In 2018, patients will see a fundamental change to the European Healthcare supply chain: every time a pack of medicines is dispensed, the bar code this pack will carry will be scanned in the pharmacy and a series of automatic checks will be carried out – all within a fraction of a second – against a Europe-wide medicines verification infrastructure of systems.
This unique pack identification in the shape of a 2D DataMatrix code – different from, but not unlike, the familiar QR codes – will be globally unique. It will contain the product code (and possibly national healthcare reimbursement number), the batch/lot number, the expiry date and a highly randomised serial number.
The results of the scan will give dispensing pharmacists instantaneous feedback about the status of the product to achieve the stated aims of the European Falsified Medicines Directive (EU-FMD), 2011/62/EU ‘Safety Features’ provisions. They will be able to see whether the pack number has been dispensed before and could, therefore, be a counterfeit product; they can ensure it is still within its expiration date; and check whether there is a recall or other notice against the batch.
Implementing this unique pack coding system presents a huge step forward in terms of patient safety
Implementing this unique pack coding system presents a huge step forward in terms of patient safety. However, it will also require a tremendous amount of work – not simply in terms of the development and deployment of the complex Europe-wide systems infrastructure, but also the implementation projects needed to achieve readiness for compliance by every pharmaceutical manufacturer supplying the 28 EU member countries, be they original brand owners, generics manufacturers, contract packers or repackagers/parallel importers.
While Big Pharma companies such as AstraZeneca, Novartis or GSK have all started their implementation programmes – many of them driven by earlier similar compliance requirements in Turkey, China, Argentina and South Korea, to name but a few – other companies, at least in some parts of Europe, are still not moving forward, thereby putting a significant part of their business into real jeopardy.
Vorsprung durch Praxis
This is not the case in all parts of Europe, however. ‘Only companies that are already engaging with the technical and organisational challenges associated with the implementation of their EU-FMD response have a realistic chance to be ready at the point of time when the EU-FMD ‘Safety Features’ Delegated Act comes into force, to continue their supply of the market with product that is packaged in line with the requirements of this legislation.’
Only companies that are already engaging with the technical and organisational challenges associated with the implementation of their EU-FMD response have a realistic chance to continue their supply of the market
This bleak but realistic assessment is given by Thomas Brückner, Head of Pharmaceutical Affairs/GMP/Medicinal Products/CAM/Pharmacopoeial Matters at the BPI (Bundesverband der Pharmazeutischen Industrie – the Federal Association of the Pharmaceutical Industry) and member of the leadership team of the German SecurPharm pilot, a German national system that began operating (at first on a limited basis) on 1 January 2013 and that operates along similar lines to the Europe-wide system currently in development.
Since the start of last year, SecurPharm has been gradually ramping up operations in the real-life German healthcare supply chain, supplying – to date – in excess of 10 million item-level serialised packs to more than 400 participating pharmacies across Germany, even though participation in the system is entirely voluntary.
To achieve this interoperability, pharma companies must put in a great deal of effort. The practical participation in the system has revealed just what challenges present themselves at every step, from generating, printing, reading and storing the unique pack identifiers to the preparation of the artwork and packaging materials, and cleaning up the master data and setting up the new business processes.
All of the above is in addition to the implementation of a complex and expensive serialisation technology stack starting from the packing lines to the site management console and the company-wide secure numbers repository.
However, it is an effort that will bring very clear benefits; thanks to this early serialisation apprenticeship, companies taking part in the SecurPharm initiative will find the transition to full participation in the post 2018 Europe-wide EU-FMD medicines verification landscape relatively painless, compared with their peers who have not yet faced up to this challenge.
So what is the reason for companies in many countries – notably the UK – failing to engage with these requirements and why are managers still delaying decisions and waiting, thereby running the serious risk of ‘losing Europe’?
Managers are sheltering behind the view that because the ‘Safety Features’ Delegated Act has not yet been published, the EU-FMD requirements are still no clear and present danger
One argument frequently encountered is the view that there is still a lack of clarity and much uncertainty about the EU-FMD requirements, as these will be defined in detail only in the ‘Safety Features’ Delegated Act expected later this year, publication of which will set the 2018 compliance clock ticking.
