New generation of packaging: no chance for pharmaceutical counterfeiting

Anyone who buys Sinupret sinusitis pills from pharmaceuticals producer Bionorica will now see on the folding carton a three-dimensional, optically variable, embossed mark, which can be seen in relief when the carton is tilted. Since the herbal medication was so often copied, Bionorica engaged the Munich company Giesecke & Devrient, which specializes in printing bank notes, to design this tangible security feature for Sinupret.

Artur Theis, a subsidiary of the Edelmann Group, developed the production process for the new packaging. The mark is printed and embossed by Braun Pharmadruck, also an Edelmann subsidiary.

Sinupret, one of the most popular products on the cold treatment market, is just the start: by the end of 2011, Bionorica intends to emboss the packaging of all its product ranges with the new quality seal.

“We want to provide the best possible safeguards for pharmacies and users”, says company head Michael Popp.

Producers who have problems with counterfeiters must make their products uniquely identifiable. This is especially true in the pharmaceutical sector.

“The danger of counterfeit medication is growing”, states Ulrike Holzgrabe of the German Pharmaceutical Society (DphG). Although producers of pharmaceuticals experience losses amounting to billions of Euros each year through product piracy, this is not the main problem, since counterfeit medications threaten the health or even the lives of unsuspecting patients.

Security mark: Bionorica recently started to provide the packaging of its sinusitis product Sinupret with a quality mark similar to a lenticular image. This makes counterfeiting much more difficult. (Photo: Edelmann)

The Internet is a weak spot

According to EU figures, the German customs authorities seized counterfeit medications worth 11.5 million Euros (~Cdn $16  million) in 2009 – 30 per cent more than in the previous year. In addition, a World Health Organization (WHO) study claims that even in supposedly safe regions such as Europe and the U.S., up to 10 per cent of all medications are counterfeit.

According to Holzgrabe, the proportion of such counterfeit products in Germany is about 5 per cent. “But this is just the tip of the iceberg”, she suspects.

Mail order business offers criminals the greatest opportunities. This sector is booming, especially in Germany. Marketing research firm ACNielsen estimates that sales of non-prescription drugs increased by a quarter last year.

According to the consumer research consultancy company GfK, one in four Germans now obtain medications by mail order. At the same time, it is apparently becoming harder for consumers to distinguish between reputable mail order pharmacies and illegal traders.

Original or fake? Counterfeiters can now copy Viagra tablets so accurately that the imitations can scarcely be distinguished from the originals. (Photo: Pfizer)

Test purchases by the Central Laboratory of German Pharmacists confirm counterfeiting rates of 50 per cent for medications sold by illegal Internet pharmacies, for example.

“Producers of pharmaceuticals are therefore more willing to look for methods to provide better security against counterfeiting”, remarks Holzgrabe.

The companies have two aims: firstly, consumers should be able to verify that they have received an original product; and secondly, experts should be able to identify counterfeits when they do inspections.

The most active companies include not only medicinal plant specialist Bionorica but also Bayer Healthcare, whose products are among the most frequently counterfeited worldwide. The company explains on its website (www.vorsicht-faelschung.de) how patients can distinguish between original Bayer preparations and imitations. In the future, Bayer Healthcare will also provide its medications packaging with counterfeit-proof features. The company has also engaged Artur Theis, a German specialist in uncopyable folding cartons, for this project.

“Our task is to make the security features suitable for a folding carton production line, and then for series production”, explains Ulrich Dörstelmann, head of the counterfeiting security department at the Arthur Theis, an Edelmann subsidiary.

Track and trace: Syringes are nested and are then packaged in tubs. Optima Group Pharma can print codes on these plastic boxes. (Photo: Optima packaging group)

Based on banknote printing

The conditions in Bayer’s Wuppertal plant, which has been converted into a complete counterfeiting security facility, are the same as those in a banknote printing company: there is strict access control to the production section; the security zones are off-limits for most of the personnel, and; all processes are exactly documented and archived.

The degree of meticulousness is unique in the German packaging industry.

The result of the cooperation with Bayer Healthcare is a sort of lenticular image that cannot be imitated by counterfeiters. “We combine printing and embossing technology and use UV security inks,” comments Dörstelmann.

The EU (European Union), however, requires yet another step to be taken by the pharmaceuticals industry to ensure greater patient safety.

