Ad-hoc COVID-19 Clinical Pharmacology Task Group: Terms of reference

The mandate of the Clinical Pharmacology Task Group has concluded. The group will no longer be meeting to release new statements, effective March 30, 2021. This is because of the welcome entry of effective and safe vaccines to the Canadian health care system. Past statements have been removed from the website.

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1.0 Background

As part of the Public Health Agency of Canada's (PHAC) response to the public health crisis caused by COVID-19, various pharmaceutical products are being considered for use in Canada. PHAC is seeking guidance on assessments of the benefits and risks of these products, which will help determine the appropriate allocation of limited supplies of pharmaceuticals to provinces and territories.

2.0 Mandate

The task group will provide PHAC with medical and scientific advice on an ad hoc basis relating to pharmaceutical products for treatment and chemoprophylaxis for COVID-19 in humans. PHAC retains all decision-making authority, policymaking responsibilities and investigatory responsibilities (e.g., literature searches, data summarization, etc.).

The task group will carry out its mandate in the following manner.

Advising PHAC on the use of emerging treatments and chemoprophylaxis agents in humans by:

3.0 Membership

The task group is composed of 6 to 8 volunteer members who are recruited from the membership of Association of Medical Microbiology and Infectious Disease Canada (AMMI), Canadian Pharmacists Association (CPhA) and Canadian Society of Pharmacology and Therapeutics (CSPT) or other experts who apply when there is a vacancy. Members are appointed based on, but not limited to, their expertise, knowledge and experience in one or more of the following areas: therapeutics; public health; prevention of infectious diseases; pharmacology; previous experience on advisory committees, paediatric or adult infectious diseases; other health related fields such as pharmacy and nursing; epidemiology and infectious disease modelling. Attempts will be made to ensure a diverse representation from across Canada.

3.1 Members

Marina Salvadori - Co-Chair
Public Health Agency of Canada

Michael Rieder - Co-Chair
University of Western Ontario

Marie Lordkipanidze - External Expert
Université de Montréal

Richard Hall - External Expert
Dalhousie University

Micheline Piquette-Miller -External Expert
University of Toronto

Abby Collier -External Expert
University of British Columbia

Srinivas Murthy - External Expert
University of British Columbia

Jonathan Kimmelman - External Expert
McGill University

3.2 Timeline

Volunteers are asked to participate temporarily and through time-limited tasks to provide advice relating to pharmaceutical products, at the request of the Director General of the Centre for Immunization and Respiratory Infectious Diseases (CIRID).

3.3 Roles and responsibilities

Volunteers have a responsibility to:

Development of recommendations

The task group will provide recommendations to the Director General of CIRID at PHAC based on consensus. Consensus is defined as general agreement, which will be determined by a process that accounts for the views and concerns of all members. When a consensus is not possible, the meeting record will reflect the diversity of members' views and concerns.

The analysis supporting discussion of a recommendation will be shared with task group members in advance of task group meetings.

4.0 Secretariat, Executive Secretary, Medical Countermeasures Secretary

PHAC will maintain a Secretariat, and provide organizational, technical, project management and administrative support to the ad hoc task group. The secretariat can be contacted through a generic email account: phac.covid-19therapeutics-therapeutiques.aspc@canada.ca.

4.1 Secretariat

The Secretariat will organize the task group meetings and distribute materials to participants, as needed. While PHAC is committed to openness and transparency, confidentiality rules may prevent the release of some materials.

4.2 Executive Secretary

The Executive Secretary provides leadership and strategic advice to PHAC management. This position works closely with the co-chairs and the Secretariat to ensure that the mandate of the ad hoc task group is met in an effective and efficient manner. The Executive Secretary will work with partners within PHAC (including Health Security Infrastructure Branch / Centre for Emergency Preparedness and Response), or other partners such as Canadian Agency for Drugs and Technologies in Health, to address analytical requirements identified by the co-chairs.

4.3 Co-Chairs

Co-chairs will be appointed by PHAC and will include one representative from within the federal government and one from membership of this task group. Co-chair responsibilities include identifying requirements for evidence analysis, approving meeting agendas, conducting meetings, and approving written advice or guidance.

Co-Chairs

Marina Salvadori
Public Health Agency of Canada

Michael Rieder
University of Western Ontario

5.0 Affiliations and interests

Volunteers are expected to conduct themselves in an appropriate manner, i.e., the use of their positions cannot be reasonably construed to be for their private gain or that of any other person, company, or organization; they must refrain from any real or perceived conflict of interest. Volunteers must update their Disclosure Form in writing whenever their situation changes. Volunteers are required to submit changes to their affiliations and interests prior to each meeting. Changes are to be submitted to the Secretariat.

PHAC will review Disclosure Forms before the task group is activated, as well as any changes to disclosures declared during the task group activation.

6.0 Confidentiality agreement commitments and security

The volunteers, as well as any observers or invitees if applicable, will be required to sign confidentiality agreements. Volunteers are expected to hold in confidence and not disclose any confidential information obtained as a result of their participation on the task group, except as permitted under the terms of the confidentiality agreement.

7.0 Media and communications

All media requests related to the task group work should be directed to the Secretariat for direction and response from PHAC's Communications and Public Affairs Branch (CPAB).

8.0 Meeting frequency and location

The task group will convene on an ad-hoc basis via teleconference or videoconference for a temporary interval in response to needs arising from the COVID-19 pandemic response. Meeting schedule will be determined by the co-chairs in consultation with the Secretariat.

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