Pfizer demands action after more fake Lipitor found in UK
pharmafile | September 6, 2005 | News story | Manufacturing and Production |
The MHRA has discovered a second batch of counterfeit Lipitor in under a month, a worrying indication of a growing trade in fake medicines in the UK.
The UK regulator has launched fresh inquiries into pharmaceutical wholesalers following its discovery of 1,500 packs of counterfeit versions of Pfizer's best-selling statin.
The agency said the illegal 40mg copies had been packaged for the UK market and carried identification numbers indicating they were not for sale in the European Union.
The MHRA stressed no patients were at risk as the counterfeits had been intercepted before reaching the legitimate supply chain to pharmacists.
The latest discovery was at a small UK wholesaler, which holds a licence to parallel import – the legal import of drugs from countries where the drugs are substantially cheaper than in the UK.
But the MHRA does not believe the copies were imported through a parallel trade route and is instead concentrating tracing its supply route within the UK.
The find follows July's discovery of 70 packs of counterfeit Lipitor in the UK supply chain after the MHRA received a tip-off from authorities in Rotterdam.
Two wholesalers believed to be linked to the distribution of the copies are currently under investigation.
Pfizer said it was forced into a mass recall of 120,000 packs of Lipitor as the 70 packs of counterfeit Lipitor - which had already entered the supply chain – carried the same batch number as the genuine batch.
According to the British Association of Pharmaceutical Wholesalers, the copies entered the supply chain because of a product shortage of Lipitor in the UK market.
It is believed a full-line wholesaler purchased the counterfeit stock from a short-line wholesaler thinking it was buying legitimate UK stock.
Operating under strict regulations, full-line wholesalers are very critical of short-line wholesalers, which they say are run with the aim of making a quick profit without sufficient regard to quality and safety.
Tony Garlick, technical director at the British Association of Pharmaceutical Wholesalers, condemned short-line wholesalers as the "Ferrari club" of pharmaceutical wholesalers.
It is not common practice for a full-line wholesaler to pick up stock from a short-liner but there has been a product shortage of Lipitor in the UK for three months. The full-liner would have believed it was purchasing legitimate UK stock, he added.
Pfizer said that it did not hold the full-line wholesaler responsible but has called on all stakeholders in the supply chain to ensure the safe and effective distribution of medicines in order to ensure patient safety. It is also demanding the UK government and 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 products from country to country is a fundamental principle of the European Union.
But Julian Mount, Pfizer's senior director of European trade, said the practices of parallel trade provide a perfect environment for counterfeiters to operate in.
Head of intelligence at the MHRA, Naeem Ahmed, said it was considering making spot checks on wholesalers and that a rigorous sampling scheme to test for counterfeit drugs was in place in the UK.
The regulator is targeting high volume products, like statins, and lifestyle medicines such as erectile dysfunction drugs, which counterfeiters tend to favour.
