[e-drug] Lack of transparency at WHO? (cont)

[e-drug@usa.healthnet.org]

E-drug: Lack of transparency at WHO? (cont)
----------------------------------------------

[Dr Robin Gray, Medical Officer, Policy, Access and Rational Use
Essential Drugs and Medicines Policy World Health Organization has 
been asked to forward the following as the WHO/Essential Drugs and
Medicines Policy response to the Public NGO Network Budapest question on
Lack of transparency at WHO? His email contact is grayr@who.int  BS]
_______________________________________________

The supply of drugs for HIV/AIDS, malaria and TB in particular, has become
a priority at both international and country level. Low-cost drugs of 
assured quality have the greatest potential for maximizing the impact 
of the efforts to combat communicable diseases.  In 2001 WHO 
initiated a pilot project on sourcing of pharmaceuticals for HIV/AIDS 
related care and treatment as its focus. Initially HIV/AIDS 
pharmaceuticals was chosen because of the overwhelming need to 
increase access to these drugs in developing countries, particularly 
in Africa, where HIV/AIDS is now the leading cause of mortality. As 
the pre-qualification model used in the project was successful, the 
same model for sourcing pharmaceuticals for
malaria and TB treatment was started in 2002.  The project is managed 
in close cooperation with members of the International Pharmaceutical 
Coordination (IPC) group, namely WHO, UNICEF, UNAIDS, UNFPA and with 
the support of the World Bank. The project has been supported also by 
organizations outside IPC group, like MSF, as well as by many 
Governments (either providing funds or making their experts 
available). The general procedures for the assessment of 
manufacturers for the procurement and sourcing of pharmaceutical 
products approved by the WHO Expert Committee on Pharmaceutical 
Specifications is considered to form the basis of the quality 
assessment system for procurement of pharmaceuticals of the project. 
The project is transparent.  All the requirements for the 
pre-qualification of products and procedures are all  available in 
the public domain

  (http://www.who.int/medicines/organization/qsm/activities/pilotproc/pilotp
roc.shtml).
[Please repair URL. BS]

The pre-qualification consists of two major parts:  the assessment of 
dossiers and product specific inspection of manufacturers. The 
assessment of dossiers is carried out by teams of drug regulators 
from both developing and developed countries and the inspections are 
carried out by qualified inspectors involving a WHO staff member, an 
independent inspector and a national inspector (the countries who 
have provided experts are listed on the website mentioned above). 
For both the
assessment of dossiers and the inspection of manufacturers, the 
technical decisions are made collectively by technical persons 
involved. At present 25 individual products from generic 
manufacturers and 33 products from originators have been 
pre-qualified for HIV/AIDS care.

  The project is led by a project manager who is a WHO staff member 
under supervision of Team Coordinator for Quality Assurance and 
Safety of Medicines (QSM) of Essential Drugs and Medicines Policy 
Department. To guarantee the transparency all the decisions and 
comments of assessors and inspectors about each individual product 
are documented, filed and communicated back to the manufacturers in 
writing. The number of applications for the pre-qualification which 
WHO is so far providing as a free of charge service is increasing 
constantly and so does the workload.  Recently a person with 
regulatory background was hired by WHO for on a short-term basis to 
assist the project manager with an increase in the number of 
applications by companies for pre-qualification of their products. 
The basic qualifications expected were more than 10 years regulatory 
experience including hands-on knowledge of either assessing the 
applications for drug registration or preparing the files for drug 
registration, and good drafting skills for variety of regulatory 
documents and correspondence.   The hiring process was according to 
current WHO requirements for contracts of this duration.

E-DRUG readers are encouraged to consult to above-noted web site for 
additional information on the process and results of the WHO Pilot 
Procurement Quality and Sourcing Project.

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