Acervo

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

VARSÓVIA - Os novos medicamentos contra a Aids já são tão eficazes que conseguem reconstruir quase totalmente o sistema imunológico atacado pela doença. É uma das conclusões da IX Conferência Européia da Aids, encerrada ontem nesta capital. O presidente da conferência, o polonês Andrzej Horban, declarou que a grande eficácia dos novos remédios induziu os especialistas a modificarem os métodos de tratamento que empregam. "Até agora optávamos pela aplicação de tratamentos contínuos, mas agora nos inclinamos pela introdução de períodos de pausa que dêem ao paciente uma maior tranqüilidade sem que seu estado de saúde piore", afirmou. Menos otimista é a conclusão à qual chegaram os especialistas que, hoje e em um futuro mais próximo, certamente não gerarão remédios capazes de curar totalmente os doentes de Aids e que, por conseqüência, o que deve ser levado em conta principalmente é minimizar os efeitos secundários dos tratamentos. Horban disse que, conferências como a de Varsóvia, permitem trocas de informação muito úteis que ajudam a melhorar os tratamentos assim como modernizar os métodos de cura. "A conferência permitiu também estabelecer que as medidas aplicadas na Polônia contra a Aids sejam tão boas como as melhores do ocidente e garantam aos pacientes os melhores tratamentos, já que os medicamentos são comprados pelo Estado". Epidemia O médico explicou que a escolha de Varsóvia como sede desta conferência se deve ao fato de na Europa Oriental se registrar uma nova onda de casos de Aids, "um fenômeno que pode ser controlado e contido com os métodos aplicados e comprovados justamente na Polônia". O especialista polonês afirmou que na Polônia surgiu o perigo de que começasse uma grande epidemia de Aids, o que, no entanto, não aconteceu, porque foram adotadas as medidas oportunas, que agora serão colocadas em prática nos países do Leste seguindo o exemplo polonês. A IX Conferência Européia da Aids, que realizou seus trabalhos durante três dias, contou com a participação de 3,5 mil especialistas do mundo inteiro.   Fonte: http://www.aids.gov.br/main.asp?ViewID=%7bDA56F374-128A-40FB-B16F-D08A1F5DD07B%7d&params=itemID=%7b476EF6EB-410A-4F07-81CA-869143D05A55%7d;&UIPartUID=%7bD90F22DB-05D4-4644-A8F2-FAD4803C8898%7d Consultado em 15/02/2007

