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WHO WHO Conflicts of Conflicts of Interest Interest Policy for Policy for WHO ExpertsWHO Experts

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Key points of principleKey points of principle Revised Guidelines For Declaration of Interests for WHO Revised Guidelines For Declaration of Interests for WHO

Experts – issued in June 2010Experts – issued in June 2010

Protect integrity and independence of the WHO's normative Protect integrity and independence of the WHO's normative work.work.

Objective is not simply to fill out the form, but more Objective is not simply to fill out the form, but more importantly to assess whether a COI exists.importantly to assess whether a COI exists.

No DOI = No participation of the expert in the work or No DOI = No participation of the expert in the work or activity.activity.

Must balance any COI issue with the needs of WHO and Must balance any COI issue with the needs of WHO and broader public health needs.broader public health needs.

Applies to Applies to individualsindividuals acting in a personal capacity i.e. not acting in a personal capacity i.e. not representatives.representatives.

DOI Form is an internal Secretariat document, but info DOI Form is an internal Secretariat document, but info contained therein may be publically disclosed.contained therein may be publically disclosed.

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WHO's COI DefinitionWHO's COI Definition

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

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Types of InterestsTypes of Interests

Direct InterestDirect Interest Personal financial gainPersonal financial gain Business interestBusiness interest Research fundingResearch funding Intellectual property interestIntellectual property interest

Interests of OthersInterests of Others Family membersFamily members Other parties with substantially similar interestsOther parties with substantially similar interests

Professional or Intellectual BiasProfessional or Intellectual Bias Public statements made and positions heldPublic statements made and positions held Involvement with Tobacco industryInvolvement with Tobacco industry

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When is a DoI When is a DoI Required?Required?

Whenever WHO is relying on the independent Whenever WHO is relying on the independent advice of an expert in order to make advice of an expert in order to make decisions decisions or recommendations or recommendations especially in relation 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 Providing advice under contractcontract or on a or on a voluntary voluntary

basis, orbasis, or Participating in Participating in scientific or technical advisoryscientific or technical advisory

meetingsmeetings

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When is a DoI not When is a DoI not Required?Required?

ObserversObservers

Industry RepresentativesIndustry Representatives

Representatives of national agencies and Representatives of national agencies and institutions, intergovernmental and non-institutions, intergovernmental and non-governmental organizationsgovernmental organizations

Governing Body MeetingsGoverning Body Meetings

Individuals under contract to WHO for the Individuals under contract to WHO for the provision of certain types of services.provision of certain types of services.

Entities / Institutions / OrganizationsEntities / Institutions / Organizations

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Assessment of the DoI Assessment of the DoI FormForm

An affirmative answer on the DoI Form An affirmative answer on the DoI Form does not automatically disqualify an does not automatically disqualify an expertexpert

Four Steps of Assessment:Four Steps of Assessment:1.1. Initial Review: Relevancy and Significance of Initial Review: Relevancy and Significance of

the Interestthe Interest2.2. Factors to ConsiderFactors to Consider3.3. The Balancing TestThe Balancing Test4.4. Possible OptionsPossible Options

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Initial Review: Relevancy and Initial Review: Relevancy and Significance of the InterestSignificance of the Interest

First evaluate whether the declared First evaluate whether the declared interest is relevant and significant.interest is relevant and significant.

Insignificant or minimal interests:Insignificant or minimal interests: Unrelated or only tangentially related to the Unrelated or only tangentially related to the

subject of the activity or work and its subject of the activity or work and its outcomeoutcome

Inconsequential in importanceInconsequential in importance Expired and unlikely to affect current Expired and unlikely to affect current

behaviourbehaviour

If the interest is insignificant, no further If the interest is insignificant, no further assessment is necessary. assessment is necessary.

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Factors to Consider Factors to Consider When Assessing an When Assessing an

InterestInterest

Its nature (Its nature (specific vs. non-specificspecific vs. non-specific) () (personal vs. personal vs. institutionalinstitutional))

Value of the interestValue of the interest

Academic/intellectual v. financialAcademic/intellectual v. financial

Number of relevant interests declaredNumber of relevant interests declared

If institutional, the position of the expert in the If institutional, the position of the expert in the institutioninstitution

Timeliness of the declared interestTimeliness of the declared interest

Whether the interest relates to an immediate Whether the interest relates to an immediate family memberfamily member

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The Balancing TestThe Balancing Test

The nature, type and magnitude of the interest The nature, type and magnitude of the interest and therefore the degree to which the it may and therefore the degree to which the it may

be reasonably expected to influence the be reasonably expected to influence the expert's judgmentexpert's judgment

v.v.The adequacy of the measures/options available The adequacy of the measures/options available

to protect the independence and integrity of to protect the independence and integrity of the process that the expert is involved inthe process that the expert is involved in

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Possible Options if a Declared Possible Options if a Declared Interest is Potentially Interest is Potentially

SignificantSignificant Conditional ParticipationConditional Participation

Expert's involvement is continuedExpert's involvement is continued Expert's interest is publicly disclosed at the start of the Expert's interest is publicly disclosed at the start of the

meeting and recorded in the reportmeeting and recorded in the report

Partial ExclusionPartial Exclusion Expert is excluded from the relevant portion of the Expert is excluded from the relevant portion of the

meeting, ormeeting, or Expert is excluded from participating in the decision-Expert is excluded from participating in the decision-

making process making process The reported interest must be publicly disclosed at the The reported interest must be publicly disclosed at the

start of the meeting and recorded in the reportstart of the meeting and recorded in the report

Total ExclusionTotal Exclusion Decision taken in consultation with the relevant ADG or Decision taken in consultation with the relevant ADG or

Director of Programme Management if in a regional or Director of Programme Management if in a regional or country office settingcountry office setting

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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.

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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.