Bacchini: from Italy we look very carefully
Starting from the summer of 2022, German pharmacists will be able to replace biosimilars, while in France, in the event of shortages or out-of-stocks of a life-saving drug, pharmacists will be able to replace it with another medicine after notifying the prescriber. Two important novelties of the last period, watched with great interest also in our latitudes. Based on the German bill, the federal agency for Health Technology Assessment (G-Ba) will first publish a regulation to establish 
the interchangeability of biological medicinal products with their biosimilars within one year of the enactment of the law, i.e. in mid-2020. Subsequently, G-Ba will decide to extend the substitutability obligation currently applied to generics to biosimilars, according to which pharmacists are required to dispense the cheapest drug, in the absence of a precise different indication from the prescriber in the Health Service Law (Loi santé), approved by the Senate and now on its way to the Assembly for the last reading.
There are several measures imparted by the text of direct interest to pharmacies: the most important, obviously, remains the provision which allows the pharmacist to dispense even without a prescription some prescription drugs, intended for the treatment of "benign pathologies" and on the basis of protocols defined by the Ansm, the French drug agency. During the debate in the Senate, an amendment by the chairman of the social affairs commission (a doctor by profession) had tried to remove the measure, but in the end the chamber rejected it. Of undoubted interest is also the provision that allows pharmacies to remedy shortages and unavailability, a particularly widespread phenomenon even beyond the Alps: in the event of unavailability of one of the drugs listed in the List of medicines of major therapeutic importance (Mitm, médicament d'intérêt thérapeutique majeur), the pharmacist is authorized to replace it with another drug with the same indications, in compliance with the indications formulated by the Ansm.
"Once again we are looking very carefully at what is happening in Germany and in France" he underlines to Filodiretto Marco Bacchini, president of Federfarma Verona and member of the Federfarma Presidential Council. This is great news. Let's think of the work that was done in Italy with the contribution of pharmacists when generic drugs were introduced and therefore it is extremely interesting and must be viewed once again with a critical spirit, but trying to seize the opportunities also for our system. What is happening in France is also interesting, i.e. the possibility of replacement in the event of a shortage of medicines. An aspect that is very worrying and very topical even in our pharmacies. Let's not forget that in France there is the possibility of delivering medicines even with a prescription in certain cases and with specific pathologies. This too is a situation that needs to be looked at carefully to get ideas for Italian legislation as well” he concludes.
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