The World Health Organization has caved in to pressure by the developing countries (specifically India and Brazil), and dropped their resolution on counterfeit drugs. This non-decision is being portrayed as a victory for the developing world’s generic drug industry -- which has long opposed the WHO attempt. Their objection is that, under the proposed new definition, their products could be defined as counterfeits.
The current definition of WHO says counterfeit drugs are 'medicines which are deliberately and fraudulently mislabeled with respect to identity or source.
The proposed definition proposed removes the clause “deliberately and fraudulently” and replaces it with “a medical product is counterfeit when there is a false representation in relation to its identity, history, or source.” It also says that ‘this applies to the product, its container, packaging or other labeling information.”
What are really at play here are the issues of semantics and transparency. What’s the difference between a product that is knowingly “substandard” versus one that is “counterfeit?” If a company deliberately fails to comply with manufacturing quality standards – what do you call the product?
For starters, you call it dangerous.
Another issue recently brought to public attention via an Associated Press story (see link here) is the manufacture of medicines in India destined for First World markets that result in the poisoning of the local population because of a lack of environmentally safe manufacturing processes.
If it’s wrong for Americans to buy products produced by slave labor, isn’t it just as wrong to purchase medicines from companies who have total disregard for the health and well-being of local citizenry?
As America focuses on peanuts as a metaphor for regulatory reform, perhaps it’s time for the global community to tie counterfeiting to corporate responsibility.
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