EU Eyes Fake
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.
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.
Dickson, Chair of the Brexit Health Alliance (BHA) – an alliance of NHS,
medical research, industry, patients and public health organisations –
“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.