In a market where counterfeit drug sales are estimated to reach $75 billion by 2010, according to the World Health Organisation (WHO), it is clear that drug counterfeiting is on the increase.
Yet there is too much talk and not enough decisive action being taken in the industry to tackle this problem, which is affecting national economies, damaging pharmaceutical brands and above all threatening patient safety, concludes a new study by Frost & Sullivan (www.healthcare.frost.com)
The study, commissioned by patient safety communications company Aegate, titled '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 Andrew Calvert, Frost & Sullivan Vice President - Financial and Business Services, Europe and Africa. “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.
It is important to note, however, that the application of the mass serialisation technology alone will not make a difference. It provides only 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 the points in the supply chain where 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.
However, while mass serialisation provides an effective and immediately available solution, its impact will not be felt on the global stage if it is embraced only by individual market participants or at a country level. In an increasingly globalised world, solutions to combat the trade in counterfeits must be globally applied.
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.
“We applaud moves by individual stakeholders to help combat counterfeit drugs, however we support Frost and Sullivan’s findings,” says Gary Noon, CEO of Aegate. “The industry as a whole still needs to do more to eradicate this alarming trend. We are committed to playing our role in supporting the industry, by having a workable authentication solution available now that will enable collective responsibility to be taken for the benefit of the patient. Aegate has patient safety at the heart of what we do.”
If you are interested in receiving more information on the study 'Working together on mass serialisation: whose responsibility is ensuring patient safety?' and on our Growth Partnership Services, then send an e-mail to Patrick Cairns - Corporate Communications at pcairns_pr@frost.com with your full name, company name, title, telephone number, email address, city, state and country. Upon receipt of the above information, an overview will be sent to you by email.
