Medicines must be safe, effective and of acceptable quality, and should be used rationally in order to produce the desired effect. They can be dangerous if there is no adequate control over their manufacture, storage and distribution or their use by the patient.
During the past few decades, tremendous advances have been made in pharmaceutical technology and science. As a result, a large number of preventive and curative medicines are now available to fight diseases. Similarly, sophisticated and highly sensitive methods have been developed to ensure the quality of drugs. Unfortunately, however, despite all the advances made, concern about the quality of drugs has not abated.
In the past few years, the number of pharmaceutical manufacturers and distribution channels has proliferated. The export of pharmaceutical products, which used to be direct from a manufacturing country to an importing country, is now taking place from stocks held in one or more intermediate countries or through trading houses via duty-free ports/zones. The activities in intermediate countries or trading houses may sometimes involve repackaging and/or relabelling which may be carried out without any controls and under conditions that do not comply with good manufacturing practices (GMP) requirements. This situation, coupled with ineffective drug regulation in many countries, has facilitated the appearance of diverse problems, one of which is the counterfeiting of pharmaceutical products.
The counterfeiting of commercial products has existed for a very long time. Counterfeit drugs, however, are a relatively new phenomenon. It was first mentioned as a problem at the World Health Organization (WHO) Conference of Experts on the Rational Use of Drugs, held in Nairobi in 1985.1
At the World Health Assembly (WHA) in May 1988, a number of countries expressed concern about counterfeit drugs that were circulating in their markets. The Assembly adopted resolution WHA41.16,2 which requested governments and pharmaceutical manufacturers to cooperate in the detection and prevention of the increasing incidence of the export or smuggling of falsely labelled, spurious, counterfeited or substandard pharmaceutical preparations.
In 1988, the WHO Expert Committee on Specifications for Pharmaceutical Preparations discussed the issue of pharmaceutical products that are poorly formulated, degraded or criminally inspired. It concluded that only adequate administrative measures in both exporting and importing countries can ameliorate the situation.3 It recommended that importing countries:
(a) establish an effective national product-licensing system for pharmaceutical products;
(b) incorporate the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce into national statutes or regulations;
(c) establish a small national drug quality control laboratory as re-commended by WHO; and
(d) undertake sampling of products within the distribution chain as an element in quality surveillance.
In 1992, WHO and the International Federation of Pharmaceutical Manufacturers Association (IFPMA) organized a joint workshop on counterfeit drugs in Geneva. The workshop discussed the problems of pharmaceutical counterfeiting, identified the possible facilitating factors and made recommendations. It also defined a counterfeit medicine as one that is deliberately and fraudulently mislabelled with respect to identity and/or source.4
During the past 15 years WHO has been collecting and collating data related to counterfeit drugs, which have formed the basis of a database on counterfeit drugs. Although most of the reports are not independently verified, as at April 1999 some 771 reports of counterfeit drugs had been received by WHO and entered into its database. Twenty-two per cent of them came from industrialized countries, and 78% from developing countries.