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The Brazilian government has warned three major drug companies that they must dramatically lower the price of anti-Aids drugs - or it will break their patents and allow cheap copies of the drugs to be imported. The government took its first official step towards allowing generic drugs to be imported by passing a decree changing drug regulations on Friday. More than 500,000 Brazilians are HIV-positive or have Aids. Since 1997, the government has offered free anti-Aids drugs to anyone who needs them - at a cost to the country over $100m a year. The Brazilian government has been engaged in talks with the three pharmaceutical firms, Merck, Roche and Abbott, which produce the main drugs used in its national programme. Negotiations continue But, after failing to get an agreement on bringing the price of patented drugs down by around 40%, the Brazilian government has now issued a decree changing its regulations. The decree would allow cheap copies of drugs to be imported or produced locally. Brazil's health minister, Humberto Costa, claimed the move would be protected under a new World Trade Organisation resolution, which allows poor countries unable to produce vital drugs themselves to import cheap copies. Mr Costa said the generic drugs would probably be sourced from China and India, and said he would know within a month whether the country would import generics or produce them in Brazil. Roche, Merck and Abbott have said that negotiations will continue, and that they still hope an agreement can be reached.  Fonte: http://news.bbc.co.uk/1/hi/world/americas/3085834.stm Acessado em 01/12/2006

With the Supreme Court striking down several patent rights provisions in the abortive Intellectual Property Bill as a violation of the people's fundamental rights, top officials and health activists met yesterday to discuss proposals for a new Bill. The aim was to ensure that millions of Sri Lankans would be able to obtain safe and efficacious drugs at affordable prices and that the rights of patients were given priority over the patent rights of global companies. This came after the Supreme Court in a powerful act of judicial activism reminded government officials that their main duty was to protect the rights of the people and not of global companies. Ministry Officials, doctors, pharmacists, local manufacturers, lawyers, and health activists took part in yesterday's motivating dialogue at the BMICH, with the focus on the "TRIPS Agreement, the Intellectual Property Bill and Public Health. The driving force behind the move to put patients rights before patent rights was Dr. K. Balasubramaniam, Advisor and Coordinator of Health Action International Asia Pacific. He said the long term objective of the seminar was to ensure that Sri Lanka had regular access to quality medicines which were safe and effective at prices consumers in Sri Lanka could afford. However this is dependent on the National Patent Law which is the policy instrument to make available low cost quality drugs and also develop the national pharmaceutical industry. The Intellectual Property Bill 2003 including the patent laws was introduced to meet Sri Lanka's international obligations under various conventions and the World Trade Organisation (WTO) agreement on the Trade Related aspects of Intellectual Property Rights (TRIPS). Attorney M. Sumathiran discussed the Supreme Court's June 17 decision which struck down the Intellectual Property Bill as inconsistent with the Constitution of Sri Lanka. The judges determined that several clauses of the Bill dealing with patents were inconsistent with Article 12 (1), which guaranteed equal rights as well as equal protection. Therefore the provisions of the TRIPS agreement cannot be applicable to developed and developing countries equally. The Judges said there could not be equality among those who were unequal pointing out at there was no level playing field when powerful multi-national companies were pitted against defenceless people. It was observed that although the TRIPS agreement strengthens the position of the patent holders, who are predominantly based in developed countries, it also provides for mitigatory measures to ensure patients are treated in a more 'equitable' manner. These measures were deliberately included in the TRIPS agreement to minimise abuse of the monopoly rights granted under a patent and to ensure that the needs of public health are met. While these measures are widely prevalent in other countries, Sri Lanka has failed to fulfill its international