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Regions Raise Concerns and Demand Agreement in Italian Medicines Agency Reform

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Regions Raise Concerns and Demand Agreement in Italian Medicines Agency Reform

Regions Push for Changes in Reform of Italian Medicines Agency

In the ongoing reform of the Italian Medicines Agency (AIFA), the Regions are standing their ground on some crucial points of the legislation. According to reports, the Regions have been in communication with the Ministry of Health to address their concerns.

One of the key issues being raised by the Regions is the appointment of the president of AIFA. They are requesting an agreement on the appointment rather than a simple opinion, as stated in the current text. The decree issued by the Salute-Mef-Pa, which redefines the regulation of AIFA, states that the President is appointed by the Minister of Health after consulting the Minister of Economy and Finance and the Permanent Conference for relations between the State, the regions, and the autonomous provinces. However, the Regions are seeking greater power in this decision-making process, which was previously envisioned.

Another point of contention is the establishment of the Scientific-Economic Commission (CSE), which will merge the technical-scientific Commission and the Prices and Refunds Committee. The Regions argue that having only 10 members in total, with the possibility of choosing only one member, is insufficient to expedite and streamline the work of AIFA, leading to delays in the approval of drugs in Italy.

While these are still informal discussions and internal debates within the involved institutions, it is evident that the proposed text would result in a reduction of the role of the Regions. However, sources indicate that there is a desire to find a solution that will facilitate a speedy implementation of the reform.

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Overall, the Regions are seeking more involvement and decision-making power in the reform of AIFA. Their concerns focus on the appointment of the president and the composition of the CSE. These issues will continue to be discussed with the Ministry of Health in order to reach a resolution.

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