10 WHO engages with non-State
actors in view of their significant role to advance and promote public health and to support countries in achieving their health
objectives. WHO’s engagement with
non-State actors is governed by the Framework of Engagement with Non-State
Actors (FENSA) and other applicable WHO
rules, policies and procedures.
20 The Framework of Engagement with Non-State Actors (FENSA) adopted by Member States at the World Health Assembly in May 2016 (resolution WHA 69.10 and its Annex) set
i. an overarching framework of engagement with non-State actors; and
ii. policies and operational procedures on engaging with each of the following four groups of non-State actors:
- nongovernmental organizations (including civil society groups and faith-based organizations);
- private sector entities (including business associations);
- philanthropic foundations; and
- academic institutions.
30 Headquarters, regional offices and country offices, entities established under WHO, WHO-hosted partnerships, facilities and secretariats and joint or co-sponsored programmes are required to follow the principles and provisions of FENSA in their engagements with non-State actors.
40 FENSA recognizes that engagements with non-State actors can bring important benefits to global public health and to WHO in fulfillment of its mandate and objectives. However, any such engagement can involve risks which need to be effectively managed and, where appropriate, avoided.
50 The Executive Board, through its Programme, Budget and Administration Committee (PBAC) monitors the implementation of FENSA, proposes revisions to the framework and can grant the privileges of official relations to international nongovernmental organizations, international business associations and philanthropic foundations (see section XVIII.1.2). WHO's interactions with non-State actors is managed transparently. The Due Diligence and Non-State Actors Unit (DAN) is the specialized unit mandated to facilitate its implementation and presents annual reports to the governing bodies on WHO's engagement with non-State actors.
Types of engagement with non-State actors
60 FENSA defines five types of engagement with non-State actors. Each type of engagement can take different forms, be subject to different levels of risk and can involve different levels and types of engagement by WHO. The types of engagement are:
- Participation in meetings:
- organized by WHO: non-State actors may attend various types of meetings organized by WHO. The nature of their participation depends on the type of meeting concerned. Non-State actors' participation in meetings of WHO governing bodies is determined by the governing bodies' respective rules of procedure, policies and practices as well as FENSA's provisions on official relations. The format, modalities and the participation of non-State actors in consultations, hearings and other meetings is decided upon on a case-by-case by the governing bodies or the Secretariat, as appropriate;
- organized wholly or partly by a non-State actor: subject to the provisions of FENSA and applicable WHO rules, policies and procedures, WHO's involvement can consist of: WHO jointly organizing a meeting with a non-State actor; WHO co-sponsoring a meeting organized by a non-State actor; WHO staff making a presentation or acting as panelists at a meeting organized by a non-State actor; or WHO staff attending a meeting organized by a non-State actor;
- Resources: financial or in-kind contributions that WHO may receive. In-kind contributions may include donations of medical products and other goods and free provision of services (pro-bono services);
- Evidence: inputs based on up-to-date information, knowledge or technical issues, and consideration of scientific facts, independently analyzed by WHO. Evidence generation by WHO includes information gathering, analysis, generation of information and the management of knowledge and research. Non-State actors may provide their up-to-date information and knowledge on technical issues, and share their experience with WHO, as appropriate;
- Advocacy: actions to increase awareness of health issues, including issues that receive insufficient attention; to change behaviors in the interest of public health, and to foster collaboration and greater coherence between non-State actors where joint action is required;
- Technical collaboration: other engagements with non-State actors, as appropriate, in activities that fall within the General Programme of Work, including: product development, capacity-building, operational collaboration in emergencies; contributing to the implementation of WHO's policies.
Scope of application of FENSA
70 Engagements with non-State actors referred to in paragraph 60 above are governed by the provisions of FENSA (i.e., the overarching framework and its four specific policies and operational procedures) and other applicable WHO rules, policies and procedures.
80 The provisions of FENSA do not apply to:
- procurement of goods and services from non-State actors to WHO (except for pro‑bono contributions), which are regulated by WHO's Financial Regulations and Rules and related policies;
- fees, payments, contributions and/or goods received by WHO from non‑State actors as a result of their use of WHO materials, information, data (such as use of the Global Influenza Surveillance and Response System under the Pandemic Influenza Preparedness Framework ("PIP Framework")) or other mechanisms or services (such as prequalification);
- engagement between WHO and individuals acting in their individual capacity and not as representatives of non‑State actors. In this case, WHO's Regulations for Expert Advisory Panels and Committees and the Guidelines for Declaration of Interest for WHO Experts apply;
- engagement between the Codex Alimentarius Commission and non-State actors. Meetings of the Commission, Committees, including independent expert committees, and Task Forces are regulated by the Rules of Procedure and other decisions adopted by the Codex Alimentarius Commission;
- engagements where WHO is assessing individual products of private sector entities, such as in the case of WHO Pesticide Evaluation Scheme (WHOPES) and WHO activities in prequalification of medical products.
