How to achieve international action on falsified and substandard medicines

BMJ 2012; 345 doi: (Published 13 November 2012) Cite this as: BMJ 2012;345:e7381

Re: How to achieve international action on falsified and substandard medicines

Jerry Norris raises the important issue of the oversight of drug quality and the role of the World Health Organisation’s pre-qualification program (WHO PQ). He is correct that WHO PQ had significant problems early on, but teething problems were resolved more than 5 years ago, and his observations today seem dated and irrational.

For example, Mr. Norris complains that when in 2004 WHO discovered low quality medicines being sold as prequalified, it withdrew its prequalification. That actually seems reasonable to us—or would Mr. Norris rather the alternative that WHO sweep the problem under the rug and not withdraw its prequalification?

Mr. Norris implies that because WHO is ineffectual, so would be a global treaty to improve medicine quality. That is a wild leap of illogic, and simply wrong. First, a global treaty would cover far more products than just the small number of WHO-prequalified medicines. Second, a treaty would not depend on WHO for its enforcement mechanisms (indeed, WHO is not a law enforcement agency). Third, in the limited role it plays today, WHO has achieved much to improve medicine quality. As we have shown elsewhere ( WHO-prequalified malaria medicines, while not always perfect, are significantly less likely to be substandard than their competitors.

We agree with Mr. Norris when he concedes that WHO processes can help bring about “a substantial mitigation of substandard drugs.” The pressing need now is for an international law mandate—basically, a treaty—to prioritize that task, not just for WHO, but for all its member states.

Competing interests: No competing interests
09 December 2012
Roger N Bate
Health Economist
Amir Attaran, Ottawa University
American Enterprise Institute
1150 17th St NW, Washington DC 20036
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