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Resumo: Os critérios para definir os preços de medicamentos no Brasil estão previstos na Resolução CMED nº 2/2004 da Câmara de Regulação do Mercado de Medicamentos. Os preços estipulados influenciam o mercado privado e público, o que torna desafiador a revisão de políticas de preços devido a necessidade de harmonizar interesses sociais e econômicos. Uma proposta de revisão dessa Resolução foi disponibilizada por meio da Consulta Pública SEAE nº 2/2021 da Secretaria de Advocacia da Concorrência e Competitividade/Ministério da Economia, porém, até o momento sem publicação dos resultados consolidados até o momento. Recomendações recentes da Organização Mundial da Saúde em relação à adoção de diferentes limiares para definição de preços de medicamentos são adotadas nessa Resolução, embora essa tenha sido publicada há 20 anos. Com o objetivo de interpretar e descrever o alinhamento e os possíveis avanços e retrocessos nos textos legais relacionados à regulação de preços de medicamentos, foi utilizado o método da pesquisa documental analítica-descritiva, de cunho exploratório. Como resultado, foram mantidas a lista de países referência para conferência de preço internacional e os limiares de referenciamento interno e externo de preços. As omissões normativas da Resolução permanecem na Consulta Pública, como a ausência de critérios para precificar radiofármacos, terapias avançadas e medicamentos sem preço internacional, e sem comparadores no mercado brasileiro para revisar preços e transpor preço provisório para definitivo. Um ponto crítico foi a criação de bônus de 35% acima do preço estipulado para medicamentos que apresentem benefício clínico adicional sem, contudo, definir contornos claros quanto às evidências científicas aceitáveis para a comprovação desse benefício. Em suma, poucos avanços foram percebidos na Consulta Pública.

Abstract: Criteria for setting medication prices in Brazil are set forth in CMED Resolution n. 2/2004 of the (Medicines Market Regulation Chamber). The stipulated prices influence the private and public markets, which makes it challenging to review pricing policies due to the need to harmonize social and economic interests. A proposal for reviewing this Resolution was made available through the SEAE Public Consultation n. 2/2021 of the Competition and Competitiveness Advocacy Secretariat/Brazilian Ministry of Economy; however, so far without publication of the consolidated results. Recent recommendations from the World Health Organization regarding the adoption of different thresholds for setting medication prices are adopted in this Resolution, although it was published 20 years ago. To interpret and describe the alignment, possible advances and setbacks between the legal texts related to medication price regulation, we conducted an analytical-descriptive and exploratory documentary research. As a result, the list of reference countries for international price verification and the thresholds for internal and external price referencing were maintained. The normative omissions of the Resolution remain in the Public Consultation, such as the absence of criteria for pricing radiopharmaceuticals, advanced therapies and medication without international and comparator prices in the Brazilian market, to revise prices and transpose provisional to definitive prices. A critical point was the creation of a 35% bonus above the stipulated price for medication that present additional clinical benefit without, however, defining clear contours as to the acceptable scientific evidence to prove such benefit. In short, few advances were noticed in the Public Consultation.

