O blog do GAT

Saúde Sapo 29.03.06

Sabia que tem o direito de aceder a todo o tipo de informação no que se refere ao seu estado de saúde? Provavelmente, já tinha conhecimento. Mas poderá não saber que este é, apenas, um de 14 direitos do doente pertencentes à Carta Europeia dos Direitos dos Utentes.

Se pertence ao grupo dos néscios relativamente à dita Carta não desespere! Não se trata de uma minoria. A comprová-lo existe um estudo sobre os 14 direitos, cujos resultados foram apresentados em Bruxelas.

O estudo, organizado pela Active Citizenship Network (ACN), procurou avaliar a forma como os direitos são respeitados em 15 países da União Europeia. Efectivamente, apenas 12 países responderam ao desafio: Alemanha, Áustria, Dinamarca, Espanha, Finlândia, Grécia, Holanda, Irlanda, Inglaterra, Itália e Portugal, Suécia.

Para tal, aquela organização internacional contou com a colaboração de entidades dos países envolvidos. Ficou encarreguada de averiguar a situação portuguesa a «Sempre Bem», associação para a promoção do bem-estar.

Ora, comparando Portugal com os restantes países, foi o estado-membro onde se registou um maior desconhecimento geral sobre a aplicação prática dos 14 direitos dos pacientes.

«Analisando os factos, há a destacar o desconhecimento generalizado da Carta Europeia dos Direitos dos Utentes, bem como o incumprimento ou deficiente cumprimento da maioria dos direitos naquilo que é visível para os cidadãos e agentes de saúde», diz o Dr. Álvaro Cidrais, presidente da «Sempre Bem», apontando outras conclusões do estudo português: «Se, por um lado, existem medidas de gestão hospitalar relacionadas com estes direitos nos Hospitais SA, por outro, há uma falta de transparência destas medidas para o cidadão comum e para os agentes de saúde.»

Mas nem tudo são espinhos. De acordo com a pesquisa, constatou-se haver muito espaço para a divulgação da Carta em Portugal e vontade do Estado em contribuir para esta divulgação. Existe, ainda, um ponto de partida interessante para o desenvolvimento de projectos de cidadania activa nesta área. Resta, pois, trabalhar no sentido de divulgar os direitos.

Chegar a estas conclusões foi possível graças à colaboração de seis personalidades-chave ligadas ao sector da saúde. Estas responderam a questionários que permitiram à «Sempre Bem» elaborar o estudo português integrado no relatório final da ACN.

Direitos dos doentes: desconhecimento
Direitos dos doentes: expectativas negativas quase superadas
Direitos dos doentes: Associação «Sempre Bem»
Direitos dos doentes: Os 14 Direitos do Doente

Mais informações aqui.

DN 24.03.06

Dez por cento dos doentes com tuberculose abandonam o Hospital de Joaquim Urbano, no Porto, sem terem alta médica, revelou o director do serviço de pneumologia, Sousa Barros. Tal só é possível porque existe uma lacuna legal relativa ao internamento e tratamento compulsivo dos tuberculosos.

Alguns desses pacientes sofrem de tuberculose multirresistente, colocando em perigo a sociedade, através do contágio. A complexidade ética, política e jurídica do internamento e tratamento compulsivo foi abordada no decorrer de um debate no Hospital de Joaquim Urbano. Os clínicos lamentaram o facto dos tuberculosos não receberem a mesma solidariedade familiar e institucional dos infectados com sida e drogas, o que obriga os serviços de saúde a assumir a total responsabilidade dos pacientes e do seu tratamento.

No entanto, em casos excepcionais, "muito limitados", os especialistas preconizam a adopção da lei aplicável aos portadores de anomalias psíquicas graves e da doença de Hansen. Foi isso que aconteceu em dois casos nos tribunais de Guimarães e do Porto, que reconheceram a legalidade do internamento compulsivo. Questão sensível, ressalvou-se, pois conflitua com os direitos e liberdades dos cidadãos. Para além disso, questionaram os clínicos, que meios e instalações o País dispõe para proceder ao internamento compulsivo?

A verdade, porém, é que uma minoria de cidadãos com a patologia infecciosa põe em perigo a saúde pública. Daí se imporem "medidas de segurança". A Comissão de Ética para a Saúde do Hospital Joaquim Urbano lembrou a elevada taxa de incidência da tuberculose, apontando os grupos de maior risco: os infectados por VIH, os toxicodependentes, os reclusos e os imigrantes.

Considerou que a tuberculose assume um contexto de perigosidade, incluindo para a comunidade, se não for cumprido o regime terapêutico prescrito. Esgotadas todas as medidas, no caso dos doentes com tuberculose multirresistente, a comissão sugere legislação de teor idêntico à lei aplicável aos portadores de anomalias psíquicas.

Lusa 24.03.06

A tuberculose é cada vez mais resistente aos medicamentos criados para a combater, indica um relatório divulgado pelas autoridades sanitárias dos Estados Unidos por ocasião do dia mundial desta doença.

Segundo os Centros de Controlo e Prevenção das Doenças (CDC), essa resistência crescente é um obstáculo importante aos esforços para combater a tuberculose em todo o mundo.

Entre 2003 e 2004, os casos de tuberculose nos Estados Unidos em que se registou resistência aos medicamentos considerados de primeira linha elevou-se a 128, ou 13 por cento. Desses doentes, 97 nasceram fora do país, de acordo com o relatório deste organismo governamental.
A nível mundial, nos 17.000 casos notificados em seis continentes entre 2000 e 2004 houve uma resistência semelhante estimada em 20 por cento.

Segundo os CDC, calcula-se que 9 milhões contrairam anualmente no mundo esta infecção bacteriana que afecta principalmente os pulmões. Dois milhões morrem em consequência da doença.

Para Kenneth Castro, director do Programa para a Eliminação da Tuberculose dos CDC, o tipo resistente da doença generalizou-se em todo o mundo e é difícil de tratar porque o seu combate exige medicamentos mais caros, mas menos eficazes. "A capacidade da doença de atravessar fronteiras torna cruciais os esforços de controlo", afirmou, acrescentando que a resistência é agravada por interrupções no tratamento e pela falta de medidas de controlo em hospitais e prisões.

Em 2005 registaram-se nos Estados Unidos 14.093 casos de tuberculose, 3,8 por cento menos do que no ano anterior.

Já sabemos há muito que os laboratórios não estão nada interessados em fazer os estudos de fase IV para avaliar os efeitos segundários em larga escala. Quando os fazem é para motivos de marketing.

Lusa 27.03.06

Um estudo da Associação Portuguesa para a Defesa do Consumidor (DECO) concluiu que a maioria dos laboratórios é pouco transparente e usa o patrocínio a grupos de doentes e médicos, bem como campanhas sobre doenças, para promover medicamentos.

De acordo com um estudo publicado na edição de Abril/Maio da revista "Teste Saúde", a maioria das empresas farmacêuticas "peca por falta de transparência".

O objectivo do estudo foi "verificar a política das empresas farmacêuticas em matéria de responsabilidade social", tendo sido investigadas 14 das empresas mais importantes a trabalhar nesta área em Portugal.

Segundo o artigo da revista, "as políticas de responsabilidade social [ preocupações sociais e ambientais por parte das empresas nas suas operações e na sua interacção com outras partes interessadas] das empresas farmacêuticas estão ainda pouco desenvolvidas". O estudo revela que "a maioria das empresas estudadas pelas associações de consumidores europeias peca por falta de transparência".

Estas empresas, prossegue a DECO, "usa o patrocínio a grupos de pacientes e médicos e campanhas de informação sobre doenças como forma de promover os seus medicamentos".
A associação constatou ainda que "as autoridades responsáveis, nomeadamente a Agência Europeia do Medicamento, são muito permissivas em relação a estas empresas".

Um dos exemplos indicados na revista refere-se aos efeitos indesejáveis dos medicamentos: "Antes de colocar o medicamento à venda, a indústria avalia a sua eficácia e efeitos secundários através de testes em animais de laboratório (primeiro) e, depois, no Homem". A venda dos medicamentos "só será permitida se houver provas de que os ganhos para o doente são superiores aos riscos". Contudo, "estes estudos não permitem identificar todos os efeitos secundários", pois "alguns só surgem quando o medicamento é utilizado em larga escala, por milhares de pessoas".

Apesar de existir um organismo público responsável por essa farmacovigilância - o Instituto Nacional da Farmácia e do Medicamento (Infarmed) - a DECO realça que "a informação catalogada não está acessível ao público", o mesmo acontecendo com a Eudravigilance, a base de dados europeia que reúne os efeitos secundários.

"A Agência Europeia do Medicamento, que controla os medicamentos na União Europeia, também não tem demonstrado muita actividade nesta área", lê-se na revista. A DECO considera "indispensável" uma "melhor avaliação dos medicamentos ", antes de ser autorizada a sua venda".

"As firmas deveriam ser obrigadas a divulgar os resultados de todos os estudos sobre os fármacos", lê-se no artigo.

Lusa 28.03.06

O acesso de pessoas ao tratamento do vírus da SIDA nos países em desenvolvimento triplicou nos últimos dois anos, especialmente na África subsaariana, informa um relatório hoje divulgado pela Organização Mundial de Saúde (OMS) e a ONUSIDA.

Segundo o documento, que analisa a estratégia "Três milhões até 2005", 1,3 milhões de pessoas recebiam tratamento em Dezembro de 2005, contra as 400.000 registadas em Dezembro de 2003.

A estratégia "Três milhões para 2005" foi lançada a 01 de Dezembro de 2003 pela OMS e a ONUSIDA e visava administrar tratamento contra o vírus da SIDA a três milhões de pessoas até ao final de 2005.

Apesar de os resultados não terem sido alcançados, "durante todos os meses do último ano 50.000 novos doentes iniciaram o tratamento", refere o documento.

O maior acesso de pessoas ao tratamento retroviral registou-se na África subsaariana, a região do mundo mais afectada pela SIDA, acrescenta o relatório.

Na África subsaariana, o número de pessoas que iniciaram o tratamento contra o HIV aumentou de 100.000, em 2003, para 810.000, em 2005, salienta o documento elaborado pelas agências da ONU.

"Dos 4,7 milhões de pessoas que precisam de tratamento retroviral nesta região, aproximadamente uma em cada seis já o recebe", refere o relatório.

