“Roche can confirm that all product associated with the batch in question was distributed by Roche to wholesalers in Romania,” the company told BioPharma-Reporter.com. “Once the product in question reached the wholesaler network, Roche has neither further control nor knowledge of the events that may have transpired.”
A spokeswoman for Roche added that whenever possible, the company "limits the number of wholesalers" that it ships drugs to. And depending "on local regulations Roche sells directly to hospitals, pharmacies or government organizations. The majority of our deliveries go to hospitals."
This is the third time in recent months that Roche products have been stolen and diverted. In June, two Roche biologics – MabThera and Avastin – were stolen and distributed illegally in Italy, though unlike the most recent case, a spokeswoman from the company said there was no evidence that the drugs were turned into counterfeits. In April, Roche had to recall nine batches of Herceptin after tampered vials were discovered in the UK, Finland, and Germany.
Roche noted that in this latest investigation, there does not appear to be any evidence that patients have been harmed by counterfeit MabThera. “As this is an ongoing investigation, we are unable to comment further on this situation and suggest you contact the appropriate health authority or law enforcement bureau for more information,” the company said.
According to German regulators, of the tampered vials, one contained a reduced amount of API, while others had missing or compromised caps, missing information leaflets, or batch numbers on their packaging that didn't match the vials, the Wall Street Journal reports.
According to a recent report from Transcrime (Joint Research Centre on Transnational Crime, Milan University), between 2006 and 2013, one hospital out of ten in Italy registered thefts of pharmaceuticals. And the average economic loss to the hospital from the theft was €330,000 ($427,000).
Track and Trace
The counterfeit discovery in Germany comes as drugmakers are beginning preparations for a tracking and verification system to further ensure the safety of the European supply chain.
Supply chain stakeholders and EFPIA (the European Federation of Pharmaceutical Industries and Associations) are currently implementing a pan-European medicines verification system, known as the European Stakeholder Model (ESM), that aims to end the resale of stolen and counterfeit drugs.
The system offers a cost-effective solution using an anti-tampering device together with 2D barcoding to verify the authenticity of medicinal products, which can combat the entry of falsified medicines in the EU supply chain and ensuring patient safety across Europe.
Serial numbers corresponding to each packaging will be recorded in the system. In cases of repackaging, there will be a link between the originators' serial numbers and the traders' serial numbers at the batch level to further secure the system.
Richard Bergström, Director General EFPIA, said: “The European Stakeholder Model is proof that, by joining together, we can best protect patients and their security in Europe. By joining the European Stakeholder Model all supply chain partners have shown their commitment to maintain the integrity of the legitimate supply chain in Europe.”