Supply chain security

Globally, one in seven medicines are estimated to be counterfeit, and over the last few years, the development of serialisation in the pharmaceutical space has been pivotal in trying to ensure that every capsule, tablet, strip or vial can be traced throughout the supply chain. It has aided regulators in identifying and removing drugs that may be counterfeit, harmful, or even stolen, potentially saving many lives. In fact, in February 2016, the European Union’s Falsified Medicines Directive (FMD) was introduced to help protect patients from the potential danger posed by falsified medicines. This was achieved by attaching a unique identification code to each medicine and allowed for tracking from the manufacturer to pharmacy.

Whilst much of the industry is still coming to terms with how to fully implement serialisation, one country, notably the UK, as of this moment does not have any verification system in place to validate drugs in the supply chain. It is nearly five years since the UK voted to leave the EU, and after the end of the transition period on January 1, 2021, Securmed, the UK National Medicines Verification Organisation (UKNMVO), said that, apart from Northern Ireland who will remain using the European system – mainland UK will be removed from the database used to track serialised medicine digital barcodes in Europe.

This issue of drug supply security and authenticity has only been mentioned in passing as Brexit trade agreements and COVID have dominated the news agenda, yet many experts warn that the UK’s departure from the EU’s FMD has created a huge potential risk. Concurrent with the significant change we are, of course, also undertaking the world’s largest ever mass immunisation programme for COVID vaccines – at the time of writing AstraZeneca, Moderna and Pfizer vaccines are already being rolled out with several more expected to follow imminently. So the issue of medical verification systems is in the national consciousness more than ever before – as it represents our only means of verifying a vaccine is genuine, and/or any other drug taken for that matter.

Yet we also believe there are still two ways to view this problem, and the glass is not empty, and this should be a moment to think of it simply as glass half full. It’s an ideal moment to re-evaluate our entire medicines supply chain. Serialisation is not perfect by design, and modern blockchain based solutions – which are immutable by definition – were not widely available when FMD came in back in 2016 and can provide far greater visibility and a full custody of medicines. It is a future-proof solution that undoubtably advanced nations will gradually switch to and the UK, with Brexit, has the opportunity to implement the world’s safest medicine supply chain.

As such, we believe the UK government must look ahead, not back, for technologies that can modernise the system and jump ahead of the rest of the world.

In fact, by implementing blockchain-based technologies, the UK would become the world’s foremost nation for drug security, leapfrogging the US – whose Drug Supply Chain Security Act (DSCSA) is widely acknowledged as the current gold standard – and the EU’s current solution. While the FMD is widely seen as a competent solution that ‘does the job’, it is not flawless. Similarly, the European Medicines Verification System (EMVS) provides a very high level of protection against counterfeiting, but only if the products are supplied in compliance with the EU-FMD/EMVS processes.

‘The benefit to the UK of a flexible, operational and configurable blockchain platform cannot be underestimated’

A further benefit of blockchain based solutions is that they can also prevent critical medicines being diverted away from UK shores – a common pharmaceutical distribution problem – and identify sub-standard drugs quickly for recall, all in real time. This is currently not possible with the EU’s FMD solution. A real-time solution, however, will enable patients and doctors to be reassured, as they will have a transparent digital record of every medicines journey from factory to the pharmacy or surgery. Moreover, it will also empower doctors, innovators and patients with the exact details of shipping and storage conditions, so vital in the transport of sensitive therapies.

To take a recent example currently forming the nadir of global attention. The novel mRNA vaccines developed by both Pfizer and Moderna require extreme temperatures (-20 for Moderna and -70 degrees Celsius in the case of Pfizer) and transportation conditions must be maintained to ensure the integrity of dosages. A blockchain solution utilising essential data would provide valuable control processes from a single dashboard accessible by all authorised entities in real-time. The benefit to the UK of a flexible, operational and configurable blockchain platform cannot be underestimated – and would enable a robust distribution system that provided complete supply chain custody.

In October 2020, the Royal Pharmaceutical Society (RPS) wrote to health secretary Matt Hancock, asking for robust plans to be put in place ‘to help authenticate the legitimacy of medicines that move between the EU and the UK’ and how there is ‘legitimate concern around how removal of these safeguards could leave the UK vulnerable to an influx of counterfeit medicines, impacting on patient care in the UK and across the EU’. The very fact that even GAVI’s COVAX programme – the vaccine distribution scheme for lower- and middle-income countries – is exploring a robust medicine verification system is good indication of the immediate risk.

Taking out the politics of the present, we also have the chance to create a new system fit for purpose in the 21st century and not one that reacts to replace past regulations, but one that is adaptable to the personalised medicines of the future where chain of custody and transport conditions are critical to medical efficacy. It’s a moment in time where if we look at the problem as ‘glass half empty’ we will just replace the old with the old. Yet if we take a ‘glass half full’ view of the world we have the chance to reimagine the supply chain verification process that will be an activate enabler of tomorrow’s medical delivery – from factory to patient and with the scope to build in new approaches like automation of customs documentation and AI-enhanced supply chains with warehouse robotics. In the case of the latter, Amazon is well known to already use this, and we don’t believe it will be too far into the future that pharma and national health providers realise the productivity gains that can be made in drug supply chains.

In our view, dropping out of the FMD is a key inflection point with respect to the UK’s pharma supply chain security. We either run the risk of being exposed to counterfeit drugs or it could be the first Western government to adopt blockchain for supply chain security. Not only would it be used for supply chain security, but it can also be used for the development of new networks in emerging areas like advanced therapies, creating the initial networks that will rapidly spread into mainstream pharma adoption globally – perhaps giving new resonance to the idea of global Britain. A system that regulators like the FDA and EMA may want to take learning from and build into their own future systems.

Adopting blockchain, we can be the ones providing an immutable and secure platform around which new data hubs can be built, with new innovations plugging into to the chain linking the patient, doctor, innovators, devices and records in a way never before possible. It is now on the government to have a moment of Blue Sky thinking and provide the UK with the best possible supply chain security solution or risk being exposed to counterfeits.