for Food and Drug Administration and Control (NAFDAC) led an aggressive effort to attack drug counterfeiting. Inspections at ports and airports increased. Unauthorized imports were seized. Raids were conducted on the large urban drug markets, and large quantities of unregistered materials and fake medicines were burned. Community mobilization efforts included school-based organizations. Ultimately, legitimate sellers turned on the illegal importers and helped to identify them to the regulators. All of that occurred because of high levels of political support, dedicated agency leadership, additional technical resources, and support from the donor community. As a result, the prevalence of counterfeiting (which by some estimates had reached 80 percent of medicines sold in some Nigerian markets) decreased significantly (see case study G, “Counterfeit Medicines in Nigeria”). Yet real difficulties also arose. The regulatory pressures put NAFDAC staff in some personal danger. Assassination attempts were made against the director, and various offices were burned down. Corruption in the police and the judiciary also undermined efforts to punish major counterfeiters. Only about 50 successful prosecutions occurred over a decade, and the large drug markets were only closed for six months each, reopening later and flourishing once again.
Regulating Use Worldwide, the accumulated evidence shows a great deal of overuse and misuse of medicines. The pattern is complicated by the fact that in low- and middle-income counties, controls on use through prescription requirements are rarely enforced. Although the situation varies by a country’s level of economic development, many medicines sellers are not registered or regulated, even those that operate formal shops. And even within a country, central urban areas are less dominated by informal supplies than are periurban slums or rural areas. Given the variations, using regulation to change the ways people use medicines can face formidable difficulties. Restrictions on citizens’ free access to private sector medicines often do not have a high level of social legitimacy and hence tend to be unattractive politically. It is one thing to use regulation to ensure that consumers get what they think they are paying for. It is quite another to use regulation to prevent them from getting what they want, especially when they are willing to pay for it. Three kinds of regulatory initiatives are widely employed in high-income countries to influence use of pharmaceuticals: Facility licensing. Licensing involves limiting which organizations can perform which functions at various stages in the supply chain. Most industrialized countries limit the sale of certain medicines to pharmacies and 176
Pharmaceutical Reform