National Advisory Committee on Immunization (NACI): Terms of reference

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1.0 Background

The National Advisory Committee on Immunization (NACI) was established in 1964, and currently reports to the Vice President (VP), Infectious Disease Prevention and Control Branch (IDPCB), Public Health Agency of Canada (PHAC).

NACI works collaboratively with the Canadian Immunization Committee (CIC), the Pan-Canadian Public Health Network, and the PHAC's Committee to Advise on Tropical Medicine and Travel (CATMAT), all of which are part of a national structure addressing immunization issues in Canada.

2.0 Mandate

NACI provides ongoing and timely medical, scientific, and public health advice relating to vaccines used for the prevention of infection and disease and the use of certain prophylactic agents (for example, immunoglobulins) for humans. PHAC retains all decision-making authority, policy making responsibilities and investigatory responsibilities.

NACI carries out its mandate in the following manner:

  1. Advising PHAC on the use of vaccines and prophylactic agents in humans by:
    • summarizing the epidemiology of specific vaccine-preventable diseases (VPDs) and information and evidence on specific vaccines and prophylactic agents, including but not limited to, vaccine efficacy, effectiveness, immunogenicity, and safety; and making evidence-based recommendations, and where there is a paucity of evidence, recommendations based on expert knowledge and practice
  2. PHAC on vaccine research and surveillance by:
    • recommending phase IV post-marketing assessment and surveillance activities for specific authorized vaccines (including surveillance of vaccine failures, adverse events and immunization coverage)
    • identifying research questions of interest to provincial, territorial and national immunization programs
    • recommending surveillance for specific infections and diseases when available data are insufficient to make a recommendation
  3. Advising PHAC on vaccine programs by:
    • providing evidence-based recommendations on vaccine(s) authorized for sale in the context of provincial and territorial immunization programs, considering scientific factors (vaccine efficacy, effectiveness, immunogenicity, safety and burden of illness) and integrating, if relevant, programmatic factors (economics, feasibility, acceptability, ethics and equity assessments) into recommendations.

      These programmatic elements consider:

      • Economics: is the product or program cost effective?
      • Feasibility: how possible is it, operationally, to carry out the program?
      • Acceptability: does the public (or providers or other stakeholders) want such a program?
      • Ethics: is the product or program the right thing to do; are values and ethical principles upheld during the decision-making process; and how will conflicting values be resolved?
      • Equity: is the product or program accessible to populations who can benefit from them?
    • providing recommendations on best practices in immunization (for example, record keeping, immunization technique, vaccine cold chain).

NACI advice to PHAC takes into consideration information needs of both public health decision makers and health care providers.

3.0 Membership

NACI is composed of 14 volunteer members who are recruited through an open nomination process and appointed based on, but not limited to, their expertise, knowledge and experience in: immunization; public health; prevention of VPDs; previous experience on vaccine advisory committees, pediatric or adult infectious diseases; allergy/immunology; other health related fields such as pharmacy and nursing; pharmacoeconomics; epidemiology and infectious disease modelling.

Appointments will reflect PHAC's policy that committee membership be fairly balanced in terms of points of view represented, the committee's function and diverse geographic areas to the extent possible. Members cannot be represented by alternates or substitutes.

3.1 Terms of appointment, resignation and termination

Members are appointed by and serve at the discretion of VP, IDPCB, normally for a term of four years, but may be asked to extend their term for up to an additional 4 years. For members completing their final term, an additional extension (1 to 2 years) may be considered, upon agreement between NACI chair, Executive Secretary and the WG chair to complete projects for which they are the lead.

Term and appointment of the Chair

The Chair will be a NACI member and appointed for a two-year term with the potential of two 1-year extensions. Selection will be based on a demonstrated ability to lead and work effectively with members, and other NACI participants. The Chair will only vote when there is a tie vote among voting members. Six months before the term of the NACI Chair is completed, the VP will seek to appoint a Chair elect.

Term and appointment of Vice-Chair

A Vice-Chair will be appointed for a two-year term with the potential of two 1-year extension upon mutual agreement. Selection will be based on a demonstrated ability to work effectively with NACI members and other NACI participants. The Vice-Chair will normally be considered first for the position of Chair when the Chair's term is completed, although the appointment of the Chair remains the prerogative of the VP, IDPCB.

