counterfeit, falsified & substandard medicines

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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:]

Clift

Senior Research Consultant

Centre on Global Health Security

Chatham House

UK

CClift@...