Natural Health Products Program Advisory Committee - Terms of Reference: Revised May 2011

I. Terms of Reference for the Committee

1. Purpose

The Natural Health Products Program Advisory Committee (the Committee) provides views, advice and recommendations on issues under federal responsibility for regulating the safety, quality and efficacy of natural health products for sale in Canada.  The Committee provides this advice and recommendations to relevant Natural Health Products Program Directorates (the Natural Health Products Directorate, the Marketed Health Products Directorate and the Health Products and Food Branch Inspectorate).

2. Mandate

The mandate of the Committee is to provide the Natural Health Products Program Directorates with views, feedback, advice and recommendations, including technical, scientific, ethical and communications, on current and emerging issues relevant to the Canadian regulatory framework for natural health products, in order to help facilitate Health Canada decision making.  These issues include:

• standards and processes for assuring safe, effective, quality natural health products for sale in Canada,
• risk and risk information for natural health products,
• technical and scientific developments related to natural health products both in Canada and abroad, and
• issues impacting the regulatory environment, including importing, and the development of harmonized approaches, where appropriate (e.g., Mutual Recognition Agreements).

In consideration of the above, the structure and mandate of the Committee are intended to support advice that is based on broad input that considers common objectives and shared responsibility and accountability for assuring ready access for Canadian consumers to natural health products that are of high quality, are safe and deliver the health benefits claimed on the label, as supported by evidence/data.

3. Reporting Structure and Requirements

The Committee reports to the Director General, Natural Health Products Directorate.  The Committee will file a report with the Director General, Natural Health Products Directorate, once per year.  The Committee may create Working Groups which will report to the Committee.

The decision-making responsibility remains with the Natural Health Products Program.

4. Membership/Participation/Qualifications

Types of Members

Committee members will be Active members only.  There will be no observer or information-only members.  The Committee will be composed of stakeholder representatives from industry, consumer, patient, health care professional, academic and government organizations.  Active members may designate one official alternate who may participate in Committee meetings on their behalf in their absence.  Additional official alternates may also, exceptionally, be designated, according to a specific, relevant area of expertise.

Working Groups are composed of Active Committee members and may include other non-Committee members who are selected for their technical/scientific expertise or knowledge relevant to the mandate of the Working Group.

Role of the Members

The role of the Active Committee members will be to fulfill the mandate of the Committee, provide their expertise and advice, and represent their respective stakeholder constituencies.  Active members are responsible for ensuring that their official alternate is fully briefed and prepared to participate in discussion of the Committee.

The Senior Executive Director, Natural Health Products Directorate, will act as Chair of the Committee.  The Chair functions as a moderator and facilitator for the Committee and ensures that all members have an opportunity to be heard and that views, feedback, advice and recommendations are clear and as detailed as deemed necessary by the members.  A Co-chair may be selected from the Committee membership, for a specific activity or term, as determined by the Committee.  The Co-chair will be selected by the Active Committee members.

The role of Working Group members, including Active Committee and non-Committee members, is to fulfill the mandate of the Working Group and to provide advice and recommendations to the Committee on identified topics or groups of topics. The role of non-Committee Working Group members is to bring knowledge and expertise to support the Working Group in its assigned tasks.

Size of the Membership

The number of Committee members will not exceed eighteen. In order to remain effective and efficient, the number of Working Groups members will be determined by the requirements of the Working Group.

Identification and Appointment of Members

Potential members will be identified from a cross-representation of key stakeholder groups that is, industry, consumer, patient, health care professional, academic and government organizations, as appropriate, through a nomination process.  The Committee members will be appointed by the Director General, Natural Health Products Directorate. See Section 3 - Identification and Appointment of Members.

Secretariat Support

Natural Health Products Directorate staff will provide Secretariat support to the Committee and its Working Groups.

5. Tenure

Term

Active Committee member terms will be for a period of 18 to 36 months in order to stagger membership term expiration.  Term extension will be considered on case-by-case basis. Committee members are Active members for the duration of their term.

