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Types of patient charges for medicines and their impact CHAPTER 6
requiring additional healthcare services and treatment, leading to increased resource use.
Certain groups of patients are particularly susceptible or vulnerable to the negative impact of cost sharing, namely the elderly, people who take regular
medication for chronic conditions and people on
low incomes. These are, in effect, people who may
experience problems affording prescribed medication, either due to regular and thus relatively large
expenses for (sometimes multiple) chronic conditions
or simply because they only have a limited income and
thus limited resources available for payment. Many
countries therefore have protective mechanisms in
place which provide exemption or reduced payments.
Caps and complementary insurance may also be available. The criteria that are used for such protection are
usually based on clinical condition and/or need, income and age, thus aiming to protect those identified
as most vulnerable.
Patients use many strategies to keep medication
cost to a minimum. Some are appropriate but others
jeopardize treatment with essential medicines where
adherence is crucial to achieve the desired health
benefit. Patients commonly do not communicate
issues of cost and affordability, or the strategies they
use to cope with cost sharing, to their doctors. They
are, however, more likely to raise these issues in community pharmacies as the places where money is
exchanged when getting prescribed medication dispensed. This provides pharmacists and their staff with
the important opportunity to explore cost issues and
inform patients about the importance of adherence to
essential medicines. They can also advise patients
about options for managing cost sharing, such as
exemptions and complementary insurance or PPCs.
Pharmacists can also liaise with physicians and other
healthcare professionals to inform and thus facilitate a
jointly agreed treatment plan that takes account of
cost sharing and affordability as much as possible.
KEY POINTS
*
There are different types of cost sharing systems:
flat fee prescription charges; proportional
co-payments (co-insurance); and deductibles
*
These systems are in place to deter unnecessary
demand and thus avoid waste
*
Many cost sharing programmes have protection
mechanisms in place for vulnerable groups
(elderly, chronically ill, low incomes)
*
Medication cost sharing reduces drug
consumption
*
The reduction in drug use in response to cost
sharing is more pronounced for less essential
medicines than essential ones
*
Patients use a variety of strategies to cope with
medication costs, and these depend on the types
of cost sharing within their country
*
Healthcare professionals, including physicians and
pharmacists, can advise on the importance of
adherence and help with medication cost
69
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Chapter Seven
WHO and the essential medicines
concept
Marthe M. Everard
7
STUDY POINTS
*
Core functions of WHO
*
Model List of Essential Medicines based on the
essential medicines concept
*
Description of essential medicines
*
Need for essential medicines for children
Introduction
The 20th century witnessed revolutionary progress in
improving human health, leading to dramatic declines
in mortality and equally dramatic increases in life
expectancy. Income growth, higher educational
levels, improved sanitation and better food all contributed to this progress. The development of pharmaceuticals, particularly essential medicines, also
played an important role (WHO 1999).
The work of the world’s leading international public health agency, the World Health Organization
(WHO), covers numerous health-related technical
areas, supporting its overall objective of ‘the attainment by all peoples of the highest level of health’.
Much has been achieved in the pharmaceutical sector
since the essential medicines concept was introduced
in 1975 and the first Model List of Essential Medicines was launched in 1977. Today, three out of four
countries in the world have national essential medicines lists as the basis for public procurement, reimbursement schemes, training, supervision and patient
information (WHO 2004a). More importantly, in
1977 less than half the world’s population had regular
access to essential medicines. Today, through a combination of public and private health systems, nearly
two-thirds of the world’s population is estimated to
have access to effective treatments essential for their
health needs (WHO 2004a). Essential medicines are
one of the most cost-effective elements in modern
health care.
The World Health Organization
Established in 1948, WHO is a specialized agency of
the United Nations system. It is the technical and
professional body concerned with international public
health issues. When WHO was endorsed on 7 April
1948 by the United Nations it had fewer than 60
member states; in 2007, it had 193 (WHO 2007a).
