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"We don't want to break patents. We want to ensure the sustainability of the STD (sexually transmitted diseases)/AIDS program, and that is why we are trying to negotiate," affirmed the Ministry of Health's secretary of Health Surveillance, Jarbas Barbosa.
Barbosa was referring to negotiations with the Merck & Dohme and Gilead Sciences pharmaceutical companies, manufacturers of medicines to combat AIDS.
According to the secretary, the two laboratories have shown receptiveness to the Brazilian government's proposal to produce the medications for free distribution to AIDS patients.
Abbott Laboratories, the manufacturer of Kaletra, on the other hand, refused to negotiate and has until July 7 to submit a concrete proposal to the government.
Otherwise, the Ministry will declare the patent broken, and Kaletra will be produced by Brazil's Farmanguinhos laboratory.
The government's proposal was sent to the three laboratories (Abbott, Gilead Sciences, and Merck & Dohme) on March 14 of this year.
The intention of the government, according to Barbosa, is to lower the costs of producing anti-AIDS cocktails.
"Kaletra is the medication that has the biggest impact on the Ministry of Health's budget. We spend around US$ 96.9 million (230 million reais) per year.
"It is estimated that domestic production can reduce the current price by up to 50%," he affirmed. The secretary pointed out that this may encourage less expensive production of new drugs that are being launched.
The representative of the Pan-American Health Organization (PAHO), Horácio Toro, said that patent-breaking will enable the population to have access to cheaper medicines, which will be available to everyone who needs them.
If Brazil produces Kaletra, it is estimated that the unit cost will drop to US$ 0.68, compared with its current price of US$ 1.17.
Barbosa informed that the reaction to patent-breaking has been positive, and he stressed that the measure does not violate legal norms.
"We are in a pioneering position, using complete flexibility. We are not disobeying rules nor tearing up contracts. We are using everything that is stipulated in international trade agreements," he concluded.
The National Industrial Property Institute (INPI) considers that the possible breaking of the patent on the anti-retroviral drug, Kaletra, by the Ministry of Health should not lead to international sanctions against Brazil.
According to the president of the INPI, Roberto Jaguaribe, "patent-breaking, which really means compulsory licensing, is provided for not only in Brazilian law but also in international instruments, such as the World Trade Organization's (WTO) Trips Agreement (Agreement on Trade-Related Aspects of Intellectual Property Rights), which foresees this possibility under special circumstances."
Jaguaribe said that a similar example of patent-breaking "was when the United States permitted multiple compulsory licensing for the production of drugs to combat eventual anthrax attacks in the country."
ABr - www.radiobras.gov.br
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