Why haven’t we achieved efficacy harmonisation?

Peter SchlotterOn behalf of ECPA-EffEG

Crop Protection European Regulatory Conference – Pre-conference Workshop Efficacy submission in the EU, Brussels 11th March 2015

COMPLEXITY in the EU!

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Introduction and Zonal Process

Barriers of harmonisation

Approaches taken toward harmonisation under 1107/2009

– Areas for improvements

– Remaining challenges

Way forward: recommendations for harmonisation by ECPA-EffEG

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Why haven’t we achieved efficacy harmonisation?

THE COMPLEX ZONAL PROCESS – Registration of products• All pesticide products must be registered in a country before

they can be advertised, sold or used

Following Annex I Inclusion (91/414) or Approval (1107/2009) of the active substance the product must be (re)-registered

• Before 91/414 (1993): registration acc. national laws in all 28 countries

– Last Annex Is under 91/414 were 2011 = many products in Europe registered under old national rules

• 91/414 Introduction of mutual recognition and voluntary worksharing (came in gradually). dRR format concept started

– Efficacy driven by BAD within MSs, other sections already EU or Zonal processes

• 1107/2009 (06/2011) Zonal process with 3 Administration Zones4

THE COMPLEX Zonal Process – The Zones• North (6)

– Denmark, Estonia, Latvia, Lithuania, Finland, Sweden

• Central (13)

– Belgium, Czech Republic, Germany, Ireland, Luxembourg, Hungary, Netherlands, Austria, Poland, Romania, Slovenia, Slovakia, United Kingdom

• South (9)

– Bulgaria, Greece, Spain, France, Italy, Cyprus, Malta, Portugal, Croatia

• Protected uses and seedtreatment

– All zones

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Biological development in Europe (Administrative vs EPPO zones)

Northern- 6 MS2 EPPO Zone

DNK

SWE

FIN

LIT

LVA

EST

GBR

FRA

IRL

BEL

NLD

GER

CZESVK

HUNROU

AUT

POL

ESPPRT

GRC

MLT

ITABGR

LUX

SVN

CYP

Southern- 9 MS3 EPPO Zone

Central – 13 MS 3 EPPO Zone

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European map with defined geographic regions: 4 EPPO Climatic Zones (in colour) and 3 European Administration Zones

Kroatien

Note: Indoor use = one Administration Zone

Trend for more systematic use of PP1/241 in designing, implementing and reporting on trial programs. Trials placed according to relative importance within EPPO zones.

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Barriers of harmonisation

Complex Process and Zonal structure

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– Implementation of Administrative and EPPO Zones

– Central Zone most critical Zone with 3 EPPO Zones (diversity)

– Southern Zone with 3 EPPO Zones (France and Croatia with 2)

– Communication within the Zone – Language is a barrier

• 28 countries with 24 official languages (linguistic diversity)

– Expansion of European Union to 28 countries

• 2004: CY, CZ, EE, HU, LV, LT, MT, PL, Sl and SK

• 2007: BU and RO

• 2013: HR

• 13 MSs joined EU more than a decade after 91/414

– National registrations and requirements

Barriers of harmonisation 1Complex Process and Zonal structure

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– EPPO and Guidelines Documents (GD)

• Interpretation of guidelines

• Not all MSs are following EPPOs and GDs

– dRR and BAD

• No agreed zonal standard or template available

• Misunderstanding content and role of BAD and dRR

• Efficacy the only section with 2 dossiers + single field trial reports

– Trials and trial reporting and quality

• Acceptance of old data reports and country registrations

– Data requirements - Number of trials required

• EPPO PP1/226, but also national guidelines (IT, IR, GR, SK,…)

• DE – number of trials on each BL weed species required

• Various requirements without considering EU expansion 10

Barriers of harmonisation 2Complex Process and Zonal structure

– EPPO PP1/226

• Definition of major crops, minor crops, major uses and minor crop

• Minor uses not adapted to Zonal context

– GEP certification + Certificates

• Not all institutes are GEP certified (also Official Institutes !)

