Rome, 20 January - If an active ingredient is not available on the market in the raw material state, the pharmacist can use the one available in an industrially produced and patented medicine, since he has no other alternatives to guarantee the patient the possibility to take advantage of the personalized medicine prescribed by the doctor.
The Council of State, confirming a previous sentence of the Lombardy Regional Administrative Court (the n.11/2015, branch of Brescia) recognized the legitimacy of the unpacking of industrially produced medicines by the pharmacist to use the active ingredient in the preparation of a masterful galenic formula.
He established it sentence no. 4257/2015, intervening in the context of a judgment on the assignment of home parenteral nutritional supply with bags of mixtures prepared on personalized prescription.
"What happens when preparing personalized nutritional mixtures, if you think about it, is that the doctor sends the pharmacist a prescription in which he indicates the quantities of each active ingredient he wants to be included in the preparation for the individual patient" reads the sentence drafted by the councilor Massimiliano Nocelli.“If the active ingredient is on the market in the raw material state, the pharmacist procures it from the manufacturer and proceeds with the preparation. If, on the other hand, the active ingredient is found in an industrially produced medicine, he can do nothing but use that, since there is no other way to guarantee the patient the possibility of using the personalized medicine that has been prescribed by the doctor".
"In other words, in order to prepare the galenic formula, the pharmacist must directly contact the possible patent holder or the authorized companies or distributors to obtain the active ingredient subject to industrial property rights" can still be read in the sentence, which in this regard refers to the ruling of the Cass. pen., section II, no. 5573 of 14 February 2012, which referring precisely to the galenic exception (art. 68 of legislative decree 30/2005), clarified that it contains "a regulatory clarification introduced in order to better protect the patent right, given the proliferation of the illegal trade in industrially produced active ingredients", without therefore forbidding the pharmacist "to prepare the master's formula also with principles covered by industrial property rights, provided that the preparation takes place in full compliance with the medical prescriptions."
Nor did the appeal by the appellant appear convincing to the judges of Palazzo Spada to a subsequent sentence of the Cass. pen., section fer., the no. 39187 of 29 August 2013, which on the contrary clarified that the purpose of the galenic exception is precisely to "allow the pharmacist to prepare and sell to the patient a medicine with a different dosage or with a different excipient compared to that of the medicine offered for sale by the patent holder and this only in cases where the patient needs this different dosage or is allergic to the excipient used for the medicinal product marketed by the patent holder."
