TraceLink recently hosted FutureLink Barcelona 2024, their annual European meeting for supply chain participants. Since Europe enacted serialization requirements back in 2019, this event emphasized very different topics from TraceLink’s US-based FutureLink meeting in May 2024.
In Barcelona, the recurring themes dealt with how the industry is beginning to utilize serialized supply chain data and digitalization to resolve critical supply chain issues. Executives from leading biopharma companies shared how they are using operations data and analytics to predict product demand and support forward-looking decision-making.
TraceLink also shared new solutions and digital platforms that facilitate operations data visibility and reduce both risk and cost.
Key Insights from TraceLink FutureLink Barcelona
E.U. serialization is more stable than in the U.S. and companies are beginning to move beyond compliance.
Europe uses a centralized repository approach for serialized data, as opposed to the more distributed data approach in the U.S. Consequently, only the lowest saleable unit is tracked and traced, and serialization at the container/case is not required. Downstream partners receive data from the centralized repositories.
Many European companies have performed compliant serialization activities since 2019, and both the data and systems are now more stable. As a result, their focus now is on developing more efficient serialized operations. Companies are starting to digitalize their supply chain processes to optimize decision-making and lower costs.
This is different from the U.S. where companies are still working towards meeting serialization compliance requirements and stabilizing the data and systems for interoperability.
Some E.U. countries are exceptions and continue working through their serialization transitions.
When the E.U. introduced serialization systems for pharmaceuticals and made it mandatory in 2019, some countries received an extension delaying enforcement of the requirements until 2025. The extension will facilitate a smooth transition from pre-existing labels and systems.
Italy, for example, is still in the process of transitioning from the Bollino system to a label that follows GS1 standards. There are also debates around the use of an antitampering sticker. Although this can be helpful to protect the drug in a package, it can also limit the visibility into the label information.
The ongoing transition for these countries means that there is still an environment of some uncertainty, and concerns exist over whether there may be an impact on product availability.
TraceLink is offering digital supply chain tools beyond track and trace compliance.
TraceLink presented new solutions under development that leverage their network to facilitate information exchange among trading partners.
Two recently launched solutions are MINT (Multienterprise Information Network Tower) and the Opus Digital Network Platform. The combination of these products is intended to create a capability for building end-to-end supply chain collaboration solutions.
Attendees had mixed reactions towards investing in the new solutions. Some felt confidently that investing in these tools as early adopters would create a scalable platform for growth. Others voiced caution, however, that companies should wait to reach a maturity level with their business processes and trading partners where they could optimally use the software capabilities.