The Chair or Vice-Chair or appropriate delegated NACI member (as determined by the VP in consultation with the Chair) will be NACI's representative on Canadian Immunization Committee (CIC), the Advisory Committee on Immunization Practices (ACIP), the Canadian Immunization Conference Planning Committee and liaison role with other National Immunization Technical Advisory Groups (NITAGs) internationally

Requirement before appointment

Before being appointed as a member, a nominee must:

Resignation process

A member may resign from NACI by writing to the Executive Secretary, with a copy to the NACI Chair, including the effective date of the resignation.

Reasons for termination

A member's appointment may be terminated for a variety of reasons including:

The Executive Secretary will notify a member in writing about the termination and will provide the member with the reason why the appointment is being concluded and the date of termination.

3.2 Roles and responsibilities

Members have a responsibility to:

  1. be available and prepared to participate in committee meetings, including virtual meetings (teleconferences, videoconferences, etc.) and email exchanges; as well as participate in the discussions about the advisory body's recommendations, advice, or report to PHAC
  2. declare any changes in their affiliations and interests prior to every meeting and notify, in writing (email), the Secretariat and the Chair of the changes in their affiliations and interests related to the committee's mandate
  3. direct any inquiries from the media or the public to the Secretariat
  4. respond promptly to email requests or other communication from the Secretariat
  5. review and provide input into all NACI statements and the Canadian Immunization Guide (CIG) chapters
  6. vote on NACI recommendations when required
  7. assist in the preparation of responses to inquiries from the public and provincial, territorial, municipal or regional governments on interpretation and implementation of NACI recommendations
  8. serve as chair or a member of NACI working groups for the development of NACI statements and revisions of the CIG

Members cannot identify an alternate should they be unable to attend meetings.

With the exception of 3.2.(h), the Chair has the same responsibilities as members as well as additional responsibilities including, but not limited to:

  1. providing input to PHAC on the selection of members and the Vice-Chair;
  2. chairing advisory body meetings
  3. inviting members to make a presentation at a meeting, when relevant and appropriate
  4. facilitating a full and frank discussion among committee members in fulfillment of the committee's mandate
  5. seeking consensus on the committee's advice among all committee members, and, if there is no agreement, ensuring that this diversity of opinion is noted in meeting records or the report
  6. delivering the committee's advice to PHAC and ensuring the preparation of the meeting records or report
  7. supporting in any other way, for the fulfillment of the committee's mandate
  8. participating in NACI Executive and meetings with the VP
  9. sitting on other advisory committees at the request of the VP
  10. participating in meetings that further the work of NACI including Global NITAG Network and chairs of PT immunization committees

The Vice-Chair, at the request of the Chair or in the case of the Chair's absence, can chair the meeting(s) and take on other tasks or responsibilities as required or delegated by the Chair. The Vice-Chair will participate in NACI Executive and meetings with the VP, as required. In addition, the Vice-Chair provides support for keeping the CIG up-to-date.

4.0 Other participants

4.1 Ex-officio representatives

Ex-officio representatives may include a representative from:

Ex-officio representatives shall have no voting status.

Ex-officio representatives may have substitutes and will support the work of NACI and PHAC by:

  1. providing knowledge and expertise
  2. communicating the views of the Department/, PHAC or Division they represent
  3. serving on working groups for the development of NACI statements and Canadian Immunization Guide chapters
  4. being available and prepared to participate in committee meetings, including virtual meetings (teleconferences, videoconferences, etc.) and email exchanges
  5. participating in the discussions about the advisory body's recommendations, advice, or report to PHAC
  6. responding promptly to email requests or other communication from the Secretariat

4.2 Liaison representatives

Representatives of national or professional associations or committees may be invited by VP, IDPCB, to participate in NACI's activities in the capacity of Liaison representatives, who have no voting status. Each group identified will be invited to identify a representative who will be expected to bring knowledge and input into NACI discussions; express the views of the organization; and communicate NACI's advice to the organization, as appropriate. Liaison representatives are recommended by their organizations; the organization may rotate or substitute this Representative as it sees fit.

