[Ip-health] Fwd: TWN Health Info: No consensus on WHO rules of engagement with non-State actors

K.M. Gopakumar kumargopakm at gmail.com
Tue Jan 27 08:15:15 PST 2015


*Title :* TWN Health Info: No consensus on WHO rules of engagement with
non-State actors
*Date :* 27 January 2015

*Contents:*

TWN Info Service on Health Issues (Jan15/03)
27 January 2015
Third World Network
www.twn.my

_______________________________________________________________________________________

*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:

   - stress the importance of recognizing the right of Member States to
   participate in the drafting of the Framework of engagement with non-State
   actors, by facilitating and delivering input directly so that the Framework
   can be approved by the Sixty-eighth World Health Assembly in 2015;


   - highlight the need to immediately establish a drafting process, in
   close consultation with, and open to, all Member States, no later than
   February 2015.

 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 the 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:

   - The management of WHO’s relations with individual experts is regulated
   by the Regulations for Expert Advisory Panels and Committees and the
   Guidelines for Declaration of Interests (WHO Experts);


   - The Organization’s Staff Regulations and Staff Rules and in particular
   the provisions of declaration of interest therein: according to Article 1.1
   of the Staff Regulations of the World Health Organization, all staff
   members “pledge themselves to discharge their functions and to regulate
   their conduct with the interests of the World Health Organization only in
   view”;


   - Scientific collaborations are regulated by the Regulations for Study
   and Scientific Groups, Collaborating Institutions and other Mechanisms of
   Collaboration.

 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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