1. Essentials (+) User Guides Data Sharing and Letters of Access under BPR (Regulation (EU) No 528/2012)
CA Meeting
13 November 2014

2. Summary Introduction Methodology
General overview of the Data Sharing User Guide
General overview of the Letters of Access User Guide
Template Documents
Points for Consideration/Discussion

3. Introduction
Fieldfisher is a law firm with significant experience in chemicals regulation, including biocidal products rules and regulations
In August 2014, the European Commission awarded contracts to a consortium led by Fieldfisher
The consortium is made up of:
CEFIC (the European Chemical Industry Council)
AISE (the International Association for Soaps, Detergents and Maintenance Products)
UEAPME (the European Association of Craft, Small and Medium-sized Enterprises)

4. Introduction
The contracts require the consortium to draft three sets of EU guidance under the BPR
The documents are intended for all companies, in particular SMEs, with practical guidance on:
Data Sharing under the BPR (a document of around 50 pages)
Letters of Access under the BPR (20-30 pages)
Consortium under the BPR (20-30 pages)
The Guides will be finalised by mid-January 2015 for publication at the end of that month
A first draft will be submitted to the Commission on 18 November 2014

5. Introduction
Each guide is being designed to be as user-friendly as possible and will include:
Description of the law and what is required under it
Flow-charts
Take-away documents
Dos and Don’ts documents
Templates (amongst others, Letter of Access template and Consortium agreement template)

6. Methodology Three principal aspects:
Regular meetings with our partners and the European Commission in order to receive their input/comments on the drafting as it progresses
European Commission has kept the Agency in the loop
On-going
Surveys to receive input from SMEs (clients of Fieldfisher and member companies of our partners)
Survey prior to drafting (completed)
Comments from SMEs on first draft of guides (completed)
Comments to be received on final version of guides (to be completed)
Input (eventually) to be received from other third parties (other stakeholders, including law firms) after 18 November 2014

7. General overview of the Data Sharing User Guide
What is the Data Sharing User Guide and how it will help?
Why impose data sharing?
Aims to be achieved by the Guide
2. Essentials + of the new BPR
What is the BPR and who needs to follows its rules?
3. New data sharing rules
What data must/may be shared and when are the obligations triggered under the BPR?
The data sharing rules
What practical steps should the prospective applicant and data owner take?

8. General overview of the Data Sharing User Guide
Data sharing rules
The type of negotiations that the parties must enter into; and the way that compensation for data sharing can be calculated
The possible outcomes of the negotiations
Successful – Article 63(1) BPR
Unsuccessful – Article 63(3) BPR
Competition law considerations
Information flows and consortium activities
SME Considerations
Annexes
Multiple take away documents

9. General overview of the Letters of Access User Guide
1. What is a Letter of Access in the context of the BPR?
Obligation to share data under the BPR
2. When do you need a Letter of Access under the BPR?
Product authorisation
Inclusion in the Article 95 List
Active substance approval
What you should be aware of as a prospective applicant and a data owner
4. The process for obtaining a Letter of Access

10. General overview of the Letters of Access User Guide
5. Access rights
The scope of access
Conditions relating to the use of the data
6. Compensation for data sharing
Fair, transparent and non-discriminatory treatment
How to calculate fair compensation
7. How the Agency/MSCAs will use a Letter of Access
8. Template Letter of Access
9. Dos and Don'ts

11. Template Documents
Data sharing agreement template
Template Confidentiality Agreement
Template Letter to Data Owner asking for data sharing negotiations
Template Letter of Access

12. Points for Consideration/Discussion
The concept of a “generic” Letter of Access
Acceptability (Article 61(1) BPR)
Consequential rights under Article 95(4) BPR
Tailor-made Letters of Access
SMEs would like the template LoA to state that the data can be used in a number of applications - e.g. for read-across
Revocation of a Letter of Access (Article 62(2) BPR)
Consequences for authorisation versus Article 95 BPR listing
Special cases of Letters of Access
Biocidal Product Family
Consortia

13. Points for Consideration/Discussion
Article 62 (2) BPR:
How can the prospective applicant know which data is needed (e.g., if no draft CAR is available)?
Which dossier requirements will the Agency apply to be included on the Article 95 BPR List?
What about future data on existing active substances where the review is ongoing?
Article 63 (1) BPR:
How are deposits viewed?
What are MSCAs’ expectations in terms of how long negotiations should take?
Special treatment / due consideration for SMEs
Reduced compensation; payment facilities?
More flexible interpretation of the law on data sharing, Letters of Access, etc.?
Definition of SMEs