HPE HPE 90 – November 2018 | Page 6

news Medicines watchdog seizes over £2m counterfeit medicines in UK drugs bust More than £2m worth of falsified medicines have been seized in the UK in less than three weeks, the Government’s medicines watchdog has revealed. The Medicines and Healthcare products Regulatory Agency (MHRA) said on 24 October that it intercepted one million doses of counterfeit medicines, worth over £2m, between 9 and 27 October, including diazepam, modafinil and dermal fillers. The drugs bust formed part of the global operation Pangea, because of which 500 tons of illicit drugs totalling around £11m were netted in 116 countries – resulting in 859 arrests. With the help of anti-crime organisation Interpol, the MHRA raided properties located in the North of England that were linked to the online trading of illegal and potentially harmful medicines. This led to one arrest, the watchdog said. In addition to the raids, the MHRA searched certain airports, mail delivery centres and websites on the open and dark web. It said that 123 websites were shut down and 535 online adverts removed. According to Interpol, around 150,000 “powerful sleeping pills” were found in shipments labelled as clothing, bedding and food across the UK. In Ireland, more illicit sleeping pills were concealed in a hollowed-out book. MHRA head of enforcement Alastair Jeffrey said the findings are just “the tip of the iceberg”. He added: “Our intelligence-led enforcement operations have seized millions of counterfeit and unlicensed medicines and devices in the UK. We will continue to take action against known criminals – working with our international partners to stop illegal medicines from entering the UK. “Criminals who sell medicines over the internet have absolutely no regard for your health and taking medicine that is ether falsified or unlicensed puts you at risk of serious harm.” No-deal Brexit would reverse FMD implementation in UK, Government says A no-deal Brexit would put a stop to the the falsified medicines directive (FMD) in the UK, the Department of Health and Social Care (DHSC) has revealed. Speaking on 7 October at the Pharmacy Show in Birmingham, DHSC senior policy manager Claymore Richardson told our sister publication The Pharmacist that if the UK failed to reach a deal with the EU after Brexit, FMD would be abolished in favour of a UK-wide system. On 4 October, the Government’s medicines watchdog the Medicines Healthcare products Regulatory Agency (MHRA) launched a consultation that looked at the impact FMD could have on the regulation of medicines and medical devices in the event of a no-deal Brexit. Mr Richardson told The Pharmacist: ‘If there was a hard, no-deal [Brexit] with no transition period, we would have to revoke FMD because people would not legally be able to comply with it.’ Under FMD, a series of European 6 | Issue 90 | 2018 | hospitalpharmacyeurope.com anti-counterfeiting measures, pharmacists will scan medicine products to verify their authenticity before decommissioning and handing them to patients. As the UK has a legal duty as an EU member state to comply with FMD by the 9 February deadline, Mr Richardson argued that we would have to implement an in-house system under a no-deal Brexit scenario. Mr Richardson said: ‘We would be looking at the options in terms of what a national system would be. ‘It’s completely common sense. If you look at all the investment and the work that’s been going in implementing FMD, if you’re going to do a UK system you would want that to build on what people have been spending their money on’. In February, the MHRA published an impact assessment document on Article 23 providers only, which include dental practitioners and optometrists among other healthcare professionals but exclude community pharmacies and hospitals, where the Government has ‘legal scope to make changes’, Mr Richardson added. He said that the Government has not allocated a specific pot of money for FMD to help those who will have to invest in the relevant equipment, such as scanners, to decommission packs of medicines before they are dispensed to patients. However, he did not clarify how much money was in this pot. Mr Richardson pointed out that this decision will be subject to change following future negotiations with the Pharmaceutical Services Negotiating Committee (PSNC).