obligations and the health needs of the public, by not incorporating these mitigatory measures into the final Draft Bill. Dr. D. M. Karunaratne, Director of the National Intellectual Property Office replying to the allegations that the provision for compulsory licensing was removed at the last minute from the Bill said in 1998 the Committee on Intellectual Property removed it because it could be a deterrent to foreign investment. Attorney Sharmila Anthony of the Centre for Policy Alternatives said the whole process of presenting the Bill lacked in transparency. She said although the Bill was published in the gazette on April 25 this year, and despite repeated inquiries and requests, it was only made available to the public on May 26, leaving just two days for the public to examine the Bill and to challenge it for any inconsistencies with the Constitution. Rohan Edirisinghe of the Centre for Policy Alternatives reiterating the position said a mere publication of an advertisement in the paper calling for suggestions for the draft Bill was not adequate notice. The final version of the Bill should have been made available for public scrutiny. He also said that the State had an obligation under International law, TRIPs and the Constitution. The Attorney Generals Department in particular has a responsibility to ensure that the state obligations under human rights are protected in draft legislation of this kind. Gothami Indikadahena, Deputy Director of Commerce made a presentation on TRIPS consistent provisions to safe guard public health objectives of the Government including some proposed amendments in conformity with the decision of the Supreme Court. Prof. Tuly de Silva, Past President of the Pharmaceutical Society of Sri Lanka said if the new Bill with TRIPS consistent provisions on parallel importing and compulsory licensing becomes law, health professionals and consumers need to be assured that the drugs that are put on the market are of good quality safe and effective He stressed that quality control should be sustained at the point of manufacture, transport and sale. This cannot be done by Drug control authorities due to the lack of qualified graduate pharmacists and also due to some 8,000 varieties of drugs being imported. (According to Professor Senaka Bibile only 300-400 varieties would be sufficient). He stressed that public health protection should not be guided by multi nationals. Sri Lanka cannot afford to go to international courts to protect its rights and as such all measures should be taken for protection in the new laws. The seminar was organized by the Ministry of Health in collaboration with the Department of Commerce and HAIAP with the support of the South East Asia Regional Office of the World Health Organisation.  Fonte: http://www.dailymirror.lk/2003/07/05/News/5.html Consultado em 05/03/2007

Se o serviço brasileiro de combate à aids foi reconhecido como modelo pela Organização Mundial da Saúde (OMS) há algumas semanas, muito se deve ao trabalho de Paulo Roberto Teixeira, 55, coordenador de DST/Aids do Ministério da Saúde. Médico especializado em aids, Teixeira iniciou o primeiro programa da América Latina no Estado de São Paulo há exatos 20 anos, quando havia menos de dez casos da doença “ainda sem nome” identificados no Brasil. Como resultado das iniciativas ininterruptas e progressivas do pais, a Fundação Bill Gates premiou ontem o programa com US$1 milhão. O valor será dividido entre 60 ONGs brasileiras escolhidas por uma comissão da sociedade civil (maiores detalhes no site www.aids.gov.br ou pelo telefone 0800-611997). “O prêmio vem num momento apropriado, como consequência do debate e da divulgação de muitos anos do progresso do nosso programa nacional de combate à aids”, disse Teixeira ao Valor, por telefone, de Washington, onde recebeu a premiação. Mas Teixeira tem mais a comemorar. Na terça-feira, o Brasil conseguiu fazer com que a Organização Mundial da Saúde aceitasse sua proposta de quebra de patentes para o acesso universal de medicamentos. Por ter sido convidado pela OMS para elaborar o plano mundial de combate à aids, Teixeira não participou das quentes discussões em Genebra no inicio da semana. Mesmo assim, os efeitos colaterais de suas batalhas anteriores por essa medida foram sentidos na Casa Branca. Washington, que se opõe ao tema, reagiu negativamente à indicação de seu nome por Jong Wook Lee, diretor eleito da OMS e que assume o posto em junho. Mesmo assim, sua próxima parada será Genebra, sede da OMS, onde estará para desenvolver um programa de combate à aids à brasileira. Leia