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Court may allow China's State FDA sued

05-12-2010 10:02 BJT

A lawsuit against the nation's food and drug watchdog for alleged mismanagement of oxygen used in hospitals could get the green light by a Beijing court by Tuesday, a lawyer representing the plaintiffs said Tuesday.

The Beijing No. 1 Intermediate People's Court told 22 medical equipment suppliers from central Henan Province that their lawsuit had merit. If indeed approved, it would be the first successful attempt to sue the State Food and Drug Administration (SFDA), lawyer Zhao Xiuhong, told the Global Times.

The suit also involves alleged conflicting standards of oxygen use in hospitals across the country.

Zhao noted that the acceptance of her clients' lawsuit by the court would be a "step forward," but if the suit is rejected, the companies could appeal to the Higher People's Court of Beijing.

The decision comes weeks after a medical scandal in which eight workers at a children's hospital in southern China were convicted for buying industrial oxygen for medical procedures.

The lawsuit is about "urging fair competition" in the country's market of medical oxygen production, which has been plagued by conflicting production standards, Zhao said.

According to a standard in the 2005 version of the Pharmacopoeia of China issued by the SFDA and China's Drug Control Law, a medical company needs to get due permission and certification from the government to produce oxygen for medical use, and the product should contain more than 99.5 percent pure oxygen.

However, an industry standard issued by the SFDA in 2003 stipulates that the net oxygen content for medical use be no less than 90 percent, which "legalized" the cheaper oxygen produced by molec-ular sieve oxygen machines, widely adopted by many hospitals for cost-saving purposes, as well as profit-driven illegal producers.

Calls to the SFDA Tuesday went unanswered.

"The court at first declined to accept the case because we were suing a government agency," Zhao said, noting that it would be tough to win the lawsuit.

There have been several rounds of appealing and dismissing between the medical companies and the national drug administration since 2003. But no solution has been reached, and this is the first time a court has opted to register the litigation.

Chen Pule, with a Zheng hzou-based medical oxygen company that is among the 22 plaintiffs, told the Global Times in Beijing that "The administration should bear responsibility for the current unfair competition between us and those hospitals that produce oxygen not strictly qualified for medical purposes."

"The conflicting standards in medical oxygen production have brought advantages to those hospitals, which don't require official approval documents and quality certificates," he argued.

"We hope the lawsuit can bring fair competition to the market. As a result of the SFDA's current regulations, hospitals that can produce oxygen in Henan have eaten up half of the market share for some 30 local medical oxygen companies," Chen said, declining to reveal his company's economic losses incurred by self-made hospital oxygen.

Also Tuesday, companies from southern Hunan and northeastern Jilin provinces also submitted indictments to the Beijing No. 1 Intermediate People's court, reports said.

Mo Congwu, with an oxygen supplier in Hunan that produces medical-grade oxygen for hospitals, told the Global Times that he has come to Beijing frequently since October 2005, when he informed the SFDA of the issue for the first time, but the agency has since kept silent.

"Take Hengyang (in Hunan Province) for instance, half of all hospitals are producing unqualified oxygen. It is threatening public health and also our business," he told the Global Times.

If the situation remains unchanged, all the medical oxygen companies in China will go bankrupt, Mo said.

Cases challenging the authenticity of medical-purposed oxygen are not new. An investigation by the drug administrative authority in east Jiangsu Province on 132 medical institutions found that 21 hospitals use industrial oxygen instead of medical oxygen, the Beijing Youth Daily reported.

Eight medical workers from a children's hospital in Hunan Province were convicted last month for having bought almost 50,000 bottles of oxygen from an industrial gas company over 15 months without an appropriate contract, according to reports.

The unqualified oxygen costs about half the price of medical-grade oxygen for hospital use, media reports have indicated.

Some hospitals, however, seemed to defend their production of low-density oxygen.

"We use the molecular sieve oxygen machine system to better serve patients," Yu Bin, who is in charge of the medical apparatus and instruments at the Kaifeng Second People's Hospital in Henan, was quoted by Zhengzhou-based Orient Today as saying.

And in the interest of safety, heavy oxygen cylinders are kept in dedicated stor-age rooms, which can lead to difficulties in moving them during emergencies or at night, Yu argued.


Luo Shiwen, a senior official with the SFDA, suggested that a special organ be set up to monitor the production of drugs and medical instruments and keep closer tabs on products.

"The organ should follow up on the whereabouts of oxygen produced by medical companies and keep records of hospitals that do not buy from qualified producers," Luo was quoted by the Beijing Science and Technology Report as saying.

Zhou Zijun, a professor of public health at Peking University, said the key to the issue is to break the monopoly of medical companies and allow more enterprises to acquire qualifications to produce medical oxygen.

Shao Zhanqiang, a doctor at the Chaoyang No. 2 Hospital in Beijing, said the oxygen used in hospitals in Beijing is of good quality due to strict administration. "If not for other reasons, the use of oxygen at hospitals is a matter of conscience," Shao said.

"Ordinary patients can't observe the difference of oxygen with different purities. So it is natural that some hospitals may use low-purity oxygen against their conscience.

"But hospitals should be aware that when it comes to emergency use, only standard oxygen can save people's lives."

Guo Qiang contributed to this story

Editor:Beauty |Source: Global Times

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