36 Drug Registration and Pricing

in the Middle East

Edda Freidank-Mueschenborn

36.1 The market

Commercial and cultural background

The Middle East is comprised of 14 independent
countries located on the Arabian peninsula: Bah-
rain, Kuwait, Oman, Qatar, Saudi Arabia, United
Arab Emirates (UAE), Yemen, Syria, Lebanon,
Israel, Palestine, Jordan, Egypt, Iraq and Turkey.
The peninsula is bound by three bodies of water:
the Mediterranean Sea to the north, Red Sea to the
west and the Arabian Sea to the east and south.
The region is not homogeneous. Individual coun-
tries differ significantly in government, economics,
per capita income, size, population and religion. For
example, Saudi Arabia is the largest country with 2
million km^2 , cf. Bahrain with only 711 km^2 .Yet
Bahrain is the most densely populated country (917
people/km^2 ) with Oman at the other extreme
(9 people/km^2 ). Absolute monarchy is found in
Kuwait and complete democracy in Lebanon. The
distribution of Islam, Christianity and Judaism will
be familiar, with some countries almost totally one
orother,whereasothersaremoremixed(e.g.40%of
the Lebanese population is Christian).
In many Middle Eastern countries, the economy
pivots on the sale of oil. However, phosphate
production and tourism (Jordan), aluminium and

textiles (Bahrain), citrus growing (Israel) and so on

are less well known. Gross domestic product

(GDP) per capita per year ranges from $1527 in

Yemen to more than $26 000 in UAE.

Arabic is an official language used by all regula-

tory authorities in the Middle East. However, some

willalsoacceptdocumentsinEnglishorFrench,and

Israel also accepts documents in Hebrew.

For most of these countries, health systems are

very modern and up-to-date. There is an average of

one physician for every 500 people in the region as a

whole, and in some countries, especially the weal-

thier oil states, medical service and medicine is free.

There are exceptions however, usually being the

poorest and least peaceful states in the region.

An important difference between the Middle

East and other high-quality medicine regions, how-

ever, is the population served. Only 30% of the

population in the Middle East is over 30 years of

age, unlike the inverted age ‘pyramids’ found in

Europe and North America.

Important authorities/organizations

Authorities

The competent regulatory authorities in the Middle

East region are the Ministries of Health (MoH) in

Principles and Practice of Pharmaceutical Medicine, 2nd Edition Edited by L. D. Edwards, A. J. Fletcher, A. W. Fox and P. D. Stonier
#2007 John Wiley & Sons, Ltd ISBN: 978-0-470-09313-9