Transcript Zonal workload outlook - Home | European Crop Protection
The Zonal Experience of the CP Industry
Kerry Gamble, Syngenta CP, Basel ECPA-ECCA Conference, 11-12 March, Brussels
Overview of the presentation
The role of Zonal and Mutual Recognition Quantitative analysis Qualitative feedback How to address the key outstanding issues?
– Managing the timelines – Managing the requirements – Delivering the objectives of 1107
ECPA Proposal for the Way Forwards Conclusions
The objectives of 1107 re Zonal and MR
Regulation 1107/2009 Preamble: (8) ‘
The purpose of this Regulation is to
ensure a high level of protection
of both human and animal health and the environment
and at the same time to safeguard the competitiveness of Community agriculture ........’ (9) ‘
In order to remove as far as possible obstacles to trade in plant protection products existing due to the different levels of protection in the Member States,
this Regulation should also lay down harmonised rules on the mutual recognition of authorisations
and on parallel trade. The purpose of this regulation is thus
to increase
the free movement of such products and
availability of these products in the Member States .’
The objectives of 1107 re Zonal and MR
Regulation 1107/2009 Preamble: (25) ‘ In the interest of predictability, efficiency and consistency, criteria, procedure and conditions for the authorisation of PPPs should be harmonised,
account being taken of the general principles of protection of human and animal health and the environment.’ -
(29) The principle of mutual recognition is one of the means of ensuring the free movement of goods within the Community.....
To avoid any duplication of work To reduce the administrative burden for industry and for MSs To provide for more harmonised availability of plant protection products.....
Therefore the Community should be divided into zones.....
With national adaptation allowed under certain conditions
Quantitative Analysis
The number of new plant protection products coming to the market every year has dropped by 70%.
The Anderson Report 2014 found that, in the next 5-7 years:
– 40-87 of the 250 AIs left are likely to be lost – Up to 44,000 jobs lost in the UK – 36% loss in farm incomes
zRMS Registrations for New Formulations
ECPA Conference 2014: Submissions Jun 11 – Dec 12 12 companies responded 177 submissions were made 58 decisions taken to date Equal in C and S; less in N 2014 Total Submissions ECPA Conference 2015: Submissions Jun 11 – Dec 13 8 companies responded 408 submissions were made 184 decisions taken to date (45%) Equal in C and S; less in N 2015 Total Submissions 22 40 76 180 188 79
North Central South North Central South
zRMS Registrations for New Formulations
150 130 110 90 70 50 30 10 -10
2014: Decisions by Time Number of Pending
16 26 16 119 No. of Dossiers ≤ 12months >12 and ≤ 18 months >18 months All Pending 150 130 110 90 70 50 30 10 -10
2015: Decisions by Time Number of Pending
148 75 42 68 76 No. of Dossiers ≤ 12months >12 and ≤ 18 months >18 months Pending ≤18 months Pending >18 months
zRMS Registrations for New Formulations
Decision Time Taken by Zone
80 60 40 20 0 7 2 13 20 6 53
2014
15 8 53 North Central South 80 60 40 20 0 13 5 13 9 48 56 67
2015
36 26 17 68 50 North Central South Decision ≤ 18 months Decision >18 months All Pending Decision ≤ 18 months Decision >18 months Pending ≤ 18 months Pending >18 months
Mutual Recognition Applications
ECPA Conference 2014: Applications Jun 11 – Sep 13 12 companies responded 369 applications 177 decisions taken to date 2014 Total Mutual Recognition Submissions
15
ECPA Conference 2015: Applications Jun 11 – Sep 14 8 companies responded 484 applications 254 decisions taken to date 2015 Total Mutual Recognition Submissions
21 155 187 167 308 North Central South North Central South
Mutual Recognition Applications
2014: Decisions by Time Number of Pending
200 192 175 150 125 100 75 50 25 0 44 74 49 No. of Dossiers Decided ≤ 4 months > 4 - ≤ 12 months >12 All Pending 200 175 150 125 100 75 50 25 0
2015: Decisions by Time Number of Pending
63 123 68 55 175 ≤ 4 months > 4 - ≤ 12 months >12 Pending ≤ 4 months Pending > 4 months No. of Dossiers Decided
Mutual Recognition Applications
Average time to decision by Zone
130
2014
103 97 90 50 10 6 6 1 North 2 -30 130
2015
90 50 10 -30 3 5 1 10 2 North 40 22 34 29 82 Central 41 19 Central 126 16 34 19 South 20 36 26 26 47 South ≤4 months >4 - ≤12 months >12 months All Pending ≤4 months >4 - ≤12 months >12 months Pending ≤4 months Pending >4 months
Key insights from the data
Registration of new formulations in 12 months, and the mutual reocognition of existing registrations in 4 months, can be achieved......... but the majority take longer And a high percentage remain pending; many zRMS registrations for longer than 18 mths and mutual recognition for longer than 4 mths The functioning of the Zonal and Mutual Recognition system still needs to be improved to achieve the 1107 objectives ECPA welcome the COM Review of Zonal and Mutual Recognition
– And the need for an evaluation based on facts and data – Let’s look at the functioning in the context of achieving the broader objectives
The Key Outstanding Issues to be Resolved
– – – – –
Increase resources to meet the demands of the regulation Reduce the national requirements (technical and procedural) Increase zonal and interzonal co-operation
• Zonal Helpdesks to co-ordinate the work and improve efficiency
dRR quality Reconsideration of Article 43
How to address the key outstanding issues?
