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Combinação tripla de anti-retrovirais genéricos em doses fixas é quatro vezes mais barata que os medicamentos de marca usados individualmente. Mesmo assim, governo dos EUA tenta impedir países de utilizarem essa importante ferramenta contra a aids. O tão esperado Plano Global dos Estados Unidos para combater o HIV/aids, divulgado no dia 23 de fevereiro, demostra claramente que a administração Bush é contra o uso de genéricos de qualidade, incluindo as combinações de doses fixas, que são remédios com dois ou três anti-retrovirais numa única pílula. Além disso, o coordenador do Plano, um ex-executivo da multinacional farmacêutica Eli Lilly & Co, Randall Tobias, já questionou publicamente, inúmeras vezes, a qualidade dos genéricos utilizados para tratar portadores do HIV/aids em países em desenvolvimento, ignorando os padrões de qualidade definidos pela OMS (Organização Mundial de Saúde) e acusando os fornecedores desses genéricos de colocar em risco a vida dos pacientes. MSF está bastante preocupada que a administração dos EUA não permita que países e programas interessados em financiamentos do Plano Global tenham acesso aos recursos do Plano para compra de remédios de qualidade a preços acessíveis, em particular em combinações de doses fixas. Essa combinação, até cinco vezes mais barata que os remédios de marca, já recebeu o certificado internacional de qualidade, segurança e eficácia da OMS, e é produzida pelos mesmos laboratórios farmacêuticos que fabricam centenas de genéricos usados pelos americanos diariamente. As combinações de doses fixas são amplamente reconhecidas como sendo um instrumento importante para se aumentar o uso de anti-retrovirais em países em desenvolvimento e, com base nas experiências de fornecer anti-retrovirais nesses países, MSF vem se tornando uma grande defensora da combinação tripla de doses fixas. Mais de 50% dos pacientes atuais de MSF e 70% dos pacientes mais recentes estão sendo tratados com base nas recomendações da OMS de se utilizarem as combinações triplas de doses fixas. Os resultados clínicos até o momento têm sido excelentes. Atualmente a OMS recomenda que a combinação tripla de doses fixas seja produzida por fabricantes de genéricos porque as patentes dos medicamentos usados na combinação são de diferentes indústrias. A combinação tripla, aprovada pela OMS, mais barata custa 140 dólares por paciente/ano e pode ser administrada na forma de uma única pílula duas vezes ao dia. No entanto, caso os mesmos remédios fossem adquiridos da indústria de marca, individualmente, o preço seria de 562 dólares por paciente/ano e o paciente ainda teria que ingerir seis pílulas por dia, o que dificulta a adesão ao tratamento. Em outras palavras, os programas de HIV/aids têm de fazer uma opção: para cada 500-600 dólares que eles gastam com anti-retrovirais, ou eles podem prolongar a vida de uma pessoa oferecendo medicamentos de marca que o paciente terá que tomar na forma de seis comprimidos, ou eles prolongam a vida de quatro portadores do HIV/aids, oferecendo uma única pílula duas vezes ao dia, produzida por fabricantes de genéricos. A administração Bush parece ignorar o fato de que essas ferramentas no combate ao HIV/aids existem hoje e estão sendo amplamente usadas em programas pelo mundo. MSF está preocupada que a Conferência sobre Combinação de doses fixas a ser realizada em Botsuana, entre os dias 29 e 31 de março, com patrocínio do governo americano, não leve ao desenvolvimento, ao estudo e à considerações sobre a segurança, eficácia e qualidade dessas combinações. Ao contrário, MSF acredita que esta conferência irá enfraquecer as recomendações da OMS e atrasar, impedir ou colocar em dúvida o uso de genéricos de qualidade a preços acessíveis. A administração Bush está isolada na sua visão sobre as recomendações da OMS já que não existe base médica ou científica para os ataques contra os medicamentos genéricos aprovados pela OMS. As recomendações da OMS têm o apoio de agências internacionais da ONU tais como a UNICEF, UNAIDS e UNFPA, assim como do Banco Mundial, do Fundo Global de Combate à Aids, Tuberculose e Malária, Universidade Columbia, Fundação Clinton entre outros. A única explicação plausível para a posição adotada pela administração Bush sobre as recomendações da OMS é que os EUA estão mais interessados em proteger as suas indústrias farmacêuticas do que em expandir o tratamento com anti-retrovirais para um número ainda maior de pessoas. MSF oferece atualmente anti-retrovirais para mais de 11.000 pessoas vivendo com HIV/aids em mais de 20 países da África, Asia, América Latina e Leste Europeu e espera que o número de pessoas que recebem os medicamentos nos seus programas chegue a 25.000 pessoas em 25 países até o final deste ano. Fonte: http://www.msf.org.br/noticia/msfNoticiasMostrar.asp?id=276 Consultado em 13/02/2007

