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Introduction Syndromic panel assays, that is, using one test to simultaneously target multiple pathogens with overlapping signs and symptoms, have been integrated into routine paediatric care over the past decade, mainly for more severely ill and hospitalised patients. Their wider availability and short turnaround times open the possibility to apply them to non-hospitalised patients as well. In this context, it is important to trial how clinicians make use of pathogen detection data and if their early availability influences management decisions, particularly antibiotic use and hospitalisation.Methods and analysis Advanced Diagnostics for Enhanced QUality of Antibiotic prescription in respiratory Tract infections in Emergency rooms is an individually randomised, controlled, open-label effectiveness trial comparing the impact of a respiratory pathogen panel assay (BIOFIRE Respiratory Panel 2.1plus) used as a rapid syndromic test on nasopharyngeal swabs in addition to the standard of care versus standard of care alone. The trial will 1:1 randomise 520 participants under the age of 18 at 7 paediatric emergency departments in 5 European countries. Inclusion criteria for the trial consist of two sets, with the first describing respiratory tract infections in paediatric patients and the second describing the situation of potential management uncertainty in which test results may immediately affect management decisions. Enrolment started in July 2021 and is expected to be completed in early 2024. We will perform a two-sample t-test assuming a pooled variance estimate to compare the log-transformed mean time on antibiotic treatment (in hours) and number of days alive out of the hospital within 14 days after study enrolment between the control and intervention arms.Ethics and dissemination The trial protocol and materials were approved by research ethics committees in all participating countries. The respiratory pathogen panel assay is CE marked (assessed to meet European regulations) and FDA (United States Food and Drug Administration) cleared for diagnostic use. Participants and caregivers provide informed consent prior to study procedures commencing. The trial results will be published in peer-reviewed journals and at national and international conferences. Key messages will also be disseminated via press and social media where appropriate.Trial registration number NCT04781530.

Objectives. To estimate the burden of permanent productivity losses caused by acute respiratory infections in South American countries in 2019. Methods. Mortality data from the Global Burden of Disease Study 2019 were analyzed to estimate the burden of disease attributable to acute respiratory infections. An approach based on the human capital method was used to estimate the cost of permanent productivity losses associated with respiratory diseases. To calculate this cost, the sum of the years of productive life lost for each death was multiplied by the proportion in the workforce and the employment rate, and then by the annual minimum wage or purchasing power parity in United States dollars (US$) for each country in the economically active age groups. Separate calculations were done for men and women. Results. The total number of deaths from acute respiratory infections in 2019 was 30 684 and the years of productive life lost were 465 211 years. The total cost of permanent productivity loss was about US$ 835 million based on annual minimum wage and US$ 2 billion in purchasing power parity, representing 0.024% of the region’s gross domestic product. The cost per death was US$ 33 226. The cost of productivity losses differed substantially between countries and by sex. Conclusion. Acute respiratory infections impose a significant economic burden on South America in terms of health and productivity. Characterization of the economic costs of these infections can support governments in the allocation of resources to develop policies and interventions to reduce the burden of acute respiratory infections.

Introdução: A carga da doença tem sido empregada em estimativas do impacto das neoplasias, mas a perda de produtividade em razão dessas enfermidades ainda não foi tão explorada. Objetivo: Estimar os anos de vida produtiva perdidos (AVPP) e a perda de produtividade por conta da mortalidade prematura relacionada ao câncer em países da América do Sul em 2019. Método: Dados de mortalidade disponíveis no Global Burden of Disease (GBD) Study 2019 foram usados para estimar a carga de doença atribuível a neoplasias. A perda de produtividade em termos monetários foi calculada usando um proxy da abordagem do capital humano (ACH). Os cálculos foram realizados por sexo, nas faixas etárias de trabalho. Resultados: O total de óbitos foi de 192.240 e o de AVPP, 2.463.155. A perda total de produtividade permanente foi de US$ 4,4 bilhões e US$ 9,4 bilhões em purchasing power parity (PPP) – 0,13% do produto interno bruto (PIB) da região. O custo total por morte foi de US$ 23.617. Houve diferenças significativas entre os países, mas a variação dos cenários mostra robustez das estimativas. Conclusão: O câncer impõe um ônus econômico significativo à América do Sul tanto em termos de saúde quanto de produtividade. Sua caracterização pode subsidiar os governos na alocação de recursos destinados ao planejamento de políticas e execução de intervenções de saúde.