Its definition of health and its overall objective are
provided in Box 7.1 (WHO 2007b).
WHO can offer a range of opportunities for cooperating with its member states, with its headquarters
in Geneva, Switzerland, dealing with global issues,
and its six regional offices focusing on technical support and national capacity building. The organization’s
presence in 147 countries allows a close relationship
with ministries of health (WHO 2007a). WHO was in
official relations with almost 190 non-governmental
and voluntary organizations involved in health promotion and healthcare provision in 2006 (WHO 2007a).
It also collaborates closely with the other agencies of
the United Nations system in health-related activities
(WHO 2007a). Increasingly, WHO plays a leading
role in various public health-related initiatives, the
so-called public–private partnerships, which should
be seen as public sector programmes with private or
commercial sector participation (WHO 2008).
WHO continues to promote the efforts of international health cooperation that was initiated by the first
SECTION ONE Pharmacy practice and society
Box 7.1
The WHO definition of health
WHO’s constitution describes health as: ‘a state of
complete physical, mental and social well-being and
not merely the absence of disease or infirmity’. Its
overall objective is: ‘the attainment by all peoples of
the highest possible level of health’.
International Sanitary Conference in Paris in 1851,
when nations joined forces to combat common health
threats such as plague, yellow fever, cholera, leprosy,
tuberculosis, smallpox and typhus. Some of these
diseases still exist today, though smallpox has been
eradicated and other diseases are in the process of
being eliminated, for example polio, measles and
leprosy (WHO 2007c).
In 1897, aspirin was introduced as the first synthetic pharmaceutical product. The 20th century saw
the discovery and further development of pharmaceutical products, such as the introduction of penicillin (1928), the measles vaccine (1943), streptomycin,
the first antitubercular drug (1945) and chloroquine,
the first antimalarial drug (1946). In the 1950s the
first clinical uses of oral contraceptives and of medicines for diabetes and mental illness were introduced,
and later medicines for other infectious and cardiovascular diseases (WHO 2007c).
Also in the 20th century, there were significant
gains in life expectancy of 20–40 years worldwide.
This was mainly due to declining infant and child
mortality rates, maternal mortality rates and fertility
rates, a drastic reduction in the disease burden of
infectious diseases caused by effective preventive
actions and improved treatment. In addition, general
sanitation measures and immunization programmes
were implemented. These achievements were the
results of dedicated international health efforts
(WHO 1999, 2007c).
Despite these successes, the current situation
indicates that not all people have benefited equally
from improvements in health status and access to
healthcare services. It is estimated that more than
1 billion people are still excluded from adequate
health care (WHO 1999). Low income countries
face ill health, mainly through communicable diseases, due to poverty-related conditions such as
inadequate food, water and sanitation, housing,
education and health servi ces . The emerge nce of
the HIV epidemic, the resurgence of tuberculosis
and malaria, and tobacco-related diseases are also
factors. In high income countries ill health, mainly
through non-communicable diseases, results mainly
from excessive eating, drinking and smoking, using
and abusing narcotic medicines, and fro m environmental pollution and urbanization (WHO 1999).
Based on the experience of containing severe acute
respiratory syndrome (SARS) and the threat of an
avian flu outbreak worldwide, WHO is reinforcing
its lead role in limiting the international spread of
epidemics and other public health emergencies. The
organization has to consider this diversity of health
challenges in order to develop strategies and programmes to meet the health needs of its member
states (WHO 2007c).
WHO fulfils its objectives through its core functions
which underpin the global health agenda set out in a
framework for an organization-wide programme of
work, and is linked to the achievement of the millennium development goals. WHO’s six core functions
can be divided into normative work and technical cooperation and are listed below (WHO 2007d):
*
Providing leadership on matters critical to health
and engaging in partnerships where joint action is
needed
*
Shaping the research agenda and stimulating the
generation, translation and dissemination of
valuable knowledge
*
Setting norms and standards and promoting and
monitoring their implementation
*
Articulating ethical and evidence-based policy
options
*
Providing technical support, catalysing change and
building sustainable institutional capacity
*
Monitoring the health situation and assessing
health trends.
