Beyond the FMD: Your next 5 priorities in pharma traceability

You think you’ve successfully completed your readiness preparation for the European Falsified Medicines Directive (EU-FMD) that came into force on 9th February 2019 and have got pharma traceability sorted out for now – think again.

Here are the 5 important things that need to be at the top of your pharma traceability to-do list in order to stay in business.

1.    EU-FMD done? – Unlikely

On the 9th February, the EU-wide European Medicines Verification System (EMVS) launched with quite some teething troubles but in the 100 days since, things have been improving significantly. The number of packs uploaded EU-wide has passed 2 BN and the system is currently operating at over 30 MN transactions per week and rising steadily.

Does that mean there is nothing else to do? Not at all. We may, in fact, be just looking at the calm before the storm.

Let’s start with the on-boarding to the EMVS: As a pharma company, hopefully you are amongst the 1,000 or so On-Boarding Partners (OBPs) that are fully connected to the European Hub or have at least concluded the contractual on-boarding steps.

But that is not a given: According to the European Medicines Verification Organisation (EMVO), there are still an estimated 600 OBPs that have yet to complete or even start the process. So, if you are one of the 600 and are not providing serialised packs with the corresponding Unique Identifies (UIs) correctly uploaded then you are on the wrong side of the law supplying product to the European Market: Signing with EMVO, the National Medicines Verification Organisations (NMVOs) in the markets that you are supplying and connecting to the European Hub must be your top priority.

However, even many companies that are up and running with their EU-Hub connection may be operating at risk: From working with a number of large pharma customers we know that the task of completing their CMO and partner on-boarding is still very much a work in progress. This means that there are still parts of their pharma supply chain that are operating outside compliance; a situation that must be remedied with urgency.

2.    Business as Usual and Alerts Management

Partner on-boarding that is taking far longer than planned is not only presenting a risk but also an unwelcome distraction at a time when companies are under increasing pressure to wind down their readiness projects and hand over to the Business As Usual (BAU) organisation.

While the handover from project to day to day operation of new systems and processes always presents its challenges, these do stack up in the case of serialisation projects and particularly in the context of the EU-FMD: It is clear that the workload in general, the level for technical expertise and the time required to hand-over have often been underestimated. Busy teams are scheduled to take over what is still a full-time job for several people, even ignoring the ongoing work with CMO connections.

This challenge is exacerbated by the need to manage the tens of thousands of alerts that the European system is generating every day. Indeed: Even though the level of alerts has dropped from the scary double-digit percentage figures seen in the early days, it is still running at above 1% of transactions – about 2.5 million alerts per month across the EU - an order of magnitude too big for comfort. EU Alert Management is currently the critical topic and will remain so for the foreseeable future. Indeed things are likely to get even more critical before they get better and while here is not the place to analyse what causes the huge number of alerts that the EMVS is throwing up every day, it needs to be pointed out that every pharma manufacturer connected to the system must be ready to monitor and dealt with these alerts.

There are two reasons why this problem may be about to get worse:

At the moment, most markets operate a stabilisation period, at the grace of the relevant National Competent Authorities (NCAs). This means pharmacist are allowed to dispense a pack even when the EMVS has generated an alert, as long as they have satisfied themselves by traditional means that the alert is a false alarm. But these stabilisation periods are coming to an end market by market and turning a blind eye to the ‘do not dispense’ message thrown up by the system will soon no longer be an option.

What will exacerbate the situation is the next wave in dispensing partners going live in the system: Then are still many markets where the stakeholders further down the supply chain – hospitals, pharmacies and others – are far from fully on-boarded. That means that the end-point verification rate in many markets is far from the 100% that will soon be the norm. But as more and more of end-users and their systems get onboarded at last, the rate of alerts will inevitably rise.

Ignoring alerts is therefore not – and actually never was – an option for pharma manufacturers, even though a lack of on any tough enforcement action may have given that impression. After all, every alert is a potential falsified product that threatens the life of patients so alert messages cannot be ignored: Not even the ‘stabilisation period’ guidance absolves manufacturers from the duty to investigate, address and fix the root causes of these alerts, regardless whether the problems are created in-house – master data, process or systems issues – or caused by their partners – such as the read errors caused by incorrect hand scanner configurations in pharmacies or technical issues with end-user software.

Once the stabilisation period comes to an end and regulators are beginning to enforce the obligations, every marketing authorisation holders needs to ensure that they have in place a reliable GxP process and expert support to manage their alerts in a controlled, documented and timely way: This means that it is a priority for every pharma manufacturer to establish a reliable process for receiving and identifying alerts, for triage, prioritisation and root-cause analysis. Whatever causes failed transactions needs to be fixed, often in collaboration with supply chain partners and the NMVOs, in a time-critical way while maintaining the level of documentation that is to be expected from operating under GxP rules.

