Access to essential medicines: Four components

After immunization for common childhood diseases, appropriate use of medicines is one of the most cost-effective components of modern health care but that is not to say that all are equally necessary across the board; where means are limited, priorities can and must be set. Decisions on the range of medicines which one must strive to make available throughout a nation have to be taken in the face of challenging political, social, ethical, economic, and medical difficulties and developments. Governments, non-governmental organizations, and households in many low-income countries struggle continuously to ensure and secure access to even the most basic life-saving medicines, especially in rural areas. In low-income countries therefore, the most urgent concerns relate to the need to attain affordability and equity of access with respect to these vital pharmaceuticals, and beyond that to attain the same for a somewhat wider range of “essential medicines”, a concept developed by the World Health Organization in 1977.

The description of essential medicines is as follows: Essential medicines are those that satisfy the priority health care needs of the population. They are selected with due regard to public health relevance, evidence on efficacy and safety, and comparative cost-effectiveness. Essential medicines are intended to be available within the context of functioning health systems at all times in adequate amounts, in the appropriate dosage forms, with assured quality and adequate information, and at a price the individual and the community can afford. The implementation of the concept of essential medicines is intended to be flexible and adaptable to many different situations; exactly which medicines are regarded as essential remains a national responsibility”[25].

The term “essential medicines” is usually applied to those medicines that are listed on the World Health Organization (WHO) Model List of Essential Medicines, most of which are off-patent; many countries have developed their own lists.

WHO has developed a global framework for “Access to Essential Medicines” which has been adopted by United Nations’ agencies and consists of four components:

(1) rational selection and use; (2) affordable prices; (3) sustainable financing; and (4) reliable health and supply systems [19]. Different stakeholders have differing roles to play in developing these compo-nents positively and seeking both to remove old obstacles and create new opportunities.

2.1. Rational selection and use

Medicines are one of the important elements in the provision of health care. While advanced methods of treatment for major infectious diseases and related conditions tend to become ever more complex and costly, many highly effective medicines are – or can be – made available at very low cost. Commonly, therefore, fully acceptable and affordable treatments can be found if one chooses well. Rational selection of medicines includes defining which medicines are most needed, identifying the most cost-effective treatments for particular conditions while taking full account of quality and safety as well, and then ensuring that they are used effectively.

Appropriate use of medicines by health professionals and mid-level health workers is being pursued by introducing evidence-based national treatment guidelines and protocols. Based on these treatment guide-lines a national list of essential medicines and key pharmaceuticals can be prepared and disseminated.

In-service training programmes and availability of unbiased drug information are needed to update the knowledge and skills of clinicians, pharmacists and nurses in effective drug use. Encouraging rational drug use by patients is of equal importance.

2.2. Affordable prices

Affordability of medicines by individual patients in low-income countries is an important factor influ-encing access to care and treatment. Seeking care is more commonly a question of buying medicines than of consulting a qualified health worker. Drug prices, which are sometimes actually higher than those in high-income countries, often have to be met entirely by sick persons or their households; it is estimated that some 50–90% or more of pharmaceutical expenses are out-of-pocket purchases [16]. The bulk of the out-of-pocket health expenses which have to be met by the individual or household commonly relate to medicines [15]. Various ways of reducing this burden on the family will be considered below, but an im-portant one is clearly to ensure that prices are brought to the lowest attainable level. That can be ensured variously by promoting competition among quality generic medicines where off-patent items are con-cerned, negotiation of prices, and therapeutic competition for on-patent medicines, use of the provisions stipulated under the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) where necessary to increase affordability of medicines still under patent [24], reduction of duties and taxes, and reduced wholesale and retail margins. It is equally important to provide transparent price information for healthcare providers and consumers so that the community knows how to find the most affordable products when they are needed.

2.3. Sustainable financing

This third component of access must be viewed in the context of overall funding of health care, in-cluding financing for prevention and treatment of priority infectious diseases with a high public health impact.

For decades, the public health sector in developing countries was mainly financed by the government, and the public health sector commonly provided medicines free of charge. Over the years, diminishing budgets have increasingly led to drug shortages in the national health system, particularly in rural areas, and to a widespread collapse of free drug supply. This is the principal reason why, as already pointed out, health care in low-income countries is today predominantly financed privately. This is illustrated in Fig. 1, contrasting the sources of health financing in eleven low-income countries with those in nine high-income countries [20].

