Vienna, 23 November 2017
Open EFSA, stakeholder
engagement and independence policy
Bernhard Url
Executive Director, EFSA
Visit to Austria
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EFSA’S STRATEGY 2020: VISION
IDENTIFY RISKS
Trusted science for safe food Protecting consumers by providing independent
scientific advice on risks in the food chain
Mission
3
EFSA 2020 STRATEGY
TRANSPARENCY & ENGAGEMENT
4
EFSA JOURNEY TO “OPEN EFSA”
EFSA consults widely its stakeholders to learn about their expectations (discussion paper Transformation to an Open EFSA)
Requests translated in measures to be applied to the Scientific Assessment cycle (preliminary implementation plan)
Measures are assessed for their internal/external impact
Final implementation plan endorsed by MB (June)
Completion of implementation plan roll out
2014
2020
2016
2015
2016
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CONSULTATION PHASE RESULTS
results • 35 MEASURES AIMING
AT INCREASING TRANSPARENCY AND ENGAGEMENT IN EFSA SCIENTIFIC PROCESS
• APPLICABLE TO DIFFERENT STEPS OF EFSA SCIENTIFIC ASSESSMENT CYCLE
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MEASURES IMPLEMENTATION - SNAPSHOT
Increase availability of information on experts, working groups and their meetings
Increase clarity of outputs (including Guidances)
Enhance transparency of evidence/methods choices
Enhance engagement via consultation (and linked initiatives)
Increase availability/accessibility to evidence and methods used
FULL LIST OF MEASURES CAN BE FOUND HERE
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DECISION TAKEN ON THE MEASURES IMPLEMENTATION AND TIMELINES
• EXPECTED BENEFITS (for EFSA, for ≠ Stakeholders…)
• WORKLOAD • TIMELINES • COSTS, etc. (for EFSA, for ≠ Stakeholders…)
+
− MEASURE IMPACT ASSESSMENT
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↑ INFORMATION ON EXPERTS, WORKING GROUPS AND THEIR MEETINGS
Full biography of Panel experts
published
Open plenaries web-streamed + flash summaries
Role/contribution of Stakeholders
acknowledged in opinion
Minutes of plenaries published
in 15 wd’s, enhanced content
(+WG)
Documentation of WGs members
selection WGs meeting dates
published ahead
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↑ CLARITY OF OUTPUTS (INCL. GUIDANCES)
High-level pre-submission scientific meetings with groups of applicants
More user friendly guidance on preparation and presentation of application dossiers
Terminology harmonisation - mapping (new)
“…reasons/objectives/timetable are made publicly available”
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↑ AVAILABILITY/ACESSIBILITY TO EVIDENCE, DATA AND METHODS USED
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↑ ENGAGEMENT VIA CONSULTATION (1)
Public Consultation planner
Simplified submission of contributions from SHs
Consultation on draft mandates: • Self-tasks draft ToRs (e.g. Chemical
Mixture) • Draft mandates, self-tasks and
internal mandates (Targeted Consultation with EC + MSs, pilot FR and DE on draft mandates)
• Stakeholder forum “Mandate WG” being established
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↑ ENGAGEMENT VIA CONSULTATION (2)
New Consultation Guidelines (why/when/who/what)
Consultation on Risk Assessment protocol (PROMETHEUS; BPA pilot)
Consultation on draft outputs
Pre/during/post consultation meetings with MSs (requested through the AF)
Technical hearings pre/post/during consultation
Early involvement of Stakeholders (Discussions/Focus Groups)
New Consultation tool (pilot in July, Genotoxicity draft opinion)
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• More information on experts and their meetings (WGs)- Q2 2018
• More engagement and transparency on Risk Assessment approaches (PROMETHEUS – already tested in 10 EFSA case-studies) • Proactive release of evidence/methods in readable/reusable format
• User-friendly guidances
(progressive implementation)
ON-GOING MEASURES (2020)
Expertise Management Programme
PROMETHEUS
Food Law 178/2002 requirement; Article 42
EFSA Stakeholder Consultative Platform
EFSA Strategy 2020
Stakeholder Engagement Approach
Implementation; Registration, Forum meeting, Targeted Mechanisms
Review of the Stakeholder Engagement Approach
Regular review every three years
OUR JOURNEY TO STAKEHOLDER ENGAGEMENT
START
ADOPTION
ROLL-OUT
2002
2005
2016
2016
2017
2017
2020
STAKEHOLDER ENGAGEMENT – OBJECTIVES
Prioritise public and stakeholder engagement in the process of scientific assessment
Possibility for stakeholders to provide recommendations on strategic planning, horizontal processes, and the review of how the various engagement platforms function
Improve the opportunities SH have to contribute to the different stages of scientific assessment, ensuring balanced representation of views
Gather knowledge, views and concerns from stakeholders as early as possible in the risk assessment process
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EFSA’S STAKEHOLDERS
EFSA’S EXPERIENCE WITH DISCUSSION GROUPS
Discussion Groups act as “learning
systems” that allow EFSA to capitalise on stakeholders’ specialist knowledge in specific areas,
Examples of successful EFSA stakeholder Discussion groups;
Emerging Risks, Chemical Occurrence
Data, GMO Allergenicity, MATRIX – electronical submission of applications for regulated products, Endocrine Disruptors, Feed Additives
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EFSA’s INDEPENDENCE POLICY AND RULES REVIEW PROCESS
New Implementing Rules on competing interest
management
2016 2017
MB Working Group
Public Consultation
MB adoption
Nov Feb Apr Jun Jan Oct Mar
MB discussion and
endorsement
Oct
MB endorsement of review process
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MAIN CHANGES OF POLICY ADOPTED IN JUNE 2017
Definition of CoI and Risk based approach
Clear cut criteria and cooling off periods
Cooperation with EFSA’s partners Enforcement, transparency and communication
Introduction to EFSA’s independence policy
Hig
hlig
hts
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NEW RULES - INNOVATIONS ON SCREENING
Horizontal principles inclusive of clearer presentation of assessment approach
Transparent formula to calculate research funding thresholds
Each interest subject to reclassification depending on financial impact on earnings
Introduction to EFSA’s independence policy
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IMPACT ON EXPERT’S EARNINGS DRIVEN (RE)CLASSIFICATION
EMPLOYMENT Corresponding to definition or
exceeding 25% of annual earnings
OCCASIONAL CONSULTANCY Corresponding to definition or below
25% of annual earnings
MEMBERSHIP IN SCIENTIFIC ADVISORY ENTITY OR
MANAGERIAL ROLE Corresponding to definition and not exceeding 5% of annual earnings
Eligibility
Introduction to EFSA’s independence policy
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COOLING OFF PERIODS FOR NON PUBLIC INSTITUTIONS
Employment Occasional consultancy Memerbship of scientific advisory body Managerial role Research funding
In the 2 years priori to DoI submission
Overlapping with the mandate
Exclusion of expert from scientific group
membership
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INCLUSIVE APPROACH FOR PUBLIC INSTITUTIONS
Members of Advisory Forum •ADoI published •No screening •Reactive approach to wistleblowing
Members of networks •ADoI published •No screening •Reactive approach to wistleblowing
Members of Scientific Committee, Scientific Panels, Working Groups •ADoI published •Screening
Participants to peer review meetings, including MS representatives •ADoI published •Screening
Introduction to EFSA’s independence policy
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INCLUSIVE APPROACH IN PRACTICE
Employment with Public institutions
resulting in public
interest activities
on a subject matter
overlapping with EFSA’s scientific
group
regarding Risk
Management
when currently
ongoing or in the past 2
years
Leads to CoI
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