No entanto, sublinha a OMS, "nove de cada dez crianças que precisam de tratamento vivem na África sub-saariana".

"Há dois anos, o apoio político e os recursos para a expansão rápida do tratamento contra a SIDA eram limitados", afirmou Lee Jong- wook, director-geral da OMS.

"Hoje, a `Três milhões para 2005` contribuiu para mobilizar o compromisso político e financeiro para se conseguir um maior acesso ao tratamento. Esta mudança fundamental nas expectativas renova as nossas esperanças de fazer frente, não só à SIDA, mas também a outras doenças", acrescentou.

O acesso universal ao tratamento contra o vírus da SIDA até 2010 é um dos Objectivos do Milénio da ONU.

As WHO and UNAIDS Call for Global Treatment Scale-up,

MSF Asks: Where Will the Essential Drugs Come From ?

Geneva, Tuesday March 28, 2006 – As the World Health Organization (WHO) and UNAIDS release a long-awaited report on their 3x5 AIDS treatment initiative and call for universal access, the medical humanitarian organization Médecins Sans Frontières is expressing concern that not enough is being done to make sure that the drugs needed to expand and sustain treatment are accessible to those who need them.

WHO and donors alike are ignoring the looming threat to access to affordable essential medicines that form one of the key barriers to global treatment scale-up. Growing numbers of people that have been on AIDS treatment for several years will increasingly need access to newer, second-generation medicines that remain priced out of reach or are not available at all.

“We won’t be able to keep our patients alive beyond the first few years unless there are some dramatic price reductions for second-line drugs,” said Dr. Karim Laouabdia, Director of MSF’s Campaign for Access to Essential Medicines. “Patients will inevitably need second-line drugs after a few years on treatment, because resistance develops, even when every single pill is taken according to the treatment plan.”

At the same time, World Trade Organization (WTO) rules on patents are threatening to dry up sources of low-cost generic versions, including some of the first-generation drugs.
Without a reliable supply of low cost AIDS drugs, national governments and treatment providers will be faced with an uphill battle, and patients risk having vital treatment interrupted or priced out of their reach.

“It was generic competition and the absence of patents on first generation AIDS drugs in key producing countries that forced prices to drop drastically over the early part of the decade, helping expand treatment,” said Ellen ‘t Hoen, Director for Policy and Advocacy at MSF’s Campaign for Access to Essential Medicines. “But we are loosing ground again. What we’re witnessing now are patent regimes that threaten to block access to both first and second-line drugs. It’s a cruel case of déjà-vu, to which the WHO seems to be blind,” she added.

Indian manufacturers are the source of 84% of antiretrovirals MSF uses in its AIDS treatment projects across the globe. Last year, India changed its patent law to comply with the WTO TRIPS Agreement, and three weeks ago, India granted its first ever patent on a drug. MSF is deeply concerned that this will set a precedent, threatening access to other essential medicines including antiretrovirals, patents to some of which are being considered by the Indian patent office right now.

Pharmaceutical companies are faster in filing patents in developing countries than in delivering the drugs. As an example, Abbott Laboratories only sells in the US a new version of the WHO recommended second-line AIDS drug (lopinavir/ritonavir) that is particularly suited for use in developing countries because it does not need refrigeration. MSF placed an order for the drug with the company’s headquarters in Chicago, but so far, Abbott has refused to proceed with filling the order, and there are no alternative sources for this product today.

MSF warns that if there is no concerted effort by the UN and the international community to make sure there is a steady supply of low-cost AIDS drugs, attaining the goal of universal access will remain impossible.

Global AIDS Alliance Responds to WHO Report on Treatment Access

Washington, March 28 -- Today WHO released a major new report on the progress to date on AIDS treatment in developing countries.

Response by Dr. Paul Zeitz, Executive Director, Global AIDS Alliance:

This report shows that setting an ambitious goal can catalyze bold action. 3x5 is not a failure. Without the challenge of 3x5 we would never have been able to get this far. The pace is clearly picking up, and we are laying the groundwork for even faster progress.

The impressive expansion of treatment sites, even in very poor countries like Malawi, shows that significant progress is possible, even in difficult settings. This is the kind of build-up in health care systems that will make possible major strides in the expansion of treatment by 2010.

Now the world needs to focus on a clear, numerical goal once again, which is clearly linked to people's lives. This goal should be 10 million people on treatment by 2010, or '10 by 10.' We need a clear goal to keep the pace up and maintain momentum. This report shows it is feasible and that, with enough resources, we can quickly expand health delivery systems and reach this goal.

The report is right to back innovative financing, including the International Finance Facility and the Airline Solidarity Contribution. We need these to be implemented as soon as possible. More countries are urgently needed to take part in moving these proposals forward.

Innovative financing should support the Global Fund, since without it we cannot maintain this momentum. Yet, the Fund is facing a financial crisis and may have to postpone additional grantmaking this year. That would be major setback to progress. The report notes that, worldwide, TB is among the most common causes of morbidity and mortality among people living with HIV/AIDS. This is another reason why we must ensure the Global Fund can proceed this year with additional grantmaking.

This report also shows that much more needs to be done to meet the needs of children living with HIV/AIDS. The world is failing children. An estimated 660,000 children younger than 15 years needed treatment in 2005, representing slightly more than 10% of the total number of people in need. Yet the report states that children comprise only about 7% of all people receiving treatment in sub-Saharan Africa and about 4% in Asia, and in Latin America and the Caribbean the median value of nine countries is 8%.

Several countries in Africa, including a number that are PEPFAR focus countries, such as Nigeria, are providing treatment to as few as 3% of the children who need it. Vietnam, another PEPFAR focus country, is providing treatment to only 4% of the children who need it. PEPFAR has clearly failed to focus adequately on quickly meeting the needs of children.

The report states there is no evidence of a systemic gender bias in access to treatment, and that is good news. However, it is very troubling that in a few cases the WHO report shows far fewer women are gaining accessing treatment than what would be expected given the extent of need. In Ethiopia, for instance, just over 30% of the adults on treatment are women, while the expected percent based on need would be closer to 55%.

The report also documents a far too slow increase in access to PMTCT. The report states fewer than 10 percent of HIV-positive women in developing countries got antiretroviral therapy during pregnancy and childbirth between 2003 and 2005, despite a tripling of overall access to the drugs in that period.

NY Times 28.03.06

Editorial

Free Trade and AIDS Drugs

The countries of southern Africa have the world's highest rates of AIDS infection. These governments have a special need to make or buy low-cost generic drugs to save their citizens. World trade rules are amenable, containing safeguards that allow countries to use generics to preserve public health. But the Bush administration is now negotiating a free trade agreement with the Southern African Customs Union. It is important that the United States does not, in the process, restrict the ability of poor people to get generic drugs in these countries.

For many years, American trade policy on medicines has been a struggle between the drug companies, whose campaign contributions and lobbying expenses are second only to the insurance industry's, and the social imperative to provide developing nations cheaper and easier access to vital drugs. Most of the time, the pharmaceutical companies have won. Free trade agreements signed with Central America and other places, for example, restrict the use of generics by allowing brand-name companies to keep their clinical data a secret for five years. The Central American agreement also prevents anyone from registering a generic product without the patent holder's agreement during the life of a patent. The agreement with Morocco allows pharmaceutical companies to extend their monopolies by patenting new uses for old medicines.

In 2000, President Bill Clinton, under pressure from global health campaigners and developing countries, signed an executive order that barred Washington from asking sub-Saharan Africa to accept tighter restrictions on generics than the World Trade Organization requires. President Bush reaffirmed that decision when he came into office in 2001.

The trade representative's negotiator says that the subject has not yet come to the table, and that the United States, well aware that southern Africa faces unique health challenges, intends to respect the executive order. These are welcome words, and it is imperative that Washington be held to that promise.

Esta gente sabe o que faz, o problema é que toda a gente se está nas tintas para eles...

Público 19.03.06

Comissão de Protecção de Dados quer evitar comportamentos discriminatórios do patronato com base em dados de saúde

O funcionário de uma empresa a quem o médico do trabalho pedir para fazer testes para aferir os seus hábitos de consumo de álcool ou droga pode, como regra geral, recusar-se a realizá-los, deliberou esta semana a Comissão Nacional de Protecção de Dados (CNPD).

Este organismo independente - a quem cabe fiscalizar o processamento de dados pessoais - tem sido consultado ao longo dos anos por empresas que pedem autorização para o tratamento de determinados dados sobre os seus trabalhadores. O que o CNPD veio fazer esta semana foi emitir regras gerais paras empresas, mas também dar a conhecer aos trabalhadores os seus direitos e os limites no tratamento dos seus dados de saúde.

Impõe o Código do Trabalho que todos os empregadores tenham serviços de medicina do trabalho. Mas no âmbito desta actividade legal nem tudo é legítimo, refere o parecer, que hoje se encontra disponível na Internet (http://www.cnpd.pt). O objectivo é evitar comportamentos discriminatórios do patronato com base nestes dados.

Por regra, o médico do trabalho não pode pedir ao trabalhador dados sobre os seus "hábitos pessoais". A excepção é aberta para informações como o consumo de tabaco e café, porque pode estar relacionado com problemas de saúde. De igual modo, só é permitido o registo de dados sobre a vida sexual do trabalhador quando se relacionar com alguma doença específica.

Já no que diz respeito ao consumo de droga e álcool as regras são diferentes. A deliberação da CNPD afirma que não pode ser autorizado "o registo generalizado e detalhado do consumo de álcool (moderado, excessivo ou perigoso" ou do consumo de estupefacientes" porque tal pode constituir "uma devassa injustificada nos hábitos do trabalhador, pelo que se revela excessivo e potencialmente discriminatório", lê-se na deliberação assinada pelos seis membros da CNPD.

Motoristas e pilotos
É aberta uma excepção para categorias profissionais onde conhecer estes dados sobre estes consumos pode prevenir perigos para a integridade física do profissional e de terceiros. É o caso de motoristas, pilotos, condutores de gruas.

O conhecimento da raça ou origem étnica do empregado é também entendido como "excessivo, inadequado e não pertinente", surgindo estes dados "como um risco de discriminação dos trabalhadores", continua o documento.