Num ataque sem precedentes à indústria farmacêutica mundial, o Vaticano acusou os grandes laboratórios internacionais de promoverem um "genocídio" ao impedir, na prática, que muitos pacientes de Aids de países pobres tenham acesso aos medicamentos que permitem controlar a moléstia. Nas palavras do padre Angelo D'Agostino, que alia a condição de jesuíta à de médico, a ação dos cartéis das empresas farmacêuticas, que se negam a tornar acessível o preço dos remédios, tendo auferido lucros, em 2002, de US$ 517 bilhões, "é genocida". Embora a acusação venha num tom de arroubo retórico, a Santa Sé está certa em pressionar a indústria farmacêutica. Não há dúvida de que laboratórios, até para efeitos de imagem no Primeiro Mundo, poderiam desenvolver uma política mais flexível para os impactos da Aids no Terceiro Mundo, em especial na África. Os números consolidados do continente são aterradores. A África subsaariana abriga entre 25 milhões e 28 milhões de portadores do HIV. Dos 3 milhões de óbitos mundiais registrados em 2003, 2,3 milhões ocorreram na região. Vale observar que os laboratórios relutam em baixar o preço das drogas para a África por temer que os remédios mais baratos sejam contrabandeados e depois revendidos na Europa e nos EUA. Estão, assim, corretas e são bem-vindas as críticas da Igreja Católica aos laboratórios. A guerra contra a Aids, porém, se trava em dois campos: tratamento e prevenção. E, no que diz respeito à prevenção, as posições defendidas por Roma, notadamente a condenação do uso de preservativos, são indefensáveis. O Vaticano poderia auxiliar de forma mais direta as populações de países pobres se aceitasse que, ao menos "in extremis", o preservativo é uma alternativa legítima, como, aliás, já defendem alguns sacerdotes.  Fonte: http://clipping.planejamento.gov.br/Noticias.asp?NOTCod=103641 Consultado em 13/02/2007

WASHINGTON (Reuters) - A nonprofit company will ask the U.S. government Thursday to grant licenses for production of cheaper, generic versions of an AIDS drug and a blockbuster glaucoma medicine that are still protected by patents. Washington-based Essential Inventions Inc. said the drugs, Abbott Laboratories Inc.'s AIDS medicine Norvir and Pfizer Inc.'s glaucoma treatment Xalatan, were developed with support from taxpayer funds and now are being sold at unreasonable prices. The nonprofit firm, founded this month by consumer activist James Love, will file complaints to Health and Human Services Secretary Tommy Thompson alleging "abusive prices of government-funded medicines," according to a statement posted on the Web site of the Consumer Project on Technology, headed by Love. Essential Inventions says the health secretary, under the 1980 Bayh-Dole Act, can provide licenses to other producers of patented medicines when needed for public health, or because the patent holder has failed to make the product available on reasonable terms. Norvir, known generically as ritonavir, is a protease inhibitor used to fight the HIV virus that causes AIDS. Last December, Abbott raised Norvir's price five-fold to nearly $8,000 a year for a 200-milligram "booster" dose used to make other AIDS drugs more effective, Essential Inventions said. Xalatan is the world's best-selling treatment for glaucoma, which can cause blindness. Sales in 2003 topped $1 billion. The drug's U.S. price generally is between two and five times higher than prices in Canada and Europe, Essential Inventions said. One U.S. pharmacy sells Xalatan for $60 for a four-to-six-week supply. Spokespeople for Pfizer and Abbott were not immediately available for comment. Development of both drugs was supported in part by grants from the federal National Institutes of Health. A spokesman for Thompson did not immediately respond to a request for comment. The nonprofit firm said it has suppliers ready to manufacture generic versions of Norvir and Xalatan, known generically as latanoprost, at "highly reduced" prices to U.S. consumers. The company's request will ask the health secretary to require any generic producers to contribute to funds for new medicine development, a move aimed at relieving concerns that generic competition would drain the research budgets of brand-name drug makers. Copyright 2004, Reuters News Service  Fonte: http://www.forbes.com/markets/newswire/2004/01/28/rtr1232471.html Acessado em: 28/11/2006

