German Companies Develop New Technology to Prevent Fakes
German companies are responding to the risk of counterfeit medicine distribution in Europe with the development of new technologies used to authenticate German products with seals and security codes.
One manufacturer, Bionorica, is using three-dimensional, optically variable embossed marks created by a Munich company which specializes in printing bank notes. In order to use these marks three German companies were needed for the development of the production process for the new packaging, to design the marks, and finally to print and emboss them on the medicine packages, reports Manufacturing Chemist.
Other German companies, including, Bayer Healthcare, Optima Group Pharma, and Bosch Packaging Technology, also have adopted tracking codes and authentication stamps for products.
Companies are responding to the increase in fake drugs within the market as well as increased use of mail order medicine services to insure product safety. German customs authorities seized 11.5m billion of counterfeit medicine in 2009, according to EU figures, while the German Pharmaceutical Society (DphG) estimates fake drugs as 5% of the current market. In addition, “test purchases by the Central Laboratory of German Pharmacists confirm counterfeiting rates of 50% for medicines sold by, for example, illegal Internet pharmacies,” reports Manufacturing Chemist.
The EU has been showing interest increasing vigilance against drug fakers in its recent meetings. In 2008, the European Commission proposed that medicines packs have security marks order to retrace their path from the retailer to the manufacturer.
The European Federation of Pharmaceutical Industries and Associations (EFPIA) launched a pilot project in Sweden in September 2009 to test anti-counterfeiting packaging. Packs for 25 pharmacies in the Stockholm region were provided with a two-dimensional data matrix code that contained an article number, a batch number, a use-by date and a serial number. Prior to sale, the pharmacists scanned and verified the code in a database in a few seconds, so that counterfeits were immediately identified. EFPIA reported that about 100,000 packs were tested successfully using this system.
Some questions on the implementation of these technological advances to insure medicine safety remain unanswered. The development of local technology to protect the safety of EU medicines, requires enormous investment in order to retool packaging lines, which will take time. Even if the EU rapidly approves its pharmaceuticals package, the implementation process could take years. Also unknown is where the data associated with a pan-European track and trace system will be stored.