NCPA - National Center for Policy Analysis


May 2, 2008

The furor over the drug heparin is just the latest in a growing string of medical problems traced back to Chinese food and pharmaceutical exports.  This newest case illustrates just how hard it will be for Beijing to solve these quality problems, even now that the extent of the problem is much clearer, says Roger Bate, a resident fellow at the American Enterprise Institute.

The pattern is familiar from cases of melamine-contaminated pet food, toothpaste and cough syrup. Yet despite the reputational black eye China suffered, the heparin contamination still happened.  Why didn't Beijing stop it?

Because Beijing can't -- at least not yet, says Bate:

  • China is a vast country with 31 provinces and 333 districts.
  • Harmonizing -- not to mention enforcing -- drug quality control across them is therefore difficult, especially since there are over 6,000 manufacturers of western drugs and more than 2,000 traditional Chinese drug makers.

Since 1998, postmarketing quality surveillance has been improving and poor-quality producers are being shut down:

  • Of the more than 40,000 lots tested in Anhui and Guangxi provinces in the past 18 months, between 3 percent and 10 percent were substandard.
  • That's an improvement from a decade ago, but this situation would still be intolerable in America, where far less than 1 percent of drugs are considered substandard by the Food and Drug Administration (FDA) -- and much of that enters the market through Internet sales.
  • Beijing has made significant progress in such testing; the most innovative programs involve mobile labs, which rely on simple testing to establish substandard drugs in the marketplace.

There are many quality drug makers in China even today and American consumers benefit from those manufacturers' products.  Rather than demonize China's insufficient oversight as many protectionists do, the United States must continue its regulatory cooperation with China.  If the heparin episode teaches anything, it's that neither country can afford to do otherwise, says Bate.

Source: Roger Bate, "China's Drug Dilemma," Wall Street Journal, April 29, 2008.

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