Health is a fundamental human right. Access to health care, which includes access to essential drugs, is a prerequisite for realizing that right. Essential drugs play a crucial role in many aspects of health care. If available, affordable, of good quality and properly used, drugs can offer a simple, cost-effective answer to many health problems. In many countries drug costs account for a large share of the total health budget. Despite the obvious medical and economic importance of drugs there are still widespread problems with lack of access, poor quality, irrational use and waste. In many settings essential drugs are not used to their full potential.

Lack of access to essential drugs

An increasing number of pharmaceutical products are available in the world market, and there has been rapid growth in both drug consumption and expenditure. However, many people throughout the world cannot obtain the drugs they need, either because they are not available or too expensive, or because there are no adequate facilities or trained professionals to prescribe them. Although hard data are unavailable, WHO has estimated that at least one-third of the world’s population lacks access to essential drugs; in poorer areas of Asia and Africa this figure may be as high as one-half.² Millions of children and adults die each year from diseases that could have been prevented or treated with cost-effective and inexpensive essential drugs.

Poor quality

In many countries drug quality assurance systems are inadequate because they lack the necessary components. These components include adequate drug legislation and regulations, and a functioning drug regulatory authority with adequate resources and infrastructure to enforce the legislation and regulations. Without these, substandard and counterfeit products can circulate freely. In addition, inappropriate handling, storage and distribution can alter the quality of drugs. All these factors may have serious health consequences and lead to a waste of resources.

Irrational use of drugs

Even people who have access to drugs may not receive the right medicine in the right dosage when they need it. Many people buy, or are prescribed and dispensed, drugs that are not appropriate for their needs. Some use several drugs when one would do. Others use drugs that carry unnecessary risks. The irrational use of drugs may unnecessarily prolong or even cause ill-health and suffering, and results in a waste of limited resources.

Persistent problems and new challenges

These problems have persisted despite all the work done to improve access to essential drugs, to ensure drug quality and to promote rational drug use. The reasons are complex and go beyond simple financial constraints. To understand them it is necessary to look at the characteristics of the drug market, and to study the attitudes and behaviour of governments, prescribers, dispensers, consumers and the drug industry. Health sector development, economic reform, structural adjustment policies, trends towards liberalization, and new global trade agreements all have a potential impact on the pharmaceutical situation in many countries. They may also affect the ultimate goal of achieving equity in health.

Changes in the patterns of disease and drug demand also represent major challenges. The rise of new diseases, such as acquired immunodeficiency syndrome (AIDS), the re-emergence of other diseases and increasing drug resistance of potentially fatal diseases, such as malaria and tuberculosis, all contribute to increased spending on drugs and growing pressure on health resources. Changes in life expectancy and in lifestyles have led to an increase in chronic diseases and diseases of the elderly, and an increase in the need for drugs to treat these chronic diseases.

A national drug policy as a common framework to solve problems in pharmaceuticals

Experience in many countries has shown that these complicated and interdependent problems can best be addressed within a common framework, as piecemeal approaches can leave important problems unsolved and often fail. In addition, the different policy objectives are sometimes contradictory, and so are the interests of some of the stakeholders. On the basis of this experience, WHO recommends that all countries formulate and implement a comprehensive national drug policy (NDP).