Practical Steps To Prevent Counterfeiting

January 14, 2011
Stephanie Sutton
Pharmaceutical Technology Europe

With counterfeit medicines increasingly appearing in legitimate supply chains and even in the clinical stages of product development, a recent white paper has outlined practical steps that may help companies address the issue of counterfeits and diverted products.

With counterfeit medicines increasingly appearing in legitimate supply chains and even in the clinical stages of product development, a recent white paper has outlined practical steps that may help companies address the issue of counterfeits and diverted products.

According to the white paper, which is based on an industry panel chaired by product development consultancy company Cambridge Consultants, the next few years will see “substantial changes” in the area of anticounterfeiting because of extensive lobbying efforts. In Europe, for instance, there is pressure to ban the repackaging of drugs and to increase the strength of supply chain security. Governments worldwide are also increasing regulations to tackle the problem.

One of the first practical steps that can be taken to protect products is to understand the risks at both a business level and an individual product level, as these will influence the decision as to what safety measures need to be implemented. Public perception is that counterfeit medicines are predominantly in the area of lifestyle drugs, but counterfeit antibiotics and cancer treatments are now finding their way into legitimate pharmacies and hospitals.

In particular, the white paper notes that many emerging biotech companies do not fully consider the implications of counterfeiting nor implement an anticounterfeiting strategy, despite the fact that some larger companies will be on the lookout for these criteria when assessing potential acquisition targets. Indeed, some participants in the industry panel explained: “As a minimum, acquisition targets would be aware of the implications of the threat of counterfeiting and have plans for possible product protection.”

Anticounterfeiting measures should be planned early because once a system has been implemented it is significantly more expensive to retrofit it than to build a requirement in from the start. An early start is also beneficial given that counterfeit products and ingredients have been detected in clinical trials.

One particularly important aspect to any anticounterfeiting business program is technology, and the white paper explains that a layered approach can be advantageous because all technologies have vulnerabilities in their design and implementation. For instance, although serialization enables the detection of counterfeits at Point of Dispense (PoD), it is predicated on the real product reaching the PoD before the counterfeit. According to the white paper, understanding these kinds of factors is crucial, particularly as regulations only provide a minimum standard for compliance.

Finally, the industry panel noted the importance of ongoing monitoring and continuous improvement, given that counterfeiters will change their tactics. The implemented solution needs to support monitoring and ensure that the process is being executed correctly.

“Looking further out, as the product protection changes, so to will the criminal’s approach adapt; therefore, a strong system philosophy will also be important to stay one step ahead,” said the white paper.

Unfortunately, there is no “one size fits all” solution and businesses will need to decide for themselves what measures are appropriate and when they should be implemented.

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