Vienna, 23 November 2017

Open EFSA, stakeholder

engagement and independence policy

Bernhard Url

Executive Director, EFSA

Visit to Austria

2

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

5

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

https://youtu.be/b048MOMLEZ4

Video report

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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