Eli Lilly is spending €75m ($102m) to meet latest global anti-counterfeiting regulations, its security experts said in an exclusive interview with in-Pharmatechnologist.com.
The investment will bring Lilly in line with “emerging track and trace standards in the US, Europe and other markets that are implementing serialisation,” said Bill Reid, senior director, global anti-counterfeiting at Lilly. The figure includes financing manufacturing capability, he told us.
Lilly welcomed the US track-and-trace scheme, signed into law by President Obama in November , which will implement a single, federal drug verification system, rather than relying on differing state legislation.
Reid also praised the World Customs Organisation (WCO)’s “IPM” tool – an interface for customs officials to communicate with pharma companies to verify suspicious medicines. The hand-held mobile device can scan a barcode or track-and-trace marking to communicate instantly with rights-holders like Lilly or authentication service companies.
The software application has been up and running since December and the WCO is encouraging all pharmaceutical firms to link their catalogues to the interface.
Reid added field officers in each country have “access to a central database where they can look at a product – they can even see a 3D image of the packaging.”
So far, seven traceability outsourcing companies are involved with WCO-IPM: Advanced Track & Trace, Authenticate it, CertiEye, Certilogo, Holoptica, PharmaSecure and Systech International.
Elsewhere, the Falsified Medicines Directive came into effect in January 2013, under which the EU is currently designing a logo to be displayed on legitimate pharmacy websites Europe-wide. It is also working towards a dedicated act to place unique identifiers on outer drug packaging.
Lilly’s efforts fight counterfeits begin with pre-launch design, their product security manager told us.
“You look to protect all new products that we’re going to bring to market,” said Derek Walmsley, a former police detective who oversees the company’s anti-counterfeiting measures in the Africa, Europe and the Middle East.
“Prior to coming to market in the start of 2000s, we launched our first overt anti-counterfeiting feature with Cialis – we looked at the shape of the tablet and colour.”
Later, said Walmsley, Lilly used colour-shifting blister packs to make the tablets stand out from fakes. Rival firms were adding holograms to their packaging, “but we knew holograms were being counterfeited so we didn’t use them.
“Counterfeiters are striving to copy our features,” he added, so as well as “overt” markings like these, “we obviously have covert protections as well.”
Fake cancer drugs
“We’re seeing counterfeit products in a number of therapeutic areas – including erectile dysfunction, oncology and mental health,” Lilly’s expert told us.
“And it isn’t limited to any specific geographic area,” he added, saying the company had found widespread, and growing, counterfeiting in the US, Europe and Asia.
“The increasing incidence in a number of countries, as well as [of fake] oncology products, is of great concern – it’s a risk to patient safety.
“For example we’ve seen counterfeit oncology medicines in Latin America and China.”
Often, patients do not know they’ve been prescribed a counterfeit, said Reid. When analysed in Lilly’s quality labs, fake drugs “might not have the right active pharmaceutical ingredient –either too little, or too much.”
Walmsley pointed out the 2008 incidence in Singapore of hypoglycaemia in 150 patients who had consumed illicit sexual enhancement drugs including, he said, counterfeit Cialis. Glyburibe – an anti-diabetes treatment – in the tablets resulted in seven comatose patients, of whom four died.
“These counterfeits aren’t manufactured under good manufacturing processes. They’re not chemists who put these products together,” said Walmsley.
“Generally there is no good counterfeit medication,” added Reid.