[Ip-health] WHA72: Statement by MMI/PHM/TWN on item 12.2 Member State mechanism on substandard and falsified medical products

Heba Wanis h.wanis at gmail.com
Sat May 25 13:49:57 PDT 2019

*12.2 Member State mechanism on substandard and falsified medical products*

Thank you, Chair.

I read this statement on behalf of 15 CSOs and networks present at this
Assembly, representing nearly 100 organisations in more than 70 countries.

We would like to draw the attention of member states and the Secretariat to
the following three issues.

First, in spite of the finalisation of definitions, the WHO continues to
conflate substandard and falsified medicines. Instead of separate data on
the circulation of substandard and falsified medical products, the
Secretariat provides aggregate data on substandard and falsified medicines.
This approach is not only erroneous but also supports the scaremongering on
quality of medicines.

Second, in 2014 the MSM called on the Secretariat to provide a Study to
deepen the understanding on the link between access to quality, safe,
efficacious and affordable medical products and the emergence of
substandard and falsified medical products. However, there is no progress
in concluding the study. We would like to stress that ensuring access to
medicines can eliminate the incentive for the circulation of falsified

Third, there should not be any interception of movement of medicines in
transit without the request of regulatory authorities in either exporting
or importing country. The interception in the name of checking movement of
substandard or falsified medicines will result in the interception of
generic medicines, ultimately compromising access. We call upon member
states to continue outstanding work in relation to this issue.

Thank you, Chair.

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