Embora o médico de trabalho seja contratado pela empresa empregadora, não deixa de estar sujeito a sigilo profissional e apenas ele e outros profissionais de saúde podem ter acesso às informações clínicas do doente. O empregador só deverá ser informado dos resultados necessários à tomada de decisão em matéria de emprego, através da "ficha de aptidão". As fichas clínicas só podem ser facultadas às autoridades de saúde e aos médicos da Inspecção-Geral do Trabalho.

A CNPD considera que os dados pessoais podem ser conservados pelo prazo máximo de "um ano após a cessação do vínculo laboral à entidade patronal". Podem ser mantidos por mais tempo se estiver em causa um processo judicial, nomeadamente devido a acidente de trabalho ou doença profissional.

CNSIDA 20.03.06

O Coordenador Nacional para a Infecção VIH/sida falou à revista Medicina & Saúde dos seus projectos e prioridades e evidenciou que a nova filosofia da Coordenação atenta no aproveitamento de sinergias para o combate ao VIH/sida e a outros problemas de saúde.
Henrique Barros realçou a importância da notificação da infecção por parte dos profissionais de saúde e do conhecimento epidemiológico do VIH/sida em Portugal.

A SIDA E A INFECÇÃO VIH NÃO EXISTEM ISOLADAS DOS OUTROS PROBLEMAS DE SAÚDE» - ENTREVISTA A HENRIQUE BARROSMedicina & Saúde, 01-03-2006

CNSIDA 20.03.06

A reunião Internacional dos especialistas em Farmacologia Clínica da Infecção VIH/SIDA realiza-se este ano e pela primeira vez em Portugal. O 7th International Workshop on Clinical Pharmacology of HIV Therapy tem lugar em Lisboa entre os dias 20 e 22 de Abril.

Atendendo a que os factores farmacológicos são uma causa importante da falência da terapêutica antirretrovírica, assim como a exposição do VIH a concentrações subterapêuticas de fármacos pode ser causada pela falta de adesão, por interacções farmacológicas e por alterações farmacocinéticas devidas à variabilidade genética inter-individual, este Workshop incluirá a actualização das interacções medicamentosas dos antirretrovíricos, modelos de farmacocinética e simulações, farmacocinética de novos fármacos, farmacogenética de antirretrovíricos, aspectos de resistência aos fármacos, toxicidade induzida pelos antirretrovíricos, o desenvolvimento de genéricos e farmacovigilância.

O workshop fará ainda um “update” sobre a monitorização terapêutica deste fármacos (TDM) nas “guidelines” clínicas.

Na sessão de abertura estará presente o Coordenador Nacional para a Infecção VIH/sida, Henrique Barros. Haverá ainda uma conferência sobre a Farmacologia Clínica do HIV em Portugal apresentada por Maria Emília Monteiro, professora da Faculdade de Ciências Médicas.
Agenda

CNSIDA 20.03.06

A Coordenação Nacional para a Infecção VIH/sida debateu na passada quinta-feira com as comissões distritais de luta contra a sida a descentralização das actividades e financiamento no que respeita a esta área.

As comissões queixam-se de financiamento tardio, mas o Coordenador Nacional pediu mais acção a nível local, para que em conjunto se consiga travar a incidência da epidemia.

Durante o encontro foram apresentados resultados preliminares de um estudo de avaliação da estratégia de descentralização para o VIH/sida, assim como foram dados alguns contributos para o desenho do programa nacional de prevenção da infecção VIH/sida 2007-2010.

DN 22.03.06

"Os dados são assustadores." É o director-geral dos Serviços Prisionais, Miranda Pereira, que o assume. "Em cada 100 reclusos que dão entrada no sistema prisional, 35 estão infectados com HIV e/ou hepatites B e C." A percentagem mais elevada diz respeito aos infectados com hepatite C, que serão pelo menos 20% da população total das prisões. Já o HIV afecta pelo menos 10%.

Estes números, que se reportam a um rastreio efectuado à entrada no sistema durante os últimos seis meses de 2005, não correspondem à totalidade da população prisional, já que parte das 12088 pessoas actualmente reclusas entrou no sistema antes do início do rastreio. Ou seja, é muito provável que a percentagem global de reclusos infectados seja ainda mais elevada que a dada a conhecer pelos dados agora disponibilizados pelos Serviços Prisionais.

Miranda Pereira, que revelou os números durante a sua presença, ontem, na Comissão Parlamentar de Saúde, a propósito dos projectos de lei do BE e de Os Verdes sobre troca de seringas em meio prisional, deu a entender que os encargos do tratamento dos cerca de 3000 reclusos diagnosticados com hepatite C - cerca de 250 euros por pessoa/semana, ou seja, cem mil euros por dia e mais de dois milhões de euros por mês - poderiam ser incomportáveis, quer financeira quer tecnicamente, para a estrutura que dirige. E defendeu vigorosamente que seja o ministério da Saúde a assumir todos os aspectos relacionados com a área da saúde no sistema prisional.

"Estamos a ter uma noção da dimensão do problema de saúde existente nas prisões, e acredito que seria muito melhor, tanto em termos de custos e eficácia como até de cumprimento da Constituição, que acabasse o subsistema de saúde que funciona nos Serviços Prisionais, em que cada prisão funciona à sua maneira com dimensões e respostas distintas", afirma, concluindo: "Sempre defendi essa tese. Está em causa um claro problema de saúde pública!"

A assunção dos cuidados de saúde em meio prisional pelos serviços nacionais de saúde é uma medida há muito preconizada quer por instituições internacionais como a Onusida e a Organização Mundial de Saúde, quer, em Portugal, pelas associações de defesa dos direitos dos reclusos e por especialistas como João Goulão, presidente do Instituto da Toxicodependência.

É também na perspectiva da igualdade no acesso à saúde que os defensores da introdução da troca de seringas nas prisões se estribam. Mas nesta matéria o director geral das prisões é menos assertivo. Em primeiro lugar porque crê que o consumo de heroína está a diminuir nas prisões como "cá fora", e a baixa quantidade de seringas apreendidas (20 em 2004 e 29 em 2005) o fazem crer que esta droga, a ser consumida em meio prisional, o será sobretudo sob a forma fumada. Depois porque interpreta os dados agora disponíveis - "que levam a crer que muitos reclusos já entram doentes" - como indiciando "uma baixíssima percentagem de infecção dentro do sistema. E questiona: "Será que para esses o sistema prisional não é uma oportunidade de saúde?"

MISSING THE TARGET
A report on HIV/AIDS treatment access from the frontlines
International Treatment Preparedness Coalition (ITPC)
28 November 2005

Demissão do Miranda Pereira já!

CM 22.03.06

O director-geral dos Serviços Prisionais, Miranda Pereira, reconheceu ontem a impotência dos serviços que dirige em tratar os mais de dois mil reclusos contaminados com hepatite C, existentes em meio prisional.

Miranda Pereira argumentou com os custos – “cerca de 250 euros por semana” – do tratamento com o ‘interferão’ (única forma de erradicar o vírus), que “são incomportáveis” para a Direcção-Geral dos Serviços Prisionais (DGSP). E sublinhou que os serviços já suportam os gastos com os anti-retrovirais para o VIH/sida.

Na comissão parlamentar de Saúde, onde se discute a troca de seringas nas prisões, o director-geral foi confrontado pela deputada Maria Antónia Almeida Santos com o retrato negro, referido em recente notícia do CM (elevadas taxas de VIH e hepatites nas prisões). Na resposta, Miranda Pereira classificou a notícia de “idiota” e “desfasada no tempo”.

Mas, depois de admitir a evidência de que “há drogas a circular nas prisões”, acabou por partilhar a “idiotice”, para usar a sua expressão, citando o mais recente rastreio à entrada: 1199 reclusos infectados com VIH, dos quais 735 acumulam com uma das hepatites; cerca de 2500 presos com hepatite C; 433 com hepatite B e 240 com as duas hepatites, B e C. No total, “corresponde a 34,9 por cento de toda a população prisional”.

"ESTACA ZERO"
Depois de há cinco anos o Governo ter promovido visitas a Espanha e Suíça, para ver os programas de troca de seringas nas prisões daqueles países, Miranda Pereira manifesta-se contra a medida.

Como argumento, alega ter sido criada, em Janeiro deste ano, uma comissão conjunta Justiça-Saúde com vista à elaboração de um plano de acção em meio prisional. Nesse sentido, classifica de “extemporânea” a iniciativa parlamentar que ontem o levou à Comissão de Saúde.

NOVOS HÁBITOS DE CONSUMO NÃO CHEGAM ÀS CADEIAS
Miranda Pereira argumentou ontem com uma “mudança no paradigma de consumos”, referindo o crescente uso de haxixe e um maior recurso à heroína fumada, em detrimento do consumo endovenoso, para defender a “inoportunidade” da adopção de um programa de troca de seringas em meio prisional. Além do que descreve como “paradoxo”: “Por um lado proíbe-se o consumo e depois permite-se, facultando os meios.”

Menos convicto da mudança de paradigma está o presidente do Instituto das Drogas e Toxicodependência, João Goulão. Para ele, “é verdade que o padrão mudou em meio livre”, mas julga que “as mudanças não chegaram às prisões”. Em reforço do seu argumento, João Goulão explica-se. “Por via fumada é preciso consumir mais heroína para obter o mesmo efeito, ‘pedra’, do que se for injectada. Apesar de haver droga nas prisões, é muito mais cara.” Além disso, acrescenta, “a heroína fumada deita cheiro, é mais fácil de detectar”.

The Onion 06.03.06

Wonder Drug Inspires Deep, Unwavering Love Of Pharmaceutical Companies

NEW YORK—The Food and Drug Administration today approved the sale of the drug PharmAmorin, a prescription tablet developed by Pfizer to treat chronic distrust of large prescription-drug manufacturers. Pfizer executives characterized the FDA's approval as a "godsend" for sufferers of independent-thinking-related mental-health disorders.

"Many individuals today lack the deep, abiding affection for drug makers that is found in healthy people, such as myself," Pfizer CEO Hank McKinnell said. "These tragic disorders are reaching epidemic levels, and as a company dedicated to promoting the health, well-being, and long life of our company's public image, it was imperative that we did something to combat them."

Although many psychotropic drugs impart a generalized feeling of well-being, PharmAmorin is the first to induce and focus intense feelings of affection externally, toward for-profit drug makers. Pfizer representatives say that, if taken regularly, PharmAmorin can increase affection for and trust in its developers by as much as 96.5 percent.

