National drug expenditure as a proportion of total health expenditure currently ranges from 7% to 66% worldwide. The proportion is higher in developing countries (24%-66%) than in developed countries (7%-30%). In the former, at the individual and household level, drugs represent a major out-of-pocket health care cost (1).

People and governments willingly spend money on drugs because of the role they can play in saving lives, restoring health, preventing diseases and stopping epidemics. But, in order to do so, drugs must be safe, effective and of good quality, and used appropriately. This means, in turn, that their development, production, importation, exportation and subsequent distribution must be regulated to ensure that they meet prescribed standards.

Since the mid-1930s, many new pharmaceutical products have flourished and trade in the pharmaceutical industry has taken on international dimensions. At the same time, however, the circulation of toxic, substandard and counterfeit drugs on the national and international market has increased. This is mainly due to ineffective regulation of production and trade in pharmaceutical products in both exporting and importing countries. The use of toxic, substandard and counterfeit drugs is not only a waste of money, but may also threaten the health and lives of those who take them. Examples include the sulfanilamide incident that led to the deaths of 107 children in the United States of America in the mid-1930s (2) and the thalidomide disaster of the 1960s which caused birth defects in children (3). More recently, diethylene glycol contamination in drug preparations, such as paracetamol, have led to multiple tragedies in Haiti and India (4,5).

In Niger, fake meningitis vaccines, administered during an epidemic in which more than 26 700 people had contracted the disease, led to the deaths of 2 500 people (6). Substandard and counterfeit products are not only a problem in developing countries, but in developed countries as well (7,8,9,10,11).

Problems relating to drug safety and efficacy are generally due to the use of drugs containing toxic substances or impurities, drugs whose claims have not been verified or which have unknown severe adverse reactions, substandard preparations or counterfeits. All of these problems can be tackled effectively only by establishing an effective drug regulatory system.