly of First Nations and the Inuit Tapiriit Kanatami, which are part of the First Nations and Inuit Health Branch's senior management table.
• Supports and relies on national and regional program advisory committees on various health-related issues.
• Ensures that regional First Nations and Inuit organizations are involved in program development and implementation.
• Supports and actively participates in co-management or trilateral forums in all regions involving First Nations and Inuit partners and provinces and territories.

K. The Public Health System

1. What is public health?

Public health is the organized efforts of society to keep people healthy and prevent injury, illness, and premature death. It is a combination of programs, services, and policies that protect and promote the health of all Canadians. Public health recognizes health inequities among sub-populations with special needs and vulnerabilities, such as Aboriginal people, children, and seniors, and aims to reduce these inequities.

Key public health issues include health emergency preparedness and response; surveillance; quarantine and border programs; immunization; healthy eating and physical activity programs; infection control measures in hospitals; as well as the detection, lab testing and regulation that support these activities.

Two principles differentiate public health from clinical medicine:

• the focus of public health is prevention rather than treatment of diseases; and
• public health addresses the health needs of populations as a whole instead of individuals.

In a modern health system, public health and primary care and treatment are equally essential tools for protecting and improving the health of Canadians. In turn, healthy citizens are critical to building resilient and prosperous communities. By helping keep Canadians healthy, public health can relieve some of the pressure on the health care system.

2. Who is responsible for the public health system in Canada?

In Canada, public health is a shared responsibility among the federal government, provinces and territories (P/Ts), local public health units, as well as international partners.

An example of how the different levels of government share responsibility for public health is how they interact in the event of public health emergencies.

• Municipal governments have primary responsibility for responding to public health emergencies in their jurisdictions.
• If a public health emergency grows beyond a municipality - either in terms of the municipality's boundaries or its ability to deal with the emergency, then the provincial or territorial governments may be asked to step in and provide assistance.
• If a public health emergency grows beyond one province and/or territory - again, either its boundary or capacity, the Public Health Agency of Canada usually gets involved - often playing a coordinating role. This can include lending its lab capacity or contributing emergency medical and equipment stockpiles and response teams. Federal authorities are also responsible for connecting with foreign countries and international organizations, such as the World Health Organization.

Individual Canadians have a critical role to play in reducing risk factors for chronic and infectious disease and acknowledging their responsibility in their own health.

3. What is the Minister's role in Canada's public health system?

The Minister plays a leadership role in Canada's public health system by convening P/Ts and other partners and stakeholders to foster collective action. The Minister is responsible for exercising the powers, duties and functions vested in him/her by statute or otherwise.

As the Minister responsible for the Public Health Agency of Canada (the Agency), the Minister of Health is accountable to Parliament for public health responsibilities outlined through the following legislation:

• Department of Health Act (1996) - responsible for promoting and preserving the health of Canadians; protecting Canadians against risks to health and the spread of diseases; sharing public health information; and conducting research into public health, including monitoring of diseases.
• Public Health Agency of Canada Act (2006) - established the Agency to assist the Minister in the exercise of powers, as defined in others acts, such as leading federal efforts and mobilizing pan-Canadian action in preventing disease and injury, and promoting and protecting national and international public health.
• Quarantine Act (2005) - undertake activities that aim to prevent the introduction of communicable diseases of public health concern into and out of Canada.

Other legislation guiding the federal role in public health includes: the Emergency Management Act, EMA (2007), the Human Pathogens and Toxins Act, HPTA (2009) and the Human Pathogens Importation Regulations (1994).

In addition to federal legislation, each jurisdiction has its own legislation which governs its respective provincial or territorial public health system.

4. What is the role of the federal government in the public health system?

Jurisdictional responsibilities in Canada's public health system are largely shaped by the Constitution Act (1867) and subsequent Supreme Court of canada decisions, which recognized federal jurisdiction in the areas of quarantine and public health issues of national concern. Court decisions have recognized the federal government's role in taking action when a health problem is national rather than local (e.g., epidemics). The federal role in public health is generally interpreted as including efforts to promote overall health, although these efforts can touch on explicit P{f jurisdiction in the areas of social services, income, and education.

