The BBC Inside Out Report, aired before Christmas, provided disturbing evidence of how, despite the best efforts of pharmaceutical manufacturers, the supply chain remains vulnerable. A number of pharmacies in London were allegedly revealed to be selling prescription-only medication over the counter: of particular concern is the fact that highly addictive benzodiazepines are among the classifications of drugs involved, pointing to an illicit trade in legitimately-produced drugs and a corruption of the UK’s prescription system.
Strict and extensive controls are in place in licensed pharmaceutical plants to ensure complete integrity of products at the point of manufacture but this case illustrates how the subsequent supply chain – which is typically long and complex – is vulnerable to abuse. During the 2011 Interpol-led Pangea IV annual week of action, which aims to tackle the online sale of counterfeit and illicit medicines, 2.4 million such pills were confiscated and almost 13,500 websites shut down (source: EFPIA).
The EU Falsified Medicines Directive, to be enacted across EU Member States in the coming months, is designed to bring greater security to the supply chain via a range of measures, one of which is improved traceability. The introduction of serialisation of individual packs – while not inherently capable of preventing practices such as those uncovered by the BBC – will certainly make life more difficult for those bent on corruption: in future, medicines which are legally produced but then diverted from the legitimate supply chain will be fully traceable.
The prospect of the source of any products seized being immediately identifiable must surely be a powerful deterrent. And falsified or counterfeit products will also be identifiable in theory because there will be no record of their unique pack identity, if, indeed, they carry one.
While the battle against illicit trade in pharmaceuticals is set to continue for many a year, I am confident that by 2016, when all but three EU Member States will be fully compliant with the requirements of the EU Falsified Medicines Directive, life will have become significantly harder for the bad guys.
