In February, the European Commission announced that the falsified medicines directive (FMD) will become law across Europe on February 9, 2019.
The FMD aims to prevent counterfeit medicines entering the supply chain. The most common counterfeits are for the treatment of sexual dysfunction, heartburn and cancer. For example, fake Avastin, which entered the US supply chain in 2012.
Under the forthcoming EU law, prescription medicines will have a unique identifier in the form of a barcode that recognises the product name, pharmaceutical form, strength, pack size, batch number and expiry date.
Each pack will also have an anti-tampering device and will need to be checked in pharmacies at the time of supply. Every pharmacy must contain a scanner, connected to a repository held by the marketing authorisation holder. If a counterfeit product is scanned, an alarm will be triggered and the marketing authorisation holder will have to notify the authorities.
The law may mean that it becomes impossible to supply imported medicines in the UK if they can be sold over the counter in their country of origin, because they will not have the anti-tamper device and barcode.
If the scanner identifies the medicine as genuine, the pharmacy must “decommission” the barcode, probably by selecting an on-screen option. Once decommissioned, it will not be possible to resupply the item.
There might be occasions when, after scanning and decommissioning, a patient does not receive the medication. This might happen if a patient is not at home to take delivery, or the wrong item was selected and then not supplied.
Decommissioned medicines cannot be returned to stock. However, pharmacies will be able to reverse the decommissioning if no supply has been made and the decommissioning is done on the same premises within 10 days. If a split pack is used, the pharmacy must verify the pack when it is first opened, and then decommission the pack.
If technical problems prevent scanning, a supply may be made. The pharmacy will be required to make a record of the barcode and verify and decommission it as soon as the technical problem has been resolved.
If a pharmacy suspects that a product has been falsified or tampered with, the Medicines and Healthcare products Regulatory Authority (MHRA) must be notified – and the product must not be supplied.
In just under three years' time, the risk of counterfeit medicines will only be able to dealt with on this Europe-wide basis – regardless of whether the UK remains in the European Union or not.
David Reissner is senior healthcare partner at law firm Charles Russell Speechlys ([email protected])