90 The implementation of certain policies as they relate to WHO's engagement with non-State actors is coordinated and aligned with FENSA. For example:
- FENSA applies to WHO-hosted partnerships and other WHO-hosted entities, subject to the policy on WHO's engagement with global health partnerships and hosting arrangements (see resolution WHA63.10 and section XVIII.2); accordingly, FENSA applies to their engagements with non-State actors (not to their governance). FENSA also applies to WHO's engagement in external partnerships and multistakeholder initiatives;
- In addition to WHO's Regulations for Scientific Groups, Collaborating Institutions and other Mechanisms of Collaboration, engagements, designations and redesignations of WHO collaborating centres are subject to FENSA.
Principles and benefits of engagement with non-State actors
100 In order to preserve WHO's independence, integrity, credibility and impartiality as an inter-governmental organization, engagements with non-State actors must:
- demonstrate a clear benefit to public health;
- conform with WHO's Constitution, mandate and General Programme of Work;
- respect the intergovernmental nature of WHO and the decision-making authority of Member States as set out in WHO's Constitution;
- support and enhance, without compromising, the scientific and evidence-based approach that underpins WHO's work;
- protect WHO from any undue influence, in particular on the processes in setting and applying policies, norms and standards (which includes information gathering, preparation for, elaboration of, and the decision on the normative text);
- not compromise WHO's integrity, independence, credibility and reputation;
- be effectively managed, including by, where possible, avoiding conflict of interest and other forms of risks to WHO;
- be conducted on the basis of transparency, openness, inclusiveness, accountability, integrity and mutual respect.
110 Benefits of engagement can include the following:
- contribution of non‑State actors to the work of WHO;
- influence that WHO can have on non‑State actors to enhance their impact on global public health or influence the social, economic and environmental determinants of health;
- influence that WHO can have on non‑State actors' compliance with WHO's policies, norms and standards;
- additional resources non‑State actors can contribute to WHO's work;
- wider dissemination of and adherence by non‑State actors to WHO's policies, norms and standards.
Management of risks, including conflict of interest
120 WHO's engagement with non-State actors can involve risks which need to be effectively managed and, where appropriate, avoided. Risks relate inter alia to the occurrence in particular of the following: conflicts of interest; undue or improper influence exercised by a non-State actor on WHO's work, especially in, but not limited to, policies, norms and standard setting; a negative impact on WHO's integrity, independence, credibility and reputation; and public health mandate; the engagement being primarily used to serve the interests of the non-State actor concerned with limited or no benefits for WHO and public health; the whitewashing of a non-State actor's image through an engagement with WHO; and the engagement conferring an endorsement of the non-State actor's name, brand, product, views or activity, or providing a competitive advantage for a non-State actor.
130 A conflict of interest
arises in circumstances where there is a potential for a secondary interest (a
vested interest in the outcome of WHO's work in a given area) to unduly
influence, or where it may be reasonably perceived to unduly influence, either
the independence or objectivity of professional judgment or actions regarding a
primary interest (WHO's work). The existence of conflict of interest in all its
forms does not as such mean that improper action has occurred, but rather the
risk of such improper action occurring. Conflicts of interest are not only
financial, but can take other forms as well.
140 When engaging with non‑State actors, WHO may be facing a combination of converging and conflicting interests. An institutional conflict of interest is a situation in which WHO's interests may be unduly influenced by the conflicting interest of a non-State actor in a way that affects, or may reasonably be perceived to affect, the independence and objectivity of WHO's work.
150 In actively managing institutional conflict of interest and other risks of engagement, WHO aims to avoid allowing the conflicting interests of a non-State actor to exert, or be reasonably perceived to exert, undue influence over WHO's decision-making process or to prevail over its interests.
Due diligence and risk assessment
160 Before engaging with non-State actors, and in order to preserve its integrity, WHO conducts due diligence and risk assessment. Due diligence refers to the steps taken by WHO to find and verify relevant information on a non-State actor and to reach a clear understanding of its profile. Risk assessment refers to the assessment of a specific proposed engagement with that non-State actor.
170 Due diligence combines a review of the information provided by the non-State actor, a search for information about the entity from other sources, and an analysis of all the information obtained. This includes a screening of different public, legal and commercial sources of information, including: media, the entity's website companies' analyst reports, directories and profiles; and public, legal and governmental sources.
