National Pharmacare Committee of Experts: Terms of reference

Context

The Act respecting pharmacare, which came into force on October 10, 2024, establishes the foundational principles for the implementation of national universal pharmacare in Canada.

The Act demonstrates the Government of Canada’s commitment to consulting widely about the way forward and working with provinces, territories, Indigenous peoples and other partners and stakeholders to improve the accessibility, affordability and appropriate use of pharmaceutical products for all Canadians.

Section 11 (1) of the Act requires that the Minister of Health establish a committee of experts to make recommendations respecting options for the operation and financing of national, universal, single-payer pharmacare.

1.0 Mandate

As outlined in the Act respecting pharmacare, the committee of experts will make recommendations respecting options for the operation and financing of national, universal, single-payer pharmacare.

To this end, the committee of experts will:

• Identify and assess the operational requirements to implement national universal single payer pharmacare in Canada. In doing so, the committee will:
  • consider existing research and the current Canadian context comprised of many different approaches to delivering drug coverage to Canadians (e.g., mixed models, universal programs with deductibles and co-pays, disease specific programs), and the differing roles and responsibilities of governments, pharmacies, health care providers and patients.
  • incorporate learnings from existing projects and programs established to improve pharmaceutical drug coverage as they develop, including the Improving Affordable Access to Prescription Drugs Demonstration Project in Prince Edward Island, the National Strategy for Drugs for Rare Diseases, and the universal, single-payer, first-dollar coverage of specified contraception and diabetes medications per An Act respecting pharmacare.
  • consider approaches to best meet the needs of Indigenous peoples and communities.
  • consider ways to best meet the needs of underserved communities, including black and racialized people.
• In developing its recommendations and advice, the Committee is to:
  • identify financial implications.
  • engage with and consider perspectives from provincial and territorial governments, Indigenous groups, and experts in relevant fields including, but not limited to public and private drug plan administrators, health care providers, industry, business, labour and academics.
  • engage with and consider the voices of those with lived and living experience, including, but not limited to, meaningful consultation with the Patient and Community Advisory Committee of Canada’s Drug Agency and the broader patient community.
  • seek to facilitate effective and meaningful participation of Indigenous peoples and communities as it undertakes its work. The review will be conducted in a manner that seeks to advance progress towards the broader goals of reconciliation.
  • apply a Sex and Gender-based Analysis Plus (SGBA+) lens to systematically integrate sex, gender, and intersectional considerations in its work.

2.0 Report

The committee of experts will provide a written report to the Minister setting out its recommendations for the operation and financing of national, universal, single-payer pharmacare by October 10, 2025, which the Minister will table in Parliament.

The committee of experts’ final report will be posted on Health Canada’s website once tabled in Parliament.

3.0 Governance

The committee of experts will operate under Health Canada's policy on external advisory bodies. All elements of this policy applies to the committee of experts.

The committee of experts will provide advice to the Minister of Health.

4.0 Membership

Prospective members of the committee of experts will be identified through a targeted solicitation process. The goals of this process is to ensure that together, members have a range of knowledge and expertise, and embody the array of experience and perspectives required to fulfill the committee’s mandate.

Members of the committee of experts are appointed by the Minister of Health. They are appointed at pleasure, and appointments may be ended without cause or consultation. The committee of experts will consist of up to 5 members, including the Chair, who collectively possess an appropriate range of knowledge, expertise, and experience related to the operation and financing of drug plans in Canada.

To preserve the independence of the federal government as a decision maker, federal government employees are not permitted to chair or be a member of the committee of experts and cannot participate in the formulation of the Committee’s advice to Health Canada.

4.1 Selection of the Chair

Health Canada has appointed the chair for approximately one year, i.e. until October 11, 2025 when the committee will sunset with the delivery of its report. The chair will be a member of the committee of experts.

4.2 Tenure

The committee of experts will sunset following the delivery of its report no later than one year after royal assent of the Pharmacare Act.

4.3 Resignation Process

A member may resign by writing to the secretariat of the Committee, with a copy to the chair, including the effective date of the resignation. It is preferred that the member give 14 days notice of his or her intent to resign.

