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Why should pharmacies bear the brunt of EU compliance?

"Much of the burden – and cost – of implementing the FMD will be thrown onto pharmacies"

Brexit may offer a way to reduce the headache of EU anticounterfeiting law, says David Reissner

The UK’s decision to leave the European Union means that – subject to our negotiations with Brussels – we will need to consider how much European legislation we keep. In view of this, I want to return to the subject of the Falsified Medicines Directive (FMD).

A few months ago, I explained that the FMD will create an end-to-end system designed to minimise the risk of counterfeit medicines entering the supply chain.

Much of the burden – and cost – of implementing the FMD will be thrown onto pharmacies. If the FMD is implemented in its current form in February 2019, pharmacies will be required to scan barcodes, check tamper-proof devices and decommission medicines (ie prevent them from being reused) – all at the same time as supplying the medicine to a patient. The requirement to do everything at this time will be a headache. Why can’t pharmacies be allowed to take some of these steps when they check the stock after it is delivered by a wholesaler?

Pharmacies will also need new hardware and software. A European Commission impact assessment published a few months ago estimated that implementing the FMD would cost pharmacies €530 (£445) per year. The commission considered placing the burden of checking the authenticity of medicines on wholesalers, but decided not to go ahead with this option because wholesalers objected, saying it would cost them a lot of money.

The commission then decided that putting the burden on pharmacists would be a good thing because “it builds a relationship of trust between pharmacists and patients by ensuring the safety of medicines dispensed to them”. But they seemed to forget pharmacists have been doing this for years.

Hospital pharmacies are not restricted to verifying, authenticating and decommissioning medicines at the time of supply. The FMD allows them to comply at an earlier point in time, to “avoid an excessive impact on [their] daily operations”. It is not clear why the commission considered that there wouldn’t also be an excessive burden on community pharmacies if they have to take all the steps to comply with the FMD at the time as supplying the medicine – often with a stream of patients coming in.

The Brexit negotiations mean pharmacy leaders now have a second chance to persuade the government that the whole cost of authenticating medicines should not be borne by the community pharmacy sector. When it comes to complying with European anti-counterfeiting legislation, the sector should not have to bear greater burdens than hospital pharmacies.

David Reissner is senior healthcare partner at law firm Charles Russell Speechlys LLP ([email protected]).

For more information about how Brexit could affect medicines supply and legislation, read C+D’s feature.

6 Comments

Pill Counter, Pharmacy

Mr Reissner counterfeiting is not top of the agenda for most pharmacists. Conditions in the workplace are probably what they are most concerned about and the fact McDonalds supervisors have a bigger pay packet.

A.S. Singh, Community pharmacist

Don and Max - completely agree with the points you have made. Seems like pharmacy is everyone's whipping horse these days

donald macarthur, Senior Management

Counterfeiting in the regulated supply chain in Europe was never really a problem. The FMD only arose after manufacturers lobbied the European Commission for a mechanism to put an end to parallel trade. They hoped importers  would not be able to tamper with the pack to replace the patient insert with a local language version as they are required to do. Like most counter-PI strategies in the past 50 years this failed. The new measure will add to manufacturers costs. Tough. But pharmacists should not have to pay for manufacturers' folly. The time needed at the point of dispensing to comply even if the system works is bad enough. Parallel importing into or out of the UK may be history, anyway, depending on the terms of Brexit. 

Dave Downham, Manager

Yep - another unforeseen consequence of Brexit. PI market disappears -> cost of drugs increases -> pharmacy or NHS bears brunt -> manufacturers laugh their heads off.

max falconer, Superintendent Pharmacist

I have already contacted PSNC, NPA and C&D urging them to do everything they can do to stop this totally misconceived Directive. I implore everyone to do the same as it will make our already extremely difficult working conditions nigh on impossible.

If enacted into UK law this will place an impossible burden on Community Pharmacy to prevent a problem that, if it exists at all, is a miniscule problem with medicines sourced through the UK Community pharmacy network.

Indeed I have asked all of the above how many authenticated cases of counterfeit medicines that they know of that have entered the supply chain and have reached Community pharmacies. I have yet to receive a response.

This may be a problem in some EU countries and with mail order, but not it appears in the UK. This is precisely the sort of legislation that may be needed for some in the EU but is a very expensive irrevelance in the UK.

Paul Mayberry, Community pharmacist

Totally agree Max. Everyone of us should support this argument and stop an additional needless bureaucratic burden being placed on front line pharmacists.

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