The EU-FMD compliance project: is Europe ready?

For pharmaceutical manufacturers supplying the European market and their supply chain partners, 9 February 2017 marked the beginning of the 2 year countdown until the EU Falsified Medicines Directive (FMD) compliance mandate comes into force across Europe

From 9 February onward, pharmaceutical companies can no longer legally put products on the European market unless they comply with three critical safety feature requirements: every pack of medicines will be tamper-evidenced; carry a 2D data matrix encoding a Unique Identifier (UI) and the UI must have been uploaded into a Europe-wide system of repositories for systematic checkout at pharmacies.

Achieving readiness to comply with these requirements is a huge undertaking and the question being asked is: “How realistic is the prospect that Europe will be ready in February 2019?” To answer the question, let us look at this as a project — a big, complex project involving many different stakeholders who each have to do their part and be ready, on time.

But — despite plenty of evidence to the contrary — big, complex projects can actually be brought to a successful conclusion in the hands of experienced professionals, following best practice and using the right tools. The question is, what is the state of the EU European FMD Readiness Project when looked at this way?

Breaking the problem down

The starting point, as every experienced project manager knows, should be a critical early project deliverable: to define a breakdown structure to organise a project into manageable chunks of work. So, let us consider the major chunks of work needed to be undertaken to achieve EU-wide FMD compliance.

The first major area of work is the obligation on all pharma manufacturers making products for the European market to be ready to apply the safety features described above. Without the capability to routinely serialise their products, to apply tamper-evidence and to manage the serial numbers securely, they will simply be out of business. Once the EU-FMD has come into force, the definition of a 'quality product' will change fundamentally from today’s definition to a 'Good Pack 2.0', adding the requirement that for every pack in the market, the corresponding UI must be available — for the duration of its shelf-life — in the relevant repositories for verification in the pharmacy.

Apart from manufacturers, their wholesaler or distribution supply chain partners are also required to establish technical capabilities to handle serialised products, because there are a number of scenarios wherein they will need to scan UIs against the repositories for verification or even checkout. The scenarios when this legal obligation applies include risk-based verification, export from Europe and early dispense in certain situations. The third stakeholder group that needs to implement new technology are pharmacists, who will be legally obliged to scan every pack of medicines dispensed to the public.

The second major area of work covers setting up the Europe-wide infrastructure of 'repositories systems' specified in the Directive, a task that is delegated — also in the Directive — to the industry stakeholders, some of whom (the pharmaceutical manufacturers) are also required by the law to fund these systems. This is a significant amount of work that includes not just the design, build and implementation of interconnected systems to cover the whole of Europe from manufacturer to dispense point, but also the set-up of the supporting organisation structures and business processes, at European and also at national level, in each of the participating 32 countries.

State of readiness

So, what is the current state of readiness? Starting with the second area of work, we can be cautiously optimistic about the progress regarding the implementation of the European and national organisations and systems. After all, this work started many years ago, even before the Falsified Medicines Directive was adopted; and despite the daunting complexity of bringing together stakeholders from all parts of the industry (with their competing and often conflicting interests), progress has been generally good, if somewhat initially slow.

Experience at the European level has shown that building trust and confidence take a long time and significant effort, a pattern that is being repeated at the level of national organisations. But recent EMVO progress monitoring reports show the pace of progress clearly picking up. As of February 2017, the European Medicines Verification Organisation (EMVO) had been in existence for 2 years and a growing number of countries — 15 at the time of writing — have also set up their National Medicines Verification Organisations (NMVOs) or are close to the point of achieving this major milestone.

Progress on the technical side follows this trajectory. The central piece of this infrastructure, the European Hub that the manufacturers will interface with to upload the UI data, was implemented in 2014 and has been connected to the first national system — Germany’s SecurPharm — since mid-2015. To help the remaining markets make the tough 2019 deadline and to achieve consistency and interoperability as well as cost-efficiency, the EMVO has selected three providers of so-called 'Blueprint' systems and strongly recommending these should be selected as the basis for the national systems.

Eight countries have so far completed their vendor selection or are very close to it, and while that number may seem low at this point, the Blueprint approach provides a strong foundation for a rapid rollout following the successful establishment of the organisational underpinning. For the markets following the Blueprint approach, EMVO can also provide additional support, such as Quality and Validation Services, and is bringing together the national Project Managers to share learning and provide mutual support. The benefit of this approach is appreciated — most markets are opting for the Blueprint. Germany is the only confirmed exception, because the SecurPharm system predates the Blueprint and is therefore strictly speaking not a Blueprint, although SecurPharm remains fully aligned with the EMVS approach in all other respects.

Although time is short and concerns remain, on a traffic light-based project status report, this area of work would merit a green status, with a cautious dash of amber, to indicate the organisational and systems infrastructure at the EMVO and NMVO level will almost certainly be ready and operational across all of Europe by February 2019.

From amber to red

Unfortunately, the other areas of this large and complex project are showing rather more alarming hues, from worrying amber to alarming red. The state of readiness across the pharmaceutical industry must be of grave concern; for a start, the latest state of play update published on EMVO’s website ( shows that out of an estimated 2500 manufacturers that will need to be on-boarded, only 50 are currently connected or in the process.

