2016 is the year when manufacturers of pharmaceutical products - regardless of whether they are brand owners, contract manufacturers, generics companies or repackagers/parallel traders – need to get serious about serialisation.
In fact, not only manufacturers but also the other stakeholders in the pharmaceutical supply chain who, as is increasingly clear, are going to be impacted by the requirements coming into force now and over the next few years.
What is the serialisation outlook for 2016?
Key requirements to watch out for are, of course, the EU-FMD and the next level of the US DSCSA.
The expected formal publication of the EUFMD "Safety Features" Delegate Act in February 2016 starts the clock ticking for the measures that will come into force in early 2019. This will impose serialisation and tamper evidence requirements on almost a quarter of global pharma sales. Even earlier, in late 2017, the next level of the US DSCSA will come into force, adding serialisation as a requirement to a further 40 per cent of pharma sales worldwide. Add to that serialisation requirement in Saudi Arabia and other markets, as well more products steadily added to the scope in China and other countries that have already established limited requirements, it is now clear that serialisation of pharmaceutical products is here to stay - and let's not forget, not just as a globally accepted element of the fight against counterfeit product but also a first step towards a new world where every box has its own identity, with all the opportunities this opens up for the future.
The key take-away message is that by the end of this decade upward of 80 per cent of all pharmaceutical products sold worldwide will need to be manufactured on packing lines that are able to serialise at item level, in some cases to apply tamper-evidence, to aggregate and supply data to the track and trace repositories that every pharma manufacturer will need to establish in order to manage this vital data securely and reliably. At the same time supply chain participants right the way down to the pharmacy will also have obligations and increasingly a role of one sort or another to play in the cause of securing patient safety.
What all serialisation requirements have in common is that they fundamentally change the definition of what a quality product is:
A pack in the market without a corresponding "high quality" serial number available for validation, for the duration of its shelf life, is no longer a "good pack" and can no longer be sold.
2016 is now going to be about execution. On the one hand, this will be about the on-going large-scale rollouts of the big pharma early adopter programmes that continue to push forward toward completion, taking a lion's share of the resources that the market is providing.
On the other hand though, the few CMOs, tier two and tier three pharmas whose programmes are in progress may seem to be in relatively good shape, but even they are not safe: As smaller players they may find that they suffer as vendors get busier and are facing commercial pressure to prioritise their bigger customers.
This is compounded by a number of the early adopters having to face up to the need that they must realign their program because the impact of the complexity had not been fully appreciated upfront.
The late adopters finally, who have prevaricated until now, will be critically reliant on excellence and even "creativity" in project execution to get their programmes in place and delivered on time: Any implementation programme that is getting kicked off only now faces a daunting amount of complex capability that must be delivered in a very short time with little or no opportunity to practice before the starting gun is fired.
And yet: Even with the deadline for the serialization requirements implementation getting close, we will still continue to see the remaining open questions and details that are awaiting clarification being used as an excuse for late adopters to delay the start of their programmes. This is despite the stark risks facing them: Not being able to serialise means losing the authorisation to sell in an increasing number of markets. It must therefore be clear that it is now far too late to allow unanswered questions be a barrier to action.
Late adopters need to understand the uncertainty, identify the consequences and design an approach to eliminate or minimise their impact.
What might such an approach look like?
Not like the textbook project approach, for a start: It is increasingly clear that the time available to implement solutions is short and maybe too short for the traditional project approach to be successful. Such a classic serialisation programme would take a step-wise approach to building the necessary capability, adding capabilities to piloted and proven elements from earlier phases, pausing to incorporate learning and possibly even re-trace some steps. Unfortunately there is no longer time to do this and all capabilities will have to be progressed in parallel with no time to pilot, review and improve, thereby significantly increasing the risks to timelines and even successful project delivery.
New and potentially radical approaches will need to be tried in order to deliver on time – for example companies are almost certainly going to have to find quicker ways to achieve the necessary commercial rigour associated with large scale expenditure than the traditional approaches that are currently taking up to a year from issuing a RFI to having signed the contract.
The role of the solution providers
But the supply chain stakeholders are not the only ones put on the spot: 2016 also looks to be the year that the solution providers will either sink or swim in the face of increasing and - for some - overwhelming demand.
Lack of capacity in the supply base remains a key concern and already we are seeing lead times from established vendors increasing to 12 months and longer. The vendors will struggle to balance the desire to increase their capacity with the attendant problems of recruiting and training staff quickly. This is done of course in the context of a demand that it potentially massive but will quickly fall away as serialisation capability transitions into business as usual.
New solutions are coming to market taking a leaner approach to the serialisation challenge as existing providers find it a challenge to streamlining their solutions but their viability remains to be proven.
Wise solution providers will have a clear strategic view of the optimal size and shape of their organisations through the immediate tsunami of demand and will carefully manage their capability to avoid neglecting existing customers and disappointing new ones through over-promising on delivery and - perhaps even more critically - support.
This means that a key question for customers now approaching vendor selection must be to get a clear view on the not only the product's capability but also the vendor's road map, for their product and their organisation.
They will also want to look out for inter-operability of the solutions at each level as a way to address the serious questions around bandwidth capability of the solutions providers and to reduce their dependency on only one supplier for what will be business-critical systems and processes.
The key themes to think about in 2016 to make your project a success
There are, of course, many things serialisation projects need to tackle – the "10 things to get right" that we have talked about in our 3C Webinars – but given the background sketched out above, the following critical themes must be prioritised:
1. Get started and get your stakeholders on board! This is the last opportunity to get the stakeholders on board – this has been the Achilles heel of most projects up to now. Projects have to nail this – the problem of the perception that deadlines are distant and uncertain may have faded for most enterprises but stakeholder engagement is also about understanding the size and scale of the undertaking.
2. The need for subject matter expertise: Serialisation is uncharted water for many companies, implementation projects are novel and leveraging the real life experience of seasoned practitioners is critical.
3. Plan for the potential time-gap between implementation and go live - how will you maintain competence in the gap and will the vendor be there to support you when everyone pushes the start button at once? This has the potential of becoming a major issue that no-body talks about. Companies install kit, commission it and then have to leave it dormant until the deadline arrives. At that point in time, it doesn't work and the people who knew how it worked have forgotten or left for other jobs. Everyone picks up the phone to the vendors who are swamped with support requests that they cannot hope to fill. Big pharmas will be ring-fencing the resource they need, maybe even pulling it in house for the duration, but the smaller companies that have succeeded in getting the kit in place, may well have to fight to get the support they will urgently need.
In the end, what makes the difference comes down to three things:
1. Holistic approach: Tackling the implementation of your serialisation capability not as a series of small projects but as a holistic effort that addresses all aspects, from printing technology to enterprise EPCIS Repository, from Master Data/GTIN clean-up to the definition and embedding of business processes that reach beyond the boundaries of your enterprise.
2. Interoperability: Achieving clarity of the requirements and of the inter-operability of different solutions available at each of the in-house solution components, through the extended company network, including CMOs and 3rd Party Logistics Providers, to encompass your end-to-end pharma supply chain.
3. Sense of urgency: There is no time for the traditional in-house approach where the team will build its experience on pilots or call upon generic Project Management Organisations who you will end up teaching as they learn on the job. In stormy weather, you need experienced navigators to help your team successfully define and deliver this mission critical capability. This is what we are offering to our customers as the most experienced organization in the field of serialization.