Letter from the CEO
This year, serialization becomes a true reality for many companies. As the leader in the market, we feel that TraceLink has a corporate responsibility to provide insight into the state of serialization as it stands today, by leveraging our unique ability to reach the entire supply chain, from end-to-end, through our 266,000+ trade partner network.
What we found was startling. Despite goodwill efforts by industry and regulators to meet compliance on time, the industry is extremely behind in being ready for serialization. There is no question that serialization among trade partners is a truly complicated endeavor - hardware shortages, interdependencies between companies and data exchange complexities are all major hurdles to overcome – but the clock is ticking, and in this report, we found that these hurdles have not yet been tackled by the vast majority of industry.
Cultivating data from 660 respondents across the supply chain (pharmaceutical companies, contract manufacturing organizations wholesale distributors, hospitals and pharmacies), we found that only one-third of the industry feel confident about their own serialization readiness for U.S. DSCSA and/or the EU Falsified Medicines Directive. And, even more shocking, not one respondent had completed all of the fundamental steps for serialization. Basic components - such as projecting the number of units to be serialized annually, or readying internal packaging lines for serialization – were only accomplished by half of the pharmaceutical and contract manufacturing respondents. Simply put, industry is still struggling with fully understanding the various components necessary to truly be serialization-ready.
As we dug deeper into the data by regulation, we found that while all pharmaceutical companies selling into the U.S. should be serializing product by now, only one-third of respondents feel “very ready” for serialization. In the EU, with less than one year remaining until the FMD deadline, the disparities between pharmaceutical companies and CMOs are staggering. Pharmaceutical companies are troubled about connectivity to their CMO partners and while CMOs appear to be overstating their actual serialization readiness.
When we published the inaugural Global Drug Supply, Safety and Traceability report in 2016, we wanted to uncover the myths versus the realities within a supply chain operating in one of the most complex industries in the world: pharmaceuticals.
This year’s survey was designed to understand what it truly means to be ready for serialization, breaking down the perception of readiness versus actual readiness faced by each constituent in the supply chain. We wanted to take a comprehensive pulse of the industry, and by doubling the number of respondents from last year’s report, we were able to gain even greater insights into not only the respondents’ perception of their own readiness, but the actions they are taking, or not taking, to be ready.
We review not only the pure data, but what’s behind the data, and its implication on the maturity curve of each segment within the industry. In 2018, as we reach the final hours of serialization in both the US and EU, the industry-wide lag in full serialization implementations remains a concern and emphasizes the criticality of trade partner connectivity within the supply chain.
This year will be pivotal as we embark on a massive digital transformation and harness the power of unlocking the full value of serialization.
President and CEO