UK will seek comment on falsified medicines plans

The UK government has said it plans to launch a public consultation on a national system to defend against falsified medicines within 12 months of the enactment of new post-Brexit legislation on the regulation of medicines.  

With the end of the Brexit transition period meaning the UK is no longer part of the European Medicines Verification Scheme (EMVS) database used to track serialised digital barcodes on medicines in Europe, which was introduced as part of the Falsified Medicines Directive (FMD).

SecurMed, the National Medicines Verification Organisation (NMVO) set up to manage the EMVS in the UK, confirmed last October that – unlike Northern Ireland which will remain in the EU system – mainland UK will no longer have access.

This means that pharmacies (and other end users such as wholesalers, hospitals and others handling or supplying medicines) will no longer be required by law to verify and decommission unique identifiers on prescription medicine packs.

The UK government has yet to comment on the expected outcome of Brexit on this issue, but in an update said it is “committed to a public consultation around the need and details of any national scheme, as well as a specific consultation on the use of data collected as part of any scheme.”

Previously it had acknowledged the need to consult with industry stakeholders, including pharmacy organisations, before introducing any new regulations, but had given no timetable for that consultation.

The update has been published in connection with the Medicines and Medical Devices Bill which was introduced last February and is currently passing through Parliament.

It has passed the House of Commons and is now being considered in committee by the House of Lords and should become law in the coming months, although secondary legislation will be required to enact the detail.

A dedicated section of the bill covers falsified medicines and the use of unique identifiers and tamper-evidence features on medicine packs, and discusses responsibilities for setting up the infrastructure, systems and processes, as well as who will maintain and pay for them.

“We want to continue to protect patients from the real and present threat posed by falsified medicinal products,” says the government in its update dated 5 January.

“Without the powers provided by the bill, we would be unable to put in place a bespoke falsified medicines system,” it goes on. “It has the flexibility to let us deliver an innovative model that protects safe access to medicines whilst delivering substantial UK and NHS specific benefits.”

Last year, the Royal Pharmaceutical Society warned that the UK would face an “influx” of counterfeits if the FMD ceased to apply at the end of the Brexit transition period.

It also asked Health Secretary Matt Hancock to ensure that “robust plans” are put in place to maintain formal links with the EU to help authenticate the legitimacy of medicines that move between the EU and the UK.

One company providing technologies that can be used to verify the authenticity of medicines – FarmaTrust – has also said the UK is risking fake COVID-19 vaccines and other medicines without a new system in place.

It wants the UK to take the opportunity afforded by Brexit to implement a blockchain-based system that would be more advanced and future proof than the EU FMD solution, and also improve on the Drug Supply Chain Security Act (DSCSA) approach due to be rolled out in the US by 2023.

“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,” claims Raja Shari, FarmaTrust’s chief executive.

“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.”