By far the most common form of private finance is out-of-pocket payment, made at the time when people seek care and treatment, rather than through a prepayment scheme. Figure 2 shows that out-of-pocket payment in the high-income areas of the world seldom exceeds 20% of the total while it exceeds 90% in some low-income countries. Out-of-pocket payment for health care tends to be both inequitable and inefficient when it plays a major role in health financing; there is clear evidence that the burden of payment for health care falls heavily on the poorest households at the time when a family member is sick; at these times, income may actually be reduced by illness and it is likely that the medicines which will be needed will be bought in insufficient quantities or not at all.

In this respect, change is underway, though it still has far to go. Thirty-three of the 37 Sub-Saharan African countries in which public health services were previously free-of-charge and funded by domestic tax revenues have introduced health financing strategies based largely on private financing in the form of fee schemes or co-payment [2].

Fig. 1. Public and private shares in health financing differ in high- and low-income countries.

Fig. 2. Out-of-pocket payment as % total health expenditure is more important in low-income countries.

Health insurance schemes are another option, though it may be difficult to implement them in low-income countries. Whereas social insurance schemes are common in Europe and are on the increase in Latin America and Asia, one finds that in Sub-Saharan Africa, protection by social insurance coverage provides for less than 8% of the population [15,21].

Sustainable financing can also be achieved by a combination of several viable financing mechanisms, including, in addition to the above, reallocation of public funds, better use of out-of-pocket spending, and international financing through grants, donations, and loans under appropriate circumstances.

2.4. Reliable health and supply systems

Health systems should provide a certain minimal level of health care which has the capacity to treat major infectious diseases and related conditions effectively with essential medicines and when necessary with key pharmaceuticals. Improvements to existing drug supply systems are usually central to health sector development.

Tackling the overall cost of health care became high on the political agenda of governments from both developing and developed countries because of increasing health and pharmaceutical expenditures.

Governments had to look for new ways of financing and delivering health services in a cost-effective way. Mechanisms for cost-containment introduced by industrialized countries and relating to medicines have been, among others, national drug formularies, non-reimbursable drug lists, restricted reimburse-ment schemes, price regulation, promotion of generic prescribing and substitution, and surveillance of prescribing costs [14].

In 1993, the World Bank published its report “Investing in Health” and encouraged governments from developing countries to set priorities in health services and to allocate resources efficiently by promot-ing an approach based on “the burden of disease” and the cost-effectiveness of interventions so to de-sign an “essential national package” of health services. That would comprise a “minimum package” of public health (preventive care) and clinical (curative care) services, including the provision of essential medicines. Governments should ensure universal access to their national packages and allocate a certain amount of resources to satisfy the needs of the poor and other target groups [11].

Drug supply systemsmust serve to ensure continuous availability of essential medicines and medical supplies of assured quality. Supply should be well planned and dependable so that shortages and stock-outs are rare, and the total costs for a given level of service should be low. In order to meet increasing drug demands and the expectations which the public have of the public health services, and to improve on failing public drug supply systems, governments have looked for new – and cost-effective – ways of financing and managing drug supplies [11]. In many low-income countries, creative mechanisms and an efficient mix of public, private, and NGO sectors in national drug supply and distribution systems have evolved [15]. It is particularly important that effective national drug legislation and regulations, includ-ing drug quality assurance and control systems be in place for monitorinclud-ing both imported and locally produced medicines circulating in the local market. In addition regulatory control is needed to determine which health professionals are authorized to prescribe and dispense medicines (an essential part of en-suring the quality of medical care), to assure the quality of drug supplies, to combat counterfeit products, and to contain drug resistance in both public and private sectors [15].

Despite all the efforts which have been made in developing countries in advancing both general health policy and the performance of the pharmaceutical sector, it is an unhappy fact that the access problem is far from being solved. Two thirds of all deaths of children under 15 are due to seven diseases for which effective prevention and therapies exist, as shown in Fig. 3 [17]. Vulnerable groups of society are still dying because of lack of access to these essential treatments. It is an unhappy fact that the world’s poorest people too often are served by the most inefficiently performing health systems [20]. Their health status is below what is attainable, and health and supply systems are unresponsive and unfairly financed.