Pretoria - GlaxoSmithKline and unlisted German drug maker Boehringer Ingelheim had agreed to allow the widespread manufacture of cheap generic versions of their patented Aids drugs in South Africa, they said yesterday. In an out-of-court settlement with Aids activists, the firms said they would grant more licences to generic firms to produce and import antiretroviral drugs, which fight the spread of HIV. Bloomberg reported that Glaxo, based in the UK, would let the manufacturers make the antiretrovirals for a fee of 5 percent of sales, instead of the 30 percent rate it had charged local manufacturer Aspen Pharmacare in a current agreement, the Competition Commission said. The commission said it was in talks with Boehringer Ingelheim about a similar agreement. The deal comes after the Competition Commission in October found the firms guilty of anti-competitive behaviour over the sale of Aids drugs and recommended to the Competition Tribunal that they be fined and required to allow the manufacture of generics. The commission said yesterday it would not fine Glaxo for anti-competitive behaviour and was discussing a similar agreement with Boehringer. South Africa has more people living with HIV/Aids than any other country - an estimated 5.3 million, equal to 13 percent of the world's infected. Last month the government approved a national drug treatment programme to tackle the spread of Aids, finally bowing to pressure to act against an epidemic killing an estimated 600 South Africans each day. This has yet to be implemented. The commission said the deal with Glaxo, which ends a year-long probe, had produced the desired outcome. "The introduction of generic substitutes should result in a drastic reduction in the prices of antiretroviral drugs," said competition commissioner Menzi Simelane. "We are pleased with the decision," Glaxo's senior vice-president, Peter Bains, said in a statement. A Glaxo spokesperson in London said the company - the world's biggest maker of Aids drugs - would extend to other firms a voluntary licence it granted to Aspen Pharmacare in October 2001 for the production of antiretrovirals. Thembalami Pharmaceuticals, a joint venture between Adcock Ingram and India's Ranbaxy Laboratories, has already been offered another licence. Glaxo would consider applications for another two licences for the manufacture of copies of its drugs AZT and lamivudine. The company said it would consider imports to South Africa if this was not practical. Boehringer would grant three licences for the production and import of nevirapine, the drug used to prevent transmission of the HIV virus from mothers to children - the first of which has already gone to Aspen. Aspen lost 10c to R12.55 yesterday.   Fonte: http://www.busrep.co.za/index.php?fSectionId=563&fArticleId=306011 Acessado em 30/11/2006

Though it received less media attention than the “Pretoria trial” in 2001, another court case had, until this month, been going on for a year in South Africa, pitting pharmaceutical companies against anti-AIDS campaigners. On 9 December it ended in the signing of an historic agreement between the two parties, opening the gates for generic anti-AIDS medicine to be made available across sub-Saharan Africa. GlaxoSmithKline (GSK) and Boehringer Ingelheim (BI), the two pharmaceutical giants involved in the case, between them hold the patents for the three antiretrovirals that make up the most commonly prescribed (especially by Médecins sans Frontières [MSF]) treatment for AIDS in Africa: AZT and lamivudine (GSK), and nevirapine (BI). Under the new agreements, producers of generic medicines will swiftly be granted licences to make and distribute these three compounds, subject to “reasonable” conditions - royalties payable to the patent-holders will not exceed 5% of the net sale price. These licenses will be “voluntary”, which saves the pharmaceutical companies the humiliation of having states issue decrees or pass requisition laws in the form of “compulsory” licenses, and should mean the medicines are made available to patients more quickly. The agreements also provide for the producers of generic medicines to make, export, market and distribute their versions of the compounds in the 47 other countries of sub-Saharan Africa (1). This is a crucial point - it had caused World Trade Organisation negotiations on the subject to break down two years running. This applies both to the public and private sectors, and to adults’ and children’s versions of the medicines. These