Boehringer Ingelheim is committed to improving access to medicines in least developed countries (LDCs). In particular, the company has an overarching commitment to combating the devastating AIDS pandemic through its engagement for the prevention of mother-to-child transmission (PMTCT) of HIV/AIDS.
Products containing the active ingredient nevirapine, which was researched and developed by Boehringer Ingelheim, are widely available in the developing world from a number of generic manufacturers.
Over the last four years, the company has granted non-assert declarations to generic manufacturers pre-qualified by the World Health Organization (WHO), to manufacture products containing nevirapine. The policy applies to all low-income countries, all LDCs and all African countries (78 countries in total). This has led to an increase in patients being treated with medicines containing nevirapine.
The non-assert policy stipulates that patents will not be enforced, that no royalties have to be paid and, most importantly, that high product quality will be ensured.
The Boehringer Ingelheim policy paper on HIV/AIDS describes the corporate policy and the benefit for the patients.
On World AIDS Day in 2000, Boehringer Ingelheim announced that its antiretroviral Viramune® (active ingredient nevirapine) would be offered free of charge for a period of five years, as part of a donation programme to developing countries for the PMTCT of HIV-1. The donation would be provided within reliable, local projects on PMTCT, with voluntary counselling and testing (VCT), to health facilities for pregnant women and healthcare for mothers and babies. The initiative was called the Viramune® Donation Programme (VDP).
Since its inception, the VDP has contributed to preserving the health of more than two million babies born to HIV-positive mothers throughout the developing world. In the intervening decade, medicine sufficient for the management of more than two million mother-child pairs in 171 programmes stretching over 71 countries were donated to PMTCT projects throughout the world. For the baby dose, oral dispensers and pouches for the filled dispenser were included in the package. Since the start of the VDP, there have been new developments and new insights into the therapies that can be offered to increase PMTCT of HIV-1 even further.
Single-dose nevirapine, as employed in the VDP and included in earlier WHO guidelines, is no longer considered an appropriate approach for this purpose.
In the light of these modified guidelines, Boehringer Ingelheim will pursue its commitment, but in an appropriate form.
Where countries experience difficulties in the transition to the new guidelines, Boehringer Ingelheim will until the end of 2013 provide interim assistance, on request, to the sites the company has supported in the past, with supplies of Viramune® tablets and suspension.
The decision to transform the current approach to PMTCT will not cause supply problems. Other products containing the active ingredient nevirapine, both tablets and oral suspension, are now widely available in the developing world from a number of appropriately qualified generic manufacturers.
Additionally, the 240 ml pack of Viramune® oral suspension will now be offered for use in PMTCT programmes at a not-for-profit price.
Boehringer Ingelheim has developed and launched an extended release form of its HIV drug, Viramune®, in 2010. Additionally, a paediatric version of its other ARV, Aptivus® (tipranavir), has been available since 2009. Both medications qualify for the non-assert scheme.
Boehringer Ingelheim also engages in healthcare-supporting activities, such as human resources development and capacity building through training and education in various ways, including:
In the 2010 survey and ranking of the Access to Medicine Foundation, Boehringer Ingelheim ranked 12th out of 20 pharmaceutical companies under review for its VDP, its non-exclusive voluntary licensing activities and its non-assert declaration policy.
The Elizabeth Glaser Pediatric AIDS Foundation, a US national non-profit organization dedicated to preventing paediatric HIV infection and to eradicate paediatric AIDS, is the largest beneficiary of our Viramune® Donation Programme.