os principais trechos da entrevista a seguir. Valor: Como o sr. avalia a premiação que a Fundação Bili Cates concedeu ao programa brasileiro? Paulo Roberto Teixeira: É um endosso internacional da sociedade civil americana, o que tem relevância para a formação da opinião pública e influência nas próprias ações do programa americano e de outros países desenvolvidos. O prêmio vem num momento apropriado, como consequência do debate e da divulgação de muitos anos do progresso do nosso programa nacional de combate à aids. Isso confirma a noção internacional de que o Brasil foi o país em desenvolvimento que conseguiu obter as maiores vitórias por ter adotado uma estratégia abrangente em relação à aids. Valor: Como será aplicado esse dinheiro? Teixeira: Do ponto de vista financeiro, US$1 milhão é um volume grande. Vai significar uma ajuda adicional ao programa e nós vamos usá-los para ONGs de apoio e casas de passagem, que cuidam de pessoas em transição em algumas cidades ou outras que não têm casa nem família. Há uma grande quantidade de órfãos que são abrigados por essas instituições. São cerca de 60 iniciativas que poderão ser beneficiadas. Vamos constituir comissão com representantes da sociedade civil para publicar um edital com o objetivo de as ONGs apresentarem suas propostas. A Unesco se dispôs a administrar o dinheiro, sem qualquer custo e como forma de contribuição. Até o próximo ano, pretendemos mostrar os resultados. Vamos separar US$ 50 mil para fazer uma doação para o Fundo de Combate à Aids, Tuberculose e Malária. Valor: Esta semana, o governo brasileiro conseguiu fazer com que a Organização Mundial da Saúde (OMS) aceitasse a proposta elaborada pelo programa de combate à aids do país para avaliar o impacto das patentes nos sistemas de saúde. É uma vitória para o Brasil? Teixeira: Foi uma vitória importantíssima obtida pelo Brasil e pelos outros países que se associaram, principalmente as nações em desenvolvimento, para tirar a questão do medicamento no âmbito da OMS dos seus limites exclusivamente técnicos e fazer valer uma nova diretriz: a de que a OMS tem que se incorporar às discussões junto à Organização Mundial do Comércio (OMC) no sentido de tomar todas as medidas para garantir o acesso universal aos medicamentos. Essa postura, até então, nunca havia sido adotada pelas instituições das Nações Unidas. No âmbito internacional, esse processo foi marcado por uma série de batalhas lideradas pelo Brasil, que culminou na declaração de Doha, em 2001. No ano passado, um dos seus artigos deveria ser regulamentado, mas, por falta de consenso com países produtores de medicamentos e desenvolvidos, não foi. A questão ainda está em negociação. Demos um pequeno passo nessa estratégia. Queremos a consagração da declaração de Doha ainda este ano. Valor: O sr. foi indicado para elaborar o plano mundial para a nova administração da OMS, que tem o combate à aids como prioridade nos próximos cinco anos. Como será essa estratégia? Teixeira: Estamos numa fase preliminar de discussões com outras instituições parceiras, como o Banco Mundial, o Fundo GlobaL O que está claro é que o diretor eleito,Jong Lee, abraçou a luta contra a aids. E dentro disso, a promoção do tratamento anti-retroviral. A tarefa mais urgente é um plano para ampliar a terapia para os países pobres. A meta é de que, em dois anos, possamos incluir três milhões de pessoas. O foco será concentrado na África. O número de pessoas é grande, embora seja pequeno em comparação com as necessidades. Valor: Quanto o seu programa vai dispor para desenvolver esse plano? Teixeira: Não fiz o orçamento. Mas meu papel não é apenas verificar o que a OMS poderia fazer ou financiar. É principalmente mobilizar parcerias internacionais, até baseadas no que fazemos no Brasil. Precisaremos de ajuda dos governos dos países ricos, universidades e ONGs internacionais. Este trabalho é que vai balizar o programa. Dinheiro é importante, mas a OMS não é instituição de financiamento. Valor: O programa do Brasil é reconhecidamente um modelo internacional. Mas quais são os avanços que esse programa ainda precisa? Teixeira: São 20 anos de trabalho, o que explica os resultados positivos. Foi uma luta grande que envolveu vários segmentos da sociedade do Brasil. Com isso, alcançamos resultados equivalentes aos dos países desenvolvidos. Temos de avançar em vários pontos. Em primeiro lugar, há um grande número de pessoas que são soropositivas, mas não sabem. Para este ano, temos uma agenda para estimular as pessoas a fazerem o teste e, se necessário, usar os medicamentos o mais prontamente