Política de medicamentos y otras tecnologías de la salud de la República de Guatemala: acuerdo No. 276-2019 / Policy on medicines and other health technologies of the Republic of Guatemala: agreement No. 276-2019

Bajo la premisa de que para contribuir al acceso universal a la salud y la cobertura universal de salud, es necesario desarrollar políticas y estrategias que aseguren el acceso a medicamentos de calidad, seguros y eficaces que se utilicen adecuadamente, la presente ley es un instrumento político estratégico, orientador de las acciones que se realicen en este ámbito, para garantizar una vida sana y promover el bienestar para toda la población guatemalteca.

Registro e incorporação de tecnologias no SUS: barreiras de acesso a medicamentos para doenças da pobreza? / The regulation and adoption of health technologies under Brazil´s Unified Health System: barriers to access to medicines for diseases of poverty?

Resumo O presente trabalho buscou verificar os aspectos relacionados ao registro sanitário e à incorporação de tecnologias no SUS para as doenças da pobreza. Trata-se de estudo exploratório, descritivo, desenvolvido entre janeiro e maio de 2016, em que foram realizados levantamentos e análises de documentos nos sítios eletrônicos da Anvisa, FDA, EMA, Conitec e Sistema Saúde Legis. Verificou-se um total de 132 medicamentos elencados na Rename 2014 para atendimento específico das doenças da pobreza, sendo que mais de um terço (49) possuem apenas um produtor nacional e outros 24 não possuem registro no país. No período de 2006 a 2014 houve crescimento de 46% do número de medicamentos na Rename para tais doenças. Apesar dos avanços do SUS nos campos da regulação e incorporação de tecnologias, dado o desinteresse de mercado e a condição de negligência para as doenças da pobreza, a atuação do Estado é imprescindível para garantir o acesso às melhores terapias disponíveis, visando à redução das iniquidades em saúde. Infere-se que o Brasil precisa avançar na regulação e incorporação de medicamentos sem interesse mercadológico, agenda inconclusa que pode gerar barreiras de acesso às tecnologias para as populações vulneráveis.

Abstract The study aimed to examine the regulation and adoption of health technologies for the diseases of poverty in the Brazil’s Unified Health System (SUS). An exploratory, descriptive study was conducted between January and May 2016 consisting of the search and analysis of relevant documents on the websites of Brazil’s National Health Surveillance Agency, the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), the National Commission for the Adoption of Technologies by the SUS, and Saúde Legis (the Ministry of Health’s Legislation System). The 2014 version of the Brazilian National List of Essential Medicines (RENAME, acronym in Portuguese) contained 132 medicines for diseases of poverty. Over one-third of these (49) had only one national producer, while 24 were not registered in the country. The number of medicines contained in the RENAME dedicated to this group of diseases increased by 46% between 2006 and 2014. Despite advances in the regulation and incorporation of technologies by the SUS, given the lack of market interest and neglect of diseases of poverty, the government has a vital role to play in ensuring access to the best available therapies in order to reduce health inequalities. It therefore follows that Brazil needs to improve the regulation of medicines that do not attract market interest.

O processo de regionalização do SUS: revisão sistemática / A systematic review of the process of regionalization of Brazil's Unified Health System, SUS

Resumo Nesta revisão foram incluídos apenas estudos específicos sobre o processo de regionalização do SUS, baseados em resultados empíricos e publicados a partir de 2006, já sob o referencial do Pacto pela Saúde. Foi evidenciado que o processo de regionalização é hoje uma realidade em todas as esferas de governo, sujeito a um conjunto de desafios comuns às diversas realidades do país. Entre os principais, os colegiados são valorizados com espaços de inovação, mas ainda em busca da superação da cultura política burocrática e clientelista. A governança regional é ainda prejudicada pela fragmentação do sistema e, em particular, pela histórica deficiência com planejamento, desde o nível local às políticas estratégicas de incorporação tecnológica. As análises permitiram implicar a cultura de amplo privilégio para negociação política em detrimento do planejamento como uma das principais responsáveis por um ciclo vicioso que sustenta a deficiência técnica da gestão.

