Gay Men's Health Crisis Statement on Nevirapine
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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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