REACH - Data Sharing Rules / Costs. Claudio Mereu Joint Managing Partner Berlin, 25 April 2017

Transcription

1 REACH - Data Sharing Rules / Costs Claudio Mereu Joint Managing Partner Berlin, 25 April 2017

2 Overview Basic principles underpinning REACH data sharing : OSOR (One Substance One Registration, organised by tonnage bands) Data must be shared in a fair, transparent and non-discriminatory fashion Co-registrants must only share costs of data they need (tonnage band) Registrant must be in legitimate possession of data (copyright / IP rights) Lead Registrant must provide itemized cost summary and allocate relevant shares to co-registrants according to their tonnage band Reimbursement mechanism depending on total number of co-registrants / third parties with access rights Data sharing negotiations: every effort before bringing the dispute to ECHA 2

3 Transparency Article 2 of Commission Implementing Regulation (EU) 2016/9 of 5 January 2016 : data-sharing agreement shall be clear and comprehensible to all parties, and include the following: (a) (b) (c) the itemisation of the data to be shared, including the cost of each data item, a description indicating the information requirements in Regulation (EC) No 1907/2006 to which each cost corresponds and a justification of how the data to be shared satisfies the information requirement; the itemisation and justification of any cost of creating and managing the data-sharing agreement and the joint submission of information between registrants of the same substance as required by Regulation (EC) No 1907/2006 (hereinafter referred to as administrative costs ) applicable for that data-sharing agreement; a cost-sharing model, which shall include a reimbursement mechanism Timing: cost itemisation shall be provided without undue delay Record keeping: duty to document/itemise all relevant costs, provide proof thereof, record of any compensation received and reimbursment mechanism for 12 years Retroactivity: existing agreeements inapplicable to prospective applicants, unless unanimous waiver 3

4 New ECHA REACH Data Sharing Guidance January 2017 ECHA published a revised Guidance on data-sharing Document Version 3.1 (mostly the same as Nov 2016 version 3.0) Objective: to improve the main aspects of REACH data-sharing in light of the clarifications and developments brought about by the Commission Implementing Regulation (EU) 2016/9 on joint submission of data and data sharing 4

5 New ECHA REACH Data Sharing Guidance Key revisions and highlights Sectio s 1 & 2 Improves the definition of phase-in and non-phase-in substances Underlines the data-sharing obligations among registrants Integrates main principles of Implementing Regulation (e.g. every effort obligation and cost sharing) Provides a comprehensive description of each provision of the Implementing Regulation Clarifies the relation of data generated under REACH and BPR 5

6 New ECHA REACH Data Sharing Guidance Sectio 3: Brings an update on data-sharing rules for phase-in substances by eliminating and amending out of date information and by highlighting remaining applicability of the process of pre-registration of substances under REACH Introduces the concept of a ''Substance Identity Profile'' and its importance for the SIEF formation Brings forward key aspects to be included in every data-sharing agreement according to the Implementing Regulation Rebalances the burden of the data-sharing activities from the Lead Registrant to the co-registrants in general Introduces the need to agree on a cost sharing mechanism which includes a reimbursement mechanism Clarifies the information to be provided to new potential registrants. 6

7 New ECHA REACH Data Sharing Guidance Sectio 5: Explains the cost sharing requirements under the Implementing Regulation (i.e. itemisation and distinction between study costs and administrative costs) Provides clarification on what should be included in administrative costs Stresses the need to consider possible future costs and variable number of co-registrants Explains the limited applicability of a risk premium and the need to justify it Clarifies an issue which has proven to be bottleneck in data-sharing negotiations i.e. datasharing related to read-across However confusion with regards to the so-called ''Affiliates approach'' two open issues: 1. It is unclear if the shares for the data and admin costs shall be calculated (i) separately per each legal entity or (ii) per company group 2. It is also unclear if there will be an infringement of REACH should industry groups decide to go for the (ii) second option (as the approach has been so far). 7

8 New ECHA REACH Data Sharing Guidance Sectio 6 Stresses the ''OSOR' principle Introduces a new subsection on intermediates, as well as the possibility to submit a separate joint submission Adds the option foreseen by the Implementing Regulation to use of the right to opt-out from the jointly submitted data in cases it can be ascertained that a registrant does not need to share certain data Clarifies the need for the opting-out registrant to discuss with other co-registrants about the relevance of the information separately submitted Adds a new subsection about disputes concerning the access to the joint submission Sectio s 7 & 8 Elaborate on competition law compliance. 8

9 Costs Breakdown Administrative Expenses Costs for Project / Dossier preparation Costs for Project Management Members time costs External work / Additional technical work Data Costs Data jointly developed by REACH Consortium Individual data / prospective applicant s data External data (literature, third parties etc.) 9

10 Costs Breakdown Administrative Expenses Costs for Project / Dossier preparation including all expenses incurred during the Consortium preparation phase (pre-consortium phase). Costs for Project Management including costs for the Consortium daily management (Secretariat costs, Legal costs, Financial/Accountancy costs) Members time costs including members contribution costs to the project and costs for submission of information External consultant costs including costs incurred by the Technical Service Provider/any external Consultant for the generation of IUCLID file and CSR (>10 ton/y) Additional technical work necessary before the substance registration or after, due to the eventually evaluation of the substance/authorisation/restriction (any future cost) 10