Resumen: Los criterios para definir los precios de los medicamentos en Brasil están establecidos en la Resolución CMED nº 2/2004 de la Cámara de Regulación del Mercado de Medicamentos. Los precios estipulados influyen en el mercado público y privado, lo que dificulta la revisión de las políticas de precios debido a la necesidad de armonizar los intereses sociales y económicos. Una propuesta para revisar esta Resolución se puso a disposición mediante la Consulta Pública SEAE nº 2/2021 de la Secretaría de Competencia y Promoción de la Competitividad/Ministerio de Economía, sin embargo, hasta el momento no se han publicado los resultados consolidados. En esta Resolución se adoptan recomendaciones recientes de la Organización Mundial de la Salud sobre la adopción de diferentes umbrales para fijar los precios de los medicamentos, aunque fue publicada hace 20 años. Con el objetivo de interpretar y describir el alineamiento, posibles avances y retrocesos, entre los textos legales relacionados con la regulación de precios de medicamentos, se utilizó el método de investigación documental analítica-descriptiva, de carácter exploratorio. Como resultado, se mantuvieron la lista de países de referencia para la verificación de precio internacional y los umbrales para la referenciación interna y externa de precios. Quedan en Consulta Pública las omisiones normativas de la Resolución, como la ausencia de criterios de fijación de precios de radiofármacos, terapias avanzadas y medicamentos sin precio internacional y comparadores en el mercado brasileño, para revisar precios y transponer el precio provisional al definitivo. Un punto crítico fue la creación de una bonificación del 35% sobre el precio estipulado para los medicamentos que presenten un beneficio clínico adicional sin definir, sin embargo, contornos claros sobre las evidencias científicas aceptables para demostrar dicho beneficio. En definitiva, se percibieron pocos avances en la Consulta Pública.

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BACKGROUND:  The aim of this work is to characterize the processes associated with patient and public involvement (PPI) in the form of public consultations (PC) during the first 10 years of operation of the National Committee for Health Technology Incorporation in the Unified Health System (Conitec) of Brazil, and to identify factors associated with changes in Conitec's recommendations following these PC. METHODS:  This cross-sectional study analysed all processes related to the adoption of technologies that took place in Brazil between 2012 and 2021 based on technical reports and self-reported information collected from PC participants. A multiple logistic regression model identified factors associated with changes in Conitec's recommendations following PC. RESULTS:  A total of 479 technical reports were published, of which 83% (n = 400) were submitted to PC. Demands were made mainly by applicants from the government (n = 262; 55%), regarding the adoption of medicines (n = 366; 76%), in which context neoplasms and infectious diseases were the most frequent indications (n = 66; 14% for each). A total of 264 (55%) processes resulted in a final recommendation in favour of introducing the technology. Over the period of 10 years, 196 483 contributions were received in response to PC. The largest volume of contributions was made by patients and their families or representatives (n = 99 082; 50%), females (122 895; 67%), white individuals (129 165; 71%) and individuals between the ages of 25 and 59 years (145 364; 80%). Alteration of the preliminary recommendation occurred in 13% (n = 53) of the PC, with a higher proportion of recommendations being altered from 2017 onwards. Increased participation by patients had a significant impact on the alteration of the preliminary recommendation (odds ratio 3.87, 95% CI 1.33-13.35, p = 0.02). CONCLUSIONS: Increased engagement of patients and their families and caregivers in PC was associated with changing the preliminary recommendation of Conitec about the adoption of technologies into the public health system in Brazil.

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Resumo Este estudo teve como objetivo analisar as razões da mudança da recomendação inicial dos pareceres emitidos pela Comissão Nacional de Incorporação de Tecnologias no Sistema Único de Saúde (Conitec) durante o processo de consultas públicas (CPs). Tratou-se de pesquisa exploratória de base documental, que analisou 45 CPs da Comissão, realizadas em 2020, das quais sete tiveram entendimento inicial alterado a partir das recomendações recebidas. Os resultados revelam que os principais argumentos considerados para modificar a recomendação preliminar foram aspectos econômicos, bem como critérios de segurança e efetividade da tecnologia analisada. A CP é mecanismo democrático com potencial para avançar no desenvolvimento de um Sistema Único de Saúde (SUS) mais igualitário e que atenda aos reais interesses da sociedade.

Abstract This study analyzes the reasons for changes to the initial recommendations of opinions issued by the National Committee for Health Technology Incorporation (Conitec) after public consultations. Through exploratory, documentary research, 45 public consultations conducted by the Committee in 2020 were analyzed. Of these 45 consultations, seven had their initial understanding changed based on the recommendations received during public consultations. Results show that the economic aspects of the analyzed technologies, along with safety and effectiveness criteria, were the main arguments considered to modify preliminary recommendations. Public consultation is a democratic mechanism with the potential to generate progress in the development of a more equitable Brazilian National Health System (SUS) that meets the real interests of society.

