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ABPI hits out at MHRA negativity on European anti-counterfeiting plans

Supply chain The MHRA position on European plans to tighten up the supply chain will not sufficiently protect patients, ABPI chief executive Stephen Whitehead has said.

The MHRA position on European plans to tighten up the supply chain will not sufficiently protect patients, Association of the British Pharmaceutical Industry (ABPI) chief executive Stephen Whitehead has said.

As the European Commission consults on plans to introduce individual barcodes to medicines packaging, which could be scanned for verification at the point of dispensing, Mr Whitehead said the MHRA's regulator's position had challenged some of the commission's proposals on the directive.

"We do not believe the MHRA view of the implementation of the directive for pharmacists, manufacturers and wholesalers will protect patients as well as is needed," Mr Whitehead told the annual conference of the British Association of Pharmaceutical Wholesalers (BAPW) on June 18.

"We do not believe the MHRA view of the implementation of the directive will protect patients as well as is needed" Stephen Whitehead, ABPI

More on the fight against counterfeits

MHRA in spat with Europe as it calls for more flexibility       in anti-counterfeiting plans

Pharmacy Voice calls on Europe not to impose       ‘unnecessary bureaucracy'

Counter attack

The MHRA had argued for the directive to be more flexible. In a letter sent to the European Commission, the UK medicines regulator said it believed "disproportionate expenditure on these measures was likely to harm public health by diverting funds from services that offer greater health benefits".

"The UK argued strongly during negotiations of the directive to ensure that scanning at the point of dispensing would not be mandatory because of the very significant challenges this would pose for healthcare providers in the UK where we have a large number of community pharmacies," the letter said.

And BAPW executive director Martin Sawer backed the regulator's stance, saying the MHRA's position was based on "real evidence". "I think it's important to progress carefully with these initiatives from a business point of view because we don't want to over-regulate, but also from a patient point of view, because we don't want to put too much concern in the marketplace when the threat from counterfeits thus far has been quite low," he said.

"If the falsified medicines directive is about future-proofing of the supply chain for the next 20 years then that's different, but I think the MHRA is taking a proportionate response but also is trying to capture the situation now while trying not to over-regulate now."

C+D reported earlier this month from the annual conference of the European Association of full-line wholesalers (GIRP) in Lisbon, where general secretary of the Pharmaceutical Group of the European Union (PGEU) John Chave argued that the number of medicines requiring verification under MHRA plans should be "as broad as possible".

Gareth Jones of Pharmacy Voice agreed and told C+D that all prescription medicines should be included under the directive to make it workable. "If there is an ever-changing group of medicines on the list, then pharmacists will always be trying to catch up with counterfeiters as drugs are always changing," he said.

"Pharmacists shouldn't have to think about it every time they dispense."

How practical is it to scan every pack of medicine at the point of dispensing?

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Peter McAuley, Community pharmacist

My comment is 'why should we need to scan every pack?'.
I buy everything from either a main line wholesaler or 2 reputable second line wholesalers.
Surely it is their responsibility to know where they are buying from and their QP to certify that every pack is not counterfeit.
Perhaps they should sign for this on every delivery to us. Put the onus back where it should be, with the supplier

Adrian Busuttil, Work for a pharmaceutical company

I spent a number of years working as a community pharmacist and now I'm working as an RP. So I can speak from both sides of the coin from a Maltese perspective. In Malta we do not have a problme with counterfeits in the legal supply chain. But I think the hassle that these measures would bring for all stakeholders outweigh the advantages of ensuring counterfeit-free supply. So I agree with the MHRA and BAPW that regulation should be kept at a minimum as much as possible.

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