[Ip-health] SOUTH CENTER STATEMENT ON ACCESS TO BIOGENERICS MEDICINES AT THE WHA 72 27.5.2019

German Velasquez gvelasquez.gva at gmail.com
Sun May 26 23:53:12 PDT 2019


SOUTH CENTER STATEMENT ON ACCESS TO BIOGENERICS MEDICINES AT THE WHA 72
27.5.2019


The South Centre take this opportunity to highlight the importance of
access to biotherapuutics, especially similar biotherapeutics. In this
regard, we call upon the Secretariat to implement OP 2(4) of the WHA 67.21
on " Access to biotherapeutic products including similar biotherapeutic
products and ensuring their quality, safety and efficacy" (WHA 67.21). It
requests the Director-General: "to convene the WHO Expert Committee on
Biological Standardization to update the 2009 guidelines on similar
therapeutic products, taking into account the technological advances for
the characterization of biotherapeutic products and considering national
regulatory needs and capacities and to report on the update to the
Executive Board”. The Secretariat, however; only issued a Question and
Answer (Q&A) document apparently aimed at providing clarifications to said
guidelines, which falls short of an update of the Guidelines as explicitly
mandated under the WHA 67.21.

Document A72/50 under consideration in this agenda item 21.3 states in
paragraph 80 that “WHO expert committees have approved guidance on (…)
biotherapeutics, including an update of the 2009 similar biotherapeutic
products guidelines;”. This report on last year´s activities, seems to
suggest that the 2018 document on Questions and Answers on the 2009
guidelines is, in fact, the update of such guidelines as demanded in
Resolution WHA67.21, but this is not the case. We kindly demand that
language on paragraph 80 of document A72/59 be amended to objectively
reflect the current situation, i.e., that the WHO Secretariat has not fully
performed yet the referred to mandate of Resolution WHA67.21.


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