[Ip-health] European members of WHO Executive Board take hard line on nomination of Novartis official to R&D group

thiru at keionline.org thiru at keionline.org
Wed Jan 19 06:43:06 PST 2011


http://keionline.org/node/1060

By thiru
Created 19 Jan 2011 - 9:38am

European members of WHO Executive Board take hard line on nomination  
of Novartis official to R&D group

At the 128th meeting of the WHO Executive Board (EB), the European  
members of the board are reportedly taking a hard line on the proposal  
by Switzerland to have Paul Herrling, an executive of Novartis,  
appointed to the WHO Consultative Expert Working Group (CEWG) on R&D  
financing. Our earlier blogs on this controversy are available here  
[1] and here [2]).

Even some industry observers are surprised that Herrling's name was  
put forward for the body, given his leading role in the FRIND and PDP  
Plus funding proposals that will be considered by the CEWG.

European members indicate they will both block the creation of the  
group, and go after other proposed members of the group, if Herrling  
is not approved. The Europeans also claim the US delegation will back  
the Europeans up on this score, and target certain members of the CEWG  
put forth by developing countries, as retaliation for developing  
countries raising legitimate questions about Herrlings conflicts of  
interest on the CEWG.

None of the high income countries claim that they would allow a party  
asking for R&D funding to review its own proposal, but they insist the  
WHO allow this on the CEWG.

The WHO guidelines for conflict of interest in the Roll Back Malaria  
project [3] define a conflict of interest as follows:

     "Meaning of "Conflict of Interest"
     A conflict of interest can occur when a Partner's ability to  
exercise judgment in one role is impaired by his or her obligations in  
another role or by the existence of competing interests. Such  
situations create a risk of a tendency towards bias in favor of one  
interest over another or that the individual would not fulfill his or  
her duties impartially and in the best interest of the RBM Partnership.

     A conflict of interest may exist even if no unethical or improper  
act results from it. It can create an appearance of impropriety that  
can undermine confidence in the individual, his/her constituency or  
organization. Both actual and perceived conflicts of interest can  
undermine the reputation and work of the Partnership".

The WHO methods of "managing" conflicts of interest provide very few  
options that would make sense. Herrling could disclose that he works  
for Novartis and is the author of FRIND and the co-author of PDP Plus,  
but everyone knows that now. Following the disclosure, the CEWG could  
allow him to fully participate in all evaluations of his and competing  
proposals (a likely scenario), or limit his participation, either  
partially or totally. In any case, it seems quite surprising that the  
WHO thinks that any of the remedies would overcome the "both actual  
and perceived conflicts of interest" standard, if the CEWG considers  
the FRIND or PDP Plus proposals, similar proposals. If the CEWG  
approves some version of the FRIND or PDP Plus proposal, certain it  
will come with a question of the independence of the evaluation.

The Roll Back Malaria Partnership Conflict of Interest Policy and  
Procedures provide a useful illustration of the policies options  
available to the CEWG, to manage declared conflicts of interest.

     "Roll Back Malaria Partnership Conflict of Interest Policy and Procedure

     If it is concluded that the declared interest is potentially  
significant, one of the following three options, or a combination of  
these options, is considered to determine under what conditions, if  
any, the Partner may participate in the discussion or event:

         (i) Conditional Participation (i.e., participation with  
disclosure): Under this option, the Secretariat and/or Chair would  
decide to continue the Partner's involvement in the meeting or work  
and publicly disclose the Partner's interest to other participants at  
the start of the meeting and in the report of the meeting and related  
publications. (This approach is especially appropriate where the  
Partner's interest is relatively minor and where disclosure would be  
sufficient to address any potential effect on the process.)

         (ii) Partial Exclusion: In this alternative, the Secretariat  
and/or Chair would limit the Partner's involvement, either (a) by  
excluding the Partner from the portion of the meeting or work where a  
conflict of interest has been identified or (b) by excluding the  
Partner from participating in the decision making process. In both  
cases, the reported interest must also be publicly disclosed to other  
meeting participants and must be recorded and published in some  
suitable way. Option (ii)(b) may be used to enable other Partners to  
listen to the views or information from the Partner with the potential  
conflict while bearing in mind the Partner's potential bias, as well  
as the need to ensure that decision-making will be taken only by  
Partners without conflicts.)

         When partial exclusion is applied, Partners with a conflict  
of interest must excuse themselves from the meeting room or other  
venue to ensure the ability of other participants to freely, openly  
and comfortably exchange information, express their views and take  
decisions. Under option (ii)(a), the conflicted Partner must excuse  
him/herself from both the discussion and the decision making. Under  
(ii)(b), the conflicted Partner must excuse him/herself from the  
decision making portion.

         (iii) total exclusion. Here, the Partner is excluded from the  
meeting or work altogether, where the nature of the conflict of  
interest is too significant vis-à-vis the subject matter or overall  
objective of the event, or where limiting the Partner's involvement to  
only a portion of the meeting or work is not feasible".

Source URL: http://keionline.org/node/1060

Links:
[1] http://www.keionline.org/node/1056
[2] http://www.keionline.org/node/1058
[3] http://rbm.who.int/docs/constituencies/RBMcoiPolicy.pdf



------------------------------------------------------------


Thiru Balasubramaniam
Geneva Representative
Knowledge Ecology International (KEI)
thiru at keionline.org


Tel: +41 22 791 6727
Mobile: +41 76 508 0997







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