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EU Eyes Fake Medicines

February 15, 2019

A Europe-wide initiative to protect patients and public health from falsified or fake medicines went live on Saturday 9 February 2019, making the medicines supply chain across Europe safer than ever before.

The new technology means that from the moment a medicine comes off the production line to the point it reaches a patient, every person and organisation it has touched can verify and authenticate the pack: from pharmaceutical manufacturers to wholesalers to pharmacies to GP surgeries and hospitals.

However, in the event of a ‘no deal’ Brexit, the UK will drop out from the new system, leaving NHS patients more exposed to the dangers of fake medicines than other patients in the EU.

The UK has contributed to the development of the Falsified Medicines Directive (FMD) – the EU regulation that makes this plan possible – and pharmaceutical companies, along with partners, have led the way in funding and setting up the system in the UK over the past two years.

The system – a world-first – will secure the supply chain of medicines, meaning that patients can be completely confident that the medicines they are taking are genuine and safe, whether that be antibiotics, statins or cancer medicines.

The new system also sees new safety features applied to packs of medicines, so that pharmacists and patients can easily see whether they have been tampered with.

But Brexit uncertainty means that organisations across the UK’s medicines supply chain don’t know whether the system will still be in place in 7-weeks’ time as a ‘no deal’ Brexit would mean a UK revocation of the FMD legislation.

If this happens, NHS patients will be less protected than patients across the EU.

Dr Rick Greville, Director of Supply Chain at the Association of the British Pharmaceutical Industry (ABPI) – the trade group which represents branded medicines manufactures in the UK – 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 ambitious system uses new technology based on a cross-Europe database – the European Medicines Verification System (EMVS) – so that medicines dispensed anywhere in the EU can be authenticated.

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.”

The new system has been developed and co-ordinated by the European Medicines Verification Organisation (EMVO) which includes representation from stakeholders across the medicines supply chain. It means that the public makes no financial contribution to increased security in the supply of medicines.

Niall Dickson, 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.”

Questions also remain around the UK’s continued access to other important European databases, including the clinical trials database and the system which flags medicines safety alerts.

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