Historical Archive

Generic debates.

“I think it is essential to ensure market competitiveness, also by boosting the generic drug sector: although it is not true that equivalents in Italy are unable to take off, given that they have already won a slice equal to 13% of the market and 24% of prescriptions, we must set ourselves the goal of reaching at least 15% as happens in other European countries”. Thus Nello Martini, general director of AIFA in his speech at the seminar "Therapeutic handbooks: state of the art and prospects" organized by the Region. ln other words, the generic is now part of the Italian pharmaceutical scenario and if anyone thinks that the trend can be reversed, they are miscalculating. Martini's intervention came at the end of a rather eventful week on this front, which opened with the controversy over the resolution of the Liguria Region, which charged the health service only with the prescription of generic lansoprazole, requiring the patient to pay the difference between generic and specialty pricing across the proton pump inhibitor class.
Not a small change, given that up to now the principle of cost sharing only applied to equivalent specialties. The first to protest were, inevitably, the Ligurian general practitioners of the FIMMG. "According to the scientific literature - said the regional secretary Francesco Prete - compared to lansoprazole, rabeprazole and esomeprazole demonstrate a greater rapidity of action and pantoprazole has a lower incidence of contraindications in the elderly who take many other drugs". This, according to Prete, could undermine the relationship of trust between family doctors and their patients. "We - he underlines - will continue to prescribe according to science and conscience, but we will be forced to note that many Ligurians will be forced to settle for the generic, pace of article 32 of the Constitution, to protect the health of the individual". The position expressed by Prete was confirmed the next day by the national secretary of the union, Giacomo Milill "The risk in our opinion - continued Milillo - is that the tools proposed to deal with the system's funding criticalities are all oriented towards the rationing of services to the detriment of public health. In particular, with regard to pharmaceutical expenditure, the use of the reference price for drug classes effectively relieves the doctor of the responsibility for prescribing, endangering the safety of patients. All this happens despite the fact that not all drugs of the same class have the same characteristics. If this were the case, in fact, AIFA could admit only one drug per class to reimbursement by the NHS, the one with the best cost-benefit ratio”.
The president of the Italian Pharmacology Society (SIF) Giovanni Biggio intervened in support of Liguria's position, saying he was in favor of the prescription of the generic lansoprazole which, “with rare exceptions, will not jeopardize the effectiveness of the treatment. I understand” added Biggio “that this legislation may have generated a sense of constraint in the doctors, but the protest should be accompanied by scientific documentation demonstrating that lansoprazole has markedly lower efficacy. And therefore it cannot replace the other branded drugs ”.
But it didn't end there, of course. Claudio Cricelli, president of the Italian Society of General Medicine addressed the issue from another point of view. "Only the Italian Medicines Agency can be the point of reference for the prescription of generics" said Cricelli "The indications of the Regions are valid only for administrative purposes and must be

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Fedaiisf Federazione delle Associazioni Italiane degli Informatori Scientifici del Farmaco e del Parafarmaco