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Terms of Reference for the Malaria Policy Advisory Committee to the World Health Organization
----------------------------------------------------------------------------------------------------------------------Aims and Functions The Malaria Policy Advisory Committee (MPAC) will provide independent advice to the World Health Organization (WHO) to develop policy recommendations to control and eliminate malaria. The mandate of MPAC is to provide strategic advice and technical input, and extends to all aspects of malaria control and elimination, as part of a transparent, responsive and credible policy setting process. MPAC will advise the WHO Director-General specifically on: 1. appropriate malaria policies and standards based on data from malaria programme implementation by Member States and malaria control partners as well as reviews of the best available evidence; 2. engagement of WHO in malaria-related initiatives 3. major issues and challenges, to achieving global malaria goals; 4. the identification of priority activities to address identified challenges Rationale The scale-up of malaria control efforts in recent years, coupled with major investments in malaria research, has produced impressive public health impact in a number of countries, and has led to the development of new tools and strategies aimed at further consolidating malaria control goals. As a result, there is growing need for the malaria policy setting process to rapidly review increasing amounts of evidence. The WHO Global Malaria Programme (WHO-GMP), in keeping with its mandate to articulate ethical and evidence-informed policies for malaria control, is convening MPAC as a mechanism to increase the timeliness, transparency, independence and relevance of its recommendations to WHO member states in relation to malaria control and elimination. Membership The MPAC will have up to15 members. The MPAC members shall not be representatives of governments, organizations or institutions but rather shall serve in an independent, personal and individual capacity and shall represent a broad range of disciplines, expertise, and experience encompassing many aspects of malaria control and elimination. These experts will be malariologists with a broad view of the interplay between scientific, political, economic and financial considerations. As such, membership will: 1. comprise individuals who possess a broad range of relevant expertise (e.g., epidemiology; malariology; maternal, paediatric and international public health; pharmacology and internal medicine; parasitology, tropical and infectious diseases; immunology and vaccinology; safety and pharmacovigilance; health systems, economics and financing; surveillance, monitoring and evaluation; vector control and biology; laboratory, social and behavioral sciences; health

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communication) acquired through credible and sustained professional experience in academia, the medical profession, clinical practice, NGOs, research institutes, and governmental bodies including national malaria control programmes, public health departments and regulatory authorities; 2. ensure appropriate geographic representation, in particular strong endemic country representation, and an adequate gender balance; 3. comprise persons who have a demonstrated professional commitment, including the ability to actively contribute to strategy and policy formulation for malaria control and elimination, and the capacity to dedicate significant personal time in preparing for and attending MPAC meetings. A nominations panel will be appointed by the ADG/HTM and will include representatives from organizations with a major interest in malaria. All MPAC members shall be nominated by the panel against set criteria following a public open call for nominations and thereafter appointed by the WHO Director -General. The Chairperson will be selected from among appointed MPAC members. The MPAC list of members and related biographical information will be made publicly available on the GMP website. Members of MPAC, including the Chairperson, shall be appointed to serve for an initial term of up to three years, renewable once, for a period of up to an additional three years. The first set of appointments will be staggered such that five persons each will serve for one, two, or three years during their first term in order to avoid a full turnover.. Prior to being appointed as MPAC members and prior to renewal of term, nominees shall be subject to conflict of interest assessment by WHO based on information that they will disclose on the attached WHO Declaration of Interest (DOI) form (Annex 1). In addition, MPAC members have an ongoing obligation throughout their tenure to inform WHO of any changes to the information that they have disclosed on the DOI form. Summaries of relevant disclosed interests that may be perceived to give rise to real or apparent conflicts of interest will be noted in MPAC reports which will in turn be made public as appropriate In addition, prior to confirmation by WHO of their appointment as MPAC members, MPAC nominees shall be required to sign a WHO confidentiality agreement (See Annex 2) and the standard agreement for WHO temporary advisers. Although all papers presented at the MPAC may be made publicly available on the GMP website, documents which are prepublication manuscripts or confidential documents from private companies will be clearly labeled as such and will only be provided to MPAC members for discussion. Membership in MPAC may be terminated by WHO, including, for any of the following reasons: 1. failure to attend two consecutive MPAC meetings; 2. change in affiliation resulting in a conflict of interest; 3. a lack of professionalism involving, for example, a breach of confidentiality. Roles and responsibilities of MPAC members Members of MPAC have a responsibility to provide WHO with high quality, well considered, evidence-informed advice and recommendations on matters described in these ToR. Members play a critical role in ensuring the reputation of MPAC as an internationally recognized policy advisory committee in the field of malaria.