4.4 End of Appointment

Health Canada may end a member’s appointment for cause by writing to the member stating the reasons the appointment is being concluded and the effective date in the following circumstances: 

1. the member has failed to act according to the Committee’s Terms of Reference;
2. the member has failed to comply with their obligations under the Confidentiality Agreement;
3. a change in the member’s affiliations and interests results in a direct financial interest that prevents participation;
4. the member has missed three consecutive meetings of the Committee without informing the secretariat of the reason(s); or
5. the member has acted in a way that jeopardizes the integrity of the Committee.

Other general reasons that could lead to the end of an appointment include:

1. the member’s term is complete;
2. the member resigns;
3. the member becomes a federal government employee;
4. the mandate of the Committee has been completed;
5. the mandate of the Committee is changed and the member’s knowledge, experience, or expertise is no longer relevant to the revised mandate; or
6. Health Canada and any collaborating government departments, agencies, or organizations decide to rescind the Committee’s mandate and Terms of Reference.

5.0 Disclosure of affiliations and declarations

Before being considered for appointment, potential members of the committee of experts were required to complete and return the Affiliations and Interests Declaration Form. The personal information in a completed Affiliations and Interests Declaration Form is protected under the Privacy Act.

As a condition of appointment, Committee members were required to give Health Canada permission to publish a brief biography and summary of his or her affiliations and interests. Each member had the opportunity to review and approve the summary for accuracy before publication during the appointment process. The summary will be available through publication on Canada.ca.

Health Canada or the Chair will ask members to make a verbal statement of their relevant affiliations and interests at the beginning of the first committee of experts’ meeting.

Members must update their declaration in writing whenever their situation changes during the course of their term on the committee of experts.

Members may not use their position on the Committee for their private gain or for the gain of any other person, company, or organization.

6.0 Security Clearance

Committee members will be required to attain reliability security clearance. This will allow for the sharing of protected or classified information (e.g. datasets, emails, confidential business information) as required. Health Canada will provide the required Personnel Screening, Consent and Authorization Form to candidates.

7.0 Indemnification

All members serve on the committee of experts on a volunteer basis. Health Canada undertakes to provide its volunteer Committee members with protection against civil liability that arises out of their actions as a member, provided the member acts in good faith, within the scope of their volunteer duties, does not act against the interests of the Crown and does not otherwise have available such protection.

In order for an eligible member to receive protection against civil liability, including for legal costs of defending an action as well as any award of damages against them, volunteer members must give prompt notice to Health Canada of any claim, action, suit or proceeding brought against the member, and must obtain Health Canada’s consent, in advance, to the legal counsel selected to represent the volunteer member and any associated costs. Health Canada may, at its own expense and discretion, participate in the conduct of the defence of any such claim, action, suit or proceeding, and any negotiations for the settlement of the same. Health Canada will indemnify the member for payment of any settlement, provided that the member has obtained Health Canada’s consent to the settlement.

Members act collectively as an advisor to Health Canada with respect to the mandate of the Committee but they are not final decision-makers. Health Canada has the ultimate responsibility and accountability for any decision resulting from the advice received from an external committee.

8.0 Roles and Responsibilities

8.1 Members

Members of the Committee have a responsibility to Health Canada and, by extension, to Canadians, to give their best advice to Health Canada.

Members of the Committee also have a responsibility to:

1. be available and prepared to participate in Committee meetings, including virtual meetings (teleconferences, email exchanges, videoconferences, etc.);
2. be available and prepared to attend a public engagement activity related to the Committee’s mandate;
3. participate in the discussions about the Committee’s recommendations, advice, or report to Health Canada;
4. consider all the input received that is related to the mandate of the Committee when preparing their recommendations, advice, or report;
5. promptly notify the secretariat and the chair(s) of any changes in their affiliations and interests related to the Committee’s mandate during the time they are members of the Committee; and
6. direct any media inquiries or public inquiries to the secretariat.

8.2 Commitment to Confidentiality

To support their ability to provide well-informed advice, committee of expert members must commit to confidentiality and ensure they will not disclose any sensitive or confidential information received as part of the member’s involvement in the Committee. Before participating in the committee of experts, members will be required to sign a Confidentiality Agreement that applies to information received in writing or verbally, including through email correspondence, telephone calls and print materials, as well as during presentations and discussions at Committee meetings. In some circumstances, the very fact that a given committee exists may also be confidential.