11 Costs Breakdown Data costs Data owned by the Consortium and jointly developed by members Prospective applicants data include data owned by prospective applicant before joining the Consortium External data includes data owned by prospective applicants or by other Consortia, used as readacross studies or reference studies 11

12 Data Costs - Replacement Value Step Three Value to be shared among parties ( Cost Allocation and Compensation ) Step Two The economic price of the data ( Data Valuation ) Step One Agree on the reliability, relevance and adequacy of the data ( Data Quality ) 12

13 Study Valuation: correcting factors Correcting factors can be applied to determine replacement value : Risk premium stemming from risk to conduct a study limited to certain complex studies (e.g. chronic tox) and to be duly justified Administrative costs (dossier preparation/supervision, travel, professional support, monitoring support) based on real cost or as a verifiable and fair surcharge to the studies value, for example: 13

14 Study Valuation: correcting factors Robust study summaries for key studies may be compensated by a maximum value of up to 30% of the value of the administrative costs. Other deduction factors: A decrement of 50% linked to restriction on use (REACH / LoA uses only) Any other decrement to be discussed / agreed upon (e.g., no co-ownership / hard copies, depreciation, age of study, multiple use by data owner, low Klimisch rating, etc.) Cost allocation according to number of parties involved cost sharing mechanism / reimbursement 14

15 Cost Allocation and Compensation Make every effort to ensure that costs are determined in a fair, transparent and non-discriminatory way : Cost allocation: Sharing data equally among all parties involved (with corrections to take into account different tonnage bands); Cost calculation may be based on alternative mechanisms (see Guidance on data sharing, e.g. applicants with same studies but variable quality, volume-based LoA etc.). Data comp formula example: data cost + dossier admin. & monitoring costs (+ risk premium in limited cases) / number of registrants * mark down and reimbursement factor 15

16 Reimbursement mechanism Reimbursement mechanism shall include: a method of proportional redistribution to each participant Allocation of future costs resulting from substance evaluation decisions and other activities by Lead Registrant (further studies, CLH etc.) Pay attention to the situation and economic viability of SMEs Existing agreements: consortia members may waive reimbursements mechanisms by unanimous consent Regsitrants having ceased activities may be required to share in costs resulting from substance evaluation decision (e.g. if decision was taken at the time when they were a consortium member) 16

17 LoA cost calculation mechanism - template Consortium balance Invoice Date Company Description Amount Invoice n Laboratory X Laboratory studies 26/02/ , Invoice n Laboratory X Last studies (corrosion studies) to close dossier 120, Invoice n.3 31/12/2009 Consortium AB Read accross from AB to CD Consortium 43, Invoice n.4 31/12/2009 Consortium AB Read accross from AB to CD Consortium 43, Invoice n.5 15/12/2009 Company A LR time for IUCLID creation 5, Consortium Secretariat time for Consortium creation (2009) 10, Invoice.6 Intercall10/12/ Consortium Advocacy activities related to the waiver with AB dossier 22, Invoice n.7 31/01/2010 Consultant Z Dossier creation and updates + waiver 9, /04/2010 Secretariat time Q1 2, /04/2010 Secretariat time for face-to-face meeting 10/06/2010 2, Invioce n.8 10/04/2010 Sheraton Meeting room and lunch for 20 people (meeting 10/04/2010) 3, /07/2010 Consortium Secretariat time Q2 1, Invoice n.9 01/09/2010 LR Invoice to Consortium for IUCLID creation and updates 1, Invoice n.10 10/09/2010 LR LR time for meeting preparation with ECHA 5, Invoice n.11 10/09/2010 LR LR travel expensis to ECHA 1, Invoice n.12 Intercall16/09/ /10/2010 Secretariat time Q3 2, Invoice n.13 05/11/2010 Inercall 05/11/ /01/2011 Secretariat time Q4 1,

18 Conclusion All agreements must have a clear cost-sharing model, including provisions for cost sharing in case of any further dossier / substance evaluation decision Itemisation of costs to be shared (including admin costs and study costs incurred before date of entry into force of Regulation No. 2016/9) Detailed justification and evidence of any cost incurred Record keeping of any compensation received from new registrants Reimbursement mechanism Yearly documentation and budget estimate of any further costs incurred 18

19 Conclusion The importance of adequate communication cannot be overstated (within Consortium, with third parties, with SIEF participants, with Lead registrant) The background and rationale for any cost-related communication must be explained Lead registrant should pay particular attention to cost reporting Data sharing negotiations must be fair, transparent and non-discriminatory Beware of IP implications (copyright / data protection) and potential effects on the market Any formal involvement of authorities (ECHA and/or EC) may resolve disputed but is likely to cause delays 19

20 Q&A Claudio Mereu Partner Tel Claudio.Mereu@fieldfisher.com 20