Six common public health functions where the federal government plays a role include:

• Emergency preparedness and response - Working to anticipate, prepare for, respond to, and recover from public health threats, including natural disasters, human-caused disasters, and criminal or terrorist acts. For example, leading Canada's preparedness for Ebola virus, advanced planning for mass gatherings, such as the 2015 Pan-Am Games, and 24/7 vigilance at our borders through the Quarantine Program.
• Health protection - activities that eliminate, as much as possible, the risk of adverse consequences to health due to environmental hazards, including food, air, water and general environment. For example, immunization and hand washing campaigns, travel health notices, and federal oversight of human pathogens and toxins in Canada.
• Health promotion- promoting healthy lifestyles to improve overall health. For example, community-based children's programming to promote the healthy development of infants and young children.
• Disease and injury prevention - reducing the chances of developing disease or injury, especially among those at higher risk. For example, common guidance provided to provinces and territories for responding to emerging infectious diseases, and programming to help Canadians lower their risk for developing chronic diseases.
• Population health assessment- Understanding the health of the populations and the factors that underlie health and health risks. For example, the Chief Public Health Officer's Annual Report on the State of Public Health in Canada, and risk assessments on the spread of emerging disease in Canada.
• Surveillance - Systematic, ongoing collection, collation and analysis of health-related information that is communicated in a timely manner to all who need to know which health problems require action. For example, national surveillance of influenza, tuberculosis, and diabetes.

One of the key ways that the Public Health Agency of Canada supports and shares responsibility for public health is by collaborating with P/Ts to address public health issues and challenges through the Pan-Canadian Public Health Network (PHN). Accountable to the F/P/T Conference of Deputy Ministers of Health, the PHN is made up of F/P/T government officials, including the Chief Public Health Officer of Canada and senior government officials responsible for public health from all jurisdictions. They meet regularly to share knowledge, expertise and best practices on public health, and develop and implement efficient and collaborative approaches.

Through its regulatory mandate, Health Canada also plays a role in supporting public health, for example, through the provision of access to safe and effective health products and food information for healthy choices (e.g., Canada's Food Guide) and efforts to reduce health risks from products and substances (e.g., tobacco) and to reduce health inequalities between First Nations and Inuit and other Canadians.

5. What is the role of the provincial government in the public health system?

Provincial and territorial governments are primarily responsible for the administration and delivery of health care, including public health care. They conduct surveillance and manage policy and program implementation and evaluation within their jurisdictions.

6. What are the responsibilities of the provincial/territorial chief public health officers across the country?

Chief public health officers (CPHOs), or chief medical officers of health (CMOH), play critical roles in Canada's public health system. CPHO/CMOHs have responsibility within their respective jurisdictions for the protection and promotion of the health of the public and prevention of disease and injury. Structural differences in public health systems across the 13 P/T jurisdictions account for variations in the defined roles of CPHOs and CMOHs. Generally, they are responsible for providing advice to their respective Ministers and/or Deputy Ministers on public health issues, as well as overseeing the management of regional public health divisions/units. For example, roles can also include contributing to broader health system analysis and planning, or functioning as an expert consultant for a specific program/content area.

One of the key mechanisms for collaboration is the Council of Chief Medical Officers of Health (CCMOH). It is a forum that allows for discussions and collaborative action on professional practice issues related to strengthening public health, for example, enhancing the professional competence of Medical Officers of Health, standards of practice and ethical issues. In addition, and as circumstances evolve, the CCMOH identifies and proposes work on a broad range of emerging public health issues.

7. What is the federal government's role with respect to public health internationally?

In our increasingly interconnected world, the health of canadians is closely linked to the health of people around the globe. The federal government undertakes a wide range of international public health activities that directly support the Minister of Health's mandate to preserve, protect and promote the health of Canadians.

International engagement presents an opportunity for officials to both share and learn from the public health innovations adopted by other partners and to leverage our respective resources and expertise to more effectively address common public health challenges.

Areas of international cooperation include collaborating with partners to prepare and respond to global health threats that can cross international borders (such as the current Ebola outbreak in West Africa), conducting joint research to better understand and identify solutions to growing/emerging challenges (e.g., dementia, antimicrobial resistance, etc.) and sharing information and best practices on approaches and programs implemented to address common public health priorities (such as obesity, tobacco control, and violence prevention).

The Health Portfolio also supports the Government of Canada's international development agenda, as it applies to human health, through the provision of policy advice to the Department of Foreign Affairs, Trade and Development (DFATD), and advancing Canada's positions on global health development in fora where the Health Portfolio is the Government of Canada lead, such as the World Health Organization and Pan-American Health Organization.

