An Increased Cooperation in Enforcement Activity: The Italian Competition Authority and the Italian Medicines Agency Sign a Memorandum of Understanding

By on January 23, 2017

On 19 January 2017, the Italian Competition Authority (AGCM) and the Italian Medicines Agency (AIFA) signed a memorandum of understanding in order to increase enforcement in the pharmaceutical sector by strengthening their investigation powers and facilitating the exchange of data. Under the agreement, AGCM and AIFA will inform each other on cases concerning alleged violations of rules enforced by one of them. In particular, in case of negotiations carried out by AIFA with pharmaceutical companies on the applicable drugs prices, or whether counterfeiting cases regarding pharmaceutical products emerge during an investigation. Furthermore, the authorities will cooperate in their advocacy activities and in carrying out sector enquiries. Finally, the authorities will exchange information and data on matters of common interest.

The memorandum of understanding confirms the increasing interest of AGCM in the pharmaceutical sector. During this year, AGCM has carried out significant high-profile proceedings. On 13 October 2016, AGCM fined the pharmaceutical company Aspen €5.2 million for an alleged abuse of dominant position in the negotiation with AIFA which led to an increase of the oncological drugs prices. According to AGCM, Aspen would have forced AIFA to accept a significant price increase for its drugs (resulting in major spending for the National Health System, as those drugs are entirely reimbursed to patients), by threatening the withdrawal of its products from the Italian market. Furthermore, Aspen would have exploited its dominant position, since no substitutes for its product are available in the Italian market, and the only alternative for the National Health System would have been to import the drugs at a higher price from other EU countries. The enforcement trend of AGCM demonstrates its commitment to identifying and challenging potential abuses by pharmaceutical companies of the regulatory procedures and of the rights conferred upon them by the relevant legislation.

Gabriele Giunta (Trainee) contributed to this blog post.





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