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FMD has reduced manufacturing capacity by 10%, says BGMA

Warwick Smith: The introduction of FMD has had a detrimental impact on manufacturing capability
Warwick Smith: The introduction of FMD has had a detrimental impact on manufacturing capability

The falsified medicines directive (FMD) has reduced manufacturing capacity by 10%, British Generics Manufacturers Association (BGMA) director general Warwick Smith has claimed.

Mr Smith expressed his disapproval of the anti-counterfeit medicines legislation during the annual Sigma conference in Cebu in the Philippines yesterday (February 17).

The FMD drugs packaging requirements, which require medicine packs to be printed with 2D barcodes, have “essentially reduced manufacturing capacity by 10%“, Mr Smith claimed.

The BGMA arrived at the 10% figure based on feedback from the organisation's members and from the wider industry, Mr Smith told C+D today (February 18).

The fact that companies must now “affix a unique identifier and also an anti-tamper device for each pack” has slowed manufacturing lines, Mr Smith added.

In the context of ongoing medicines shortages, the capacity reduction means there is “less wiggle room” for manufacturers, compounding other factors that have caused the supply chain to weaken, he added

FMD is an EU medicines scanning law that came into force last February, with the aim of preventing counterfeit medicines from entering the drugs supply chain.

Shortages “outside of our control”

Mr Smith’s also discussed medicines shortages and the complex reasons they occur.

One cause of shortages given by Mr Smith was changes to the environmental legislation in China that has seen factories move from urban to rural locations. Factors like these are, he said, “outside of our control”.

Of the range of issues that have led to shortages most are “due to government policies rather than anything that is being done in the distribution chain”, Mr Smith claimed.

A C+D investigation last month revealed that the Department of Health and Social Care recorded 178 medicine shortages in England from January-November 2019.

Follow @CandDEliza on Twitter to catch up with all the latest coverage from the Sigma conference in the Philippines.


What is your take FMD and its impact?

cardiff pharmacist, Superintendent Pharmacist

I understand that the multiples are not fully compliant as yet..and I know that the pharmaccies in Holland are just ignoring it!!

So why are we , in the UK, the only pharmacies being forced to do this time wasting activity!

Mr CAUSTIC, Community pharmacist


one of my reasons for voting for brexit was over the fridge mountain . we had fridges everywhere and everyone else in europe ignored it . what is the penalty for ignoring scanning ? perhaps we should all start to ignore the scanners now . the white on black barcodes are difficlut to scan and often with others you have to scan at right angles. Selotape causes problems and the packs look a mess once opened, Apart from that FMD wastes a lot of time .



CCG Pharmacist, Primary care pharmacist

GP practices are, largely, also uncompliant and have been advised by LMCs not to bother as 'it will go away'.....

Mr CAUSTIC, Community pharmacist

As we have not discovered any fakes ,with the disclosure it is reducing capacity as well , it is time for Boris to take action and withdraw our obligation to scan . The time wasted in scanning is increasing stress in the workplace . That will lead to more errors . Reduced capacity also reduces manufacturer's profits which will lead to higher prices. If a miniscule number of fake packs had been discovered one could not justify withdrawing the directive but there have been NONE.




David Moore, Locum pharmacist

You might also remind Boris that we've left the EU and he should tell what to do with their FMD scanners.

Bob Dunkley, Locum pharmacist

In these straightened times for contractors, who on earth can afford to go to a conference in the Phillipines? If I ran the Department of Health I would be looking closely at those contractors who went, as it would appear they are making some money the source of which is denied to their fellows.

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