Change is afoot for pharmaceutical companies, with new serialisation legislation on the agenda. To help stem the problem of drug counterfeiting, they will be required to adopt a unique serial number labelling system and adapt their business processes accordingly. Torben Vogt, life sciences expert at NNIT, explains how companies can derive real business value from the investments they are now required to make.
Drug counterfeiting has long been an issue in the life sciences industry, and the problem has grown in severity over the past ten years. Because drugs are commercial brands, there is significant money to be made on the black market from counterfeiting big-name products. This can lead to heavy loss of revenue – a WTO estimate places the figure at $200 billion per annum – and, more seriously, millions of deaths each year.
"The problem with counterfeit pharmaceuticals has been increasing rapidly," says Torben Vogt, life sciences industry expert at IT consultancy NNIT. "Obviously it’s a serious concern both from the healthcare authorities’ and the regulators’ point of view."
Luckily, the situation is under scrutiny. Over the coming years, serialisation legislation will come into effect in all major markets – a measure expressly intended to minimise counterfeiting and, most importantly, save lives. All life sciences businesses will be required to place a unique serial number on each pack of drugs, which can be machine-read at the point of sale. Some countries already have active legislation in place, for instance China and Turkey, whereas the US and EU markets will be called for compliance by 2015 and 2017 respectively.