On 26 September 2013, pursuant to Article 4 of Legislative Decree no. 281/1997, the Government, the Regions and the Autonomous Provinces of Trento and Bolzano formalized an Agreement on the proposal of the Minister of Health concerning the definition of guidelines for the implementation of an active pharmacovigilance program, through the conclusion of agreements between AIFA and individual Regions for the use of the resources referred to in Article 36 par. 14 of Law no. 449/1997 for years 2010-2011.
As provided for in Article 4 of the abovementioned Agreement, the Agency has disbursed the amount related to the conclusion of the Agreement, equal to EUR 50,000 per Region and 40% of the funds on a per capita basis, for each of the years from 2010 to 2011, as described in the Annexes to the Agreement. These portions are aimed respectively, at guaranteeing continuity of regional pharmacovigilance activities throughout the national territory and ensuring the establishment/maintenance of CRFVs/regional bodies/structures.
In addition, specific agreements have been concluded with individual regions for multi-regional and regional projects.
Particular importance has been given to multi-regional projects, with a Lead Region, to which more funding has been allocated than in previous years (30% instead of 10%). All regions have joined at least one multi-regional project, with the exception of the Valle d'Aosta Region, which has renounced to obtain the portion dedicated to these projects. Regions with more than 3 million residents have ensured involvement in at least two multi-regional projects.
Overall, 17 multiregional projects and 73 regional projects have been approved, with annual and multi annual duration.
As provided for in Article 4 of the abovementioned Agreement, a portion equal to 5% of the available fund for AIFA was used for the coordination costs of multi-regional projects, through the conclusion of special agreements between AIFA and the Project Coordinator Centre.