brunofw2

The prospect of bioterrorism on a massive scale has painted the Bush administration into a corner, as it tried to address demands for price reductions on the anti-anthrax drug Cipro while maintaining an anti-generics position in international trade negotiations. When the anthrax scare first hit, Cipro was understood to be the drug of choice for treatment. Secretary of Health and Human Services Tommy Thompson said he wanted a stockpile adequate to treat 10 million exposed persons. That meant he needed 1.2 billion Cipro pills (the treatment regimen is two pills for 60 days). Bayer, which holds the disputed patent rights to Cipro in the United States, could not meet that demand in a timely fashion. For the drugs it was able to supply, Bayer was charging the government $1.89 per pill. The drugstore price was more than $4.50. Indian companies sell a generic version of the same drug for less than 20 cents. In October, Senator Charles Schumer, D-New York, called on the administration to use its authority, under existing law, to issue compulsory licenses to generic companies to make Cipro for sale to the government. “We cannot just rely on Bayer to ensure we have a sufficient supply of Cipro,” Schumer said. “First, Bayer can only produce so much Cipro, and we should not put our best response to anthrax in the hands of just one manufacturer. Second, buying Cipro only from Bayer –– who charges a lot more than generic manufacturers would –– means we spend a lot more and receive a lot less. Hopefully, we won’t even need to use the Cipro we already have on hand, but if we make arrangements to purchase it from multiple generic drug manufacturers, we’ll have it if we need it.” Schumer’s call for generic competition cast a spotlight on Bayer’s monopoly control over Cipro — controversial, in that generic companies had sued to challenge Bayer’s patent, but dropped suit upon receiving payment from Bayer [see “Names in the News,” this issue] — and its resultant power to set prices and limit supply. But the Bush administration chose not to exercise its authority to introduce generic competition. With the spotlight shining on Bayer’s price-gouging for Cipro, however, the Department of Health and Human Services (HHS) was forced into action. Against a backdrop that he might be forced to issue compulsory licenses if Bayer refused to drop the price, Secretary of HHS Tommy Thompson cut a deal with the company to lower Cipro prices, agreeing on a price tag of 95 cents a pill. The Washington Post reported soon after that HHS pays Bayer 45 cents per Cipro pill for purchases under a separate government program. Nonetheless, Thompson and Bayer congratulated each other on HHS’s tough negotiating skills and Bayer’s generosity. “This agreement means that a much larger supply of this important pharmaceutical product will be available if needed,” Thompson said. “The beneficial price also means that we can have more funds available to assist state and local health responders to be ready for all eventualities. I commend the Bayer Corporation for its ongoing efforts to ensure a fully adequate supply of this valuable product.” “Bayer is fully committed to supplying America in its war on bioterrorism,” said Bayer president Helge Wehmeier. “This agreement between Bayer and the Department of Health and Human Services is an important security measure that will enable the nation to have in its stockpile ample supplies of Cipro to combat the threat of anthrax. Cipro has become standard for anthrax treatment. The men and women of Bayer are 100 percent committed to delivering this vital antibiotic to the U.S. government on schedule.” Activists campaigning to improve access to essential medicines had a different take. “The government is cutting corners on public health to protect its negotiating position in the Doha World Trade Organization meeting,” said James Love, director of the Consumer Project on Technology, “where the issue of compulsory licensing of drugs, and imports under a compulsory license where a country does not have domestic capacity for production, is a central issue, with the United States, Canada and the European Union opposing the Africa group. Americans are being put at risk in order to protect the pharmaceutical companies doing business in Africa and other developing countries.” The issue, said Asia Russell of the Health GAP Coalition, was that the U.S. government “did not want to set a precedent that could be used against the U.S. administration at the upcoming WTO meeting.” “If U.S. officials had agreed to license production of generic ciprofloxacin,” she said, “all their arguments against patent flexibility in poor countries seeking generic AIDS drugs would have fallen to pieces — and Robert Zoellick, the