Kerry Gamble, Syngenta CP, Basel ECPA-ECCA Conference, 11-12 March, Brussels The Zonal Experience of...

Kerry Gamble, Syngenta CP, Basel

ECPA-ECCA Conference, 11-12 March, Brussels

The Zonal Experience of the CP Industry

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

Overview of the presentation

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 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

The number of new plant protection products coming to the market every year has dropped by 70%.

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

zRMS Registrations for New Formulations

22

79

76

2014 Total Submissions

North Central South


Submissions Jun 11 – Dec 13


408 submissions were made

184 decisions taken to date (45%)

Equal in C and S; less in N

40

188

180

2015 Total Submissions

North Central South

2014: Decisions by Time

Number of Pending


No. of Dossiers-10

10

30

50

70

90

110

130

150

1626

16

119

≤ 12months>12 and ≤ 18 months>18 monthsAll Pending

No. of Dossiers-10

10

30

50

70

90

110

130

150

75

42

68

148

76

≤ 12months>12 and ≤ 18 months>18 monthsPending ≤18 monthsPending >18 months


Number of Pending


Decision Time Taken by Zone

North Central South0

20

40

60

80

720 15

2 6 813

53 53

2014

Decision ≤ 18 monthsDecision >18 months All Pending

North Central South0

20

40

60

80

13

4836

5

56

2613

67 68

917

50

2015

Decision ≤ 18 monthsDecision >18 months Pending ≤ 18 monthsPending >18 months

Mutual Recognition Applications

15

187167

2014 Total Mutual Recognition Submissions

North Central South


Applications Jun 11 – Sep 13


369 applications


21

308

155

2015 Total Mutual Recognition Sub-missions

North Central South


Applications Jun 11 – Sep 14


484 applications



Number of Pending


No. of Dossiers Decided0

25

50

75

100

125

150

175

200

44

74

49

192

≤ 4 months

> 4 - ≤ 12 months

>12

All Pending

No. of Dossiers Decided0

25

50

75

100

125

150

175

200

63

123

6855

175

≤ 4 months

> 4 - ≤ 12 months

>12

Pending ≤ 4 months

Pending > 4 months


Number of Pending


North Central South-30

10

50

90

130

622 166

34 34

1

29 192

103 97

2014 ≤4 months>4 - ≤12 months>12 months All Pending

Average time to decision by Zone

North Central South-30

10

50

90

130

3

4020

5

82

36

1

4126

10 19 262

126

47

2015 ≤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

– 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

The Key Outstanding Issues to be Resolved

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

How to address the key outstanding issues?

Predicted volume of product renewal submissions in 2016:

– March 31st: 1,764 submissions

28 AIR2 AIs x 9 products in 7 countries (notifier only!)

– July 31st 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 Timelines – 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!

Managing the Requirements – 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

Renewal Guidance Rev 11 – Article 43

– 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?

Managing the Requirements: dRR Quality

– 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

Delivering the Intentions of 1107

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

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

For the sanity and well being of everyone!

Conclusions

Kerry Gamble, Syngenta CP, Basel ECPA-ECCA Conference, 11-12 March, Brussels The Zonal Experience of...

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