The silent pandemic

Today as many as 1 in 10 medicines sold internationally are counterfeits. In some emerging countries that figure may be closer to 7 out of 10. Counterfeiters target branded drugs as well as their generic alternatives. Responsible for up to 700,000 deaths worldwide every year, the scourge of counterfeit medicines has become a global pandemic.

The Pangea V & VI operations, simultaneously coordinated by Interpol in 99 countries worldwide, including France, led to the dismantling of several production networks and the seizure of millions of counterfeit drugs. Produced predominantly in Asia and then shipped to Europe, these false medicines enter the legitimate distribution chain via unscrupulous wholesalers. In recent year the trade in fake drugs has expanded dramatically in developed nations thanks to the internet. Online sales have become the preferred method of distribution for counterfeiters, attracting millions of web users. Every day more people buy drugs online, oblivious to the fact that 50% of the products on offer are fakes. People turn to the internet for their medicines in order to save time or money, or to freely buy medicines which would normally require a doctor’s prescription.

A serious health risk

Flexmag06-Focus02 Flexmag06-Focus03

Leaving aside the money lost by the legitimate pharmaceutical industry, by far the most important issue at stake here is the risk posed to patients. In the best case scenario, these counterfeit products contain little or no active ingredient. In such cases the medicines are ineffective and the treatment will not work. On the other hand, an excessive concentration of the active ingredients can have some very serious side effects. In order to simplify the manufacturing process, many counterfeiters have no qualms about using toxic substances such as lead paint, wax, arsenic or boric acid, all of which can prove lethal for the unsuspecting patient. Moreover, insalubrious production conditions can cause further complications, as many clandestine laboratories are crawling with bacteria and contaminant particles.

IV bag primary packaging, a method of combatting counterfeits injectable drugs

Until 2010 it was generally only dry medicines which were at risk from the counterfeiters, but nowadays counterfeit injectables are also a serious problem. These drugs are used in the treatment of severe illnesses (cancer, heart problems, serious infections), and fakes have been found in a number of clinics in the USA. However according to the IRACM (Institute of Research Against Counterfeit Medicines) no injectable solution packaged in flexible bags has yet been successfully counterfeited. Filling and sealing these supple bags requires sophisticated equipment and materials: a special filling nozzle to fill the bags, and a specially-adapted connector to seal them (twist-off, luer-lock etc.) The filled bag can only be correctly sealed via a thermo-sealing process, which requires highly specialised equipment. Furthermore, injectable products in sealed bags are always packed in additional protective packaging. This additional level of security makes pouched products all the more difficult for counterfeiters to reproduce.

Appalling figures of counterfeit drugs

  • 1 sold drug in 10 is likely a fake (FDA)
  • Responsible for 700 000 deaths per year (IPN-2009)
  • A $ 75 billion fake drug trafficking (WHO-2010)
  • 7 millions doses of fake medecines seized by European Customs (EC-2009)

Sylvie Ponlot

EC: European Commission
FDA: Food and Drug Administration
IPN: International Policy Network
WHO: World Health Organisation