Pharma has 'little appetite' for more anti-counterfeiting

Pharmaceutical executives are not inclined to invest more in measures to fight counterfeit drugs even though they are aware the trade is growing and current efforts don't go far enough, a new report reveals.

Published by PwC's strategy consulting business Strategy&, the survey of pharma execs found they "showed little appetite for new spending on anti-counterfeiting measures", with the main reason being because they had already spent so much to comply with new mandates such as the European Union's Falsified Medicines Directive (FMD), which has cost companies about €500m.

The report also revealed that a large majority of interviewees said they were satisfied with their companies' supply chain integrity protections and only a few saw much need for major improvements in anti-counterfeiting technology.

"Pharmaceutical industry leaders tend to underestimate the threat even as they acknowledge weaknesses in their defences," the report says. "Not only do these executives misjudge their own vulnerability, but they also overlook the opportunities awaiting those that capitalise on rapidly evolving anti-counterfeiting technologies that do more than improve on existing supply chain safeguards."

According to the consultancy firm, the trade in fake pharmaceuticals is the most lucrative sector across the counterfeit market, with sales of bogus drugs reaching $200bn annually.

Traditionally, pharma counterfeiters have had their stronghold in less developed markets but PwC notes the increasing use of digital channels, notably online pharmacies, to penetrate developed countries. Furthermore, counterfeiters are expanding beyond the traditional baldness and erectile dysfunction drug knock-offs to develop fraudulent versions of treatments for malaria, tuberculosis, HIV/AIDS and even cancer.

Although companies have "plowed billions of euros into defensive measures", PwC says this hasn't slowed counterfeiters, with common anti-counterfeiting tactics only blocking about half of the fake drugs. PwC describes such tactics as "marginally effective".

Yet despite the satisfaction of their current anti-counterfeiting measures, the executives interviewed still acknowledged that today's security tools fall short and have to be frequently overhauled. But because of the large costs attached to anti-counterfeiting "additional measures would have to show significant cost-benefit value to attract support", the report found.

The analysts also claim that new regulatory initiatives – spurred off the back of rising public awareness – often leave large gaps for counterfeiters to exploit.

For instance, track and trace and mass serialisation are becoming more common in many countries, such as the EU's FMD, which introduces strengthened requirements including unique identification numbers to packaging. But PwC warns that counterfeiters with access to production or distribution facilities "could snap photos of legitimate, package-specific barcodes, and use the images to create forgeries. They could then slap the forged codes on packs of falsified drugs, and slip them into distribution channels with little chance of detection."

"Both the technology and the regulatory controls are porous," PwC says. "Counterfeiters usually crack today's systems in two to three years, forcing companies to shell out regularly for expensive upgrades. Even at peak effectiveness, conventional mass serialisation catches only 35 to 50 percent of fake drugs."

Improved data systems and smartphone-based anti-counterfeiting apps were considered the most beneficial measures to address fakes, the report found.

PwC urged companies to adopt emerging technologies to "gain an edge over rivals relying on yesterday's solutions".

"Companies that seize this opportunity will reduce harm to patients and ease the financial impact of counterfeiting. What's more, the new technologies hold promise for enhancing manufacturing efficiency and even boosting sales as customers discover that they can buy drugs safely on the Internet."