8. Who are the other key players in the public health system?

The federal government engages with a wide variety of stakeholders and communities across the country to further public health objectives.

Provinces / Territories

• Discussion and collaboration with jurisdictions on strategies, surveillance, northern and Aboriginal public health issues, etc.
• Leveraging intergovernmental platforms, such as the F/P/T Pan-Canadian Public Health Network, to advance federal policy priorities within the intergovernmental context.

International Partnerships

• Engagement in multilateral organizations such as the World Health Organization (WHO), the Pan-American Health Organization (PAHO), and the Global Health Security Initiative (GHSI).
• Bilateral engagement with countries and regions (e.g. United States, Mexico, European Union, and China).

Federal Partners

• Close relationship with portfolio partners - shared services with Health Canada; collaboration with the Canadian Institutes of Health Research and the Canadian Food Inspection Agency.
• Collaboration with departments responsible for the health of federal populations, food safety, emergency preparedness, international affairs, as well as those addressing the social determinants of health.

Stakeholders

• Strategic relations with domestic public stakeholders such as National HIV/AIDS partners, public health and health professional organizations such as the Association of Medical Microbiology and Infectious Disease Canada and the Canadian Public Health Association.

Private Sector

• Innovative partnerships to leverage private sector funds and infrastructure such as the diabetes risk screening tool with Shoppers Drug Mart, and other healthy living partnerships with YMCA, AirMiles, Play Exchange, Canadian Tire, CBC, etc.

Emergency Preparedness and Response (infectious disease and food-borne illness outbreaks)

1. What is an infectious disease?

An infectious disease is a disease caused by micro-organisms, i.e. a virus, bacterium, fungus or parasite. These micro-organisms can spread through air or water or food; by direct physical contact or indirect contact with a contaminated object or surface; or via an insect, animal or another person.

Factors that contribute to the spread of infectious diseases include: travel, urbanization and immigration; housing; health care practices and public health infrastructure; low immunization coverage rates or pockets of unimmunized individuals; food production and preparation methods; the use and misuse of antibiotics and microbial adaptation; and human behaviour.

Some recent Canadian examples of infectious disease outbreaks include the severe acute respiratory syndrome (SARS) outbreak of 2003, the listeriosis outbreak of 2008, and the H1N1 flu pandemic of 2009.

2. What is a food-borne illness?

A food-borne illness is caused by consumption of contaminated food, while a water-borne illness is caused by drinking contaminated water.

The Public Health Agency of Canada estimates that each year about one in eight Canadians (four million people) get sick from the food they eat. Four pathogens cause about 90% of the 1.6 million illnesses caused by known pathogens: Norovirus (1 million cases), Clostridium perfringens (177,000 cases), Campylobacter (145,000 cases) and nontyphoidal Salmonella (88,000 cases).

3. What is a pandemic?

A pandemic occurs when a specific illness spreads around the world to people from many different countries. Infectious disease pandemics are the result of new or changed microorganisms.

The 2009 H1N1 flu pandemic was due to a new influenza strain for which people did not have immunity. The spread of HIV infection in the 1980s and 1990s has also been described as a pandemic.

4. When does the federal government get involved?

Within Canada, most infectious diseases occur in sporadic individual cases or small, localized clusters. These are typically investigated by provincial/territorial departments of health and their local public health regions.

When a large scale outbreak occurs in more than one province or territory, the federal government takes a leadership role in coordinating the response. Different roles and responsibilities are taken by different areas of the Health Portfolio. For instance, in a food-borne illness outbreak the Public Health Agency of Canada collates information from ill persons, analyzes exposure information to identify commonalities, and liaises with provincial/territorial and federal public health and food safety partners to determine if further public health action is warranted.

For food-borne illness, the federal Health Portfolio has ongoing roles as follows:

• The Public Health Agency of Canada conducts national surveillance and epidemiology of reportable diseases and outbreak monitoring, and also provides advice to protect people's health.
• Health Canada develops food safety standards and policies to help minimize the risk of food-borne illnesses.
• The Canadian Food Inspection Agency carries out inspection of the food industry to ensure that it meets its food safety responsibilities.

