Nomos e Pharma Value hanno sviluppato un documento di approfondimento per analizzare la riforma di AIFA definita nelle scorse settimane al Senato e capirne i prossimi passaggi.
L'obiettivo è offrire uno strumento ai gruppi di interesse impattati, dalle associazioni dei pazienti alle aziende farmaceutiche, passando per le Regioni e il personale dell’AIFA stesso, per orientarsi sulle tempistiche delle proprie attività in corso.
Nomos e Pharma Value si impegnano ad aggiornare il documento con le novità giuridico-istituzionali, le informazioni e le riflessioni sulla base dei prossimi sviluppi.
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This is our English version of the analysis "Towards the reform of governance of the Italian Medicines Agency and the Single Committee" produced in collaboration with Pharma Value.
We analyzed the reform and understand the next steps, capturing the details without ever losing sight of the whole. We wanted to offer a tool to help follow the progress of the legislation and to highlight the competences that characterize the members of the current committeess.
It is a starting point that helps to understand what is needed and who has been represented to date in order to see what the real impact of the reform initiated by the new government will be.
We are now at this point: the decree-law Nato, Calabria, Aifa Committees has been published on the Official Journal on December 27 (entry into force on December 28). The text approved by the Senate includes:
- The abolition of the existing committees at the end of the extension
- The establishment of the Scientific and Economic Commission of the Drug that will inherit its functions
- The establishment of the President of AIFA as the new legal representative.
- The reference to a decree of the Minister of Health for subsequent operational details
The next step will be the ministerial decree which is expected within 60 days of publication in the Official Journal.