"Out of a test group of 180, 172 study participants reported a dramatic rise in their passion for pharmaceutical companies," said Pfizer director of clinical research Suzanne Frost. "And 167 asked their doctors about a variety of prescription medications they had seen on TV."

Frost said a small percentage of test subjects showed an interest in becoming lobbyists for one of the top five pharmaceutical companies, and several browsed eBay for drug-company apparel.
PharmAmorin, available in 100-, 200-, and 400-mg tablets, is classified as a critical-thinking inhibitor, a family of drugs that holds great promise for the estimated 20 million Americans who suffer from Free-Thinking Disorder.

Pfizer will also promote PharmAmorin in an aggressive, $34.6 million print and televised ad campaign. One TV ad, set to debut during next Sunday's 60 Minutes telecast, shows a woman relaxing in her living room and reading a newspaper headlined "Newest Drug Company Scandal Undermines Public Trust." The camera zooms into the tangled neural matter of her brain, revealing a sticky black substance and a purplish gas.

The narrator says, "She may show no symptoms, but in her brain, irrational fear and dislike of global pharmaceutical manufacturers is overwhelming her very peace of mind."
After a brief summary of PharmAmorin's benefits, the commercial concludes with the woman flying a kite across a sunny green meadow, the Pfizer headquarters gleaming in the background.
PharmAmorin is the first drug of its kind, but Pfizer will soon face competition from rival pharmaceutical giant Bristol-Myers Squibb. The company is developing its own pro-pharmaceutical-company medication, Brismysquibicin, which will induce warm feelings not just for drug corporations in general, but solely for Bristol-Myers Squibb.

"A PharmAmorin user could find himself gravitating toward the products of a GlaxoSmithKline or Eli Lilly," BMS spokesman Andrew Fike said. "This could seriously impede the patient's prescription-drug-market acceptance, or worse, Pfizer's profits in the long run."
"Brismysquibicin will be cheaper to produce and therefore far more affordable to those on fixed incomes," Fike added.

The news of an affordable skepticism-inhibitor was welcomed by New York physician Christine Blake-Mann, who runs a free clinic in Spanish Harlem. "A lot of my patients are very leery of the medical establishment," Blake-Mann said. "This will help them feel better about it, and save money at the same time."

PharmAmorin's side effects include nausea, upset stomach, and ignoring the side effects of prescription drug medication.

Agência AIDS 18.03.06

Moçambique espera fornecer gratuitamente remédios anti-retrovirais, de combate à Aids, para cerca de 50 mil pessoas até o final de 2006, disse o ministro da Saúde do país na sexta-feira, 17. Esse contingente é quase duas vezes maior do que o número atual de moçambicanos que recebe os medicamentos. A Aids é um grande desafio para esse país, onde há 1,5 milhão de pessoas infectadas pelo HIV.

Moçambique foi elogiado por organismos internacionais e é tido como um modelo de reforma, em meio à qual sua economia cresceu uma média de 7 a 8 por cento ao longo da última década. O ministro da Saúde do país, Ivo Garrido, afirmou a repórteres que a falta de meios de transporte no vasto território moçambicano e a carência de profissionais da área e de hospitais tinham prejudicado a expansão do programa de anti-retrovirais. "Essas são questões que o governo vem enfrentando", acrescentou.

Moçambique deve escolher coordenadores regionais para os programas de combate à Aids em todas as suas 11 regiões. O país enfrenta também a malária e a tuberculose. Garrido afirmou à Reuters no ano passado prever que ao menos 6.000 técnicos da área de saúde sejam mortos pela Aids até 2010, afetando de forma grave os planos do governo para expandir os serviços de saúde.

Apenas 1 por cento das cerca de 70 crianças moçambicanas aptas a receber o tratamento com anti-retrovirais tinham acesso aos medicamentos, revelou o Fundo das Nações Unidas para a Infância (Unicef). Cerca de 1,4 milhão dos 19 milhões de moçambicanos com idades entre 15 e 49 anos estavam infectadoss pelo HIV em 2004, segundo dados do Ministério da Saúde. A Aids matou 97 mil moçambicanos em 2004 e cerca de 20 mil desses eram crianças com menos de 5 anos de idade.

A cloroquina está a ser estudada como anti-retroviral.

Lusa 16.03.06

Uma empresa farmacêutica chinesa forneceu ao Governo moçambicano 30 mil unidades de um novo tipo de anti-malárico, produzido com base numa planta de onde se extrai a artimisinina, considerada eficaz no combate à malária.

Em Moçambique, a malária é, em conjunto com a tuberculose e o HIV/SIDA, a principal causa de morte, sendo ainda responsável por 60 por cento de internamentos nas unidades hospitalares do país.

O representante da empresa chinesa, Victor Fung, que entregou o donativo ao ministro da Saúde de Moçambique, Ivo Garrido, assegurou para breve a comercialização daquele medicamento no mercado moçambicano e africano. "É nossa intenção, num futuro próximo e de acordo com a evolução do conhecimento do produto, vir a contar com a contribuição local na produção e distribuição desse medicamento para os restantes países do continente africano, a região do mundo mais afectada pela malária", disse.

A próxima introdução da nova terapia contra a malária será complementada com a efectivação de ensaios clínicos que se deduz poderem mostrar que os resultados a alcançar serão semelhantes aos dos países que optaram por introduzir aquele fármaco.

No ano passado, as autoridades sanitárias de Moçambique reintroduziram o DDT, banido na década de 80 por ser considerado prejudicial ao meio ambiente, mas o seu uso está a ser rejeitado, em alguns casos, pela população. Populações de algumas regiões de Moçambique estão a interditar a entrada dos agentes envolvidos na campanha de pulverização nos bairros suburbanos alegadamente por o produto estar a provocar irritações cutâneas.

As autoridades sanitárias justificaram a atitude com o facto destas populações não estarem a seguir estritamente as recomendações fornecidas pelos agentes, situação que acreditam contribuir para a irritabilidade da pele.

Além daqueles medicamentos, algumas unidades sanitárias de Moçambique continua a administrar a cloroquina, apesar da comprovação da resistência do mosquito ao fármaco.

Mais acerca das liçencas do Tamiflu.

Lusa 16.03.06

A Indonésia vai produzir cinco milhões de comprimidos Tamiflu, medicamento considerado mais eficaz contra a gripe das aves, indicou hoje a sociedade farmacêutica Indofarma. A encomenda do governo indonésio à Indofarma, no valor de 8,8 milhões de dólares, será satisfeita com a cooperação da empresa indiana Hetero Drugs, que detém uma licença da empresa suíça Roche, revelou a Indofarma.

A Indonésia é um dos países do Mundo mais afectado pela gripe das aves, que provocou 22 mortos, segundo os números divulgados pela Organização Mundial de Saúde (OMS). Em todo o Mundo, uma centena de pessoas morreram vítimas de gripe das aves desde o aparecimento da doença no Sudeste Asiático no final de 2003.

Roche indicou que poderá produzir 300 milhões de comprimidos Tamiflu até 2007, mas essa produção não será suficiente para satisfazer as exigências. Várias licenças foram também atribuídas a empresas estrangeiras.

O GAT tem audiência marcada com o Secretário de Estado no dia 5 de Abril.

Lusa 16.03.06

O Ministério de Saúde (MS) está a preparar um ante-projecto de decreto-lei que regula a introdução de medicamentos inovadores nos hospitais e obriga, nomeadamente, à sua prévia avaliação económica, adiantou hoje o Secretário de Estado da Saúde, Francisco Ramos.

À margem do debate sobre o Serviço Nacional de Saúde que decorreu na Assembleia da República, Francisco Ramos, questionado pelos jornalistas, justificou a necessidade deste documento como uma forma de "dar instrumentos legais para se fazerem os contratos-programa previstos no protocolo" recentemente assinado entre o Ministério da Saúde (MS) e a indústria farmacêutica.

De acordo com fontes da indústria farmacêutica contactadas pela Agência Lusa, o início da negociação deste ante-projecto de decreto-lei após a assinatura do protocolo apanhou as empresas de surpresa e está a colocar reticências à sua adesão à vertente hospitalar do acordo.

Esta era uma possibilidade prevista pelo próprio protocolo mas, na altura da assinatura do documento, a subscrição da vertente hospitalar pelos laboratórios foi apresentada pelo MS como um instrumento necessário à contenção da despesa em medicamentos nos hospitais.

Segundo as mesmas fontes, enquanto a parte do protocolo que preconiza um crescimento zero na despesa em medicamentos vendidos nas farmácias foi já subscrita por laboratórios que representam 90 por cento do mercado, à vertente hospitalar aderiram até ao momento empresas que representam pouco mais de 20 por cento do mercado.

Na área hospitalar, o protocolo determina um máximo de quatro por cento para o crescimento da despesa em medicamentos mas não abrange os medicamentos inovadores, cuja introdução nos hospitais passa a estar sujeita a contratos-programa, a negociar entre o Instituto Nacional da Farmácia e do Medicamento e os laboratórios.

Francisco Ramos adiantou que o documento está em fase de "consulta aos parceiros" e argumentou que, se a "exigência de avaliação económica [de medicamentos inovadores] já existe para a comparticipação [dos fármacos vendidos nas farmácias], também tem de existir nos hospitais" onde, segundo o MS, a despesa em fármacos tem crescido a uma média anual de 12 por cento.

Questionado pelos jornalistas sobre se o ante-projecto de decreto-lei não vai acabar por se substituir ao protocolo, tornando irrelevante que as empresas o assinem ou não, Francisco Ramos retorquiu que "o Governo tem obrigações a cumprir" e se o protocolo "é um instrumento importante", "protocolos são protocolos, legislação é legislação".

Isto é mesmo da treta e perder tempo. Actualmente, colhe-se sangue do caso índex e ponto final. Ninguém pergunta nada...

Lusa 15.03.06

O Conselho de Ética para as Ciências da Vida vai elaborar um parecer sobre a possibilidade dos profissionais de saúde pedirem um rastreio ao VIH/Sida a doentes com cujos fluidos contactaram por acidente, disse hoje a sua presidente.

