Intended for healthcare professionals


What to do about unsafe medicines?

BMJ 2013; 347 doi: (Published 11 September 2013) Cite this as: BMJ 2013;347:f5064
  1. Gillian J Buckley, program officer1,
  2. Jim E Riviere, university distinguished professor 2,
  3. Lawrence O Gostin, university professor3
  1. 1Board on Global Health, Institute of Medicine, Washington, DC 20001, USA
  2. 2College of Veterinary Medicine, Kansas State University, Manhattan, KS, USA
  3. 3O’Neill Institute for National and Global Health Law, Georgetown University Law Center, Washington, DC, USA
  1. gbuckley{at}

Because buyers cannot be aware of deceit in the sale of drugs, regulators need to balance the scales

“Let the buyer beware,” lawyers have cautioned since medieval times.1 This is good advice when buying grain or livestock, but for as long as there have been markets people have recognized that some products’ defects are not readily apparent to even the savviest shopper. This problem, now called information asymmetry, is perhaps most acute in the medicines market, where falsified and substandard drugs blend almost perfectly with good ones. Because buyers cannot be aware of the deceit in the sale of drugs, regulators need to step in and balance the scales. In much of the world, however, the regulation of drugs is neglected. In this vacuum, drug quality declines and patients suffer.

It is difficult to measure the human suffering caused by unregulated medicines, a recent Institute of Medicine report concluded.2 …

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