Managing the timelines
– Resourced, prioritised, manageable plan of work – Efficient and effective processes in place to deliver it
Managing the requirements
– Clearly defined and agreed external quality standard – Change management process for the implementation of new guidance
Delivering the intentions of 1107
– Progress harmonisation (technical and procedural) – Increase zonal and interzonal co-operation – Establish the helpdesks
Managing the Timelines – Article 43
Predicted volume of product renewal submissions in 2016:
– March 31st: 1,764 submissions – July 31st 28 AIR2 AIs x 9 products in 7 countries (notifier only!) Glyphosate submissions ‘63 man years of effort’ – September 30th 756 submissions 12 AIR3 AIs x 9 products in 7 countries (notifier only!)
Request for phasing from Mar 2016 – manageable for industry and MSs And a plan to understand how the totality of the work wil be delivered with the available resources in industry, consultants and Authorities – what will the priorities be?
Evaluation of new innovative products should take priority!
Managing the Requirements – Article 43
First submissions for AIR2 product renewal in Mar 2016 In Mar 2015: Still no final GD for renewal Industry welcome a pragmatic approach aimed at managing the workload But urgently need clarity, predictability and consistency Need an EU wide adoption and not MS specific preferences
– Mandatory implementation of the guidance – MS specific preferences will create absolute chaos!
Renewal Guidance Rev 11 – Article 43
Key points to note in Rev 11:
– Revised assessments/ further data AND address new scientific guidance ONLY for areas of assessment updated as a result of new/ changed AIR endpoints (‘new information’) – GAPs may only be amended as a result of new/changed AIR endpoints – no harmonisation or use extensions – If the applicant can justify ongoing data generation, a dRR is not included in the application at 3 months after EIF – it is provided when all data is available
Renewal Guidance Rev 11 – Article 43
Key uncertainties remaining:
– AIR2 PR submissions to old data requirements – update to Transitional Measures GD at SCoPAFF in March?
– Which dRR template to be used – clarify in GD to be noted at SCoPAFF in March?
– Which GAP changes will be acceptable?
– How will MR be managed in future if there is no complete dRR at PR?
– How to identify what is ‘new information’ if no zonal dRR to start from?
– How will the registrations be managed during the extension under Article 43(6)?
Clarity, predicatability and consistency are urgently needed
Managing the Requirements: dRR Quality
– – – – –
Key message to industry is that excellence in dossier quality will support a smooth process and assist Authorities in meeting timelines In such a complex and uncertain regulatory environment and with long lead times to dossier production, Industry feel that they are trying to hit a moving target Quality needs definition – content, format, structure Expectations between MSs and with industry are not always the same – Industry need one agreed understanding of what this means Is a working group on dossier quality needed to ensure applicants know what is needed? Is this within the remit of the dRR Workgroup?
Delivering the Intentions of 1107
– – – – – – • • • •
Lack of harmonisation within and across zones (even within zRMS)
Technical national requirements including mitigation Procedural national requirements Inconsistency in implementation of new guidance Use of different endpoints than those established at EU level
Creates complexity Prevents effective work-sharing Creates additional work for industry, zRMS and cMSs Causes delays Further harmonisation is needed if zonal evaluation and mutual recognition are going to work
Delivering the Intentions of 1107
– –
Productivity gains will only be achieved through improved zonal and interzonal co-operation
• • • • •
ECPA recommend a zonal and interzonal helpdesk to support the Steering Committees with:
Facilitating the work sharing Facilitating the ways of working Facilitating the planning according to the resources Facilitating harmonisation initiatives Support efficient co-ordination between zRMSs
ECPA Proposal for the Way Forwards
Work together to share understanding and solve the problems
– –
Harmonisation – technical and procedural Manageable and consitent implementation of Article 43
– –
Create shared external quality standards for submissions Develop a change management process for the implementation of new guidance
– –
Provide a resourced and prioritised plan of work Establish the helpdesks to facilitate the process
Conclusions
Successful functioning of zonal and mutual recognition are key to achieving the broader objectives of 1107 The data shows that it can work but is not fully functioning yet There are a number of key outstanding issues to be resolved Industry need predictability, efficiency and consistency