U.S. Trade Representative, wouldn’t tolerate that, no matter how high the stakes. Thousands die daily from untreated AIDS globally, and Zoellick is blocking the use of common-sense strategies among poor countries to promote generic AIDS drug access.” If a desire to avoid a precedent was their goal, however, the administration failed. It was enough that the threat of compulsory licensing loomed over the HHS negotiations with Bayer. Brazil quickly alleged hypocrisy in the U.S. position — noting U.S. willingness to use compulsory licensing at home (or at least the threat) while working to effectively block poor countries’ use of the same policy tool, as did the New York Times. “When the federal government wanted to stockpile the antibiotic Cipro as a treatment for anthrax,” the Times editorialized, “Health and Human Services Secretary Tommy Thompson persuaded Bayer, the patent holder, to cut the price of the drug by threatening to buy generic versions. Yet the Bush administration is derailing efforts by poor countries ravaged by AIDS to facilitate their efforts to do the same.” The Cipro dispute appeared key to swinging momentum to poor countries as the WTO negotiations approached. African and other poor countries sought a declaration that the WTO’s intellectual property rules not be interpreted in ways that undermine efforts to advance public health. Above all, they sought to clarify their existing right under WTO rules to do compulsory licensing. The Cipro issue also sparked new efforts to consider how intellectual property rules affect health care in the United States. Some consumer groups have sued to challenge Bayer’s patent on Cipro. Others are using the Cipro example to oppose a fast-moving Congressional proposal to extend patent terms for drugs companies that undertake studies on how their drugs affect children [see “Behind the Lines,” this issue]. As a more structural response, Representative Sherrod Brown, D-Ohio, introduced legislation, H.R. 3235, the Public Health Emergency Medicines Act, that would reiterate the government’s ability to do compulsory licensing in case of public health emergency (the government currently has this right, without regard to situation of national emergency) and establish that compensation paid to patent holders should be “reasonable.” It lists a variety of criteria to determine reasonability, including how much the patent holder invested and risked in the drug’s development, and how significant the government contribution was to the drug’s research and development. It also would permit the government to authorize generic producers to manufacture on-patent drugs in the United States for export to countries undergoing public health emergencies. Fonte: http://multinationalmonitor.org/mm2001/01november/nov01front.html Acessado em: 29/11/2006

EUA temem que Brasil amplie medidas Para norte-americanos, decisão contra o laboratório Roche poder ser apenas a primeira de uma série Os EUA temem que o Ministério da Saúde decida ampliar o uso do argumento de "emergência nacional" para quebrar patentes de outros remédios consumidos no Brasil e não limite essa estratégia aos medicamentos anti-Aids. Apesar disso, o Departamento de Estado norte-americano ainda não decidiu como reagir, de forma oficial, à decisão do governo brasileiro de quebrar a patente do nelfinavir, medicamento anti-Aids do laboratório suíço Roche. Até a manhã de ontem, o Departamento de Estado acreditava que a quebra não afetaria diretamente o interesse da indústria norte-americana nem um acordo sobre patentes fechado em julho entre os EUA e o Brasil. Além disso, os EUA reconheciam terem eles próprios sugerido ao Brasil, durante o conflito encerrado entre os dois países, que substituísse o argumento da quebra de patentes por falta de produção local (motivo original do conflito já encerrado) pelo argumento de emergência nacional. Essa avaliação, porém, começou a mudar ao longo do dia com a constatação de que, nos EUA, a patente do nelfinavir pertence à companhia Agouron, uma subsidiária norte-americana da Pfizer. Diante desse fato, o Departamento de Estado passou a avaliar, a pedido dos suíços, se, ao quebrar a patente da Roche, o Ministério da Saúde teria desrespeitado ou não seu compromisso de informar previamente os EUA sobre a quebra de patentes norte-americanas. Além disso, depois de consultas com a indústria norte-americana e com o laboratório suíço, cresceu o temor dentro do governo norte-americano de que a decisão do governo brasileiro seja apenas a primeira de uma série. Os EUA querem saber se o Brasil tem planos de ampliar a mesma estratégia usada contra a patente do nelfinavir para a quebra de patentes de outros medicamentos (principalmente no campo das doenças crônicas, onde o