Given the timeframe, this low number of active participants must be a serious concern at this stage; we are into the amber tinged with red territory. The only reason it is not solid red is that the EMVO have recognised the likelihood of late on-boarding and have made provisions to manage surges of activity and maintain a responsive turn-around time for on-boarding partners. But what is clear is that for manufacturers who are taking an overly optimistic view and delaying their implementation until the end of 2018, there is no guarantee that their connection to the system will be up and running by early February 2019.

This concern is amplified by the next — and related — indicator on the project status report, which must show a deep, alarming red for manufacturer readiness in general. It’s difficult to find accurate figures for the state of preparedness in the industry, but anecdotal evidence reflects slow progress, especially in the sector of mid-size to smaller companies.

Even the major companies with well-established projects in place — driven partly by requirements in other markets that are compatible or at least comparable with the EU requirements (Turkey, South Korea, Saudi Arabia to name but a few) — are still reporting concerns about whether they will be fully ready in time. This is despite being in a comfortable place compared with other sectors of the industry.

Industry surveys and show of hands at conferences consistently indicate only a minority of pharmaceutical manufacturers have completed or even started their implementation efforts. It is beyond the scope of this article to speculate about why so many companies are risking their European business, but one argument is that the law makers will move the compliance deadline when it becomes clear that industry will not be ready in time. Presumably, this argument is based not just on wishful thinking but on the experience in early adopter markets that issued earlier serialisation or traceability requirements where changes to the compliance date — even at late stages — have been seen. However, there are no indications that this scenario will play out in Europe.

The Directive and Delegated Regulation are very clear about the date, in fact, Article 50 is concise and to the point, stating: “This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. It shall apply from 9 February 2019.”

Neither the Q&A published on the European Commission Website nor any public utterances give any support to the assumption that a change of compliance date is being considered. Indeed, the overall shape of the requirement and a fair amount of detail regarding the obligations on pharmaceutical manufacturers has been public knowledge since 8 June 2011 when the original Directive was issued.

It will be interesting to see how this plays out, but one must sympathise in anticipating the difficult position that many Qualified Persons (QPs) will find themselves in as they are reviewing the batch documentation for release, to discover that their company has produced Good Packs 1.0 that now fall short of the post compliance-date Good Pack 2.0 requirement.

Other areas of concern

The last area of work to consider covers the stakeholders further along in the pharmaceutical supply chain — the pharmaceutical wholesaler and distributors, pharmacists and other dispensing points. This is a large and very diverse group encompassing around 10000 wholesalers, 150000 retail pharmacies and many other organisations that dispense pharmaceuticals, such as hospitals, self-dispensing doctors, care homes, prisons, etc. The task of getting all these organisations ready in time to take part in the Europe-wide process cannot be underestimated. Here, too, investment is required to establish new technical capabilities and processes to manage shipments of serialised product and support the routine scanning of the unique identifier on every single pharmaceutical pack that is dispensed to a patient.

Wholesalers and distributors as a distinct group of participants in the European supply chain are likely to be ahead of the curve, given that other regulations such as the 2013 guideline on “Good Distribution Practice of Medicinal Products for Human Use” have raised the bar on process and system requirements that this group needs to comply with.

This adds to the requirements in the EU-FMD that sets out a number of scenarios wherein they will need to scan UIs against the repositories for verification or even checkout, such as risk-based verification, export from Europe and dispense at the point of supply (DR Article 22 ad 23).

Having been aware that every member of this group must invest in establishing new technical capabilities to handle not just lot traceability but manage serialised products, many wholesalers and distributors across Europe are reported to be making progress towards establishing systems and processes that will allow them to comply with their regulatory obligations, including the readiness to connect to the national systems as and when they come online.

By contrast, progress in the pharmacy sector must be described as mixed. As a stakeholder group that (in Europe at least) has been exposed for less time to serialisation and traceability requirements than manufacturers, their position is further back along the adoption curve. As key stakeholders of the national organisations, they are now nevertheless engaging with the other stakeholders and increasingly committed to progress at national level. Signs of this progress are the full-scale pilots involving community pharmacies that are planned in several countries later in 2017. In parallel, extensive engagement with the pharmacy systems’ IT providers is under way to ensure that “the last mile” of the technical end-to-end system provision is in place to meet the implementation timeline of 2019 readiness.

Given the diversity of this area, it is particularly difficult to come up with a single process indicator; but, if pushed, the traffic light would probably be marked as amber with a red tinge. While the technical requirements bar is set lower than for other stakeholders, the sheer number of participants that need to complete their implementation within the next 2 years must be of concern.

So, are we ready?

The EU-FMD is an ambitious requirement and the practical challenges of implementation across 32 countries with their diverse backgrounds, practices and requirements are daunting. But while it is true that there are still many details to be worked through, the basic requirements are very clear and have been published for more than half a decade now.

The roadmap for achieving EU-FMD readiness should be well-known and in some areas, notably the work area to establish the medicines verification infrastructure consisting of the European Hub and National Systems, good progress has been made. It now remains for all other stakeholders to step up to the challenge and do their bit.

The anniversary of the publication of the Delegated Regulation is a good reminder that time flies and everyone involved in the supply of pharmaceutical products to patients in Europe will need to focus on the ultimate goal to be achieved in a short period of time to ensure the provision of safe medicines to every European citizen.