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[e-drug] Chatham house paper on counterfeit, falsified & substandard meds

E-DRUG: Chatham house paper on counterfeit, falsified & substandard meds
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[This 16-page Chatham house briefing paper tries to bring some order in the 
often confusing counterfeit discussions. WB]

http://www.chathamhouse.org.uk/publications/papers/view/-/id/972/

* Counterfeit, falsified and substandard medicines pose a serious threat
to human health, particularly in poorer countries with weak regulatory
mechanisms.

* But the relationship between combating counterfeit medicines,
addressing safety, quality and efficacy issues and enforcing privately
owned intellectual property rights has become controversial.

* There are concerns that a wider definition of 'counterfeit' threatens
the trade in generic medicines of assured quality on which many
developing countries depend; and about the legitimacy of the
International Medical Products Anti-Counterfeiting Taskforce (IMPACT),
the detention of generic drugs in transit in the European Union, and the
negotiation of the Anti-Counterfeiting Trade Agreement (ACTA).

* 'Counterfeit' has a specific meaning in intellectual property, related
to wilful trademark violations. But in relation to medicines it is now
sometimes used in a much broader sense to do with misrepresentation of
identity or source, or even medicines that are simply 'substandard'.

* Some countries use the term 'falsified' to describe medicines that
misrepresent their identity or source, but do not necessarily violate
intellectual property rights.

* 'Substandard' medicines are those that do not meet quality standards
specified for them, but may also be defined specifically to cover
products from authorized manufacturers which fail to meet quality
standards set for them.

* Failure to reach agreement on the definitions of counterfeit,
falsified and substandard medicines hampers the constructive policy
debate and collaboration at the international level that are necessary
to take effective action against the producers and distributors of these
medicines.

The full paper can be downloaded from:
http://www.chathamhouse.org.uk/files/17868_1110bp_counterfeit.pdf

[Submitted by:]

Charles Clift
Senior Research Consultant
Centre on Global Health Security 
Chatham House
UK
CClift@chathamhouse.org.uk



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