5. Which departments and agencies are involved in an infectious disease outbreak?

The main federal departments involved in response to an infectious disease outbreak or pandemic are:

• Public Health Agency of Canada - undertakes surveillance and outbreak investigations to identify and track the outbreak and to identify control measures; working with federal, provincial and territorial partners.
• Canadian Food Inspection Agency - conducts food safety investigations; coordinates food recalls and other measures to control the potential source of illnesses; provides laboratory analyses of food samples; and liaises with international partners.
• Health Canada - conducts health risk assessments of implicated sources of illnesses; assigns a health risk to the implicated sources of the illnesses; and develops health policies and standards based on investigation findings, when applicable.
• Public Safety Canada - ensures coordination across all federal departments and agencies responsible for national security and the safety of Canadians.

6. What federal government actions are taken when there is an infectious disease outbreak?

Once it has been determined that the number of cases of an illness is higher than expected, the federal government works with public health partners to investigate the outbreak. This includes collecting information from cases, analyzing exposure information to identify commonalities, and liaising with public health and food safety partners to share information and coordinate action.

The federal Health Portfolio has emergency response plans in place to guide outbreak response activities and interactions with federal, provincial, and territorial partners.

The Public Health Agency of Canada is responsible for administration and enforcement of the Quarantine Act at Canada's ports of entry. The Agency also manages the National Emergency Strategic Stockpile which can provide health emergency assets, including pandemic supplies, pharmaceuticals, and social services supplies, to provinces and territories upon request.

The National Microbiology Laboratory's high-containment capacity allows Canada to rapidly and safely conduct research on novel pathogens and provide leadership for public health laboratories across Canada.

The Public Health Agency of Canada works in close collaboration with federal, provincial, and territorial partners to communicate important information through its website and social media.

7. Which departments and agencies are involved in an outbreak related to a food-borne illness?

The Public Health Agency of Canada (PHAC), Health Canada, and the Canadian Food Inspection Agency (CFIA) have legislated responsibilities for responding to food-borne illness-related events.

PHAC is mandated to assess and reduce the risk of food-borne, water-borne and zoonotic disease in Canadians through national surveillance and targeted special studies. PHAC works collaboratively with CFIA on food safety related events and with Health Canada on drinking water related events. Within the Government of Canada, PHAC is the usual first point of contact for issues related to actual or potential food-borne or water-borne illness outbreaks and is responsible for leading and coordinating the response to cross-jurisdictional outbreaks, and liaising with international partners.

Health Canada is responsible for minimizing public health risks from the consumption of foods contaminated with bacterial, parasitic, viral and prion-disease agents, including: conducting health risk assessments of implicated sources of illnesses; assigning a health risk to the implicated source; developing health policies and standards based on investigation findings; and, providing laboratory analysis of food samples.

CFIA has the lead role in responding to a food safety, animal health or plant health disease outbreak with the support of provincial and federal authorities. CFIA traces food from production and processing to distribution and retail to identify suspected sources of problems; conducts food safety investigations; and conducts recall actions based on Health Canada's risk assessments when a product could pose a risk to public, animal, or plant health.

8. What federal government actions are taken when there is a food-borne illness outbreak?

The Public Health Agency of Canada, the Canadian Food Inspection Agency, and Health Canada work with public health officials, and provincial ministries of health to confirm the source of food-related illnesses when an outbreak is suspected.

When cases occur in multiple provinces, federal officials lead the investigation, provide reference laboratory services, conduct food safety investigations and conduct recall actions.

If an outbreak escalates to the point where additional federal support and leadership are needed, either by occurring in one or more jurisdiction, overwhelming the resources of the lead jurisdiction, or by being international in nature, then the federal Health Portfolio provides national coordination and ensures linkage across federal departments.

9. How is information communicated to the public when there is an infectious disease or food-borne illness outbreak?

The Public Health Agency of Canada, the Canadian Food Inspection Agency and Health Canada work closely with federal and provincial partners on coordinated public communications for infectious disease and food-borne illness outbreaks.

The Public Health Agency of Canada posts public health notices, fact sheets, risk assessments, and bulletins to public health professionals and the public on its website as well as through social media channels such as Facebook and twitter.

For emergency situations, the Public Health Agency of Canada has a public information line that can be set up for around-the-clock coverage.

10. What are the federal government's responsibilities with respect to international infectious disease or food-borne illness outbreaks?

Governments work together when there is a national or international outbreak of food-borne illness. Canada follows the International Health Regulations (IHRs) which have been established to ensure international cooperation among countries for monitoring, reporting and responding to public health events. Under the IHRs, any country that is aware of a potential public health emergency of international concern must notify the World Health Organization to facilitate information-sharing with other countries so that appropriate public health measures can be put in place.

