| Simon King at Domino Integrated Solutions Group maintains that hybrid track-and-trace solutions have the capacity to turn the tide against the counterfeiters
Over the past year, developments in tracking, tracing and authenticating pharmaceutical products have provided a good example of an industry getting its act together to tackle a serious threat – in this case the cost of counterfeit medicines in terms of money and danger to patients. The US Food and Drug Administration (FDA) estimated this to be some $32 billion in 2004, a sum that is increasing year on year, and there is alarming evidence in Europe that counterfeit medicines are entering the legitimate supply chain in increasing numbers. According to the European Commission, more than 500,000 examples were seized at Europe’s borders in 2005 – twice the 2004 total – and the World Health Organization says that around one per cent of medicines in Europe are now counterfeit.
INDUSTRY REACTION TO THE COUNTERFEIT THREAT
No one can accuse the pharmaceutical industry of taking the threat lightly. To illustrate the quickening pace of progress towards securing the supply chain, compare the situation described almost a year ago by the European Federation of Pharmaceutical Industry Associations (EFPIA) with the current state of affairs. In November 2006, the EFPIA lamented that “the integrity of the medicines supply chain is continuing to fracture”, with the result that “opportunities to improve patient safety at a European level and enhance the control of the supply chain are being lost, while the multiplication of systems adds incremental production costs for manufacturing and increases further both the complexity and differentiation across the European market.”
In the intervening months events have moved on apace. The growing danger of bogus medicines has been highlighted by high-profile incidents such as the discovery in May 2007 that a fake version of a leading prostate cancer drug had entered the UK, not through internet channels but rather via the conventional wholesaling chain.
At the same time, 2007 has seen what can best be described as a ‘technological consolidation’ around the 2D Data Matrix code as the ‘data carrier of choice’ at item or patient pack level at the present time, in preference to other technologies – in particular, to radio frequency identification (RFID). In May 2007 the EFPIA announced its support for a “pan-European and industry-wide solution to protect patient safety through a more transparent medicine supply chain” based on 2D Data Matrix. Two months earlier, the Council of Europe had issued a document entitled Safer Medication Practice similarly advocating that healthcare organisations and stakeholders adopt 2D Data Matrix as the foundation of improved packaging and coding systems. |
