As the EU Falsified Medicines Directive deadline nears, CMOs & CPOs should embrace tech solutions that add serialisation return on investment. David Carpentier, founding partner & CTO for Adents, tell us more.
Technology
Ensuring the safety of the pharmaceutical supply chain has become a worldwide priority, and two important deadlines are about to close in on the global market. With Europe’s Falsified Medicines Directive (FMD) set to come into full force in less than six months (February 2019), and the US Drug Supply Chain Security Act’s deadline to be imposed November 2018, it behoves all players in the pharma manufacturing sector to make intelligent decisions about the systems they employ to ensure serialisation compliance.
At this critical juncture, it’s important for manufacturers to think long-term, rather than short-term, and to seek ways to maximise opportunities for growth. Forward-thinking pharma companies need to look beyond the need to print unique product identification codes on all Rx units of sale. That’s easy enough to achieve… but what comes afterward? And how can manufacturers benefit from the changes they’ll need to implement to comply with the more complex serialisation requirements?
With an overabundance of supply chain data at their fingertips, it’s vital for manufacturers to figure out a way to harness and use this information. The ability to manipulate this data in productive, forward-thinking ways may well determine their future success and viability. Those companies that embrace regulatory changes and use them as an opportunity to optimise their supply chains are likely to be the ones left standing amid continued consolidation.
And the same is true for their hired contract manufacturers and packagers — if not more so. Embracing new technologies will give CMOs and CPOs a critical competitive edge as the industry moves toward Industry 4.0 connectivity.
Going beyond basic requirements
Smart pharma companies are seeking out partnerships with CMOs and CPOs whose solutions go beyond basic requirements. Success lies in the implementation of systems that offer elevated capability, scalability and flexibility — and, in turn, a high level of integration in terms of data exchange and process alignment.
The key is to find hardware-agnostic serialisation solutions that can adapt or scale up to meet future track & trace mandates, as well as help improve business practices. The objective is to integrate tools that can better utilise the reams of data generated by the serialisation process. This data can be mined and analysed to produce worth that goes well beyond its initial purpose of tracking and storing for brand owner regulatory reporting.
Questions to ponder
As companies move toward implementing more comprehensive, beyond-compliance serialisation systems, they should ask themselves several questions.
Will my long-term needs be met by my overall strategy?
The most common flaw with many current serialisation solutions is that they are inherently short-sighted and likely to be obsolete sooner rather than later. It’s important to keep in mind that more stringent serialisation regulations will be phased in eventually, as the ultimate goal is full supply chain traceability.
Why invest in a technology that will need to be replaced in the near future?
Serialisation solutions should not be approached as one-time, single-use drop-ins; rather, they should be scalable systems that can address rolling deadlines with phased-in requirements.
What knowledge have we gained since starting the serialisation implementation process?
Having come to a greater understanding of the serialisation process, we need to look back and consider what we have learned. What have we done correctly? What might we have done differently? What improvements can be made going forward?
Cyber-security poses another threat. As we move toward enterprise-level serialisation, solutions will need to be interconnected in a way that, in the age of ‘Internet of Things’, can expose vulnerabilities.
For those pharma companies considering forgoing a previously planned transactional-only (Level 2) serialisation system in favour of a more flexible enterprise-level solution (Level 4), the importance of proper encryption and virus protection cannot be overstated. Similarly, the necessity of protecting cloud storage and securing data transmission between trading partners must be emphasised.
Communication standardisation is another important issue. Part of the EU FMD is the formation of the European Medicines Verification System (EMVS), a pan-European system designed so that medicines can be verified at the point of dispensation. Upon the FMD enactment, Marketing Authorisation Holders (MAHs) that commercialise drug products distributed in the FMD’s jurisdiction will be required to upload their product serialisation data to the European Hub.
Reporting to the European Hub will entail generating and managing serialisation data compliant with each target market. This involves certification as an official OBP (On-Boarding Partner) Gateway Provider — a designation European pharma manufacturers would be wise to seek in serialisation partners and vendors.
The potential of integrating tech
According to the Organisation for Economic Co-operation and Development (OECD), an estimated 10% of pharmaceutical products sold worldwide and 2.5% of global imports are counterfeit. With trust and transparency of significant concern for businesses, government agencies and consumers around the globe, tighter control of supply chains is crucial.
While blockchain presents unprecedented opportunities to secure entire supply chains, comprehensive end-to-end security means more than just documenting transactions on a shared ledger.
In collaboration with Microsoft, my company recently developed Adents NovaTrack, a platform that lends itself to the building of traceability applications using such technologies as blockchain, Artificial Intelligence (AI), etc. This marriage of technologies brings comprehensive visibility throughout product distribution chains and life cycles and addresses not only performance and security, but also governance and scalability.
Conclusion
The need to find creative solutions to address both current and emerging serialisation and track & trace regulations is clear.
Hardware-agnostic solutions are part of the answer, as they are much less likely to become obsolete, and lend themselves to making adjustments as production needs change or evolve. A process as intricate as serialisation requires an outsized number of components to ‘play nicely’ with each other, and these ongoing transactional relationships are best mediated by software.
Beyond-compliance ROI and the creation of true business value requires utilising the massive amounts of data generated by serialisation efforts to improve business practices. Solutions now exist that open new horizons beyond regulatory compliance in terms of data analysis and machine learning tools.
The bottom line: Smart pharma companies, CMOs and CPOs require comprehensive solutions to help meet the challenges of current and future serialisation deadlines. To meet this need, new tools to strengthen and future-proof supply chains continue to be developed — of which Adents NovaTrack is one example. Utilising blockchain, AI and IoT technologies, this platform enables the building of traceability applications.