For the Italian Competition Authority toxicology studies are essential facilities (Sapec Agro/Bayer-Helm)
The decision of the Italian Competition Authority (ICA) in the Sapec Agro/Bayer-Helm (Case A415) is a rare case of Article 102 TFEU condemnation. Bayer Cropscience (BCS) was accused for having refused to grant some of its competitors access to toxicology studies in its possession on fosetyl. The BCS had as effects its competitors having to exit the market for the plant health products based on fosetyl. Indeed, the regulatory regime in force subjected the granting of market authorization for plant health products based on fosetyl to the production of toxicology studies on the effects of this substance. The ICA rejected the commitments offered by BCS and found that BCS had to grant its competitors access to the studies, because the studies constituted essential facilities. Therefore the ICA fined € 5.124.359,00 BCS for abuse of dominant position in the market for the production and commercialization of fosetyl-based fungicides. The most noteworthy aspect of Sapec Agro/Bayer-Helm i...