The provincial, territorial and federal governments have a Memorandum of Understanding on the Sharing of Information during a Public Health Emergency to ensure timely and accurate information sharing in support of response efforts.

11. Is the Minister involved in the emergency response to an infectious disease or food-borne illness outbreak?

The Minister of Health is responsible for leading the federal response to public health emergencies, and under the International Health Regulations, for ensuring that Canada maintains core public health capacity to protect global public health from the spread of diseases, chemical spills or nuclear accidents that could cross international boundaries.

The Minister must also adhere to the Emergency Management Act which requires the Minister to identify the risks that are within or related to his or her area of responsibility and prepare emergency management plans with respect of those risks. In addition to the responsibilities under the Emergency Management Act, the Minister of Health has the following responsibilities in response to an emergency affecting the Health Portfolio:

Domestic responsibilities:

• Legal and policy obligations related to Cabinet, including Cabinet Committees and other Ministers;
• Management of parliamentary relations;
• Coordination role with P/T Ministers of Health and other P/T Ministers;
• Emergency financial authorities; and
• Public communications including risk communications to the Canadian public.

International responsibilities:

• International leadership in preparedness and response activities through dialogue and consultation with international counterparts.

The Minister of Health will be briefed by senior officials on events where one or more of the following conditions exist:

• There is a food recall with a public recall warning;
• There is confirmed illness with public health impact associated with a food product that is not recalled;
• Intentional contamination is suspected or confirmed;
• A food recall has been issued in another country where the food may pose a significant public health risk to Canadians; and
• Significant media attention is expected or already occurring due to type of product, volume, etc.

L. Access to Information and Privacy

1. What is the Access to Information Act?

The Access to Information Act (ATIA) gives Canadian citizens, permanent residents, or any person or corporation present in Canada a right to access information that is under the control of the government institution. The ATIA is intended to complement existing procedures for access to government information such as Proactive Disclosure and Open Government initiatives.

The ATIA is founded on the principle that government information should be available to the public and exceptions to the right of access should be limited and specific. The application of the ATIA requires a balancing of this principle of openness and transparency against the need to protect certain types of information. Under the ATIA, government institutions are not required to release certain types of information that may be injurious to the conduct of government, such as information related to deliberations with other governments (e.g., foreign governments or provincial governments), information related to international affairs and defence, policy advice, and information on law enforcement and investigations.

2. What is the Privacy Act?

The Privacy Act (PA) protects personal information held by a government institution and provides the public with a right of access to their own personal information. The PA is founded on the importance of personal information, and requires appropriate safeguards for its collection, retention, use, disposal and disclosure.

The PA protects personal information held by a government institution and provides the public with a right of access to their own personal information.

3. What happens if the government releases personal information by accident?

Treasury Board Secretariat (TBS) policies require material privacy breaches to be reported to the Privacy Commissioner and TBS. Breaches are investigated by the Privacy Commissioner. Affected individuals are generally notified when their personal information has been breached.

4. Does the Access to Information and the Privacy Act apply to a Minister's office?

Records in the Minister's Office are not normally subject to the ATIA or PA since the Office is not considered part of the government institution. That said, these records may be subject to both Acts in certain circumstances. For example, a decision by the Supreme Court of Canada (SCC) held that a record found exclusively in a Minister's office could be deemed to be under the control of a government institution if a two-step test is satisfied. The two steps are as follows:

• Do the contents of the record relate to a departmental matter?
• If so, could a senior official of the government institution reasonably expect to obtain a copy of the record upon request?

If a record meets the first step of the control test, one must go to the second step. This second step is an objective one to be assessed on a review of all relevant factors including the following:

• the substantive content of the record;
• the circumstances in which it was created; and
• the legal relationship between the government institution and the record holder.

If the two-step control test set out by the sec is satisfied, then the record is deemed to be under the institution's control and must be disclosed unless it is subject to any specific statutory exemption under the AITA or PA.

In the event records in a Minister's Office may be relevant to a request, the Deputy Minister's Office (DMO) will interface with the Minister's Office and provide the Access to Information and Privacy Operations Division with any relevant records as per the above test. DMO would also provide a rationale for any exemptions recommended and would identify any sensitivity in the records.