Objetivo. Descrever e comparar os marcos regulatórios das políticas de acesso rápido/alternativo a medicamentos (acesso expandido e uso compassivo) em países da América do Sul. Métodos. Realizou-se um estudo exploratório e descritivo, com análise documental. Além de revisão da literatura científica sobre o tema, foram levantadas informações e normas oficiais caso estivessem disponíveis nas páginas eletrônicas das autoridades reguladoras de medicamentos. Foram coletadas informações sobre a forma como cada país define os conceitos de acesso expandido e uso compassivo, fase clínica em que o medicamento fica disponível para esses usos alternativos e obrigações de médicos e patrocinadores. Resultados. A partir dos critérios de inclusão, foram selecionados para o estudo Argentina, Brasil, Chile, Peru e Uruguai. O levantamento de informações mostrou que Argentina e Brasil apresentam um cenário regulatório mais estruturado. O Chile apresenta uma norma sobre acesso expandido e uso compassivo, porém sem definir explicitamente esses conceitos. No Peru e Uruguai, foi constatada a ausência de definições importantes quanto ao acesso expandido. Não foram identificadas quaisquer bases de dados com informações sobre acesso expandido e uso compassivo, corroborando a percepção de escassez de dados empíricos para avaliar os resultados dessas políticas. Conclusões. Todos os países analisados contam com um marco regulatório que permite o acesso rápido/alternativo a medicamentos por pacientes em situação de risco. Porém, não existem bancos de dados e transparência de informações que permitam caracterizar quais medicamentos e pacientes se beneficiam desse acesso alternativo e avaliar os resultados dessas políticas na América do Sul.

Introduction: Sepsis is a serious and expensive healthcare problem, when caused by a multidrug-resistant (MDR) bacteria mortality and costs increase. A reduction in the time until the start of treatment improves clinical results. The objective is to perform a systematic review of economic evaluations to analyze the cost-effectiveness of diagnostic methods in sepsis and to draw lessons on the methods used to incorporate antimicrobial resistance (AMR) in these studies. Material and Methods: the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines were followed, and the Consolidated Health Economic Evaluation Reporting standards (CHEERS) checklist was used to extract the information from the texts. Results: A total of 16 articles were found. A decision model was performed in 14. We found two ways to handle resistance while modelling: the test could identify infections caused by a resistant pathogen or resistance-related inputs, or outcomes were included (the incidence of AMR in sepsis patients, antibiotic use, and infection caused by resistant bacterial pathogens). Conclusion: Using a diagnostic technique to detect sepsis early on is more cost-effective than standard care. Setting a direct relationship between the implementation of a testing strategy and the reduction of AMR cases, we made several assumptions about the efficacy of antibiotics and the length-of-stay of patients.

Background: The most recommended treatment for a Helicobacter pylori infection is high doses of combined antibiotics. The objective of this article is to perform a systematic review of the economic evaluation studies applied to assess the efficiency of diagnostic testing for H. pylori infections, so that their main characteristics can be identified and to learn from the literature how the antimicrobial resistance (AMR) issue is incorporated into these economic evaluations. Methods: We conducted a systematic review to compare the costs and clinical effectiveness of diagnostic strategies for H. pylori infections. We followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines and extracted the items from the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) checklist. Results: We found thirteen articles that were of good quality according to CHEERS: six studies focused on diagnostics of Helicobacter pylori infections associated with dyspepsia and four on duodenal ulcers. Testing was found to be the most cost-effective strategy in eight articles. Four studies considered AMR. Conclusions: Testing was more cost-effective than empirical treatment, except in cases of high prevalence (as with developing countries) or when patients could be stratified according to their comorbidities. The introduction of AMR into the model may change the efficiency of the testing strategy.

