[e-drug] 25 years of essential medicines

[quickj@who.int]

E-DRUG: 25 years of essential medicines
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[This review article by WHO/EDM staff, published today in WHO Bulletin,
deserves integral publication in E-drug. Well done, WHO and EDM! WB]


Twenty-five years of essential medicines

WHO Bulletin, November, 2002, 80 (11), pp 913-4

Jonathan D. Quick[1], Hans V. Hogerzeil[2], Germ�n Vel�squez[3], Lembit
R�go[4]

The twentieth century opened with only one widely available modern
medicine: acetylsalicylic acid (aspirin). In the 1940s the first
antibiotic, the first mass produced antimalarial, and the first
antitubercular were introduced. The 1950s and 1960s saw the rapid
introduction of oral contraceptives, medicines for diabetes, and then
medicines for mental illness, many infectious diseases, cardiovascular
diseases, and cancer. By the 1970s effective medicines - though not always
ideal - existed for nearly every major illness. Yet for half the world's
population, it was as if they were still living in the nineteenth century.
For them, modern medicines were unavailable, unaffordable, of poor quality,
or ineffective because not properly used.

In 1975 the World Health Assembly introduced the concepts of "essential
drugs" and "national drug policy", and they quickly became part of the
global public health vocabulary. The Health Assembly was building on
precedents set in Scandinavia, North America and some pioneering developing
countries, in the hope that they would provide a way to begin closing the
huge gap between those who were benefiting from the pharmaceutical harvest
of the mid-1900s and those who were not.

In October 1977, WHO produced the first Model List of Essential Drugs and
in 1978 the Declaration of Alma-Ata identified "provision of essential
drugs" as one of the eight elements of primary health care. According to
the current WHO Expert Committee on the Selection and Use of Essential
Medicines, "Essential medicines are those that satisfy the priority health
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." Thanks partly to the recognition and
application of these principles, the situation has changed enormously since
1977. The following examples give some idea of the contrast.

In 1977, perhaps a dozen countries had what would now be considered an
essential medicines list or an essential drugs programme. Today, four out
of five countries - at least 156 countries in total - have adopted national
essential medicines lists. National lists are widely used for public
procurement systems, reimbursement schemes, training, public education, and
other national health activities. Most countries have recently updated
their list, and WHO has updated its own model list of essential medicines
on average every two years for the 25 years.

In 1977, the concept of a national drug policy was unknown to almost
everyone. Today, over 100 countries have national drug policies in place or
under development. These policies are being introduced at increasing speed
in every region. More importantly, a growing number of countries are moving
directly from policy to action. The national drug policy is increasingly
serving as a framework within which interested parties can work for
pharmaceutical sector reform within countries.

In 1977, objective information on rational use of drugs was extremely
limited, especially in developing countries. Today, at least 135 countries
have their own therapeutic manuals and formularies, which provide health
professionals with current, accurate and unbiased advice on the rational
use of drugs.  And this year the WHO Model Formulary was launched.

In 1977, medical training was often based on brand names, and little
attention was given to systematic teaching about rational drug use. Today,
generic names are the norm in medical training, and the WHO Guide to Good
Prescribing is being adopted by leading medical universities in rich and
poor countries alike. Over 60% of the countries in the world report having
some provision for generic substitution in private pharmacies.

In 1977, the WHO Programme for International Drug Monitoring was just being
formally established. Today, a network of 68 countries provides global
monitoring for adverse drug reactions and regularly picks up signals of
medicines posing potential safety problems.

In 1977 there was virtually no publicly available price information, few
countries actively encouraged generic substitution, and many countries
forbade generic substitution. During the first half of the 1980s, world
market prices for drugs on the WHO model list fell by 40% through increased
demand and competition. At least 12 countries now provide pharmaceutical
price information on public web sites.

Perhaps most importantly: in 1977, less than half the world's population
had regular access to essential medicines, while today nearly two-thirds
do, through a combination of public and private health systems. In absolute
terms, the number of people estimated to have access to essential medicines
grew from roughly 2.1 billion in 1977 to 3.8 billion in the late 1990s.

These improvements and others related to them have been achieved over the
last 25 years through the efforts of individual governments,
nongovernmental organizations, universities, professional associations, the
private sector, international organizations such as WHO and UNICEF, and
other stakeholders.

In spite of so much achievement, however, it is estimated that a third of
the world's population - roughly two billion people - lack regular access
to essential medicines. In the poorer parts of Africa and South-East Asia
50% of the population lack such access. The 2001 Report of the Commission
on Macroeconomics and Health estimates that by 2015 over 10 million deaths
per year could be averted by scaling up interventions for communicable
diseases, noncommunicable diseases, and maternal and perinatal conditions.
The majority of these interventions depend on essential medicines.

