Dated: 5/6/2008
Counterfeit drug sales are estimated to reach $75 billion by 2010, says the World Health Organisation (WHO).
However, there is too much talk and not enough decisive action being taken in the industry to harness this problem, which is affecting national economies, damaging pharmaceutical brands and above all threatening patient safety, concludes a new study by Frost & Sullivan.
The study, commissioned by patient safety communications company Aegate, entitled Working Together on Mass Serialisation: Whose Responsibility is Ensuring Patient Safety?, reviews the steps that have been taken to try and address this burgeoning issue both from a national legislative level and through the use of new technologies.
The analysis concludes that as counterfeit medicines impact patients’ health and have such a negative effect on all involved in the supply chain, a collective push towards a solution with tangible benefits for all parties is urgently needed.
“It is Frost & Sullivan’s opinion that with the current growth of the counterfeit drug market, the industry needs to stop talking about finding a solution and start working together to put one in place,” says Frost & Sullivan Vice President - Financial and Business Services, Europe and Africa Andrew Calvert.
“To do this successfully there needs to be an acceptance right across the supply chain of shared liability.”
Frost & Sullivan believes that mass serialisation, a process by which a unique number is assigned to each saleable unit (pallet, case or individual package of drugs), can provide the foundation to develop a workable solution to help combat the trade in counterfeit drugs.
However, mass serialisation technology only provides the key to authentication processes that can validate drugs at critical points in the pharmaceutical supply chain, which can often involve more than 20 stages.
This enables the assurance of product quality before dispensing and the opportunity to identify sources within the supply chain at which counterfeits may have leaked in.
Although there are costs involved in setting up mass serialisation systems, pharmaceutical companies and governments stand to benefit from a secure supply chain, improved product recall, brand protection, point of sale security, and improved service to pharmacists and patients.
However, with a few notable exceptions, the industry has been slow to recognise the rewards of this approach.
“With mass serialisation ready and accessible to make a difference now, the industry is running out of excuses for not facing up to their moral responsibilities and putting patients first,” Calvert says.
The WHO and the European Federation of Pharmaceutical Industries and Associations (EFPIA) are however working to encourage adoption.
In addition, Frost & Sullivan identified that countries such as Belgium and Greece, who are early adopters of mass serialisation, have seen great benefits.
The report concludes that an element of compulsion and collective action is needed by all market participants to combat drug counterfeiting and to drive interest and uptake in patient safety solutions that make use of mass serialisation.
The responsibility for this ultimately rests with Governments who have the power to enact legislation.
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