Many countries, especially developing countries, are now being pushed to liberalize their economy. This is often reflected in reorganization of the health sector in the form of privatization of pharmaceutical production, import and distribution, decentralization of decision-making and diminution of the state’s role as regulator. In the pharmaceutical sector such changes create further opportunities for more manufacture and trade in drugs, while at the same time weakening regulation.

Experience has shown that poor regulation of drugs can lead to the prevalence of substandard, counterfeit, harmful and ineffective drugs on national markets and in international commerce. This can result in serious harm to the health of individual consumers and even to the health of a wider population. Therefore, when domestic production, and import and distribution networks expand, countries must strengthen key drug regulatory responsibilities so as to ensure the safety, quality and efficacy of drugs, and the accuracy of product information.

Responding to these changing situations will demand that countries assess their drug regulation performance, using indicators that focus on structures and inputs, processes and outcomes (Figure 2). Also, they must identify strengths and weaknesses and the reasons for them, and consider alternative regulatory options, making the most appropriate and practicable choices. Development of a framework to help organize discussion of the elements of drug regulation, to raise questions relating to those elements that require examination, and to stimulate broader thinking in policy design, is therefore recommended. An example of a framework for evaluating the structure, processes and outcome of drug regulation is given in Annex 2. It is based on work WHO is carrying out as part of a multi-country study of drug regulation.

Figure 2. Framework for the assessment of drug regulation