Europe Prepares To Battle The Counterfeiters

In an age dominated by the internet and uncertainty over the best packaging security methods to employ, counterfeit medicines have the ideal environment to thrive. In Europe, however, the recent legislation on falsified medicines, which comes into effect in 2013, could be about to turn the tables on the situation. PTE interviews Alison Williams of Aegate about the current counterfeiting situation in Europe and what action companies are taking, and will be required to take by 2013.
Nov 01, 2011
By Pharmaceutical Technology Editors
Volume 23, Issue 11

How has the problem of counterfeit pharmaceuticals in Europe altered in the past year? Is the situation improving or getting worse?

Alison Williams. Senior Vice President at Aegate.
It very much depends upon which statistics you looks at. According to the Pharmaceutical Security Institute (PSI), in 2010, there were 327 incidents of counterfeits in Europe, compared with 354 in 2009. However, if you look at which therapeutic class of drugs are being targeted, this is changing significantly with the PSI reporting a 182% increase in metabolic drugs compared with a 43% decline in hormonal treatments in the past year.

Turning to the internet specifically, two weeks ago a co-ordinated effort by Interpol involving 81 countries confiscated 2.4 million illegal and counterfeit pills with an estimated value of $6.3 million. 13,500 web sites were shut down and 55 individuals are currently under investigation or under arrest.

These co-ordinated events always result in seizures and arrests and raise a degree of public awareness; however, these represent just a fraction of the actual scale of the problem. What is clear is that we cannot be complacent. Looking at the PSI statistics, every different type of therapeutic class is at risk and purchasing medicines on line is clearly unsafe.

Many counterfeit medicines come from the internet. Why do so many consumers ignore the dangers of buying drugs online?

In the digital age we live in with Facebook, Twitter and on-line shopping, many consumers are not distinguishing between purchasing DVDs, CDs or books from medicines. They trust the internet and are not aware of the dangers of buying medicines on line. The other problem is a general lack of visibility and appreciation of the role that high street pharmacists play in dispensing safe medicines; for example, appreciating the importance of checking for drug interactions or contraindications.

In addition, it is well known that some consumers purchase medicines on line to avoid embarrassing encounters with their general practitioner, such as for impotence drugs. The problem with this, however, is that need for this medicine may be hiding an underlying serious physical issue that will remain undiagnosed.

Another reason consumers often cite—particularly in France, Germany and Spain—is that there is no nearby pharmacy, which makes purchasing on-line the most convenient option. Others describe better availability of medicines and being able to shop around on price as being important.

However safeguards must be in place; just last month two 13 year old girls were admitted to hospital in the UK complaining of heart palpitations. They had been taking weight loss pills that they had bought on line. Similarly, in May a 27 year old paramedic died after taking sleeping tablets.

How are pharma companies, organisations and stakeholders currently addressing the issues of counterfeiting? What type of packaging security measures and authentication systems are being adopted?

The vast majority of pharmaceutical companies do address their brand security; the types of measures used include covert and overt solutions. Of course, the covert markers, such as colour-change inks or ultra-violet markers, are aspects that are not communicated and instead used for forensic testing purposes. Products that are deemed at risk may have several different type of security device applied.

Legislative requirements for unique barcoding of medicines are emerging across the globe at present with Brazil, Argentina, India, Turkey, France all moving towards a 2D datamatrix code. This is a small square shaped barcode which can cleverly carry data such as a unique number inside the code. When read by a reader the information can be verified as being correct and also authenticated to confirm this is indeed unique and the item has not be sold before.

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