The term of a Working Group is for a specific, limited period of time, therefore the terms of Active Committee members on Working Groups will generally end at completion of the Working Group term or at expiration of their term as Active Committee member, whichever comes first.

Non-Committee Working Group members will be Working Group members until completion of the Working Group's term, or a shorter term based on the mandate and activities of the Working Group and as identified and recommended by the Active Committee members who sit on the Working Group.  A non-Committee Working Group member term may be terminated for cause, as identified and recommended by the Active Committee members on the Working Group, at any time upon written notice from the Director General, Natural Health Products Directorate, or his or her delegate.

Forfeiture of Membership

Active Committee members who are absent from two consecutive meetings of the Committee will forfeit membership in the Committee, unless the member's official alternate has replaced the Committee members or the member has provided notice and reason for the absence.  The Secretariat will issue a notice to the member prior to membership forfeiture, to provide an opportunity for the member organization to nominate another representative from their organization.

Non-Committee Working Group members who are absent from two consecutive Working Group meetings will forfeit membership in the Working Group. 

A written letter of the forfeiture will be provided by the Director General, Natural Health Products Directorate, or his or her delegate.

Withdrawal and Termination of Membership

An Active Committee or non-Committee Working Group member may withdraw from service on the Committee or Working Group at any time upon written notification to the Director General, Natural Health Products Directorate. A written acknowledgement of the withdrawal will be issued by Director General, Natural Health Products Directorate, or his or her delegate.  Where an Active Committee or non-Committee Working Group member has a designated official alternate, this alternate may replace the member on the Committee where the alternate's skill set is similar to that of the member.  Replacement members for Working Groups will be selected by the Active Committee members who sit on the Working Group.

An Active Committee or non-Committee Working Group member's failure to act in accordance with the Committee Terms of Reference may give cause for termination of membership.  Where this is the case, the Director General, Natural Health Products Directorate, will advise the member in writing, stating the reason for the termination and the effective date.

6. Security and member Conduct

Security Clearance, Confidentiality Agreement and Affiliations and Interests Declaration

It is desirable that the members are able to work in an environment conducive to full and frank discussion of the issues identified for their deliberation.  To this end, as a condition of appointment and prior to beginning their participation as a Committee or Working Group member, potential Committee and Working Group members will be required to receive a security clearance to the level of "enhanced reliability", and to complete and sign a Confidentiality Agreement and a Declaration of Affiliations and Interests.

Subject to future review, invited expert guests will not be required to meet these above requirements.

Member Conduct

Committee and non-Committee Working Group members are expected to conduct themselves in an appropriate manner, i.e., the use of their position cannot be reasonably construed to be for their private gain or that of any other persons or organization. They must refrain from any conflict of interest, and indeed, its very appearance.

In situations where conflict of interest or the appearance thereof arises in the course of the work of the Committee or Working Group, the individual involved must declare its existence and disqualify himself/herself from participation in the discussion and/or from further membership on the Committee or Working Group according to the circumstance or specific situation. It will be incumbent upon the member to update his/her disclosure should his or her personal situation change or where the matters before the Committee or Working Group may affect the conflict of interest situation of a member.

Members must ensure that documents received from Health Canada are securely stored at all times.

All members are expected to protect and maintain as confidential any trade secret or privileged information divulged during the work of the Committee or Working Group. Members must not discuss this information with persons not on the Committee or Working Group, or divulge this information until such time as this information has been officially released for public distribution by the Department.

Members may share general information on Committee and Working Group activities with their constituencies, for information and input.

7. Indemnification and Legal Assistance

To be determined pending decision by HC Legal Services relating to recent Treasury Board revocation of the Government of Canada Volunteer Policy.

