Serialisation expert Christoph Krähenbühl of 3C Integrity explains the significance of the latest update on the Delegated Act on ‘Safety Features’ for medicines.
Q: What can you tell us about the update on the EU-Falsified Medicines Directive Safety Features Delegated Act?
A: The European Commission's Directorate-General Health and Consumers - DG Sanco - has just published an update on the implementation measures for Directive 2011/62/EU - the EU-FMD - entitled Overview and state of play
. This is important because it gives us more clarity on one of the two big questions around the EU-FMD: What is the date when pharma manufacturers need to comply? The other big question is, of course, what are the measures that they need to comply with As I've explained previously
in this newsletter - and also covered in a recent white paper
- it is actually well established what manufacturers need to do.
Q: Can you remind us what that is?
A: Get ready to play their part in a Europe-wide medicines verification process. This means that they need to be ready to apply a Unique Identifier (UI) and tamper-evidence (TE) to all prescription medicines supplied to the EU market (barring few exceptions to be defined in a white list). The nature of the UI is also well understood and in line with the type of requirements that are demanded in almost all other markets where serialisation requirements have been established: ECC 200 datamatrix barcode, containing four elements - product code (usually GTIN), batch number, expiry date and serial number. For all of these there are industry guidelines available
Q: What is included in today's update?
A: This is important because it tells us two things: First of all, in Q2 2015, with the adoption of the Delegated Act, we will have the details of the measures formally confirmed. This then removes the excuse of 'ignorance' that some companies are still using to delay getting stuck in. The second thing this gives us is clarity of timing: There will be a short delay to allow routine scrutiny of the Delegated Act provisions by the World Trade Organisation (WTO) etc., before it will be formally published in the Official Journal of the European Union. And that sets the compliance timer ticking: For member states that do not have pre-existing systems and measures in place, the compliance period is three years. These are the majority of member states, so that means that the compliance deadline here is Q4 2018.
Q: Does this mean that the requirements have gone back?
A: The previous timeline had been that the DA would be released before the end of this year and the publication in the OJ would be expected in the first half of 2015. So yes, but only by six months - a welcome few months given the state of readiness we observe today. These might be an essential period for many manufacturers making a difference between the deadline being achievable or not. Let's not forget, that the deadline is a 'hard deadline' - any expectations that there would be generous transitional arrangements have been dashed in an earlier update, so any pharmaceutical pack produced after the deadline need to carry the UI and TE. Products already in the market can be sold for another two years but after the end of the two-year transitional period all packs have to comply with the safety features requirements or be withdrawn from the market.
Q: So what does this mean for pharma manufacturers?
A: It basically means: "Be ready then or you can no longer sell your products in Europe." But taking a step back, what does the EU actually require? Well the good news as far as manufacturers are concerned - and even more so wholesalers and distributors - is that the EU-FMD does not require full traceability, only point-of-dispense verification and some checks (estimated about 3 per cent of volumes) of packs in transit by wholesalers. For manufacturers this means that they need to establish systems and processes to reliably: (1) code each sales pack; (2) collect the number in a secure database; (3) submit the data in time into the European system, which is likely to be the EMVS, built by the European Stakeholder Model coalition under the leadership of EFPIA. And (4) be ready to deal with any alerts should they arise in a timely manner.
Q: Sounds like quite a challenge for manufacturers….
A: Well, yes, it can be: Just listen to the case studies being presented by early adopters - usually big pharma - who have been implementing for years, now, spending three-digit million dollar figures in the process. However, in our experience, working with a range of customers from very different areas of the pharma world, the picture need not be quite so bleak: We find that there are ways of implementing these projects in a leaner way, if they are set up right at the start. It is these early stages of a project that are critical, when people are tripped up by the "unknown unknowns".
Unfortunately, one effect that these deadlines has is that it panics people into heading for the vendors, chequebook in hand, to secure a place in the queue and they miss out doing some of the other work that is essential to getting their project set up for success. It is an understandable concern, given the limited vendor capacity, but at the same time, building the serialisation technology stack is only a part of what needs to be done. Companies can get into trouble not just by not having taken enough time to identify their own requirements correctly - and every customer is different, there is no one-size-fits-all approach! - but also by not identifying and tackling the other areas that are essential to making their implementation project a success, such as artwork, coding, processes, master data, etc. These areas need a lot of attention and early on, because – to give just one example - sorting out your cartons to ensure that they can be coded with the UI can easily take longer that installing your serialisation capability on the lines and your repository.
This is something we spend quite a bit of time on during our two-day pharma serialisation workshops
- the next one will be January 27-28 in Uppsala, Sweden - that is aimed at giving companies a head-start into their serialisation implementation programme. When delegates first see the agenda, they are often impatient, but by the end they totally get it. So hopefully we are doing our bit for getting companies ready to comply with the EU-FMD in time!
Christoph Krähenbühl is a respected observer and commentator on all aspects of coding and serialisation in the pharmaceutical industry. He is managing director of 3C Integrity Consulting Ltd., specialising in providing strategic consulting, practical support and training. He is recognised for his extensive experience and thought leadership, which is based on years of practical involvement in implementing solutions in the pharmaceutical industry, including Project Manager of the global serialisation system in early adopter AstraZeneca and was one of the members of EFPIA's Coding and Serialisation expert team that designed the European Medicines Verification System (EMVS).