Lessons learned from early EU FMD adopters

Data exchange, investment costs, resources and hardware identified as some of the biggest challenges.

What has been the industry’s greatest challenge in meeting the FMD requirements?

Allan Bowyer, Director of Industry Marketing, TraceLink: "The biggest challenge for the industry was the requirements around exchanging data with both supply chain partners and the EU Hub.

"Manufacturers have had to invest significantly in a solution with data-sharing capabilities as well as in packing line hardware and operations to print the required barcodes and apply physical anti-tamper devices.

For smaller companies, the investment and resource requirements were an even greater obstacle. This led to consolidation and the proliferation of strategic partnerships where contract packaging organizations (CPOs) with a solution in place are being heavily relied on by MAHs and contract manufacturers with relatively small portfolios."

Lauren Catalano, technical services manager at Sharp Packaging Solutions: "For Sharp, the two greatest challenges were

Due to the increased volume, it takes a scalable and sustainable implementation process that is efficient and maintains timelines for production."

Staffan Widengran, director corporate projects, Recipharm: "Many companies underestimated the complexity of implementing serialisation solutions that can be universally applied to ranging market needs. Most contract development and manufacturing organizations (CDMOs) cater for a global client base and each market has different legislative requirements. This means that there was not a one-size-fits-all solution that could be employed across the board.

"One of the key challenges Recipharm encountered in meeting the Falsified Medicines Directive (FMD) requirements was the onboarding of its customers. The lack of control over the preparedness of customers proved to complicate the matter for contract partners across the industry, as it meant that each customer was at a different stage in their serialisation journey. The data exchange challenge was also tricky. Recipharm adopted a network-tenant approach and used TraceLink’s Life Sciences Cloud in order to minimise such complexities and connect to its customers and other supply chain partners more easily. By joining the same network as our customers and suppliers, we can interoperate in one shared area and seamlessly exchange data. As a result of this and our other preparations, we have successfully onboarded 95% of our customers to date."

What is your advice to a business preparing to implement serialization?

Allan Bowyer: "Managing the product coding, master data, serialization and compliance data for products in the European market is much more complex than first thought. It is imperative that businesses look at the availability of master data within their organizations and identify its sources, whether it is company products or trade partner master data.

"The next area is focusing on external integrations and connections as businesses have less control over these and the process is more complicated – integrating with CMOs and 3PLs and connecting to the European Medicines Verification Organisation (EMVO) should be started as early as possible.

"For smaller companies, they really need to start discussing connection and exchange requirements with their supply chain partners and customers at the earliest possible juncture. In the run-up to the FMD and DSCSA deadlines we saw a lot of the larger organizations prioritize their connections by the strategic or financial importance of the partner business – small companies were often very low on this list.

"The crucial decision lies in how partners agree to exchange data. Given the intricacy of serialization and disparate IT systems, businesses that choose to create point-to-point connections with partners instead of adopting a network-tenant approach will create additional layers of complexity, cost and risk that have caused significant issues in the industry already. I’d recommend that businesses perform due diligence in researching partners and solution providers to ensure they possess proven expertise. Implementing serialization is a substantial investment and given the business risk of unsaleable product, it is crucial that it is done right the first time."

Lauren Catalano: "The best advice for a business that is just now preparing to implement serialisation is to gain as much awareness and understanding of the regulations and requirements before making any decisions. Then, collaborate internally to understand the impact on your business to develop a sound scalable strategy, and contract and partner with reputable and experienced vendors."

Staffan Widengran: "Many drug manufacturers and marketing authorisation holders (MAH) did not realise or identify the complexity of implementing a serialisation solution. As such, compliance was not met by all companies in time for the deadline. To legally distribute medicinal products to the European market and avoid further project delays, non-compliant pharmaceutical companies should outsource their serialisation requirements to third parties.

"Preparation has been key to our serialisation success. Recipharm introduced a dedicated taskforce in order to equip our organisation with the internal resources needed to effectively manage the scale of our serialisation programme and handle such a complex implementation."

Leaders from across the life sciences industry will gather in Barcelona, 11-13 June 2019, for FutureLink to discuss how the industry is faring 4 months post FMD, and to provide knowledge and insight around the next wave of global track and trace requirements. Panels will also explore future applications related to the digital supply network and breakthroughs that are revolutionizing the industry.