2 SIEFs SIEFs are big social experiment in cooperation and contract law Large numbers of participants Different interests and incentives Different timelines (depending on tonnage band) Results in « Hold Out » problem and huge transaction cost
3 The Conundrum REACH creates conundrum Consortium is voluntary, and SIEF is mandatory Consortium is ahead, and SIEF lags behind Consortium is manageable, and SIEF often is not Consortium has detailed cost and data sharing rules, and SIEF does not
4 The Conundrum REACH creates conundrum Consortium produces dossier, and SIEF does not Consortium is capable of meeting REACH objectives, and SIEF often is not BUT REACH SUGGESTS SIEF DOES IT ALL AND DOES NOT EVEN ONCE REFER TO CONSORTIUM!
5 Consortium - SIEF How can Consortium and SIEF effectively work together? How can Consortium lead? What role do IT tools play? What expectations do SIEF participants have? What role can ECHA play?
6 Consortium - SIEF How can SIEF members get what they need from Consortium? Should Consortium be open? Should Consortium take data from SIEF Members? How can SIEF Members get information or be involved in Consortium processes? Do SIEF Members have to accept Consortium’s rules?
7 Specific Issues 1. What to do about dysfunctional or self-interested (and self-appointed) SIEF Formation Facilitator? 2. Does SIEF need organizational structure if there is already open-ended Consortium? Why should Consortium duplicate organizational structure in SIEF? 3. How to manage SIEFs with tens, hundreds, or thousands of members? 4. How to resolve sameness issues? 5. Can « Super-SIEFs » be created and managed?
8 Specific Issues 6. If Consortium cannot secure support of SIEF, can Consortium opt out? 7. Can Consortium impose Lead Registrant on SIEF? 8. Can SIEF participant force study on Consortium if Consortium already has end-point covered? 9. Does Consortium have to share dossier with other SIEF members, or is providing access to individual studies sufficient?
9 Specific Issues 10. What kind of « proof of cost » of study is required? 11. Is agreement with owner necessary for REACH use of published study? 12. How can data be shared accros SIEFs? 13. What does cost-sharing in « fair, transparent and non discriminatory way » require? 14. May OR be charged cost share for each non-EU manufacturer represented by it?
10 Specific Issues 15. Do data sharing requirements apply to affiliates of SIEF members and non-EU manufacturers represented by OR? 16. What if data owners do not have right to grant access? 17. What if Lead Registrant refuses to request confidential treatment? 18. What if Lead Registrant registers too late or does not pay fee timely? 19. On what grounds can C&L proposal be disputed?
11 Thank you for your attention! Prof. Lucas Bergkamp Tel These materials have been prepared for informational purposes only and are not legal advice. This information is not intended to create an attorney-client or similar relationship.