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MPAC has no executive or regulatory function. Its role is to provide advice and recommendations to the Director-General of WHO. MPAC members may be approached by non-WHO sources for their views, comments and statements on particular matters of public health concern and asked to state the views of MPAC or of details related to MPAC discussions. MPAC members should refer all such enquiries to WHOGMP. Meetings and operational procedures MPAC will meet normally biannually for three days, with dates generally set at least six months in advance. The frequency and duration of meetings may be adjusted as necessary. MPAC recommendations will, as a rule, be taken by consensus. In the exceptional situation that a consensus on a particular issue cannot be reached, the Chairperson shall report the majority and minority view. It is the also the Chairpersons responsibility to ensure there is clarity for MPAC members on what exactly is being decided. Representatives of the Roll Back Malaria Partnership Secretariat (RBM), the Global Fund to fight AIDS, Tuberculosis and Malaria (GFATM) Secretariat, UNICEF and the Office of the United Nations Special Envoy for Malaria will be invited to participate as observers in MPAC meetings and deliberations. Relevant staff from WHO Headquarters and Regional Offices will attend as members of the Secretariat. In addition, three rotating National Malaria Control Programme managers from around the world will be invited as resource persons to observe and participate in the meeting. WHO-GMP may also invite other observers to MPAC meetings, including representatives from WHO regional technical advisory groups, non-governmental organizations (NGO), international professional organizations, technical agencies, and donor organizations. Additional experts, and Technical Resource Persons, may also be invited to meetings, as appropriate, to further contribute to specific agenda items. Observers shall not take the floor unless requested to do so by the Chairperson and shall under no circumstances participate in the formulation of MPAC recommendations. MPAC will work with WHO-GMP to develop its priorities of work and meeting agendas, with input from malaria endemic countries. In time, it is possible a wider group will be invited to contribute on agenda items in advance of each meeting via open consultation on the GMP website. MPAC will be kept informed by WHO-GMP and partner agencies of progress in the implementation of strategies and the attainment of objectives at country and regional level. WHO-GMP, together with the MPAC Chairperson, will determine which policy recommendation issues and information from other WHO technical advisory groups should be brought to the attention of the MPAC. Time-limited and specific Evidence Review Groups (ERGs) will be established to review and provide evidence-based information and options for recommendations (See Annex 3). These options are to be discussed by the full MPAC in sessions open to representatives of stakeholders interested in Malaria as invited by the WHO Secretariat. In order to seek broader input and allow for the exchange of information and views and to ensure transparency and inclusivity, the majority of discussions will occur in the aforesaid session. However, the actual deliberations of and development of recommendation by the MPAC will take

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place in a closed session in order to protect the integrity and independence of the committee from pressure and undue influence. Transparency will still be ensured however, as minutes approved by WHO, will be made available on the WHO-GMP website following the meeting, together with the approved MPAC recommendations from the meeting. See Annex 3 for further details on MPAC Evidence Review Groups. Approved meeting agendas, documents, minutes and recommendations will be archived and continue to remain publicly available and easily accessible on the WHO-GMP website. In addition to attendance of meetings, active participation will be expected from all MPAC members throughout the year, including participation in MPAC Evidence Review Groups, video and teleconferences, as well as interactions via e-mail. Review of documents may also be solicited. MPAC members may be requested to participate as observers in other important WHO departmental or cross-departmental meetings. It is estimated that the time commitment required from MPAC members is a total of three weeks over the course of a year. MPAC members will not be remunerated for their participation in MPAC; however, reasonable expenses such as travel expenses incurred by attendance at MPAC or related meetings will be compensated by WHO in accordance with WHO applicable rules and policies.. MPAC reports to the WHO Director-General (or designee). The MPAC Chairperson will debrief the WHO Director-General (or designee) and the WHO-GMP Director following each MPAC meeting. Minutes of MPAC meetings will be taken and circulated among MPAC members. The recommendations of the MPAC shall, once they have been approved by WHO, be published and posted on the GMP website normally within two months of each MPAC meeting. In addition, these recommendations and conclusions may be translated into other languages, with links provided from partner websites such as the RBM website. It is expected that recommendations will not exceed two pages for most issues. On some occasions, depending on the size of the issue and the impact of the recommendations, the recommendations may also be published in print form. In the absence of a robust evidence base, temporary conditional recommendations (to be clearly identified as such) based on a combination of the best available evidence and expert opinion, may be issued to provide guidance for regions and countries in the interim period. Conditional recommendations will be reviewed in brief at every MPAC meeting in case adjustments need to be made based on newly available evidence. Role of Current Technical Expert Groups (TEGs) Selected current TEGs (e.g. the TEG on Malaria Chemotherapy), will continue to function, but will fall under the umbrella of MPAC together with the shorter-term Evidence Review Groups as described in Annex 3 and illustrated in Annex 4. The MPAC together with the WHO-GMP Director will review the need for existing Standing TEGs, and recommend to ADG/HTM any modifications in relation thereto..

