The AIFA press release is very short, but also very clear. "With reference to the news that appeared in the press about the non-substitutability of antiepileptic drugs with generic-equivalent medicines containing the same active ingredient, the Agency specifies that no regulatory procedure has been implemented and that, in any case, no decision can debate the general principle of the equivalence of generic medicines and the criterion of substitutability". The question of a possible modification of the substitutability procedures arose from the dissemination of an opinion of the Technical-Scientific Commission (CTS) of AIFA itself. According to the CTS document, for three classes of drugs, antiepileptics, blood products and biological drugs (this category is quite broad) "the possibility that the pharmacist replaces the drug prescribed by the doctor is inadvisable due to problems of a clinical nature. It is therefore appropriate - claims the CTS - do not include them in the lists of equivalent drugs with relative reference prices, developed by the Agency" . Commenting, Walter Marrocco, family doctor and member of the commission, had declared that "in some cases, chemical differences, even minimal in the products, can create difficulties in the treatment of some pathologies. In these particular situations, in which even minimal variations count , it is necessary to ensure that the patient can keep the drug (brand or generic) that has been shown to be most effective for him".
AIFA's clarification now disproves the possibility, in some ways implicit in the statements previously reported, that a sort of branded generic is created, or rather a generic specialty, to which characteristics different from those of the other generics can be attributed. The case of biological drugs is perhaps different, on which there are different positions in the scientific community: while the concept of biosimilar has been accepted in Europe, in the United States the FDA has not yet reached a conclusion. In fact, many believe that due to the peculiarities with which biological drugs are obtained from selected cell lines, it is difficult to hypothesize the preparation of an exactly equivalent drug without having the original material.
But that of generic drugs remains a hot topic, despite the fact that similar concerns do not arise in the rest of Europe, where the generic drug has been present for some time and has reached a far greater diffusion. The latest position taken in this regard, the one expressed by a note from the Italian Federation of general practitioners, the main trade union in the category. "We are ready to make further efforts to support and promote the prescription of generic medicines in daily practice, let's open a discussion on substitutability and launch a concrete proposal: a study of effectiveness with the involvement of all general medicine" reads the document, signed by national secretary Giacomo Milillo. "The drug represents a fundamental tool for us family doctors who use it in clinical practice. Furthermore, FIMMG - underlines Milillo - believes so much in this statement that it has decided to dedicate the next national congress to the drug. We do not think to question the general principle of the equivalence of generic medicines, however we would like to open a profound reflection on substitutability and not only for medicines with a narrow therapeutic range: we believe it is useful to intervene on all medicines and in particular on those used for the treatment of chronic conditions that must be taken for long periods of time”.
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