The global health agenda is a guide for all stakeholders, not for WHO alone, and it outlines seven
priority areas. The first three areas are closely related
to health: investing in health to reduce poverty;
building individual and global health security; and
promoting universal coverage, gender equality and
health-related human rights. The other four areas
focus on specific tasks such as: tackling the determinants of health; strengthening health systems and
equitable access; harnessing knowledge, science and
technology; and strengthening governance, leadership
and accountability (WHO 2007d).
Many countries rely on WHO norms and standards, including quality assurance, especially for
biological, pharmaceutical and diagnostic products.
WHO will continue to encourage efforts, including
72
WHO and the essential medicines concept CHAPTER 7
those of industry, to develop new and affordable
biological, pharmaceutical and diagnostic products.
WHO has expanded its global normative work after
the adoption by its member states of the WHO
Framework Convention for Tobacco Control and
the revised International Health Regulations in
2005 and through the establishment of its commissions on macroeconomics and health (2002), intellectual pro perty rights, innovation and public health
(2003), and the social determinants of health
(2005) (WHO 2007d).
WHO’s work in essential medicines
The departments of Medicines Policy and Standards
(PSM) and Technical Cooperation for Essential Drugs
and Traditional Medicine (TCM) are central to
WHO’s goal in medicines to help save lives and
improve health by ensuring the quality,efficacy, safety
and rational use of medicines, including traditional
medicines, and by promoting equitable and sustainable access to essential medicines, particularly for
the poor and disadvantaged (WHO 2004a). Essential
medicines are one of the most cost-effective elements
in modern health care and their potential health and
economic impact is considerable in terms of saving
lives, reducing suffering, and protecting, maintaining
and restoring health.
Besides norm and standard setting for essential
medicines, WHO provides guidance on regulatory
standards, defines international non-proprietary
names, provides therapeutic advice, such as standard
treatment guidelines, and produces a Model List of
Essential Medicines and a Model Formulary. Technical
assistance to member states is also provided on the
development and implementation of their national
medicines policies. A national medicines policy is a
commitment to a goal and a guide for action, providing a framework in which the national goals, objectives
and priorities are formulated for both the public and
private pharmaceutical sectors. It identifies strategies
needed to achieve these objectives (WHO 2004a).
The essential medicines concept
During the 1970s a growing number of low-income
countries had more than 20 000 different brands of
pharmaceutical products circulating in their markets.
This situation was similar to that in high-income countries, despite the differences in their prevailing common diseases and their socio-economic positions.
Also, pharmaceutical products were promoted and
marketed with little concern for the different health
needs and priorities of individual countries (WHO
2006a).
In the mid 1970s some governments of lowincome countries (Costa Rica, Cuba and Sri Lanka)
started to realize that if medicines were to meet the
real health needs of the majority of their populations
and be equally available to all, then criteria had to be
set, especially for selection of medicines. The concept
of essential medicines was born. This concept proved
to have a positive impact on drug procurement, distribution, use and prices as well (WHO 2006a).
The concept of essential medicines is forward looking (Quick 1997). It incorporates the need to:
*
Regularly update medicines selections to reflect
new therapeutic options and changing therapeutic
needs
*
Ensure drug quality
*
Continue to develop better medicines, medicines
for emerging diseases and medicines to meet
changing resistance patterns.
The concept of essential medicines encourages health
systems to focus on access to those medicines that
represent the best balance of quality, safety, efficacy
and cost to meet the priority health needs within a
given healthcare setting. 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 (Quick 1997).
