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Italian Medicines Agency Agenzia Italiana del Farmaco

Regional pharmacovigilance funds

Regional Funds

The Italian Medicines Agency, in compliance with national pharmacovigilance legislation annually allocates ad hoc funds for active pharmacovigilance activities.
Regional Authorities are responsible for the development and promotion of active pharmacovigilance programs, which are agreed with AIFA. Subsequently, special agreements are concluded to allow Regions to access the fund.

Agreement between the Government and Regional Authorities concerning use of 2012-2013-2014 funds

Agreement between the Government and Regional Authorities concerning use of 2015-2016-2017 funds

The Agreement between the Government and Regional Authorities dated 6 June 2019 for the use of the 2015-2016-2017 funds introduces one important change: compared to previous years, in fact, specific funding has been dedicated to national-scale projects designed to study efficacy and safety of medicines in the real world setting, in order to generate strong evidence, transferable across the national territory.

Moreover, a higher portion of funding has been allocated to activities of Regional Pharmacovigilance Centres (CRFV) and, finally, an amount remains reserved for the presentation of regional projects aimed at evaluating the use of medicines and the effects of pharmacological treatments in clinical practice.

With determination no. 565/2020 of 8 May 2020, AIFA authorized the disbursement to individual regions of a “fixed amount” of pharmacovigilance funds (PhV Funds) allocated for the three-year period 2015-2016-2017 and amounting to €150,000.00 (one hundred fifty thousand/00) for each individual region. The abovementioned amount is aimed at guaranteeing continuity of regional pharmacovigilance activities in a homogeneous manner throughout the national territory. In accordance with the aforementioned Agreement, the provision of the fixed amount is not subject to an agreement.

The remaining funds have been allocated between the different regions, on a per capita basis, per year and by region, as described in the "PhV funds 2015-2016-2017 breakdown Table" (available in the related documents box).

The abovementioned portions of PhV funds, equal, respectively, to 50 % of the remaining funds allocated for Regional Pharmacovigilance Centres (CRFV), 20 % of the remaining funds allocated for the implementation of regional active pharmacovigilance projects and 30% of the remaining funds allocated for participation in national active pharmacovigilance projects, will be supplied following the conclusion of specific agreements between AIFA and individual regions.

Agreement between the Government and Regional Authorities concerning  use of  2012-2013-2014 funds

On 30 March 2017, pursuant to art. 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 2012-2013-2014.

As provided for in paragraph 7 of the abovementioned Agreement, a copy of which is made available here, the Agency has disbursed the amount related to the conclusion of the Agreement, equal to EUR 50,000 per Region, for each of the years from 2012 to 2014. These sums are aimed at guaranteeing continuity of regional pharmacovigilance activities in a homogeneous manner throughout the national territory.

With reference to the remaining portion of the fund, equal to 40% of the funds allocated to Regional Pharmacovigilance Centres (CRFV), 30% of the funds allocated to regional activity/project plans and 30% of funds allocated to multiregional projects, AIFA has concluded the disbursement phase for both CRFV and regional projects and is releasing the funds for multi-regional projects.

Overall, ninety-two projects have been approved, fifteen of which have a multi-regional dimension.

Agreement between the Government and Regional Authorities concerning  use of 2010-2011 funds

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.

Agreement between the Government and Regional Authorities concerning use of 2008-2009 funds

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).

Ufficio di riferimento

Reference offices

Post Marketing Surveillance Department

Anna Rosa Marra

ar.marra@aifa.gov.it

Nested Applications

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