8. Reimbursement

Active Committee members or their official designated alternate are eligible to be reimbursed for travel expenses incurred as part of a Committee meeting, according to federal government policy. In order to efficiently manage a limited budget, Active Members who are representing an industry organization are not reimbursed for these expenses. Health Canada will determine reimbursement, on a case-by-case basis, for Active Members who represent an industry organization and consider that this policy would prevent their participation on the committee or reduce their ability to participate. Active Committee members who are official members of a Working Group or their official designated alternate are eligible to be reimbursed for travel expenses incurred as part of a Working Group meeting. Non-Committee Working Group members are not eligible to be reimbursed for travel expenses. Health Canada will determine reimbursement, on a case-by-case basis, for non-Committee Working Group members who are representing not-for-profit organizations.

Active Committee members participate in Committee workplan development to identify efficiencies and support effective use of resources.

9. Management and Administration

The management and administration of the Committee will be as follows:

Issues for Committee Review

The Director General, Natural Health Products Directorate, will task the Committee with issues and any specific questions for which Committee feedback is being sought.  These may include issues raised by any of the Natural Health Products Program Directorates or Committee members.

Meetings

Meetings will be held in the National Capital Region or by teleconference and webinar as appropriate.  It is generally expected that there will be two face-to-face Committee meetings per year.  Working Group meetings will generally be held by teleconference.  The date of the next Committee meeting will be identified at the end of each meeting.

Meetings will be held at the call of the Chair in consultation with Committee members.

Meetings are generally attended by Active Committee members only.  Guests may be invited to attend part of a Committee or Working Group meeting, for a specific agenda item. Guests only receive information relevant to that agenda item, as required.

Natural Health Products Program staff may from time to time attend part of a Committee meeting as technical expert/resource person or as observer.

Conduct at the meetings

All members of the Committee will have equal status during discussion.

Discussions during meetings are intended to be open, frank and free-flowing and respectful of different points of view.  As such, discussion is intended to be informal and, while consensus and unanimity is desirable, they are not necessary.  Difference of opinion in advice and feedback will be respectfully and constructively deliberated on and represented in the reports.

The Committee member will be expected to provide advice and recommendation that considers common objectives and shared responsibility and accountability in assuring ready access for Canadian consumers to natural health products that are of high quality, are safe and deliver the health benefits claimed on the label, as supported by evidence/data.

Committee members will be expected to demonstrate fairness, respect and a commitment to examination of the matters under review. Topics that do not fit within the mandate of the Committee will not be discussed and should be referred to the Natural Health Products Directorate.

Role of the Secretariat

The Secretariat attends meeting of the Committee and its Working Groups and will prepare, manage and distribute Committee and Working Group documents, including meeting invitations, agendas and notes, reports and administrative documents.

Invitations to attend meetings will be issued by the Secretariat in writing.

Committee meeting agendas will be developed by the Secretariat, in consultation with the Chair, based on business arising from the previous meeting and other identified issues.  Working group agendas will be developed by the Secretariat, in consultation with the Working Group Chair.

Members will receive an agenda, briefing materials and other documentation as far as possible but at least five days in advance of meetings.

Committee meeting notes will be prepared and distributed by the Secretariat within three weeks of the meeting.  Working Group meeting notes will be prepared and distributed as determined by the activities of the Working Group.

The Secretariat will distribute Working Group records to Active Committee members upon request within a reasonable delay.

The Secretariat will be responsible for meeting logistics and member travel.

Records of the Committee

Notes from Committee and Working Group meetings will summarize key action items and discussion points.   Additional meeting notes will be prepared in a format supporting ease of incorporation into Committee and Working Group Reports, and will reflect the overall views and advice of the Committee. 

Committee and Working Group Reports will be prepared by identified Committee and Working Group members, with support from the Secretariat as required.

Committee Reports will capture all formal reporting of views, advice and recommendation provided to the Director General, Natural Health Products Directorate, and may include documentation of the differing opinions and the stakeholder group(s) that support each advice recorded for each formal recommendation, and the rationale for support or non support of the recommendation.