The Model List of Essential Medicines
In 1977, inspired by the essential medicines concept,
a WHO expert committee discussed the question of
how many medicines were really needed to treat common health problems. It concluded that approximately 208 individual medicines and vaccines could be
considered essential and together could provide safe,
effective treatment for the majority of communicable
and non-communicable diseases. Moreover, the majority of drug products were off patent and could be
produced at relatively low cost (WHO 2006b). In the
same year, the first Model List of Essential Drugs was
published by WHO and has since been updated every
73
SECTION ONE Pharmacy practice and society
2 years. It was met with a mixture of surprise, opposition and enthusiasm by the medical and pharmaceutical establishment and created a revolution in
international public health (Quick 1997).
Essential medicines are defined as those medicines
that satisfy the priority healthcare needs of the population. Essential medicines 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 WHO Model List is a guide for the development of national and institutional essential medicine
lists. It was not designed as a global attempt to establish a uniform medicines list, as this is neither feasible
nor realistic. However, for the past 30 years the Model List has led to a global acceptance of the concept of
essential medicines as a powerful means to promote
health equity. By the end of 2003, 156 member states
had official essential medicines lists, of which 99 had
been updated in the previous 5 years. Most countries
have national lists and some have provincial or state
lists as well. National lists of essential medicines usually relate closely to national guidelines for clinical
healthcare practice. Therefore, they can be used as
decision-making tools for drug procurement in the
public sector, for schemes that reimburse medicine
costs, for medicine donations and local medicine production. Moreover, they can be used as educational
tools for the training and supervision of health workers and used as informational tools for consumers
(Quick 1997; Fig. 7.1). National lists should reflect
the national priorities in medication needs. This does
not imply that no other medicines are useful, but
Figure 7.1*Relationship between treatment guidelines and a
list of essential medicines (WHO 2002).
simply that in a given context those medicines selected are the ones most needed for the national health
services. They should, therefore, be available at all
times in adequate amounts and in the proper dosage
forms (Quick 1997). Access to essential medicines of
assured quality is fundamental for the optimal performance of a healthcare system. Uninterrupted supplies
of essential medicines to a great extent determine the
credibility of health services (Quick 1997).
Many international organizations, including
UNICEF, UNHCR and UNFPA as well as nongovernmental organizations and international nonprofit medicine supply agencies, have adopted the
essential medicines concept and base their medicine
supply lists largely on the WHO Model List (Quick
1997).
In 1999, the WHO Expert Committee on the
Use of Essential Medicines reviewed the procedures
for updating the Model List. They recommended to
WHO that the process of developing the list should
be seen as an example of a model drug evaluation
procedure for national drug and therapeutics committees (Quick 1997). It should be a systematic and
transparent process. In addition, the methods for
updating the Model List should be revised because
selection of medicines should be evidence based
rather than consensus based, should have a clearer link
between essential medicines and guidelines for clinical
health care, and should consider the high cost of many
new and effective medicines. At the beginning of
2002, the Model List was revised by the expert committee, applying the new procedure (Quick 1997).
Updated selection criteria
The updated criteria for the selection of essential
medicines are based on several factors, including public health relevance and the availability of data on the
efficacy, safety and comparative cost-effectiveness of
available treatments. Most essential medicines should
be formulated as single compounds. Fixed-dose combination products are selected only when the combination has a proven advantage in therapeutic effect,
safety or compliance over single compounds administered separately. When making cost comparisons between medicines, the cost of the total treatment, not
only the unit cost of the medicine, is considered.
Factors such as stability in various climatic conditions,
the need for special diagnostic or treatment facilities
and pharmacokinetic properties are also considered if
appropriate.
74
WHO and the essential medicines concept CHAPTER 7
When adequate scientific evidence is not available
on current treatment of a priority disease, the expert
committee may either defer the issue until more evidence becomes available, or choose to make recommendations based on expert opinion and experience.
Cost and cost-effectiveness comparisons may be
made among alternative treatments within the same
therapeutic group (Quick 1997; see also Ch. 19).
