Article 1, paragraph 285 of Law no. 207 provides that ‘following the assessment conducted by the Scientific and Economic Committee of the Italian Medicines Agency (AIFA), having heard the stakeholders and the patients’ and citizens‘ associations, the Agency itself, by means of a decision of the president, upon proposal of the technical-scientific director to be adopted by 31 March 2025, shall define the evaluation criteria for the attribution of therapeutic innovativeness that allows the funding of access to reimbursement by the National Health Service with the resources of the Fund referred to in paragraph 283’.

To this end, the document on the ‘Evaluation criteria for the attribution of therapeutic innovativeness and on the management of anti-infective agents for infections with multi-resistant germs’ is made available for public consultation.

The consultation is open to all stakeholders as well as patients’ and citizens’ associations: contributions shall be sent in non-anonymous/anonymised form exclusively in word format to the email address: infoinnovativi@aifa.gov.it.

The deadline for submission is 18:00 on 22 March 2025; documents received after this deadline will not be taken into consideration.

In order to better organise and evaluate the comments that will be received, please send them in a clear and concise manner, preceded by an abstract summarising the points covered by any comments and/or observations.

In compliance with the principles of participation and transparency, all the documents received will be made public on a special page of the Agency's institutional website, in accordance with the regulations in force on the processing of personal data.

Finally, it should be noted that any observations, indications and/or comments received, while remaining subject to evaluation by the Agency, will not necessarily be included in the final document.