5 Things You Should Know about Pharmaceutical Anti-Counterfeiting

Sébastien Mauel, Head of Product Security at Ares Trading SA, an affiliate of Merck Serono SA, joins Pharma IQ to discuss anti-counterfeiting.

Pharma IQ: How severe would you say the counterfeiting situation is within the pharmaceutical industry these days, and how has it changed over the past decade?

S Mauel: The pharmaceutical industry and the legitimate supply chain are highly regulated, therefore as long as you source your medicines from a reputable pharmacy, the risk of getting a counterfeit product is low. This risk becomes much higher in developing countries where the distribution system is less secure, and also when you purchase medicines from uncontrolled sources, such as certain online pharmacies, which provide no guarantee at all about the quality of the medicines they sell.

The counterfeit problem in the pharmaceutical industry and in other industries is similar in the sense that the more you search, the more you find. It is difficult to give numbers as the situation can be very different from one country, market, or product to another. Industries and authorities are definitely devoting more efforts to this issue, and logically are detecting more cases of fraudulent activities.

Pharma IQ: What are the main threats facing the industry at the moment and what actions can industry take to protect itself?

S Mauel: Criminals have now realised that the risk-benefit ratio is clearly more favourable when dealing with fake medicines than with narcotics or any other kind of goods. The general public, on the other hand, is not yet sufficiently informed of the risk of sourcing medicine from uncontrolled sources. Consequently, it is likely that the problem of fake medicines will continue to grow, especially as long as the legislation lags behind and doesn't allow the judicial system to punish offenders much harder.

Pharmaceutical manufacturers are implementing proprietary security solutions on their products, and also working on common safety measures to secure the distribution such as those promoted by the EFPIA.

Pharma IQ: How has EFPIA serialisation impacted or changed the anti-counterfeiting landscape in pharmaceuticals?

S Mauel: The "Verification at the Point of Dispense" solution proposed by the EFPIA seems offer the highest level of security for patients while being the most cost-effective for the industry. The efficacy of such a system was demonstrated during the pilot phase and we are strongly in favour of its implementation in Europe, which will make it nearly impossible for counterfeiters to infiltrate the legitimate supply chain.

European governments should now make such a verification system mandatory in 100% of the pharmacies, which would provide a guarantee to the patients that the products they use are always genuine.

Pharma IQ: How has the culture evolved as a result of changes within the international counterfeiting landscape – and indeed, have you changed the way you tackle counterfeiters?

S Mauel: The awareness level is definitely increasing and the safety of our patients has become the key driver for product security initiatives such as not only serialisation, but also the implementation of tamper-evident sealing and authentication features on the packaging matterial. In all of our affiliates we have a person responsible for anti-counterfeiting who knows how to react when suspicious cases are detected and how they should be reported.

Counterfeiters are now not only prosecuted by law enforcement agencies for distributing illegal medicines, but also sued by pharmaceutical companies for intellectual property infringements.

Pharma IQ: What do you see as being the areas of highest threat, and what are likely to be the most successful preventative measures in the future?

S Mauel: In the developed countries, the lack of knowledge among the general public is still a major problem. Many are simply not aware of the existence of counterfeit medicines. Many also think of the internet as a cheaper or more convenient way to get medicines and don't realise the danger this may represent for their health. In less developed parts of the world, the way that medicines are purchased and dispensed is different and it is not likely that a secure distribution process will be put in place in the near future; in that case, a verification system using the mobile phone network could be a solution. In both developed and developing countries, well-targeted awareness campaigns are certainly a must to incite people to always source their medicines from legitimate and controlled suppliers.

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