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RESUMO Este estudo objetivou analisar o conteúdo da consulta pública da Política Distrital de Alimentação e Nutrição. Secundariamente, apresentar o perfil dos participantes e relatar a sistematização da análise realizada. Trata-se de estudo documental, exploratório, transversal, de abordagem qualiquantitativa. A amostra inicial foi composta por 115 contribuições, sendo 59 excluídas e 56 submetidas à análise de conteúdo descrita por Bardin e à análise multivariada e em função da frequência (p<0,05) no software IRaMuTeQ. Os eixos norteadores da análise do conteúdo foram: Insegurança Alimentar e Nutricional, Equidade, Ambiente Escolar, Importância da Atenção Primária à Saúde, Responsabilidade pela Garantia da Política, Alimentos e Nutrientes. O perfil geral dos participantes foi heterogêneo em relação ao segmento de atuação, sendo as instituições de ensino e pesquisa (38%) o de maior representação. As contribuições destacaram a preocupação da sociedade civil em garantir a segurança alimentar e nutricional da população do Distrito Federal. Constatou-se que a diversidade das contribuições associada à análise sistemática pode subsidiar a elaboração de políticas públicas mais condizentes com a realidade e fortalecer sua implementação, tornando-a mais tangível. Assim, a participação da sociedade em decisões políticas deve ser incentivada e ampliada, pois é fundamental para democratização e equidade.

ABSTRACT This study aimed to analyze the content of the District Food and Nutrition Policy's public consultation, present the participants' profiles, and report the systematization of the analysis performed. This is a documentary, exploratory, cross-sectional study with a qualitative and quantitative approach. The initial sample consisted of 115 inputs, with 59 exclusions and 56 retained for the content analysis described by Bardin and multivariate analysis by frequency (p<0.05) in the IRaMuTeQ software. The guiding axes defined for the content analysis were Food and Nutritional Insecurity, Equity, School Environment, Importance of Primary Care, Responsibility for Policy Assurance, and Food and Nutrients. The overall profile of the participants was heterogeneous concerning the activity segment, with the highest representation being education and research institutions (38%). The inputs highlighted the concern of civil society in assuring food and nutrition security for the population of the Federal District. We observed that the diverse inputs associated with systematic analysis could support the elaboration of public policies more consistent with reality and strengthen its implementation, making it more tangible. Thus, society's participation in political decisions must be encouraged and expanded, as it is essential for democratization and equity.

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BACKGROUND: There is a growing body of literature that recognizes the importance of public engagement in health technology assessment. However, there is still uncertainty regarding how the results should be recorded, analyzed, and used by decision makers. OBJECTIVE: Synthesize the contributions of the Brazilian public (women, health professionals, managers, educational institutions, and companies) about the implementation of the National Clinical Guidelines for Care in Normal Birth from the public consultation carried out in Brazil. METHOD: IRaMuTeQ software was used to organize and summarize the corpus based on three types of analysis: descriptive statistics; descending hierarchical classification; and specificities analysis. The public consultation was conducted in 2016 by the National Committee for Health Technology Incorporation (CONITEC) in the Brazilian public health system as part of the guideline development process. RESULTS: The corpus consisted of 303 texts, separated into 1233 text segments, 1081 of which were used, corresponding to retention of 87.67%. Five classes emerged from our analyses: mandatory presence of an obstetrician during labor and delivery in hospital settings; barriers and facilitators for guideline implementation; use of evidence-based practices by health professionals; progression of labor and delivery and women's rights; and mobilization to promote the guideline For each class, the most frequent words and sentences with the highest chi-squared scores were presented. Barriers were associated with lack of financial resources, training and professional motivation, and facilitators with training to change the practices of health professionals. Obstetric nurses emerged as an alternative for supervising normal births as well as the mandatory presence of an obstetrician during childbirth in hospital settings. CONCLUSION: Our findings summarize the contributions provided by the Brazilian public and shed some light on the barriers and facilitators of clinical guidelines for care in normal birth. These topics are not typically explored by quantitative studies. Including this information in the decision-making process would not only increase public engagement, but provide greater evidence for implementing the clinical guidelines nationwide.

