BEIJING (Reuters) - A U.S. commerce official said on Friday that China did not have the ability or will to regulate its economy properly, allowing the export of a chemical that tainted a blood-thinning agent suspected of killing dozens.
Christopher Padilla, the under secretary of commerce for international trade, told a group of businessmen that the United States was concerned Chinese regulators did not have the authority to monitor both pharmaceuticals and bulk chemicals.
“This is a loophole that must be closed,” Padilla said.
Padilla said the State Food and Drug Administration lacked the authority to regulate both the makers of active pharmaceutical ingredients and those that make bulk chemicals, which may be used in pharmaceuticals but are not considered to be of medicinal use.
“The rapid growth of China’s economy has clearly outstripped the ability and the will of the government to effectively police that economy,” he said.
U.S. researchers from the Massachusetts Institute of Technology identified this week a chemical contaminating the blood-thinner heparin from China and showed how it could cause a sometimes fatal allergic reaction.
The tainted heparin had been used by at least 81 U.S. patients who died soon afterwards.
Their cases forced manufacturer Baxter International to recall the commonly used blood-thinner and caused a diplomatic squabble between the U.S. and China.
The Chinese manufacturer did not register with SFDA as a maker of active pharmaceutical products, said Padilla.
Padilla, who is leading a group of healthcare executives to China, said effective monitoring was a part of broader healthcare reforms that mainland authorities were tackling.
Healthcare services and products are one of the United States’ fastest growing exports to China.
The reforms could include a basic level of state-funded health insurance and changes to the way it delivers healthcare, regulates hospitals and provides primary care, he said.
“I have a new found respect for the enormity of the challenge that China faces in the healthcare reform effort,” he said.
Disputes between patients and hospitals are common in China, where market reforms of the 1980s ended cradle-to-grave healthcare and lax supervision has lead to overcharging, bogus treatments and corruption.
China could unveil a new master plan for its health service this year that is likely to institute universal medical coverage paid for by insurance rather than general taxation.
But many were skeptical.
“It won’t happen this year,” said Rachel Lee, a principal for The Boston Consulting Group based in Shanghai.
“Foreign investors are very interested in China, but the problems are also very large,” she said.
Reporting by Kirby Chien; Editing by Alex Richardson