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AFRO-NETS> Gay Men's Health Crisis Statement on Nevirapine



Gay Men's Health Crisis Statement on Nevirapine
-----------------------------------------------

Gay Men's Health Crisis Statement on Boehringer-Ingelheim and Nevi-
rapine for the Prevention of Mother-to-Child Transmission of HIV

June 26, 2001

Almost a year ago, Boehringer-Ingelheim (BI) announced a five-year 
program to provide nevirapine (NVP) free of charge to developing 
countries for the prevention of mother-to-child transmission (MTCT) 
of HIV. A year later, it is uncertain how much "free" NVP has actu-
ally reached HIV+ women in labor and their infants. What is clear is 
that there are significant problems with the donation program and, in 
the time since the program was announced, almost 600,000 babies have 
been infected through MTCT. 

The BI program was designed to provide free nevirapine to countries 
where the health ministry has approved NVP for prevention of MTCT and 
for programs officially approved by the company. Many of the coun-
tries that could benefit most from BI's offer have yet to approve NVP 
and qualify for the program. Sadly, only a handful of applications 
for the donation program have been processed and approved. As a re-
sult, many institutions wanting to implement MTCT prevention programs 
have had to try to find a source of discounted NVP and buy it for 
themselves. 

We are requesting several actions by BI to facilitate wider access to 
NVP: 

1) Streamlining of the requirements for the program, which would al-
low health care providers to apply directly for a supply of drug 
rather than having to seek approval of health ministries, and which 
would allow sites with minimal accompanying services to receive ap-
proval from the company itself. Insisting on approval of health min-
istries and a comprehensive set of accompanying services for qualifi-
cation for the program may be setting up insurmountable barriers for 
many sites that could benefit from the donation program. 

2) Simplification of the application process. 

3) Issuance of a voluntary license to allow a generic producer to 
market NVP in the developing world or a statement of non-enforcement 
of patent rights to NVP in these countries, which would allow generic 
manufacturers access to these markets. If the track record of the do-
nation program has been disappointing to date, perhaps other market-
based solutions will have greater success. 

4) Increased efforts to secure the approval of NVP for the prevention 
of MTCT from the US Food and Drug Administration (USFDA). A few de-
veloping countries are delaying their approval of NVP for this pur-
pose until the USFDA approves NVP for MTCT prevention. BI should sub-
mit the needed data to the FDA to facilitate the review of their drug 
for this indication. The USFDA should expeditiously review and ap-
prove BI's dossier upon submission. 

5) Faster development and roll-out of smaller dose bottles or deliv-
ery devices (e.g. 1 ml syringes) of NVP syrup. Many sites are having 
difficulty with the 240 ml bottles, since the average infant dose is 
about 0.6 ml. 

For more information, contact:

Gregg Gonsalves
Director of Treatment Advocacy
Gay Men's Health Crisis 
119 West 24th Street 
New York, NY 10011, USA
Tel: +1-212-367-1169 
Fax: +1-212-367-1235 
mailto:greggg@gmhc.org 

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