Boehringer Ingelheim continues providing non assert declarations to manufacture HIV/AIDS medicines

Boehringer Ingelheim continues to be willing to provide WHO qualified generic pharmaceutical companies non assert declarations to manufacturer and export products containing the HIV/AIDS medication nevirapine to Rwanda and other defined developing countries.

Canada has taken a leadership role through the Canadian Access to Medicines Regime (CAMR) to provide a framework to allow important patented HIV/AIDS medications to reach the developing world.

Boehringer Ingelheim has repeatedly stated that patents must not prevent HIV patients from having access to life-saving anti-HIV drugs in resource limited settings. In order to accelerate access to anti-retroviral medicines, the company initiated non-assert declarations in May 2007 (one of these declarations was previously granted to Apotex for the purpose of the initial Rwandan shipment of the combination product).

The non-assert declaration means that the company will not enforce its patent rights against the agreement partner. The company has further waived the provision of a nominal royalty fee under the access policy so the partnering companies can supply the nevirapine containing drugs without any payments to Boehringer Ingelheim. Generic manufacturers whose nevirapine product and production site have been pre-qualified by WHO are enabled to supply in total 78 countries which are either Least Developed Countries (LDC) according to the UNDP classification, or low income countries according to the World Bank classification and all other countries in Africa.

By providing only WHO pre-qualified generic producers with the non-assert declaration the quality of nevirapine is guaranteed. This is crucial in countries with weak or non-existent Drug Regulatory Authorities and is in line with our Corporate Responsibility.