The Board of Appeal adopts its first decision on data sharing under the BPR
Case A-005-2015 concerns an Agency decision 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.
Helsinki, 24 August 2016 – 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.