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Press release - AIFA directions for the European Fakeshare project

AIFA’s Director General, Luca Pani: “the online selling of counterfeit medicines or dangerous products represents a phenomenon that must be faced at a global level. AIFA is already active in this field from many different perspectives, by means of the European project Fakeshare is developing an innovative Information Technology model aiming at empowering the contrast activities against the illegal web pharmacies and, at the same time, to enhance collaboration and information sharing at international level”.

The Italian agency of medicines (AIFA) is the leading institution of a European project of cooperation and intelligence, named FAKESHARE, that will begin in May 2013 and was formed to protect the health of citizens from the dangers deriving from the illegal trade of medicines on the web.

AIFA’s two-year project has been approved by the European Commission, which will support it with funding of more than 350.000 euro in the framework of the “Prevention of and fight against crime” program.

In the program’s activities developed by AIFA will participate, as co- beneficiaries, the regulatory agencies of Spain (AEMPS), Portugal (INFARMED), the Universities of Rome (“La Sapienza”, Faculty of Medicine and Psychology) and Trento (Faculty of Law) and the Italian Ministry of Economic Development.

The aim of the project is to coordinate and optimize the counteracting activities developed by the single EU Member States, by guaranteeing a shared management of the monitoring activities on the e-pharmacies towards the Information Technology ad hoc systems developed by AIFA.

The initiative takes into consideration the necessity of counteracting the growing phenomenon of the online trade of illegal and dangerous medicines, even in the light of the forthcoming enactment of the European Directive 2011/62/EU, which will introduce some relevant innovations in relation to the terms of sale of medicines via the web in the Member States.

Among the ultimate goals of FAKESHARE, in particular, is the establishment of a shared web system between the administrations of different Member States, aimed at managing the investigation on the data of illegal online pharmacies, often operating from servers located outside the EU.

The IT infrastructure that will be developed will support the police in activities aimed at taking down unauthorized sites. FAKESHARE also envisages the involvement of other partners, both public and private, that will support the activities of cyber intelligence and sharing at European level. The cooperation will include NAS (Italian health focused police force), the regulatory Agency of Chile (ANAMED), LegitScript (USA private agency for e-pharmacies evaluation), the investigation Agency PSI (Pharmaceutical Security Institute) and the European federation and the manufacturers\producers of medicines EPFIA (European Federation of Pharmaceutical Industries and Associations).