In short, millions of children and adults are still needlessly suffering
and dying because for them essential medicines are unavailable,
unaffordable, unsafe, or wrongly used. Closing the gap between potential
and reality entails action in five areas: drug financing, drug
affordability, rational selection and use of medicines, effective drug
regulation, and efficient supply systems.

While in many developed countries over 70% of pharmaceuticals are publicly
funded through reimbursement plans and other mechanisms, in developing and
transitional economies 50-90% of drugs are paid for by the patients
themselves. Medicines are the major out-of-pocket health expense for poor
households in most developing countries. Fairer drug financing can only
come through a combination of efforts, including appropriate government
funding (often this means increased), expansion of health insurance
coverage and pharmaceutical benefits, extension of employer roles in health
and drug financing, support from NGOs and community financing sources, and
better use of out-of-pocket spending.
For governments, health insurers and households alike, the price of
pharmaceuticals represents a substantial barrier to access. Pharmaceutical
prices vary widely among countries and within countries, and differences in
wholesale prices commonly vary from fivefold to tenfold. Price information
for products of assured quality is indispensable for achieving optimum
value for money. Generic and therapeutic competition are two of the most
powerful tools for bringing down drug prices. For newer medicines, the
World Trade Organization (WTO) agreement on Trade-Related Aspects of
Intellectual Property Rights ("TRIPS") has established for WTO members a
global minimum for patent protection. Many experts predict that, unless
countries appropriately apply TRIPS safeguards and unless further progress
is made to deal with some of the outstanding issues concerning the TRIPS
agreement, the price of new drugs will be unaffordable for many millions of
people.

Unsafe and wasteful drug use persists: 25-75% of antibiotic prescriptions
in teaching hospitals are inappropriate, half of the world's 15 billion
injections per year are unsafe, and 50% of patients worldwide fail to take
medicines correctly. Over the last decade, evidence has accumulated
demonstrating that rational use can be measurably improved by focused
interventions such as treatment guidelines linked to essential medicines
lists, training and supply; by active formulary management through hospital
drugs and therapeutics committees; by feedback to providers based on their
own prescribing and dispensing practices; and by training of licensed
drug-sellers. Interventions shown to be efficient need to be implemented
and additional research is needed to develop even more effective methods.

Estimates of the share of substandard and counterfeit drugs on national
markets vary from under 5% for many high-income countries to over 15%. In a
recent WHO report  60% of the substandard and counterfeit drugs listed had
no active ingredient and half were antibiotics and other anti-infective
agents. It is estimated that fewer than one in three developing countries
have fully functioning drug regulatory authorities. In addition, failure to
comply with good manufacturing practices often results in toxic, sometimes
lethal, products. Effective drug regulation requires political commitment
at the highest level, a sound legislative and judicial base, drug
regulatory authorities that are adequately staffed and financed, up-to-date
information support, manufacturers that are responsible and responsive, a
well-organized pharmacy profession and an enlightened public, including the
media.

Finally, many countries still have to contend with an inefficient
combination of private supply systems serving mostly urban areas, and
unreliable public supply systems attempting to serve the entire country.
Inadequate staffing, corruption, lack of incentives, and inability to learn
from past experience all contribute to unreliable supply systems. Yet
examples of efficient drug supply systems combining public and private,
centralized and decentralized approaches exist in some countries in Africa,
Asia, Latin America and elsewhere. Reliable essential drug services are run
by nongovernmental organizations in several countries in Africa. The
potential to improve access through the private sector has been documented
in several recent studies. And successful subregional bulk procurement
schemes operate in the Eastern Caribbean, Latin America, the Middle East,
among a number of Pacific Islands, and elsewhere. Critical to success in
these examples has been a focus on results and a willingness to learn from
the experiences of other countries and other regions.

Essential medicines are perhaps the most cost-effective element of public
health after immunizations and key health promotion habits such as regular
exercise. Safe, effective, quality medicines that are appropriately used
already save millions of lives each year and prevent untold suffering. Much
has been achieved in the 25 years since the first WHO model list of
essential medicines was drawn up. But there is a large unfinished agenda.
Fairer financing, affordable prices, rational selection and use, effective
drug regulation, and efficient supply systems are all central to closing
the gap between those who today benefit from essential medicines and those
who do not.

[1]  Director, Essential Drugs and Medicines Policy, World Health
Organization, Geneva CH-1211, Switzerland (quickj@who.int). Correspondence
should be addressed to this author.
[2]  Coordinator, Policy, Access, and Rational Use, Essential Drugs and
Medicines Policies, World Health Organization, Geneva, Switzerland
(hogerzeilh@who.int)
[3]  Coordinator, Drug Action Programme, Essential Drugs and Medicines
Policies, World Health Organization, Geneva, Switzerland
(velasquezg@who.int)
[4]  Coordinator, Quality and Safety of Medicines, Essential Drugs and
Medicines Policies, World Health Organization, Geneva, Switzerland
(ragol@who.int)


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