– Harmonisation of GAPs

– Dose rate expression in 3 D crops

– Authorities and efficacy evaluators

• Workload

• Diverse knowledge of efficacy evaluators within countries and Zone

• Level of participation of evaluators in committees and conferences

• Lack of trust leading to repeating evaluation11

Barriers of harmonisation 3Complex Process and Zonal structure

– Approaches taken towards harmonisation under 1107/2009

– Areas for improvements

– Remaining challenges

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• Part A – National Risk Management

• Part B - Core assessment for the zone

– Section 1 - identity, phys-chem, further info

– Section 2 – methods

– Section 3 – tox

– Section 4 – residues

– Section 5 – EFate

– Section 6 – Ecotox

– Section 7 – Efficacy will become section 3 (Beginning 2016)

– National addenda to any section 1-7

• Part C – Confidential

• Parts A and B may be released to 3rd parties after authorisation!

Approaches taken towards harmonisation under 1107/2009: dRR

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Relationship between draft Registration Report (dRR) and zonal BAD (Part B, section 7 new 3)

Process to transform documents of the efficacy package into a registration report (RR).

Source: Technical Guidance Paper dRR

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– The Zonal BAD is a detailed analysis of the overall trial work which considers the PPP in relation to its benefits and risks within a specific Administrative zone

• It’s a complex dossier

• The Zonal BAD can cover many countries & situations

• It can cover a multitude of uses (crops, targets) with possibly different GAPs

– The Zonal dRR is considered a stand-alone concise summary of the Zonal BAD

• It is a sizeable summarization of the relevant zonal information

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Approaches taken towards harmonisation under 1107/2009

Approaches taken towards harmonisation under 1107/2009: New dRR table of content

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Finalisation of a new dRR format for future submissions:

– The new dRR will be named as Section 3 and contain a new and more organised Table of Content

• Improved clarity of the different chapters of the dossier

• Benefits are presented followed by the potential risks of the PPP to:

– The crop

– Other parts than the crop

– Chapter 3.0 is added at the beginning to report on the summary & conclusion from the zRMS associated to a GAP table with recommendations

– Commenting boxes seen valuable as soon as initial dRR is a good document

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Approaches taken towards harmonisation under 1107/2009: New dRR

Conducting the needed experimentation and reporting of the data under a dossier format is to be done following EPPO standards:

– A set of general standards (26) and efficacy standards (>200) is available

– New additional standards are under preparation to complete the needs

This allows using a common language,

that is deemed to follow the Uniform Principles and,

should facilitate possible Mutual Recognitions,

within and between Administrative Zones.

But we see real differences in the use and interpretation of the guidelines Need to adjust the EPPOs to the Zonal process, PP1/226...

Areas for improvements: The EPPO standards

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GEP accredited organisations are allowed to conduct experimentation that is needed for a submission for registration

Few exceptions are accepted:

Official Scientific Institutes are sometimes not GEP.

For historical reasons, reports from experimentation conducted in countries prior to GEP implementation can be used and should be accepted.

GEP certificates from the Testing Organisations are submitted together with the Biology Assessment Dossier.

GEP certificates are documents under diverse formats and in local languages. To ease the use of these documents, ECPA has created an internet database that collects these documents.

Areas for improvements: The GEP certification

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Currently 1185 certificates, 675 organisations and 427 registered users across EU

Entry of new certificates is checked to avoid duplication of certificates

No limitation on access to the database – evaluators do not need to be registered users

Open to applicants, regulators, official testing organisations - visible to all

EU GEP Certificate Databasedeveloped by ECPA EffEG

www.gepcertibase.eu

A table containing a list of certificates with hyperlinks to certificates, can be downloaded and copied/pasted into dossiers – no need to

insert paper copies of certificates – not accepted by all MS

A table containing a list of certificates with hyperlinks to certificates, can be downloaded and copied/pasted into dossiers – no need to

insert paper copies of certificates – not accepted by all MS

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BE project to develop a standardized format following the ECPA proposal

– Trials should be implemented under GEP accreditation (where established)

– Trials should be conducted according to EPPO standards • According to the general standards PP1/152, PP1/135, PP1/181,

PP1/225,…

• As well as specific efficacy standards (PP1/XXX)

– Trial reports should be of good quality• It is recognised that format of trial reports is varied with increasing use of

electronic data capture

• Flexibility by MS of acceptance of old data reports and trial format

• New trial reports will comply with PP1/181

Areas for improvements: The studies (Trials,…)

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From Official documentations:

– EPPO PP1/226 (major pest on major crop, major pest in protected conditions, minor use)

– Northern Zone Guidance document with major crops as appendix

• good example of MS working together (authorities and industry)

– National requirements (IT, IR, GR, FR, SK...).

