Novartis unveils verification plans

Novartis is rolling out a digital marker technology across its product portfolio as the primary pillar of its defence against counterfeiting and diversion of medicines.

Michael Otto, a regional security adviser based at the drugmaker’s Basel headquarters, told the Anti-Counterfeiting Pharma conference in Wiesbaden recently that the technology had already been added to several products in the range, and would eventually roll out across the firm’s entire product range.

Otto, who worked in law enforcement for 17 years before joining Novartis’ corporate security division, said that the verification feature project has been in the implementation phase since 2008 and by 2011 the intention is to include the feature on the packaging of all 200-plus products in its portfolio.

The pilot started in the USA and Switzerland, and it has now rolled out to seven sites manufacturing 10 products in Novartis range at particular risk of counterfeiting. Other countries already applying the marker, which integrates with the software used by Novartis’ print suppliers, include Turkey, the UK, Germany, Italy and Spain.

Otto told SecuringPharma.com that the marker is encoded by an algorithm and when read can identify a genuine Novartis product down to the batch it came from, including the location and time of manufacture, via a web-based verification system.

“A customs authority, for example, simply have to put the packaging on a regular office scanner and send a PDF file to Novartis,” he said. “The web-based database can be queried to establish whether the packaging carries the [marker] and is authentic.”

“This is a big project, but we hope it will at least allow us to reliably carry out package verification,” continued Otto. From 2010, the objective is to put this on primary packaging too, for example to authenticate the blister and vials.

The technology was developed by an unnamed Swiss company and, at least for the time being, it is being used exclusively for Novartis, he added. It provides a way to reduce the burden of handling suspect samples which - before this technology was implemented - all had to be sent to a Novartis lab analysis.

With 400-500 samples a year costing around 2,500 Swiss francs (€1,650) each for analysis this was quite a costly exercise, but with the verifier it is possible to reduce the number of samples that need to be tested. Novartis also recently invested in a near-infrared (NIR) spectroscopy unit which should also reduce the cost of analysis for suspect samples.

The scale of the problem

Otto also painted a picture of the level of counterfeiting faced by Novartis across its range, revealing that all products – not just newer, high-value brands – are at risk.

“What we are seeing is a shift in the type of products that are being faked, from ‘everyday’ products such as Voltaren [diclofenac] for arthritis to high-value products, and particularly oncology products,” he said.

Traditionally, counterfeiters targeted older Novartis products, making it an important public health issue which has had only a small impact on the bottom line. But that is changing with more of the firm’s key products counterfeited, including lymphoma and stomach cancer drug Glivec (imatinib), Zometa (zoledronic acid) for treating cancer that has spread to the bones and breast cancer treatment Femara (letrozole).

Novartis first started to notice an acceleration in counterfeiting in 2003, and has now encountered bootleg copies of its brands in almost every country of the world. That carries with it an enormous public health impact, as well as being an economic drain on the company. It is hard to gauge, but Novartis has seen a noticeable uptick in sales of genuine products after successful enforcement actions in some cases.

In response the firm is devoting increased resources to tackling the problem, and has ongoing investigations and enforcement actions in a number of countries.

One case encountered in the Russian market gives a clear example of the capabilities of the counterfeiters.

Novartis is still considering whether to apply holograms on packaging, but Russian counterfeiters have already applied them, for example in the case of the antihistamine product Tavegyl (clemastine) the fakers have added a hologram which reads ‘Protected against counterfeits’.

In another case in Germany and Greece, the company was made aware of a product called Genotonorm -  in packaging indicating it was made by Novartis’ generics subsidiary Sandoz. Genotonorm is the trade name of a product, but is sold in France by Pfizer, said Otto.

An anonymous tip-off alerted the company to the fakes, which claimed to contain somatropin (human growth hormone) and were being promoted in body-building circles.

Otto described the geographical distribution of counterfeiting as encountered by Novartis, noting that more than three quarters of incidents involve a developing country as the source, transit point or the location of counterfeit discoveries and seizures.

The list of countries includes China, Russia, Columbia and Mexico, with the Middle East also emerging as a distribution hub. Unfortunately in some countries, inaction by authorities means that the drugmaker has to fund enforcement actions itself, he noted.

Meanwhile, another growing problem for Novartis is cargo theft, either stolen shipments in transit or raids on warehouses, said Otto, adding that the USA, Mexico and Africa were hot spots for this type of activity. In one case alone thieves absconded with $25m-worth of Novartis product.

In addition to adding technology to packaging and other efforts such as increased enforcement actions and a sampling programme, Novartis is also offering training to enforcement agencies in order to explain how the pharmaceutical industry functions and how counterfeits enter the supply chain.

Despite all these measures, it is important to avoid being lulled into a false sense of security, stressed Otto.

“We should not underestimate the counterfeiters’ ability to adapt,” he concluded.