Pfizer has demanded strict new anti-counterfeiting measures in the UK and across Europe following the discovery of fake versions of Lipitor in the UK supply chain.

UK medicines regulator the MHRA says its own proactive monitoring of the supply chain brought about the discovery of the counterfeit batch of 20mg Lipitor, which has now been recalled.

The MHRA says preliminary tests of the counterfeits suggests there is no risk to patients, but Pfizer says criminals are increasingly exploiting loopholes in the system which must be closed urgently.

"Patient safety is our top concern and we are seriously alarmed at the discovery of counterfeit medicine in the UK," said Kate Lloyd, medical director of Pfizer UK.

"Patient safety is at risk if counterfeit products can easily be introduced into the supply chain through cross border trade, as patients will not gain the benefits their doctor intended when selecting their medicine."

Pfizer is now demanding the UK government and the European authorities consider five measures:

• Outlawing the repackaging of original manufacturer medicines by third parties.
• Supporting the introduction of tamper-resistant medicines packaging and new medicine delivery mechanisms in Europe.
• Introducing a standardised, European barcode system for medicines allowing for their safe recall and identification.
• Committing greater resources to combat the increasing involvement of organised crime in medicines counterfeiting.
• Applying of stricter penalties to those found guilty of counterfeiting medicines or knowingly supplying counterfeit medicines.

The banning of re-packaging of medicines  is currently not possible in Europe because this process is a legal requirement for the parallel trade of medicines between EU countries.

The European Commission has repeatedly defended the practice of parallel trade through the courts, maintaining that free movement of any product from country to country is a fundamental principle of the European Union.

The industry continues to argue in favour of an exception in the rule for pharmaceuticals, and may gain greater support as cases of potentially dangerous counterfeits increase.

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pharmafocus@wiley.co.uk