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Published on 9 October 2018

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No-deal Brexit would reverse FMD implementation in UK, Government says

A no-deal Brexit would put a stop to the the falsified medicines directive (FMD) in the UK, the Department of Health and Social Care (DHSC) has said.

Speaking yesterday (7 October) at the Pharmacy Show in Birmingham, DHSC senior policy manager Claymore Richardson told The Pharmacist that if the UK failed to reach a deal with the EU after Brexit, FMD would be abolished in favour of a UK-wide system.

Last week (4 October), Government’s medicines watchdog the Medicines Healthcare products Regulatory Agency (MHRA) launched a consultation that looked at the impact FMD could have on the regulation of medicines and medical devices in the event of a no-deal Brexit.

Revoking FMD under no-deal Brexit

Mr Richardson told our sister publication The Pharmacist: ‘If there was a hard, no-deal [Brexit] with no transition period, we would have to revoke FMD because people would not legally be able to comply with it.’

Under FMD, a series of European anti-counterfeiting measures, pharmacists will scan medicine products to verify their authenticity before decommissioning and handing them to patients.

As the UK has a legal duty as an EU member state to comply with FMD by the 9 February deadline, Mr Richardson argued that we would have to implement an in-house system under a no-deal Brexit scenario.

He said: ‘We would be looking at the options in terms of what a national system would be.

‘It’s completely common sense. If you look at all the investment and the work that’s been going in implementing FMD, if you’re going to do a UK system you would want that to build on what people have been spending their money on’.

Assessing FMD costs

In February, the MHRA published an impact assessment document on Article 23 providers only, which include dental practitioners among other healthcare professionals but exclude community pharmacies, where the Government has ‘legal scope to make changes’, Mr Richardson added.

He said that the Government has not allocated a specific pot of money for FMD to help contractors who will have to invest in the relevant equipment, such as scanners, to decommission packs of medicines. He did not clarify how much money was in this pot.

Mr Richardson pointed out that this decision will be subject to change following future negotiations with the Pharmaceutical Services Negotiating Committee (PSNC).

This article was orginally published on our sister publication The Pharmacist



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