The movement of counterfeit drugs across borders is causing problems

Counterfeiting and its associated activities are estimated to cost the industry between $12bn-$18bn a year. The World Health Organisation estimates that up to 10 per cent of all medicines worldwide may be counterfeit. The range of counterfeit products includes, antibiotics, steroids, hormones, analgesics, anti-histamines, anti-malarial and so-called 'lifestyle' drugs. There is a significant health risk to patients from counterfeit products and the number of reported incidents is rising. EU accession has opened borders with known sources of counterfeits and in the US a proposed bill recommends legalising the importation of drugs by individuals.

Many pharma companies have developed and use a range of features designed to prevent counterfeiting and to enable better identification. However, counterfeit and fraudulent products are still reaching patients.

In a survey reported by the Pharmaceutical Security Institute, 72 per cent of firms that had experienced an incident stated that their exist­ing security devices did not prevent and could not have prevented the problem.

The legal supply of parallel imports, and the re-boxing that takes place in the supply chain, means that a proportion of security devices added to outer cartons never actually reaches the dispensing outlet. In many situations budget is being wasted on ineffective security devices.

The Food and Drug Administration (FDA) pub­lished a report in February 2004 that responds to the increase in drug counterfeiting and recommends that mass serialisation at a unit level should be implemented in the next three years.

The FDA believes that pharma should act now in setting up anti-counterfeiting teams to tackle this issue and gain rapid experience with some of the new technology solutions available, such as Radio Frequency Identification.

Using existing proven technology authentication products will be validated as genuine before being given to a patient. This approach has the potential to achieve significant risk and cost reduction as well as provide customers and patients with the reassurance that particular brands can be trusted and relied upon.

Dispensing doctors using parallel imports need to be particularly careful of their suppliers.  Even major wholesalers may have bought counterfeits quite innocently.   Beware of small ads in the pharmaceutical press and ultra-cheap drugs.  

(Amended from: Pharmaceutical Marketing - June 2004 - Alison Williams and Andy Gill)

  (14/6/04)

UK is target for counterfeit drugs, says think-tank

The UK could become a big new market for counterfeit drugs, a European think-tank has warned.

The free movement of pharmaceuticals through Europe and the current need for repackaging (in the appropriate language) makes it easier for counterfeit pharmaceuticals to be sold through the legitimate distribution chain, Graham Satchwell, a former police officer, says in a report for the Stockholm Network.

Mr Satchwell called for greater awareness, a co-ordinated effort to combat counterfeiting, an urgent review of the methods by which products are repackaged for sale in the UK, and to uniquely identify each medicine pack using RFID tagging, in his report A Sick Business - counterfeit medicines and organised crime.

“It is true that plenty of controls are in place, but I’m not sure that they’re adequately policed,” he said. “No one knows the scale of the problem but it is growing, year-on-year.”

(22/11/04)         See also CLICK