Annual report 2018

Galenica annual report 2018 | 33 Sustainability coverage The safety and health of patients take top priority at Galenica. To ensure these, the com- pany is actively involved throughout the entire value chain in protection against drug counter- feiting. Galenica is progressively implementing the European Commission’s Falsified Medicines Directive, even though it is not mandatory in Switzerland. Since February 2019, all prescription medication packaging in the European Union (EU) must have certain security fea- tures to protect against falsifications. These are, on the one hand, a so-called tamper-evident closure, so that it is imme- diately evident whether medication packaging has already been opened, and, on the other hand, a Datamatrix code with a unique serial number, which must be checked for authenticity before the pack is dispensed to the patient. This is to ensure that no falsified medicines are distributed. For several years now, the World Health Organization (WHO), the Organisation for Economic Cooperation and Develop- ment (OECD) and the Swiss Agency for Therapeutic Prod- ucts (Swissmedic) have observed a steady rise of global trade in falsified therapeutic products, i.e. medicines and medical devices. Falsifications not only affect lifestyle drugs such as those for erectile dysfunction or slimming aids but also life-saving products, including cancer drugs and anti- biotics, and therefore pose a serious risk to patient health. Due to the strict licensing and authorisation procedures for medicines in Switzerland, the risk of falsified medicines reaching pharmacies or medical practices via official dis- tribution channels is very low. However, the import of falsi- fied medicines by individuals via the Internet is steadily increasing. At the Galenica Group, all Business sectors face the chal- lenges of protecting against falsification and are taking tar- geted measures to combat falsified medicines, for example by implementing the new EU Falsified Medicines Directive (FMD). Ideally equipped for the future As a pre-wholesaler, Alloga works on behalf of mainly inter- national pharmaceutical manufacturers. As part of a joint project with Galexis, headed by Project Manager and Busi- ness Analyst Efkan Sahingöz, Alloga has integrated the EU FMD into its internal quality management and IT systems. New scanners have been introduced to read the two-dimen- sional Datamatrix code, and the software has been con- nected to the verification system. “We are getting Alloga ready on a technical level to meet FMD requirements for international partners,” says the project manager. “Specifi- cally, this means that Alloga can check the authenticity of pharmaceutical packaging labelled accordingly in Incoming Goods at the request of the pharmaceutical partner. If pre- scription medicines are returned by pharmacies, hospitals or physicians, Alloga will be able to check each individual pack and, if necessary, deactivate it in the database before the pack is destroyed.” A Europe-wide networked database system ensures immediate verification of the medicine’s authenticity. Galexis also introduced new scanners in 2018 and updated its software system. “We are now working on a concept to develop solutions for integrating the new verification activi- ties into our work processes, for example for incoming goods,” explains Efkan Sahingöz. In contrast to Alloga, which works on behalf of mainly international partners, Galexis, as a wholesaler, is the owner of the medicines it distributes, and as a Swiss company, it is not affected by FMD. It has therefore not yet fully completed the implemen- tation of the directive. The project manager points out, however, that Galexis is fully prepared to implement FMD entirely if it also becomes mandatory in Switzerland. Galexis would then also be equipped to verify the authenticity of a pack labelled accordingly when medicines arrive from suppliers or have been returned by customers. Galenica