In 2013, a change in copayment rate was introduced in the Basque Country (one year later than in the other regions in Spain), and improvements were made to drug packaging. In 2014, a National Program Against Bacterial Resistance (Spanish abbreviation: PRAN) was approved. The aim of this study is to analyze the impact of change to the copayment rate, the adjustment of drug packaging, and the approval of PRAN on the consumption of antibiotics. Raw monthly data on the consumption of antibiotics (costs, packages, and daily defined doses per thousand people (DID)) were collected from January 2009 to December 2018 in the Basque Country. Counterfactual and intervention analysis (Autoregressive integrated moving average (ARIMA) model) was performed for the total series, disaggregated by group of antibiotics (2019 WHO Access, Watch, and Reserve (AWaRe) Classification) and active substances with the highest cost per prescription (cefditoren and moxifloxacin), the lowest cost per prescription (doxycycline and cloxacillin), and the most prescribed active ingredients (amoxicillin, azithromycin, and levofloxacin). Introduction of copayment led to a ‘stockpiling effect’ one month before its implementation, equal to 8% in the three consumption series analyzed. Only the adjustment of drug packaging significantly reduced the number of packages dispensed (−12.19%). PRAN approval reduced consumption by 0.779 DID (−4.51%), representing a significant decrease for both ’access’ and ’watch’ group antibiotics. Despite the delay in implementing changes to copayment, there was a ‘stockpiling effect’. With the adjustment of packaging, fewer packs were prescribed but with a higher drug load and price. PRAN approval reduced both the consumption of ’access group antibiotics’ (first-line treatment) and ’watch group antibiotics’ (second-line treatment).

Fundamentos: Las infecciones causadas por el Streptococcus pneumoniae en el adulto tienen repercusiones importantes en la salud. El objetivo fue analizar el impacto económico y sanitario en 5 años de la vacunación de la cohorte española de 65 años inmunocompetente con la vacuna antineumocócica conjugada 13-valente.Métodos: Mediante un modelo de transmisión dinámica basado en ecuaciones diferenciales se analizó la carga de la enfermedad neumocócica (EN) en sujetos de 65 años en 5 años, siendo vacunada anualmente el 36,5% de la cohorte. Se aplicó la eficacia de la vacuna del 52,5% observada en el estudio CAPITA en pacientes de 65 años inmunocompetentes, cobertura de serotipos vacunales del 63,4% (estudio CAPA), incidencia de infección neumocócica de 162,2/100.000 casos año (CMBD 2010-2013) y proporción de vacunados previamente al arranque del modelo del 0,99%. La perspectiva fue la del Sistema Nacional de Salud (SNS). Costes de casos de EN según CMBD y precio de venta de laboratorio de la vacuna conjugada.Resultados: En 5 años la vacunación con vacuna conjugada 13-valente espera evitar 10.360 casos de EN (7.411 hospitalizaciones por neumonías) y 699 muertes (14.736 años de vida ganados -AVG-), en una cohorte de 65 a 69 años de edad. El coste de vacunación esperado de 36,5 millones de euros se compensaría completamente por la reducción de 41,5 millones de costes médicos evitados, con un ahorro neto acumulado de 3,8 millones de euros a precios constantes (4,9 a precios corrientes).Conclusión: La vacunación con vacuna conjugada 13-valente en adultos de 65 años inmunocompetentes resulta eficiente para el Sistema Nacional de Salud, reduciendo la carga de enfermedad y evitando un número importante de muertes.

Fundamentos: el objetivo del trabajo es es conocer si el impacto del Real Decreto-Ley 16/2012 en el número de recetas y el gasto farmacéutico, evaluadas por el Ministerio de Sanidad, Servicios Sociales e Igualdad (MSSSI), se corresponden con las obtenidas por otros métodos estadísticos habitualmente empleados. Asimismo, se han elaborado unos modelos para predecir la evolución de ambas variables entre septiembre de 2013 y diciembre de 2014. Métodos: se aplicó la metodología Box-Jenkins conjuntamente con el análisis de intervención de Box-Tiao a datos del periodo 2003-13 para predecir mensualmente los valores de las series de recetas y gasto farmacéutico. Las predicciones se emplearon en un análisis contrafáctico para compararlas con las series de recetas y gasto real. También se efectuaron predicciones para el periodo de septiembre de 2013 a diciembre de 2014 para observar el impacto de la medida en un horizonte superior al real Resultados: el análisis contrafáctico estimó el descenso en el número de recetas en un 12,18% y el del gasto farmaceutico en un 12,83%, mientras que al calcularse mediante el análisis de intervención fueron 12,75% y 14,03%, respectivamente. Conclusiones: la reducción estimada del número de recetas para el periodo de junio de 2012 hasta agosto de 2013 es similar a la ofrecida por el MSSSI, mientras que para la serie del gasto farmacéutico fue inferior a la ofrecida por el MSSSI. La metodología de Box-Jenkins genera errores de predicción menores al 3% por lo que se considera útil para anticipar fiablemente los consumos futuros.