Risk of adding complexity to be considered while producing additional documents/requirements

Need for revision of PP1/226 within the frame of Zonal development

Can we get harmonisation without National requirements?

Establishment of a Zonal working group or round table (e.g. Northern Zone)?

Remaining challenges:Trial requirements :

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• Ireland 2013: Guideline Requirements for Irish based trials on wet weather fungal diseases for Efficacy Submissions in the Biological Dossier to PRCD in relation to the authorisation of a PPP.

• Slovakia 1/2014 (UKSUP): Metodicky pokyn

• Number of trials to be submitted in SK

• France: CEB, Document technique N° 23, Recommandations pour une surveillance de la résistance aux fongicides en vigne

• Greece 2013: National guidelines, Supplementary to EPPO Standards, Appendix II and III

• Italy 2015: Studi di efficacia e selettività necessari revisione Ferrero_1.proporta

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Areas for improvements: National guidance documents

Within the submission of a Zonal dossier it looks more efficient to claim for Minor uses across countries despite minor uses are still under National regulation

– Status of minor crops differ in different countries

– Group of targets: some countries authorize pest group, others single pests

Efficacy – different interpretations from Authorities make the Zonal submission critical

What about the value of the EUMUDA database?

Can we seek for common principles?

Revisit the Extrapolation guidelines within the frame of Zonal development?

Remaining challenges:Minor uses

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Will become the highest workload for both applicants + authorities in the next 3-4 years.

Only a light dRR (no BAD) is needed with following assumptions*:

– GAPs remained unchanged

– No new uses ! No new MS! No formulation change!

Update the following items:

– Overview of the country registrations and uses and the GAP

– Update Resistance section

– No new efficacy trials to be submitted

Agreement is valid for CZ submissions

This process is not yet agreed for SZ

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Remaining challenges:Re-registration article 43 of 1107/2009

*C. Prohaska, Head of AGES: Informa meeting, Berlin Feb . 2015

Dose rate expression in 3D crops is progressing: the LWA concept

– Key benefits:

• Single and scientifically more accurate dose rate expression across Europe

• Applicable for wall-shaped canopy crops

• Experienced and agreed by Companies through Working Group activities

– Agreed for experimentation for pome fruit trees

– Under progress for stone fruit trees and high growing vegetables

– Under evaluation for grapes

BE has already introduced LWA in 3 D crops

DE is planning the introduction in grapes 2016

AT is supporting LWA concept

Harmonisation in Europe and in the Zone is needed– Acceptance of previous trials and data sets

Remaining challenges:Dose rate expression and standardization

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ECPA Efficacy Expert Group

Way forward:

Recommendations for harmonisation

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• Improve level of trust

• Communication and cooperation within MS evaluators and industries and within the Zones

– Develop pragmatic (Zonal) approaches that have a wide acceptance from MS and industry (round tables, workshops…)

– Example Northern Zone guidance on efficacy

• More flexibility by MSs in regard of acceptance of old data or previous registrations without submission of new data

• Improve Zonal harmonization in the evaluation

– Stop specific national requirements

– Development of harmonized Zonal documents

– Light dRR for re-registration for all Zones (article 43 of 1107/2009)

ECPA EffEG Recommendations for harmonisation

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• Implementation and use of the new dRR template

• Communication zMS evaluators and industry – e.g. pre-submission and follow up meetings   

• Improve Zonal process – time and re-evaluation by cMS after Zonal approval by zRMS

• Field trial report format + quality – acceptance of older reports and format for re-registration

• Use of GEP certificate database

• Follow guidance documents and use of EPPO standards

– Revision of EPPO 226: Number of trials for major and minor use – (linkage 226-278-241, better definition of minor uses)

• Zonal harmonization of expression rates for 3 D crops   

ECPA EffEGRecommendations for harmonisation

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Why haven’t we achieved efficacy harmonisation?

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Complexity …

Improvements achieved

Promotion of harmonisation is needed among all stakeholders in the future

Peter Schlotter   on behalf of ECPA EffEG

Office: +49 45533126;

Mobile: +49 171 2445705;

pschlotter@dow.com  

Dow AgroSciences GmbH

Truderingerstr. 15

D-81677 Munich

Thank you