180 The objective of due diligence is to:
- clarify the nature, profile and purpose of the entity proposed to engage with WHO and the interest and objectives of the entity engaging with WHO and what it expects in return;
- determine its legal status, area of activities, membership, governance, sources of funding, constitution, statutes, and by-laws and affiliation;
- define the main elements of the history and activities of the entity in terms of the following: health, human and labour issues, environmental, ethical and business issues; reputation, image and financial stability;e
- ensure that the entity is not: (i) a tobacco industry and/or an entity collaborating or working to further the interests of the tobacco industry, nor (ii) an arms industry; and
- ensure that the entity and members of its decision-making bodies are not listed on the United Nations Security Council Consolidated List.
190 Due diligence facilitates the categorization of a non-State actor into one of the groups under FENSA: nongovernmental organization, private sector entity, philanthropic foundation, or academic institution; and determines which of the four specific policies on engagement will apply, in addition to the provisions of the overarching framework, to its engagement with WHO.
200 Risk assessment involves the assessment of risks associated with a proposed engagement with a non-State actor, in particular the risks described in paragraph 7 of FENSA and paragraph 120 above and is to be conducted without prejudice to the type of non-State actor.
Risk management
210 Risk management concerns the process leading to a management decision whereby the Secretariat decides explicitly and justifiably on entry into engagement, continuation of engagement, engagement with measures to mitigate risks, non-engagement or disengagement from an existing or planned engagement with non-State actors (other than decisions related to official relations – see section XVIII.1.2). It is a management decision usually taken by the unit engaging with the non-State actor based on a recommendation of the relevant FENSA focal point or the specialized unit (DAN).
220 WHO takes a risk-management approach to engagement, only entering into an engagement with a non-State actor when the benefits in terms of direct or indirect contributions to public health and the fulfilment of WHO's mandate outweigh any residual risks of engagement, as well as the time and expense involved in establishing and maintaining the engagement.
Specific provisions
230 WHO does not engage with the tobacco industry or non-State actors that further the work and interests of the tobacco industry. WHO also does not engage with the arms industry. For entities receiving funding from or engaging with the arms industry, a case‑by‑case assessment is made for each specific engagement
240 WHO must exercise particular caution when engaging with non‑State actors whose policies or activities negatively affect human health and may not be in line with WHO's policies, norms and standards, in particular those related to noncommunicable diseases and their determinants, as well as to protect WHO's normative work from any undue influence. In these situations, as for other proposed engagements, a case-by-case assessment is conducted in accordance with FENSA and other relevant policies.
250 Secondments from non-State actors, which are considered as in-kind donations from the releasing entities, are governed by FENSA and the Criteria and principles for secondments from nongovernmental organizations, philanthropic foundations and academic institutions (see World Health Assembly document A70/53). WHO does not accept secondments from private sector entities – see section III.4.10.
260 Grants may be provided by WHO to non-State Actors (nongovernmental organizations and academic institutions, excluding philanthropic foundations, private sector entities and business associations) that are legally registered in the country they operate in, in compliance with the provisions contained in section XVI.3 on Letters of Agreement for Grants from WHO (GLOA) and related standard operating procedures (see FIN.SOP.XVI.003). However, in order to ascertain whether a non-State actor is in good standing, that it meets the required criteria and standards as per WHO's policies and rules including FENSA, and it is not affiliated in any manner with tobacco and/or arms industries nor has encountered any reputational issues, WHO must conduct due diligence and risk assessment on both the entity and the specific proposal, as described below, prior to issuing any GLOA.
270 As noted in paragraph 60 above, WHO's involvement in meetings organized wholly or partly by a non-State actor is governed by FENSA and other applicable WHO rules, policies and procedures. In particular, WHO does not co-organize meetings with, nor co-sponsor meetings organized wholly or partly by, private sector entities. Furthermore:
- Co-organization (or joint organization) of meetings by WHO and a non-state actor, which means that WHO (jointly with the non-Stat actor) is responsible for the planning, organization, content, and outcome of the meeting, requires that WHO exercise proper control over the meeting and must agree to all aspects of the meeting, including administrative arrangements, participants and documents. In addition to FENSA, all conditions and procedures for organizing WHO meetings apply;
- WHO co-sponsorship of meetings organized by a non-State actor, which implies the active participation of WHO in the planning and organization of the meeting convened by the non-State actor, is subject to FENSA and to the conditions set out in section IX.3.
280 As noted in paragraphs 60 and 80 above, pro bono (in kind) contributions from non-State actors, including pro bono (in kind) services, are subject to FENSA.