Liaison representatives may include persons from:

The role of Liaison representatives is to support the work of NACI by:

  1. providing knowledge and expertise;
  2. serving as a member of NACI working group/s for the development of NACI statements and the revision of the CIG
  3. serving as the Chair of a NACI working group, as required
  4. sharing their respective organization's pertinent news with NACI
  5. reviewing and providing feedback on NACI statements and CIG chapters
  6. being available and prepared to participate in committee meetings, including virtual meetings (teleconferences, videoconferences, etc.) and email exchanges
  7. directing any inquiries from the media or the public to the Secretariat

As for NACI members, Liaison Representatives will declare any affiliations and interests at the beginning of every meeting and notify the Secretariat and the Chair of any changes in their affiliations and interests related to the committee's mandate during the time they are members of the advisory body in writing.

4.3 Presenters, invited guests, and observers

PHAC may invite certain individuals who are not advisory body members or participating representatives to provide input on a specific topic or agenda item. As well, these individuals may ask to speak to NACI on a given topic or agenda item or may ask to observe all or part of a meeting. Their request will be considered by PHAC, in consultation with the Chair and Executive Secretary.

5.0 Secretariat, Executive Secretary, NACI Executive and Priorities Committee

PHAC will maintain a Secretariat, an Executive Secretary, and a NACI Executive to provide organizational, technical, project management and administrative support to NACI.

5.1 Secretariat

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

5.2 Executive Secretary

The Executive Secretary provides leadership and strategic advice for achieving the mandate of NACI, including its management. This position works closely with the NACI Chair, the Secretariat and the NACI Executive to ensure NACI's mandate is met in an effective and efficient manner. This position provides advice to PHAC on NACI related issues and keeps NACI informed of issues that may impact its operation.

The Executive Secretary provides guidance to the Secretariat and chairs the NACI Executive. After NACI submits advice to PHAC, the Executive Secretary will report back to the committee on how that advice was used.

5.3 NACI Executive

The NACI Executive consists of NACI Chair and Vice-Chair, the Executive Secretary, the Project Manager, the Canadian Immunization Guide Scientific lead, and the Director Immunization Programs and Pandemic Preparedness Division. The executive meets three to six times a year, in person or via teleconference. The Executive Secretary will chair Executive meetings.

6.0 Affiliations and interests

Members, liaison representatives and ex-officio representatives (NACI participants) 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. NACI participants must update their Disclosure Form in writing whenever their situation changes. Members 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 making appointments and on an ongoing basis, at least annually, as well as any time the external advisory body mandate is changed.

Disclosure should be made at the earliest possible time and, in any event, prior to any discussion and decision-making on any related subjects. In situations where conflict of interest or the appearance thereof arises in the course of the work of NACI, participants must declare the existence of the conflict of interest and may be required to recuse himself or herself from participation in the discussions on that subject matter, or from further participation on NACI or a Working Group, depending on the particular circumstances.

Any disclosure and measures taken in connection with a real, potential or apparent conflict of interest should be captured in the record of any meeting in which a disclosure is made or measures taken.

Completed Disclosure Forms will be treated as confidential information and will be kept on file by PHAC. However, as a condition of membership, NACI members will be asked to permit PHAC to publish on its website a Summary of Expertise, Experience, and Affiliations and Interests Declaration, which will be based on the completed Declaration Form. NACI members will be asked to review the content of the Summary for accuracy before it is released.

A person with affiliations and interests related to the mandate of NACI may still be a NACI participant, as PHAC strives for a range of relevant knowledge, expertise, and experience and it recognizes that sometimes, people with affiliations and interests related to the mandate of NACI have valuable knowledge, expertise, or experience and may have a worthwhile contribution to make to the committee's work.

PHAC, after consulting the Chair and Vice-Chair, may limit the participation of a NACI participant with respect to an agenda item or meeting topic, depending on the nature of the NACI participant's affiliations or interests.

7.0 Confidentiality agreement commitments and security

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

PHAC 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.

7.1 Security clearance

As a condition of appointment, all NACI members must undergo a security clearance at the reliability level.

8.0 Legal assistance and indemnification

PHAC undertakes to provide its volunteer advisory body members with protection against civil liability provided the volunteer member acts in good faith, within the scope of their volunteer duties and does not act against the interests of the Crown; and does not have available to him/her such protection.

