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

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

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)

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

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)

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

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?

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

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

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

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

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

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