Unavailable drugs, prices increased tenfold: Aifa blocks export of 30 medicines

ROME – There is a shortage of medicines on Italian soil. For several months, important medicines, even life-saving ones, have been diverted to richer markets – starting with Switzerland –, where there is a private willingness to pay a decidedly higher price for the same pharmaceutical product. Even ten times as much.

The Italian Medicines Agency (AIFA) became aware of the anomalous traffic of products abroad and intervened, blocking the export of thirty labels, the last seven of which were stopped at the end of June.

A third of the handbook is missing

Of a list of 10,000 drugs, the Italian market is short of 3,876 (half of which have actually ceased marketing). Of these, 325 do not have an equivalent, i.e. a generic or a biosimilar. Only 32, however, do not have a real therapeutic alternative. For these, Aifa has decided to start importing.

Among the missing and importable packages, some have been showing distribution problems since July 2017 (the tablets of Mifepristone from the Exelgyn, which has since been out of the market). For others, however, production problems are expected until July 2027: the Pancrelipation from the Viatris Italia, for example: it is necessary for pancreatic insufficiencies and there is no substitute drug.

From September 6th to October 15th there was not and there will not be the flu vaccine (nasal spray) from Astrazeneca. Pfizer will have problems with the Methotrexate sodium until the end of the year.

Fines for those who do not report their absence

The causes of a shortage may depend on the unavailability of the active ingredient (increasingly produced in China and India), production-related issues, regulatory measures, an unexpected increase in requests for the medicine or concentrated health emergencies. If the checks carried out reveal a shortage not communicated by the pharmaceutical company, the Region can report it to AIFA and start a procedure that will lead to a sanction imposed on the legal person responsible for the authorisation and marketing of the medicine (AIC).

In the absence of an equivalent or therapeutic alternative, hospitals and health companies can request to import the drug. Among the thirty-two present in the six-monthly list (March-August 2024), Aifa has decided to channel to the national territory, for example, the Trimeton for allergic rhinitis, the Pyramid of the Moon Persantini for anticoagulant therapies, theAltiaz post-infarction, the Methotrexate for the treatment of leukemia, rheumatoid arthritis, psoriasis. Finally, drugs for kidney failure, the treatment of schizophrenia, both adolescent and adult, have been recalled.

Creon costs seven times more in Switzerland

The history of the Creon, in its three dosages, is exemplary. It is a necessary medicine for pancreatic insufficiencies and difficult to find in Italian pharmacies. It would cost 17.34 euros. When it is on the shelf, it is sold at double the price here, but it can be requested in Italian Switzerland. They ship it upon bank transfer of 125 euros, seven times as much. Some Regions (Piedmont) are purchasing it on their own to distribute it in local pharmacies.

The scientific technical director of Aifa, Giampiero Russoexplains: “In a globalized world, the issue of drug shortages is a complex and now chronic problem. The new Scientific-Economic Commission of the Ministry of Health, in operation since February, has inherited a large backlog and is trying to reduce intervention times, but it is not easy to do so in advance. We often have to chase the problem. A relevant aspect of shortages is communication, sometimes a Region makes a mistake in making the tender and then has difficulty finding the drug. Attention on the issue is at a European level, but there is no doubt that pharmaceutical companies tend to go towards markets that guarantee them greater economic returns. Often these private individuals, when they enter into negotiations with us, take into account the prices they apply abroad. Economic pressure exists, indeed. And speaking of Creon, last year we purchased large quantities through the Military Pharmaceutical Institute. Often, however, we show problems of internal knowledge. We will make an effort to periodically communicate all information, but the provisions of the AIFA are not well received by the Regions and pharmacies. Many oncology doctors, for example, did not know that they could use a procedure to obtain another lacking drug, 5-fluorouracil”.