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EFSA policy on Declarations of Interests

Management Board Meeting, 10-11 September 2007 Bucharest

Management Board Meeting, 10-11 September 2007, Bucharest

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Legal Basis

• Legal Basis: Article 37 of Regulation 178/2002 with

Annual declarationDeclaration at the beginning of a meeting

• Current Implementation:Guidance on Declarations to Interests (MB 16.12.2004) with

Annual Declaration of InterestsMeeting minutes

Management Board Meeting, 10-11 September 2007, Bucharest

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• Clarify and document the nature of the interests

• Further strenghten procedures for the screening of DoIs

• Identify potential conflicts of interest

• Transparent procedure on the consequences in case of a potential conflict of interest

Objectives

Management Board Meeting, 10-11 September 2007, Bucharest

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Approach taken

• Joint effort by ADMIN and SCIENCE

• Reviews by EFSA Panel secretariats

• Comments provided by Scientific Committee

• Internal operational aspects considered

Management Board Meeting, 10-11 September 2007, Bucharest

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Scope

The policy applies to:

• Members of the Management Board• Members of Advisory Board• Members of the Scientific Committee, the

Panels and other EFSA Experts• EFSA Staff

Management Board Meeting, 10-11 September 2007, Bucharest

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Content• Interests are part of expertise

• Having an interest does not imply there is a conflict

• No legal obligation not to hold interests as such but a legal obligation to declare them

• Responsibility of declaration lies with the experts

Principles on Interests

Management Board Meeting, 10-11 September 2007, Bucharest

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Content• Interests include:

– Ownership– Membership Management, Advisory Body or

Other– Employment and Consultancy– Research Funding and Intellectual Property– Other interests– Interests of close family members

Principles on Interests

Management Board Meeting, 10-11 September 2007, Bucharest

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Content• Potential Conflicts emerge in the context of a

specific EFSA activity

• Potential conflicts of interests can only be established through a case by case assessment

• In case a potential conflict of interest is identified EFSA must be in the position to take precautions to ensure impartiality of its activities is maintained

Principles on Conflict

Management Board Meeting, 10-11 September 2007, Bucharest

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Management Board/Advisory Forum

• Annual Declaration of Interest

• Declaration at the beginning of each meeting:Chair (MB) or Executive Director (AF)

decides on appropiate action

Management Board Meeting, 10-11 September 2007, Bucharest

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EFSA Staff

• Annual Declaration of Interest (AD grade)

• Subject to the rules of the Staff Regulations and Conditions of Employment of other Servants (CEoS)

• Executive Director decides on appropriate action

Management Board Meeting, 10-11 September 2007, Bucharest

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Experts: Process for AnnualDoI

Experts: Complete ADoI

(Guidance)

EFSA secretariat:Screening ADoI (Procedure)

Management Board Meeting, 10-11 September 2007, Bucharest

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Experts: Process for Specific DoI

Experts: Complete SDoI (Guidance)

EFSA secretariat:Screening DoI and Inform Chair (Procedure)

EFSA secretariat and Science Management:Consequence

Management Board Meeting, 10-11 September 2007, Bucharest

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Example 1

The expert working in a company which manifactures a product being reviewed by his/her panel

• Exclusion from the activities of the panel related to the product

Nature of Activities and subject matter

Interest based on Annual

Declaration of Interest

Conflict of Interest Level based on the Specific

agenda or mandate

Current activity

Previous activity

current past none

IV Employment Y Y C B A

Management Board Meeting, 10-11 September 2007, Bucharest

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Example 2

The panel expert works on a guidance document, the Expert has been a member of the Scientific Advisory body (national institution) which has done similar work

• Involvement in all activities is permitted

Nature of Activities and subject matter

Interest based on Annual

Declaration of Interest

Conflict of Interest Level based on the Specific agenda

or mandate

Current activity

Previous activity

current past none

III Member of a Scientific Advisory Body N Y B A A

Management Board Meeting, 10-11 September 2007, Bucharest

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Example 3

The expert employed by a Ministry in a unit dealing with the agenda of cloning issue, the Working Group is a study realted to cloning

• The expert cannot chair the Working Group

Nature of Activities and subject matter

Interest based on Annual

Declaration of Interest

Conflict of Interest Level based on the Specific agenda

or mandate

Current activity

Previous activity

current past none

III Member of a Scientific Advisory Body Y Y B A A

Management Board Meeting, 10-11 September 2007, Bucharest

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• EFSA Policy

• Guidance on Declarations of Interests with Forms on• Declaration of commitment• Annual Declaration of Interests• Specific Declaration of Interests• Declaration concerning confidentiality

• Procedure for identifying and handling potential conflicts of interests with• Evaluation of Declaration of Interests Form

Conclusion