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Annex 1

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Annex 2

CONFIDENTIALITY UNDERTAKING

1.

The World Health Organization (WHO), acting through its Department of ., has access to certain information relating to ., which information WHO considers to be proprietary to itself or to other parties collaborating with it (hereinafter referred to as "the
Information").

2.

The Undersigned, as a member of the .Committee ("the Committee"), may have access to the Information in the course of his/her participation in the Committee (whether at or in relation to Committee meetings, internet-based collaborative workspaces, telephone conferences or otherwise). WHO is willing to provide the Undersigned the Information, or arrange for the provision of the Information to the Undersigned, for the purpose of performing his/her responsibilities in connection with the activities of the Committee ("the Purpose"), provided that the Undersigned undertakes to treat the Information as confidential and proprietary, and to disclose it only to persons who have a need to know for the purpose and are bound by like obligations of confidentiality and non-use as are contained in this Undertaking. The Undersigned undertakes to regard the Information as confidential and proprietary to WHO or parties collaborating with WHO and agrees to take all reasonable measures to ensure that the Information is not used, disclosed or copied, in whole or in part, other than as provided in this Undertaking, except that the Undersigned shall not be bound by any such obligations if and to the extent he/she is clearly able to demonstrate that the Information: a) b) c) d) was known to him/her prior to any disclosure by or for WHO to the Undersigned; or was in the public domain at the time of disclosure by or for WHO to the Undersigned; or becomes part of the public domain through no fault of the Undersigned; or becomes available to the Undersigned from a third party not in breach of any legal obligations of confidentiality.

3.

4.

5.

The Undersigned also undertakes not to communicate the deliberations and decisions of the Committee to persons outside this Committee except as agreed by WHO. If requested to do so, the Undersigned agrees to return to WHO any and all copies of the Information. The Undersigned furthermore agrees that any and all rights in the work performed by him/her in connection with or as a result of his/her membership of the Committee shall be exclusively vested in WHO. The Undersigned hereby irrevocably and unconditionally assigns all such rights to WHO and waives any moral rights attached such work.

6.

7.

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The Undersigned understands and agrees that WHO reserves the right (a) to revise such work, (b) to use it in a different way from that originally envisaged, or (c) not use or publish it at all. 8. The obligations of the Undersigned shall survive the termination of his/her membership of the Committee. Any dispute relating to the interpretation or application of this Undertaking shall, unless amicably settled, be subject to conciliation. In the event of failure of the latter, the dispute shall be settled by arbitration. The arbitration shall be conducted in accordance with the modalities to be agreed upon by the parties or, in the absence of agreement, with the rules of arbitration of the International Chamber of Commerce. The parties shall accept the arbitral award as final.

9.

Name:

Signature: Date:

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Annex 3 Purpose, structure and functioning of MPAC Evidence Review Groups

------------------------------------------------------------------------------------------------------------------------Purpose and decision for establishment MPAC Evidence Review Groups (ERGs) may be established by WHO to increase the effectiveness of MPAC deliberations, by reviewing and providing evidence based information and options for recommendations together with their implications for discussion by the full MPAC. ERGs will be established on a time-limited basis to help address specific questions identified by MPAC when the issue is particularly complicated and cannot be addressed by existing standing WHO advisory committees. In some cases, depending on the nature and complexity of the issue to be addressed, the MPAC may recommend that the issue might be most efficiently addressed through a Standing Technical Expert Group (TEG).. However, the MPAC must balance the need for efficiency with that of transparency. The recommended need, charge and duration for an ERG is discussed and agreed during MPAC meetings, as are the deliverables. ToR and identification of needed expertise Each ERG will operate under specific Terms of Reference (ToR). ToR and proposed related expertise to serve on the ERG are developed by WHO taking into account the recommendation of the MPAC. ERG Membership Each ERG will include a minimum of two MPAC members (one of whom functions as Chairperson). Additional subject matter experts serving in their own individual capacity with a view to meet the identified needed expertise for the group, will also be invited in ERGs. Emphasis will be placed on ensuring endemic country representation on the ERG. WHO's Conflict of Interest policy for WHO Experts will apply to the ERG. .ERG members shall not be representatives of governments, organizations or institutions but rather shall serve in an independent, personal and individual capacity. To the extent they have not already done so in their capacity as MPAC members, ERG members will be required to sign the standard agreement for WHO Temporary Advisers and the WHO confidentiality agreement. At least one WHO Headquarters staff, (who functions as the ERG lead technical focal person), and WHO Regional Office (RO) staff, will participate as members of the secretariat. The size of the ERGs will ideally be between four to eight members and should not exceed 10 members; the final size will be determined by WHO based, inter alia, on the need for expertise, representation, and the scope of the problem. Individuals other than ERG members may participate in ERG meetings only by secretarial invitation... Occasionally the ERG Chairperson, in consultation with the lead WHO technical focal person and the MPAC Chairperson, may recommend the participation as technical resource persons of additional malaria experts who are not members of the ERG and who may be asked by WHO to provide information to the ERGs on an ad hoc or as needed basis.

