[Ip-health] Turkish Weekly Journal- Eliminating Counterfeit Medicines is a Public Health Challenge - WHO

[Terri - Louise Beswick]

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Eliminating Counterfeit Medicines is a Public Health Challenge - WHO

Friday, 8 January 2010

Counterfeit medicines are found everywhere in the world. They range from
random mixtures of harmful toxic substances to inactive, ineffective
preparations.

Some contain a declared, active ingredient and look so similar to the
genuine product that they deceive health professionals as well as
patients. But in every case, the source of a counterfeit medicine is
unknown and its content unreliable.

Counterfeit medicines are always illegal. They can result in treatment
failure or even death. Eliminating them is a considerable public health
challenge.

Extent of the problem

Defining the extent of counterfeiting is difficult for a number of
reasons.

The variety of information sources makes compiling statistics a
difficult task. Sources of information include reports from national
medicines regulatory authorities, enforcement agencies, pharmaceutical
companies and nongovernmental organizations, as well as ad hoc studies
on specific geographical areas or therapeutic groups.

The different methods used to produce reports and studies also make
compiling and comparing statistics difficult.

Studies can only give snapshots of the immediate situation.
Counterfeiters are extremely flexible in the methods they use to mimic
products and prevent their detection. They can change these methods from
day to day, so when the results of a study are released, they may
already be outdated.

Finally, information about a case under legal investigation is sometimes
only made public after the investigation has been concluded.

Counterfeiting is greatest in regions where regulatory and enforcement
systems for medicines are weakest. In most industrialized countries with
effective regulatory systems and market control (i.e. Australia, Canada,
Japan, New Zealand, most of the European Union and the United States of
America), incidence of counterfeit medicines is extremely low - less
than 1% of market value according to the estimates of the countries
concerned. But in many African countries, and in parts of Asia, Latin
America, and countries in transition, a much higher percentage of the
medicines on sale may be counterfeit.

Not only is there a huge variation between geographic regions in terms
of incidence of counterfeit medicines, variation can also be significant
within countries: for example, between urban and rural areas, and
between cities.

All kinds of medicines have been counterfeited - branded and generic -
ranging from medicines for the treatment of life-threatening conditions
to inexpensive generic versions of painkillers and antihistamines.

In over 50% of cases, medicines purchased over the Internet from illegal
sites that conceal their physical address have been found to be
counterfeit.

Public health risks

Counterfeit medicines pose a public health risk because their content
can be dangerous or they can lack active ingredients. Their use can
result in treatment failure (and contribute to increased resistance in
the case of antimalarials that contain insufficient active ingredient)
or even death. Unlike substandard medicines where there are problems
with the manufacturing process by a known manufacturer, counterfeit
medicines are made by people with the intent to mislead.

The extreme difficulty in tracing the manufacturing and distribution
channels of counterfeit medicines makes their circulation on markets
difficult to stop. Even a single case of a counterfeit medicine is
unacceptable since it indicates that the pharmaceutical supply system in
which it was detected is vulnerable. Worse, it undermines the
credibility of national health and enforcement authorities.

Contributory factors

Several factors contribute to the counterfeit medicine problem.

Paying for medicines can consume a significant proportion of individual
or family income. Some people seek medicines that are sold more cheaply.
These are often available from non-regulated outlets, where the
incidence of counterfeit medicines is likely to be higher.

People might also purchase medicines from non-regulated outlets if, as
is often the case in the rural areas of developing countries, medicines
supplies at regular health facilities do not meet demand.

Counterfeiting medicines can be very lucrative. Since many countries
have not yet enacted deterrent legislation, counterfeiters often do not
fear prosecution.

The growth in international trade of pharmaceutical ingredients and
medicines adds a further dimension of complexity to this issue. For
example, trade through brokers and free trade zones where regulation is
lax or absent (and medicines repackaged and relabelled to conceal
country of origin) is increasing.

WHO response

Stringent regulatory control of medicines and enforcement by national
medicines regulatory authorities contributes significantly to prevention
and detection of counterfeit medicines. WHO provides direct country and
regional support for strengthening medicines regulation.

To fight counterfeit medicines effectively, a range of stakeholders -
not just health professionals - is needed. In 2006, WHO helped to create
the International Medical Products Anti-Counterfeiting Taskforce, or
IMPACT. The aim is to involve a range of stakeholders in collaborative
efforts to protect people from buying and taking counterfeit medicines.

To prevent the manufacture and distribution of counterfeit medicines,
IMPACT's areas of focus are: legislative and regulatory infrastructure,
regulatory implementation, enforcement, technology, communication.


Friday, 8 January 2010



http://www.turkishweekly.net/news/95305/eliminating-counterfeit-medicine
s-is-a-public-health-challenge-who.html