Em declarações à Agência Lusa, Paula Martinho da Silva adiantou que o parecer foi solicitado ao Conselho Nacional de Ética para as Ciências da Vida (CNECV) "há algum tempo, por um hospital".

A questão central, precisou a presidente do CNECV, é saber se "é legítimo ou não solicitar o rastreio ao VIH a uma pessoa que recorreu aos serviços de um profissional de saúde e que, por acidente, tenha existido um contacto deste com os fluidos do doente".

Este projecto de parecer, que Paula Martinho da Silva espera ver concluído até Maio, visa analisar esta questão "na perspectiva da protecção do profissional de saúde", realçou.
Actualmente, os testes de rastreio ao VIH/Sida são efectuados voluntariamente, a pedido do próprio.

A reunião mensal do CNECV, que decorreu terça-feira, foi ainda marcada pelo começo da discussão de um outro parecer, sobre o Diagnóstico Genético Pré-Implantatório, solicitado pela Assembleia da República.
...

Lusa 16.03.06

Representantes dos parlamentos da Comunidade dos Países de Língua Portuguesa (CPLP) vão reunir-se dias 28 e 29 em Maputo, para encontrarem formas de mobilizar as comunidades dos seus círculos eleitorais no combate ao HIV/SIDA.

O secretário-executivo adjunto do Conselho Nacional de Combate ao SIDA, de Moçambique, (CNCS), Diogo Milagre, disse hoje à Lusa que o encontro "pretende sensibilizar os parlamentares a usarem a sua influência nos seus círculos, para mudarem o comportamento dos seus eleitores em relação ao HIV/SIDA".

"Os deputados podem recorrer à sua capacidade de persuasão para apelar à mudança de comportamento face ao perigo do HIV/SIDA", sublinhou Milagre. Os organismos da CPLP vocacionados para o combate ao HIV/SIDA querem que os deputados atribuam maior importância à sensibilização das mulheres e jovens, os mais atingidos pela doença, acrescentou aquele responsável do CNCS.

Levar os parlamentares a terem uma maior sensibilidade legislativa em matérias relacionadas com o HIV/SIDA é outro dos propósitos do encontro de Maputo, afirmou Diogo Milagre. "A iniciativa de lei de que os parlamentares dispõem também pode ser colocada ao serviço do combate do HIV/SIDA, como já aconteceu em Moçambique com a aprovação de uma lei que sanciona a estigmatização", enfatizou Milagre.

Moçambique é um dos países mais afectados pelo HIV/SIDA na África subsaariana, com uma prevalência estimada em 16,2 por cento, segundo o último estudo do governo sobre a doença, realizado em 2004. Dos 1,4 milhões de casos detectados nessa avaliação, 800 mil são mulheres, um retrato que demonstra a "feminização" da doença em Moçambique, como reconheceu quarta-feira em Maputo o ministro da Saúde de Moçambique, Ivo Garrido, num encontro com os deputados à Assembleia da República sobre o HIV/SIDA.

Mais acerca do acesso ao novo Kaletra.

Unnecessary Delays by Abbott: The "CPP" myth debunked

10 march 2006

MSF needs the new and improved version of LPV/r (lopinavir/ritonavir) for its AIDS projects now – the drug is a crucial component of second-line antiretroviral therapy, and is particularly important for use in many developing counties where MSF operates, since it no longer requires refrigeration, as the old version does. Today this heat-stable, fixed-dose combination is only available in the US.

However, Abbott has not begun the process of registering this drug in developing countries and claims that this process cannot begin until the drug is registered in Europe. This document explains why the company does not need to wait but instead could begin filing for registration in developing countries now.

Abbott claims that a Certificate of Pharmaceutical Product (CPP) must be issued from Europe in order to register the new formulation in developing countries. We claim that this is a choice. According to WHO, the CPP must be issued by the exporting country and therefore could be issued today by the US FDA.

What is a Certificate of Pharmaceutical Product? The CPP is one part of a multi-pronged strategy to improve national drug authorities’ ability to regulate products by creating a standard that clearly communicates a drug’s status with respect to marketing authority and manufacturing standards. Essentially the CPP says, "yes we (e.g. the US FDA) have registered this product as safe for sale in our country and we inspect and have confidence in the manufacturing practices of the producer." Not all countries even require a CPP to register a drug for use, but those that do, require it from the exporting country. For instance, Abbott has said it will file for registration of the new LPV/r formulation in South Africa – the only developing country the company has slated for registration so far – where the drug regulatory authority does not require a CPP for registration. Abbott could file for registration in all developing countries, and if a country does require a CPP, it could be issued from the US drug regulatory authorities.

Reading Between the Lines: The facts about the CPP

Abbott says it needs an EU CPP in order to register the drug in African countries, because the new version of LPV/r is manufactured in a plant in Germany. But the key point here is not where the drug is produced, but from which country it will be exported. Abbott may want to export this product from Europe instead of from the US, but this is a commercial decision, NOT a regulatory requirement. New LPV/r was approved by the US FDA in October 2005, and is available only in the US right now. MSF has confirmed that the US FDA inspects the manufacturing plant in Germany where the product is manufactured and has been assured that the FDA could issue a CPP.

The Bottom Line:
As not every country requires a CPP for registration, Abbott should immediately register the drug in those countries that do not require a CPP, and should obtain a US CPP to expedite registration in countries that do.

Does the CPP issue affect individual shipments, in the period before the drug is registered?
No. Because MSF and other organisations and institutions will obtain special authorization to get new LPV/r to HIV/AIDS projects, the CPP is a requirement related to registration but not special authorisation to import.

Novo folheto das Panteras Rosa.

Gilead Sciences Europe Ltd,
Att. Jennifer Watt,
1 Furzeground Way,
Stockley Park,
Uxbridge UB11 1BD
United Kingdom

CC to:
John C. Martin, President and CEO, Foster City, CA
Amy Flood, Director Public Affairs, Foster City, CA


Brussels, March 15, 2006


Dear Jennifer,

ECAB has discussed the matter of Gilead ARV registration and distribution in Eastern Europe at our last meeting in April 2005 already. These and other discussions have so far led to no concrete results. Gilead has clearly failed to meet our expectations. Patients in the region are in urgent need of Gilead’s compounds, and we don’t understand how your company is missing this important market.

While Gilead continues to publicize its Access Programme for Africa, the company so far never gives any mention to Eastern Europe – as if the region with one of the fastest growing epidemics wouldn’t exist.

It is unacceptable that five years after the licensing of Tenofovir, this drug is still not registered or available in Central and Eastern European countries, and that Gilead has failed to even communicate concrete plans about scaling up regional distribution to ECAB.

At the DDC meeting in January this year, Gilead representatives mentioned a person in Milan being responsible for the area. It was also said that negotiations about registration and distribution with a third company were under way. But again, the information received was more than vague.

Given the situation and urgency, ECAB expects from Gilead:

1. Contact information for the person responsible for the region in Milan.
2. Gilead to communicate a provisional timeline regarding registration and distribution in Central and Eastern European countries, per country.
3. Information regarding Gilead’s pricing policy per country in the region.
4. Gilead to set up an Access programme for Eastern European countries in need.

ECAB is aware of administrative obstacles that may exist in the region and is committed to support the company in addressing those.

To conclude the list of countries where ECAB expects Gilead to address the questions raised above:
- Albania
- Armenia
- Azerbaijan
- Belarus
- Bosnia & Hercegovina
- Bulgaria
- Croatia
- Estonia
- Georgia
- Hungary
- Kazakhstan
- Kosovo
- Kyrgyzstan
- Latvia
- Lithuania
- Macedonia
- Moldova
- Romania
- Russian Federation
- Serbia and Montenegro
- Slovakia
- Tajikistan
- Turkmenistan
- Ukraine
- Uzbekistan

March 15, 2006

Miles White
Chairman and CEO
Abbott Laboratories
100 Abbott Park Road
Abbott Park, IL 60064

Dear Mr. White,

We are writing to you to express our concern about the lack of availability in developing countries of the new melt extrusion (Meltrex) formulation of lopinavir/ritonavir (LPV/r), marketed as Kaletra (200/50mg tablets).

LPV/r has been recognized as an essential medicine by the WHO and will be included in its revised antiretroviral treatment guidelines, in which boosted protease inhibitors represent the cornerstone of second-line therapy. As you know, the tablet formulation of LPV/r, approved by the US Food and Drug Administration in October 2005, has critically important advantages for patients in developing countries: no dietary restrictions, lower pill burden, and most importantly, storage without refrigeration. Due to the storage requirements of the old formulation, there is the risk that some patients in tropical climates are currently using degraded LPV/r capsules. In short, there is an urgent need in developing countries for access to the new heat-stable formulation of LPV/r, as no other boosted protease inhibitors are practical to use in the hot climates of many of these countries.

We urge Abbott to take the following actions to make this crucial second-line option accessible in developing countries:

1. Immediately file for registration of the new LPV/r formulation in all countries where the old formulation was registered or pending, as well as in other developing countries.

According to the WHO/AMDS registration database published in October 2005, the old formulation of LPV/r (133/33.3 mg soft gel capsules) is registered in 55 countries and registration is pending in 13 others, covering 68 of the 69 countries eligible in Abbott’s Access Program. But the new formulation of the drug has not been registered in any country except for the US. We urge you to immediately file for registration of the new formulation of LPV/r (200/50mg tablets) in developing countries, so that the old formulation can be replaced by the new one, as was done in the US.

2. Communicate the countries and the filing dates where registration of the new formulation of LPV/r is pending and a timeline for submissions to remaining countries.

We ask that Abbott communicate the countries and the filing dates where registration of the new formulation of LPV/r is pending so that health advocates in these countries can work with national drug regulatory authorities to overcome any delays and provide a timeline for submitting remaining registration requests.

3. Publish a price for the new formulation of LPV/r for least-developed and middle-income countries.

Since May 2002, Abbott has been selling the old formulation of LPV/r in Africa and Least Developed Countries for $500 per patient per year on an FOB basis (freight, insurance, customs handling, taxes and duties paid by purchaser). Abbott has not yet made public any price for the new formulation of LPV/r in developing countries. We ask that Abbott establish a price that is at least as low as the price for the old formulation in least-developed countries.

Abbott’s Access Program for the old formulation of LPV/r excludes middle-income countries, resulting in prices up to 12 times more than in least-developed African countries. We urge you to make the new formulation available at an affordable price in middle-income countries where millions live on less than US $2 per day.

