(2003; 148 pages)
2.14 Conflict of Interest
Before undertaking the work, each evaluator and inspector will also (in addition to the above mentioned confidentiality undertaking) be required to sign a Declaration of Interest. If based on this Declaration of Interest, it is felt that there is no risk of a real or perceived conflict of interest and it is thus deemed appropriate for the evaluator or inspector in question to undertake this work, he/she will discharge his/her functions exclusively as adviser to WHO. In this connection, each evaluator and inspector is required to confirm that the information disclosed by him/her in the Declaration of Interest is correct and that no situation of real, potential or apparent conflict of interest is known to him/her, including that he/she has no financial or other interest in, and/or relationship with a party, which:
(a) may have vested commercial interest in obtaining access to any Confidential Information disclosed to him/her in the course of the evaluation/inspection activities described in this document; and/or
(b) may have a vested interest in the outcome of the evaluation activities/inspection including, but not limited to, parties such as the manufacturers whose products are subject to evaluation or manufacturers of competing products.
Each evaluator and inspector will undertake to promptly advise WHO of any change in the above circumstances, including if an issue arises during the course of his/her work for WHO.
All inspectors furthermore agree, that at the manufacturer’s request, WHO will advise the manufacturer in advance of the identity of each inspector and composition of the team performing the site inspection, and provide curricula vitae of the inspectors. The manufacturer then has the opportunity to express possible concerns regarding any of the inspectors to WHO prior to the visit. If such concerns cannot be resolved in consultation with WHO, the manufacturer may object to a team member’s participation in the site visit. Such an objection must be made known to WHO by the manufacturer within ten days of receipt of the proposed team composition. In the event of such an objection, WHO reserves the right to cancel its agreement with the inspector, and the activities to be undertaken by that inspector, in whole or in part.