Health Canada will mark information according to the level to which it is protected under the Policy on Government Security.

The chair will ensure that everyone participating in the meeting, telephone discussion, email exchange, or in another form of communication has received clear instructions on the confidentiality of the proceedings.

8.3 Chair

The Committee chair has a responsibility to: 

1. chair Committee meetings;
2. at the start of each meeting, clarify the purpose and anticipated outcome(s) of the meeting;
3. invite members to make a presentation at a meeting, when relevant and appropriate;
4. identify when information and discussions should be treated as confidential and clarify expectations of members regarding this information;
5. ask members to make a verbal statement of their relevant affiliations and interests at the beginning of every meeting;
6. facilitate a full and open discussion among Committee members in fulfillment of the Committee’s mandate, including in formulating its recommendations, advice, or report to Health Canada;
7. seek consensus on the Committee’s advice among all Committee members, and, if there is no agreement, to ensure that this diversity of opinion is noted in the meeting records or the report;
8. deliver the Committee’s advice to Health Canada and ensure the preparation of the meeting records or report;
9. support, in any other way, the fulfillment of the Committee’s mandate.

 8.4 Media and Communications

Members are expected to notify the Secretariat of any media enquiries related to the committee of experts’ work and direct such enquiries to the Secretariat.

All media requests related to the committee of experts’ statements or activities will be directed to Media Relations, Health Canada, who will coordinate responses with the department.

8.5 Secretariat

The secretariat is housed in the Office of Pharmaceuticals Management Strategies, Health Policy Branch. The secretariat is the administrative liaison between Committee members and Health Canada and is an organizational and administrative resource for members.

The secretariat provides Health Canada with leadership and strategic advice in the management of the Committee and works closely with the chair. In addition, the responsibilities of the secretariat include the following:

1. coordinate the member appointment process;
2. coordinate the preparation and distribution of materials for Committee members, observers, and others, with consideration to sensitive or confidential information;
3. assist with the work of the Committee, as required;
4. provide administrative support to Committee members;
5. support public access to information about the Committee, as appropriate;
6. act as a liaison between Health Canada and the Committee, including seeking input from Health Canada’s subject-matter experts;
7. assist the chair in carrying out the his or her responsibilities;
8. carry out any additional duties as appropriate to support the Committee, including developing risk assessment and mitigation strategies for the Committee;
9. consult with the chair and members to consider whom to invite to provide input to the Committee;
10. consider whom to invite or accept as an observer to all or part of a Committee meeting;
11. discuss whether broader input is needed and how it will be sought;
12. determine whether all or part of a Committee meeting should be held in private;
13. restrict a Committee member’s participation in a meeting due to the nature of that person’s affiliations or interests; and
14. determine that the mandate of the Committee has been fulfilled.

9.0 Management and Administration

9.1 Meetings

Committee of experts meetings will take place virtually, on a monthly  basis with the possibility of face-to-face meetings if necessary. Additional ad-hoc meetings may be held on an as-needed basis at the discretion of the Secretariat, in consultation with the Chair, to consider specific work streams associated with the committee’s mandate.

The secretariat will send out the invitations to attend a meeting. Members will generally receive the agenda and briefing material one week in advance and presentations three days before a meeting. 

The committee of experts is encouraged to reach a consensus on its formal advice whenever possible. When a consensus is not possible the final report will reflect the diversity of opinions.

9.2 Travel and Expenses

Members of the Committee who travel for authorized Committee purposes will have their travel and accommodation expenses reimbursed according to the Travel Directive and Directive on Travel, Hospitality, Conference and Event Expenditures.

9.3 Invited Presenters

The Secretariat or the Chair, in consultation with members, may invite individuals with particular expertise or experience to provide input on a specific topic or agenda item. Invited guests may participate in the discussion if the Chair specifically invites them to do so, but they do not participate in the development, review or revision of the report.

Health Canada may require an invited presenter to complete:

• Declaration of Affiliation and Interest Form
• Confidentiality Agreement

9.4 Intellectual Property

Health Canada must preserve its ability to freely use (for example publish, reproduce, translate) the work authored by members of the committee of experts. As such, members who have contributed to the formulation of written materials in their role on the EAB will be required to assign to the Government of Canada any copyrights they own and to waive any moral rights they have in those materials. Written materials could include any documents, reports etc.