4. Develop a heat-stable formulation of RTV and make it accessible in developing countries.

A separate, heat-stable formulation of ritonavir (RTV), marketed as Norvir, is also needed in developing countries so that care-providers can implement the forthcoming WHO guidelines and pair RTV with other available and affordable, heat-stable protease-inhibitors.

5. Develop a pediatric formulation of the new formulation of LPV/r.

WHO draft pediatric guidelines recommend LPV/r for use in children if there is cold-chain access. While this new formulation overcomes the storage challenges presented by the old formulation, care-providers would not be able to cut or crush tablets because the new LPV/r is a coated tablet. Therefore, care-providers need a pediatric version of this formulation so that they can provide adequate second-line regimens for children as well as adults.

6. Work with countries to make the new formulation of LPV/r easily available while registration applications are being considered.

Because the drug registration process can take months if not years to complete, we ask that Abbott establish a reliable interim system to distribute this new formulation to treatment programs in developingcountries while registration is pending.

Sincerely,

Stephen Lewis, United Nations Secretary General’s Special Envoy for HIV/AIDS in Africa
Craig McClure, Executive Director, The International AIDS Society
Médecins Sans Frontières / Doctors Without Borders (MSF)
European AIDS Treatment Group
American Academy of HIV Medicine (AAHIVM), USA
AIDS Treatment Activist Coalition (ATAC), USA
...

Lusa 14.03.06

O Banco Mundial (BM) anunciou hoje, na Cidade da Praia, o financiamento de um programa de educação e combate à Sida nos Países Africanos de Língua Oficial Portuguesa (PALOP). O programa vocacionado especificamente para os países africanos de língua portuguesa vai ser gerido em parceria com a Comunidade de Países de Língua Portuguesa (CPLP).

Lembrando que existem redes semelhantes na África Ocidental e Oriental, Geraldo Martins, especialista do BM em educação, adiantou em declarações à Lusa que "a Comunidade dos Países de Língua Portuguesa, pela sua força linguística, é uma potência em matéria de combate à epidemia do HIV/Sida".

"O Banco Mundial está aberto a parcerias e esta é, certamente, uma aposta que queremos que vingue para bem dos países da Lusofonia", acrescentou a propósito do projecto, anunciado no final da reunião de especialistas da CPLP em educação que decorre desde segunda-feira na capital do arquipélago.

Segundo Geraldo Martins, os meios a disponibilizar, técnicos, financeiros e de consultoria, vão ter o apoio da Fundação Calouste Gulbenkian, "que demonstrou total apoio ao programa". Os preparativos finais do programa - que "estará de pé no próximo ano" -, o montante a aplicar bem como as estratégias a seguir serão decididos numa reunião internacional em Setembro na Cidade da Praia, acrescentou.

"Esperamos que a CPLP nos apresente um plano de acção que, uma vez validado pelo secretário executivo da comunidade, possa ser positivamente avaliado pelo Banco Mundial", explicou o representante do Banco Mundial. Antes, o BM aguardará pela decisão do conselho de ministros da educação da comunidade, disse ainda Geraldo Martins.

A nova coordenadora do grupo executivo da CPLP para a educação, a portuguesa Maria Emília Galvão, eleita no encontro que hoje terminou, realçou "o envolvimento de Portugal neste desafio" proposto pelo Banco Mundial. "Vamos fazer com que a rede lusófona de combate ao HIV/Sida se faça com pragmatismo", disse, adiantando que Portugal assume o compromisso de, com o BM, "dinamizar a luta contra a Sida na CPLP, particularmente na África de língua portuguesa".

O II encontro dos especialistas da CPLP em educação, que teve lugar na sede do Instituto Internacional de Língua Portuguesa (IILP), contou com a presença de Angola, Cabo Verde, Brasil e Portugal.

"Por motivos de ordem vária, São Tomé e Príncipe, Guiné-Bissau e Moçambique não compareceram na reunião", disse o presidente do Instituto, Manuel Brito Semedo.

Público 13.03.06

A Comissão Europeia anunciou hoje que vai enviar dois milhões de euros de ajuda humanitária para as regiões do centro e do sul de Moçambique, que têm sido afectadas pela seca.
Em comunicado, a Comissão Europeia diz esperar que o fundo possa ajudar os moçambicanos a ter acesso a água própria para consumo e a informação sobre saúde pública. Esta ajuda pretende ainda promover a informação sobre a infecção pelo HIV/sida.
...

Washington Post Examines Brazilian-U.S. Differences on HIV/AIDS Prevention, Treatment Policies
[Mar 02, 2006]

The Washington Post on Thursday examined the "ideological disagreement" between the Brazilian and U.S. governments over HIV/AIDS prevention and treatment policies. The U.S. government has "officially adopted" abstinence messages as the "basis" for prevention programs, while Brazil emphasizes condom distribution, especially among commercial sex workers, for its prevention programs, the Post reports (Reel, Washington Post, 3/2).

Brazilian officials in April 2005 wrote to USAID to say the country would refuse the remaining $40 million of a $48 million HIV/AIDS grant -- which began in 2003 and was scheduled to run through 2008 -- because of a Bush administration requirement that HIV/AIDS organizations seeking funding to provide services in other countries must pledge to oppose commercial sex work (Kaiser Daily HIV/AIDS Report, 5/2/05). USAID officially declared Brazil ineligible for renewal of the grant last month.

Although the loss of USAID funding has financially strained Brazil's HIV/AIDS programs, Brazilian health officials said it has not devastated their programs, according to the Post. The government planned to distribute 25 million condoms during the annual Carnival festival, which ended on Tuesday, and later this year Brazil plans to open the world's first state-owned condom factory in the state of Acre.

According to the Post, the U.S. and Brazil also differ on whether countries should break patents on antiretroviral drugs and produce generic versions at lower costs (Washington Post, 3/2). Under the World Trade Organization's intellectual property agreement, governments can approve the domestic production of generic versions of patented drugs during emergency public health situations if they fail to reach an agreement with the patent holder (Kaiser Daily HIV/AIDS Report, 1/17). The Brazilian government spends about $400 million annually -- about two-thirds of its HIV/AIDS-related budget -- to provide no-cost access to antiretroviral drugs to all HIV-positive residents who need them (Washington Post, 3/2).

Não é preciso ir até à Ucrânia para encontrar tais discriminações...

CNSIDA 10.03.06

As ambições do programa do governo ucraniano no que respeita ao combate da infecção VIH/sida não está a ser bem sucedido, devido à forte estigmatização existente na sociedade em relação à população que se encontra em contextos mais vulneráveis, nomeadamente os utilizadores de drogas injectáveis.

De acordo com um relatório da Human Rights Watch existe violência e mesmo tortura por parte das forças de segurança em relação aos toxicodependentes, atendendo a que o consumo de drogas naquele país é considerado crime.

O mesmo relatório denuncia ainda que a polícia impede que os utilizadores de drogas tenham acesso aos serviços de saúde e de prevenção do VIH, como a troca de seringas, apoderando-se inclusivamente das mesmas.

Também os prestadores de serviços de saúde são muitas vezes discriminatórios, com a recusa de atendimento a toxicodependentes, afastando-os dos serviços e não os considerando aptos para aderirem a tratamentos anti-retrovíricos, quando seropositivos.

Na Ucrânia, a terapia de substituição por metadona é feita a uma pequena escala e os medicamentos anti-retrovíricos, para o tratamento do VIH/sida, só está disponível a uma pequena percentagem da população.

O mesmo relatório incentiva o governo ucraniano a aplicar medidas que diminuam a estigmatização e violência nas pessoas mais expostas ao risco de contrairem VIH/sida. No entanto, a Human Rights Watch alerta para a falta de infra-estruturas de saúde que respondam às necessidades de prevenção e tratamento e para a falta de investimento e financiamento a esta área.

Rhetoric and Risk

EU splinters when buying drugs

By Elisabeth Rosenthal International Herald Tribune

TUESDAY, NOVEMBER 15, 2005

Ever since the single European market came into being, Europe has been able to enforce uniform standards for everything from air quality to cigarette packet warnings.

But when it comes to one of the most crucial aspects of caring for health - the purchase and supply of medicines - it is every country for itself.

The availability and price of a drug depend almost entirely on where the patient lives, having been set during negotiations among individual countries and makers. Smaller, poorer countries often pay higher prices for the newest drugs because they lack the market volume to win discounts.

A one-month supply of Prozac, an antidepressant, costs 18.49, or $21.66, in Italy but 40.48 in Slovakia. A 40-milligram tablet of simvastatin, a popular drug that fights high cholesterol and heart disease, could cost as much as 3.40 in Austria and 1.05 in France, according to the Euro-Med-Stat database, a European Union mechanism for tracking pharmaceutical sales.

"There is something really wrong with this system," said Pietro Folino-Gallo of the Italian National Research Council, who runs Euro-Med-Stat. "Each county starts fresh with negotiations. What happens to patients has nothing to do with science or medicine."

Governments collaborate little, if at all, when negotiating drug prices even though those prices have been rising 5 percent a year since 1997. The 25 EU member states spend a combined 100 billion on medicines each year. Drug costs eat up about 15 percent of medical budgets in Western Europe, and can run as high as 50 percent, as in Slovakia.

Wealthier countries like France and Norway still reimburse patients fully or nearly fully for most prescription medicines that cost ever more, though escalating costs threaten the solvency of many national health plans.

But poorer countries like Bulgaria simply cannot. Bulgaria, scheduled to join the EU in 2007, already spends 30 percent of its health budget on medicines. So the poorest Europeans face the highest co-payments; often, they simply do without state-of-the-art medicine.

Dr. Nina Gotcheva is one of Bulgaria's most eminent physicians. She rattles off findings from the latest medical journals and international conferences with ease. But these lessons are too expensive to benefit the patients in frayed suits and babushkas who pad through her hospital's graying halls.

She would like to treat patients with acute heart attacks with a high dose of Atorvastatin, a cholesterol-lowering drug. She would like to give simvastatin - another drug in the statin family taken for long periods of time, if not for life - to patients with high cholesterol or high blood pressure to prevent them from getting heart disease.

