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By Lisa R. Burchi and Zameer Qureshi

On August 23, 2016, the European Chemicals Agency’s (ECHA) Board of Appeal (BoA) adopted its first decision on a data sharing dispute under the Biocidal Products Regulation (BPR).

Thor GmbH (Thor) lodged the appeal in 2015 after ECHA granted permission to a company to cite studies owned by Thor for the substance reaction mass of 5-chloro-2-methyl-2H-isohtiazol-3-one and 2-methyl-2H-isothiazol-3-one (CIT/MIT).  According to ECHA, Thor had insisted on a technical equivalence assessment of its substance with the other company’s active substance to check if the companies’ substances had similar chemical composition and hazard profiles.  ECHA stated this was not required under BPR and data owners “do not have the right to demand any form of similarity check as a prerequisite for getting a letter of access.” 

The BoA ruled in favor of Thor, which raised five pleas in law, as the companies had mutually agreed to perform a technical equivalence assessment before sharing data.  The BoA concluded that while ECHA “might be correct” in concluding that the technical equivalence assessment is not a legal requirement for data sharing under BPR, “this legal observation cannot constitute an assessment of the parties’ efforts to reach an agreement within the meaning of Article 63.”  The BoA stated “it is part of the Appellant’s and the prospective applicant’s contractual freedom to insert a clause relating to a technical equivalence assessment in the data sharing agreement.”

The BoA also reviewed the negotiations between the parties to determine whether those parties make every effort to reach an agreement, and found that ECHA “did not consider all the relevant facts in a balanced manner when assessing whether every effort had been made by Appellant and the prospective applicant under Article 63.”  The BOA found that ECHA disregarded some of Thor’s efforts based on its legal conclusion that there was no need to perform a technical equivalence assessment.  Consequently, the BoA concluded that Thor had made every effort to reach an agreement with the other company and ECHA had failed to consider all the facts of the case.

Although ECHA’s decision was annulled, there remains a question whether a new decision is required.  Since the BoA’s decision, the prospective applicant submitted a successful application under Article 95, which may negate the need for the prospective applicant to cite to Thor’s data.  The case was remanded to ECHA to determine whether a new decision is required.  


 

By Lisa R. Burchi and Lisa M. Campbell

On January 6, 2016, the European Union (EU) published its Commission Implementing Regulation (EU) 2016/9 regarding the joint submission of data and data sharing under the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) in the Official Journal of the European Union.  The European Commission (EC) Competent Authorities for REACH and CLP (CARACAL) has been developing this Regulation to clarify further what is meant by determining data sharing in a “fair, transparent, and non-discriminatory manner” associated with the sharing and joint submission of information and also the costs relating to a registrant’s obligation to share information in accordance with REACH. 

Many of the requirements set forth in the Regulation may be already in place in existing Substance Information Exchange Forums’ (SIEF) data-sharing agreements. Nevertheless, the Commission found based on information collected following the 2010 and 2013 REACH registration deadlines that “data sharing and joint submission have not been used to their full potential, their implementation falling short of expectations.”  The Commission found that these problems were “especially prejudicial to small and medium size enterprises.”  The requirements set forth apply prospectively as well as retroactively, meaning that all companies that are parties to REACH data-sharing agreements are affected by this new Regulation. 

Discussion

The Regulation seeks to “promote good management practices” and “ensure the efficient functioning of agreements” related to data sharing.  The requirements set forth in the Regulation are intended to further the OSOR principle, ensure transparency and fairness in data-sharing agreements, and end excessive charges.  The Regulation furthers its goals of promoting transparency and fairness by ensuring that a cost-sharing model and reimbursement mechanism are in place when future registrants provide additional compensation and by eliminating concerns that potential registrants pay for studies that are not required of them under REACH. 

The Regulation will enter into force on January 26, 2016.  All agreements to be executed after this date must be in compliance with these new requirements. More information can be found in The Acta Group’s (Acta®) memo REACH:  EU Publishes Regulation Regarding REACH Joint Submission of Data and Data Sharing.