5. Are there other exceptions to the Access to Information and the Privacy Act?

Cabinet Confidences (e.g., Cabinet documents such as Memoranda to Cabinet and Treasury Board submissions, draft legislation, communications between Ministers, etc.) are excluded from the ATIA and PA. Once 20 years has elapsed, these types of records will no longer be considered Cabinet Confidences and will become subject to the ATIA and PA.

6. How is access to information and privacy handled at Health Canada and the Public Health Agency?

The Access to Information and Privacy Operations Division (ATIP Division) of the Corporate Services Branch is responsible for managing the statutory requirements under the ATIA and the PA on behalf of Health Canada (HC) and the Public Health Agency of canada (PHAC). Although each institution must independently fulfill its requirements under the Acts, services have been delivered to both institutions through a single ATIP Division since June 2012.

The ATIP Division receives formal requests for information under both Acts, informal requests for information and consultations from other departments, formal complaints and supports related litigation.

Processing requests entails careful review of hundreds of thousands of pages of records held by HC and PHAC. The ATIP Division receives input regarding sensitivities and will consult external parties and other levels of government to determine what information can be disclosed. Requests and associated records are often scientific and technical in nature, adding complexity to the role. In addition, the health dimension of records adds to the sensitivity of the information, requiring careful scrutiny to ensure the ATIA is appropriately applied to both support objectives of openness and transparency, while protecting necessary information.

7. What is the Minister's role in access to information and privacy?

While the Minister of Health is responsible for the implementation of the Acts, any of its powers, duties or functions under the ATIA or PA may be delegated to officers or employees of their institution(s) (but not to exempt staff). Given the technical nature of the legislative requirements, required expertise, coupled with the significant volume and tight time constraints to respond to requests, it is typical for Ministers to delegate all of the powers to officials within the institution. This practice also helps insulate the Minister and his/her staff from possible allegations of delay or interference in the timely processing of requests for information.

Currently, powers under the Acts have been delegated to the ATIP Director, the responsible Director General and the Assistant Deputy Minister, Corporate Services Branch. The current delegation orders were signed on July 11, 2013 and remain in effect.

Under each of the Acts, each institution must table an Annual Report to Parliament. Such reports must be tabled within three months after the fiscal year or, if the House is not then sitting, within the next 15 sitting days. The 2014/15 Annual Reports for HC and PHAC have been completed but have not yet been tabled; they will be submitted to the Minister in the coming weeks for review and approval and must be tabled within the first 15 sitting days of the new Parliament.

Grants and Contributions

1. What are grants and contributions?

Grants and contributions are transfer payment instruments used to implement Government of Canada decisions and commitments (e.g., Cabinet decisions). Grants and contributions transfer payments are monetary payments to a third party that does not result in the acquisition by the Government of Canada of any goods, services or assets.

The Government of Canada can provide grants and contributions funding to other orders of government, non-government organizations and individuals. These are used when other organizations (outside the Government of Canada) can more appropriately and/or effectively fulfill the Government of Canada's objective, due to their subject matter expertise, capacity and/or ability to reach the intended population.

To establish a grant or contribution program, the Minister makes a submission to the Treasury Board committee of Cabinet that articulates the terms and conditions under which the program will operate. Treasury Board approval is required to implement the grant or contribution program.

2. What is the difference between a grant and a contribution?

A grant is funding provided without conditions. Pre-established criteria determine who is eligible to receive funding and for what purpose, but once the grant is issued it is not subject to conditions or audit. The recipient may be required to provide an annual report.

A contribution is funding provided with conditions whereby the recipient must provide financial reports, report on progress against defined expectations and is subject to audit and evaluation.

3. When do we use a grant?

Grants are appropriate when the amount of funding to be provided can be determined in advance and eligibility criteria and information obtained before payment provide assurance that the grant will be used for the purpose for which it is provided. Grants are not appropriate where funding provided to a recipient is to be further distributed to one or more persons or entities.

Grants are typically used for a one-time activity that does not require monitoring and oversight because the Government is confident in the organization's or the individual's ability to carry out the work. For example, the International Health Grants Program supports payment of Canada's membership in key multilateral health organizations.

4. When do we use a contribution?

Contributions are more often used for longer-term, more complex projects requiring oversight (e.g., financial reports, report on progress against defined expectations, audit and evaluation). An example of a contribution is Health Canada's Anti-Drug Strategy Initiatives contribution program which supports, among other things, community-based health promotion and prevention activities targeted to youth as well as larger scale projects to health organizations to train health professionals in best practices.

