Today, the Commission Implementing Regulation 2016/9 on joint submission of data and data sharing in accordance with the REACH Regulation was published in the Official Journal of the EU. It will enter into force on January 26, 2016.
The Implementing Regulation does not add to the rules established by the REACH Regulation. Rather, it seeks to “promote good management practices” and “ensure the efficient implementation of agreements” (recital 3). To this end, it lays out obligations for parties to data sharing agreements - these are described below.
Thus, with immediate effect:
- Since the Regulation applies to agreements concluded before or after its entry into force, all lead registrants and all consortia members must review the existing data sharing and consortia agreements to ensure compliance with the new obligations, and amend as and if necessary.
- Consortia members must ensure that the data sharing agreement used by each of them is compliant.
- Even if all parties agree to waive certain obligations, the consent for the waiver must be obtained from each party.
- New agreements must be drafted in compliance with the new Regulation.
- Co-registrants who already signed data sharing agreements must review and request amendments if justified.
- Registrants who are part of separate joint submissions must justify opt-out.
ECHA has indicated that it would amend the Data Sharing Guidance consistently with the new Regulation.
A. Data sharing agreements
- Must include the itemization of shared data, including cost of each data item and explanation as to how the data satisfy the information requirement.
- Must include itemization and justification of administrative costs, which are recognized as compensable expenses (they include costs related to management, study preparation and/or monitoring costs). This may be challenging for certain “commodity” consortia, which apply a flat fee in consideration of the high number of registrants.
- Must include a cost-sharing model, with a reimbursement model.
- For agreements already in force on January 26, 2016, all parties can agree to waive the obligation to itemize data and administrative costs. However, a new party is not bound by an existing waiver, and can ask for the itemization of costs – in this case, previous registrants must “provide proof of costs” of studies, and “make every effort” to itemize other (administrative) costs.
- Yearly documentation of costs incurred post-registration is mandatory. The yearly documentation must be kept for “a minimum of” 12 years following submission of a study, and be made available free of charge “within reasonable time.”
B. Data sharing rules
- A registrant is only required to share costs related to information that he is obliged to submit.
- The cost-sharing model applies to all registrants, including late co-registrants. The number of estimated potential registrants is recognized as a relevant factor.
- The cost-sharing model must refer to costs resulting from substance evaluation decisions. Registrants who ceased activities under Article 50(2) or 50(3) REACH may still be required to share the substance evaluation costs.
- Equal sharing is re-affirmed as the default cost-sharing model, in absence of any other agreement between parties to a data‑sharing negotiation. This may entail difficulties for those consortia applying a flat rate for the LoA and for which the individual data requirements of the co-registrants may not be known.
- The reimbursement mechanism must include a “method of proportional redistribution to each participant of their share of costs paid” when a new registrant joins. The economic viability of certain reimbursements is recognized as a relevant factor. For agreements already in force on January 26, 2016, all parties can agree to waive the obligation to include a reimbursement mechanism. However, a new party is not bound by an existing waiver, and can request the inclusion of a reimbursement mechanism in the cost-sharing model.
- Future costs may be included in the cost-sharing model, but they must be justified and indicated separately.
- The cost-sharing model cannot cover costs related to compiling information for establishing substance sameness. This re-enforces the need for the Lead registrant to prepare a complete and detailed SIP.
C. The OSOR principle
- ECHA has an obligation to “ensure that all registrants of the same substance are part of the same registration.” Any subsequent submission of information must be part of the existing submission for that substance.
- However, when a registrant does not need to share vertebrate animal studies, he can submit separately all or part of the technical information (Article 10(a) REACH). The separate submission (full or partial) will remain part of the same registration. The Regulation requires that the co-registrant opting out informs the previous registrants.
D. Remaining questions include:
- Data sharing agreements are typically signed between two parties, the Lead registrant and each of the co-registrants. What does “unanimous consent” to waive itemization of costs mean in this context? Is it sufficient for each co-registrant to agree on a case-by-case basis, or does one disagreement result in changes to all bilateral agreements? Likely, the former.
- The Regulation refers to “data sharing agreements” without defining them. Do they relate to consortium agreements, involving two or more parties, or so-called SIEF/LoA agreements, which typically involve only two parties (the Lead registrant and the applying co-registrant)?
- How will ECHA ensure that all registrants are part of a single joint submission? Today, two or more joint submissions co-exist. If the relevant IT systems are changed, will the changes operate retroactively? In which framework, and how (does it depend on all registrants agreeing to sign a single agreement)?