Complaints resulting from suspicions of counterfeiting occur between 100 and 200 times a year. A doctor, pharmacist, hospital or patient contacts one of Boehringer Ingelheim’s national subsidiaries to say that the packagings or the tablets look different to the usual ones. The batch number and expiry date details on the packaging do not match the details on the blister packs or on the bottle label, and possibly the expected effect is not experienced or there are unexpected side effects. In short, there is a suspicion that someone may have provided the doctors or patients with counterfeit medicine.
“In order for us to be able to investigate such cases, we ask that any suspicious products are sent to us. Only then will we be able to come to a reliable conclusion. In some cases, photos can already provide initial indications of counterfeiting,” explains Johannes Schön, who is responsible for protection against counterfeiting at Boehringer Ingelheim. The products that are sent in will then be forwarded to the facility that manufactures the corresponding original for Boehringer Ingelheim. “Our colleagues there can compare the packaging with the retention samples and submit the products for chemical analysis,” says Schön. In more than 90 per cent of cases, the suspicion turns out to be unfounded. However, if there is something amiss, this can range from the manipulation of the expiry date on the packaging to complete counterfeiting of products with alien ingredients. “Luckily, our product portfolio isn’t as badly affected by counterfeiting as those of other manufacturers,” says Schön. This is because counterfeiters focus more on antimalarials, antibiotics and lifestyle products such as medicines to treat erectile dysfunction, dieting aids or hair restorers.
Counterfeit medicines represent a growing problem – not least because the internet makes it easy for criminals to trade in counterfeits: “Operation Pangea”, which is coordinated every year by Interpol, seized more than five times as many counterfeit drugs and prohibited medicines in 2016 than in 2011, with almost ten times the value. Frequently, tablets or solutions contain no active ingredient at all. Sometimes, they do actually contain the active ingredient, but in much lower concentrations than they should. What is worse is that many criminals also use toxic substances to manufacture counterfeits.
Boehringer Ingelheim has been involved in combating counterfeit medicines for years – not only through the interdepartmental work of Johannes Schön and his colleagues, but also primarily by undertaking from the outset a whole range of measures to make the supply chain for medicines more secure. The company campaigned intensively for the implementation of the new Counterfeit Protection Directive of the European Union (EU) through the European Federation of Pharmaceutical Industries and Associations (EFPIA). This directive is due to be implemented across Europe by February 2019. While the precise regulations were being drawn up by EU politicians, Boehringer Ingelheim already started the implementation of the new regulations, piloting in Germany and Sweden.
In partnership with a major competitor and with representatives of pharmaceutical, wholesale and pharmacists’ associations, Boehringer Ingelheim launched the securPharm initiative in 2012. securPharm has developed a system for the unique labelling of medicine packaging. A data matrix code, familiar from train tickets for example, contains encrypted information about the manufacturer and the medicine, the batch number and expiry date. The same information is stored in a central database. As soon as a pharmacist scans a pack prior to selling it, the system checks whether the data is valid and records the sale of the product. “This means that no one can sell the same pack twice,” explains Schön. “And the pharmacist recognises a pack with an incorrect code immediately.”
The securPharm system has been tested at around 400 pharmacies in Germany since January 2013, and 40 products from Boehringer Ingelheim now feature the code, with more in the pipeline. “When the EU directive makes these kinds of anti-counterfeit systems mandatory in 2019, we will already have an enormous lead,” says Schön. The company also takes part in anti-counterfeit initiatives outside Germany, enabling, for example, the detailed tracking of delivery parcels and pallets. Special seals were designed to prevent packs from being opened unnoticed prior to sale.
Boehringer Ingelheim also puts emphasis on providing information. For instance, patients can also detect counterfeits if they keep a number of typical warning signs in mind. Is the seller trustworthy, or was the offer really too good to be true? Does the pack look as if it has been tampered with? Are there spelling mistakes in the text? Do the tablets or capsules differ from their usual colour or form? If a medicine actually tastes or smells different to usual, patients should make sure that they ask their pharmacist or contact the manufacturer directly – even more so in the absence of any effect or if the medicine produces unusual side effects. “Counterfeiters will keep trying,” says Schön. “But together, we can make it as hard for them as possible.”