Drug shortages have reached record levels: the situation in Italy and the EU
The causes are well known: production problems, shortages of active ingredients, concentration of production in Asia and logistical fragilities. To which is added an issue of information capillarity
Key points
In Italy, the phenomenon of medicine shortages reached record proportions in August. According to data from Aifa and Sifo, more than 4,000 medicines were in short supply, including antibiotics, anticancer drugs, anticoagulants, and commonly used products such as analgesics and antidepressants. In mid-October, the Agency's updated list counted almost 3,000 entries: the essential bronchodilator for asthma or bronchospasm sufferers, salbutamol, is among the most difficult to find, even in its equivalent versions. Reports are coming in from all over Italy. Assoutenti speaks of parents forced to 'go round dozens of pharmacies' to find essential medicines.
La stessa emergenza colpisce gli ospedali: oncologi del Policlinico Gemelli di Roma e farmacisti ospedalieri di Palermo e Udine riferiscono difficoltà nel reperire molecole fondamentali come vincristina, capecitabina e lenalidomide, utilizzate nei protocolli antitumorali. In diversi casi si è dovuto ricorrere all’importazione dall’estero o a protocolli terapeutici sostitutivi, con conseguenze pesanti per la continuità delle cure. Come conferma lo studio Sifo-Aifa 2024 da cui emerge che il 97% dei sanitari ha dovuto gestire pazienti in attesa di farmaci non disponibili, con effetti su continuità terapeutica e fiducia nel sistema. Le cause sono note: problemi produttivi, scarsità di principi attivi, concentrazione della produzione in Asia e fragilità logistiche. A ciò si aggiunge la frammentazione del sistema di segnalazione: sebbene l’Aifa disponga di un elenco aggiornato e blocchi temporanei all’export, i flussi informativi tra aziende, regioni e farmacie non sono sempre tempestivi. Lo strument
The government has announced a plan for security of supply with accelerated import procedures, incentives for domestic production and a portal for traceability. However, the measures are still being finalised.
Then there is the issue of equivalent (or generic) drugs, which is crucial. As Stefano Collatina, president of Egualia, points out, if prices stand still while costs rise, many companies will abandon essential medicines. The sector, he argues, is not asking for subsidies but for 'sustainable rules': multi-adjudication tenders, realistic auction bases, incentives for European production and a review of the payback.
Equivalents ensure access to basic care for millions of patients and are the backbone of the health service. Their economic sustainability is therefore also a matter of national security, as Nomisma and industry analysts point out, linking the crisis to the global dynamics of active ingredient supply.
