Multinational pharmaceutical company Boehringer Ingelheim on Monday gave a guarded response following threats by the Treatment Action Campaign (TAC) and the Generic Anti-Retroviral Procurement Project (GARPP) to bypass it and import generic nevirapine.
The company was responding to a request from the TAC and the GARPP to get permission to import generic nevirapine for use in combination-anti-retroviral treatment, and the threat of court action if no permission was forthcoming.
According to the TAC’s electronic newsletter on Monday, the latest request follows previous attempts by the TAC and Médécins Sans Frontières South Africa to obtain voluntary licences for nevirapine since 1999.
The newsletter said the Boehringer Ingelheim group had the exclusive right to sell nevirapine in South Africa, which it markets as Viramune and sells at R410,40 for an adult’s monthly supply. But a quality generic equivalent, already registered for use in the country by the Medicines Control Council, can be bought for just more than R70.
”In other words, five times as many people could be treated at the generic price,” said the newsletter, highlighting the fact that without Boehringer Ingelheim’s permission the two Aids activist projects could expose themselves to litigation.
Should the company refuse the TAC and the GARPP the right to import generic nevirapine — on its own and as part of combination products — the organisations will apply to the commissioner of patents for compulsory licences that will entitle them to import generic nevirapine.
Said Boehringer Ingelheim technical director Kevin McKenna: ”We will have to study it [the request] very carefully. Obviously, I need to have a clearer picture, but there is one thing that has disturbed me, and that is the apparent aggressive tone of the letter.”
McKenna said he imagined that the company would respond within the ”next couple of weeks” after having discussed it first with its principals in Germany.
In terms of the Patents Act, the commissioner can grant such licences if it was shown that Boehringer Ingelheim has abused its right in the nevirapine patent.
According to TAC and the GARPP, South African patent law already recognises that the rights in a patent are being abused by ”charging an excessive price that results in limited access”.
Nevirapine is used as one of three drugs in the treatment of HIV/Aids in adults and children. A single dose of the drug is also used extensively in poor countries and communities to reduce the risk of mother-to-child HIV transmission. It is an essential component of triple drug therapy for pregnant women with HIV/Aids. — Sapa