Hard Times for Counterfeiters

Drug Safety

In future, a complex packaging code aims to make life difficult for the makers of counterfeit drugs. Experts from Bayer Technology Services are behind the implementation, conceptually and technically.

Practical and safe: A comparison between the scanned code and the database instantly shows whether the pack is from an original manufacturer.

You had to look very carefully. Even then, you would only be able to see it with the help of ultraviolet light. Something just didn’t seem right about the paper of the package insert and the packaging itself. It wasn’t up to the usual quality. But for a long time, no one noticed. The whole thing only came to light because someone stumbled across tiny irregularities in the instructions inserted with the stomach medicine. But by then, the counterfeiters had already slipped the sham packages into German pharmacies in large quantities – and had earned good money by doing so.

That case happened just a few years ago. At that time, no health concerns were caused by the fakes, because the pills had been correctly produced by a contract manufacturer. Even so, every patient who buys his or her medication from a pharmacist has to be certain that they are getting the genuine product. That means a product that comes from the manufacturer shown on the packaging, a product that fulfills strict quality standards.

Around the world, authorities and manufacturers are working on solutions that provide this certainty. Dr. Stefan Artlich is also part of this. For many years, on behalf of Bayer Technology Services, the mathematician has been part of an expert team of the European Federation of Pharmaceutical Industries and Associations (EFPIA), whose goal it is to come up with an appropriate coding plan that covers the European Union, Norway, Liechtenstein, Switzerland and Iceland.

Artlich and the other experts involved have long had a clear idea of what the solution will look like: Every drug package would carry a unique data-matrix code – a one-of-a-kind grid of small black and white squares. The two-dimensional code looks similar to the well-known QR code, which can be scanned using a smartphone, and is a further development of the barcode. The barcode, however, runs into problems when confronted by the small dimensions of medication packaging: the sequence of bars, by itself, is not enough to encode all of the important information. The code is supposed to include the product number, batch number, expiration date, and an individual serial number up to 20 figures long – each of these, therefore, represents a long sequence of digits.

“Before the pharmacist hands over a package to a customer, all the staff member has to do is scan this code,” Artlich explains. “Because each code is unique, if anything is not as it ought to be then it would instantly show up, for example if the scanned code has ever been passed across a counter somewhere else.”

But to guarantee that this actually happens, it has to be possible to carry out a code query in real time. The prerequisite for this, of course, is that all pharmacies have to be connected to a central database in which all codes that have ever been printed on a package are stored.

“At our projects on sites all over the world, I’m glad I can rely on Bayer Technology Services’ experience.”

Thomas Hendrischke

Program Head 2D Matrix Code, Product Supply, Pharmaceuticals

A few years ago, a pilot project involving 25 pharmacies in greater Stockholm confirmed that the process works. In that pilot, too, Bayer Technology Services played an important role (see technology solutions 1/2010).

Over the past few years, however, Stefan Artlich and his colleagues have not only been concerned with the technical questions of coding. “We have also travelled extensively throughout Europe to promote the concept to the authorities and manufacturers associations in each country,” Artlich explains. By “we,” he means the four experts in the EFPIA core team, three of whom are specialists from Bayer Technology Services – from the Operational Excellence & Logistics department, to be exact. “Bayer Technology Services’ contribution to this project has really been exceptional,” underscores François Bouvy, who heads the Market Access working group at EFPIA. “Their commitment was a decisive factor, both for the technical realization as well as the acceptance of the system in the European countries.”

Winning acceptance was also the focus at the European Commission in Brussels, where the concrete implementation of the system ultimately had to be decided. As a result, Artlich and his fellow campaigners made many trips to the Belgian capital. “Again and again, we presented the technical possibilities and our own progress in developing an overarching concept for all of Europe to the employees concerned with the topic at the European Commission, all with the goal of guaranteeing an efficient solution for supplying patients with safe medicinal products,” Artlich explains.

As simple as the coding idea seemed at first glance, the precise organization of a schedule for implementing the project in some 30 countries turned out to be extremely complicated. A lot of questions needed to be answered: Where was the central database supposed to be set up? Who would be responsible for its operation? How could the elaborate infrastructure be put in place in countries like Estonia or Malta? From time to time, alternative technologies, too, entered the discussion; for example, using a chip built into the packaging that could be read wirelessly. But because of technical hurdles with RFID technology, the data matrix approach won out in the end.

