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Medicines have to pass through a rigorous series of clinical trials to prove their efficacy and safety. Once licensed, production is stringently regulated to ensure that drugs are manufactured to a uniformly high quality. These systems are essential if patients are to have confidence in the medicines they are prescribed. By bypassing these systems, the manufacturers of counterfeit medicines are not only illegally profiting from others' endeavours--they are also putting patients' lives at risk.

Counterfeits have been of concern ever since medicinal products were first used. Shortly after cinchona bark was introduced as a treatment for malaria in the 17th century, adulteration with other barks undermined public confidence. Similarly, when its active ingredient, quinine, was produced in the early 1800s, it too was counterfeited. The US government accused Britain of supplying fake quinine as an underhand ploy to sabotage the USA's war with Mexico.

In 1913, Carl Alsberg of the US Bureau of Chemistry launched "a stubborn campaign against fraudulent patent medicines". He said: "Fake drugs do incalculable harm to the misguided sick, who grasp at the false hopes they hold on to." Concern about trade in counterfeit medicines thus has a long history. In the modern era, it has evolved into an organised global criminal industry worth billions of dollars.

Roger Bate is the Legatum Fellow in Global Prosperity at AEI. Brian Ellliott is the executive director of the Medicines Transparency Alliance Secretariat. Ron Guido is the vice president of Global Brand Protection at Johnson and Johnson. Julian Harris is a research fellow at the International Policy Network. Hans Hogerzeil is the director of essential medicines and pharmaceutical policies at the World Health Organization. Paul Newton is the head of the Wellcome Trust-Mahosot Hospital-Oxford Tropical Medicine Research Collaboration in Laos. Aline Plancon is the INTERPOL-IMPACT project manager at INTERPOL, Andrew Jack is the pharmaceuticals correspondent to the Financial Times, Michael Boyd is the director general of the International Federation of Pharmaceutical Manufacturers and Associations, Geneva, and vice president of public affairs internations at the Schering-Plough Corporation. William Castell is the chairman of the Wellcome Trust. Pedro Velasco Martins is the principal administrator in charge of IPR Enforcement at the European Commission DG for Trade. Mark Walport is the director of the Wellcome Trust. Hashim Yusufu is the director of enforcement at the National Agency for Food and Drug Administration and Contol in Nigeria.

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