Replacing drugs in pharmacies, new in France and Germany.

Fedaisf editorial staff

June 26, 2019

Bacchini: from Italy we look very carefully

Federfarma – 26 giugno 2019

A partire dall’estate del 2022 i farmacisti tedeschi potranno sostituire i biosimilari mentre in Francia in caso di carenze o rotture di stock di un farmaco salvavita, i farmacisti potranno procedere alla sostituzione con un altro medicinale previa segnalazione al medico prescrittore. Due rilevanti novità dell’ultimo periodo guardate con molto interesse anche alle nostre latitudini. Sulla base del disegno di legge tedesco l’ente federale per l’Health Technology Assessment (G-Ba) pubblicherà prima un regolamento per stabilire l’intercambiabilità dei medicinali biologici con i loro biosimilari entro un anno dall’emanazione della legge, ovvero a metà del 2020. Successivamente G-Ba deciderà di estendere anche ai biosimilari l’obbligo di sostituibilità attualmente applicato ai generici, in base al quale i farmacisti sono tenuti a dispensare il farmaco più economico, in assenza di precisa diversa indicazione del prescrittore nella Legge sul servizio sanitario (Loi santé), approvata dal Senato e ora in viaggio verso l’Assemblea per l’ultima lettura.

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.