But what happens if the data matrix code is forged? At the end of the day, one has to assume that will happen. Artlich nods: “It’s definitely conceivable that criminals will get their hands on a package and simply combine the product and batch numbers with different serial numbers.”

But a simple trick prevents this from being successful. “Not every number is also a valid serial number,” explains Artlich. On the contrary, in fact: of 10,000 consecutive numbers, only one, on average, will actually be used as a serial number. As a result, the chances of a counterfeiter actually hitting on a real code by using a randomly chosen number falls to one in ten thousand. And to make things even more difficult: deciding which numbers are used as serial numbers at all is a decision made by the BayCoder. BayCoder is a special program developed personally by Artlich and his colleagues (see box), which Bayer Technology Services markets worldwide, also to companies outside the Bayer Group.

One in Ten Thousand

One million packages of a particular product are to be given a serial number. In a classical scenario, they would simply be numbered consecutively from 1 to 1,000,000. The problem with doing it this way is that counterfeiters who already know the product and batch number have it easy, because every serial number lower than 1,000,000 actually exists on a package.

However, things would be different if you were able to select your serial numbers from a larger range. And exactly that is what the BayCoder software does. Specially developed by Bayer Technology Services, BayCoder starts with a selection that is 10,000 times as large as the number of packages. In this particular example, that means ten billion numbers. Then the program generates a random sequence of these numbers. The first million numbers in this completely unsorted sequence would then be used as serial numbers for the one million packages. On average, therefore, only one number in ten thousand from the selected range is an actual serial number. As a result, counterfeiters who attempt to integrate a serial number into their data matrix code take the risk that 9,999 out of 10,000 fake products will be identified as such as soon as the code is scanned and compared with the database, because most of the numbers in the range simply don’t exist there. Even armed with the knowledge of several existing serial numbers, the BayCoder algorithm remains uncrackable.

The code concept has now found acceptance, and the European Commission has made a firm commitment to the data matrix approach for recognizing counterfeit medicines. The Europe-wide rollout is planned to take place by the end of 2018.

In several non-EU countries, the data matrix code is already in day-to-day use. Turkey, for instance, has stipulated the use of such a security measure since 2010. And in Argentina, China, Saudi Arabia and South Korea, medicines also have to carry a 2D code. Other countries, including Brazil, are about to introduce a corresponding system. For Stefan Artlich and his fellow data matrix advocates, all this global activity has brought with it more work, because it means they have to support their colleagues at Pharmaceuticals and Consumer Health in adding the required code to the product packaging for each of those countries.

Dr. Stefan Artlich
Freut sich über den hohen Sicherheitsstandard der DataMatrix-Code-Lösung: Dr. Stefan Artlich

“For imported products, an initial solution provided for adding the codes for the respective countries retroactively,” says Artlich. But in the mid-term, the products will need to come off the production line already fully encoded. “Bayer is currently in the process of integrating this step-by-step into the respective production lines at all sites around the world.” Bayer Technology Services employees are involved in all local site projects; in some, Artlich himself is on site. The first projects have already been completed successfully: In Berlin, Berkeley (USA), and in Segrate in Italy, the first product packaging bearing the new code rolled off the production line at the end of 2014. And more sites will be added this year, including Leverkusen and Weimar in Germany, Ansung in South Korea and Turku in Finland.

At Bayer, they know to appreciate the support provided by Artlich and his team. “I’m happy to be able to fall back on Bayer Technology Services’ experience, also with the projects taking place at other sites,” says Thomas Hendrischke, who heads the corresponding program on the Product Supply side.

Some countries, with their security concept, go even further than the European Union does. In addition to the security code, they require complete traceability for every single package along the entire supply chain. In concrete terms, that means knowing when a particular package was loaded onto a certain ship or a certain truck, and where – all of this information has to be recorded in the database by the manufacturer and distributor. For Artlich and his colleagues, this presents an additional challenge. They are currently working to ensure that Bayer fulfills this requirement for the fifth largest pharmaceutical market in the world: Brazil. A test phase with selected products is already running. And time is pressing: the South American country is planning the introduction of the matrix code for 2016.

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