290 Before any arrangements are made for nil-remuneration consultancies with consultants who are to remain on the payroll of a non-State actor and in addition to all other applicable conditions (see section III.16.2), the hiring unit must provide full details of the proposed engagement (with all necessary supporting documents as per paragraph 300 below) to DAN for due diligence and risk assessment in accordance with the requirements of FENSA.
Procedure for engaging with non-State actors
Initiation of proposals
300 When, following exploratory discussions with a non-State actor concerning the possibility of engagement, a technical unit considers entering into an engagement with a non-State actor, the technical unit concerned must:
- first establish whether the engagement would be in WHO's interest and in line with the principles of WHO's engagement with non-State actors (see paragraph 100 above) and the priorities defined in the General Programme of Work and Programme budget and regional strategies (if relevant);
- request the non-State actor to provide: (i) a copy of the entity's founding document i.e., legal status (by-laws, charter, constitution or similar document), the composition of its decision-making body (governance such as the Board, Council, Assembly), sources of funding (lists of donors and sponsors), its affiliation (parent entity, subsidiaries or branches); and the tobacco-arms disclosure statement dated and signed by its authorized representative. If the non-State actor is in official relations, the request for the aforementioned documents is not necessary as the entity is required to submit them on an annual basis. However, the risk assessment on the proposed engagement should be conducted by the FENSA focal point (see paragraph 310 below);
- draft a concept note, using the relevant template, with a description of the proposed engagement, the objectives and goals of the project, details on the roles and responsibilities of WHO and those of the non‑State actors participating in the project, the budget of the project (if applicable), the expected outcomes of the project, and any additional information relevant to the project; and compile the documents submitted by the non-State actor; and
- submit the proposal with all the documents listed above to the designated FENSA Focal Point.
Due diligence and risk assessment procedures
Simplified procedure
310 The relevant FENSA focal point conducts a simplified due diligence and risk assessment on proposals (see the Guide to Staff for more information on this matter).
Standard procedure
320 If the FENSA focal point considers the engagement to be of high risk, for example, because it raises a conflict of interest, or involves policies, norms and standard setting, or involves different stakeholders with different roles and responsibilities, the FENSA focal point may refer the proposed engagement to DAN, specialized unit for the conduct of a standard due diligence and risk assessment. When referring any proposed engagement to DAN, the FENSA focal point must provide to DAN all the documents referred to in paragraph 300 above, including all the information required and received from the non-State actor, and details of the proposed engagement, using the relevant templates and checklists (see DAN's Intranet https://intranet.who.int/homes/dan/ ).
Decisions on engagement
330 In line with their delegation of authority, managers of WHO technical units proposing an engagement with a non‑State actor make the final decision on engagements and the resulting outcomes and implications of engagements.
Implementation, management and monitoring
340 The initiating technical unit is responsible for implementing, managing and monitoring the engagement with the non-State actor.
The WHO Register of non-State Actors
350 The Register of non-State actors is an Internet-based, publicly available electronic tool used by the Secretariat to document and coordinate engagement with non-State actors. It contains the main standard information provided by non-State actors engaging with WHO and collaboration plans between WHO and non-State actors in official relations with WHO and annual reports. It also includes information on secondments with non-State actors.
360 The accuracy of the information provided by the non-State actor and published in the Register is the responsibility of the non-State actor concerned and does not constitute any form of endorsement by WHO. Such information must be updated by the non-State actors, annually or upon the request of WHO.
Zero tolerance for all forms of Sexual Misconduct and other types of abusive conduct, fraud or corruption
370 All entities are expected to ensure that the conduct of their employees and any other persons engaged by them is consistent with the WHO standards of conduct. In particular, WHO has zero tolerance towards any form of sexual misconduct (an all-inclusive term encompassing all forms of sexual exploitation, sexual abuse, sexual harassment and sexual violence), other types of abusive conduct, fraud or corruption.
380 In this regard, and without limiting any other provisions contained herein, the entity warrants that it shall:
- take all reasonable and appropriate measures to prevent any form of prohibited behaviour by any of its employees and by any other persons engaged by it to perform any activities or to provide any services for WHO on the entity's behalf. This refers, in particular, to:
- sexual misconduct, as defined and addressed in the WHO Policy on Preventing and Addressing Sexual Misconduct;
- other types of abusive conduct, as defined and addressed in the WHO Policy on Preventing and Addressing Abusive Conduct; and,
- all forms of fraud or corruption, as defined and addressed in the WHO Policy on Prevention, Detection and Response to Fraud and Corruption.
