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.
This article, published in Getting the Deal Through, reviews the legislation that creates the pharmaceutical regulation framework in Italy, particularly with regard to mergers and acquisitions, anticompetitive conduct, product development and licensing agreements, and marketing agreements.