Can you say for sure that the medication you take has all the ingredients it claims to have? How would you feel if you knew that the medication you were taking was in fact harmful to your health because it contained undisclosed noxious ingredients? When medication is produced by legitimate pharmaceutical manufacturers, the consumer generally wouldn’t have to be concerned about these outlined dangers. Legitimate pharmaceutical manufacturers are regulated. Consumers need to be concerned about the content and quality of a product when the medication they are taking is produced by counterfeit pharmaceutical manufacturers. Counterfeit drugs as defined by the World Health Organisation – applicable to both generic and branded products – includes the following points:
Medicine which is deliberately and fraudulently mislabeled in terms of its identity and/or source;
- Medicines which may include products with the correct or incorrect ingredients;
- Medicine may have or not have sufficient active ingredients;
- Medicine which is packaged in fake packaging. (World Health Organisation, 1999)
According to the World Health Organisation, approximately 10% of global medicine supply is counterfeit (United Nations Office on Drugs and Counterfeiting, 2014). Although it is reported that Africa, Asia and Australia represent less than 10% of the global market for pharmaceuticals, counterfeit medications in these regions is relatively high in comparison to the rest of the world. In some developing countries, it is reported that counterfeit pharmaceuticals range between 10% and 30% (United Nations Office on Drugs and Counterfeiting, 2014). This is a significant percentage, given that people’s health is at stake.
Consequences Resulting from the Production of Counterfeit Medication
Placing peoples’ health at risk is the most serious consequence from this illegal trade. According to a report done by the World Health Organisation in 2000 statistics emerged on the content of counterfeit medication:
- 1% of reported counterfeit medicines had no active ingredient,
- 2% had incorrect quantities of the active ingredient,
- 4% contained the wrong ingredients,
- 6% had the correct amount of ingredients but were in fake packaging,
- 5% contained high levels of impurities and
- 1% were copies of the original product (Toscano, 2011).
Not only does this illegal trade affect the direct health of the individual taking the counterfeit medication – which could even lead to death – but this problem also affects the efficacy of the genuine medication. When counterfeit medication has less than the acceptable dosage of the required active ingredient, microbes develop a resistance to the medication. This means that microbes change in a way that reduces or eliminates the effectiveness of the medicine, chemicals or other agents designed to prevent or cure infections (Centers for Disease Control and Prevention, 2013). Not only are the consumers of counterfeit medication unlikely to be healed when this happens, but clinicians efforts to prescribe the appropriate treatment becomes complicated.
Other less serious consequences result from the counterfeit pharmaceutical market. Legitimate pharmaceutical manufacturers are suffering huge losses. This is due to the fact that consumers are, at times, not able to differentiate between the legitimate drug and the fake drug due to the accuracy with which the packaging is copied. When they remain ill after ingesting the fake drug or contract diseases that they were supposedly protected against, they associate the bad experience with the brand that the counterfeit product is claiming to be. The consumer has no other reference other than the packaging the medicine was packaged in. Where consumers decide to purchase a brand that is not reputable because it is cheaper, they may to some degree be aware of the risk of taking the medication. Where consumers and brand managers alike are at a disadvantage is when they believe they are purchasing medicine from a reputable brand based on the indistinguishable packaging and in fact it is a fake.
Something needs to be done. Although governments and other institutions such as the World Health Organisation have a vested interest in combating this crime, the weight of the responsibility to fix this problem is most heavily felt by the legitimate pharmaceutical manufacturers. When consumers consume the counterfeit product that looks almost identical to the genuine product, who can blame the consumer for turning to the legitimate manufacturer for answers. Pharmaceutical manufacturers need a solution that can help consumers to differentiate between their genuine product and the cheap fakes. Whatever the solution is, it needs to be inimitable so that counterfeit manufacturers are unable to copy this too.