- promptly report any actual or suspected violations of these WHO policies of which the entity becomes aware to the WHO Office of Internal Oversight Services ("IOS") at investigation@who.int;
- promptly communicate to IOS any measures that may be necessary or appropriate to protect the confidentiality and wellbeing of the survivor or victim; and,
- promptly respond to any actual or suspected violations of the above referenced WHO policies of which the entity becomes aware, and to cooperate with and to keep IOS informed of the status and outcome of any measures of protection, corrections to operations, investigation, and disciplinary action taken against any perpetrator by the entity.
Use of WHO's name. logo and emblem
390 WHO's name, logo and emblem are recognized by the public as symbols of integrity and quality assurance. WHO's name, acronym, logo and emblem shall therefore not be used for, or in conjunction with, commercial, promotional marketing and advertisement purposes. Any use of the name or emblem requires an explicit written authorization by the Director‑General of WHO (see also section I.7.2 and the related WHO Guidelines on use of the WHO logo).
Non-compliance with FENSA
400 Non-compliance by a non-State actor with FENSA can include inter alia the following: significant delays in the provision of information to the WHO Register of non-State actors; provision of wrong information; use of the engagement with WHO for purposes other than protecting and promoting public health, such as for commercial, promotional, marketing and advertisement purposes; misuse of WHO's name and emblem; attempt at undue influence; and abuse of the privileges conferred by official relations.
410 Non-compliance with FENSA can have consequences for the entity concerned after due process including a reminder, a warning, a cease-and-desist letter, a rejection of renewal of engagement and termination of engagement. WHO reserves the right to decline engagement with a non-State actor should the entity refuse to provide information or not comply with provisions set in FENSA. Non-compliance with FENSA is considered in the review of official relations by the Executive Board and non-compliance can result in termination or discontinuation of official relations.
420 Any financial contribution received by WHO that is subsequently discovered to be non-compliant with FENSA or other policies shall be returned to the contributor.
Roles and responsibilities
Technical units
430 Technical units at all levels of WHO may propose, initiate and implement engagements with non‑State actors in accordance with their delegation of authority. All WHO staff members have the responsibility to be aware of and apply corporate policies when engaging with non‑State actors, including FENSA.
440 WHO takes a proactive approach to engaging with non-State actors in the implementation of its public health mandate. Therefore, the question of strategic engagement with non‑State actors should be part of any planning process of technical units.
Managers
450 In line with their delegation of authority, managers of WHO technical units proposing an engagement with a non‑State actor makes the final decision on engagements and the resulting outcomes and implications of engagements.
FENSA focal points
460 The roles of FENSA focal points include the following:
- to conduct assessments and due diligence on proposed engagements with non‑State actors in line with simplified procedure;
- to determine whether an engagement referred by the technical unit qualifies for the simplified procedure to be conducted by the department or if it is of high‑risk to be submitted for review by the specialized unit responsible for performing standard due diligence and risk assessment;
- to act as primary contacts for the respective technical units on questions related to FENSA;
- to support the departments and units in developing engagement proposals in line with FENSA;
- to provide, on an annual basis, a summary of engagements of regional offices or WHO headquarters divisions with non‑State actors. These would inform the report by the Director‑General on implementation of FENSA to be presented during the January session of the Executive Board;
- to represent the regional office/WHO headquarters division in the FENSA focal points network; and
- to stay informed and updated through training on topics related to engagement with non‑State actors.
Specialized Unit
470 The specialized unit supports consistent, integrated and systematic implementation of FENSA across WHO, reports on implementation of FENSA to the Executive Board (through its Programme, Budget and Administration Committee) and performs standard due diligence and risk assessment on proposed engagements (high‑risk and/or complex engagements) referred to it and on proposed designations and redesignations of WHO collaborating centres. The specialized unit also facilitates and leads the preparation and submission of applications for admission into official relations by non‑State actors to the Executive Board and the review of entities currently in official relations with WHO.
FENSA Proposal Review Committee
480 The FENSA Proposal Review Committee serves as an arbitration body to consider the senior management's risk approach and functional needs and as a formal source for case law with regard to the application and implementation of FENSA.
490 The Committee holds regular meetings to discuss cases requiring senior management guidance, demonstrating strong leadership from senior management, as requested by Member States. The Committee shares recommendations for the Director-General's final decision.
500 The functions of the FENSA Proposal Review Committee are to:
- review proposals for engagements considered to have a significant associated risk;
- review proposals for engagements that illustrate specific aspects of engagement and require a consistent interpretation of the existing policies;
- review proposals for engagement where there is a difference of opinion between the proposing unit/division and the assessing unit;
- clarify other questions on interpretation of FENSA provisions;
- make recommendations to the Director‑General on the way forward concerning the above‑mentioned proposals of engagement.