Fieldfisher defends the first case on data sharing under the BPR adopted by ECHA Board of Appeal
On 23 August 2016, the Board of Appeal of the European Chemicals Agency (''ECHA'') ruled on the first case (Case A-005-2015) under the Biocidal Products Regulation (EU) No 528/2012 (''BPR''). The case concerns an ECHA Decision under Article 63(3) of the BPR (the ''Contested Decision''), in which ECHA had considered that the data owner had failed to make every effort to reach an agreement on data-sharing. The Board annulled the Contested Decision. The Appellant in the proceedings, for whom the decision is favourable, is Thor GmbH (''Thor''), represented by the Fieldfisher biocides team led by partner Koen Van Maldegem, with the assistance of advocate Peter Sellar.
By way of factual background, the Contested Decision granted a company (the ''Prospective Applicant'') applying to be included in the Article 95 list permission to refer to certain studies owned by Thor concerning the substance reaction mass of 5-chloro-2-methyl-2H-isohtiazol-3-one and 2-methyl-2H-isothiazol-3-one (''CIT/MIT''). The main issue in the case was that Thor and the Prospective Applicant had agreed to establish technical equivalence between their respective substances, and Thor had consistently kept to this pre-requisite for data sharing. In essence, under Article 54 of the BPR, a technical equivalence assessment must determine the similarity between the two, in chemical composition and hazard profile. ECHA argued that this was not required under the BPR and data owners ''do not have the right to demand any form of similarity check as a pre-requisite'' for sharing their data.
The Board, however, found that ECHA had not considered all the relevant facts in a balanced manner as both companies had mutually agreed to perform a technical equivalence assessment before sharing data, both at the beginning of negotiations, and after ECHA had said that such an assessment was unnecessary and confirmed that establishing technical equivalence can be in the interest of both parties involved in data sharing negotiations. More importantly, the Board stated that although ECHA ''might be correct'' in considering that the technical equivalence assessment is not a legal requirement for data sharing under the BPR, it is part of the companies’ contractual freedom to add the assessment to their data sharing agreement.
The Board of Appeal concluded that Thor made every effort to reach an agreement with the Prospective Applicant, and ECHA failed to consider all the facts of the case.
By ruling in favour of contractual freedom, the Board has acknowledged that parties can agree between themselves on how to conduct their data sharing negotiations. Despite clarifying the confusion over contractual freedom, the Board did not address the four remaining pleas in law raised by the Appellant, and as such missed a good opportunity to clarify certain procedural questions which would have made future data sharing negotiations under the BPR smoother.
Nevertheless, this decision has far-reaching consequences, since as a first legal case under the BPR, it sets an important legal precedent on how ECHA manages data sharing disputes which involve complex scientific, regulatory and procedural issues under the BPR such as technical equivalence.
For more information and questions please contact Koen Van Maldegem