«We are working to reduce the times of access procedures through a process of de-bureaucratization and administrative simplification which must guarantee citizens the most rapid usability of truly innovative medicines». This is what was highlighted by Robert Giovanni Nisticò, president of AIFA, at the end of the first meeting with the president of Farmindustria, Marcello Cattani, which took place on Thursday 9 May 2024 at the Agency’s headquarters. As observed by the body, it was «a constructive and immediately operational discussion, which led to the establishment of a technical working group which will have the task of identifying the simplification tools that allow priority to be given to the approval of drugs capable of improving the quality of care and the therapeutic options available”. An objective – it was agreed – which will also have to be achieved by relieving the Agency’s Scientific and Economic Commission (CSE) of some procedures that could be carried out directly ex officio.
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Rapid approval pathways for new antibiotics
As explained by Nisticò, “with a close series of CSE calls, we are clearing up the significant backlog that formed in the phase preceding the AIFA reform because our objective is to give priority in particular to drugs that fill a therapeutic gap.” A reflection in this sense was also started on the need to provide incentives and rapid approval paths for new antibiotics capable of replacing those that have generated forms of bacterial resistance. «There is an effective model and it is that of the legislation that has made it possible to encourage research into orphan drugs for rare diseases, which can be reproduced for new antibiotics that are not resistant to bacterial infections. But for this – the AIFA president specified – a regulatory intervention will be needed, also at a European level, with respect to which we will undertake to raise awareness among decision-makers at various levels”.
Speeding up access authorization processes
Again with a view to speeding up the access authorization processes, the technical-scientific director of AIFA, Pierluigi Russo, announced the forthcoming introduction of an online platform «to make communication between companies and the Agency more effective and transparent in report on the CSE process, in addition to the update of the guideline relating to the dossiers requesting the price and reimbursement of medicines”. Finally, the commitment to the application of the European regulation on Health Technology Assessment (HTA) was confirmed, which favors a multidimensional evaluation of the drug on the healthcare system, economic aspects and protection of citizens’ health.
