The Italian Competition Authority (AGCM) and the Italian Medicines Agency (AIFA) recently signed a Memorandum of Understanding with a view to strengthening their cooperation. The Memorandum underlines that the two agencies share common interests, which relate in particular to keeping high levels of competition, granting access to medicines and preserving the economical balance of the pharmaceutical system. The Memorandum thus intends to help its signatories perform their mission in a more coordinated and efficient manner.
The main issues tackled in the Memorandum are, on the one hand, the potential violations of competition rules in the setting of drug prices, which are agreed upon in negotiations between AIFA and the pharmaceutical companies, and, on the other hand, unlawful counterfeits/online marketing of medicines.
The Memorandum provides that each agency shall report to the other in case it comes across, within the framework of its activities, a risk of violation of the provisions for which the other agency is responsible.
The two agencies also undertake to cooperate in developing reports to the Italian Parliament and Government and in carrying out enquiries on shared interest matters.
In order to ensure such cooperation works, they agree to exchange documents, data and information, establish regular communication channels and carry out any other appropriate activities, including informal activities.
Being aware that this is a sensitive aspect, the Memorandum specifically indicates that divulgation to third parties of documents, information and data acquired as a result of its implementation will have to comply with the secrecy and privacy provisions the receiving agency is subject to.
AGCM President, Mr Pitruzzella, reportedly declared that the Memorandum will intensify the already existing cooperation between the two agencies. He pointed out that the end users in the pharmaceutical sector - the consumers - are particularly vulnerable, and that, on the other hand, the companies operating in the sector make substantial investments. In this framework, he considers AIFA’s contribution and expertise to be particularly valuable.
The Pharmacies’ association, Federfarma, welcomed the Memorandum pointing out its underlying importance in the fight against illegal online marketing and infringement of pharmaceutical products and affirmed its willingness to cooperate in fighting online infringers.
Although the Memorandum is not particularly detailed and did not have wide media coverage, it is likely to have a rather positive impact, for instance in helping prevent situations such what occurred in the Aspen case (see our lexology post of 3 November 2016), where AGCM fined a pharmaceutical company for an abusive price increase which actually resulted from an agreement negotiated between such company and AIFA.