In adapting the Model List to their own needs,
countries often consider factors such as local demography and the pattern of prevalent diseases; treatment facilities; training and experience of available
personnel; local availability of individual pharmaceutical products; financial resources; and environmental factors.
In March 2007, the 15th Model List of Essential
Medicines was prepared by the WHO expert committee. This Model List contains 346 individual medicines for the treatment of infectious and chronic
diseases which affect populations worldwide (WHO
2007e). Over the last 30 years, 199 (2005) new med-
icines were added to and 99 (2005) medicines deleted from the Model List.
The Model List has a ‘core’ list indicating the minimum drug needs for a basic healthcare system and
a ‘complementary’ list including mainly essential
medicines for priority diseases which may be costeffective but not necessarily affordable (Quick
1997). The Model List reflects a model product, de-
veloped through a model process, and both models
can be used for advocacy purposes (Quick 1997).
The WHO Model Formulary
In 1995, the WHO expert committee recommended
that WHO should develop a Model Formulary which
would complement the WHO Model List. It would
provide independent information on essential medicines for pharmaceutical policy makers and prescribers worldwide. A Model Formulary would be a
useful resource for countries wishing to develop their
own national formulary.
The first edition of the Model Formulary was
launched in 2002 based on the 12th Model List.
The electronic version of the Model Formulary is
intended as a starting point for developing national
or institutional formularies by adapting the text of
the Model Formulary for their own national list of
essential medicines. A third edition of the Model Formulary will be based on the 15th Model List (2007)
and will be available in 2008 (WHO 2004b).
The need for essential medicines for children
Over thirty years ago, in 1977, the first Model List of
Essential Drugs was launched. This list defined medicines that satisfy the priority healthcare needs of the
population, but until now the Model List has not
included many medicines specifically for children.
Every year there are over 40 million deaths in developing countries and over 10 million among children
under 5 years of age (WHO 2005). The six main
causes of death are pneumonia, diarrhoea, malaria,
preterm birth, asphyxia and pneumonia/sepsis in
newborn babies and these account for 73% of all
deaths in the under fives. In addition, AIDS claims
over 300 000 deaths in children under 15 years annually. Under-nutrition is a contributing cause of death
in over 60% of diarrhoea cases, 57% of malaria cases
and 52% of pneumonia cases (WHO 2005).
For all these conditions, essential medicines are
available and are life saving. However, access to safe,
effective and affordable essential medicines for children (‘paediatric formulations’) remains a problem.
In particular, the HIV pandemic has highlighted the
urgent need for adequate formulations for children as
well as for acute infectious diseases, where medicines
are either not available on the market or not financially or geographically accessible (WHO 2007f).
Studies of current practice worldwide revealed
that healthcare workers estimate the dose of medicines by assuming that children are small adults,
which is physiologically incorrect. They often dispense medicines to small children by using fractions
of adult dosage forms such as half or quarter tablets,
or by crushing tablets or opening capsules – both
meant for adults. These strategies are not recommended and can result in either under- or overdosing,
with potential efficacy and safety problems. Even if
formulations for children are available, many healthcare workers may not know how to prescribe these
medicines appropriately (WHO 2007f).
In May 2007, the World Health Assembly
endorsed the WHO resolution on ‘Better Medicines
for Children’, including the development of a Model
List of Essential Medicines for Children (WHO
2007f). Therefore, WHO updated their Model List
of Essential Medicines to include essential medicines
for children, based on their clinical needs and the
burden of disease. This resulted in the publication
of the first Essential Medicines List for Children in
July 2007. Based on this list, WHO will identify the
75
SECTION ONE Pharmacy practice and society
appropriate dosage forms and strengths of medicines
for children, develop and promote quality standards
and support mechanisms for licensing of children’s
essential medicines by drug regulatory authorities.
WHO will, in partnership with UNICEF, encourage
manufacturers to develop appropriate medicines at
affordable prices.