consumo de remédios é maior). No entanto, os EUA agem com cautela. Os norte-americanos esperam que o governo brasileiro e a Roche cheguem brevemente a um acordo e não pretendem interferir, com uma declaração pública, numa negociação em curso entre o Ministério da Saúde brasileiro e o laboratório suíço. Para quebrar a patente do nelfinavir, o Brasil anunciou que irá usar o artigo 71 da Lei de Patentes, que prevê a licença compulsória em casos de emergência. Nos últimos meses, os EUA têm argumentado que a quebra de patentes só tem amparo legal se for motivada por uma emergência nacional. Segundo os norte-americanos, as leis internacionais de comércio proibiriam um país de quebrar a patente de um produto sob a justificativa de que seu detentor não o produz localmente. Os EUA reconhecem como legítima a quebra de patentes em casos de emergência nacional. O problema é que não há, no Brasil ou nos EUA, uma definição clara da expressão "emergência nacional" e, em tese, ela pode ser usada para evitar uma epidemia e não apenas para eliminá-la.  Mídia dos EUA dá amplo espaço à decisão do Brasil da Redação A quebra da patente do princípio ativo nelfinavir pelo governo brasileiro teve ampla repercussão na mídia estrangeira, principalmente nos Estados Unidos. Muitos jornais, entre eles o "The New York Times", destacaram que é a primeira vez que um país em desenvolvimento decide liberar genéricos sem permissão do detentor da patente. Ativistas da área de saúde disseram que a decisão, se for colocada em prática, será um exemplo para outros países em desenvolvimento. "Isso pode encorajar outros países a emitir licenças para copiar anti-retrovirais", disse ao "San Francisco Chronicle" Paul Davis, da ACT UP-Philadelphia, ONG que cobra maior acesso à medicina em países pobres. O "Financial Times", do Reino Unido, também citou essa possibilidade e, na edição on line de hoje, o editorial diz que a decisão brasileira é um mau precedente. Para o diário, os ataques de governos a direitos de patente de empresas são um retrocesso, pois a descoberta de novos tratamentos, como a vacina para a Aids, depende da pesquisa e de lucros que as leis de patente protegem. Segundo o "The Wall Street Journal", a Roche terá tempo para negociar com o Ministério da Saúde, já que a distribuição do genérico em escala comercial poderá começar em fevereiro de 2002. Mas autoridades brasileiras disseram que, ainda que o gasto caia com a produção local, o país terá de importar mais remédios patenteados no futuro, porque o número de pacientes de Aids deverá crescer e alguns terão resistência a drogas existentes. Já o "USA Today" publicou texto da agência de notícias Reuters que inclui comentário da Roche. A empresa disse que o Brasil deveria informar a decisão ao representante comercial dos EUA. Mas autoridades brasileiras disseram que isso não era necessário em caso de emergência nacional. Ao "Washington Post", uma autoridade norte-americana que não quis se identificar disse que a medida deve ser estudada antes de comentário oficial, mas concordou que Washington não fez objeções à produção de nelfinavir sob a lei brasileira. A droga, fabricada pela Roche, é vendida em conjunto com a Pfizer (EUA), que detém a patente.  Desconto mantém patente, diz Serra Leila Suwwan da Sucursal de Brasília Um dia após o anúncio da quebra de patente do nelfinavir, medicamento fabricado pela Roche e que compõe o coquetel anti-Aids, o ministro da Saúde, José Serra, acenou trocar a medida da véspera por uma redução no preço do remédio. As negociações suspensas há duas semanas devem ser retomadas em breve. A Roche já pediu audiência ao ministro. Caso consiga uma redução de mais de 40% no preço do Viracept -nome comercial do nelfinavir-, será mais uma vitória para o ministro Serra, que é pré-candidato tucano ao Planalto. "Se o presidente da Roche vier agora e fizer uma proposta boa, não temos por que não aceitar", afirmou Serra. O processo de quebra de patente ainda não começou e depende de um decreto que caracterize ""estado de emergência". Mas o ministro quer pressa na negociação: "Se for mais adiante, quando a Far-Manguinhos estiver fabricando, aí não tem jeito", ressalvou Serra. O ministro não explicou o que seria uma "boa" proposta, mas adiantou que, para evitar a quebra de patente, a Roche deve apresentar um desconto semelhante ao concedido pela Merck Sharp&Dohme, laboratório que fabrica o indinavir e o efavirenz, outros dois remédios anti-retrovirais. "Seria mais fácil para todos se a Roche atuasse como a Merck. A Merck atuou de maneira mais sábia", disse Serra. Redução Em março, a Merck reduziu o preço do indinavir em 76,5%, e do efavirenz, em 63,8%, gerando uma economia de US$ 38 milhões para a pasta. A Roche diminuiu o preço do nelfinavir em 13% para a