TWN Info Service on Health Issues (May16/09)
31 May 2016
Third World Network

WHO: Health Assembly adopts framework for non-State actor engagement

Geneva, 31 May (K M Gopakumar) – The 69th World Health Assembly (WHA) adopted the Framework of Engagement with Non-State Actors (FENSA) on the concluding day of Assembly that took place at the World Health Organization headquarters in Geneva on 23-28 May.

The adoption of FENSA is the conclusion of a process initiated as part of the WHO reform in 2011. The FENSA process was formally kick started following the WHO Executive Board decision in the form a chair summary that stated: “Further discussion will be required on WHO's engagement with other stakeholders, including different categories of nongovernmental organizations and industry, and the proposals to review and update principles governing WHO relations with nongovernmental organizations, and to develop comprehensive policy frameworks to guide interaction with the private-for-profit sector, as well as not-for-profit philanthropic organizations”.

In 2015 the Secretariat-led process was taken over by the Member States and text-based negotiations started at the Open Ended Intergovernmental Meeting (OEIGM). Since its first meeting from on 30 March to 1 April 2015, Member States carried out several rounds of formal and informal negotiations.

However, the OEIGM could not reach a consensus on the text, and accordingly the OEIGM proposed the formation of a drafting group to continue the negotiations during the 69th WHA.  On 23 May when the WHA opened, a drafting group was constituted to resume negotiations.  FENSA textual negotiations were concluded on 26 May during the night session of the drafting group. At the afternoon session on 27 May the drafting group concluded negotiations on the resolution to adopt FENSA.

FENSA consists of an overarching framework of engagement with Non-State Actors (NSAs) and four separate policies for governing the engagements with four categories, i.e. Non-Governmental Organisations (NGOs), private sector, philanthropic foundations and academic institutions. The overarching principles set out the common rules for all NSAs and treat all NSAs on an equal footing. The separate policies provide certain customised aspects of the overarching principles to the respective categories of NSAs. The framework regulates five types of engagements: participation, resources, advocacy, evidence, and technical collaboration.

During the WHA, FENSA negotiations focussed on Paragraphs 27, 32, 33 and 35 of the overarching framework and Paragraphs 12, 13 and 14 of the private sector policy.

The April 2016 negotiations on the paragraphs in the overarching framework reopened the already agreed text on paragraphs 27, 32, 33, 34 and 35. The WHA negotiations on the reopened text resulted in the deletion of Paragraph 34 and the addition of a new Paragraph 27bis.

The deletion related to a specialised central unit to analyse the information provided by the technical unit on NSAs that the technical unit proposes to engage with. As a result of this deletion, due diligence and risk assessment would be carried out not by a central specialised unit but a specialised unit. There is no clarity on whether the specialised unit would be there at all levels or only at the WHO headquarters and regional office levels.

Another deletion was the reference to an Engagement Coordination Group, which was to resolve disagreements between the technical unit and specialised central unit with regard to the nature of engagement. The Engagement Coordination Group is replaced with a dedicated Secretariat mechanism to take decision on proposals of engagement referred to it (Paragraph 35). The text has not spelt out the circumstances when such proposals will be referred to the dedicated Secretariat mechanism.

The most important feature is the addition of a new Paragraph 27bis. This paragraph provides discretion to the technical units to classify certain engagements as ‘low risk’ due to “its repetitive nature (footnote) or because it does not involve policies, norms and standard setting” and accordingly “a simplified due diligence and risk assessment” is applied.  Further it provides no any details or list of low risk engagements. It only states: “The simplified due diligence and risk assessment, and information to be provided by non-State actors as well as the criteria of low risk engagements are described in the guide for staff.”

[The full text of Paragraph 27bis reads:

“The technical unit makes an initial assessment. If the engagement is of low risk, for example because of its repetitive nature (f1) or because it does not involve policies, norms and standard setting, a simplified due diligence and risk assessment modulating the procedures in paragraphs 28 to 36 as well as 38bis can be performed by the technical unit and the risk management decision taken, taking such steps as are necessary to ensure full compliance with paragraphs 6 to 8.(f2) For all other engagements full procedures apply.”

[Footnote 1: “provided that due diligence and risk assessment have already been carried out and the nature of engagement has remained unchanged”

[Footnote 2: “The simplified due diligence and risk assessment, and information to be provided by non-State actors as well as the criteria of low risk engagements are described in the guide for staff”.]

Thus one has to wait till the preparation of the guide for staff to find out the list of low risk engagements or the criteria to classify low risk engagements. According to an observer, the Secretariat is unlikely to give a list of low risk activities but will instead provide criteria to classify low risk, most probably without any examples, to benefit from the ambiguity in the text.

The final negotiations on the private sector policy resulted in the deletion of the proposal to create a pool fund under Paragraph 14.  The idea of this fund was to pool contributions from multiple private sector sources, that do not create conflicts of interest and to avoid perceived influence of specific contributors on WHO’s work.

With regard to Paragraph 13 that sets the conditions for accepting financial and in-kind contributions from private sector entities to the WHO’s programmes, amendments proposed to the Paragraph 13 (a), 13(b) and 13(g) were all deleted. (See FENSA text prior to the final WHA negotiations:

Paragraph 13(a) states: “Such contributions should not be used for the normative work”. However, it does not define the term normative work. However, the footnote to Paragraph 6 defines policies, norms and standard setting to include information gathering, preparation for, elaboration of and the decision on the normative text”. It is yet to to be seen whether the Secretariat would stick to the definition in Paragraph 6 or use its discretion to define the words ‘normative work’ in a different way.

[Third World Network (TWN) recently published instances of involvement of persons linked to the pharmaceutical industry in the drafting of Guidelines on good Regulatory Practices: see]

The WHA resolution that adopts the FENSA decides to replace the two existing policies governing WHO engagements with NGOs and the private sector. Further, the resolution requests the Director-General to start the implementation immediately and take all necessary measures to fully implement FENSA.  Further, it requests the Director-General to expedite the full establishment of WHO’s NSA register.

Instead of developing a comprehensive conflict of interest policy, the resolution requests the Director-General “to include in the Guide to staff, measures that pertain to application of the relevant provisions contained in the existing WHO policies on conflict of interest, with a view to facilitating the implementation of FENSA”. However, a delegate told TWN that it is unlikely that WHO has such polices except a document to assess declarations of interest of experts invited to join the various expert committees.

The resolution also requests the independent Expert Oversight Advisor Committee to monitor the implementation of FENSA in its report to Programme, Budget and Administrative Committee (PBAC) of the Executive Board. It further requests the Director-General to conduct an evaluation of FENSA implementation in 2019 and submit the results of the evaluation along with any revisions to FENSA to the January meeting of the Executive Board in 2020.+