5. What kinds of grants and contributions does the Health Portfolio manage?

There is a wide range of grants and contributions across the Health Portfolio which support research, health promotion and prevention, strengthen Canada's health care system and deliver health services in First Nations communities.

The Public Health Agency of Canada (PHAC) manages programs under a broad range of categories which aim to reduce inequities or target socially, economically and geographically vulnerable populations. These include: children's programs (including Aboriginal Head Start, Prenatal Nutrition); HIV/AIDS, Hepatitis C, Canadian HIV Vaccine Initiative; healthy living and chronic disease prevention; international health; and innovation strategy.

Health Canada has two branches that manage grants and contributions:

• First Nations and Inuit Health Branch (FNIHB) provides contribution funding to First Nations and Inuit with the aim to provide effective, sustainable and culturally appropriate health programs and services that contribute to the reduction of gaps in health status between First Nations and Inuit and other Canadians. This includes funding or services related to issues such as mental wellness and healthy living; public health programs (e.g., communicable disease control and environmental public health monitoring and inspections) as well as Non-Insured Health Benefits to over 800,000 status Indians and recognized Inuit.
• Strategic Policy Branch manages a range of grants and contributions targeted to specific health issues (e.g., substance abuse, mental health, palliative and continuing care) and focused on strengthening the health system at a national level (e.g. organ donation and transplantation, patient safety, health information systems, access to services in minority official languages).

The Canadian Institutes of Health Research (CIHR) provides grants and awards to health researchers and trainees to perform research in universities and research hospitals across Canada.

The Canadian Food Inspection Agency (CFIA) has one contribution program, the Federal Assistance Program (FAP). Its purpose is to provide a vehicle whereby the Agency's Program Managers can broaden their reach by supporting projects and initiatives that will strengthen the underlying science, improve the national and international regulatory framework and improve the effectiveness of the inspection system.

6. Is the Minister involved in awarding funding through the grants and contributions process?

For grants and contribution funding, the Minister is responsible for approval of the overall design of programming (e.g., through a Memorandum to Cabinet) and for obtaining overall funding (e.g., through a submission to Treasury Board). Currently, day-to-day decisionmaking has been largely delegated across portfolio organizations (per the Delegation of Financial Signing Authorities (DFSA) Instrument).

In the case of funding awarded by CIHR, the Minister is not involved in the approval process. Rather, funding is awarded by a peer-review process. The Chief Science Officer is responsible for ensuring the integrity of the peer review processes, and the Chief Financial Officer is responsible for confirming the availability of funds. Following this due diligence, the President and CEO of the CIHR makes final funding decisions.

7. Approximately how much money will the Health Portfolio spend in grants and contributions in 2015-2016?

In 2015-16 the Portfolio is managing almost $3B in grants and contributions, with the majority in Health Canada and CIHR.

8. How can Canadians and organizations find information about grants and contributions and whether they are eligible to apply?

Strategies to inform Canadians and organizations about funding opportunities are tailored to the specific programs. Although there is no Portfolio-wide single window, tools for disseminating information include posting information on the internet and liaising with stakeholders.

As noted below, requests for proposals are designed to meet the needs of the program. Some may be quite narrow in scope depending on the expertise and capacity needed. Others may be open only to provincial/territorial governments or international organizations and therefore not advertised beyond those sectors.

In the case of CIHR, whose grants and contributions are specific to research, funding opportunities for grants and awards are posted on a web portal called ResearchNet.

Researchers and trainees wishing to apply must be affiliated with an institution that is eligible to receive CIHR funding. Other eligibility criteria may be specified in the funding opportunities.

Government departments and agencies also publish on a quarterly basis all grants and contributions provided to recipient organizations.

9. How are eligibility criteria for grants and contributions determined?

Eligibility criteria are determined in accordance with the program requirements, stipulated in the program Terms and Conditions, approved by Treasury Board.

In some cases, the terms and conditions may identify one designated recipient.

• This is the case with several pan-Canadian organizations, such as the Canadian Institute for Health Information, the Mental Health Commission of Canada, and Canadian Blood Services, which have been established for a specific purpose and have the mandate and expertise to meet the objectives of their respective grant or contribution received from Health Canada. They may in turn partner with other recipients, but the funding from Health Canada transfers solely to the named organization.

Some programs have multiple recipients.

