Human Immunodeficiency Virus (HIV) News and Information

In order to substantially extend access to the active ingredient Nevirapine, Boehringer Ingelheim in May 2007 decided to not enforce its patents and offers interested manufactures listed on the WHO prequalification programme non-assert declarations enabling them at no additional costs to supply Nevirapine-containing medicines for eligible countries.

These eligible countries are defined as all low income countries according to the World Bank classification of economies, all countries classified as Least Developed Country (LDC) according to the United Nations Development Programme and all African states which are not classified as low income of LDC.

The policy has been positively received and has encouraged the emergence of quality generic products with the active ingredient Nevirapine in developing countries. It applies to Viramune® IR (immediate release) and will also include Viramune® XR (extended release) once launched.

The protease inhibitor Aptivus® (Tipranavir) also falls under this policy.

The company offers a tiered preferential price. Viramune® can be supplied at:

• Not-for-profit price for all low income countries according to the World Bank classification of economies, all countries classified as Least Developed Country (LDC) according to the United Nations Development Programme and all African states which are not classified as low income of LDC.

• Reduced price for all middle income countries not benefiting from the not-for-profit price.

The preferential prices apply to the supply to the public sector in the countries.

Since its inception, the Viramune® Donation Programme has contributed to preserving the health of babies born to HIV+ mothers throughout the developing world. In the intervening decade, medicine sufficient for the management of more than 2 million mother-child pairs was donated to pmtct projects throughout the world.
Over the ten years since the start of the Viramune® Donation Programme, there have been new developments and new insights into the therapies that can be offered to reduce mtct of HIV-1 even further. Single dose Viramune® (with its active ingredient Nevirapine) as employed in the Viramune® Donation Programme is no longer considered as an appropriate approach for this purpose.
More comprehensive regimens have been developed and have been included in the latest guidelines on pmtct launched by WHO in July of 2010 at the World Aids Conference in Vienna.

In the light of these modified guidelines, Boehringer Ingelheim will pursue its commitment in a modified form. Two aspects will be involved:

First, where countries experience difficulties in the transition to the new guidelines, the company will provide interim assistance, on request, to the sites we have supported in the past, with supplies of Viramune® (tablets and 20 ml suspension) until the end of 2013.

Second, the 20 ml bottle of Viramune® oral suspension for children, previously donated for pmtct as part of the VDP, will become obsolete; the larger 240 ml pack of Viramune® oral suspension will now be offered for use in pmtct programmes at a not-for-profit price.

The decision to transform the current approach to pmtct will not cause problems of supply. 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. Boehringer Ingelheim has made a non-assert declaration to generic manufacturers pre-qualified by the WHO, to manufacture products containing the active ingredient Nevirapine for the developing world.

Boehringer Ingelheim regards capacity building and human resources development as a crucial objective in any health care development policy in emerging economies. This is the genuine task of committed Governments, supported by the private sector and civil society as well as bilateral or international assistance programmes. Boehringer Ingelheim contributes to this endeavour, for example with active involvement in capacity building, health education and training programmes, improving health care infrastructure and special efforts such as strengthening of supply chain management systems.