Abstract This review focuses only on specific studies into the SUS regionalization process, which were based on empirical results and published since 2006, when the SUS was already under the aegis of the Pact for Health framework. It was found that the regionalization process is now underway in all spheres of government, subject to a set of challenges common to the different realities of the country. These include, primarily, that committee-structured entities are valued as spaces for innovation, yet also strive to overcome the bureaucratic and clientelist political culture. Regional governance is further hampered by the fragmentation of the system and, in particular, by the historical deficiency in planning, from the local level to the strategic policies for technology incorporation. The analyses enabled the identification of a culture of broad privilege for political negotiation, to the detriment of planning, as one of the main factors responsible for a vicious circle that sustains technical deficiency in management.

Technological incorporation in the Unified Health System (SUS): the problem and ensuing challenges / Incorporação tecnológica no SUS: o problema e seus desafios

Technological incorporation is a central topic among the concerns regarding health care systems. This paper discusses the role of technology dynamics in health systems' cost increases, suggesting two different approaches - a 'pragmatic-economic' approach and a 'rational-defensive' approach - as guidelines to explain the reasons for this centrality. The paper shows how judicialization results from this situation and discusses two doctrinal views - 'reserve for contingencies' and 'rational use' - as the views that usually guide the debates in the courts and among health policy makers. The paper suggests that the attitude currently prevalent in the Brazilian judiciary system can prejudice the principle of equity by improperly evaluating the principle of integrality. We present a brief genealogy of HTA and a timeline of HTA in Brazil. We also discuss the relevance and the impact of Law 12401/2011, which regulates the principle of integrality in the Unified Health System (SUS) and propose three challenges to the development of HTA actions aiming at technology incorporation in Brazil. Finally, we discuss the entry and the role of private health insurance companies, emphasizing changes in the scenario and in their position.

A incorporação tecnológica é um tema atualmente colocado no centro das preocupações dos sistemas de saúde. O texto presente discute o papel da dinâmica tecnológica no aumento dos custos desses sistemas e sugere duas abordagens - 'pragmático-econômica' e 'racional-defensiva' - como orientadoras da explicação daquela centralidade. Aponta a judicialização como uma resultante dessa situação e discute duas visões doutrinárias - a 'reserva do possível' e o 'uso racional' - como as que habitualmente orientam o debate nas cortes e entre os formuladores/executores das políticas de saúde. Sugere que a postura predominante hoje no judiciário brasileiro pode ferir o princípio da equidade ao avaliar de modo inadequado o princípio da integralidade. Apresenta uma genealogia sumária da ATS e uma linha do tempo da mesma no Brasil. Discute a relevância e o impacto da Lei 12.401/2011, que regulamentou a integralidade no SUS, e propõe três desafios para o aprofundamento das ações de ATS com vistas à incorporação tecnológica no Brasil. Finalmente, discute a entrada e o papel da saúde suplementar nesse tema, enfatizando mudanças conjunturais de postura.

Declining sex ratio: role of society, technology and government regulation in Faridabad district, Haryana.

BACKGROUND: A declining sex ratio at birth has been documented during censuses in India. The decline is especially more in the northern states of Haryana and Punjab. We attempted to assess the role of society (preference for a male child, awareness and acceptability of the practice of sex determination), technology (availability and affordability) and government regulation in the adverse ratio for girls in the Ballabgarh block of Haryana in northern India. METHODS: The population (about 80 000) in the Ballabgarh block has been under constant demographic surveillance for the past 30 years and the data are stored electronically. This was used to determine the sex ratio at birth in the area since 1990. The data on availability of ultrasound machines was collected from the district authorities, as registration of these machines was made mandatory under the Prenatal Diagnostic Techniques Act, 1994. We interviewed 160 mothers and grandmothers to determine the awareness and acceptability of sex determination methods and practices. RESULTS: The demographic data for the past 10 years showed a declining sex ratio-from 881 in 1990-91 to 833 in 2000-01. The data support the view that in the initial part of this period, ultrasound was used for sex determination of all-order births but subsequently was used more in higher-order births. Our interviews with the mothers and grandmothers of the area showed that the practice of sex determination is prevalent and the attitude of the society is ambivalent. The increased availability of ultrasound machines in the area in the past 10 years corresponded to the decline in sex ratio. When the government made the practice illegal, the sex ratio improved only to fall again as the law was not implemented. Later years saw a more stringent implementation of the law and the sex ratio improved again. CONCLUSION: There is a 'demand' for sex determination technology and, therefore, this would continue to be 'supplied'. At most the 'supply' can be regulated. Social engineering efforts need to be targeted at reducing the demand if the sex ratio is to be improved.