Domenico Di Giorgio, director of counterfeit prevention at the Italian Medicines Agency (AIFA) told delegates at the European Directorate for the Quality of Medicines (EDQM) conference in Strasbourg last week that: “Counterfeiting of medicinal products is a very, very old problem.
“2,000 years ago Dioscorides wrote the first pharmacopoeia in which he gave advice on how to detect counterfeit or falsified medicines.”
However, unlike its regularly updated modern equivalent, there was only ever a single edition of Dioscorides which Di Giorgio joked is an indication drug faking has become more common.
More seriously, he pointed to French customs’ recent seizure of 10 tonnes of counterfeit pharmaceutical products shipped from China as “tea” as well as the thousands of smaller shipments of fake drugs stopped by authorities each year as evidence of the scale and complexity of the problem.
“Imagine living in a world where doctors are afraid to write prescriptions because it was unclear whether or not the pharmacy had real pharmaceuticals,” Di Giorgio said, warning that this already happens in Africa, Asia and Latin America.
Online problem
So counterfeiting is not new and efforts to prevent fake medicines penetrating the European supply chain are important for patient safety.
But are fake drugs in pharmacies the real problem in Europe?
Not really according to Di Giorgio, who said that in Europe there are few deaths resulting from the use of fake pharmaceutical products.
He contrasted this with the damage done by fake anti-malarial drugs that lack APIs, explaining that: "The most counterfeited products in the world are antibiotics and anti-malarials” adding that in Africa “drugs without active material are the most deadly because people are dying as a result of not treated correctly.”
In Europe, where organisations like EDQM’s laboratory network collaborate with forensic units, customs and law enforcement officials, fake drugs in the legitimate supply chain are less of a problem according to Di Giorgio, citing Know-X database data.
“In 2017, we analysed more than 5,000 suspicious products, 4,000 of which were counterfeit or falsified…but only 23 of them were from the legal supply chain.”
“In reality it means the problem is in the illegal chain” according to Di Giorgio, who said online pharmacies are the biggest source of fakes.
Slimming and dietary supplements
In Europe, the bigger problem is drug ingredients in dietary supplements according to Di Giorgio.
He explained that the EDQM lab network recently tested 370 dietary supplement samples, most of which were labelled as “herbal” medical products from China, and found that 47% contained undeclared APIs.
Similarly, half of the 520 batches of supplements billed as sexual enhancement products that were analysed by the EDQM were found to contain APIs.
“Of course the [drug counterfeiting] problem in European countries is a very big one, but while the 2011 Falsified medicines directive and the Medicrime convention have touched the problem in the legal chain, which is not really the biggest in Europe.
“The biggest problem is in the dietary supplement market, which are food of course. In reality, not many institutions are interested in it” Di Giorgio. Said, adding that “this is the problem of counterfeit medicinal products. Food, not medicines.”