Lipitor, made by Pfizer, is currently the world’s biggest selling medicine, with 11 million prescriptions being written in the UK alone last year. Global sales amount to £12 billion a year. The fakes were discovered by the Medicines and Healthcare products Regulatory Agency (MHRA) through a proactive programme of monitoring the supply chain for counterfeit Lipitor.

Counterfeit medicines are a huge global problem. The World Health Organization estimates that 10% of medicines worldwide are fake, with 60% being found in the developing world. It says counterfeits are responsible for a ‘significant’ number of deaths, and the criminal trade is believed to amount to as much as £20bn every year.

Pfizer is ‘seriously alarmed’ at the discovery of counterfeits in the UK. ‘There is currently an investigation under way to discover how this could happen,’ a spokesperson for the company said. ‘Pfizer will be working with the MHRA and law enforcement agencies to conduct a full and thorough investigation into this incident and to ensure those involved are subject to criminal proceedings.’

The company is seriously concerned about the security of the UK medicines supply chain, and has been for some time, the spokesperson added. ‘As this incident illustrates, the current system lacks integrity which has allowed counterfeit medicines to enter the legitimate supply chain.’

‘Patient safety is at risk if counterfeit products can easily be introduced in to the supply chain through cross border trade,’ says the company’s UK medical director Kate Lloyd. This parallel trading system in medicines is believed to provide a way of entry to the market for the criminals who deal in fake drugs. EC trade rules mean third parties are allowed to buy up stocks of prescription medicines in countries where the state-controlled price is low, repackage them, and then re-export them to countries where the prices are more expensive, taking a cut in the process. However, it does mean that it is normal for medicines to reach pharmacies in non-original packs, making it simpler for the criminal element to infiltrate the supply chain.

Pfizer is already introducing a number of measures designed to protect the integrity of its products. It is phasing in tamper-evident packaging, and this played a part in the identification of the fake Lipitor.

The company has a number of suggestions which could also help secure the supply chain. These include outlawing the repackaging of original medicines by third parties (such as parallel traders), introducing a standardised European barcode system, and committing greater resources to combat the increasing involvement of organised crime in medicines counterfeiting.

UK pharma industry trade association ABPI believes this is an isolated incident, but it would back any move to tighten the supply system for medicines. ‘All medicines should reach the patient in the manufacturer’s original packaging – product integrity must be maintained,’ says its director general Richard Barker. ‘The simpler the system, the less likely it is to provide opportunities for criminals.’