concorrência pública de março deste ano. Depois, o laboratório ofereceu uma redução adicional de 30%, baixando o preço de cada comprimido de US$1,12 para US$0,78. "Trinta por cento não era bastante", disse Serra. De acordo com o ministro, o preço pode diminuir mais que 40%. Por menos do que isso, o ministério vai optar pela produção no laboratório Far-Manguinhos. Similares Apesar de a Roche ser detentora da patente do nelfinavir, a Anvisa (Agência Nacional de Vigilância Sanitária) já registrou quatro medicamentos similares. O medicamento similar tem o mesmo princípio ativo que o medicamento de marca, mas não tem as comprovações de equivalência química e de absorção pelo organismo (testes de bioequivalência e biodisponibilidade). "Sendo um medicamento patenteado, não deveriam existir similares", disse Serra, que desconhecia a existência dos registros. Os quatro similares são nacionais, fabricados pelos laboratórios goianos Neo-Química e Iquego e os paulistas Laob e Eurofarma. Quebra A quebra de patente, caso ocorra, não fere o acordo de cavalheiros fechado entre o Brasil e os Estados Unidos para evitar um processo na OMC (Organização Mundial do Comércio) porque a licença compulsória seria decretada devido a uma "emergência nacional", e não à falha da Roche de fabricar o produto no país. Segundo a Embaixada dos Estados Unidos, a quebra de qualquer patente por motivo de emergência nacional nunca foi questionada pelo país. Para Serra, a desvalorização cambial é um dos motivos da emergência. "Os preços ficaram insuportáveis", disse.

U.S. drug maker Merck and Co. has agreed to slash the prices of two AIDS drugs in Brazil, bowing to pressure from the government, which was poised to break the drugs' patents, the Health Ministry said on Thursday. After weeks of negotiations, Merck agreed to drop the price of Indinavir by 65 percent -- to 47 cents from $1.33 for a 400 mg dose -- and of Efavirenz by 59 percent -- to 84 cents from $2.06 for a 200 mg dose. The drugs are used in an anti-AIDS cocktail that Brazil gives free to patients in its much-praised campaign against AIDS. "We consider this a victory,'' said Paulo Teixeira, national coordinator of the Health Ministry's AIDS program. "But our main satisfaction is to have found an acceptable solution for the country, for the company and for everyone.'' Merck officials in Brazil and the United States were not available for comment. The Brazilian government, in its aggressive campaign against AIDS, had said it would break Merck's patent on Efavirenz and start manufacturing the drug in June unless the company lowered its prices. Under the price accord, Brazil agreed to halt its plans to break the patent, although it reserved its right to do so ''whenever necessary, in accordance with national interests,'' Teixeira said. The price reduction will save the ministry about 83 million reais ($39 million) out of a $305 million AIDS drug budget. Efavirenz accounts for more than 10 percent of that budget. ROCHE IN ROUND TWO With victory under its belt, Brazil now plans to target drug maker Roche Holding AG, which manufactures Nelfinavir, also part of Brazil's AIDS cocktail. "We have been in negotiations with Roche, but nothing has been agreed on,'' Teixeira said. ``If there is no price accord, we will go ahead and break their patent.'' Brazil has become a model in the global AIDS fight, but a law that permits it to manufacture AIDS drugs under certain conditions has angered the pharmaceutical industry, which is trying to punish the country in the World Trade Organization. Under Brazilian law, foreign companies must start manufacturing drugs locally within three years of winning a patent concession or lose exclusive rights in Brazil. Merck's negotiations with Brazil heated up after the company slashed the prices of AIDS drugs Crixivan and Stocrin for countries in sub-Saharan Africa earlier this month. Brazil got a smaller discount but accepted the offer, recognizing that it was financially better-off than many African nations, Teixeira said. Brazil and Merck, however, remain at odds over Efavirenz, a generic version of Stocrin. Merck has threatened to take Brazil's state pharmaceutical company to court for allegedly breaking Stocrin's patent by importing Efavirenz from India. Teixeira said the legal dispute continued, although Brazil was confident it had abided by national laws. Brazil's activist public health policy has meant that only 0.6 percent of its adult population is infected with HIV or AIDS, compared with the world's estimated high of 35.8 percent in Botswana. But its rate still works out as 530,000 cases. Starting in 1996, Brazil began making AIDS drugs as part of its policy of free treatment for all patients. It now legally makes eight of the 12 drugs used in the AIDS cocktail. Fonte: http://www.globalaging.org/health/world/fakedrugs.htm Acessado em 04/12/006

