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1 EFSA policy on Declarations of Interests Management Board Meeting, 10-11 September 2007 Bucharest
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Management Board Meeting, 10-11 September 2007, Bucharest 2 Legal Basis Legal Basis: Article 37 of Regulation 178/2002 with Annual declaration Declaration at the beginning of a meeting Current Implementation : Guidance on Declarations to Interests (MB 16.12.2004) with Annual Declaration of Interests Meeting minutes
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Management Board Meeting, 10-11 September 2007, Bucharest 3 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
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Management Board Meeting, 10-11 September 2007, Bucharest 4 Approach taken Joint effort by ADMIN and SCIENCE Reviews by EFSA Panel secretariats Comments provided by Scientific Committee Internal operational aspects considered
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Management Board Meeting, 10-11 September 2007, Bucharest 5 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
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Management Board Meeting, 10-11 September 2007, Bucharest 6 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
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Management Board Meeting, 10-11 September 2007, Bucharest 7 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
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Management Board Meeting, 10-11 September 2007, Bucharest 8 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
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Management Board Meeting, 10-11 September 2007, Bucharest 9 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
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Management Board Meeting, 10-11 September 2007, Bucharest 10 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
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Management Board Meeting, 10-11 September 2007, Bucharest 11 Experts: Process for AnnualDoI Experts: Complete ADoI (Guidance) EFSA secretariat: Screening ADoI (Procedure)
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Management Board Meeting, 10-11 September 2007, Bucharest 12 Experts: Process for Specific DoI Experts: Complete SDoI (Guidance) EFSA secretariat: Screening DoI and Inform Chair (Procedure) EFSA secretariat and Science Management: Consequence
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Management Board Meeting, 10-11 September 2007, Bucharest 13 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 currentpastnone IVEmployment YYCBA
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Management Board Meeting, 10-11 September 2007, Bucharest 14 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 currentpastnone IIIMember of a Scientific Advisory Body NYBAA
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Management Board Meeting, 10-11 September 2007, Bucharest 15 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 currentpastnone IIIMember of a Scientific Advisory Body YYBAA
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Management Board Meeting, 10-11 September 2007, Bucharest 16 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
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