Europe moves to stamp out fake drugs

In mid-May, Germany's Federal institute for drugs and medical devices found counterfeit batches of Roche's antiviral flu drug Tamiflu, apparently sourced from South Korea and sold over the internet. One batch contained a simple antibiotic; another had no active ingredients at all. Later in the month came the discovery in the UK of counterfeit batches of Lilly's anti-psychotic Zyprexa, of Sanofi-Aventis' anticoagulant Plavix, and of AstraZeneca's cancer drug Casodex. 

The worrying feature of the UK incidents was that the fake drugs were not sold direct to consumers via the internet. They had entered the conventional wholesaling chain. 

The UK's Medicines and Healthcare products Regulatory Agency (MHRA) is investigating. A spokesperson said the Plavix and Zyprexa incidents are 'the same case', though it was not certain that the Casodex incident was linked to the other two. The fact that all three entered the UK via a 'parallel importing' route is suggestive. In parallel importing, drugs manufactured for sale in one country are bought and re-packaged by an independent firm, and then shipped for sale to a different country - typically one where the drug fetches a higher price. The UK, which pays more for its medicines than most European countries, is a common target of parallel or 'grey' imports. 

This is the first verified case of fake medicines being shipped through parallel import channels. Pharmaceutical manufacturers regularly complain that the re-packaging and re-labelling used by 'grey importers' makes their products vulnerable to forgery: 'Parallel traders re-package and over-label medicines, which can never be in the interests of patient safety,' said a spokesperson for the European Federation of Pharmaceutical Industry Associations (EFPIA). The parallel traders' association, the European Association of Euro-Pharmaceutical Companies, retorted that EFPIA's comments were just a smear, that there was no evidence linking its members' activities to counterfeiting, and that they were 'victims, not perpetrators'. 

Big pharma is now introducing complex technical measures to fight the counterfeiting threat. Some manufacturers have started shipping their product packs with tiny, unique metal aerials called radiofrequency identifier devices or RFIDs. These are difficult for forgers to copy, so can vouch for a batch's authenticity. 

But take-up of RFID technology has been held back by its cost. So, following the rash of fakes in May, EFPIA announced it was throwing its weight behind an alternative technique called 2D data-matrix barcoding. The body wants every medicine pack in Europe to be stamped with a unique, encrypted barcode before leaving the factory. Pharmacies and wholesalers will scan the codes and match them against a central database to check their authenticity, and thus be able to trace the pack's journey through the distribution chain. If a scan shows that the serial number in the barcode has been used before, the pack is a possible forgery. 

AstraZeneca is already using this technology in a pilot programme. Its director of product security, David Teale, says the industry believes the serial numbers cannot be copied. Bayer also plans to have the system operational in at least one country next year. 

EFPIA's call to action certainly seems justified by the figures. In 2006 the number of fake medicine items seized by customs in Europe was 2.5 million - a dramatic increase on the 500,000 captured in 2005, which itself was double the 2004 tally. 

However, the desire for safety may not be the whole story behind bar-coding. The industry also plans to use it to frustrate its parallel-importer enemies. Since coding clearly will not work if third parties are allowed to re-package medicines after manufacture, EFPIA director-general Brian Ager has called on the European Commission to alter EU regulations to 'stop intermediaries tampering with medicines'. If enacted, that would severely handicap parallel traders. 

The Commission defends parallel importing as fair competition, in accordance with the EU's aims. But Gunther Verheugen, its vice-president for enterprise and industry, has now promised to look closely at the safety issues raised by drug counterfeiting, and has launched a study of the business, to report at the end of 2007. If the fake medicine panics continue to increase, the Commission may be forced to a compromise. 

Pete Mitchell