Ai sensi dell’art. 1, comma 819, della legge 27 dicembre 2009, n. 296, la Conferenza Permanente per i Rapporti tra lo Stato, le Regioni e le Province Autonome di Trento e Bolzano ha formalizzato, in data 18 aprile 2024, l’Accordo concernente la definizione degli indirizzi per la realizzazione di un programma di farmacovigilanza attiva, attraverso la stipula di convenzioni tra l’Agenzia italiana del farmaco e le singole Regioni per l’utilizzazione delle risorse di cui all’articolo 36, comma 14, della legge 27 dicembre 1997, n.449, relative agli anni 2018, 2019, 2020, 2021 e 2022.

Il Fondo di Farmacovigilanza disponibile per le suddette annualità è pari complessivamente a € 58.500.000,00 (cinquantotto milioni/00).

Con la determinazione del direttore amministrativo n. 134/2024 del 9 maggio 2024, l’AIFA ha autorizzato l’erogazione a favore delle singole regioni della “quota fissa” dei fondi per la farmacovigilanza (Fondi FV) stanziati per gli anni 2018-2019-2020-2021-2022 e quantificata per ogni singola regione in complessivi € 375.000,00 (trecentosettantacinquemila/00). La predetta quota è finalizzata a garantire su tutto il territorio nazionale in modo omogeneo la continuità delle attività regionali di farmacovigilanza. 

Il fondo residuo disponibile è stato ripartito tra le diverse regioni in quote così come quantificate, su base capitaria, per anno e per regione, nelle apposite “Tabelle di ripartizione FONDI FV 2018, 2019, 2020, 2021 e 2022”.

L’Accordo prevede una quota del 30% del fondo residuo disponibile per il finanziamento di progetti a carattere nazionale destinati, in particolare, alla valutazione dei medicinali nel post-marketing e alla informazione e comunicazione scientifica ed una quota del 70% del fondo residuo disponibile per il finanziamento delle attività dei Centri Regionali di Farmacovigilanza (CRFV). Tali quote dei fondi FV saranno erogate a seguito della stipula di apposite convenzioni tra l’AIFA e le singole regioni.

Con riferimento alla quota destinata al finanziamento dei progetti nazionali, seguirà la pubblicazione delle modalità e delle tempistiche di richiesta di accesso a suddetti fondi.

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.

On 28 October 2010 a second Agreement concerning the use of available funds for years 2008 and 2009, amounting to EUR 25 million per year, which were incorporated into AIFA's ordinary budget, was signed.

An Active Pharmacovigilance Fund Commission was also set up at AIFA, consisting of internal staff from the Pharmacovigilance and Administrative Affairs departments.

The management of activities relating to active pharmacovigilance funds is assigned to the Commission, which shall work in cooperation with Regions to ensure the transfer and use of available resources. A number of thematic areas of interest for pharmacovigilance had been identified in the guidelines on the use of 2007 funds:

1. a) Study of adverse drug reactions
2. b) Medicine use evaluation and promotion of prescription appropriateness
3. c) Independent information and training
4. d) Strengthening pharmacovigilance activities of the Ethical Committees in clinical trials

In addition to the areas of interest described above, for years 2008-2009, the possibility of developing or strengthening activities of Regional Pharmacovigilance Centre, or encouraging their establishment in the regions still lacking, has been introduced. Within the scope of the 2008-2009 funds, AIFA approved 139 regional projects and 8 multi-regional projects, which were deemed worthy of funding, through the conclusion of 19 agreements with Regions and 4 agreements with centers responsible for coordinating national projects. In total, active pharmacovigilance funds for years 2007-2009 distributed to Regions, in accordance with the 2007 Financial Law, amounted to approximately EUR 70 million. It should be remembered that the Autonomous Provinces of Trento and Bolzano did not apply for pharmacovigilance funding for years 2008-2009, following the revision of the financial system of the Autonomous Provinces and of the financial relations with the State (Law no. 191 of 23 December 2009, art. 2, par. 106-126 – 2010 Financial Law).