A matter of life and death

© Takeda

© Takeda

© teas SE

© Pixelio

© Pixelio

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There is a significant growth of counterfeit drugs the world over. Following WHO information, about half of the drugs offered on the Internet in industrialised countries are not what they pretend to be. Over the past few months some 34 million of counterfeit tablets were confiscated during customs controls within EU member states alone.
Mr. Guenter Verheugen, an EU commissioner, referred to an "attempted mass murder".

No sector has been spared its share of product counterfeits, piracy and plagiarism. Every year, counterfeit products worth many billion Euros are brought on to the market, causing tremendous damage. Over and above, this represents a blow to the brand’s image and customer confidence. The sales of brand manufacturers suffer. But what is at stake is no longer just economic disaster. If counterfeit spares, say for planes and cars, do not comply with the safety requirements imposed on original manufacturer-supplied parts, they endanger human lives. The same holds true for the pharmaceutical industries. According to the latest estimates, between 6% and 10% of the pharmaceutical products sold on the world market are counterfeit products. And this percentage is on the increase. Dangers are therefore evident in dimensions that literally involve questions of life and death.

Fully traceable

Counterfeit drugs, ending up in ever greater numbers in the hands of patients mainly involve antibiotics, cancer and malaria medication, statins, analgesics, slimming pills and Viagra. Following a study submitted by OpSec Security over 90% of the suppliers of counterfeit medication are based in China and India. Medical care in these countries is also affected by this issue. Thus, the South China Business Journal reported that as early as in 2002 some 200,000 to 300,000 people in China alone died after taking counterfeit drugs.
This does not mean, however, that these drugs are also shipped into the world at large from those countries. Many B2B platforms operate warehouses in Europe to supply their European customers via these facilities, so as to circumvent customs controls. A major problem results from insufficient controls of web-based suppliers. The latter again and again offer new versions, attracting potential customers with rock-bottom prices. This pricing competition between mail order suppliers leads to purchasing reactions of intermediate traders that can no longer be properly controlled. Patients are hardly in a position to establish beyond doubt whether their purchases come from a safe mail order pharmacy operating within the law, or from an illegal supplier. It is expected that the EU will take specific action to fight the trade in counterfeit drugs in 2010. On 7 December 2009, DIE WELT, a German newspaper, quoted Mr. Guenter Verheugen, the EU commissioner: "I reckon that an agreement will be reached by the EU next year, allowing for 100% of drugs, starting from manufacturing and ending at the point of sale. To do so, safety coding will be put on drug packages, including a bar code. There will also be a seal. This allows for clear proof, whether, and - if so - by whom, a package was opened and will prevent any manipulation".

More effective measures of protection

What pharmaceutical companies stand in urgent need of is a set of effective ways to protect consumers, as well as their brands, against such unnecessary risks. Drug labelling therefore is an indispensable first step to install a successful tracing system to chase away illegal suppliers. Optimum effects will be guaranteed by multiple-layer safety solutions to certify that pharmaceutical products represent the genuine stuff. Numerous technologies can be called upon to provide such open or covert protective measures, which are tamper-proof. A recent example was offered by the Tesa Scribos company towards the end of last year. The company added a new solution to its portfolio. It is called “Tesa CodeSeal” and comes with an integrated code. Although traditional safety labelling allows uncovering illicit package opening, this method mostly fell short of proving where the product was made and whether it was genuine. This new label, offered by an affiliate of Tesa SE, now combines a proof for visible manipulations with a label-specific security code. Both label and code form an inseparable entity, and every label has a computer-calculated identity of its own. There are specific encryption processes in place to prevent product pirates from generating valid manufacturing codes. Incorporating codes into the code seal label will, from the very onset, condemn to failure any attempted forgeries. The manufacturer also promises that additional contents, such as bar codes allowing for product traceability may be integrated into this concept without the slightest problem.

Safety by design

This safety code, made visible by removing the label to be completed afterwards, may be verified by the human eye or by involving internet links or text messages, respectively. In addition, each and every code may serve as access identification for customer and product registration in customer loyalty reward programmes. Also, there is much room for individual design concepts. There is also a need for completing a successful balancing act between regulatory requirements and the intended packaging design. This means that there are ever more complex needs covering the primary packaging of medicines. Over and above optimised packaging processes, this also involves matters of outsourcing manufacturing to other countries. As an example, there are estimates according to which 80% of the agents used by US manufacturers are imported and 40% of over-the counter medication sold in the United States also comes from abroad. These figures make it mandatory for every manufacturer to check very closely whether sufficient controls are in place in those countries to prevent counterfeit products from being made. Also, in-process control methodology will assume ever greater importance.