ROME (ITALPRESS) – “In addition to the mockery the damage, both for the pharmaceutical industry, which is a strategic lever of the country, and for the health of citizens. Pharmaceutical companies, already affected by a Budget Law that represents a ‘mazzatà for its competitiveness, have learned that the application of the EU regulation on the European tracking of medicines, would oblige them to adopt in their complex industrial processes, from February 9, 2025, some provisions of which to date are not even known technical specifications. Provisions that would require administrative steps and authorizations that are still unclear.” Thus Farmindustria and Egualia in a joint note, pointing out that “the texts circulated would lack obvious elements such as the necessary transition period of at least 24 months for the fulfillments required of companies and such as the certainty of being able to continue to operate according to the standards in force today for a period suitable to update their procedures. The enabling act provides for a reasonable time for adaptation; all countries have it. Only Italy would lack it. In compliance with other regulations, companies would thus not be able to proceed with the release for marketing of batches of drugs produced after February 9, 2025. This would mean a real and dramatic risk of drug shortages, even for serious diseases, and production stoppages. It would also have critical effects on ’employment. A state of crisis, then, with heavy consequences for the whole country, which must be avoided without fail. The industry,” they continue, “has repeatedly represented these risks to the institutions since 2022, offering the widest availability for confrontation. The mechanism as icing on the cake would also foresee in Italy, compared to the EU regulations, the persistence of additional devices to be affixed on the packages that will generate additional costs for companies and industrial complexities, so far completely ignored. Citizens who would also pay the costs would see their health protection seriously challenged. Without the government’s immediate acknowledgement of what the industry, which has always been committed to continuity in the supply of medicines, has reported, companies would be forced to declare shortages for a great many medicines without any responsibility, with predictable social alarms. This would be an unbelievable outcome for those who care about the good of Italy. And the pharmaceutical industry is certainly among them,” they conclude.(ITALPRESS).-Photo: Ipa Agency-