Dissemination of Information on the Committee

The following information on the Committee will be posted on the Natural Health Products Directorate webpage of the Health Canada website after the removal of confidential information: Committee Terms of Reference, Meeting Agendas and Reports, and Active Committee and Working Group member lists and biographical information.

Action to be Taken by the Committee

Active Committee and Working Group members will contribute to discussion and provide feedback on draft documents, provide administrative and biographical information, and respond to queries related to meeting logistics and travel or other Committee-related activity, as required.

Action to be Taken by the Natural Health Products Program

The Director General, Natural Health Products Directorate will, following consideration of the advice and recommendations received from the Committee, provide feedback to the Committee on any action that will or will not be taken based on the advice and recommendations received and provide the reasons for the decisions.

Review of the Committee

The Natural Health Products Directorate, in conjunction with Natural Health Products Program Directorates, will review the Committee annually to ensure that the Committee continues to meet on-going needs. The Director General, Natural Health Products Directorate, retains the prerogative to disband the Committee following such review, as necessary.

These Terms of Reference will be subject to review every two years or sooner as required.

These Terms of Reference draw on the guidelines outlined in the Health Products and Food Branch Guidance on Advisory Bodies.

II. Rules of Engagement for Committee Working Groups

1. Working Groups review issues identified by, and report to, the Committee.  Working Groups are required to produce a formal summary report of their recommendations with rationales including all views (minority and majority) for the Committee's deliberations.  See also point 2.
2. Recommendations of the Working Group are to be reached in the spirit of consensus with all views considered valuable.  While consensus or unanimity is desirable, it is not necessary, and minority opinions will be represented in the report the Working Group delivers to the Committee.  Given the diversity of stakeholders represented on the Committee and Working Groups, each Working Group's report will identify the stakeholder group(s) that supported each of the recommendations.  See also point 3.
3. Committee members with expertise and/or an interest in the issues to be reviewed by the Working Group will form the Working Group's official membership.  Other Committee members may also participate on Working Groups as observers.  The official designated alternate of a Committee member may represent the Committee member on a Working Group in their absence, to support continuity.  Committee members are responsible for ensuring that their official alternate is fully briefed and prepared to participate in discussions of the Working Group.
4. Additional individuals with expertise in the issues under review by a Working Group who are not Committee members or their official designated alternate may be appointed as members of a Working Group, as required by the activity and focus of the specific Working Group. Additional non-Committee members are recommended and appointed as members of the Working Group by the Committee members who sit on the Working Group.
5. It is desirable that the Working Group members are able to work in an environment conducive to full and frank discussion of the issues identified by the Committee for their deliberation.  To this end, as a condition of appointment and prior to beginning their participation as a Working Group member, potential Working Group members must undergo a government security clearance (to enhanced reliability), provide a Declaration of Affiliations and Interests and sign a Confidentiality Agreement.  See also points 6 and 11.
6. Working Group meetings are generally held by teleconference.  Teleconference security codes are for the stated/identified purpose only and for use by individuals invited to participate in the Working Group meeting only.  All information provided to Working Group members as part of a teleconference meeting is subject to the Confidentiality Agreement to which Working Group members are bound.
7. Working Group members providing expertise for issues identified for deliberation do so in consideration of common objectives and according to their respective roles and responsibilities in assuring ready access for Canadian consumers to natural health products that are of high quality, are safe and deliver the health benefits claimed on the label, as supported by evidence/data.
8. Individual experts may be invited by the Working Group to provide one-time/short term input on a specific topic or agenda item, based on an identified need.  They may participate in a Working Group meeting only for the deliberation of the relevant specific issue for which their expertise is being requested. They will receive information as required only and may not participate in the formulation of advice or recommendations to Health Canada.  Subject to future review, these invited experts will not be required to meet the confidentiality agreement affiliations and interest declaration or security clearance requirements noted under point 5.
9. Working Group members are encouraged to identify and submit Source Documents relevant to the activities of the Working Group to the Committee Secretariat for distribution to Working Group members.
10. Committee members may choose to receive some or all of the Working Group records, including agendas, notes, source documents and reports.  Non-Committee Working group members receive: agendas, notes and source documents related to their respective Working Group, and the report delivered to the Committee on behalf of their respective Working Group.
11. In keeping with points 5 and 6, notes from Working Group meetings will not be posted to the Health Canada website and must not be published or released by any Working Group member, as these notes form part of the deliberations necessary for the development of its report to the Committee.   Working Group member lists and biographies will be posted to the Health Canada website.
12. Working Group members may consult with their respective organizations regarding input on issues under review by the Working Group, or as requested by the Working Group, where there is value identified in obtaining more information and with due consideration to the confidentiality aspects noted in above points 5, 6 and 11.
13. Committee members who are official members of a Working Group or their official designated alternate are eligible for reimbursement of travel expenses incurred as part of a Working Group meeting.  Health Canada will determine reimbursement, on a case-by-case basis, for non-Committee Working Group members who are representing not-for-profit organizations.