possível. Apesar dos esforços, também temos problemas no tratamento de grávidas para evitar a transmissão do HIV aos filhos. Não atingimos 50% das grávidas estimadas no Brasil. Isso está vinculado à questão estrutural geral e do Sistema Único de Saúde do Brasil. Temos ainda uma grande dívida em relação à saúde dos presidiários, onde a atenção no item HIV-aids é importante. Acho relevante, porém, dizer que, apesar disso, temos a convicção de que sabemos e podemos superar as barreiras existentes. É isso o que tem chamado a atenção mundial. Durante muito tempo, a maioria dos países em desenvolvimento era céticos em relação às suas possibilidades. Fomos corajosos. Valor: Como o sr. avalia a questão da prevenção da aids no Brasil? Teixeira: O Brasil se destaca pela integralidade das ações e muito na área de prevenção. Estimava-se mais de 1,2 milhão de infectados para o ano 2000. E o pais fechou o ano com menos de 600 mil infectados. Temos dados claros sobre a queda dos grupos mais vulneráveis, como profissionais do sexo, usuários de drogas injetáveis e de homossexuais. São resultados da campanha preventiva bem concretos. Valor: Em que situação estão as pesquisas para vacina contra a aids e de novos tratamentos? Teixeira: Em relação à vacina, não devemos ter um resultado eficiente nos próximos cinco anos, tanto para evitar o contágio como para neutralizar a infecção. Quanto ao tratamento, os progressos têm sido rápidos. A perspectiva de haver um controle medicamentoso cada vez com maior eficiência é nítida. Os tratamentos estão mais simples. De 30 comprimidos por dia, grande parte das pessoas passou a tomar apenas duas cápsulas diárias. Valor: Qual é a sua avaliação sobre os seus 20 anos de trabalho no combate à aids? Teixeira: Quando comecei, não havia a confirmação do isolamento do HIV. Até 1984, trabalhamos com muita sombra. Somente em 1985 passamos a contar com teste anti-HIV. Trabalhamos durante uns 12 anos de forma bastante difícil. Quando conseguimos a tratar as doenças oportunistas passamos a ter mais esperança. O AZT, em 1989, trouxe novas perspectivas. A virada veio em 1996, com o coquetel. Foi quando o otimismo tomou conta. Isso só ocorreu no Brasil porque se construía uma infra-estrutura havia 13 anos. Só hoje, a terapia tripla começa a se materializar na maioria dos países em desenvolvimento. Daí a importância de termos enfrentados questões difíceis, como drogas, sexualidade, estigma. O Brasil foi muito corajoso. Por isso, colhemos os melhores resultados. Olhando para trás, tenho alivio, o que faz minimizar os dez primeiros anos, que foram trágicos e as perdas imensas. Fonte: http://www.aids.gov.br/data/Pages/LUMISDA56F374ITEMIDF14CAEDCE600421D941758AEB7792DB7PTBRIE.htm Consultado em: 13/02/2007

A Canadian province is challenging an American firm's claim to human genes. TORONTO – The genetic test that Teacher Nancy Kumer had two years ago may have saved her life. Ms. Kumer says the test likely prevented her from developing breast cancer, which would have been "a horror." But an international battle is brewing over who owns the genes used in that test. It's a fight that will determine the expense and availability of such tests, which in turn could affect thousands of lives. The province of Ontario is effectively daring the Utah-based Myriad Genetics to take it to court over the firm's claim to the exclusive use of the genes. In Europe, several dozen hospitals, researchers, and others are already legally contesting Myriad's patent claim. Such cases could determine who - if anyone - owns the right to what have been called the building blocks of human life. "This is really a landmark case," said Abdallah Daar, an ethicist at the University of Toronto, who anticipates a Canadian court challenge. "And I would hope that it will not be resolved on a technicality, but that it will go to a higher court that will probe the principles behind it and the societal implications of owning broad patents." Based in Salt Lake City, Myriad Genetics has patented mutated parts, or sequences, of the BRCA1 and BRCA2 genes, and a test to detect those genes, which indicate an elevated risk of developing breast and ovarian cancer. In a news release, Myriad's president, Gregory Critchfield, called the test "a powerful tool in the fight against cancer." While presence of the mutations does not inevitably lead to cancer, studies in last year's New England Journal of Medicine showed that women past childbearing who tested positive and then had their ovaries removed cut their risk of ovarian cancer "completely," and reduced their chances