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Info Service on Health Issues (Jan15/03) No consensus on WHO rules of engagement with non-State actors Geneva, 27 January (K M Gopakumar) – Member States continue to disagree on the rules to regulate the World Health Organization’s engagement with non-State actors. A new version of the draft framework from work started by the WHO Secretariat in 2012 did not get consensus at the 21st session of the Program and Budget Committee (PBAC) held on 21-23 January at the WHO headquarters in Geneva. The report of the PBAC to the on going 136th Session of the WHO Executive Board (EB) suggested further revisions and refinements of the framework for its finalisation. It states: “The Committee welcomed the improvement made by the Secretariat with regard to the readability of the framework of engagement. However, it suggested that further revisions and refinements should be made to the framework in order to further facilitate readability”. The EB is meeting from 26 January to 3 February in Geneva and considered the latest draft framework on 27 January. (For details of the document please see: http://apps.who.int/gb/ebwha/pdf_files/EB136/B136_5-en.pdf) According to the PBAC report, many Member States have suggested a process to review, amend and improve the framework. It states: “Several delegations proposed to initiate a process to review, amend and improve the draft framework of engagement with non-State actors, including, inter alia, provisions on conflict of interest, with a view to reaching agreement on the framework at the Sixty-eighth World Health Assembly”. During the 27 January discussion in the EB only four countries viz. the United States of America (USA), Brazil, the Russian Federation and South Africa made interventions. The USA stressed the need for improving certain sections of the framework such as conflict of interest and proposed a drafting group during the EB. Brazil also proposed the formation of a drafting group to work till the 68th WHA in 2016 to finalise the document. It also stated that WHO should play the role of coordination instead of drafting the document. South Africa on behalf of the African Group said that the framework failed to incorporate suggestions came from the regional committee deliberations and proposed a mechanism to address this concerns. Meanwhile Argentina circulated a draft decision as a “conference paper”, which proposes a drafting process to finalise the framework. The operational paragraphs of the draft decision read:
It further requests the WHO Director-General (DG) to: “ (a) consolidate all proposals emanating from the consultation process on the Framework and to include them in the documentation to be presented to the Sixty-eighth World Health Assembly; (b) identify resources to conduct the consultations, especially with regard to ensuring participation by developing or least developed countries”. During the afternoon session on 27 January a vast number of countries supported the draft decision proposed by Argentina. The DG then suggested that Member States meet tomorrow (28 January) onwards to provide inputs into the process. However, it is not clear the process will involve drafting of the document. The meetings will be chaired by Argentina. The framework document contains an overarching framework of engagement with non-State actors and four specific policies for the engagement with non-governmental organisations (NGOs), private sector entities, philanthropic foundations and academic institutions. The draft framework is part of the WHO reform process that was kick started in 2011. Since 2012 the Secretariat has been working on a draft Framework to regulate WHO’s engagement with non-State actors (NSA) and to date has failed to deliver a satisfactory Framework. (When adopted, this framework will replace the current “Principles Governing Relations between the World Health Organization and Nongovernmental Organizations” and “Guidelines on interaction with commercial enterprises to achieve health outcomes”.) The current version of the framework for the deliberation of the PBAC and EB was drafted when the 67th World Health Assembly (WHA) instructed the Secretariat to carry out further changes to the framework. The decision requested the DG to prepare a comprehensive report of the comments made by Member States during the 67th WHA and the follow-up comments and questions raised, including clarification and response thereon from the Secretariat, by the end of July 2014. Further, it requested the DG to “to submit a paper to the Executive Board at its 136th session in January 2015, ensuring that Member States receive it by mid-December 2014 …” The PBAC report clearly shows that the new draft framework fails to satisfy the Member States. According to the report of the Secretariat (EB136/5) to which the draft framework is annexed, Member States raised concerns on the following issues: conflict of interest, due diligence process and criteria, receipt of the financial resources from the private sector entities, (staff) secondments, applicability of provisions of private sector policy to non-private sector entities, official relations, boundaries: entities with which WHO will not engage, involvement of Member States in oversight and management of engagements, partnerships, competitive neutrality, medicine donations, protection of WHO’s name and emblem, evaluation of the framework, role of academic institutions and the readability of the documents. [Member States expressed their concerns initially through a list of specific follow-up comments and questions to DG in June 2014. Later the Regional Committees deliberated on the concerns related to the framework (http://www.who.int/about/who_reform/non-state-actors-comments/en/). The report of the deliberations of the Regional Committees are submitted to the WHA through the EB (http://apps.who.int/gb/ebwha/pdf_files/EB136/B136_INF2-en.pdf).] However, except for the issue of secondments the framework does not provide any satisfactory answer to any other issue raised by Member States. (Paragraph 46 of the overarching framework reads: “It is proposed as a new rule that WHO does not accept secondments from non-State actors”.) The important shortcomings of the proposed framework are as follows. Conflict of Interest According to the report of the PBAC Member States proposed a “process to review, amend and improve the draft framework of engagement with non-State actors, including, inter alia, provisions on conflict of interest”. There is no comprehensive policy on conflict of interest in WHO to manage both institutional and personal conflicts of interest. Currently conflict of interest is managed mainly through the following three instruments:
However these documents are highly inadequate to manage conflicts of interest (COI). Take for instance, WHO’s relations with individual experts and the Guidelines for Declaration of interest. According to the Guidelines, “The Secretariat may conclude that no potential conflict exists or that the interest is irrelevant or insignificant. If, however, a declared interest is determined to be potentially or clearly significant, one or more of the following three-measure for managing the COI may be applied. The Secretariat (i) allows full participation, with public disclosure of your interest; (ii) mandates partial exclusion (i.e., you will be excluded from that portion of the meeting or work related to the declared interest and from the corresponding decision making process); or (iii) mandates total exclusion (i.e., you will not be available to participate in any part of the meeting or work).” Thus the assessment is made by the Secretariat and the reasons for such assessment is not available in the public domain. In practice the Secretariat often follows an approach that a declaration of interest is sufficient and does not take steps to exclude from expert committees such experts who have declared their interest. Instead of excluding them from the expert committees the persons with declared interest are excluded from certain parts of the discussions. For instance, an expert who has declared shares of their partners in the pharmaceutical companies or even former employees of the pharmaceutical companies were allowed to be part of the WHO Expert Committee on Specifications on Pharmaceutical Preparations and asked not to participate discussions on specific products. (See page 13 of this document: http://www.who.int/medicines/areas/quality_safety/quality_assurance/expert_committee/TRS-970-pdf1.pdf) Similarly the report of the Expert Committee on Biological Standardisation often contains the following paragraphs without giving access to the declared interest: “The decisions of the Committee were taken in closed session with only members of the Committee present. Each Committee member had completed a Declaration of Interest form prior to the meeting. These were assessed by the WHO Secretariat and no declared interests were considered to be in conflict with full meeting participation”. [See page (vi) in the following document: http://www.who.int/biologicals/WHO_TRS_980_WEB.pdf?ua=1] The Framework defines both individual COI and institutional COI. However, the Framework does not include a comprehensive guideline to avoid COI. It also does not provide any concrete examples/instances of disengagement/limited engagement on the ground of COI. Engagement with Organisations with divergent interests The Framework is also silent on WHO’s engagement with NSAs with divergent interests. For instance, often the interest of WHO would come into conflict with the interest of industry bodies and business associations. While the interest of WHO remains the protection of public health, the interest of private sector firms or business associations is to safeguard their profits. Therefore it is important that WHO should not engage with NSA with divergent interest, which is directly in conflict with the objectives of WHO. For instance, WHO’s engagement with pharmaceutical industry associations to set the norms and standards related to quality of medicines would undermine WHO’s objective of access to affordable medicines. The current practice of WHO shows that WHO is an active participant in private standard setting bodies such as the International Conference on Harmonisation (ICH): http://www.ich.org/about/organisation-of-ich/steering.html). Currently WHO has no policy to avoid engagement with NSAs that have conflict of interest. There is evidence of such conflict in some of the observers such as the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) and ICH that attend the Expert Committee on Specifications for Pharmaceuticals, a norm setting body. Framework and existing policies There is also no clarity with regard to the application of NSA policy on existing policies such as the Policy on External Partnership. There are around 89 plus external partnerships or collaborations with which WHO is currently engaged. The Framework simply states: “WHO’s involvement in external partnerships is regulated by the policy on WHO’s engagement with global health partnerships and hosting arrangements. For the management of risks of WHO’s engagement in these partnerships the present Framework for engagement with non-State actors applies” (Paragraph 48.a). However, there is no clarity on whether the Secretariat would review the existing external partnerships using the Framework on NSA. A non-exhaustive list of partnerships and collaborations shows that WHO is currently engaged in more than 88 engagements listed as external partnerships and collaborations (http://www.who.int/about/who_reform/partnerships-collaborative-arrangements-with-WHO-involvement.pdf?ua=1). WHO’s involvement in the International Conference for Harmonisation is conspicuously missing in the list. As a result, there is no clear guidance on