agreements thus validate the suggestion made to the South African government by the Clinton foundation on 23 October, that generic treatments should be available at $140 per patient per year, extending the principle to the entire region in quite spectacular fashion. It is a huge step forward: as recently as 1999, Bill Clinton’s vice-president, Al Gore, was attacked as one of the staunchest supporters of the corporations in their uncompromising stance against South Africa - and in those days brand name medicines cost $10,400 a year. Finally, the generic producers will be allowed to combine the compounds, with each other or with other products, producing fixed-dose pills. This reduces the risk of resistant virus strains appearing (2) and is therefore an important innovation in treatment. Paradoxically, this will (at first) only be available in sub-Saharan Africa. Are we at last witnessing an armistice in the “patents war” underway since the 1996 Vancouver conference, which had simultaneously brought to light both the huge hope combination therapy offered AIDS sufferers, and the gulf separating those in the North, who could pay for the expensive treatment, and those in the South, who couldn’t even afford to treat the opportunistic infections associated with AIDS. This is not the place to list the dates - though such a chronology is certainly needed - of all the negotiations, grassroots actions, and court cases where those who would defend patents at all costs faced down those who would give priority to saving lives, in what is the most horrifying pandemic since the black plague. Nathan Geffen, national director of the Treatment Action Campaign (TAC) in South Africa, is jubilant. He says: “Today, 10 December, is International Human Rights Day. It is also TAC’s 5th birthday. With the announcement of the South African government treatment plan a few weeks ago and this agreement today, there is real hope for people with HIV/AIDS, their friends and family in the months ahead that they can get life-saving medicines. Five years of struggle are resulting in the rights of people with HIV/AIDS being realised.” TAC was instrumental in ensuring that the 9 December agreements included all 47 sub-Saharan African countries - a further sign that a new internationalism is emerging to fight the parallel globalisations of the epidemic and of intellectual property rights. However, various questions remain unanswered. Speaking from Geneva, Ellen ’t Hoen of MSF’s campaign for access to essential medicines refers to TAC’s strategy in bringing the negotiations to an end. “The beauty of the compulsory licence is that you’re no longer dependent on the will of the company to cooperate,” she notes. “But if this is carried out as TAC has it, every generic manufacturer can enter the market, and that’s good news for South Africa and all of sub-Saharan Africa. Now the Medicines Control Council [South Africa’s regulatory body for medicines] should fast-track the approval of three-in-one pill pre-approved by the World Health Organisation. And we need to make sure that GSK and BI do not apply delaying tactics - but the eyes of the world are once again turned on them, and they know that the legal case can be reactivated if they don’t comply.” The 9 December agreements only apply to three compounds and two manufacturers. Now, “triomune for all” (triomune is nevirapine and lamivudine mixed with stavudine (3) and produced by the Indian generic manufacturer Cipla) is no panacea, though it is a very important tool of initial treatment. Other patent-holders must join the movement swiftly in order for the victims of resistant strains or opportunistic infections to be cured. Moreover, the geography of the epidemic is not restricted to sub-Saharan Africa. Alarming figures coming out of Asia, the Eastern European countries, North Africa and Latin America show that there are still mountains to be moved. But, though this battle is far from being the end of the war on AIDS, it does teach us one thing: as Nathan Geffen told Le Monde diplomatique, it is not just necessary to move these mountains; it is possible to move them, one by one. “The entire Competition commission process, from the initial complaint through to the settlements, demonstrates that activists can combine pressure through demonstrations and litigation to achieve fair and just objectives.” This victory should help to alleviate the feeling of powerlessness that we all sometimes feel when faced with the scale of this health catastrophe. Fonte: http://mondediplo.com/2003/12/19aids Acessado em 30/11/2006