Boehringer fails to register tipranavir in Brazil after using Brazilian patients in registrational study

Boehringer Ingelheim, the manufacturer of tipranavir, has refused to launch the drug in Brazil because it disagrees with the patent law of the country. By not registering the medicine in the country, it is difficult for treatment-experienced patients who need this potentially life-saving protease inhibitor, to access it. No medicine can be sold, offered by the Public Health System – without registration.

The decision not to register a drug is a right of the patent holder, this appears contrary to the international ethical guidelines for clinical research outlined in the Helsinki declaration. Paragraph 19 states ‘medical research is only justified if there is a reasonable likelihood that the populations in which the research is carried out stand to benefit from the results of the research’. [1]

The obligation to make treatments readily available in any country that has contributed to the research for approval is specifically to stop Western companies running less expensive studies in countries where research is relatively cheap, only to then produce drugs that are not available to citizens from those countries.

Brazil contributed over 10% patients (92 of the total 863 patients) in the RESIST II study run in Europe, Australia and South America. Boehringer continues to provide tipranavir to he Brazilian patients that were part of this study.

Recently, the Public Prosecutor of the State of S⭠Paulo went to court for an import license for tipranavir and T-20, for a patient with advanced HIV who has resistance to other treatments, even thought the patient has no money to import the drug. The court decision had not been reached as HTB went to press. [2]

Boehringer have been reported as not registering tipranavir because of lack of guarantee of the patent. According to Adauto Castelo Filho, one of the researchers involved in the Brazilan study, the decision was taken already in the middle of 2006. This was before the Brazilian government announce compulsory license efavirenz. [3]

An estimated 2,000-3,000 patients could benefit from tipranavir in Brazil. The lack of coordination between the Brazilian Government, the Ministry of Health and Boehringer is not in the interest of Brazilian patients.

Cost of the drug is clearly also an issue. A recent paper published in PLoS Medicine calculated that Brazil had saved approximated one billion USD since 2001 though it’s programme of negotiating with pharmaceutical companies and use of generics. [4]


  1. World Medical Association Declaration Of Helsinki: Ethical Principles for Medical Research Involving Human Subjects
  2. Estado De São Paulo – 10 January 2008,0.htm
  3. Médicos Sem Fronteiras, Campanha Acesso a Medicamentos Essenciais Access Campaign for Essential Medicines
  4. Nunn A et al. Evolution of Antiretroviral Drug Costs in Brazil in the Context of Free and Universal Access to AIDS Treatment. PLoS Medicine 2007;4(11):e305 doi: 10.1371/journal.pmed.0040305.

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