which policy will prevail in case of a conflict between the framework and existing policies. Lack of Clarity on determination of the nature of NSA The framework is silent about the classification of NGOs as business interested NGO (BINGO) and Public Interested NGO (PINGO). It currently proposes to treat international business associations such as the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) as part of the private sector but also as NGOs and allows them to attend governing body meetings. The framework proposes granting of official relation (to WHO) to international business associations and philanthropic foundations. This alters the current criteria in the Principles Governing Relations with Non-Governmental Organisations which states: “The main area of competence of the NGO shall fall within the purview of WHO. Its aims and activities shall be in conformity with the spirit, purposes and principles of the Constitution of WHO, shall centre on development work in health or health-related fields, and shall be free from concerns which are primarily of a commercial or profit-making nature”. The admission of international business associations in official relation is directly in conflict with this principle. The Secretariat and the governing body such as the EB did not implement this principle when granting official relation status to NGOs and admitted international business associations like IFPMA. The technical justification for this lapse is that the memorandum of association of international business associations states those organizations as a not-for-profit entities. In other words, the framework does not make any difference between PINGOs and BINGOs. Many NGOs currently in official relation are funded by industry. Examples include the Global Alliance for Improved Nutrition and the International Alliance of Patient Organizations. Paragraph 12 of the framework defines philanthropic foundations and states that these “shall be clearly independent from any private sector entity in their governance and decision making”. Often many foundations and NGOs are established by private sector entities to channel their funding. There is a need to spell out concrete/specific criteria (such as source of funds and board representation) to assess the nature of philanthropic foundations at arms length from their donors. However, the framework is silent on the criteria to determine the nature of the foundations and NGOs. Similarly Paragraph 14 of the framework states that the Secretariat can decide to consider to apply the relevant provisions of the policy on private sector engagement to a nongovernmental organisation, a philanthropic foundation or an academic institution. Though the “influence of private sector entities” and decision-making processes “independent of private sector influence” are referenced in Paragraph 14, there is no concrete criteria to determine this. It is left to the Secretariat to make the determination, with the result that such decisions would be made without a transparent process. Private Sector and NGOs are treated at par Further, it is also not clear in the framework if there are any extra privileges enjoyed by the NGO sector compared to the private sector entities and international business associations. In other words the framework is not imposing any limitations on the private sector and international business associations with regard to their engagements with WHO. The only difference is that private sector entities are excluded from attending the WHO governing body meetings. However private sector entities can easily bypass this rule by getting themselves into the delegation of international business associations.. Regulation of Resources There are no clear criteria to regulate the financial contributions from NSA to avoid the risk of donor-driven agenda. The Framework puts a limited set of regulation on funding from the private sector but it is insufficient. For instance, Para 29 states that WHO can accept contributions from the private sector for financing staff salary. This is a major concern. Thus the draft Framework is silent on addressing the risk of donor-driven programmes. One of the suggestions from Member States was to put a celling on the voluntary contributions from NSA and any contribution beyond that amount should go to the core voluntary fund, which gives enough freedom for the Secretariat to allocate resources in under funded programmes. Further, the NSA policy on NGOs (which under the WHO system includes industry associations and groups sponsored by industry) and academic institutions does not spell out the detailed rules for certain types of engagements such as resource contribution. The private sector can use NGOs, academic institutions and philanthropic foundations to route their resources to WHO. According to an analysis by the Secretariat, in 2012 NGOs contributed 4.8 % of the revenue of WHO against 1.5% from the private sector. Soft approach to industries other than tobacco and arms The framework does not spell out the criteria to exclude certain industries other than tobacco and arms. Many Member States expressed concern over the soft approach to other industries, which pose a public health risk such as the food and beverage industry. The framework in Paragraph 44 states: “WHO does not engage with the tobacco or arms industries. In addition, WHO will exercise particular caution when engaging with other industries affecting human health or affected by WHO’s norms and standards”. However, no details have been provided in the framework on how the Secretariat is going to exercise caution while engaging with these parts of the private sector. The nature of WHO’s engagement with the food and beverages industry, for example, is absolutely critical in its activities in the area of non-communicable diseases.+ (With inputs from Mirza Alas and edited by Chee Yoke Ling)
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