europeanpharmaceuticalreviewJanuary 15, 2021
Tag: UK , FarmaTrust , COVID-19 , medicines , supply chain
The UK is currently struggling to secure its medicines supply chain having left the EU, and consequently the EU’s Falsified Medicines Directive (FMD), on the 1 January 2021. However, rather than viewing drug supply security and authenticity as an insurmountable problem, FarmaTrust is calling on the UK government to take the opportunity modernise the UK’s drug security system.
The UK-based global medical authentication provider added that supply chain security is especially important with the world’s largest ever mass immunisation program currently under way for COVID-19 vaccines.
According to the enterprise, the UK could become the world’s foremost nation for drug security by implementing blockchain-based technologies, which, it said, are more advanced and future proof than the solutions implemented by the FMD. It added that these technologies would position the UK ahead of the US, 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-19 immunisation programme – it is 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, with Brexit, the UK 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-19 vaccines which require extreme cold storage,” commented Raja Sharif, Chief Executive Officer at FarmaTrust.
Estimates suggest that one in seven medicines are counterfeit. The EU’s FMD (FMD, 2011/62/EU) and Delegated Regulation (EU/2016/161) were designed to secure medicine within the EU. However, the UK no longer has access to this system and many experts warn that without action, the UK is at risk of having counterfeit medicines enter its healthcare system.
Securmed, the UK National Medicines Verification Organisation (UKNMVO), announced to solution providers 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. While, the Department of Health and Social Care are aware of this issues, FarmaTrust said they are yet to comment.
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