JOHANNESBURG, South Africa -- The South African government has been tossed a hot potato by Indian drug maker Cipla, which asked Wednesday for legal permission to supply the country with low-cost generic copies of patented AIDS medicines. The gambit by Cipla Chief Executive Yusuf Hamied for a "compulsory license" for eight anti-retroviral drugs used to treat AIDS completely sidesteps the landmark legal battle between South Africa and 39 leading pharmaceutical companies over drug-patent rights. The lawsuit, which opened this week, has been postponed until April 18 to give the drug makers more time to challenge a 1997 law that allows the government wide discretion to limit patent rights in order to import cheaper medicines. AIDS Fighters Win Skirmish in South African Legal Fight (March 7) Price War Breaks Out Over AIDS Drugs in Africa as Generics Present Challenge (March 7) AIDS Epidemic Puts Drug Firms in a Vise: Treatment vs. Profits (March 2) Bush Won't Alter Clinton's AIDS Policy Despite Criticism From Drug Firms (Feb. 21) Drug Industry, AIDS Community Is Jolted by Cipla AIDS-Drug Offer (Feb. 8) Cipla's request tests claims by the drug giants that the legislation under dispute is unnecessary because patent law allows the government more acceptable alternatives such as granting compulsory licenses in emergencies to achieve the same goal. But the request could also prove to be a trial of the government's assertions that the drug firms' reluctance to provide affordable medicines is at the heart of its own poor response to the AIDS epidemic sweeping the country. An estimated four million South Africans are believed to be infected with the virus that leads to the disease. Some critics suggest that the government, which only a year ago was pilloried for its policies questioning the link between HIV and AIDS and dismissing AIDS drugs as "toxins" might be using the lawsuit and the negative publicity it has focused against the drug companies to restore its own tattered credibility. They warned that the government risked slipping back into disrepute if the Cipla opportunity was squandered. Officials privately say they are worried that should Cipla win its bid to supply the country with cheap AIDS drugs, the government will not have the budget to buy them or distribute them. "We are in real danger that Cipla could open the door on the AIDS drugs barrier in this country and we will not be able to walk through," said one health-ministry official. Mr. Hamied said so far neither the government nor any of the drug companies that own the patents he plans to copy have tried to contact him. Mirryena Deeb, the head of the Pharmaceutical Manufacturers Association of South Africa, a trade group party to the lawsuit against the government, told a news conference Thursday that her organization had no plans to challenge Cipla's request. "On the contrary, we welcome it because it proves what we have been saying all along: that we are only against [the 1997 law] and not access to cheaper drugs," she said. However, she added that some PMA members, which include the large international firms, might challenge the application in their individual capacity. Cipla told the Registrar of Patents at the Department of Trade and Industry in a letter on Wednesday that it was eligible for a compulsory license because the large pharmaceutical companies had abused their patent rights by failing to meet demand "on reasonable terms." Now the government must examine its argument and hear any challenges by patent holders. But according to Stephen Saad, Chief Executive of Aspen Pharmacare, South Africa's largest generic-drug manufacturer, the government could at any time declare AIDS a national emergency and grant compulsory licenses to make generic AIDS drugs without a challenge. Prepared for such an event, Aspen already has a contract with Cipla's Indian rival Hetero to make three generic AIDS drugs in South Africa. "We're just waiting for the government to give the word. It's just not coming," he said. Health Minister Manto Tshabalala Msimang says she ruled out the option after a meeting of African Health ministers last year concluded that national emergencies could only be called for a temporary period of time, which is not sufficient to deal with the AIDS problem on the continent. Write to Robert Block at bobby.block@wsj.com Fonte: http://lists.essential.org/pipermail/pharm-policy/2001-March/000764.html Acessado em 30/11/2006

O documento desenvolvido no âmbito da OMS tem a função de reestabelecer critérios éticos na promoção de remédios (aqui entendida como qualquer atividade “informativa e de persuasão desempenhad