At the Next Generation Pharmaceutical (NGP) Manufacturing Summit in Montreux, a hot topic of discussion was counterfeiting, especially in light of the EU's Falsified Medicines Directive. In a keynote workshop, Protecting Brand Integrity: Innovations in Traceability & Anti-Counterfeiting, a concern shared by all was the lack of detail in the new legislation, but there were also many other questions to answer. One was whether current technology is good enough, and the general view was that it more than met the industry's needs. Perhaps the problem is that sophistication is only useful if it can be fully controlled. Although track and trace technology is fairly simple and gaining momentum, one of the panellists noted that it is a single tool and not the sole solution. Serialisation is clearly important though, with the Turkish Ministry of Health leading the charge. Trackinside's Adrian Simmons called for the pharma industry to look at lessons learned in other markets, stating that the excuse "we are different because we are pharma" does not apply to this issue; the automotive, food and beverage, and entertainment industries all have valuable experience.
The big question, however, was "who should be driving anti-counterfeiting?" In a quick show of hands, the split was about 75% pharma, 20% regulatory and 5% vendor. Perhaps lobbying by advocacy groups, as in other industries, would help get everyone on the same page; regulatory requirements certainly push pharma, so maybe pharma should push back. One thing that is certain though is that the counterfeiters will be hot on the heels of any decision.Best wishes,
Rich Whitworth, Editor