Prohibition on proactive serialization for the EU FMD

The EU Commission has re‐affirmed very controversial direction given at the GS1 Healthcare global conference in Budapest this past October. This affirmation is regarding the interpretation of the Delegated Acts and the European Stakeholder Model, or ESM.

To date the EU model of pharmaceutical product serialization has served as a desirable model for the industry in achieving greater levels of medicines patient safety.

The beauty of the EU model is that it takes a "walk before we run" approach and places the power of medicines verification squarely on pharmacy at time of dispensing to patients. It also eliminates further uncertainty for industry by identifying an organization and a system to manage verification. These are the European Medicines Verification Organization and the European Medicines Versification System, EMVO and EMVS respectively.

It has its "cons", but until recently has been preferred by industry over more onerous ePedigree and end-to-end track and trace regulations such as Turkey's ITS and the US DSCSA.

EU FMD background

As a refresher, the Unique Identifier is one of two elements referred to as Safety Features according to the Falsified Medicines Directive, or FMD. The safety features are required for compliance on all EU packages by the end of 2019.

The first element is an Anti‐tampering Device generally understood to comprise a means of indicating to pharmacist and patient that the original packaging has been tampered with. The Unique Identifier is comprised of the Product Code, Serial Number, Batch Identification and Expiry Date. It also may include a National Reimbursement or National Identification Number if requested by the individual EU member state.

Industry has elected to follow EFPIA and GS1 recommendations to carry this information in a GS1 Datamatrix code on the packages. This is in alignment with the EU FMD requirements. Human readable information is also a key component as many believe it is wise to include in the event the 2D code becomes unreadable or is damaged during distribution. We refer to this human readable information as HRI.

The prohibition issue

What I'd like you to contemplate at this point is two‐fold: the necessary real‐estate on product packaging to carry the 2D code and HRI, and the uploading of this information to national or EU level databases prior to distribution by the manufacturers.

What has the EU Commission affirmed that has profound implications on implementation of the Unique Identifier and uploading of information? The following:

The tamper evident packaging technology can be applied before the deadline of the FMD Delegated Act. However, the Unique Identifier should only be placed once there is an operational repository (EMVS) where the relevant identification data can be uploaded. Retroactive implementation of the Unique Identifier and uploading is not permitted.

This prohibition by the EU Commission raises serious concerns for the pharmaceutical industry and supply chain. We could explore the total supply chain and impacts to all stakeholders, however highlighting the challenges this presents for pharmaceutical manufactures should be sufficient to foster a call to action.

What safety feature prohibition means for pharmaceutical manufacturers

Manufacturers cannot simply flip a switch to implement Safety Features and upload information to active EMVS databases on the compliance deadline in 2019. Many have hundreds, if not thousands of SKUs that are impacted by the FMD. The implementation requirements to packaging and distribution capabilities are also profound and will collectively run up a tab for industry exceeding $1bn.

Manufacturers need a significant amount of time and planning to ensure compliance by the 2019 deadline for the majority of EU member states. It is impossible to achieve compliance by simply delaying all of the necessary implementation changes and revisions to packaging and artwork.

Revising packaging for tamper evidence and artwork to permit space for the 2D code and HRI is not trivial. This is a massive undertaking even for smaller pharmaceutical manufacturers. As a result of this some have been fairly proactive and have already started to implement Safety Features on commercial product, including the Unique Identifier. Indeed we've already read of reports of serialized product showing up at pharmacies even though there is no EMVS to access for verification.

Furthermore manufacturers, wholesale distributors and retail pharmacies will need a fair amount of time to deplete existing non‐serialized inventory once the deadline is in effect. Removal of non-serialized inventory just prior to the deadline is impractical, wasteful and would ultimately be unsuccessful given the movement of medicines across the EU.

It is generally accepted that prior to this affirmation by the commission, non‐serialized medicines would exist in the legitimate supply chain for well into 2020. Indeed non‐serialized medicines could persist for years given remaining expiry dating on products.

There is at least one other important question related to what the commission has stated. What will the commission do if the deadline passes and there is no operational repository within a member state?

The solution

I firmly believe that this probation on proactivity from the EU Commission is deeply rooted in their advocacy for patient safety. It's hard to contemplate any other basis for this direction. It's clear that this will create enormous problems for the EU medicines supply chain, and perhaps globally. It will put at risk access to medicines as supply chain stakeholders scramble to meet an impossible interpretation of the FMD as the deadline approaches. It may even put at risk the success of the ESM and spur dissent amongst member states.

Simply stated, and I make no attempt to be profound, the EU Commission needs to enter into a dialogue with industry. It is my belief industry wants to comply with the FMD – all of their collaboration with industry bodies and the commission has been to make the ESM a success. I strongly encourage the EU Commission to enter into discussions with industry to discuss practical interpretation of FMD implementation and ensure the success of the European Stakeholder Model.