[india-drug] World Bank brings out manual for HIV drug procurement

[Sunitha Srinivas <s.srinivas@ru.ac.za>]

(Source:http://www.pharmabiz.com/article/detnews.asp?articleid=20670
Thanks?.SS)

World Bank brings out manual for HIV drug procurement
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Tuesday, March 02, 2004 08:00 IST 
Joe C Mathew, New Delhi

The World Bank has come out with a comprehensive antiretroviral (ARV)
procurement manual to address the specific requirements and unique
features of the medicines and supplies that are part of the HIV/AIDS
Care Package. The bank has given prominence to procuring generics
whenever possible, and has also compiled detailed information on
intellectual property rights (including information how/when to use
compulsory licensing and/or parallel importation) for countries and
companies that need an update on their rights under TRIPS. 

The "Technical Guide for HIV/AIDS Medicines and Related Supplies:
Contemporary Context and Procurement, February 2004," complements the
Technical Note - Procurement of Health Sector Goods, May 2000, Revised
February 2001, March 2002 and March 2003. The guide endorses the use of
fixed dose combination medicines including generic FDC ARVS. It gives a
detailed interpretation of Article. 39.3 of the TRIPS Agreement that
permits a drug regulatory authority to establish bio-equivalence and to
approve a generic medicine for marketing even when that authority uses
a drug company's otherwise confidential data for purposes of
comparison. 

The guide recommends the countries to go for fast-track regulatory
approval of WHO pre-qualified medicines. "In most cases, it is strongly
recommended to purchase products already prequalified by the
WHO-initiated project." It has said. 

Another major highlight of the technical guide, which is to be the
guide book for World Bank staffers, is the non preference for locally
produced products - "Bidders supplying product manufactured locally
must demonstrate that the quality of the local production meets WHO
equivalent standards and their prices are competitive with
international prices."

The guide contains tips on procurement processes such as tendering,
pooled procurement and assistance for procurement. Suggestions on how
to obtain lower drug prices and how to calculate the cost of an ARV
programme are given. The guide also contains information on purchasing
diagnostics, including HIV testing kits. 

The guide is targeted at people responsible for making procurement
decisions. The World Bank guidelines are in all material respects
similar to those of the Global Fund. In contrast, they differ sharply
from the US PEPFAR bilateral initiative which does not endorse FDC ARVs
and WHO pre-qualification.


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