New EU Guidelines for Counterfeit Pharmaceuticals

©GS1-Germany

In February of this year, the European Parliament approved an additional section of the EU pharmaceuticals package: In the future, pharmaceuticals which require prescriptions must mandatorily have safety information on their packaging which documents their genuineness and thus effectively declares war on the counterfeit pharmaceuticals.

“I am very happy that we have succeeded in reaching an agreement on this sensitive topic in a very prompt fashion. Owing to a substantial increase in counterfeit pharmaceuticals, this is urgently required and will greatly benefit patients and consumers in Europe”, declared the German EU Parliament member Peter Liese in this regard. With the overwhelming adoption of the corresponding EU Guideline, an authentification system is supposed to prevent counterfeit pharmaceuticals from making their way into legal sales channels. Beginning in 2013, the new provision in the individual EU member countries is supposed to be incorporated into national law.

More Lucrative than the Drug Trade

Counterfeiting pharmaceuticals has since become more lucrative for criminals than dealing drugs. According to information provided by the Bundesvereinigung Deutscher Apothekerverbände (German Pharmacists’ Association), a kilogram of a counterfeit of the lifestyle pharmaceutical Viagra® cost on average 90,000 euro in 2008 on the black market. A kilogram of cocaine costs an estimated 65,000 euro, heroine 50,000 euro, marijuana 8,000 euro and ecstasy 1,300 euro. But it has long since no longer just involved lifestyle medications like Viagra, anabolic steroids or diet pills. Even pharmaceuticals fighting cancer or HIV are being counterfeited and sold and thus concretely endanger people’s lives. The fight against counterfeit pharmaceuticals is supposed to now be taken up across Europe because, according to the experts, it can no longer just be waged upon a national level.

Safety Information on the Packaging

Among other things, it has been mandated that new safety information will be affixed to the pharmaceuticals packaging and the documentation of the sales channels will be improved. When the sale is being made, the scanning of the bar code is supposed to precisely check where the medication originated and whether it is an original preparation. The law is obligatory initially only for pharmaceuticals which require prescriptions. However, within five years, it is supposed to be examined whether even pharmaceutical OTC products that are sold without a prescription can be included.

Counterfeits on the Internet

But even the problem of trading counterfeits on the Internet is supposed to be addressed. Through an EU logo which the Commission will mandate for the websites of Internet pharmacies, it is supposed to make it easier for the consumer to check whether the individual website belongs to a certified pharmacy. The guideline also mandates that all certified Internet pharmacies be linked to a central website of the member countries which again are supposed to be linked to a European web site. An early warning system, which has also been included in the EU guideline, is also supposed to help: As soon as a counterfeit medication is discovered in Europe, all EU member countries and players in the supply chains are supposed to be notified – and thus it will be guaranteed that the consumers will be quickly protected.

Option: The 2-D Data Matrix Code

However, it is still not completely clear how the authentification systems are supposed to look precisely because the safety information requirement that has been adopted has not yet been implemented. Currently, options such as, for example, serialisation numbers, bar codes or 2-D data matrix codes are being considered. Thus, each product will leave its tracks because it will be read by all participants from production to the incoming and outgoing goods deliveries as well as when storage and commissioning are made. Any information about the flow of goods can be saved in databases and makes it possible to have a detailed reconstruction of the entire value-creation chain. If counterfeit products are smuggled in, then the history of the product will be disrupted and will become noticeable: This can be, for example, a serialised EAN upon a counterfeit product which was not assigned by the manufacturer or the packaging has an identification number which had already been assigned which was thus collected multiple times at different locations when it was read.

The “Wolke Inks & Printers” Company will use the interpack to introduce its “m600” printing systems, by means of the use of which such identification features can already today be clearly and precisely affixed. With the “m600 advanced” inkjet printing system, for example, product, outer packaging and transport packaging can be directly affixed with clearly readable, variable data that are printed in high resolution – such as bar codes, 2-D data matrix codes, GTIN information, expiration dates, logos or batch numbers. Even the overprint of the individual serial numbers, encrypted in a 2-D bar code, is possible without any problems owing to a corresponding coding system. According to information provided by the company, the production speeds are approx. 300 metres per minute.