Last week, it was revealed that 2007 saw 70,000 packs of fake life-saving drugs prescribed to NHS patients. So how serious is the problem of counterfeit drugs? Eoin Gleeson reports.
Fake drugs: how big is the problem?
It’s hard to get accurate data, but fake drugs are estimated by the US Food and Drug Administration (FDA) to account for about 10% of global pharmaceutical sales. They are thought to lead directly to the deaths of more than half a million people worldwide a year. The problem is worst in Asia and Africa, where the World Health Organisation (WHO) estimates as much as 50% of drugs sold are fake. But developed countries are not immune – the WHO reckons about 1% of drugs in these markets are fake, equating to about eight million packs of medicines worth £425m a year in the UK.
Is it really that bad?
Mike Deats of government medicines watchdog the Medicines and Healthcare Products Regulatory Agency (MHRA) reckons the number is “potentially smaller”, but it is undoubtedly growing – there have been 14 major recalls in Britain in the past three years, compared with just one in the previous decade, says Mark Townsend in The Observer, and British border officials seized more than half a million counterfeit pills last year alone. The 2007 recall of 70,000 packs of drugs – 30,000 of which are unaccounted for and so have probably been consumed – included medicines to treat prostate cancer and schizophrenia. The recovered packs contained 50-80% of the correct pharmaceutical ingredient, Deats told the BBC. But ineffective antibiotics made of talcum powder, birth-control pills made of rice flour, and more dangerous substances are regularly seized by border officials.
Where do the fake drugs come from?
Mainly from Asia – 75% of fake drugs have some origin in India, reckons the OECD. Most active ingredients for brand-name drugs can be bought over the internet cheaply, and you don’t need a sophisticated lab to duplicate pills. Organised criminals are now involved in counterfeiting prescription drugs across the globe, says Henry Miller in The Washington Times – everyone from the Russian mafia and Chinese triads to terrorist groups such as Hezbollah and the IRA. The fake drugs follow a convoluted path to Western markets. The key factor that ensures their safe passage is the spread of free trade, says Walt Bogdanich in The New York Times. Free trade zones – areas designated to encourage trade, where tariffs are waived and regulatory supervision is light – are an ideal gateway because of the huge volume of goods that pass through their ports. Counterfeiters use the stopover to switch route information on the containers and to relabel the products. Dubai is particularly attractive, due to its strategic location in the Persian Gulf between Asia, Europe and Africa. The single market in Europe is also opening the door to counterfeit drugs. As wholesalers buy drugs cheaply from places such as Spain and Greece, reselling them in the UK, products are often “repackaged” by intermediaries along the supply chain, passing through as many as 20-30 pairs of hands. This results in a fertile breeding ground for counterfeit drugs trading. With just 0.1% of goods entering the UK physically checked by customs officers, the National Audit Office believes Britain is “one of the easiest places in the EU to smuggle counterfeit”, says Townsend.
How do fake drugs end up in the legal drug supply?
Via duped or unscrupulous brokers and wholesalers. Instead of selling small amounts of fake drugs online, counterfeiters are starting to target pharmaceutical wholesalers who supply everyone from high-street pharmacies to NHS trusts. After the drugs have been diverted – laundered, if you like – through a number of ports, wholesalers may end up unwittingly buying counterfeit drugs. Money also enters into the bargain. The wholesale price for prostate cancer treatment Casodex in Britain is £128 for a pack of 50mg tablets, for example; the same pack can be had for £5 from a Chinese counterfeit gang.
What’s being done about it?
A global tracking system to deal with the international flow of counterfeit drugs is badly needed. But that level of global cooperation doesn’t look like happening anytime soon. In the US, a national computer system to record a drug’s journey from factory to patient has been stalled repeatedly by the pharma industry, which fears extra bureaucracy will raise costs and disrupt supply chains. “Drug companies will keep the ball in the air until something bad happens,” pharmacist Stan Goldenberg told the Los Angeles Times. And beyond a couple of pilot tracking schemes, UK authorities aren’t making much headway either. The EU has just mandated that European drugs must carry barcodes. But the failure to ban the repackaging of drugs has left a loophole, says Dr Adam Fein of Pembroke Consulting. And with huge profits to be made (see below), the trade looks likely to keep growing.
Hard versus medical drugs
From the criminal’s point of view, moving into prescription drugs rather than illegal drugs is a no-brainer. According to Mick Deats, “there is far less risk [than with cocaine and heroin] and when you look at the money you’re going to make, you are going to make more out of counterfeits”. A counterfeit drug costing a fraction of a penny can be sold for 50 times as much on Western markets. And under the Trade Marks Act, the maximum penalty you can serve is ten years in prison. With fake medicines easy to produce, low risk to sell, and vastly more profitable than the traditional drug trade, don’t expect this problem to disappear anytime soon.