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RESUMEN Introducción: existen factores que conducen a los pediatras a prescribir medicaciones "sintomáticas" y antibióticos, orientados a reducir síntomas y la ansiedad de los padres, práctica que no es inocua, porque algunas pueden producir daño. Objetivo: Determinar frecuencia de prescripciones de medicaciones sintomáticas y antibióticos, en consultas pediátricas de menores de 5 años de dos centros de atención, público y privado. Materiales y Métodos: Estudio observacional, descriptivo con componente analítico, prospectivo, transversal. Se incluyeron menores de 5 años que acudieron a consultas del Hospital Regional de Pedro Juan Caballero y Clínica Privada del Niño de la misma ciudad, en septiembre-octubre de 2017. Los datos fueron analizados en SPSSv21. Variables principales: Edad, sexo, procedencia, centro de consulta motivo de consulta, medicamentos prescriptos. Resultados: Fueron incluidos 200 pacientes, 51.5% (103) fueron del centro privado y 48.5% (97) del público. Mediana de edad: 16 meses, no hubo diferencias en relación al sexo. Motivos de consultas más frecuentes: Infección de vías aéreas superiores en privado (32%) y público (26%). El uso de Medicaciones sintomáticas fue: privado 32,4%(53/179), público 29,6%(53/179), recibió una sola medicación sintomática el 29,7%(33/111) y 27,9%(31/111) respectivamente. La frecuencia de prescripción de antibióticos en el privado fue 2,5%(5/179) y público 1,7% (3/179). El 89.5%(179/200) recibió algún tipo de medicación. Conclusión: Poco menos de la mitad utilizaron medicación sintomática y una tercera parte antibióticos, sin diferencias entre el centro público y privado. Menos de un cuarto de los pacientes de ambos sectores utilizaron más de una medicación sintomática.

ABSTRACT Introduction: there are factors that lead pediatricians to prescribe "symptomatic" medications and antibiotics, aimed at reducing symptoms and parental anxiety, a practice that is not harmless, because some can cause harm. Objective: To determine the frequency of prescriptions of symptomatic medications and antibiotics in pediatric consultations for children under 5 years of age in two care centers, public and private. Materials and methods: An observational, descriptive study with an analytical, prospective, cross-sectional component. Children under 5 years of age who attended consultations at the Pedro Juan Caballero Regional Hospital and the Private Children's Clinic of the same city, in September-October 2017, were included. The data were analyzed in SPSSv21. Main variables: Age, sex, origin, consultation center, reason for consultation, prescribed medications. Results: 200 patients were included, 51.5% (103) were from the private center and 48.5% (97) from the public. Median age: 16 months, there were no differences in relation to sex. Reasons for the most frequent visits: Upper airway infection in private (32%) and public (26%). The use of symptomatic medications was: private 32.4% (53/179), public 29.6% (53/179), received a single symptomatic medication 29.7% (33/111) and 27.9% (31/111) respectively. The frequency of prescribing antibiotics in the private sector was 2.5% (5/179) and the public 1.7% (3/179). 89.5% (179/200) received some type of medication. Conclusion: Just under half used symptomatic medication and one third used antibiotics, with no differences between the public and private centers. Less than a quarter of the patients in both sectors used more than one symptomatic medication.

