The Brazilian government might again get into a worldwide fight about anti-AIDS drugs. Now it’s over Nelfinavir, a drug from the Swiss laboratory Roche.
Last June, the World Trade Organization defended Brazil in the so-called patent war between American laboratories — which had the support of the U.S. government — and the Brazilian Health System.
After a series of discussions and international meetings, Brazil’s proposal was accepted: The country would be allowed to break American patents on anti-AIDS drugs only for situations agreed upon as incontestable.
This time around, the health minister of Brazil announced the possibility of producing a generic alternative to Nelfinavir, or breaking its patent. The proposal was made public after the Brazilian government had no success in asking Roche to lower its prices. Brazil has the support of the United Nations and the WTO. Each pill of Nelfinavir costs the equivalent of US$1.36, but the drug is only one of 12 medications that comprise the anti-AIDS cocktail.
There are about 600,000 HIV-infected people in Brazil, according to the Brazilian National Coordinate for AIDS and Sexually Transmitted Diseases.
Brazil spends about $90 million alone to buy Nelfinavir from Roche, according to the health minister. The government spends about $300 million a year to buy and distribute the 12-drug cocktails; Brazil distributes the medication for free to AIDS patients within its borders.
Under Brazilian law, the compulsory license for producing anti-AIDS drugs may be taken from patent-holders in two situations: national emergency and abuse of economic powers. Brazil said both situations apply in this case. “We’ve tried, but Roche didn’t lower Nelfinavir’s price,” said José Serra, Brazilian health minister.
Representatives of Roche are not commenting on the situation.
After the compulsory license announcement, Roche scheduled a meeting with the minister, but no official decision has been made yet. According to government officials, Brazil might wait until the end of this year before it produces a Nelfinavir generic drug at Farmanguinhos laboratory in Rio de Janeiro.
Farmanguinhos already produces seven of the 12 drugs that make the anti-AIDS cocktail.
With compulsory licensing, production costs could be lowered by more than 40 percent. The license allows the country to produce a generic drug with the government still paying the royalties. That means Roche would still receive an amount for its patents.
Meck Sharp & Dome, a German laboratory that also provides anti-retroviral drugs, has already formed an agreement with Brazil’s government. In March, the lab authorized the local production of Efavirenz and Indinavir. Brazil pays only the royalties.
Efavirenz is used by 15 percent of Brazilian AIDS patients and has a reasonable reduction in costs: from a $2.05 pill to one for 84 cents. Indinavir is used by 25 percent of the patients and the pill’s cost has fallen from $1.33 to 33 cents. According to the health ministry, this means an almost $40 million overall reduction in general costs.
“Our situation should be an example for other Latin American, Caribbean and African nations. Everyone should have free access to these medications,” said Minister Serra.