The Board of Appeal adopts its first decision on data sharing under the BPR

Case A-005-2015 concerns a decision by the European Chemicals Agency (ECHA) on a data-sharing dispute which granted a company applying to be included in the Article 95 list permission to refer to certain studies owned by another company. The Board of Appeal annulled the contested decision in which the Agency had considered that the data owner had failed to make every effort to reach an agreement on data-sharing. The Board of Appeal found that the every effort criterion requires the Agency to assess, in a balanced manner, the efforts of both parties to a data-sharing dispute. The Agency had, among other things, considered that the data owner had insisted, contrary to the provisions of the Biocidal Products Regulation, on the performance of a technical equivalence assessment of its active substance with the other company’s active substance as a condition to the data-sharing. The Board of Appeal concluded, in particular, that the Agency had not considered all the relevant facts in a balanced manner as it did not take into account the fact that the parties had mutually agreed to the performance of a technical equivalence assessment before sharing data. Further information on the decision is available at: BOA decisions Decision in case A-005-2015

ECHA, 24 August 2016 ;http://echa.europa.eu ;