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The expected amendment of the speakers which provides for changes to the rules established by the spending review on the methods of prescribing generics has been shelved for the moment by the Industry Commission pending the opinion of the Budget.
28 NOV – For now, no changes have been made to the spending review and to the regulations which require the indication of the active ingredient on the prescription when prescribing equivalent drugs.
The Industry Commission of the Senate has in fact shelved, pending the opinion of the Budget Commission, the amendment 13.0.100 of the rapporteurs to the "Growth" decree law, which incorporates the amendment proposed by last week by Senator Germontani (Api-Fli).
The text of the shelved amendment softens the government rule by providing the doctor with the double possibility: either to write the active ingredient or to write both the active ingredient and the commercial name of the generic drug.
News also for pharmacists who will be authorized to replace the generic with another product at the same price, if the customer requests it and this also in the case of indication of the name of the medicine on the prescription by the doctor.
However, the prohibition of replacing the medicine remains if the doctor has placed the wording "non-replaceable" duly justified on the prescription. The indication of the medicinal product by the doctor is binding for the pharmacist even in the case of products with the same price, unless otherwise requested by the customer.
Another novelty is the possibility for pharmaceutical companies to reduce the price of their expired patent medicines at the same time as an equivalent goes on the market. With a rule of 2009, which the amendment repeals, these companies, for the first nine months following the placing on the market of the equivalent, can in fact lower their prices but not to the level of those of the equivalent (cf. paragraph 4, art.13, law 77/2009).
And finally the obligation for the Regions to comply with the indications of AIFA with reference to the therapeutic equivalence between medicines with different active ingredients.