Brexit won’t stop UK implementation of Falsified Medicines Directive

martin sawer

The UK government has confirmed that Brexit will not put a stop to its plans to implement the EU’s Falsified Medicines Directive, Martin Sawer, executive director of the Healthcare Distribution Association, told delegates at the Sigma conference in Rio de Janeiro on 14 February 2017 via a live video link.

The directive — a legal framework that seeks to strengthen the medicines supply chain — will come into effect on 9 February 2019.

As part of the directive, measures to verify the authenticity of medicines at certain points in the supply chain will be introduced — for example, 2D barcodes on individual medicines packs to be scanned and checked before dispensing.

“FMD and medications verification scanning will happen whether the sector is ready or not,” Sawer said, adding that implementation will probably have “significant costs and training requirements”.

Also, speaking via live video link, Gareth Jones, head of corporate affairs at the National Pharmacy Association, which represents independent pharmacies, said the pharmacy sector was unlikely to see a “big bang” on launch day but that it should expect to see an increase in the number of packs with barcodes from that date. Pharmacies will likely need to fund software and hardware updates to link with a new medicines database, he added.

SecurMed UK, a not-for-profit organisation set up to deliver the UK’s Medicines Verification System, will appoint an IT provider for the project in the next few weeks, said Sawer. After this, a verification system will be developed and will then need to be tested with UK system suppliers.

Jones said that decisions still have to be made on when pharmacies will need to scan each medicine pack, adding that the fact that medicines cannot be returned into a pharmacy’s stock after ten days “could create a lot of waste”.

“Pharmacies need to consider changing the flow of the dispensing process for efficiency, and data protection needs to be considered,” he concluded.

  • The Pharmaceutical Journal attended the Sigma conference courtesy of Sigma Pharmaceuticals.
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Citation
The Pharmaceutical Journal, PJ, February 2017, Vol 298, No 7898;298(7898):DOI:10.1211/PJ.2017.20202346