of breast cancer by 53 percent. Myriad moved to protect its patents by warning Canadian provinces that they should cease and desist from using any other test that employs the same genetic material, and they should pay royalties for unauthorized tests or face legal action, according to Ontario's health minister Tony Clement. However, Mr. Clement called gene patenting "abhorrent" and served notice that Ontario would fight Myriad. "We do not accept their claim and we are disregarding that claim," he said. In April, Ontario will offer its own test, which uses the same gene in a different process. The province says its test provides results quicker than Myriad's and costs two-thirds less than the approximately $2,300 that Myriad charges for its test. Alberta is also offering its own test. Myriad did not answer requests for interviews. Dr. Daar likens Myriad to an inventor of a mousetrap, claiming he owns any device that traps mice. "Nobody can own our genes," he says. "They are the property of us human beings." Groups that oppose gene patenting, like the Canadian Cancer Society, say that as more genetic therapies come into use, gene-patent owners may stop others from making new, possibly better tests. "It really puts a chilling effect on research," says Society president Julie White. With millions of dollars to be made, biotech companies are hoping to stake out promising genes. It is yet unclear how many genes have been patented. Published reports say 20,000, though both Canadian and US patent offices say that is exaggerated. In a ruling in 2000, the US patent office required that for genes to be patented, the applications must demonstrate "substantial, real-world utility." Canada's patent manager, the Canadian Intellectual Property Office, also requires that all patent applications - including genes - demonstrate "well-founded" utility, according to Dr. Michael Gillen of Canada's Patent Appeals Board. Dr. Gillen argues that gene patents are a new take on old practices. Patents have been awarded for years for proteins, plant alkaloids, even for certain drugs - although all occur in nature or in peoples' bodies. "Patents are granted because once they're isolated from nature and purified in some way, they have a practical utility," Gillen says. "For example, the BRCA1 cancer gene - as an isolated gene - you can put that into a kit and use it in a test to test for cancer. The gene as it occurs in nature doesn't have that same utility. That's where the value-added comes, and that's the intellectual part of the equation and that's why patents are granted." BioteCanada, which says it represents 85 percent of Canadian genetic researchers, defends gene patents. Communications director Cate McCready says that patents balance the risk and high costs of genetic research with the hope of financial returns.  Fonte: http://www.csmonitor.com/2003/0227/p07s03-woam.html Acessado em 29/11/2006

Sally Farmer knew it was highly likely that she had inherited a mutation on a gene linked to breast cancer when she decided to have a genetic test three years ago. The disease had claimed the lives of two great-aunts, her mother and a sister. And she, too, had developed breast cancer three years earlier. "I was sure I'd be positive, but you always hope against hope, for your children's sake," she says. Before having her DNA analysed, Farmer discussed the pros and cons with a genetic counsellor. "No one should have a genetic test willy-nilly. It's a big decision to make." It cost Farmer nothing to find out she had inherited the family mutation as the test was carried out in a Sydney public hospital. In future, however, if any of her relatives want the same test on their DNA, to establish their risk of breast cancer and take preventative action, they may face bills of thousands of dollars. Genetic testing for a range of potentially fatal diseases is about to become big business in Australia. The family mutation that Farmer inherited is on a breast cancer gene known as BRCA1. The Australian patent for it was awarded to a US company, Myriad Genetics, in 1998. Genetic laboratories in this country have, with considerable anxiety, simply ignored Myriad's patent, hoping the company would turn a blind eye, as it did. No more. Last week Myriad signed a deal with an Australian biotech company, Genetic Technologies, giving it exclusive rights in Australia and New Zealand to test for mutations in BRCA1 and the other breast cancer gene, BRCA2, as well as in genes related to colon cancer, melanoma and hypertension. The move has alarmed doctors and consumers