In view of the need to achieve the millennium
development goals on the reduction of malnutrition
and child and maternal mortality, and the focus of the
director-general of WHO on improving health in
Africa (WHO 2007a), developing a Model List of
Essential Medicines for Children will become a powerful tool for reducing infant and child mortality.
Given that in 2007 i t was 30 years since the first
essential medicines list was published, this was also
an opportunity for WHO to promote the essential
medicines concept and WHO is looking to the future by creating a Model List of Essential Medicines
for Children.
Conclusion
Over the years, the essential medicin es concept
has become a global concept and is a powerful
tool to promote health equity. Although originally
intended for low-income countries, an increasing
number of high-income countries also use its key
components. Heal th systems, from basic health systems in the poorest countries to highly developed
national health insurance schemes in the industrialized countries, have recognized both i ts therapeuticanditseconomicbenefits.Thisrecognitionhas
been triggered by the introduction of many new
and often expensive drug therapies, increasing drug
costs and by observed quality variations in healthcare provision (Quick 199 7).
The essential medicines concept is now widely
accepted as a highly pragmatic approach to providing the best of modern evidence-based and costeffective health services. It is as valid today as it
was when first introduced in 1975. The concept
does not exclude all other medicines but focuses
on those medicines that have the best balance of
quality, safety, efficacy and cost for a g iven health
service (Quick 1997). Moreover, the concept is
forward looking. It stimulates research and development for better pharmaceutical formulations and
for more efficient responses to new or re-emerging
diseases. It has also been adopted by international
and bilateral aid agencies and by non-governmental
organiz ations that include strategies on rational
drug selection, supply and use in their programmes
of work (Quick 1997).
In its present form, the Model List aims to identify
cost-effective medicines for priority conditions, together with the reasons for their inclusion, linked to
evidence-based clinical guidelines and with special
emphasis on public health aspects and considerations
of value for money. Information that supports the
selection of essential medicines, such as relevant
WHO clinical guidelines, systematic reviews, key
references and indicative cost information, is being
made available via the WHO website. The Model
List’s primary function is to facilitate the work of
national and institutional committees in developing
national and institutional lists of essential medicines.
Moreover, the list has also resulted in greater international coordination in healthcare development
and in health emergency situations (Quick 1997).
Linked to the Model List, the WHO Model Formulary provides independent information on essential
medicines for pharmaceutical policy makers and prescribers worldwide. It is also a useful resource for
countries wishing to develop their own national formulary (WHO 2004b).
Millions of children die each year because they do
not have access to medicines that are child-specific.
Access to safe, effective and affordable essential medicines for children is a global problem (WHO 2007f).
There is an urgent need for adequate formulations in
acute and chronic care and treatment of children.
Medicines for children do not exist or are not available
on the local market, or are unaffordable.
The WHO World Health Assembly resolution on
‘Better Medicines for Children’ supports the development of a Model List of Essential Medicines for
Children which will identify the gaps in the range of
medicines and formulations specifically for children
(WHO 2007f).
KEY POINTS
*
WHO was founded in 1948 and has 193 member
states (2007)
*
Health is described as ‘a state of complete
physical, mental and social well-being and not
merely the absence of disease or infirmity’
*
The essential medicines concept was launched
in 1975, and encourages health systems to focus
on access to those medicines that represent the
best balance of quality, safety, efficacy and cost to
meet the priority health needs within a given
healthcare setting
76
WHO and the essential medicines concept CHAPTER 7
*
The first Model List of Essential Medicines was
published by WHO in 1977 and included 208
individual medicines
*
The 15th Model List, updated in 2007, consists of
346 essential medicines divided into a ‘core’ and
‘complementary’ list
*
The Model List reflects a model product and a
model process, which can both be used for
advocacy
*
A new Model List of Essential Medicines for
Children will guide the need for new and improved
formulations for children
77
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