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Why should pharmacies bear the brunt of EU compliance?

5 July 2016

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.

This article was written by David Reissner.

For more information please contact David on +44 (0)20 7203 5065 or david.reissner@crsblaw.com.