3.    Aggregation

One group of end-users that will drive up the level of alerts as the come online are hospitals. Hospitals currently shows the lowest level of engagement with the end-to-end pack verification process: Only about one in four Hospitals across Europe is today in a position to scan pack at the point of dispense and check against the relevant National System. This is not the place to discuss why this is the case or allocate blame, but instead to highlight one area that is gaining increased attention in the context of the discussion about hospitals’ engagement – or lack of it: the call for aggregation.

Aggregation has not been designed into the EU system, which operates strictly at pack / item level. However the recital to the Delegated Regulation (DR) and also the European Commission Q&A make clear that it is perfectly acceptable to use aggregation to facilitate more efficient operations. True, little attention has been paid to this topic in the past in Europe, but calls from hospitals to find a way to facilitate their goods-receipt and verification processes have changed this. Aggregation is now a topic of re-invigorated discussion, with the current focus on the associated challenges of data security, responsibilities and the best practical way to incorporate this approach in the EU system.

While no formal requirements or timelines have been issued as yet, it is likely that this will be a question of when rather than if: The established practice and requirements in other markets as well as horizon scanning of emerging developments in the pharma supply chain leaves no doubt that stakeholders collaborating more closely will create significant improvement in efficiencies; this includes the advance sharing of information to make it possible to confirm receipt of a pallet and all the items contained on it in one operation instead of thousands of individual scans. While implementing aggregation is therefore not a top priority today in terms of ‘license to operate’, it will become a requirement sooner rather than later, also in the EU, whether mandated in the context of a future EMVS Version 2 or driven by supply chain partners agreeing other ways of exchanging this data securely.

Establishing aggregation capability should therefore be a priority for every manufacturer’s serialisation/traceability roadmap, also for Europe.

4.    Russia

For manufacturers looking beyond Europe, this question does not even arise: As the requirements in more and more markets are firming up, the direction is clearly towards models that mandate full traceability, be that in Brazil, markets in the middle east or China, to name just a few major current developments.

It is Russia, however, where attention needs to focus next to actively engage as the compliance deadlines are approaching rapidly: Full traceability is required for all medicines for sale in Russia, from 1st Jan 2020, for some medicines even earlier.

However, it is not just the short timeline that makes Russia’s requirements really challenging:

Much attention has been on the item-level coding requirement with the eye-catching need to include additional cryptographic elements totalling 92 characters in addition to product code and serial number, resulting in a 2D DataMatrix almost double the size of what had to be printed for Europe. While the length of the Cryptocode elements is now likely to be reduced to 48 characters and possibly even less, the Russian requirements still introduce a level of detail way beyond what other markets are demanding. This includes price information in many reports and the need to provide updates to the central database at every major step in the supply outside as well as inside Russia.

The Russian pharmaceutical traceability requirements present a challenge like no other, but our industry-leading experts can help - learn more at GTT Russia on 24-26 June.

These challenging requirements are not emerging out of the blue, they have, in fact, been evolving over a number of years and been refined in the course of a pilot phase over the course of the last two years. For various reasons, however, many pharma manufacturers have failed to pay sufficient attention. But whatever the cause of this lack of attention – typically the preoccupation with EU-FMD and a combination of the ‘cry wolf’ and the ‘lost in translation’ effects –now it is high time to address this if you are supplying medicines to Russia: If Russia is a market where you are active, then Russia readiness needs to jump to the top of your priority list of actions.

5.    Gearing up for the next new paradigm

Finally, moving beyond urgency and looking at importance, it is worth asking the question ‘what next’?

At the risk of giving the impression that a round of buzzword bingo is about to start, there are significant changes likely to affect the pharma supply chain that will inevitable have an impact on what companies have been putting in place to maintain their license to operate and that will affect the shape of future requirements.

Let us consider just one area: the significant advance in new medicines that are rapidly moving into the market – biologics, gene therapy, cell therapy – and the very different profile in terms of volumes and values as well as how they are manufactured and distributed. The inevitable question is: How will these novel treatments fit concepts such as the EU-FMD that was developed almost 10 years ago when blockbusters / oral solid dose medicines were the dominant paradigm? It is clear the paradigm shift whose beginnings we are only just seeing - alongside other development such as genomics, big data, artificial intelligence and other novel technologies - will inevitably impact the medicines supply chain.

What this means in practical terms is not yet clear but as companies are – hopefully – framing their supply chain readiness programs not just in tactical / reactive ways but are taking a more strategic perspective beyond the immediate compliance needs, the increasing call for real-time responsiveness and bi-directional information is a given: The leading paradigm of the future will be high visibility and full traceability along the whole supply chain, real-time, step by step. It would therefore be a shame to consider the significant investments made so far as short-term spend to achieve compliance and not look at this as part of an investment in capabilities that can be leveraged to achieve greater efficiencies, higher levels of collaboration and better outcomes for every partner in the supply chain, from producer to patient and payer.

Next steps – way forward – how can EHS help?

• In-market strategy
• Strategic Project management with serialisation experience to guarantee the outcome
• Healthcheck
• Service Bureau – Alert Managament
• Validation services
• EHS will provide a comprehensive offer of services, covering all aspects of a T&T program, from inception, through delivery to sustainability