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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