Viable Solutions Available
There are solutions available that will help the consumer to differentiate between the authentic product and the fake product. In order to empower consumers to be able to differentiate between products, it is required that the solution implemented is found on the product itself. This requires the product to have some sort of mark or identifier. For protection against counterfeiting, these marks or identifiers should either be hidden or inimitable. The first solution proposed would be high-speed ink jet unique 2D code marks. A 2D barcode is a machine-readable symbol, which encodes information that can be read by barcode scanning applications running on most smart phones. These barcodes are being adopted as the standard for serialized numbering schemes, pointers to content on the Internet, and connection to authentication databases on the network. In general, the 2D codes could contain any information required including expiry dates, date of manufacture and product numbers. In this case, however, the 2D codes could contain a unique number generated from a third party repository with a guarantee that no numbers would be duplicated. Consumers would be able scan the code with their smart phone in order to read the unique number from the product. This solution can however be copied. The 2D code could be scanned and replicated by the counterfeit manufacturer, which could render the solution futile. This would require the counterfeit manufacturer to purchase the above outlined technologies. The cost of purchasing the technologies and the extra effort to replicate codes may ward off some counterfeit manufacturers, however depending on the market and price of the product copied, some may still imitate this solution.
In order to make this solution inimitable, the code marked onto the product should be made more secure. A patented digital authentication technology called PeltaTM is suggested to achieve this. The PeltaTM technology extends the capability of the 2D code by adding a second layer of information which is hidden and invisible to the standard 2D code reader. The first layer of information is visible and includes information that can be read by scanning the code. The second layer of data encoded into on the 2D barcode is encrypted in a proprietary format, undetectable by scanners and thereby enhancing security measures. Individuals are able to use their smart phones or code reader applications to scan and read the code, but not the encrypted message. Only authorised personnel of legitimate pharmaceutical manufacturers have access to encrypted code information, which cannot be copied or reproduced if scanned by counterfeit pharmaceutical manufacturers. In addition, the covert information can also be random, machine generated codes for unknown sequencing or serialisation. All that is required is for the consumer to have the application to read the PeltaTM code. Once the code is scanned by the consumer, the application will indicate whether the product is an original or fake without revealing the covert code. Consumers are then able to discern between the fake and authentic product.
Although the aim of the discussion up to this point has been to help consumers to discern between fake and authentic medicines, other covert marking methods are worth discussing. These covert marking methods are other viable solutions to further the security features available. The wider public would not likely have the means to verify the covert marks, however, brand owners would be enabled to authenticate their products. Two particular covert marking methods are of interest, which include invisible ink and inks doped with DNA trace elements.
Invisible ink is a specialty ink whereby the marks are not visible to the naked eye. When these marks are placed under UV light, the marks become visible. Counterfeit pharmaceutical manufacturers may be able to copy the packaging, but if they are unaware of the invisible ink, they would fail to copy this security feature. Another specialty ink available is an ink that is doped with trace elements. When this ink is printed onto material, it appears to be black, but when scanned, the trace elements become visible. This security feature is very effective, as counterfeit pharmaceutical manufacturers may believe that by copying the mark that they are effectively imitating the product.
Counterfeit pharmaceuticals pose a huge threat to the health and well being of the population. In addition, legitimate pharmaceutical companies’ brands are perceived negatively when the counterfeit drugs’ packaging looks identical to the authentic product. Howard Zucker (former Assistant Director General of WHO and former head of IMPACT) indicated that the fight against counterfeit medicine could be addressed through 5 different avenues. These five areas include technology, strong legislation, enforcement of unilateral regulatory standards and public knowledge. The above discussion highlighted some technologies available for legitimate pharmaceutical manufacturers to utilise in order to protect their clients and brand from the harmful effects of fake drugs.
Centers for Disease Control and Prevention, 2013. Antibiotic resistance questions and answers. Retrieved on November, 2014 from the world wide web: http://www.cdc.gov/getsmart/antibiotic-use/antibiotic-resistance-faqs.html
Toscano, P. (2011). The dangerous world of counterfeit prescription drugs. Retrieved on November, 2014 from the world wide web: http://www.cnbc.com/id/44759526
United Nations Office on Drugs and Counterfeiting, 2014. Counterfeit Products. Retrieved on November, 2014 from the world wide web: https://www.unodc.org/documents/data-and-analysis/tocta/8.Counterfeit_products.pdf
World Health Organisation, 1999. Guidelines for the development of measures to combat counterfeit drugs. Retrieved on January, 2015 from the world wide web: http://whqlibdoc.who.int/hq/1999/WHO_EDM_QSM_99.1.pdf?ua=1
Traceability Solutions is the authority on marking, identification and traceability solutions for various industries. The company is based in Northriding, Johannesburg and has branches in the Eastern Cape, and Western Cape.
For more information on this solution and other solutions available for part marking, identification, track and trace contact Traceability Solutions on +27 11 704 4744 or visit our website on www.tracesol.co.za.