World Intellectual Property Organization

How can technology help to fight counterfeits?

September 2009


By Jean-Marc Bobée

The European Union reports that, compared to 2005, seizures of counterfeit drugs at EU borders increased by 380 percent in 2007. The World Health Organization (WHO) brochure “IMPACT - International Medical Products Anti-Counterfeiting Taskforce” reports on “a trail of death in Argentina” in 2004; tells the story of a 22-year old Argentine woman who died of liver failure after being injected with a highly toxic counterfeit; and notes that over 100 patients were killed in Panama by counterfeit glycerin. The danger is worldwide.

Counterfeit drugs, including counterfeit medical devices, have been made to look so similar to the genuine products that even health professionals cannot tell them apart. The article provides an overview of counterfeit medicines in the global marketplace, and identifies some of the technologies manufacturers employ to keep counterfeits out of distribution chains. It was adapted for WIPO Magazine from a longer version by Jean-Marc Bobée originally published in STP Pharma Pratiques, Volume 19, number 1, January-February 2009.

The World Health Organization (WHO) defines a counterfeit medicine as one that is deliberately and fraudulently mislabeled with respect to its identity and/or source, and this can apply to both branded and generic products. Counterfeits may include medicines with the correct ingredients, the wrong ingredients, no ingredients, insufficient active ingredients or fake packaging. In all cases, however, counterfeits are illegal. They are also dangerous and deadly products as they mislead patients into believing they are taking a medicine to preserve or improve their health while, in reality, they are not getting what they need.

WHO estimates that from 7 to 10 percent of the world’s pharmaceuticals are counterfeit. In developing countries where criminals can exploit weaker regulatory systems, this rises to 25 to 50 percent of the pharmaceutical market. Regrettably, counterfeit medicines have become big business: WHO puts the global value of trade in counterfeit pharmaceuticals at between US$32 and 46 billion. (WHO, Fact sheet No. 275, 2003).

Why counterfeit pharmaceuticals?

Counterfeiting, especially of high-end products such as medicines, tends to be an extremely lucrative criminal activity. Law enforcement and prosecution of alleged perpetrators can be challenging, and penalties often lenient – hence the growing involvement of organized crime in counterfeit medicines.

More sophisticated technology for copying legitimate labels and packages is now available and facilitates the distribution of fake products that are made to look indistinguishable from legitimate ones. And the growth of e-commerce, allowing the purchase of prescription medicines online, is a key factor in increasing counterfeit trade as it connects consumers directly with suppliers of controlled products outside the legal distribution chain, and outside the regulatory authority of government agencies.

Quality of counterfeiting improving


Can you tell the fake Novalgina from the real product? (Photo: STP Pharma Pratiques.)

Sometimes, the copy is of such good quality it is impossible to tell the difference between the fake package and the genuine one – thus requiring a physicochemical pack analysis to compare the suspicious sample with a reference sample kept by the company. As is clear from this example from Peru, a visual examination of the packing alone is not likely to help in identifying the counterfeit.

 

Technology for the fight against counterfeiting

While technology can sometimes add to the problem, it also provides tools that help manufacturers keep one step ahead in combating counterfeiters. Three key principles make up an efficient technological anti-counterfeiting strategy:

  • Use of harmonized and standardized coding and identification systems for secondary packs of pharmaceuticals;
  • Use of overt and covert features to authenticate products; and
  • Guarantees as to the integrity of the original manufacturer’s packaging throughout the entire supply chain.

Packaging – Maintaining the integrity of the original manufacturer’s packaging throughout the entire supply chain is of paramount importance. It provides a guarantee that the packaging code applied by the original manufacturer is unchanged, making it easier to spot if goods – packaging – have been tampered with. Using tamper-evidence technologies to secure secondary packaging (i.e., the packaging of the pills themselves inside the box) also helps uphold the integrity of the contents. For example, product packages can be fitted with security seals or glued with perforated cartons. Another option is to design carton folding boxes in such a way that they break (tamper evidence) when the package is first opened.

Special markings - Overt or visible markings allow authentication of products at every stage along the supply chain (e.g., wholesalers, pharmacies, hospitals, etc.). Several security features are available on the market – among which are holograms, color shifting inks and guilloches (also used for banknotes). Covert or hidden markings are used by manufacturers to authenticate genuine products and detect counterfeits. Examples are chemical tags, such as ink, which constitute a chemical signature that can be embedded in different elements of the packaging.

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Examples of special markings (from left to right): holograms, color shifting inks/films and guilloches. (Photo STP Pharma Pratiques)

The choice of authentication technologies should always be specific to each manufacturer in order to reduce the risk of copying by counterfeiters. If each company had its own proprietary system, counterfeiters would have to try to copy as many types of markers as the number of products they are trying to counterfeit.

Standardized and serialized coding and identification systems - In addition to sophisticated inner and outer packaging, and overt and covert markings, manufacturers can implement a third step: a standardized coding and identification system. Traceability and security of medicines can be controlled using specific codes imprinted on internal packaging, especially if pharmacies are equipped to interpret the codes.

While this technology already exists and is used to identify batches, or large quantities, of products, it can and should be deployed at the pharmacy level. For example, pharmacies could use a barcode reader to verify a product’s authenticity – including other information in the barcode on the product such as the batch number and expiry date. Scanning each pack at the dispensing point and linking it to e-prescription systems guarantees that each patient receives the right product, and expired products, as well as counterfeits, are automatically detected. In addition, attributing a specific, randomized number per box can prevent the dispensing of counterfeits.

Counterfeiters also keep up with the latest technological developments, meaning continued efforts to improve them are needed. However, the good news is that these technologies can make an effective contribution to building efficient anti-counterfeiting strategies, especially in the areas of authentication and traceability.

Adapted for WIPO Magazine by Thomas Bombelles, Global Challenges Division, WIPO

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