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 and here).
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 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 or similar proposals. If the CEWG approves some version of the FRIND or PDP Plus proposal, it will certainly 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 ProcedureIf 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.