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WHO-GMP staff will identify scientific studies to address questions that arise regarding appropriate malaria policy decisions and may commission data analyses addressing efficacy, effectiveness, safety, feasibility, economic and budgetary aspects of malaria policy. Modus Operandi MPAC ERGs will render consensus advice or recommendations to the MPAC. MPAC ERG Chairpersons, other ERG representatives, or the ERGs as a whole, are not empowered to speak on behalf of MPAC. Rather, they serve the MPAC by gathering and organizing information upon which the MPAC can deliberate and act. Thus, while MPAC ERGs can and should examine an area in detail and define the issues, including the development of options for recommendations, the actual exchange of information and views and the actual deliberations and development of recommendations occurs at the open and closed sessions of the MPAC. The final policy recommendation is made by MPAC. Evidence Review Group Process: Effective communication and a strong working collaboration between the ERG Chair and the lead WHO technical focal person are significant determinants of the effectiveness of an ERG. The development of a brief one to two page summary of each ERG meeting by either one of these people will facilitate the function of the ERG. Summaries should be provided to the MPAC Executive Secretary, who supports the smooth functioning of the MPAC and its proceedings, so that WHO-GMP senior staff, malaria Regional Advisers and MPAC members can be informed in real time of progress and issues. With the lead WHO technical focal person, the Chairperson of the ERG will develop a plan for routine operations of the Group. ERGs accomplish most of their work through teleconferences. The number and frequency of ERG teleconferences will depend on the urgency of issues being considered by the group and the amount of preparatory work needed prior to a topic being brought up for plenary discussion and decision making at MPAC. Some ERGs may more effectively achieve their purpose through exchange of e-mail communications with intermittent teleconferences, or videoconferences. In-person meetings of ERGs may facilitate progress and may with WHO's agreement be convened by WHO. If possible, they should be scheduled in association with MPAC meetings and should be anticipated at least three months in advance of the MPAC meeting. WHO normally supports travel costs for the duration of MPAC meetings for MPAC members, chairs of regional technical advisory groups, WHO Regional Advisers and any experts invited by WHO to present at MPAC in accordance with WHO applicable rules and polices. WHO may support travel for additional persons for the purpose of a ERG meeting.. As issues mature, proposals for presentation to the MPAC will be submitted to the WHO Secretariat normally no later than 10 weeks ahead of each MPAC meeting for circulation to MPAC members. The decision to proceed with tabling the issue at the next MPAC meeting will then be taken jointly by the Chairperson of MPAC and the WHO-GMP Director after consideration of issues raised during the consultative process.

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Management of Conflict of Interest and Undue Influence: When a MPAC ERG is formed, and at the start of each ERG meeting, participants will respond to a request to report conflicts of interest relevant to the focus of the ERG. This will be done using the Declaration of Interest form (See Annex 1). MPAC members, organization representatives or WHO staff members who have conflicts of interest may not participate in the ERG. Persons who serve as consultants may participate as technical resource persons in the ERG. As such, they bring specific expertise that is essential to the efforts of the ERG. However, potential conflicts, both personal and those of their organizations, must be declared and evaluated by WHO before their invitation can be confirmed. All consultants participate in ERGs at the discretion of WHO. The value and impact of MPAC recommendations, and subsequent WHO policies and recommendations, are critically dependent upon public trust in the integrity of the policy setting process. Thus, participation of any consultant may be curtailed, even in the absence of a declared conflict of interest, if in the judgment of WHO, a potential for the appearance of undue influence exists. -----------------------------------------------------------------------------------------------------------------------

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Annex 4 MPAC Working Diagram

Evidence Review Groups

ERG a ERG b

ERG c
Standing TEG on chemotherapy

WHO COs MoH and NMCPs

SAGE
JTEG
(with IVB)

MPAC
WHO GMP Secretariat

WHO DG

WHO malaria policy recommendations and guidelines

Other WHO departments VCAG

(with NTD)

WHO ROs

RBM: Secretariat, WGs and SRNs

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