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[e-drug] The World Medicines Situation

E-DRUG: The World Medicines Situation
-------------------------------------

When WHO released its landmark "World Drug Situation" report in 1988, it caused 
an uproar. Now, 16 years later, its successor, the "World Medicines Situation", 
has silently been released on the WHO/EDM website: 
http://www.who.int/medicines/library/theme/theme_sup.shtml

The World Medicines Situation (available as pdf download - 1052KB - see 
http://www.who.int/medicines/organization/par/World_Medicines_Situation.pdf) 
provides an accessible source of information on the pharmaceutical situation at 
global and national levels. It assembles the available evidence regarding the 
production and consumption of medicines, and a range of issues in national 
medicines policies, including the level of people's access, patterns of use, 
the challenges of medicines regulation and promoting rational use. Numerous 
different sources of data are used. A 32-page annex of statistics is included.

The introduction of the 145-page report states:

"This second review of the world medicines situation (first published in 1988 
as The World Drug Situation) presents the available evidence on global 
production, research and development, international trade and consumption of 
pharmaceuticals. In addition, it draws on the most recent surveys and studies 
in WHO Member States to examine the state of national medicines policy. The aim 
is to provide an easily accessible source of information on the pharmaceutical 
situation at global and national levels.

Although the text is based on and around the available data, these data pose 
several challenges. For example, reliable data on the large pharmaceutical 
markets in the world's most populous countries, the People's Republic of China 
and India, are in short supply.
Trade, production, expenditure and consumption data all come from different 
sources.

In addition, the use of monetary values, rather than an indicator of volume, 
gives a distorted picture of production and consumption since it fails to 
reflect the scale of global consumption of traditional medicines and low-priced 
generics (both branded and non-branded).

Another problem is that certain key terms, such as "generic" medicines, are 
used differently by different parties, and usage is also changing. While 10 
years ago the term "drugs" was widely used by WHO and other agencies, in 
today's usage this seems too vague and inclusive, and is increasingly 
understood to refer to illicit substances. As a result, the term 
"pharmaceuticals" is now increasingly used (meaning both medicines and 
vaccines) or alternatively "medicines". All three terms are used in this 
report, with explanations given when needed, and this is reflected in the 
change in title from the 1988 report.

Meanwhile, the pharmaceutical industry itself is difficult to define. Its 
products extend from first aid and cough remedies which are on sale to all, to 
highly specialized medicines for use only by hospital specialists. Some 
definitions bundle veterinary medicines and vaccines, bulk ingredients, medical 
devices and diagnostic products with finished pharmaceutical products. The 
Standard International Trade Classification (SITC Rev 3) distinguishes 
pharmaceuticals from medicaments and itemizes 57 four- and five-digit sub-items 
of these two commodities. Within these classifications the main focus of this 
report is medicines for human consumption, including those available only on 
prescription and
those which can be purchased over the counter. However, in Chapters 1 and 3, 
the broader industrial and trade classifications are used.

The manufacturers of pharmaceuticals are numerous and diverse. At one end of 
the spectrum are the many firms of all sizes which collect and process herbs 
and medicinal plants for use in traditional medicine. No data are available on 
the volume of products involved. At the other end of the spectrum are large, 
'integrated' transnational corporations, with the capacity to develop new 
molecular entities and to manufacture, market
and distribute medicines to most parts of the globe. Situated in between is a 
wide range of manufacturers differing in size, the kind of pharmaceuticals 
produced and in manufacturing and marketing techniques. In India, for example, 
20 000 pharmaceutical manufacturers have been inventoried, but only 250 of 
these are in the 'organized' sector, and they
account for 70% of the country's total output of branded generics. Elsewhere, 
China' s rapidly growing pharmaceutical industry has an estimated 7500 
manufacturers but, according to one source, only 87 of these have 
internationally accepted Good Manufacturing Practice certification.1

Finally, the pharmaceutical markets of the high-income countries differ widely 
from those in developing countries. Not only is per capita spending on health 
and medicines many times higher in high-income countries, but a much greater 
share of the medicines bill is publicly subsidized. In the lowest-income 
countries, spending on medicines comes largely from household resources and has 
to be paid for out of pocket at the time the
person is ill. Markets also differ in the extent and effectiveness of 
regulation in areas such as medicine prices and safety. This report therefore 
covers a wide range of different products from multiple and varied sources, 
prescribed, purchased and consumed in very different domestic contexts.

The report does not attempt to deal in a comprehensive way with a number of key 
policy issues in medicines policy, such as parallel trade, intellectual 
property rights, counterfeiting, or corporate pricing strategy, around which 
vigorous debate continues at both the national and international level. Whilst 
WHOs concerns and policy positions are made
clear at relevant points in the text, our primary aim is to provide an 
up-to-date set of basic information on the global medicines situation and on 
the current status of national medicines policies. It is hoped that these data 
will serve as a useful set of reference material for analysts, researchers and 
others concerned with the global pharmaceutical situation."

Happy reading to E-druggers, and compliments to WHO/EDM for finalizing this 
important publication.

Hard copies of the "World Medicines Situation" may be obtained from 
edmdoccentre@who.int (quote WHO/EDM/PAR/2004.5)

regards

Wilbert
---------
Wilbert Bannenberg, E-drug moderator
Email: wjb@planet.nl

The 1995-2004 E-drug archives are at http://www.essentialdrugs.org/edrug/

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