Yet 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 (healthcare.frost.com)
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.
It is important to note however, that the application of the mass serialisation technology alone will not make a difference. It 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.
However, while mass serialisation provides an effective and immediately available solution, its impact will not be felt on the global stage if it is only embraced 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 CEO of Aegate, Gary Noon. “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.
Aegate (aegate.com) provides a unique patient safety network that opens a direct, IT enabled communications channel between pharmacies and pharmaceutical companies. The channel communicates real time pertinent information at the time of dispense. For pharmaceutical companies they can utilise the Aegate network to reach the pharmacy (and patients) directly with communications at the time their products are being dispensed. Whilst for the pharmacist it offers assurance that good quality medicines are being delivered to patients via the distribution of relevant and timely information at the time of dispensing - increasing confidence in patient safety. Aegate has been trading since 2003 and is backed by PA Consulting Group.
About Frost & Sullivan
Frost & Sullivan, the Global Growth Consulting Company, partners with clients to accelerate their growth. The company's Growth Partnership Services, Growth Consulting and Career Best Practices empower clients to create a growth focused culture that generates, evaluates and implements effective growth strategies. Frost & Sullivan employs over 45 years of experience in partnering with Global 1000 companies, emerging businesses and the investment community from more than 30 offices on six continents.