There is a structural underfunding of expenditure for direct purchases, only partially reduced by the creation of funds for innovative drugs and by the revision of the expenditure ceilings introduced with the Budget Law 2021. Another example of a structural limit is represented by the approval process of new drugs. These, when approved at the EMA level, are made available to Italian patients many months later because they are subject to a double approval step, an evaluation by Aifa (418 days on average) and bureaucratic steps at the regional level. The effect produced by these delays is a -19% per capita consumption in Italy compared to the average of the large European countries. This is what emerged during themeeting ‘Innovation in healthcare as a driving force for the country’s economic and social recovery’, organized with the support of the Italian American Pharmaceutical Group (Iapg) and the European and Japanese Group of Farmindustria (EUNIpharma), in which, among others, theformer Minister of Health Beatrice Lorenzin.
“In the Budget Committee we approved the amendment of the Democratic Party for the unification of the two funds dedicated to the reimbursement of innovative oncological and non-oncological drugs – recalled Lorenzin, member of the Budget, Treasury and Planning Commission of the Chamber of Deputies – This is a first step effective towards an actualization of the mechanisms for accessing innovation. We will work further to increase the pharmaceutical fund as a whole and in particular to activate a mechanism for periodic adjustment with respect to the authorization processes of the many new highly innovative molecules arriving in the next three years. research always gives us new and extraordinary therapeutic opportunities that risk not being really accessible for our patients throughout the territory. Thanks to this change, finally all the resources allocated will ensure patients full access to innovative therapies “.
In order to support the pharmaceutical production chain of biotechnologies, according to Lorenzin “it is necessary to invest funds. In the dramatic situation of Covid – the former minister recalled – we are also in an extraordinary situation. We have financed a health fund for the emergency that amounts to almost 18 billion euros in this year and a half, and around 22 billion are foreseen in the Recovery Plan. We are in a completely different situation from the point of view of the financing of the National Health Service compared to what we experienced in the previous 10-12 years characterized by chronic underfunding. In the complementary fund that we voted on last week there are approximately 500 million euros for investments in biomedical which is a strategic asset for Italy’s economic development “.
But for the parliamentary of the Democratic Party the time has come to transform Aifa’s governance: “We must make it our FDA – he concluded – a regulatory agency capable of promoting research and science in our country in a supply chain where all the members live and interact with each other”.