Libby White looks behind the scenes of the fast approaching countdown towards the EU FMD directive, due for implementation in February 2019. The Wasdell Group (one of the UK's leading pharmaceutical contract packaging providers), TraceLink (developers of track and trace network solutions and pharmaceutical serialisation for the life science supply chain) and Domino Printing Sciences (developers of commercial inkjet printing, thermal transfer printing, print and apply machines, digital printing presses and laser printing products) share their insights into the challenges, benefits, and solutions surrounding the implementation of the directive.

Bart Vansteenkiste, global sector manager, Life Sciences, Domino Printing Sciences firstly reminds us of the key objectives of the EU FMD: “The EU is demanding that manufacturers of pharmaceutical goods sell their products in tamper-proof packaging that will feature a 2D data matrix code, a human readable unique serial number, a product code, batch number and expiry date for the contents,” he says. “All products under the FMD will need to have clearly displayed, legible codes that can be read by the human eye and a scanner. Medicine manufacturers must ensure their coding and marking equipment can produce the necessary information to sufficient standards, which will enable every stage of the supply chain to easily identify the medicine in question. Any incomplete or faded codes will lead to product rejection, rework or recall – this can cause a back log in the supply chain, resulting in downtime and substantial costs to the company.”

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Bart Vansteenkiste, global sector manager, Life Sciences, Domino Printing Sciences

Facing the challenge

Jean-Marie Aulnette, TraceLink’s VP EMEA sales, believes that many early serialisation adopters have found that managing the master data, serialisation and compliance data for products in the European market is much more complex than first thought. Businesses that chose to create point-to-point connections with supply chain partners for the exchange of serialisation data instead of adopting a network-tenant approach created additional layers of complexity. Some of these businesses are still at risk of failing to meet the deadline and if they are not already close to validating their solution, they will almost certainly not be compliant in time.

He comments, “These companies have no choice but to rely on support from providers that can deliver cost-effective, pre-validated solutions for data management and exchange to meet the deadline.”

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Jean-Marie Aulnette, TraceLink’s VP EMEA sales

Bart Vansteenkiste shares some alarming figures: it is estimated that only around 50 per cent of Europe’s production lines will be FMD ready by the February deadline, with Germany and the UK leading the way in terms of number of companies readily prepared to date.

“It is not yet known how the European commission will respond to this, but it is unlikely that they will prevent the production and shipping of half of the medicine market,” he predicts. “Similarly, when the US-based FDA implemented their medicine directive last year, they found out only 40 per cent of US medicine manufacturers would be readily compliant by its November 2017 deadline. Following this discovery, an extension was granted, but today only 60 per cent of the US-market is ready – not 100 per cent as the FDA had hoped for.”

The EU’s reaction to what will inevitably be a similar situation for FMD come February is not yet clear. But in a high-pressure market, pharmacists will be more willing to distribute products that align with the FMD requirements, rather than risk being involved in a potential legal issue with counterfeit or inadequate medicines.

Daniel Tedham, MD of the Wasdell Group, points out that any company that is not close to validating a solution must now look to outsource serialisation to third-party contract partners to make the FMD deadline.

“Many manufacturers that do not count packaging as a core competency made the decision to outsource very early in their planning for FMD compliance,” he comments. “Offsetting some of the costs associated with buying and installing new hardware, ensuring the right IT infrastructure was in place and training staff were often the major factors in these decisions. This approach also allowed manufacturers to minimise production downtime required to equip lines. As the deadline looms, outsourcing agreements are likely to become more prevalent.”

Providing solutions

Wasdell invested £2.8 million in serialisation capabilities in 2016 and offers compliant products to all markets, including Europe and the US. Daniel Tedham notes: “Our new facility in Ireland will also offer serialisation for all products. As part of its serialisation service, Wasdell also offers three tier aggregation from carton to pallet to ensure compliance with the DSCSA’s enhanced traceability requirements that will phase in as of 2023, and any future changes to regulation in the EU.”

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Daniel Tedham, MD of the Wasdell Group

TraceLink’s European Union Compliance module offers a network-tenant approach to FMD compliance that allows drug makers to on-board and exchange serialisation data with supply chain partners through a single connection to the TraceLink Life Sciences Cloud. The module also supports the provision of compliance reports to the European Medicines Verification System (EMVS) and verification at the point of dispense. TraceLink also offers EU FMD Express, a cost-effective, simplified compliance solution that lets smaller manufacturers comply with EU FMD and integrate with the EU Hub.

Domino suggests that for sharp and clear data production at high speeds, Thermal Inkjet printers can produce codes that are easily discernible and maintain their quality throughout the supply chain. With superfast drying capabilities, tamper evident labels, which are becoming an integral part of FMD, can now be safely applied without smudging the ink. TIJ’s high quality alphanumeric text, barcodes and 2D matrix codes can also strongly adhere to a variety of porous and non-porous packaging surfaces.

Laser printers are also capable of delivering high speed and high-quality codes onto multiple substrates. The technology produces durable, indelible serial numbers and matrix graphics onto the different packaging types. Laser printers are not only suitable for delivering the necessary FMD coding requirements, but they are also a more sustainable alternative as they require no inks or solvents, reducing a company’s overall carbon footprint.

Looking ahead

Daniel Tedham urges industry leaders to look beyond short-term compliance requirements and think about adapting to legislative developments. This will not only open the door for greater supply chain efficiencies but enable pharmaceutical companies to react faster when faced with new legislation.

He underlines, “Integrating aggregation will allow businesses to realise the full benefits of serialisation and deal with any likely future amends to regulations. The more palpable benefits of aggregation are seen in logistical operations - businesses throughout the supply chain can scan pallet barcodes and ascertain its contents, speeding up the supply chain and avoiding time-consuming manual unpacking and checking processes.

“By having full traceability and greater visibility throughout the supply chain, aggregation enables full inventory management control and an efficient product recall system, should an adverse event occur.”

Compliance with the FMD is just the first step, according to Jean-Marie Aulnette: “Through the new digital networks created, fundamental processes can be transformed through digitalisation – creating supply chain insights, efficiencies, new processes and new services. The opportunities associated with serialisation include the issuance of supply chain-wide digital recall notifications and the launch of engagement programs that enable patients to interact with real-time product information based on the uniquely identifiable products.”

He concludes: “The pharma supply chain will soon have the foundations in place for a digital transformation that will revolutionise the industry.”