III. Identification and Appointment of Members

1. Identification Process for Active Committee Members

Active members of the Committee are those individuals who are selected to participate in the deliberations of the Committee in achieving its mandate.  The Committee's mandate is to provide views, feedback, advice and recommendations pertaining to those issues and targeted areas of interest of the Natural Health Products Program which have been identified by the Program Directorates (the Natural Health Products Directorate, the Health Products and Food Branch Inspectorate and the Marketed Health Products Directorate).

Identification of Issues and Targeted Areas of Interest

As a first step, in order to determine the necessary or desirable expertise needed to provide broad, representative stakeholder feedback to the Program, the Program Directorates will identify those aspects and issues pertaining to the natural health products regulatory program for which feedback and advice is being sought.

Considerations for the Identification of Required Stakeholder Expertise and Representation

Active Committee members are selected for their knowledge and expertise in natural health products and the regulatory environment under which the Program operates. Members should be aware of factors relevant to the issues identified by the Program Directorates and the membership should reflect the diversity of natural health products stakeholder interests. The membership of the Committee as a whole will therefore reflect as required such considerations as follows (see also Table 1):

• consumer and patient groups;
• natural health products industry:
  • small, medium and large manufacturers, importers, labellers, distributors, etc
  • associations
  • specific product types or categories e.g., traditional, homeopathic, etc;
• retailer associations;
• health care professional associations, e.g., pharmacists, nurses, Naturopathic Doctors, herbalists, homeopaths;
• academia/research;
• other regulatory authorities, e.g. National Association of Pharmacy Regulatory Authorities.

The Program Directorates will identify what considerations are relevant for the identification process.

Candidate Identification Process

A call for nominations will be sent by the Director General, Natural Health Products Directorate to key organizations inviting them to identify and nominate a candidate from within their constituency.

2. Appointment Process for Active Committee Members

Candidate Selection Process

The Director General, Natural Health Products Directorate, selects Committee members based on the factors for consideration and expertise required as outlined in the first step (Identification of Issues and Targeted Areas of Interest).

The Director General will initiate a Selection Process that will include Active Committee members.  Committee members whose terms are up for renewal will not participate in the selection process.

Candidate Appointment

Appointment of members will be for a set length of term with the maximum term based on requirements and availability of candidates and on ongoing review to identify and address emerging needs.

Candidates are not officially appointed Committee members until they undergo a government security clearance (to enhanced reliability), provide a declaration of affiliations and interests and sign a confidentiality agreement.  Members who do not meet security requirements do not receive an appointment letter and their candidacy is rendered void.

3. Identification Process for Committee Working Group members

Members of Committee Working Groups are Active Committee members and other individuals who have been selected to participate in the deliberations of a Working Group in achieving its mandate.  The mandate of a Working Group is to provide advice and recommendation to the Committee on topics or groups of topics identified by the Committee.

