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Counterfeiting of high-cost hospital medicines: new Urgent Alert in Europe

The new targets of pharmaceutical crime, subject to forgery and theft, are not only monoclonal antibodies, whose market values range from two to twenty million Euros per kg (with an average of eight million/kg against 36,000 Euros/kg of gold), but many other high-cost medicines.

On August 3, the regulatory authority of the Czech Republic released a new Urgent Alert (Rapid Alert) concerning the counterfeiting of Exjade, a product used in therapy against thalassemia; the blisters intercepted in the checks carried out by the company that was importing the product to the German parallel trade channel had absolutely legal lot numbers, but the production and expiration dates were tampered with, and were contaminated with non-pharmaceutical material with no correspondence to the composition original of the product.

This Rapid Alert is the latest in a series that have been published in recent months by the European authorities, and in particular the German ones, relating to the falsification of high-cost hospital products or other medicines which until a few years ago were not subject to counterfeiting, such as Herceptin , Humira, Viread or Botox: the work shared at European level on the CD "Herceptin case” has led to the development of new verification strategies shared between operators and administrations, making it possible to promptly block those infiltrations that had affected the European market in recent years.

The strengthening of the controls that generated these Alerts has led to undeniably positive results, such as the eradication of hospital thefts (which up until May 2014 were an emergency for Italy, and have ceased since that date), but has not illegal drug trafficking has certainly been eliminated: the criminal groups that manage these flows have in recent years developed various distribution strategies for their extremely dangerous products.

In recent months, the offers for these types of drugs have multiplied even on illegal websites: the web and the structures that procure from the web have become a source of risk not only for the usual counterfeit "recreational" products such as those for sexual, distributed through e-pharmacies and sex shops, but also for life-saving products or products with a critical use profile, which are illegally offered to patients and healthcare or merely commercial structures such as beauty centres, evidently not able to easily identify any counterfeits.

The "pirated" e-pharmacies sell these falsified medicines by pretending to offer "Asian" medicines, stolen from the market in developing countries, where they are legitimately distributed and produced in derogation from patent rights for humanitarian reasons; but the products that are offered are often counterfeit, ineffective or toxic copies, and criminals have no qualms about supplying them to hospital facilities, even including those that assist poor patients, as happened in 2012 in Pakistan into a humanitarian tragedy of catastrophic dimensions.

Medicines illegally supplied by uncontrolled channels, such as online pharmacies or Italian and foreign facilities not controlled by national health authorities represent a serious risk for unwary buyers: AIFA and project partners Fakeshare are about to launch a web campaign dedicated to these risks, centered on a series of (unfortunately) real cases of fatalities linked to their assumption.

AIFA – 07/08/2015

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Promote the cohesion and union of all members to allow a univocal and homogeneous vision of the professional problems inherent in the activity of pharmaceutical sales reps.

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Fedaiisf Federazione delle Associazioni Italiane degli Informatori Scientifici del Farmaco e del Parafarmaco