• These programs tend to be more project-based where recipients receive funding for defined periods of time. The eligibility criteria will determine the nature and type of organizations specific to the program requirements. For example if the purpose of the program is to provide education and training for health care professionals, the program could seek to engage recipients such as academic institutions (provide the training), health professional associations (receive the training and identify learning needs), and provincial/territorial governments (regulate professions).

10. How do Canadians and organizations apply for grants and contributions?

The application process varies by program. For programs with one designated recipient there is no application process, but rather a rigorous process to determine the specificity of what is expected during the funding period.

For programs with multiple recipients a Request for Proposals (RFP) will be issued (see below). This is also known as a Call for Proposal (CFP) or an Invitation to Submit a Funding Request (ISFR).

Health Canada's First Nations and Inuit Health community-based programs require a mandate, as evidenced by a Band Council Resolution (BCR) or other formal mandate for initial agreements. Recipients must then conduct a comprehensive health planning process where the recipient undertakes either a health program plan, or develops a work plan or health plan to reflect their community's needs. The type of plan undertaken or developed coincides with the recipient's assessed capacities.

Some programs accept unsolicited proposals on an on-going basis.

For CIHR grants, researchers and trainees in eligible canadian institutions may submit an application for funding through ResearchNet.

11. What is an "RFP"?

A Request for Proposals (RFP), or call for Proposals (CFP), or Invitation to Submit a Funding Request (ISFR) is generally referred to as a solicitation process. It will inform potential applicants that funding is available for a specific purpose over a specific time period.

Generally, it includes information on eligibility criteria, the requirements in a funding application, whether letters of support or partnerships are required, timelines, amount of funding available and anticipated start dates for the project.

12. What is the review process for grants and contributions?

Each grant or contribution program establishes its review process according to its terms and conditions. This process is articulated before the Request for Proposals is issued.

A review committee assesses funding proposals on a pre-established set of criteria. The basis for recommendations to proceed with funding (e.g., consensus, minimum score, geographical representation) is determined in advance.

The make-up of the review committees will often include subject matter, financial and program expertise. It may be necessary to consult with legal services, communications, official languages, federal/provincial/territorial relations or other Departments depending on the nature and scope of the program.

CIHR's review process relies on an internationally-recognized peer-review system to ensure scientific quality and excellence of grants and awards. Each year, more than 3,000 researchers volunteer their time to participate in peer review committees that are responsible for valuating research applications, rank them based on a defined set of evaluation criteria, and provide unding recommendations to CIHR.

13. Who decides who receives funding through grants and contributions?

The responsible program makes a recommendation to senior management, which may be presented to the Minister for approval, depending on the program in question (see Question 6). Once the appropriate approval has been given, program officials communicate with the recipient and enter into a funding agreement.

14. What is a funding agreement?

A funding agreement (grant agreement or contribution agreement) is legally binding and articulates the obligations and responsibilities of the recipient and the Government (Portfolio organization).

Key elements of a funding agreement include, but are not limited to:

• expected deliverables, time frame and resources to be provided;
• requirements for the recipient to provide financial and progress reports;
• payment schedule including the basis for issuing, withholding or recovering payments;
• the government's right to access records and premises, including the right to audit;
• expectation of the recipient to participate in performance measurement and evaluation activities;
• intellectual property and privacy considerations; and
• administrative information such as incorporation number, signing authorities.

15. What oversights and safeguards are in place to ensure sound financial management of grants and contributions?

There are a number of provisions in place to ensure effective management and sound stewardship of grants and contributions. These include, but are not limited to:

• Officials are responsible for the oversight of their assigned programs. This includes on-going communications with the recipient to ensure their deliverables are on track, provide support and direction to the recipient and to brief internally as appropriate to manage issues as they arise.
• Risk-based management, including annual risk assessments at the program and recipient level to determine the level of monitoring and reporting required.
• Performance measurement strategies are implemented with each recipient that clearly articulate expected outputs and outcomes and how these will be measured.
• Audits may be conducted.
• Program evaluations are conducted every five years.
• Internal controls: each portfolio organization has internal controls in place to manage internal approvals, payments to recipients, public reporting, audit and evaluation.

CIHR has established a financial framework which defines business processes for the planning, reviewing, approving and reporting of all of CIHR's investments. Final due diligence is exercised to confirm the availability of funds prior to competition funding results being announced to the research community. All eligible institutions must sign an agreement with CIHR, outlining the roles and responsibilities of research institutions in the administration of grants and awards. CIHR periodically reviews the institutions' financial administration of grants and awards to ensure compliance and effectiveness.