"But you can't even discuss this," Gotcheva said in her tidy office, a poster of the Golden Gate Bridge on the wall, courtesy of Bristol-Myers Squibb, which makes the statin Pravachol.

Of 200,000 Bulgarians with coronary artery disease who should be on statins, only 30 percent can take them, she said, because neither the patients nor the national health service has the money. Simvastatin costs 1.05 a pill in Bulgaria, and 50 percent to 70 percent of that must be paid by the patient.

"These are the most important drugs for prophylaxis and prevention in people with heart disease," she said with a sigh. "But I have no solution. The solution is financial and political, not medical, for them."

Over all, Europe spends more than 8 billion a year on statins, economists say.

Once a drug has been approved for use in Europe, manufacturers decide where to sell and how to market it. The approval process is generally coordinated for all European countries as a bloc, handled by the European Medicines Agency in London.

But pricing, in contrast, is determined separately. The cost of a drug is determined in often protracted negotiations among drug makers and health and finance officials. Countries, especially wealthy ones that have been able to negotiate discounts, keep the decisions secret for fear of losing a good deal. Consumers generally cannot take advantage of a lower-priced medicine across the border, since prescriptions apply only in the country of origin.

In some countries the new drug may not be sold at all, if potential profits are not deemed adequate. Only 20 percent of approved drugs are sold in the Czech Republic, for example, because it is not a profitable market, said Dr. Sabine Vogler, a health economist at the Austrian Health Institute in Vienna.

Price tends to be tightly linked to potential sales volume - the higher the drug maker's potential profit, the better the price a country can demand, experts say. Drug companies have little incentive to cut deals - like offering rebates - with poor or small countries.

On the other hand, finance officials in poor countries sometimes drag their feet in reaching a price accord on beneficial but costly drugs, in the hopes of delaying a new expense. In Poland, for example, where outlays for imported drugs rose to $1.5 billion in 1998 from $258 million in 1991, price negotiations sometimes drag on for four years after a drug has been approved by the European Medicines Agency, as officials protect their budgets by simply refusing to pay the higher prices demanded by pharmaceutical companies. That effectively keeps innovative medicines off the market.

Once a price is established, governments must decide whether they will reimburse patients fully for the cost, a decision that depends not on scientific merit but on budgets. In many of the former Eastern bloc countries, like Bulgaria and Hungary, governments spend less than 400 per person a year on health care. In the 15 countries that were in the EU before its expansion last year, governments can afford to pay more than four times that amount.

Norway, for example, provides statins for free to all patients who are prescribed the drugs; statins account for 10 percent of its health budget.

In France, only patients with severe long-term heart problems may take the drug at no cost, while French citizens with less urgent illnesses pay 35 percent of the cost of statins prescribed to them.

But patients in Bulgaria pay as much as 70 percent, and many who would have been treated with statins in Western Europe are not eligible at all.

"Even if a drug is cost effective compared to others, you have to think if your country can afford to pay 100 percent or only a part," said Borislav Borissov, a former head of Bulgaria's national drug agency who now runs a pharmaceutical consulting firm.

Health officials are blunt about the trade-offs. "It is sometimes a choice of this: Do you buy medicines or pay doctors' salaries?" said Dr. Dusan Keber, a former Slovenian health minister.

Many smaller and poorer countries attempt to link the prices they are willing to pay to deals cut by larger countries. As a matter of policy, Slovenia caps prices it will pay for new drugs at 80 percent of the price paid to drug companies by a trio of richer countries (France, Italy and Germany), although the cap is not applied to "innovative" drugs.

But attempts to control cost are easily subverted. Drug companies introduce drugs first in Germany and Britain, where there are no price controls, to set a high price as a benchmark, said Dr. Robert Launois, director of the Network for Health Economics Evaluation, a Paris-based research concern.

The Baltic states have sought a way around this by experimenting with joint purchasing. But in general, European countries lose out by failing to act together for lower prices, economists say.

The present alarm over bird flu in Europe, for example, has touched off a perverse pricing war for the drug Tamiflu, which all countries are stockpiling to combat the virus. Each country negotiates its price, and there is no public information about what they are paying.

"Even information that should be open to all, that would allow a market to work, is not," Vogler said. "Countries who are getting a great deal, they don't want that out in the open."

Politicians in the richer West European countries have continued to focus on whether a new drug is beneficial; cost is no object, they tell voters, when it come to health care. But with the astronomical prices of the newest drugs, that approach is harder to maintain. In France, total spending on drugs equals more than $600 per person, according to the Organization for Economic Cooperation and Development.

"The situation here is becoming very hypocritical because no one talks about cost - it's considered vulgar," Launois said. "But inevitably the cost story is there behind every decision."

Generic drugs may prove a partial solution as drugs come off patents, although drug patents typically last about 20 years. Simvastatin has recently come off patent in some European countries and will lose protection in the rest by 2006, and analysts expect spending to fall. In Bulgaria, Prozac, which used to cost 50 a month and so was rarely used, is now made generically by a local company that charges 3.60 a month.

Acknowledging the cost of new and improved medicines, Bulgaria's national health system raised the budget for cancer drugs this year to $150 million, from $25 million. But hospitals are still forced to borrow from other parts of their operating budgets to afford them, and patients sometimes do without, said Georgi Mihaylov, an oncologist who is head of Bulgarian Medical University.

"We are asked to comply with EU standards on pollution," Mihaylov said, "so why can't we cooperate more on the cost of health care?"

Free-for-all over generic drugs in Europe

By James Kanter International Herald Tribune

TUESDAY, NOVEMBER 15, 2005
PARIS

Generic drugs - or copycats, as big pharmaceutical companies prefer to call them - are far less widespread in much of Europe than in the United States. In an age of ever more complex medicine at higher prices, that has heightened the battle raging over access to affordable, effective drugs.

In Europe, it is a tussle that can involve government agencies, big pharmaceutical companies, doctors, patients and lobbying groups. In the end, everyone appears dissatisfied.

The companies that produce branded pharmaceuticals are rich and powerful. They have united with patients seeking access to their drugs and have helped finance groups that lobby for patients' rights. They have fought to slow down the introduction of generic drugs that could lower health care costs. They lavish spending on doctors who could prescribe their medicines and help finance studies that could favor their products.

The governments in Europe that regulate them are powerful, too. They help finance health care lobbying groups. They make decisions on approving drugs for sale or buying them for their citizens. They forbid the companies from advertising to consumers. They tell doctors and patients which drugs will be paid for by the state.

Patients and companies have sometimes united against cash-strapped governments anxious to lower drug costs and therefore reluctant to buy expensive new treatments.

Richard Horton, editor of The Lancet, the British medical journal, cites "an unholy alliance" between companies and desperate patients who hope that new medicines will help them.

Doctors feel torn. The government often will not fully pay for the newest treatments, so suggesting them could put a financial burden on their patients. At the same time, pharmaceutical companies make the doctors a prime target of their marketing.

According to Jon Hess of Cutting Edge Information, a research company, total ad spending by drug companies in Europe is only 13 percent lower than in the United States. On both sides of the Atlantic, drug companies spend about 50 percent more promoting product awareness than they do for research and development, according to Stewart Adkins of Lehman Brothers.

Companies also invite doctors to lavish conferences or finance research, a practice that raises questions about the findings. Top British cardiologists can collect more than £5,000, or $8,700, for an hour of lecturing to colleagues, and they also may be paid for articles that review drugs in medical journals, according to a report by members of the British House of Commons in April.

Jim Kennedy, a family doctor in London and a spokesman for the Royal College of General Practitioners, said drug companies often paid hospitals and clinics in Britain and elsewhere in Europe to conduct research geared more toward use of a specific drug than ascertaining its safety or medical value.

"Often the question being asked is stupid and the trial ridiculous," Kennedy said. "It's an area we need to tighten up on."

Big drug companies have sought to restrict generic versions of their medicines. Amgen is opening a new front, waging a fierce lobbying campaign that could impede copying of its next-generation medicines in Europe, arguing that their manufacture is complex and that the issue is the quality and safety of medicines for years to come.

Generic manufacturers agree that new technologies require new rules on copying, but they accuse patent owners like Amgen of seeking to impose extra testing to delay production of generics and protect profit as long as possible.

Drug companies frequently justify their most contentious behavior on grounds of quality. Amgen is "not trying to extend our patents," said Kevin Sharer, chief executive of the company. "All we're trying to do is participate in the dialogue at the public level and assure the patient's safety."

In the same vein, the Swiss drug maker Roche denies deliberately stalling wider production of its flu treatment, Tamiflu, to maximize profit ahead of a possible bird-flu pandemic. The company says ramping up production is hard because Tamiflu, the only drug that studies indicate may slow the symptoms of bird flu when it spreads to humans, requires a delicate, 10-step process.

The pharmaceutical companies have also helped finance events organized by the European Patients' Forum, a nongovernmental organization.

That poses a conflict of interest for the forum, according to Health Action International, an Amsterdam-based group partly financed by European governments.

The European Patients' Forum participated in workshops this year at the main EU regulator, the European Medicines Agency, on the kind of information patients should receive and how to warn them if safety problems arise.

Left out of the forum's promotional material was the fact that many of its activities were backed by some of the largest pharmaceutical companies and the public relations firms they employed. For a conference in June, Pfizer paid for travel and accommodations. Amgen financed a meeting in February about copying biological drugs.

The forum is "a model of secrecy and conflict of interest," said Jeremy Smith, a spokesman for Health Action International.

Günter Verheugen, vice president of the European Commission, said in a letter to Smith on Aug. 29 that he had asked the European Patients' Forum to "make the information on its funding public."

Anders Olauson, president of the forum, said campaigners had blown industry involvement out of proportion. He said companies should "remain an important source of funding for many patient organizations and their work" because governments often neglect members of groups like his who are fighting for better care for patients with rare diseases or, say, serious chronic conditions like AIDS or Alzheimer's. He added that a Web site with full details of the forum's financing would be ready by late November.

At the same time, European governments rival the big pharmaceutical companies in defending their interests, though often those interests vary depending on which ministry is involved, according to Greg Perry, director general of the European Generics Association, a Brussels-based lobbying group for the generic drug industry.

Perry said finance ministers seek "to protect their industry, in contrast to the efforts of health ministers, who struggle to keep pharmaceutical expenditures to sustainable levels."

