From Nation, issue no.411, March 25, 2009
Translated by Zhang Junting
Original article: [Chinese]

"The factory is shutting down. Go and ask the relevant department if you have any questions," said a guard as he pushed Tao Zhiming out of the front gate of Jingang Andi Biological Group.

Tao made the special trip from Zibo, Shandong province to the factory in Liaoning province on March 12, two months after China's State Food and Drug Administration revealed that a batch of human rabies vaccines produced by the company in 2008 contained illegal additives which could render them ineffective.

Worse, most of the vaccines had already been injected into patients like Tao, who had spent 300 yuan on five injections in one month. It was Tao's last few injections which turned out to be from the company's problematic batch, of which 30,000 remained unrecovered.

Who Is Liable?
With an empty vaccine box and a clinic registration note, Tao hurried to the hospital where he was vaccinated, where he said he demanded why, after the SFDA had already informed the public about the fake vaccine, he was still administered the injection. The hospital apologized and promised to return his money.

But Tao said that when he asked what he should do if something serious should happen to him as a result of the vaccine, the hospital answered, "We have no idea, go ask the producer".

Tao said he was wholly unsatisfied with their response. "Rabies is 100% fatal to humans. It feels like I'm carrying a time bomb on my back. Who should be responsible for me?". He added that he later called the Dalian Food and Drug Administration, and though they were polite, did not give him "valuable information".

With this backdrop Tao decided to trek to Dalian, where he found Jingang Andi Biological Group's factory in a corporate tax haven district of the city.

Tao said he was met by a middle aged guard standing outside the gate, who told him workers had been on vacation for nearly two months, and that the boss was arrested a month ago.

Now, Tao carefully keeps the empty vaccine box and his prescription. "If something happens to me, this is all the evidence I've got."

The state food and drug administration officially alerted the public to the vaccines produced by Jingang Andi on January 12, and asked the company to recall all rabies vaccines produced in 2008.

The company used to be the second largest producer of rabies vaccine in China, with millions of vaccines being sold all over the country each year. By comparing the number of sold vaccines to already recovered ones, it was determined that 30,000 vaccines had yet to be recovered

Aftermath

"The recall is ongoing, but a portion of the vaccines will never be recoverable," said Mao Li, a division chief in the Dalian food and drug administration. Mao said that some vaccines could not be recovered because some hospitals have already destroyed them, some had been used, and some had already been distributed to remote areas with poor transportation and communication, making them difficult to track.

However, a vaccine dealer in Dalian told the EO that it would not be hard to track the unrecalled vaccines, which, unlike other medicine, the government mandated clear sales and usage tracking for. Even if a vaccine is used, it's easy to track down the patient by address, they said.

Yet many cases will never be tracked down. Tao admitted that one reason he was in such a rush to find a liable party was because the address he left at the hospital was fake. "I didn't think too much and left a random address I came up with. Many people leave fake addresses, as far as I know," said Tao.

Only a few cities have thus far published the number of both used and unused vaccines, such as the Shanxi Food and Drug Administration. Meanwhile, fearing public panic, some drug administrations in certain cities denied that problematic vaccines had ever been purchased in the first place, only to be deluged with complaints from residents there who discovered they had been injected with them.

One Dalian food and drug administration official who wished to remain anonymous told the EO, "The public need not worry too much about the 30,000 unrecalled rabies vaccines, because besides the recall efforts, the state food and drug administration has been closely watching for adverse reactions from affected users ever since the the issue became known. In the mean time, we have set up a channel for such reactions to be reported through, and up to now, we haven't heard of any". The official didn't articulate in detail how the reporting channel works.

One official with the Beijing Food and Drug Administration told the EO that "even if adverse reactions ocurred, it didn't necessarily mean that the medicine was problematic, or warranted blaming the medical company or supervising departments. Adverse reactions to treatment can stem from management problems, poor monitoring measures, the production process, and misuse."

Experts have been advising the government to establish a system of compensation and relief for victims of harmful medicine, and suggested that a special law for liability and relief in such cases should be drafted.

On March 8th, 31 delegates to Beijing's top political and legislative meetings gathered to discuss a draft of the Drug Safety Law, drafted by Niu Zhengqian, vice-secretary general of China's Medical Enterprise Association. Niu said the National People's Congress should place the Drug Safety Law on its agenda while drafting the Food Safety Law, which it has since passed.

Wang Mingwen, a delegate to the National People's Congress and professor at Sichuan's Xichang University, proposed an even more specific Harmful Medicine Liability and Relief Law. He said that since there was no such law in China, victims of harmful medicine could only refer to Product Liability Law for compensation, which he said had already proven ill-equipped for dealing with such cases.