Despite the efforts made nationally and globally during the last few decades to improve drug regulation at national and international levels, it is currently estimated that less than one in six WHO Member States have well-developed drug regulation. Those that do are usually industrialized countries. Of the remaining Member States, about three in six implement drug regulation of varying levels of development and operational capacity. The remaining two in six countries either have no drug regulatory authority in place or a very limited capacity that hardly functions.
Generally, in most developing countries (particularly in the least developed countries), drug regulation is very weak and the quality, safety and efficacy of imported or locally manufactured drugs cannot be assured. Very few developing countries have an operational licensing system for premises and persons engaged in the production, importation, wholesale and retail distribution of drugs, as well as for the assessment and registration of products. Operational drug inspectorates are generally non-existent and access to quality control laboratories is often lacking. Where quality control laboratories do exist, the necessary materials, trained personnel and funds to sustain them are commonly in short supply. (The boxes in Annex 1 illustrate the status of drug regulation and drug quality assurance in the WHO African Region and a number of countries.)
To make matters worse, in industrialized countries, where drug regulation is said to be well developed, drugs for export are not regulated to the same standard as those used for local consumption.19 Drugs exported to developing countries via free trade zones in developed countries are relabelled to avoid providing details of their provenance.20 Studies have also shown that the promotional material provided to developing countries differs significantly from that given to physicians and the public in developed countries.21,22,23,24,25 Even in some developed countries, drugs that have not been assessed for safety and efficacy - as in the case of “grandfather drugs”a in Germany - are not only exported to developing countries without any restrictions or assurance of efficacy and safety, but continue to be sold in their originating countries.26
a In Germany, at the end of 1996, approximately 28 000 of the more than 50 000 drugs on the German market were these so-called grandfather drags - that is. drugs which had not gone through a regulatory procedure.
The reasons for the observed weaknesses of national drug regulation vary from country to country, but according to a recent working group sponsored by the World Bank, and attended by representatives of WHO, the United Nations Children’s Fund and other organizations, the main barriers to effective drug regulation are:27
• absence of policy, and weak legislation and regulation;
• lack of political support/will;
• insufficient human resources;
• lack of financing;
• absence of transparent procedures;
• flawed information flow;
• poor attention to cultural constraints;
• weak or non-existent consumer and professional associations;
• absence of priorities.