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BACKGROUND: Public engagement in health technology assessment (HTA) is increasing worldwide. There are several forms of public engagement and it is not always possible to determine which stakeholders participate in the HTA process and how they contribute. Our objective was to investigate which types of social representatives contributed to the public consultation on the incorporation of Trastuzumab for early-stage breast cancer treatment within the public health system in Brazil, held in 2012 by the National Committee for Health Technology Incorporation (CONITEC). METHODS: A mixed methods approach was used to analyze social representativeness and the composition of the corpus from the public consultation, which consisted of 127 contributions. Three types of analysis were performed using IRaMuTeQ software: classic lexical analysis, descending hierarchical classification and specificities analysis. The contributions were clustered according to the main categories of discourse observed, into four social representation categories: 1) patient representation/advocacy; 2) pharmaceutical industry/advocacy; 3) healthcare professionals; and 4) individual contributions. RESULTS: Category 1 contained words related to increased survival due to use of the drug and a low score for words pertaining to studies on Trastuzumab. The word "safety" obtained a positive score only in category 2, which was also the only category that exhibited a negative score for the word "risk". Category 3 displayed the lowest scores for "diagnosis" and "safety". The word "efficacy" had a negative score only in category 4. CONCLUSIONS: Each category exhibited different results for words related to health systems and to key concepts linked to HTA. Our analysis enabled the identification of the most prominent contributions for each category. Despite the promising results obtained, further research is needed to validate this software for use in analyzing public contributions.

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The objective of this paper is to identify the stakeholders and their contributions to the public consultation carried out with regard to the mandatory trans fat acids food labeling proposal in Brazil. Methodology thematic analysis of the documents. Results 25 stakeholders made suggestions regarding the proposed law, and the majority belonged to the food industry sector. The following issues were raised: lack of knowledge among the consumers about trans fat acids; lack of information about trans fat acids in food composition tables and infrastructure to analyse the trans fat content of foods; voluntary trans fat labelling. Conclusions The stakeholders addressed important issues, such as improving nutritional knowledge among the population. However, few stakeholders linked to consumers took part in the public consultation, which might lead to disproportionate influence of the food industry on the development of future food policies.

Objetivo identificar os atores sociais e as suas contribuições na consulta pública realizada sobre a proposta obrigatória de rotulagem de alimentos no Brasil com gordura trans. Metodologia análise temática dos documentos. Resultados 25 atores apresentaram sugestões para a proposta da lei, e a maioria pertencia ao setor da indústria de alimentos. Temas encontrados: falta de conhecimento entre os consumidores sobre a gordura trans; falta de informação sobre gorduras trans em tabelas de composição de alimentos e de infraestrutura para analisar o teor de gordura trans nos alimentos; rotulagem voluntária da gordura trans. Conclusões Os participantes abordaram questões importantes, como a necessidade de aumentar o conhecimento dos consumidores sobre gordura trans. Entretanto, houve poucos atores sociais ligados aos interesses dos consumidores que participaram na consulta pública, e isso pode levar a um desequiibrio de poderes nas discussões sobre nutrição no Brasil.

Objetivo Identificar actores sociales y sus contribuciones en la consulta pública realizada sobre la propuesta obligatoria de rotulación de alimentos en Brasil con grasas transgénicas. Metodología Análisis temático de documentos. Resultados 25 actores presentaron sugerencias para la propuesta de ley, y la mayoría pertenecía al sector de la industria de alimentos. Temas encontrados Falta de conocimiento entre consumidores sobre grasas transgénicas; falta de información sobre grasas transgénicas en tablas de composición de alimentos e infraestructura para analizar grado de grasas transgénicas en alimentos; rotulación voluntaria de grasas transgénicas. Conclusiones Los participantes abordaron cuestiones importantes, como la necesidad de aumentar el conocimiento de los consumidores sobre grasas transgénicas. No obstante, hubo pocos actores sociales ligados a los intereses de los consumidores que participaron en la consulta y eso puede llevar a un desequilibrio de poderes en discusiones sobre nutrición en Brasil.

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