A very painful determination. This is the AIFA act on therapeutic equivalence, the one that should allow the Regions to compete with each other drugs with different active ingredients but with the same indication and without any superiority studies. Obviously being able to proceed with tenders in which different products are put into competition but with similar results on the same pathologies would lead to savings, and obviously the industry does not welcome the act, indeed it openly opposes it given that some time ago it threatened to make appeals after appeals.
The outgoing director of Aifa, Luca Pani, had published the decision on March 31st and then suspended it within a few days. It was decided due to the critical issues "from many sides and also reported to the Ministry of Health", taking time to assess the situation. However, the deed is required by a 2012 law by the then minister Balduzzi and Aifa will be unlikely to be able to withdraw it: a final decision will need to be made in November. Pani is outgoing and will probably leave this rather uncomfortable story behind.
On the one hand, the system's need to contain costs while maintaining the best possible level of care for patients, on the other, the industry that wants to make profits and moves its pawns. Just today Federanziani, one of the most active patient associations, which receives important economic contributions from the world of the pharmaceutical industry, has 
deployed asking for the withdrawal of this determination, after going to speak directly with the president of the drug agency Mario Melazzini.
Attention, we are not talking about an absolute novelty. For some years now, competitions for therapeutic equivalence have been held in Italy. There were Regions which through a tender chose which drug to use, for example to combat cholesterol, among the many on the market with the same effects. Obviously the winner covered only a certain percentage of needs, because there was still the possibility (for about 20-30% of patients) of having a different therapy on the basis of the doctor's certificate. The Balduzzi law has delegated to AIFA the task of establishing the criteria on the basis of which different drugs can be considered equivalent. But AIFA now, or rather for four years, has to make the determination.
It will soon be understood if the pressures of the industry and of the pawns it is able to move will prevail over a law and if the Medicines Agency, which awaits new top management and therefore a new way of working, will bow its head or not.
(A note: I see that the family doctors' unions are taking sides for the withdrawal of the determination. But the drugs taken into consideration are mainly hospitals, therefore they have nothing to do with those professionals)
Michele Bocci – 19 October 2016 – R.it Blog
Related news: Determines AIFA 458 of 03/31/2016
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Scaccabarozzi: anti-modernist whoever supports therapeutic equivalence