Faced with understandable concerns about the impact and the cost of implementation, managers are sheltering behind the view that because the ‘Safety Features’ Delegated Act has not yet been published, the EU-FMD requirements are still no ‘clear and present danger’.
But this represents a potentially dangerous lack of strategic thinking.
While it is true that things seem to be ‘in flux’, a closer look quickly dispels the fallacy of this argument. The fact is that there has been, from the time when the legislation was first published in 2011, a clear and reasonable forward view of what the safety features part of the EU-FMD would entail.
The directive mentions ‘unique identifiers’, ‘authenticity of medicinal products to be verified’, ‘individual packs to be identified’ and the ‘provisions on the establishment, management and accessibility of the repositories system in which information on the safety features, enabling the verification of the authenticity and identification of medicinal products’ – setting out a clear vision of a Europe-wide medicines verification process.
The 2D DataMatrix code will contain the product code (and possibly national healthcare reimbursement number), the batch/lot number, the expiry date and a highly randomised serial number
This vision with the key element of a mandatory point-of-dispense check, supported by a set of interoperable systems, has been confirmed and refined since 2011 through consultation processes and stakeholder updates, steadily reducing the uncertainties around the content of the ‘Safety Features’ DA, leaving essentially only the question of the timing of the DA as open.
A ticking time bomb
Recent updates from the European Commission have now even removed all but the last traces of uncertainty in this respect, with EUROPE DIRECT, the EU information service confirming, in response to a request for clarification, on behalf of the responsible Commission department (DG SANCO/DG Health and Consumers): ‘The Commission aims at adopting the Delegated Act by the end of 2014. Publication in the Official Journal of the European Union will follow in the first half of 2015, due to Parliament, Council and WTO scrutiny rights.'
If this timing is respected, the Delegated Act will become applicable sometime in the first half of 2018. This will set the three-year compliance implementation clock ticking for almost all member states (apart from potentially Italy, Belgium and Greece, where it could be argued that existing vignettes and bollini provide a unique identifier, buying these markets an additional three years time to implementation).
Companies who believe they have extended time to achieve compliance will find that they are gravely mistaken
This unambiguous message is that manufacturers whose packs do not carry these required unique identifiers and who are not in a position to upload these serial numbers in a timely, secure and reliable fashion to the Europe-wide system infrastructure will no longer be able to sell their products in Europe.
Arguments have been made in the past that there will surely be transitional arrangements, but the EU Commission has made it quite clear that companies who believe they have extended time to achieve compliance will find that they are gravely mistaken. The Commission’s view is that the three years between the issuing of the DA and compliance date are, in fact, the only transitional period allowed – and there will be no further extension.
Increased lead times
Companies that have not yet started their implementation programme and may not even have budgeted for any implementation activity in 2015, are running the very real risk that they will be losing their European sales from 2018 onwards. Even companies that have started on their programme but not yet engaged with technology stack solution providers are facing serious challenges: from speaking to vendors, it is clear that they are now facing increasing orders and their lead-times are already extending.
Companies that have started on their programme but not yet engaged with technology stack solution providers are facing serious challenges
Add to that the realistic estimate of a best-case implementation timeline for the first pilot line to repository installation taking at least 18 months, and it becomes obvious that the task of implementing the serialisation capability and operating it reliably and without a significant hit on productivity across the majority of a company’s packing lines is a multi-year endeavour that now clearly pushes hard against a December 2017 compliance deadline.
None of this should be a surprise to pharma company managers, and any project or operation managers with experience in this area will confirm what has been set out above. So why is the attitude amongst many companies still ‘head firmly buried in the sand’?
One can only speculate: is this just the usual short-termist habit of UK PLC, preoccupied with the next quarter-end figures and not capable of thinking strategically? Or is this UK pharma moving away from Europe?
Whatever the answer, one could argue that these concerns about the state of pharmaceutical companies’ readiness might be serious enough to ask some probing questions about their viability in the market beyond the 2018 EU-FMD ‘Safety Features’ compliance date.
Christoph Krähenbühl is MD and joint partner with CEO Ian Haynes in 3C Integrity, a specialist consulting firm which runs training programmes to prepare pharma companies of all sizes for implementation.
