Is Europe ready for serialisation?

Christoph Krähenbühl, senior director at 3C Excellis Europe, is widely recognised as a thought leader in pharmaceutical serialisation. He has been involved in serialisation projects since 2006 and has been supporting the European stakeholder response to the incoming serialisation laws as an expert and a member of the European Medicines Verification Organisation management team. Here he looks at how ready the pharmaceutical industry is for serialisation.

Pharmaceutical manufacturers supplying the European market and their supply chain partners have seen an important milestone pass earlier this year. February 2017 marked the beginning of the two-year countdown until the EU Falsified Medicines Directive (FMD) compliance mandate comes into force across Europe.

From that date, pharmaceutical companies can no longer legally put products on the European market unless they comply with the three critical “safety feature” requirements. That every pack of medicines will be firstly tamper-evidenced, secondly carrying a 2-D data matrix encoding a Unique Identifier (UI), and finally the UI must have been uploaded into a Europe-wide system of repositories for check out at pharmacies.

Preparing 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’s look at this as a project - a big, complex project that involves many different stakeholders who each have to do their part and be ready on time.

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 if we apply these perspectives?

 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 that organises the project into manageable chunks of work. So let’s consider the major chunks of work that need to be undertaken to achieve EU-wide FMD compliance.

The first major area of work is the obligation on all manufacturers producing 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 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.

Wholesaler or distributor supply chain partners 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 check out. The scenarios where this legal obligation applies include risk-based verification, export from Europe and early dispensing in certain situations.  The other group of stakeholders that need to implement new technology are  pharmacists, who will be legally obliged to scan every pack of medicines dispensed to the public.

Another major area of work covers setting up the Europe-wide infrastructure of “repositories systems” specified in the directive. This is a task that is delegated to the industry stakeholders, some of whom - the pharmaceutical manufacturers - are also required by 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. It also includes setting up supporting organisation structures and business processes, at national and European level, in each of the participating 32 countries.

 Are we ready?

The 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 over half a decade now.

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

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