[Pharm-policy] Gay Men's Health Crisis Statement on Boehringer-Ingelheim and Nev irapine for the Prevention of Mother-to-Child Transmission of HIV

[Gonsalves, Gregg]

Gay Men's Health Crisis Statement on Boehringer-Ingelheim and Nevirapine 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 actually 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 countries 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 result, 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 allow
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 approval from the company
itself.   Insisting on approval of health ministries and a comprehensive set
of accompanying services for qualification 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 donation
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 developing
countries are delaying their approval of NVP for this purpose until the
USFDA approves NVP for MTCT prevention.  BI should submit the needed data to
the FDA to facilitate the review of their drug for this indication.  The
USFDA should expeditiously review and approve BI's dossier upon submission.
5)	Faster development and roll-out of smaller dose bottles or delivery
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
Phone: 212-367-1169
Fax: 212-367-1235
Email: greggg@gmhc.org