Identification of Working Group Issues and Areas of Interest

As a first step, in order to determine the necessary or desirable expertise needed to provide feedback to the Committee, the Committee will identify those aspects and issues pertaining to the Program for which feedback and advice is being sought.

Considerations for the Identification of Required Expertise and Representation

Active Committee members may elect to participate on a Working Group based on their knowledge and interest in the topic or group of topics assigned to the Working Group.  The membership of the Working Group as a whole will therefore reflect such considerations as are determined by the specific activity of the Working Group.

In consideration of the above, Active Committee members who sit on the Working Group may identify the need for additional Working Group members, based on gaps they identify in expertise within the mandate of the Working Group and in consideration of factors relevant to the Working Group in its assigned tasks.

Candidate Identification Process for Non-Committee Members

Active Committee members who sit on the Working Group identify and recommend candidates for nomination as non-Committee Working Group members.

4. Appointment Process for Non-Committee Working Group Members

Candidate Selection Process

Active committee members who sit on the Working Group select additional Working Group members based on the specific subject for which they have expertise.

Candidate Appointment

Appointment of additional, non-Committee, Working Group members will be for a set length of term, based on the requirements of the specific activities of the Working Group and ongoing review to identify and address emerging needs.

Candidates are not officially appointed as Working Group members until they undergo a government security clearance (to enhanced reliability), provide a declaration of affiliations and interests and sign a confidentiality agreement. Members who do not meet security clearance requirements do not meet appointment requirements and their candidacy is rendered void.

A non-Committee Working Group member term may be terminated for cause, as identified and recommended by the Active Committee members who sit on the Working Group, at any time upon written notice from the Director General, Natural Health Products Directorate, or his or her delegate.

Table 1 - Considerations for Active Committee Membership (2009-2010)

Sector	NHPD's Targeted Interest Area	Considerations
Consumer & patients	Understanding needs of non-industry stakeholders, including but not limited to information	national or regional association experience in NHPs or NHPD/HPFB advisory committee
Industry - Association	Understanding needs of industry stakeholders, including but not limited to  product quality, safety, efficacy and Good Manufacturing Practices (GMPs)	represent significant stakeholder constituency (e.g., national representative of key NHP sector)
Industry - Individual	Understanding needs of industry-applicant stakeholders, including but not limited to  product quality, safety, efficacy and GMPs	augment or fill  gap in NHP sector (e.g., small, medium, large, very large; export, domestic, specific product areas)
Other	Understanding needs of non-industry stakeholders, including but not limited to information, including adverse reactions	represent significant stakeholder constituency (e.g., regulatory authority, regulated health care practice)
	Understanding needs of retail stakeholders	represent significant NHP retail stakeholder constituency
	Gaining technical expertise in standards of evidence and product testing	NHP-related research or academic area

Table 2. Version History

Date	Version	Description
January 14, 2010	Version 1 - Approved	Approval of the Terms of Reference by the NHP-PAC at its January 14-15, 2010 meeting (Meeting #4).
July 22, 2010	Version 2 - Revised: -- Section 4 - Size of the committee-- Section 8 - Reimbursement	Maximum number of members changed from 15 to 18. Specification added regarding the policy for reimbursement for travel expenses incurred as part of a Committee meeting for Active Members representing an industry organization.
November 8, 2010	Version 3 - Revised: -- Section 7 - Indemnity and Legal Assistance	Text updated to reflect revocation of the Government of Canada Volunteer Policy.
May 17, 2011	Version 4 - Revised: -- Section 5 – Withdrawal of Membership	Text updated to reflect that failure to act in accordance with the Terms of Reference constitutes a reason for termination of membership, as per discussion and decision at the NHP-PAC March 28-29 2011 meeting (Meeting #9). Section header change to: Withdrawal and Termination of Membership