Brazil Breaks Patent Monopoly on Costly HIV Medicine to Increase Access to Treatment

On FridayJune 24 in Brazil President Luiz Inácio Lula das Silva Lula and Minister of Health Humberto Costa issued a decree authorizing a compulsory license which would effectively end the patent monopoly in Brazil on a drug used for the treatment of people living with HIV/AIDS. Issuance of a compulsory license is legal under World Trade Organization rules and is a cost-cutting measure used to protect public health. In this case the government has said that the National Institute of Drug Technology (Far-Manguinhos) is able to produce generic versions of Abbott's lopinavir/ritonavir (brand name "Kaletra") for as much as 60% less than Abbott¹s price.

On March 15 2005, Brazil announced its intent to issue compulsory licenses for three high-priced, patented AIDS medicines if drug companies did not negotiate voluntary licensing agreements.

Currently a majority of the government's budget for antiretrovirals is spent on the purchase of three patented drugs: Abbot's Lopinavir/Ritonavir, Gilead's Tenofovir, and Merck's Efavirenz. Brazilian public and private companies are producing 7 out of 16 antiretrovirals that are used in the triple therapy although there is capacity to produce all of the needed medicines.

"The medicines are critical for HIV treatment when initial combinations of medicine have failed. The high cost of second generation patented HIV/AIDS drugs threatens the sustainability of treatment program not only in Brazil, but throughout the developing world," said Asia Russell. "Now other countries, particularly countries with the capacity to produce and export medicines to other countries must follow suit and break the patent monopolies of overpriced AIDS drugs in order to ensure access to affordable life-long treatment."

"In the past Brazil has been reluctant to export out of fear of an even bigger political attack by the U.S. Hopefully, this signals that Brazil has now crossed the bridge, that it will issue similar licenses for additional second generation AIDS drugs and that it will produce for export," said Brook Baker of Health GAP.

The decree contains a provision that permits Abbott 10 days to respond with a price as low as the generic price; advocates urged the government of Brazil to produce Kaletra generically even if Abbott chooses to respond with an price equal to the Brazilian generic. ³Competition through multiple sources of production of essential medicines is critical to increasing sustainable access to affordable treatment,² said Sharonann Lynch. "To meet needs for the long haul, developing countries can't leave the manufacture of life-saving drugs solely in the hand of the patent-based industry."

Brazil's National STD/AIDS program has been internationally lauded for its program of universal HIV treatment access and bold prevention campaigns. Last month Brazil rejected $40 million in AIDS funding from the United States that was conditioned on Brazil agreeing to condemn prostitution.

"The success of the Brazilian AIDS treatment program has been made possible by the local production of generic medicines. This policy has brought down the price of raw materials for antiretroviral medications internationally. The Health Ministry must stand up to pressure from the pharmaceutical companies and the U.S. government--not only for the Brazilian people, but for people living with AIDS around the world," said Sean Barry of Health GAP.