German Associations Assess Counterfeit Drugs Protection Initiative
Several German pharmaceutical industry and pharmacists associations have started a nationwide pilot project to assess the efficiency of a protection system against counterfeit drugs. In anticipation of the test phase, 3S Simons Security Systems warns that the recently introduced initiative securPharm does not prevent counterfeit drugs from getting into the legal supply chain.
According to current plans, securPharm relies solely on the data matrix code to secure drug packaging. Even though the code provides new route and process tracking options, it is yet not counterfeit-proof. "Wrong data matrix codes can easily be printed on packages of fake drugs using an ink-jet printer," said Rolf Simons, Managing Director of 3S Simons Security Systems. "In order to not harm the health and life of patients, securPharm should be combined with a real anti-forgery system. This is the only way to make sure that counterfeit drugs are not distributed to German pharmacies via the traditional pharma supply channels."
Given the risks that fake drugs may cause, it is important that consumers are able to identify any medicine as original. This would strengthen the mutual trust between manufacturers, distributors and customers. 3S Simons Security Systems — with its headquarters in Nottuln, Westphalia, Germany — is an internationally renowned manufacturer of labelling systems for legally binding counterfeit protection.
Legal supply chain should become safer
In Germany, there are reports about fake drugs that primarily refer to illegal Internet suppliers located outside the EU. By contrast, the distribution of drugs via pharmacies and officially registered mail-order pharmacies is deemed to be safe. However, given the international interdependencies regarding the movement of medicinal products, there is yet a risk of fake drugs getting into the legal supply chain.
To combat falsified medicine, the EU Parliament adopted a pharmaceutical directive on counterfeit medicine in 2011. This directive states that packaging of medicinal products has to be marked with a safety feature in order to be able to verify the authenticity of the medicinal product and single packages. Pharmaceutical manufacturers, pharmaceutical wholesalers and pharmacists are currently developing the security system securPharm, which is going to be tested in a pilot project in January 2013. The EU member states have to provide the EU Commission with details on their specific national systems by July 2013. In this context, securPharm could be used as reference model.
Data matrix code provides no counterfeit protection
However, it remains doubtful whether Securpharm will actually provide the required high level of protection against counterfeit drugs since the data matrix code is not forgery-proof. For instance, counterfeit data matrix codes can be printed on packages of fake drugs using an ink-jet printer. Pharmacists would not be able to identify these counterfeit drugs in case the serial number has not yet been queried in the database or has been entered as sold. They would then sell the fake product to the patient. The system would reject the original in a subsequent query and would identify it as a counterfeit drug because the product status has been set to "sold".
Combining traceability and counterfeit protection
When looking at the design and concept of the system as currently being developed by pharmaceutical manufacturers, pharmaceutical wholesalers and pharmacists, there are concerns that organised crime will continue to infiltrate the legal supply chain with counterfeit drugs. In order to prevent this from happening, Securpharm would have to be combined with a counterfeit protection system.
Micro colour codes, for instance, can protect both drug packaging and data matrix codes. The colour code is stored to securPharm's database of manufacturers or pharmacists and thus allows tracking a drug's production and supply chain, from the manufacturer all the way to the pharmacist. Each manufacturer is provided with an individual colour code that ensures unambiguous allocation of the different drugs. Micro colour codes applied onto the drug packaging are invisible to the naked eye, however they are detectable under a simple microscope. This is possible thanks to the counterfeit protection system SECUTAG from 3S Simons Security Systems. Its micro colour code technology, which has been counterfeit-proof for more than 15 years, unambiguously identifies products as originals and is accepted as evidence by international courts.
No tolerance towards counterfeiting or piracy
This method allows pharmacy staff to identify the drugs and the data matrix codes as originals. First, the data matrix code is read during the verification process. Then, the micro colour code is checked. In case of conformance, the authenticity of the drug and the data matrix code can be proven unequivocally.
Consumers cannot be sure whether their pharmacist has given them the original drug, unless the production and supply chains are based on seamless protection systems ensuring traceability (data matrix code) and counterfeit protection (micro colour code). "There must not be any number of unreported cases and any tolerance concerning fake drugs, especially when drugs are distributed through pharmacies," said Simons. "Any counterfeit product must be identified and removed from the market place."
Such a protection strategy will not only reduce control costs along the production and supply chain but it will also strengthen the image of pharmaceutical companies as guarantors of high quality. This is because the system can be communicated to the public. It enables consumers to identify whether they have bought the original product or not. If they do not check the product's authenticity, they assume a share of the responsibility. This may be relevant when it comes to unjustified product liability and damage claims.
3S Simons Security Systems GmbH, +49 25 02 23 33 0, info@secutag.com, www.secutag.com.