Packets of fake pills are being smuggled into high-street chemists and sold as real medicines that prevent heart attacks or fight cancer, putting the lives of millions of British patients at risk.
Criminal gangs that cut their teeth selling fake Viagra on the internet and went on to push dummy drugs in poor countries are now suspected of infiltrating the supply of medicines in the developed world.
"Counterfeit drugs could be compared to arms trafficking. It really is the same kind of dangerous crime," said Françoise Grossetête, a French MEP and member of the parliament's public health committee, at an international conference on the problem in Brussels. "It could become a form of terrorism."
The Medicines and Healthcare products Regulatory Agency (MHRA) has recalled 14 batches of counterfeit drugs in the past three years, compared with none in the previous decade. These included fakes claiming to be the world's best-selling drug, Lipitor, which cuts cholesterol, Plavix, which helps to prevent blood clots, and Casodex, which fights prostate cancer. Criminals have also targeted Zyprexa, an anti-psychotic prescribed for schizophrenia and bipolar disorder.
The MHRA described the situation as "serious", and said its enforcement and intelligence unit was dealing with the problem.
The World Health Organisation (WHO) estimates that 1 per cent of drugs in the developed world are counterfeit. In Britain, that would mean up to seven million fake prescriptions a year, almost all of them undetected. Illegal pills may contain little or none of the real medicine's active ingredient, and because they are manufactured in unhygienic conditions, could have dangerous contaminants. Often the fakes can be spotted only with laboratory tests.
Patients who report to their doctors that a drug isn't working are likely to be put on a higher dosage than they need, or be switched to alternatives that could be less effective or have more dangerous side effects. No Britons have died yet because of counterfeit drugs, the MHRA claims. However, any deaths would almost certainly be attributed to the patient's illness. Medicines taken by people who appear to die of natural causes are not routinely checked.
The WHO has reported several cases where counterfeits have led to mass deaths. More than 2,000 people died during a meningitis epidemic in Niger in 1995 after being inoculated with fake vaccines.
Prescription drugs are traded throughout the EU and around the world. Often a packet of pills will pass through dozens of companies between the manufacturer and the chemist. They are frequently repackaged, with labels and instructions in different languages. Although British drug traders need a licence from the MHRA, it has no control over who handles the pharmaceuticals elsewhere in the EU.
Many of the fakes are produced in India or African countries, and then imported into the EU. John Taylor, the head of the anti-counterfeiting team in the EU Customs Department, said national authorities seized four million fakes last year, up 50 per cent on 2006. "Once they are in the EU, they travel around freely," he said.
Aegate, a British company, has recently completed an audit of its successful system in Belgium, Greece and Italy that uses a bar code to check whether a drug is authentic. No counterfeits made it through to patients. Although the firm's high-security computers are in the UK, efforts to provide the service to British pharmacies are at an early stage, partly because chemists here do not have integrated computer systems. Most still rely on paper prescriptions.
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