1. 1 WHO Conflicts of Interest Policy for WHO Experts

2. 2 Key points of principle Revised Guidelines For Declaration of Interests for WHO Experts – issued in June 2010 Revised Guidelines For Declaration of Interests for WHO Experts – issued in June 2010 Protect integrity and independence of the WHO's normative work. Protect integrity and independence of the WHO's normative work. Objective is not simply to fill out the form, but more importantly to assess whether a COI exists. Objective is not simply to fill out the form, but more importantly to assess whether a COI exists. No DOI = No participation of the expert in the work or activity. No DOI = No participation of the expert in the work or activity. Must balance any COI issue with the needs of WHO and broader public health needs. Must balance any COI issue with the needs of WHO and broader public health needs. Applies to individuals acting in a personal capacity i.e. not representatives. Applies to individuals acting in a personal capacity i.e. not representatives. DOI Form is an internal Secretariat document, but info contained therein may be publically disclosed. DOI Form is an internal Secretariat document, but info contained therein may be publically disclosed.

3. 3 WHO's COI Definition A "conflict of interest" means any interest declared by an expert that could impair or be perceived as impairing his or her objectivity and independence in providing advice to WHO. A "conflict of interest" means any interest declared by an expert that could impair or be perceived as impairing his or her objectivity and independence in providing advice to WHO.

4. 4 Types of Interests Direct Interest Direct Interest Personal financial gain Personal financial gain Business interest Business interest Research funding Research funding Intellectual property interest Intellectual property interest Interests of Others Interests of Others Family members Family members Other parties with substantially similar interests Other parties with substantially similar interests Professional or Intellectual Bias Professional or Intellectual Bias Public statements made and positions held Public statements made and positions held Involvement with Tobacco industry Involvement with Tobacco industry

5. 5 When is a DoI Required? Whenever WHO is relying on the independent advice of an expert in order to make decisions or recommendations especially in relation Whenever WHO is relying on the independent advice of an expert in order to make decisions or recommendations especially in relation to the development of technical norms, policies or guidelines. This typically occurs when an expert is either: This typically occurs when an expert is either: Providing advice under contract or on a voluntary basis, or Providing advice under contract or on a voluntary basis, or Participating in scientific or technical advisory meetings Participating in scientific or technical advisory meetings

6. 6 When is a DoI not Required? Observers Observers Industry Representatives Industry Representatives Representatives of national agencies and institutions, intergovernmental and non-governmental organizations Representatives of national agencies and institutions, intergovernmental and non-governmental organizations Governing Body Meetings Governing Body Meetings Individuals under contract to WHO for the provision of certain types of services. Individuals under contract to WHO for the provision of certain types of services. Entities / Institutions / Organizations Entities / Institutions / Organizations

7. 7 Assessment of the DoI Form An affirmative answer on the DoI Form does not automatically disqualify an expert An affirmative answer on the DoI Form does not automatically disqualify an expert Four Steps of Assessment: Four Steps of Assessment: 1. Initial Review: Relevancy and Significance of the Interest 2. Factors to Consider 3. The Balancing Test 4. Possible Options

8. 8 Initial Review: Relevancy and Significance of the Interest First evaluate whether the declared interest is relevant and significant. First evaluate whether the declared interest is relevant and significant. Insignificant or minimal interests: Insignificant or minimal interests: Unrelated or only tangentially related to the subject of the activity or work and its outcome Unrelated or only tangentially related to the subject of the activity or work and its outcome Inconsequential in importance Inconsequential in importance Expired and unlikely to affect current behaviour Expired and unlikely to affect current behaviour If the interest is insignificant, no further assessment is necessary. If the interest is insignificant, no further assessment is necessary.

9. 9 Factors to Consider When Assessing an Interest Its nature (specific vs. non-specific) (personal vs. institutional) Its nature (specific vs. non-specific) (personal vs. institutional) Value of the interest Value of the interest Academic/intellectual v. financial Academic/intellectual v. financial Number of relevant interests declared Number of relevant interests declared If institutional, the position of the expert in the institution If institutional, the position of the expert in the institution Timeliness of the declared interest Timeliness of the declared interest Whether the interest relates to an immediate family member Whether the interest relates to an immediate family member

10. 10 The Balancing Test The nature, type and magnitude of the interest and therefore the degree to which the it may be reasonably expected to influence the expert's judgment v. The adequacy of the measures/options available to protect the independence and integrity of the process that the expert is involved in

11. 11 Possible Options if a Declared Interest is Potentially Significant Conditional Participation Conditional Participation Expert's involvement is continued Expert's involvement is continued Expert's interest is publicly disclosed at the start of the meeting and recorded in the report Expert's interest is publicly disclosed at the start of the meeting and recorded in the report Partial Exclusion Partial Exclusion Expert is excluded from the relevant portion of the meeting, or Expert is excluded from the relevant portion of the meeting, or Expert is excluded from participating in the decision-making process Expert is excluded from participating in the decision-making process The reported interest must be publicly disclosed at the start of the meeting and recorded in the report The reported interest must be publicly disclosed at the start of the meeting and recorded in the report Total Exclusion Total Exclusion Decision taken in consultation with the relevant ADG or Director of Programme Management if in a regional or country office setting Decision taken in consultation with the relevant ADG or Director of Programme Management if in a regional or country office setting

12. 12 CEWG COI Process I DOI Forms and Guidelines where sent out to all 21 experts. All were completed and returned to the Secretariat. A dept. meeting with Legal was held during which all DOI Forms were reviewed. Internal note to file was made. Ongoing obligation to disclose: CEWG members need to fill out DOI forms before each new meeting. Continuing obligation to report changes to information provided.

13. 13 CEWG COI Process II All relevant interests, as determined by the Secretariat, will be publically declared and noted in the meeting report. All relevant interests where discussed with the concerned expert, clarifications sought and consent to declare obtained. In one case, it is being recommended that an expert recuse himself from part of the meeting where he has a COI.