such as Farmer, a member of the Breast Cancer Action Group of NSW. "I think it is appalling that you can patent a gene," she says. "Nobody makes genes. They're part of a human being. "The Royal College of Pathologists of Australasia warns that the exclusive licence may put vital tests out of the financial reach of many people. Gene patenting may also restrict research and "put a noose" around the practice of good medicine, says its president, Professor David Weedon. "Genes impact on most human diseases and it is a fundamental right that human beings have access to their own genetic make-up," he says. The executive chairman of Genetic Technologies, Dr Mervyn Jacobson, counters that the company will provide a medically significant public service: "We'll be offering comprehensive testing for all known mutations [associated with breast cancer] for the first time in Australia." It is too early to discuss price specifics, he says, bridling at a comparison with the present free system in public hospitals. "People are doing the tests illegally and are not offering the full scope of tests." In a gold rush of gene discovery, biotech companies have applied for, or been awarded, patents covering thousands of human genes. Genetic Technologies, which specialises in paternity testing, has patents covering the 98 per cent of our genome known as "junk" DNA, or non-coding DNA that scientists originally believed had no function. In a cross-licensing deal, Myriad receives a non-exclusive licence from the Australian company for analysis of this region of human DNA, which, says Jacobson, contains some mutations linked to breast cancer. He justifies his company's rights over use of virtually all human DNA by saying that it spent $20 million proving "junk" DNA played a vital role in gene regulation "when the world said we were wasting our time." The patent system is designed to reward this kind of innovation and risk-taking, he says. And governments, not companies, set the rules for awarding gene patents, which only last 20 years, he reminds critics. Fears that patents stifle research are "nonsense and sour grapes", he says: "Researchers are finding mutations in non-coding DNA all over the world and we welcome it." The hunt for BRCA1, which is also associated with ovarian cancer, was hotly contested and controversial. In 1990, its location on chromosome 17 was narrowed down to around 1000 genes by a publicly funded American researcher. Scientists around the world then joined the race, with researchers linked to Myriad just pipping some of the public teams at the post. In Europe, genetic societies and cancer research institutes from 11 countries have joined forces to oppose BRCA1 patents awarded to Myriad, arguing that they lack invention and novelty, and that a monopoly on the gene will make the tests "exceedingly expensive". Dianne Nicol, of the Centre for Law and Genetics at the University of Tasmania, says some provinces in Canada have also continued BRCA1 and BRCA2 testing, despite Myriad's aggressive enforcement of its patents. "They've ignored it and said, 'Take us to court'." In July, the Nuffield Council on Bioethics, a British panel of leading bioethicists, produced a lengthy report concluding that many gene patents are of doubtful validity, because the discoveries were not inventive enough. It also believes patents on DNA sequences should be awarded sparingly, because they can inhibit innovation by increasing the costs for other scientists wanting to investigate the same gene. Dr Mildred Cho, a biomedical ethics researcher at Stanford University, California, has found that, in the US, patents have reduced access to genetic-testing services. In a survey of directors of the country's 200 or so genetic-testing laboratories, a quarter said they had been prevented from offering a test because of the enforcement of a patent or licence. Half had decided not to develop new tests because of commercial constraints. "They felt the effects of patents were overwhelmingly negative in terms of limiting access to tests for patients," says Cho, who is visiting Australia. Australian doctors are also concerned that people may have commercial testing without appropriate genetic counselling. Nicol says one option would be a copyright system whereby governments determine a fair royalty that laboratories must pay to test companies' particular genes. "It's time we took this issue seriously in Australia," she concludes. "It's one that will cost us a lot of money." Fonte: http://www.smh.com.au/articles/2002/11/08/1036308482978.html Acessado em 29/11/2006