The UK is now facing a significant problem in how it secures the country’s medicines’ supply chain after leaving the EU on January 1st. But rather than view this as an insurmountable problem, FarmaTrust – a UK-based global medical authentication provider – is calling on the UK government to be true to its word and deliver new Brexit benefits.
This issue is especially important with the world’s largest ever mass immunisation program currently under way for COVID-19 vaccines – with both AZ and Pfizer vaccines now being rolled out – at the same time as our only means of verifying authenticity is revoked.
This issue of drug supply security and authenticity has only been mentioned in passing in Brexit coverage to date, yet many experts warn that the UK’s departure from the EU’s Falsified Medicines Directive (FMD) has created a huge potential risk. FarmaTrust is calling on the Government to seize the initiative and take this as an opportunity to modernise the system and jump ahead of the rest if the world. By implementing blockchain-based technologies – more advanced and future proof than the existing European FMD solution – the UK will become the world’s foremost nation for drug security. Positioning the country ahead of even the United States – whose Drug Supply Chain Security Act (DSCSA) is widely acknowledged as the current gold standard.
“While we currently have an active fake medicines risk for the UK – especially with the scale of COVID immunisation programme – it’s also an ideal moment to re-evaluate our entire medicines supply chain. Blockchain based solutions – which are immutable by definition – were not widely available when the EU directives came in 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 right now. This type of solution will also prevent critical medicines being diverted away from UK shores and identify sub-standard drugs quickly for recall all in real-time – currently not possible with the EU’s FMD solution. It means patients and doctors will be reassured, as they will have a transparent digital record of every medicines journey from factory to pharmacy or surgery. With even the exact details of shipping and storage conditions retained – which is so critical to many medicines efficacy, for example, several of the recent COVID vaccines which require extreme cold storage,” commented Raja Sharif, CEO at FarmaTrust.
Globally, one in seven medicines are estimated to be counterfeit and the EU Falsified Medicines Directive (FMD, 2011/62/EU) and the Delegated Regulation (EU/2016/161) are designed to secure medicine within the EU – but now the UK no longer has access, many experts warn that without action it remains an exposed risk for counterfeit medicines to enter our healthcare system.
Securmed, the UK National Medicines Verification Organisation (UKNMVO), announced to solution providers late in October 2020 that, with the exception of Northern Ireland – which will remain using the European system – mainland UK will be removed from the database used to track serialised medicine digital barcodes in Europe. The Department of Health and Social Care are aware, but have yet to comment on this specific expected Brexit outcome.