Essential medicines are the medicines that address the priority health care requirements of a given population. These medicines are selected through an evidence-based process with due regard to public health relevance, quality, safety, efficacy and comparative cost-effectiveness.
A fundamental criterion for essential medicines is that they must be available within the context of functioning health systems, and always in suitable amounts and dosage forms. The selection of essential medicines is a cornerstone of national medicine policies and supports the smooth functioning of the entire pharmaceutical system.
2007 marks the 30th anniversary of the World Health Organization's (WHO) Model Essential Medicines List (EML). The EML was created in 1977 with the aim of providing a model for governments to select medicines to address local public health needs and create national lists. Ever since its conception, the model list has proved to be a powerful tool for the promotion of primary health care by rationalizing the selection and use of medicines as well as their cost.
In its first, 1977 version, the EML identified 208 medicines to address the global burden of disease at the time. The list is revised by a committee of independent experts every two years to reflect new health challenges, pharmaceutical developments and changing resistance patterns.
The latest version, updated in March 2007, contains 340 medicines that address most global priority conditions, including malaria, HIV/AIDS, tuberculosis, reproductive health and, increasingly, chronic diseases such as cancer and diabetes. Antiretroviral medicines (ARVs), used in the prevention and treatment of HIV/AIDS, were first incorporated in 2002.
Currently, 156 of the 193 WHO Member States have official essential medicines lists, of which 127 have been updated in the past five to 10 years. Some countries have provincial or state lists as well.
The availability of medicines in developing countries is undermined by several factors. These include poor supply and distribution systems, insufficient health facilities and staff, low investment in health and the high cost of medicines. The EML is a tool that can help manage the purchasing and distribution of medicines and the selection of quality assured and cost-effective products.
In 1977, a few months before WHO published the first EML, Mozambique had already created its national pharmacopeia; a list consisting of 430 essential medicines. The country has managed to increase local access to medicines from 10% of the population in 1975 to 80% in 2007.
A WHO survey carried out in 2006, reports that patients interviewed at the dispensing area of public facilities were paying a median of 2 800 Metical for their medicines plus fees — equivalent to a half hour’s wage for the lowest paid unskilled government worker.
According to the same survey, among 465 medicine samples tested for regulatory purposes only 34 (7.4%) failed identity or assay.
In 1960, Peru created a list of basic medicines in an attempt to address at least the most pressing pharmaceutical needs of the population.
In 1971, the country promoted the Basic Medicines Program, stimulating the creation and use of the first national list of essential medicines. The country's initiative, 36 years ago, provided an example for WHO and contributed to establishing the organization's first model list of essential medicines.
Sri Lanka (then Ceylon) created a medicines list for purchase by the state health care system in 1959. In addition, the Ceylon Hospitals Formulary was published providing information for the use of these medicines. They also set up an international procurement system which decreased costs and at the same time increased the availability of these medicines.
In spite of industry opposition, Sri Lanka introduced a state controlled monopoly in 1972, to procure medicines for the entire country through the creation of the State Pharmaceutical Corporation (SPC) thus extending the initiative to the private sector. Up to date, there has been sufficient availability of free essential medicines to the population through public sector facilities.
Until 1977, SPC was responsible for importing and distributing medicines to both the public and private sectors. After 1977, due to pressure from the private sector, the Sri Lankan government granted permission to companies to import multiple brands of medicines. However, the government remains in charge of choosing the types of medicines to be imported to ensure that priority health care issues are covered.
In 1987, Sri Lanka created the State Pharmaceutical Manufacturing Corporation (SPMC) with the aim of importing raw materials and manufacturing generic essential medicines. Ever since, government resistance to privatization and monopoly on procurement has kept quality as well as prices under control even in the private sector.
A critical factor of Sri Lanka's success is universal education, which has resulted in greater awareness of the importance of health and a strong demand for health services in general. Health professionals’ education and training are tailored to the national medicine supply policy and system, including the essential medicines concept.
The manufacture of medicines on an industrial scale is about 100 years old. The appearance of antibiotics in the late 1930s led to a revolution in health care and made it possible to treat diseases which until then had been considered fatal. The WHO Model List of Essential Medicines came three decades later, as an outcome of the first meeting of the Expert Committee on the selection of essential medicines - which also published a technical report, in October 1977. The document presented a compilation of essential medicines that could be adapted to countries and served as a guideline for establishing national lists.
However, the first substantial developments in the concept of essential medicines advocated by WHO happened two years before, in Geneva, during the World Health Assembly in 1975. At the time, a report by the WHO Director-General reviewed the main problems faced by countries in the area of medicines and set out possible new policies regarding the adoption of 'basic essential medicines' as a guideline to improve access to priority treatment.
In 1978, the World Health Assembly passed Resolution WHA 31.32, urging Member States to establish national lists of essential medicines and adequate procurement systems. In that same year, the Declaration of Alma-Ata was adopted at the International Conference on Primary Health Care, Alma-Ata, Kazakhstan.
The Declaration expressed the need for urgent action by all governments, all health and development workers, and the world community to protect and promote the health of all the people of the world. It was the first international declaration underlining the importance of primary health care and to include the provision of essential medicines and vaccines as a major component of primary health care.
By the time the EML came into being a small number of countries already used a similar approach in their medicines provision programmes. For instance, hospitals in the United States, Sweden, the Netherlands and Switzerland were already operating with selections of 300 to 500 medicines. Mozambique, Peru and Tanzania were among the first developing countries to create national lists.
Many international organizations, including UNICEF and UNHCR, as well as nongovernmental organizations and international non-profit supply agencies, have adopted the essential medicines concept. Essential Medicines Lists guide the international procurement and supply of medicines, schemes that reimburse medicines’ costs, donations, and local production.
The International Federation of the Red Cross and Red Crescent Societies and Médecins Sans Frontières (MSF) - as well as professional bodies such as the British Medical Association and the International Pharmaceutical Federation (FIP) - have also adopted the essential medicines approach and base their medicine supply system mainly on the EML. The List has been extensively used to develop international lists for special indications, such as The Interagency New Emergency Health Kit (1998); the UN List of Emergency Relief Items; Essential medicines for reproductive health (2006).
WHO collaborates successfully in promoting essential medicines strategies with the following international organizations: United Nations Development Programme; Federation Red Cross; Médecins sans Frontières; UNICEF; United Nations High Commission for Refugees; United Nations Fund for Population Activities; IDA; EPN; OXFAM.