NACI Members shall give prompt notice to PHAC of any claim, action, suit or proceeding brought against the member. If the member is eligible for protection against civil liability, PHAC will, at its own expense, participate in the conduct of the defense of any such claim, action, suit or proceeding, and any negotiations for the settlement of the same.

9.0 Travel and accommodation expenses

Members who travel for authorized committee purposes will have their travel and accommodation expenses reimbursed according to the National Joint Council Travel Directive. Liaison representatives and ex-officio representatives will be expected to pay for their travel expenses. One exception is when the liaison member is serving as Working Group chair; expenses will be reimbursed for travel to NACI meetings.

10.0 Media and communications

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

When appropriate, PHAC may request the Chair, Vice-Chair or a member to address a question raised by the media. The media request must first be directed PHAC's CPAB or the Secretariat, and PHAC must decide to ask a member to respond to the question. PHAC will provide guidance to the member on how to address the question.

If NACI members are asked a question by the media that relates to the mandate of NACI, they may respond to the question in their personal/professional capacity (for example, an academic professor may speak about his/her research). NACI members must avoid expressing any opinions on behalf of NACI or PHAC, or providing information that would be considered Confidential Information under the Confidentiality Agreement. NACI members may also, in their personal/professional capacity, speak to information that has been published by PHAC. If asked by the media to discuss NACI or discuss how NACI examined certain issues, NACI members should refer the media to the Secretariat.

11.0 Transparency

PHAC is committed to transparency as an operating principle. Transparency of NACI is served by posting NACI materials (excluding confidential and personal information) on PHAC's web site. These materials include:

Members will receive, based on their preference, NACI materials in French or English or both official languages.

12.0 Meetings

For planning and conducting meetings of NACI, Working Group or other related meetings, the secretariat will follow PHAC's Green Meeting Guide.

In keeping with the federal Official Languages Act, advisory body members have the right to receive documents and participate in discussions in the official language of their choice.

12.1 Meeting frequency and location

NACI will meet three times a year, face-to-face, in the National Capital Region. Additional meetings may be held on an as needed basis at the direction of PHAC, in consultation with the NACI Chair. Teleconferences between meetings will be held as needed, at the call of the chair.

12.2 Quorum, recommendations and voting

The committee provides its advice to PHAC as a group, by achieving consensus whenever possible. If members cannot come to a consensus, then the record must note that there is a diversity of opinion with respect to the recommendations or advice.

A quorum of at least two-thirds of members is required to authenticate a vote. With a total voting membership of 13, quorum will be a minimum of 9 voting members. Members who have been absent for all discussions and have not been able to review all background documentation will not be permitted to vote. An abstention will count as a neutral vote. Where there is a tie, the Chair will cast the deciding vote.

12.3 Deliberations and reports

The Secretariat will prepare a non-attributable Record of Decision that includes the recommendations and advice resulting from each committee meeting. This includes in-person meetings, virtual meetings, conference calls, and videoconferences. If parts or all of this record are confidential, the document will indicate this.

Once reviewed by the Chair and Executive Secretary (or Working Group Chair and the PHAC Medical / Technical Lead for working group meetings), the draft record will be provided to NACI participants in a timely manner. As soon as is possible, the committee will then confirm the draft as an accurate record or will correct it.

A member who did not participate in a portion of a meeting because of affiliations and interests may not receive the section of the document pertaining to those affiliations and interests until that part of the document becomes public.

For each meeting, a Summary of Discussions that does not contain confidential information will be prepared by the Secretariat. Once reviewed by the Chair and Executive Secretary it will be distributed to NACI participants for comments within one month following the meeting. Once approved by members, the Summary of Discussions can be used for information sharing and will be posted on PHAC's website.

12.4 Publication and restriction of the committee recommendation

The committee's recommendations may be published on PHAC's website when they do not contain any information that must remain confidential. Information from these publications may include links to information on other websites.

When applicable, PHAC will include specific guidelines for the publication of information and recommendations by the committee.

After approval by VP and/or Chief Public Health Officer (CPHO), NACI recommendations may be published on the PHAC's website and in the Canada Communicable Disease Report, and occasionally reprinted in other publications.

Last updated: December 2017

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