FAQ 6: What are Essential Medicine? Why a country must have an Essential Medicines List (EML)?

Essential medicines were originally defined by the World Health Organization (WHO) as those which: satisfy the needs of the majority of the population and therefohould be available at all times, in adequate amounts, in appropriate dorice the individual and community can afford.

Development of the concept

The idea of defining essential medicines – and establishing a list of them – was developed from a report made to the 1975 World Health Assembly. These efforts were aimed to increase the range and availability of medicines for populations with poor access.

The Expert Committee on the Use of Essential Medicines was established to assist member states to select and procurst report of the Expert Committee included (a) criteria for determining if a medicine fit the definition of an essential medicines and (b) the first model essential medicines list (EML) as two examples of how the concept of essential medicines could be implemented.

Since then WHO has updated the model EML every two years. In 2007, thirty years after introduction of the essential medicines concept, a model EML for children was also introduced.

Adapting the concept at national level

There should be clear links between the national EML, standard treatment guidelines, national expenditure on essential medicines, and procurement practices within the country.

The model EML is expected to be adapted at national level based on the local public health context of the country. Most countries have published a national EML. Most lists have been updated in the past five years; this exercise is crucial to reflect new therapeutic options and changing therapeutic needs.

Selection of medicines for the national EML

Within a country, the selection of essential medicines is usually a two-step process. The first involves regulatory approval, which is based on a review of efficacy, safety, and quality of medicines (without comparison between medicines). From these registered products, essential medicines within a therapeutic class are then selected on the basis of comparative efficacy, safety, and cost. To best ensure the widest acceptance of the list, the selection process for essential medicines needs the involvement of a number of stakeholders, including prescribers, dispensers, academics, health facilities, civil society, professional organizations, and others.

Before 2002, relatively expensive medicines were basically not found on the WHO model EML. This was successfully challenged by public health advocates and treatment activists. With the issue abolished, traditionally more expensive medicines (such as antiretrovirals) were quickly included on the WHO model EML and the official definition of essential medicines was updated to:

Essential medicines are those that satisfy the priority health care needs of the population. They are selected with due regard to disease prevalence, 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 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.

It is also important to stress that essential medicines are not second rate medicines for poor people, but that they represent the most cost effective treatments for a given condition

Weaknesses in the concept

The essential medicines concept and the model WHO EML have often been credited for establishing priorities for developing countries on selection of, and expenditure on, medicines to meet the needs of their populations. However, there is a concern that the process has eliminated some key medicines which, although they might not be needed for the majority of the population, may be crucial for the treatment of certain diseases (such as cancer) and specific age groups (such as the elderly).

Although considerable progress has been made in the 30 years since the WHO introduced the essential medicines concept, the benefits have been inequitable. Only two-thirds of the world’s population has access to the medicines they need, leaving one-third — about 2 billion people — without access. And in the poorest parts of Africa and Asia, more than half of the population lacks access.

A renewed commitment to the essential medicines concept is urgently needed in order to realize the spirit and intention of the deliberations of 1977.

Access, quality and rational use of medicines and essential medicines

The economic impact of pharmaceuticals is substantial – especially in developing countries. While spending on pharmaceuticals represents less than one-fifth of total public and private health spending in most developed countries, it represents 15 to 30% of health spending in transitional economies and 25 to 66% in developing countries. In most low income countries pharmaceuticals are the largest public expenditure on health after personnel costs and the largest household health expenditure. And the expense of serious family illness, including drugs, is a major cause of household impoverishment. Despite the potential health impact of essential drugs and despite substantial spending on drugs, lack of access to essential drugs, irrational use of drugs, and poor drug quality remain serious global public health problems:

Lists of essential medicines also guide the procurement and supply of medicines in the public sector, schemes that reimburse medicine costs, medicine donations, and local medicine production. Many international organizations, including UNICEF, UNHCR and UNFPA as well as nongovernmental organizations and international non-profit supply agencies, have adopted the essential medicines concept and base their medicine supply system mainly on the Model List.

References
1.World Health Organization. The selection and use of essential medicines. Report of the WHO Expert Committee, 2002 (including the 12th Model List of Essential Medicines). Technical Report Series No 914. Geneva: WHO,
2.Hans V Hogerzeil The concept of essential medicines: lessons for rich countries
3.Laing R, Waning B, Gray A, Ford N, ‘t Hoen E. 25 years of the WHO essential medicines lists: progress and challenges. Lancet 2003 May 17;361(9370):1723-9
4.Stolk P,Willemen MJC, Leufkens HGM. “Rare essentials” : drugs for rare diseases as. Essential Medicines. Lancet 2003;361:1723-9
5.J Robertson1 and SR Hill2 The Essential Medicines List for a Global Patient population
6.Backgrounder and Facts for launch of the United Nations report Delivering on the Global Partnerships for Achieving the Millennium Development Goals: WHO

7.World medicines situation. 4.
5.J Robertson1 and SR Hill2 The Essential Medicines List for a Global Patient population
6.Backgrounder and Facts for launch of the United Nations report Delivering on the Global Partnerships for Achieving the Millennium Development Goals: WHO
7.World medicines situation

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