Industry Commissioner Günter Verheugen announced that in 2011 there will be a standard procedure at EU level in the fight against the counterfeiting of medications. In 2008, the Commission proposed that medication packaging should be protected by a security mark and that in that future it should be possible to retrace their path from the counter back to the factory.

Counterfeit pills: The customs authorities are seizing ever increasing numbers of counterfeit medicines (Photo: BMG)

The WHO is also a strong supporter of counterfeit-proof labeling. Producers of pharmaceuticals are therefore pushing for the introduction of an electronic proof of origin in form of a track and trace system, with which the complete supply chain can be monitored.

In order to test and demonstrate coding and identification solutions, the European Federation of Pharmaceutical Industries and Associations (EFPIA) launched a pilot project in Sweden in September 2009. For several weeks, medication packaging for 25 pharmacies in the Stockholm region were provided with a two-dimensional data matrix code which is able to hold more information than a simple bar code.

In the Swedish project, the code contained an article number, a batch number, a use-by date and a serial number. At the pharmacy, the code was scanned and compared immediately with an entry in a database. The whole process took only a few seconds, so that counterfeits were immediately identified. Only after this security check did the customer receive the medication.

About 100,000 medication packages were tested using this system – with great success, according to the EFPIA.

Origin checks by scanner

Experts expect the track and trace system to be implemented throughout Europe in the near future.

According to Dörstelmann, the EU’s pharmaceutical package could become law very soon.

New printing module: Bosch has developed a system that can print a track and trace code on up 400 packages per minute. (Photo: Robert Bosch GmbH)

New printing module: Bosch has developed a system that can print a track and trace code on up 400 packages per minute. (Photo: Robert Bosch GmbH)

Manufacturers of machinery and systems are well prepared for a switchover. For example, Optima Group Pharma–specialists in filling and sealing syringes and vials–offers, upon request, coordinated track and trace solutions for producers of pharmaceuticals.

“Ready-to-use syringes are stored and transported in special syringe nests in plastic boxes referred to as tubs. Our machines label the containers, so that they can be traced at any time”, explains Optima Group Pharma spokesman Henning Felix.

Bosch Packaging Technology, which supplies filling, processing and packaging machinery for the pharmaceuticals industry, also has printing and tracing equipment in its portfolio.

Daniel Sanwald, Bosch product manager, describes the printing module function: Each minute, up to 400 folding cartons are transported on a conveyor belt at high-speed through a printer, which labels each carton with a data matrix code containing a production number, use-by date and serial number. A camera subsequently checks and verifies the code. The data are finally stored on a high-capacity central server, from which they can always be called up. If a product that cannot be identified in this way turns up in a pharmacy, it must be a counterfeit.

“If track and trace becomes mandatory, thousands of production lines will have to be retooled. We can see enormous market potential for our technology”, says Sanwald.

A security offensive by producers of pharmaceuticals would also increase demand for high quality packaging materials producers.

In order to cut costs during the economic crisis, many companies bought packaging and packaging components for their medications in China. The disadvantage, however, is that these products are often of poorer quality, so that dosage sprays, catheters or pumps, for example, may not function correctly or may break more easily.

“All those who subscribe to patient safety and who want to send a clear signal that quality is a top priority, will no longer use these products in the future”, says Peter Rösch, head of sales at atomizer pump manufacturer Aero Pump, adding that he can see a large market for his company’s quality products.“We put a high priority on dimensional accuracy and precision, and we invest heavily in quality assurance and innovation. As well, Aero Pump will also present its innovations at the interpack 2011 tradeshow in Germany.”

It is unlikely that pharmaceutical counterfeiters will be attracted by medications that have been provided with a security mark, a code and top quality packaging. However, there are still many obstacles on the path to obtaining maximum patent protection.

Enormous investment is required to retool packaging lines, a key stumbling block in preventing many pharmaceutical companies from acting quickly. Also, even if the EU rapidly approves its pharmaceutical packages, the implementation process could still take years.

Another aspect that has yet to be clarified is where all the data associated with a pan-European track and trace system should be stored. Will there be several geographically dispersed servers or one central system?

“And then someone must be the owner. This raises the question of who trusts whom?” muses Bosch’s Sanwald.

At interpack 2011, the leading international trade fair for the packaging industry, manufacturers of machinery and systems will present their track and trace solutions from May 12 – 18, 2011 in Düsseldorf, Germany.

For more information on interpack 2011, visit www.interpack.com.