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 is the application of the doctrine of essential facilities. The decisive factor in qualifying the toxicology studies on fosetyl as essential facilities was the regulatory regime. Such studies could not be replicated because of the regulatory provision which prohibited new toxicology studies on vertebrates when such studies had been already made by other entities. This is an important development in the application of the doctrine of essential facilities under Italian Competition law. According to the ICA ruling, a facility is essential in that it cannot be duplicated not only when the duplication is economically unviable but also when it is statutorily prohibited.

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