/ 4 December 2006

Drug pirates leave death in their wake

No one will ever know how many Chinese men — and women — were sexually satisfied after taking the American Number One, Male Exclusive, Great Big Brother pills sold by Xi Yongli.

When the product was raised in court recently, it was not its potency that was on trial. Rather, it was the legality of using a drug better known as Viagra.

In the latest case to highlight the rampant piracy in China’s pharmaceutical industry, Xi and his accomplices were found guilty of making 60 tonnes of pills without a licence or the permission of Pfizer — the US company that has the patent on Viagra’s active ingredient, sildenafil citrate.

According to reports by the Xinhua state news agency, Xi and his gang rented an old pharmaceutical factory in Bangbu city, Anhui province, in May 2001. Although he registered the business as a food company, Xi bought bulk supplies of sildenafil and mixed them with sugar and other ingredients to make pills and capsules. By the time he was caught in October 2005, the company had sold more than 21-million yuan ($2.96-billion) worth of drugs, almost half of which was profit for Xi.

Seized

The Bangbu intermediate court sentenced Xi to eight years in prison at the end of a widely publicised case that was hailed by the authorities as a sign that China is getting tough on counterfeiters. But trade negotiators and medical experts warn that the problem of pirated drugs continues to be a largely hidden epidemic with dire consequences not just for business but for health.

Last month Peter Mandelson, the European Union trade commissioner, revealed that fake birth control pills and HIV retroviral drugs from China had been seized by European customs officers. This year the US federal drug administration intercepted 51 shipments of Chinese-made counterfeit Tamiflu — the most popular drug for the treatment and prophylaxis of bird flu.

They are part of a much bigger piracy problem, covering everything from DVDs and Burberry sweaters to golf clubs and Harry Potter knock-offs. In the race to make money, many local governments turn a blind eye to infringements of intellectual property rights by factories that provide jobs, taxes and — all too often — bribes to officials. Some towns, such as Shantou in Guangdong province, are notorious all over Asia for the speed at which their factories can copy the latest product. According to Mandelson, half the fakes found in the EU originate in China.

Some counterfeiting is hilariously brazen. A few years ago, Durex executives were astonished to discover pirated condoms bearing their brand name on the production line of a prospective Chinese partner’s factory. “It sparked a discussion among the visitors about whether they had found the perfect supplier,” said Calum MacLeod, a consultant to Durex at the time. “But from a corporate ethics point of view, it was not realistic.”

The consequences can be deadly. In May, 11 people were killed by antibiotics made in Heilongjiang. The manufacturers had mistakenly added diethylene glycol, an industrial toxin, to the ingredients. Last year, the media in Guangdong reported the deaths of two boys from rabies, against which their parents thought they had been inoculated until police found 40 000 boxes of fake vaccine. A year before, at least 50 babies in Anhui province died and more than 100 were severely malnourished after being fed fake milk formula, some of which had only 6% of the vitamins, minerals and protein needed for a growing infant.

The worst affected are the poor, who look for the cheapest products and have the least safety information. According to the World Health Organisation, less than 1% of drugs in wealthy nations are fake. In developing countries, the proportion can reach 30%. A Lancet study found a third of anti-malarial drugs in Cambodia, Laos, Burma, Thailand and Vietnam had no active ingredient.

Concerns

Many of those fake products have been traced back to China, which along with India and Russia are thought to be the biggest suppliers in the world. It is a huge market. The US Centre for Medicines in the Public Interest predicts that global sales of counterfeit drugs will reach $75-billion in 2010 — an increase of more than 90% from 2005.

In a sign of increasing concerns about this trend, the World Health Organisation (WHO) launched Impact — the International Medical Products Anti-Counterfeiting Taskforce — this month to coordinate global law enforcement and anti-counterfeiting technology. Henk Bekedam, representative for WHO in Beijing, said China was starting to look seriously at the problem, which affects its own growing legal pharmaceutical industry. “Fake drugs are a global problem and there is no reason to believe China is an exception. Piracy is a disease … we need to report on it, find out where it is coming from, and go and deal with it.”

According to official figures, China investigated 310 000 reports of counterfeit drugs last year, worth about 51m yuan, and destroyed 530 factories. But only 214 cases were prosecuted. New pharmaceutical plants must now be approved by the central government. Some international patents, such as that of Pfizer for Viagra, have been recognised. And a 50 000-yuan reward is on offer for information about drug piracy.

But huge loopholes remain. As well as 4 850 registered pharmaceutical companies in China, there are still countless illegal plants operating in much the same way as Xi’s “food factory”. The worst consequences will be a lot more serious than erectile dysfunction. – Guardian Unlimited Â