PHARM Connect Congress | 22-23 FEBRUARY 2017
Drug Safety and the EU’s Falsified Medicine Directive in the Spotlight
More than 400 decision makers and professionals attended the congress from over 25 countries with the same purpose: sharing their experiences, building new partnerships, finding the best solutions for their company and preparing for the challenges of the new regulations.
Medicine falsification is an escalating problem both on European and global levels. The emerging market of fake and uncontrolled medicines not only impairs the pharmaceutical manufacturers, but the end users of these products can suffer tragic consequences as well. Due to the European Union’s new directives, the pharmaceutical industry in Hungary and the rest of Europe is facing tremendous investment pressure. In fact, serialization - ensuring the traceability of all prescription drug packages - will become mandatory across all EU countries in 2019.
What EU Falsified Medicines Directive will bring?
In order to avoid any interruption or temporary stoppage in the manufacturing process, factories are urged to implement the serialization solutions in the production process – as reported by the panel discussion of Neil Lawrence, the Global Serialization Champion of GlaxoSmithKline, Grzegorz Brzoskowski, the CEE/Baltic Regional Security Director of Sanofi, Réka Balogh, Serialization Project Coordinator, QA Expert of Gedeon Richter and Dr. Lajos Hegedűs, former Managing Director of TEVA Pharmaceuticals & Chairman of the Production Committee of the Hungarian Pharmaceutical Manufacturers Association (MAGYOSZ).
“In the future, the requirement for serialization and authentication can apply to any pharmaceutical product and products made for children. This is to prevent toxic foodstuffs and forged parts from entering the markets and prevent abuse of such substances” – as stated by Stefan Rowinski the project director of Atlantic Zeiser, one of the leading providers of track & trace, coding and serialization solutions.
Pharmaceutical companies will be required to mark the packages they produce with a traceable barcode in the future. Wholesalers and distributors can save these codes in their systems for the purpose of ensuring authenticity and investigating any possible drug thefts. This enables pharmacies and hospitals at the end of the distribution chain to check the origin of the medicine based on the given barcode.
Where to find the best solutions for the challenge?
The implementation of serialization solutions will result in some inevitable extra costs for the pharmaceutical manufacturers. A substantial portion of the expenditure will come from installing new technology in packaging lines. Some production lines will need to be fully remodelled and automated. Many factories are postponing the investment decision therefore; the issue will become increasingly urgent for everybody at the same time. Only those that launched the serialization project fast enough will be able to comply with the regulations in time.
Representatives of the leading specialists in trademark protection were already available at the PHARM Connect Congress in 2017. At the event, the companies instructed pharmaceutical factories on how to initiate and launch serialization projects. They will be available in the 2018 edition of the congress as well.