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[e-drug] Independent or integrated Drug Regulatory Authority?


  • From: "Wilbert Bannenberg" <wjb@wxs.nl>
  • Date: Sat, 15 Sep 2007 13:33:35 +0200

E-DRUG: Independent or integrated Drug Regulatory Authority?
------------------------------------------------------------

Dear E-druggers,

A practical question for debate!

A small developing country with only a few pharmacists in the public sector
(the majority are in the private sector), wants to start implementing its
National medicines Policy, set up a National Drug Regulatory Authority, and
also control the professional activities of pharmacists and pharmaceutical
assistants/technologists.

Following traditional WHO recommendations, the country would need to
establish:
- a coordination unit for NMP implementation (secretariat normally held by
the Directorate of Pharmcy / Chief Pharmacist)
- a (small) Drug Regulatory Authority (with regional collaboration /
harmonisation)
- a Pharmacy Council (or seek integration with the dentists and doctors in a joint Health Professions Council?)

However, the human and financial resources of the country do not allow to
set up all these institutions separately.
The question arises whether one could set up one small, integrated unit that incorporates all these 3 functions?

NDA Uganda and DACA Ethiopia have tried to merge these functions: what were
their experiences?
Anyone knows of other countries that have tried this integrated approach?
What about conflict of Interests between regulators and policy implementers?
Should the new organisation be autonomous from MOH or can it be part of MOH
or government structures?

Your experiences are welcome!

Wilbert
----
Wilbert Bannenberg
E-drug (co-)moderator

Email: wjb@wxs.nl
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