Boehringer Ingelheim GmbH
Ute E. Schmidt
Boehringer Ingelheim has repeatedly and clearly stated that patents must not prevent access from life-saving drugs for HIV patients living in resource limited settings. In line with this and in order to accelerate access to anti-retroviral medicines, the company has initiated non-assert declarations in May 2007, well before the idea of the UNITAID patent pool was conceived. The declarations have been welcomed by all stakeholders including NGOs such as medicines sans frontieres, patient organisations and the press (e.g. article by Andrew Jack, "HIV drug price slashed” Financial Times, 15 May 2007).
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. This goes far beyond the conditions of the patent pool currently under discussion. 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. The drugs can be produced in any country for supply of the these 78 countries on the combined list. Another important aspect is that 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. This policy has been praised in particular by patient interest organisations from resource-limited countries affected by low-quality products.
Being aware of our responsibility and actively striving for the idea of a pool Boehringer Ingelheim welcome the UNITAIDs initiative. We have been in constructive discussions with the promoters of the pool idea for some time and we will carefully observe future developments. For now we are certain that our approach as promoted for instance also by academic institutions is the better option. We have committed ourselves in our publicly available HIV Policy to also apply this approach to our other anti-retroviral medication tipranavir. We are exploring options how best to collaborate with potential generic producers.
In the past Boehringer Ingelheim granted Voluntary Licenses to several companies in Africa enabling them to produce generic nevirapine for low income countries as per World Bank classification. In order to further improve and facilitate access to nevirapine, Boehringer Ingelheim will not enforce its patents and offers interested manufactures listed on the WHO prequalification list non-assert declarations allowing them 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 and all African states which are not classified as low income of LDC like South Africa, Botswana.