Patients in the UK would miss out on enhanced medicines safety in the event of a no deal Brexit, pharma industry and NHS leaders are warning.
The Falsified Medicines Directive (FMD) is a new EU initiative to protect patients and public health from falsified or counterfeit medicines which goes live tomorrow [Saturday 9 February], creating what is being called ‘the safety medicines system in the world’.
A decade in the making, the new system will see all medicines fitted with two new features: a unique identifier (UI) in the form of a 2D data matrix (barcode) and an anti-tamper device (ATD).
This means that every medicine pack can be tracked as it progresses from the manufacturer through the supply chain, pharmacies, primary care and hospitals and finally to the patient.
The UK has played a leading role in developing the FMD, however a ‘no deal’ Brexit would see the UK drop out of the new system, leaving NHS patients more exposed to the dangers of fake medicines than patients in the EU.
Last year UK authorities seized more than 1m doses of counterfeit medicines and medical devices worth more than £2m in the space of just one week, as part of Interpol’s globally co-ordinated Operation Pangea.
The new hi-tech system is a world-first, and will make it much more difficult for potentially life-threatening counterfeit medicines to reach patients.
However the UK is less than 50 days from its planned departure from the EU, and could crash out via a no-deal Brexit if no agreement is approved in time by Parliament.
A ‘no deal’ Brexit would mean the UK would have to revoke the FMD legislation, just seven weeks after its introduction.
Dr Rick Greville, director of supply chain at the UK industry’s Association of the British Pharmaceutical Industry (ABPI) said:
“Billions of packs of medicines travel around the EU annually, destined for over 500 million patients. This new system means that patients across Europe will have the best protection from fake medicines in the world.
“It would be an absolute travesty if NHS patients aren’t part of a system specifically designed to protect them. But that’s exactly what could happen in a ‘no deal’ Brexit. It is just another reason why we urgently need a Brexit deal.”
The system uses new technology based on a cross-European database – the European Medicines Verification System (EMVS) – so that medicines dispensed anywhere in the EU can be authenticated.
ABPI chief executive Mike Thompson
Mike Thompson, Chief Executive of the ABPI, said: “‘No deal’ is not in the interest of the NHS or its patients. Not being part of the safest medicines system in the world, one that the UK has helped design and build – and which provides protection against fake medicines – makes no sense. Being part of a system that keeps them safe is the minimum that UK patients should expect.”
Niall Dickson, Co-Chair of the Brexit Health Alliance (BHA) – an alliance of NHS, medical research, industry, patients and public health organisations – said: “It would be a tragedy were the UK not to be a part of this new system which ultimately protects patients from fake medicines. And it is another reason why the growing prospect of leaving the EU with no deal is a matter of such concern.
“No patient should suffer as a result of Brexit. A ‘no-deal’ without alternative arrangements to protect patients is simply not acceptable and could put lives at risk.”
The fears about missing out on this new security system is just the tip of the iceberg when it comes to Brexit and medicines. Questions also remain about the UK’s continued access to other important European databases, including EudraCT the European Clinical Trials Database and the EudraVigilance pharmacovigilance system which flags medicines safety issues.