Italian Drug Producers Warn of Potential Medicine Shortages Due to EU Track-and-Trace Regulation
Italian drug producers, represented by Farmindustria and Egualia, have issued a stark warning to the government about an impending pharmaceutical crisis. From February, millions of people in Italy could find that certain drugs are no longer available on the market. The cause behind this potential catastrophe lies in a seemingly minor issue that has been discussed among pharmaceutical companies, the Ministry of Health, and the Italian Medicines Agency (AIFA) for years: the traceability of medicines.
Italy was among the first European countries to implement a tracking system for prescription drugs and over-the-counter medications. Since 2014, every medicine purchased from a pharmacy has sported an intricate label – known as the pharmaceutical bollino – comprising three layers with information and codes ensuring the authenticity of the drug. AIFA data shows that, thanks to this bollino, the prevalence of counterfeit medicines in Italy is virtually non-existent, at 0.1%. In Europe, the figure stands at 1%.
However, Italy must now align with a 2016 EU regulation that introduced a new, standardized tracking system for all European countries. This new model mandates the printing of a two-dimensional Datamatrix code on each package, the establishment of a national archive linked to the European Medicines Verification System (EMVS) to verify a medicine’s authenticity, and the use of tamper-proof packaging to prevent tampering.
Italy and Greece were granted a six-year derogation to adapt to this new system due to their recent adoption of effective tracking measures. That derogation expires on February 9, 2025.
The Datamatrix code can be read by devices used throughout the supply chain, from pharmaceutical companies to pharmacists. It contains a unique product code, a serial number, the production lot number, and the expiration date. This code allows pharmacists to cross-reference data in real-time with the Italian and European archives to detect counterfeits.
The regulation also requires packaging that cannot be easily tampered with, using techniques such as special seals that show if a package has been opened before it was sold.
In January of this year, a joint venture called NMVO (National Medicines Verification Organisation) was formed to adapt Italian production to the new requirements. The NMVO, along with the Ministry of Health and AIFA, has held numerous meetings to discuss the implementation of the new rules.
On August 30, the Council of Ministers approved a draft decree-law laying out the general principles for adjusting Italian procedures to the EU regulation. Parliament has given a favorable opinion with observations, but the government has yet to give final approval.
Pharmaceutical companies and pharmacist associations have repeatedly urged the Ministry of Health to accelerate the process or, at the very least, allow for a transition period to the new rules. Despite the urgency, important details remain unclear. Companies do not know how to adapt their complex production processes, and it is not clear whether tamper-proof seals must be made using special paper provided by the state printing institute or if existing market seals will suffice.
Furthermore, the draft decree does not specify what should happen to packages produced with the old bollino, nor has any testing been done with Datamatrix reading devices. The decree proposes fines of up to €80,000 for each non-compliant sale, a figure that pharmacist associations deem excessive compared to those in Germany, Spain, and France.
The booming industry is seeking an adjustment period of between 18 and 24 months from February, suggesting that negotiations with the government have so far been unsuccessful. Without a clear path forward and with the deadline looming, the pharmaceutical industry warns of potential medicine shortages that could have severe repercussions on public health.