In France, for instance, where there is strong backing for national champions like Sanofi-Aventis, fewer than 15 percent of medicines sold are generics. That is still an increase from three years ago, and as a result, France has lopped some 400 million, or $468 million, off its annual drug bill.

Perry said this pattern was commonplace in Europe, even if some countries like Britain and the Netherlands now are using generics at roughly the same rate as the United States, where half of medicines sold are generic.

Then there is always the big stick of European Union regulation to use against big drug companies.

In October, EU antitrust officials raided pharmaceutical companies in Denmark, Italy and Hungary suspected of colluding to shut out generic rivals.

And in June, the antitrust regulators fined AstraZeneca of Britain 60 million for misleading them about the timing surrounding its patents on Losec, a drug for stomach ulcers that became the best-selling drug in the world during the 1990s. It was the most aggressive action to date against a large pharmaceutical company for blocking low-cost competitors. AstraZeneca has appealed to an EU court.

An even fiercer fight pits pharmaceutical companies against traders who buy large quantities of patented drugs from wholesalers in countries like Spain and Greece, where governments set relatively low prices. These traders then repackage the medicines and sell them in higher-cost countries like Denmark and Germany, in a business worth about 5 billion annually.

For most of the past 20 years, EU authorities backed these parallel traders as a way of building a single market in goods and services.

The tide began to turn in drug makers' favor last year when senior European judges said that the German company Bayer could maintain some of its supply restrictions. But the traders are still fighting, and in October they filed a new complaint against Pfizer for offering rebates to Spanish wholesalers who agree not to sell drugs for re-export.

Blocking the traders is a serious matter for drug companies at a time when U.S. consumers and even some insurers are bypassing established distribution channels and scouting overseas for the best deals on medicines.

Europe's jungle of drug regulators

By James Kanter International Herald Tribune

MONDAY, NOVEMBER 14, 2005

PARIS
Barbara Clark discovered she had early-stage breast cancer in February, had the tumor removed in March and started chemotherapy in April. Then Clark, a British nurse, opened a new front in June in her battle to get well - against the government.

Clark had read about Herceptin, a treatment for advanced breast cancer that new research showed might help at an early stage. But her doctor told her that the health authorities would not pay the annual bill, which runs to £30,000, or more than $50,000: The drug maker, Roche, was not even going to apply for approval until January.

After that, it would take months to get even fast-track approval at the European Medicines Agency, and then several more weeks of review at the National Institute of Clinical Excellence, a British body that advises the government on the effectiveness of approved drugs.

Unwilling to wait, Clarke waged a media campaign that eventually forced authorities to give her a subsidized prescription on "compassionate" grounds.

"I don't have a greater right to life than anyone else," said Clark, 49, who lives in Somerset, England. But, she added, "I didn't want to be among the last generation to die."

Many other anxious cancer patients are still waiting for Herceptin to be approved for early-stage breast cancer treatment. Only then will they be able to use it and obtain reimbursement from their health care provider - which in Europe is often the government.

To these people, at least, the affair underscores their argument that cumbersome regulatory practices, far from ensuring safety, actually put lives at risk.

"Women do not have time to wait for bureaucratic red tape, to wait for all the levels of approval that we now face," said Dorothy Griffiths, a member of Fighting for Herceptin, a pressure group.

But then The Lancet, the British medical journal, raised questions last week about Herceptin's effectiveness for early-stage breast cancer, noting that some women in studies had had heart problems that demanded further investigation.

With that, Herceptin became a clear example of the complexities and flaws in Europe's system for approving and distributing drugs. Getting a new medicine from the laboratory to the pharmacy shelf is a labyrinthine process.

Regulators are trying to streamline it, but in the meantime, a web of budgets, politics and restrictions on marketing sometimes conspires to prevent new medicines from reaching medicine cabinets as quickly as patients and industry would like, or at a price governments or individuals can afford.

Peter Sutherland, who has served as director general of the World Trade Organization and as the EU commissioner for competition policy, once called the splintered regulation of pharmaceuticals "the single most spectacular failure of the single market" in Europe.

Many European governments made universal health care essentially free after World War II. But there is a flip side. When funds run low - often as a result of pressure to reduce taxes - drugs become harder to get. Many of the delays creep in because European governments, now some of the largest health insurers on the planet, are reluctant to add expensive new drugs like Herceptin to their reimbursement rosters unless they are proved to be more beneficial than similar drugs already available.

The patchwork of public health care systems across Europe - ranging from big, rich countries like Germany to poor, smaller ones like Bulgaria - means the availability of drugs is often as much about the health of national budgets as about the need for safe and effective treatment.

Once a medicine is approved, the cost to patients - which is negotiated separately in each country - can be all over the map, depending on whether a government can afford reimbursement.

Meanwhile, rules that bar drug advertising in Europe also encourage pharmaceutical companies to generate buzz about medicines and to quell competition from generics and importers, which offer patients cheaper alternatives.

The first step in the long path from the lab to the pharmacy - determining whether a drug can be used for treatment - is fraught with complications.

Unlike the one-stop system in the United States, where the Food and Drug Administration has the sole power to approve or reject a medicine, drug makers seeking approvals in Europe may go through a pan-European checkpoint or through any of several national ones.

Depending on what the drug is, pharmaceutical companies may need to get approval from the European Union, through its European Medicines Agency, or they can knock on the doors of individual governments, with whom many companies have nurtured close contacts.

New rules could speed the ability to satisfy demand for access to next-generation drugs like Herceptin. As of next Sunday, drug makers will be obliged to seek EU-wide approval from the European Medicines Agency for all new medicines for major diseases, including AIDS, cancer, diabetes and neurodegenerative disorders, rather than seek direct government approval.

Antibiotics and heart drugs are among the few treatments that a national authority, like the medicines and health care products regulatory agency in Britain, will still be allowed to approve first.

But as governments seek to rein in spending on new drugs, they have added yet another layer to the approval system. In Britain, for example, the National Institute of Clinical Excellence judges whether medicines approved by safety regulators are valuable enough to be subsidized by the government.

For years, European governments had the sole power to approve medicines for their national markets.

In the early 1990s, as efforts to build a single European market gained a head of steam, the European Union won a mandate to establish an agency in London to centralize approvals for the EU market. The European Medicines Agency became a largely voluntary alternative for drug companies that would otherwise go to national governments for approval. The EU passed rules giving drug companies incentives to go to its agency instead.

Yet echoes of the old system remained. At the time of the European Medicines Agency's creation, drug makers were also given a second option for obtaining EU-wide approval that proved more popular. They could go to one member state first, without risk of intervention from any other countries, and later ask other countries to recognize the approval across the EU.

Companies rushed to countries where they had good relations with individual regulators. Germany, France, Britain and the Netherlands were popular choices.

In cases where countries did dispute approvals, the European Medicines Agency would arbitrate and in most cases force an approval. In the United States, by contrast, a drug maker may apply for approval only at the Food and Drug Administration, and its decision applies across the entire country.

Yet even when the European Medicines Agency does review a drug, part of the approval process is farmed out to member state agencies - usually two per drug - because national governments wanted to remain involved and because they had set up the EU agency with only a small core staff. Even so, critics say, this system created an environment that wound up favoring drug companies.

According to Silvio Garratini, who resigned 18 months ago as the Italian representative to the European Medicines Agency, it allowed companies to select one of the two member states that would be involved in reviewing their applications. It also allowed companies to withdraw applications in secret to avoid jeopardizing chances of approval elsewhere, if it looked like things were going badly, he said.

The agency's day-to-day operation is overseen by European Commission officials responsible for industrial policy, rather than health matters, said Garratini, who now heads the Mario Negri Institute for Pharmacological Research in Milan.

"Drugs," Garratini said, are "more important as goods for sale than as tools to protect the health of patients."

The agency said it would curb the practices criticized by Garratini, and its officials see the changes coming this month as an important step toward meeting patient demands more quickly and becoming more like the century-old Food and Drug Administration.

Martin Harvey Allchurch, spokesman for the European Medicines Agency, said the new emphasis on speedier, centralized approvals should help drug companies do business in the European Union by reducing paperwork and the scope for disagreement about safety.

Yet even as the agency gains powers for fast-track approvals, governments are scrambling to slow things down. Their main concern is to avoid significant new health care costs that could skyrocket as patients like Clark turn up the pressure to be reimbursed for expensive, high-profile new medicines.

This year, the German government set special criteria to determine whether a new drug is eligible for generous reimbursement terms. It began forcing drug makers to show that new medicines - including those already approved by the European Medicines Agency - represent a "significant therapeutic improvement" over similar ones already on the market. If a drug maker fails this test, the new medicine can be priced the same as cheaper medicines produced generically after patents expired.

When only two patented drugs had passed the test by February - one from Bayer of Germany and another from SanofiAventis of France - there was an outcry from the United States on behalf of its drug makers who failed to get patented drugs approved for reimbursement in Germany, said Neena Moorjani, spokeswoman for the Office of the U.S. Trade Representative.

The office sharply criticized Germany in its 2005 watch list, which serves as an early warning to countries suspected of undermining the value of U.S. brands and products.

But what some patient groups and the pharmaceutical industry fear most is that EU governments could one day require the European Medicines Agency itself to examine drugs in terms of their economic value, not just for quality, safety and efficacy.

Jeremy Smith of Health Action International, an Amsterdam-based pressure group partly financed by European governments, argues that therapeutic advance should be a condition of approval.

"Why, otherwise, should these companies be entitled to a vast financial reward?" asked Smith, who criticized the pharmaceutical industry for flooding the market with "me too" drugs for conditions like heartburn and high cholesterol that can generate high profits.

Many doctors agree that tests of value for money are necessary to maintain enough resources to offer nearly free universal health care. Any budget crunch, these doctors say, is likely to get worse as next-generation treatments become available, including those to help people lose weight, stop smoking or have better sex lives.

"There is a need to fast-track certain medications, but we also need to evaluate the evidence around a treatment to see how it squares up to other medicines already available," said Dr. Jim Kennedy, a general practitioner near London who heads the prescribing committee at the Royal College of General Practitioners, a 24,000-member association based in London. "Sooner or later in any system, you only have a finite amount to spend on health care."

At the European Medicines Agency, Harvey Allchurch sees this coming - one day.
"There is the tiniest possibility we will be tasked to look at therapeutic value," he said. "But that is way down the line."