[Ip-health] WHO: Health Assembly adopts framework for non-State actor engagement

Mirza Alas mirzalas at gmail.com
Tue May 31 01:45:48 PDT 2016

*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

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 <http://twn.my/title2/health.info/2016/hi160411.htm> 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 27*bis*.

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 27*bis*. 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 27*bis* 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 38*bis* 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: http://apps.who.int/gb/ebwha/pdf_files/WHA69/A69_6-en.pdf.)

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

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.+


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