Saturday, January 3, 2009

Counterfeit Drug Definition Absent from Agenda of WHO Executive Board Meeting

Currently the World Health Organization definition of a counterfeit medication definition reads as:

"A counterfeit medicine is one which is deliberately and fraudulently mislabeled with respect to identity and/or source. Counterfeiting can apply to both branded and generic products and counterfeit products may include products with the correct ingredients or with the wrong ingredients, without active ingredients, with insufficient (inadequate quantities of) active ingredient(s) or with fake packaging."

Once again, bowing to pressure from some member countries, the WHO's Executive Board has left the important issue of counterfeit medication definition off the agenda for its meeting in January 2010 because of controversy surrounding the definition of counterfeit medication.
The WHO contends that a strong, consistent definition of counterfeit is necessary in order to develop global strategies to combat the problem and has been engaged for some time in developing a standard definition that all member countries can agree on.

At the heart of the definition’s continued delay is the objection from countries like India and Brazil over the use of the term "counterfeit" and the contention that it will cause some legitimate generics manufactured in these countries to come under the WHO definition. Essentially these countries believe that drug manufacturers that own international intellectual property rights for medications will use the WHO definition as a legal tool against drug manufacturers in their countries which produce generic medications that may infringe on the intellectual property of companies globally.

These countries are delaying the issue within the Executive Board and continue to ask for a revised definition which would be more specific to falsified or substandard medicines.

The WHO is now hoping that this issue will be discussed at the 2010 World Health Assembly in May.

Although a definition seems trivial and simple to some, this is an important step forward in combating an important healthcare issue that impacts everyone globally. Without this definition, it is difficult for regulatory and law enforcement agencies to collaboratively and comprehensively work together on attacking counterfeit medications at their source. Basic agreement on what is or is not a counterfeit allows unscrupulous organizations and individuals the ability to usurp legal loopholes and to operate, hide and spread their dangerous wares throughout the globe.

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