WHO group finally tames fake medicines tongue-twister

A World Health Organization (WH) working group has come up with a new lexicon to replace the current clunky nomenclature for illicit and low-quality medicines.

For years, WHO has been using the cumbersome phrase 'substandard/spurious/falsely-labelled/falsified/counterfeit' medicines or SSFFCs, having got tangled up in an acrimonious debate about the use of the word 'counterfeit' and allegations that - as a term associated with intellectual property rights - its use could lead to a conflation with legitimate generic drugs.

Now, the WHO's technical working group has recommended just two words – 'falsified' and 'substandard' – to cover the gamut of cases under the SSFFC umbrella. The idea still has to be approved by World Health Assembly (WHA) member states, and will come in front of the executive board in May 2017.

"The term 'falsified' appears to adequately include all the various types of deliberate misrepresentation of a medical product in such a way which enables the specific exclusion of intellectual property rights," according to the working group.

The proposed definitions are as follows:

*Substandard medical products - Also called 'out of specification', these are authorized medical products that fail to meet either their quality standards or their specifications, or bot; and *

Falsified medical products - Medical products that deliberately/fraudulently misrepresent their identity, composition or source.

"The terms of reference of the Member State mechanism on SSFFC medical products expressly exclude the protection of intellectual property rights" from the mandate of the member state mechanism for handling falsified and substandard medicines, said the working group.