Committee meeting in Italy
Insider Insights

AIFA reform: delays continue as CTS and CPR committees have been extended again


Reforms to the Italian Medicines Agency (AIFA) have been eagerly awaited, but they’ve encountered yet another roadblock. Approved towards the end of 2022, these changes are set to reshape the healthcare landscape in Italy.

The most significant transformation involves the merging of the Technical and Scientific Committee (CTS) and the Pricing and Reimbursement Committee (CPR) into a single entity called the Scientific and Economic Commission for Medicines (CSE). This unified body will be responsible for both scientific assessments and pricing and reimbursement decisions.

Originally scheduled for implementation in February 2023, these reforms have been plagued by delays, leaving stakeholders in limbo. What’s concerning is the repeated extensions of the terms of the current committee members, who were initially appointed in 2018. Six extensions in total, with three of them happening after the reform’s approval, have left us questioning the feasibility of the reform’s timeline.

The 5th extension, announced in May, was initially set to conclude on October 1st. However, doubts have been mounting over the past month regarding the achievability of this deadline. These doubts have now been confirmed with the announcement of a 6th extension, which will keep the committees in place until December 1st.

These repeated delays underscore the complexities and challenges associated with overhauling an agency as critical as AIFA. All stakeholders are now looking forward to clarity in the coming months. The big question is, will the December deadline be met, marking the start of the new AIFA?


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