Is Europe ready for the EU falsified medicines directive?

Christoph Krähenbühl, senior director at 3C Excellis Europe, talks to EPM about Europe’s readiness for the EU falsified medicines directive (EU FMD).

This month sees an important milestone for all pharmaceutical manufacturers supplying the European market and their supply chain partners: 9 February 2017 marks the beginning of the two-year countdown until the EU FMD comes into force across Europe.

From that date, pharmaceutical companies can no longer sell products in Europe unless they comply with the three critical ‘safety features’ requirements — that every pack of medicines is tamper-evidenced, carries a 2D data matrix with a unique identifier (UI) and that the UI has been uploaded to a European repository system for systematic check-out at pharmacies.

The question is: How realistic is the prospect that Europe will be ready in February 2019? To answer this question, let us consider the different areas of work in turn.

Pharmaceutical manufacturers

The first major area covers the obligation on all pharma manufacturers supplying Europe to routinely serialise their products, to apply tamper-evidence and to implement the necessary systems and processes.

Progress in this area must raise big concerns: The latest update published on the European Medicines Verification Organisation’s (EMVO) website shows that out of an estimated 2,500 manufacturers that will need to be on-board, only 50 are currently connected or in the process. With just over 100 weeks to go, this low number chimes with other anecdotal evidence — many manufacturers are taking an overly optimistic view and delaying their implementation, especially in the sector of mid-size to smaller companies. This is worrying because even major companies with well-established projects (driven partly by serialisation requirements in other markets) are still reporting concerns about their readiness for February 2019.

Why so many companies are risking their European business is open for speculation. One argument is that companies expect the lawmakers to move the compliance deadline when it becomes clear that industry will not be ready in time, something that happened with serialisation requirements in other markets.

However, there are no indications to support this assumption. The ‘Directive and Delegated Regulation’ are very clear about the date, 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” and neither the Q&A published on the European Commission website nor any public statements give any support to the assumption that a change of compliance date is being considered.

Europe-wide repository systems

Then there is the work of setting up the Europe-wide infrastructure of ‘repository systems’, delegated by the directive to the industry stakeholders.

This is a significant effort that includes not just the design, build and implementation of interconnected systems to cover the whole of Europe from manufacturer to end use but also the set-up of the supporting organisation structures and business processes, at a European as well as a national level, in each of the participating 32 countries. Despite the monumental task, indications are that one can be cautiously optimistic about progress. Stakeholders from all parts of the industry (with their competing and often conflicting interests) have been actively collaborating since before the publication of the directive in 2011. As of February 2017, the EMVO has been in existence for two 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 has also been made on the technical side: The central piece of this infrastructure, the European hub, into which manufacturers can connect to upload the UI data, was implemented in 2014. It has been connected to the first national system — Germany’s SecurPharm — since mid-2015 and other countries are also making progress towards the establishment of their national systems, helped by the ‘Blueprint’ approach: A shortlist of three providers favoured (and pre-checked) by EMVO to achieve consistency and interoperability as well as cost-efficiency.

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. It is therefore safe to assume that the organisational and systems infrastructure will almost certainly be ready and operational Europe wide by February 2019.

Wholesalers and pharmacists

Apart from manufacturers, wholesalers are also required to establish technical capabilities to handle serialised products, because there are a number of scenarios where they will need to scan UIs against the repositories for verification — or even checkout, such as risk-based verification, export from Europe and early dispense in certain situations.

The estimated 10,000 pharmaceutical wholesalers are likely to be ahead of the curve, given that other regulations like the 2013 guideline on ‘Good Distribution Practice of Medicinal Products for Human Use’ have raised the bar on process and system requirements that they need to comply with. The EU FMD adds to these requirements, setting out a number of scenarios where UIs need to be scanned against the repositories for verification or even check-out, such as risk-based verification, export from Europe and dispense at the point of supply (DR article 22 ad 23).

While compliance will require effort and investment, many wholesalers and distributors are making good progress towards establishing systems that will allow them to comply with their regulatory obligations, including the readiness to connect to the national systems as and when these come online.

The third stakeholder group that needs to implement new technology are the approximately 150,000 pharmacists who will be legally obliged to scan every pack of medicines dispensed to the public.

This is a tough call, because pharmacists have been less exposed to serialisation and traceability requirements compared with manufacturers and as such are further back along the adoption curve. However, in many European member states they are now engaging with the other stakeholders and getting increasingly involved and committed to progress at a national level. A sign of this progress are the full-scale pilots involving community pharmacies planned in several countries for 2017. In parallel, extensive engagement with the pharmacy systems’ IT providers is underway, 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.

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. 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 over 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 just over 100 weeks, ensuring the provision of safe medicines to every European citizen.