SÃO PAULO, Brazil -- Raising the stakes in a high-profile battle over drug prices, Brazil is expected to publish a decree Friday that authorizes imports of generic versions of patented AIDS drugs that the country says it can no longer afford to buy from multinational pharmaceuticals companies. The decision drew praise from advocates of Brazil's innovative AIDS program, which keeps 135,000 people alive by supplying them with free drugs. But critics warned it could reopen an extremely sensitive issue that members of the World Trade Organization thought they had laid to rest just last weekend, ahead of a key WTO meeting in Cancun, Mexico, next week. Among other things, it could provoke retaliation from Washington or the drug companies, which are trying to balance their intellectual-property rights with the need to appear responsive to poor countries suffering from runaway diseases. "They're playing with fire," says Jon Huenemann, a former assistant U.S. trade representative who is now with the Washington consulting firm of Fleishman-Hillard. "The sensitivities of this are obvious and we're right on the edge here." At the very least, the decision appears designed to bring maximum pressure on three makers of the AIDS drugs: Abbott Laboratories, Merck & Co. and Roche Holding AG. Brazil has been in negotiations with the companies for weeks, demanding at least a 40% cut in the price of three drugs, Lopinavir, sold as Kaletra in the U.S., Efavirenz, also known as Sustiva, and Nelfinavir, also known as Viracept. But the talks haven't advanced, according to Brazilian health officials. "We prefer to negotiate but we have to change our legislation so that we can produce [these drugs] locally or import them from countries that can sell them for a lower price," said Alexandre Grangeiro, the AIDS program's chief. Brazil's AIDS program is anchored in the local manufacture and free distribution of generic versions of AIDS drugs. The country produces seven of the 14 drugs it distributes. But the cost of the three patented drugs, which the country doesn't produce, accounts for 63% of its $200 million annual budget for AIDS drugs and threatens Brazil's free-drug policy, health officials say. Latin America's largest country is considered a model for the prevention and treatment of AIDS. Its epidemic hasn't reached the proportions of Africa; nor is it as poor. But it is the only large developing country that distributes AIDS drugs to all those who need them. It costs Brazil about $2,000 a year for each patient to provide antiretrovirals, far less than the $12,000 it costs per person for treatment in the U.S. Still, the cost is beyond the means of the majority of the estimated 500,000 Brazilians who are HIV positive. Brazil's decision follows a WTO deal last week that allows poor countries to import or produce generic versions of patented drugs to combat illnesses such as AIDS and malaria in a public health emergency. The carefully constructed accord expanded on a previous WTO rule that allowed poor countries to violate patents in manufacturing generic versions of drugs, but not to import such drugs. Many experts saw the new rules as intended to help the poorest of the poor countries that had no domestic drug-manufacturing capabilities and so were incapable of making generic drugs on their own. But Brazil has a vibrant drug industry and has been a leader in developing generic versions of popular drugs. Indeed, Brazilian officials say they have already reverse-engineered the three drugs in question. But they added that they wouldn't be able to manufacture them in sufficient quantities soon enough to relieve the immediate financial burden of their AIDS drug program. Brazil says its new policy doesn't technically fall under the recent WTO agreement. The decree signed by President Luiz Inácio Lula da Silva enables Brazil to acquire AIDS medications that it doesn't produce itself from countries, such as India and China, which don't have to comply with international patent laws until 2005. Analysts on both sides of the debate saw the move as at least taking advantage of a climate of flexibility sparked by the recent WTO accord. "Brazil is taking the lead again in ensuring universal access to antiretroviral drugs," said Ellen t'Hoen, a coordinator for Paris-based Medecins Sans Frontiers. "It is showing the political will to implement WTO flexibility. This is extremely good news." Merck supplies Efavirenz to Brazil for $2.10 a daily dose. A Merck executive said the company sells the drug for 95 cents a day to poor African countries in accordance with a United Nations index. "We reduced our price to Brazil by 85%" during the past two years, said David Greeley, Merck's director of public relations for Latin America. "We are reviewing Brazil's request for a price reduction against our global policy." Merck said it also is studying a Brazilian request for a license from Merck to produce Efavirenz locally, which would guarantee the patent isn't violated. Brazil says it can produce Efavirenz for about 90 cents and intends to import it until it can make the drug on a large scale. Two years ago, Brazil threatened to produce copies of two AIDS drugs at a local laboratory. Roche ultimately reduced the price of Nelfinavir, or Viracept, by half. Now, Brazil says it can make the drug for even less. A Roche spokesman in Basel, Switzerland, expressed surprise at Brazil's decision to issue a decree. "Our first priority is still to come to a mutually acceptable solution," spokesman Horst Kramer said. Abbott supplies Lopinavir, branded as Kaletra, for $1.50 a capsule to Brazil. The company said it hoped to keep selling to Brazil but said the company offers the drug at a lower price only to impoverished African countries. Brazil says it can produce the drug or acquire a generic version for about 25 cents a capsule. Fonte: http://www.accessmed-msf.org/prod/publications.asp?scntid=5920031122422&contenttype=PARA& Acessado em 01/12/2006

LONDRES - O Ministério da Saúde abrirá, no segundo semestre, o processo de registro do mais recente tipo de droga criado para tratamento da Aids, usada, experimentalmente, por alguns médicos brasileiros. Vendido nos Estados Unidos e na Suíça, o Fuzeon pertence à chamada terceira classe de remédios contra a doença, pois combate o HIV antes de ele atacar a célula sadia. Outros países europeus, como Alemanha e Suécia, devem autorizar a venda do produto nas próximas semanas, segundo o pesquisador Max Bucher, coordenador do Hospital and Specialty Care da Roche, fabricante do medicamento. "É uma nova maneira de atuar contra o vírus. O Fuzeon impede que o HIV entre na célula", afirmou. Dois testes, um com pacientes dos Estados Unidos e Canadá e outro com europeus e australianos, mostraram resultados positivos em analises da quantidade de vírus no corpo. Nos dois grupos, o número de pacientes com nível "indetectável" de HIV quase dobrou. Bucher explicou que o Fuzeon é autoaplicado pelo portador do HIV, duas vezes ao dia. Isso, segundo o pesquisador, teria agradado aos pacientes, cansados de tomar vários comprimidos por dia. Nos testes realizados no Brasil, porém, alguns pacientes reclamaram de dores nos locais onde o remédio é injetado. "Trata-se de uma injeção subcutânea, que pode deixar o local dolorido de sete a dez dias. Mas os pacientes ensinam uns aos outros a aplicar e descobrem modos que diminuem o incômodo", afirmou Bucher. A maioria, segundo ele, tem preferido injetar o remédio no abdome. A Roche estima que atenderá de 12 mil a 15 mil pacientes, em todo o mundo, com o novo medicamento. Até 2005, esse número deve subir a 40 mil portadores do HIV.  Fonte: http://www.aids.gov.br/main.asp?ViewID=%7BDA56F374%2D128A%2D40FB%2DB16F%2DD08A1F5DD07B%7D&params=itemID=%7B2E1C7D79%2DC608%2D4F4F%2D9998%2DC20B523DA731%7D;&UIPartUID=%7BD90F22DB%2D05D4%2D4644%2DA8F2%2DFAD4803C8898%7D Consultado em 15/02/2007