Background: Many established products (EPs – marketed for eight years or more) are widely used off-label despite little evidence on benefit–risk ratio. This exposes patients to risks related to safety and lack of efficacy, and healthcare providers to liability. Introducing new indications for EPs may represent a high societal value; however, manufacturers rarely invest in R&D for EPs. The objective of this research was to describe incentives and disincentives for developing new indications for EPs in Europe and to investigate consequences of current policies. Methods: Targeted literature search and expert panel meetings. Results: Within the current European-level and national-level regulatory framework there are limited incentives for development of new indications with EPs. Extension of indication normally does not allow the price to be increased or maintained, the market protection period to be extended, or exclusion from a reference price system. New indication frequently triggers re-evaluation, resulting in price erosion, regardless of the level of added value with the new indication. In consequence, manufacturers are more prone to undertake R&D efforts at early to mid-stage of product life cycle rather than with EPs, or to invest in new chemical entities, even in therapeutic areas with broad off-label use. This represents a potentially missed opportunity as developing new indications for EPs offers an alternative to off-label use or lengthy and expensive R&D for new therapies, opens new opportunities for potentially cost-effective treatment alternatives, as well as greater equity in patients’ access to treatment options. Conclusion: There are potential benefits from the development of new indications for EPs that are currently not being realized due to a lack of regulatory and pricing incentives in Europe. Incentives for orphan or paediatric drugs have proven to be effective in promoting R&D. Similarly, incentives to promote R&D in EPs should be developed, for the benefit of patients and healthcare systems.

Fundamentos: En un contexto de dificultades presupuestarias, la cuantificación de los costes de la no seguridad constituye un instrumento adicional que puede ayudar en la adopción de decisiones y en la mejor gestión del sistema sanitario. Hasta el presente no se ha llegado a estimar los costes de la no se- guridad en nuestro país de una forma integral. Este artículo tiene por objetivo presentar una primera aproximación al cálculo de los costes de la no seguridad referidos al año 2011. Métodos: Para efectuar los cálculos se partió de una estimación de los costes de los pacientes hospitalizados para el año 2005 referentes a los errores de medicación, infecciones nosocomiales y complicaciones quirúrgicas, que se actualizaron al año de referencia. Para los costes de los pacientes no hospitalizados se tuvo en cuenta la Encuesta Nacional de Salud y las estimaciones de la tasa de errores de medicación y de los costes de los tratamientos procedentes de otros autores. Resultados: El coste de la no seguridad en los pacientes hospitalizados fue de 2.474 millones de euros y de 960 millones de euros para los pacientes no hospitalizados Conclusiones: Esta estimación indica que los costes de la no seguridad.

Fundamento: Los programas de dispensación de metadona se han organizado en cada Comunidad Autónoma de una forma específica, desconociéndose sus costes derivados a pesar del interés que puede conllevar una gestión más eficiente. Nuestro estudio tiene por objetivo calcular los costes del programa de metadona en la ComunidadAutónoma de La Rioja. Métodos: El estudio se realizó en 2010. Los datos fueron recogidos a partir de los registros existentes en diferentes instituciones sanitarias, según las diferentes fases del programa. Los costes se clasificaron en función de las diferentes etapas y de los diferentes centros de dispensación. Resultados: El análisis de los datos muestra un coste total anual aproximado de 165.759 ¿ para una concentración de 2 mg/ml de metadona, que significa un coste anual de 412,34 ¿ por paciente . Conclusiones: La fase de dispensación de la metadona es la que mayor coste supone, el centro cuyos pacientes en términos relativos cuestan más al programa es el que cuenta con menor número de pacientes atendidos, debido a los costes fijos que han de repartirse entre menos personas, si bien el centro de Logroño tiene el mayor coste total por atender al mayor número de personas pero su coste medio por paciente es menor.

Objetivo: Los modelos de Markov son el método estándar utilizado en los estudios de coste-efectividad para representar la historia natural de la enfermedad. El objetivo de este trabajo es mostrar los elementos clave en la construcción de modelos de Markov de tipo probabilístico. Métodos: Se ha utilizado el ejemplo de un nuevo tratamiento para una enfermedad genérica. Para ello se ha construido un modelo de Markov con parámetros introducidos como distribuciones estadísticas para llevar a cabo el análisis de sensibilidad probabilístico mediante simulaciones de Monte Carlo. Los resultados se analizaron en forma de plano coste-efectividad y curva de aceptabilidad. Resultados: La razón coste-efectividad incremental para el paciente medio es de 22.855€/año de vida ajustado por calidad (AVAC). En el análisis de sensibilidad probabilístico el resultado de todas las simulaciones se sitúa en el cuadrante nordeste, que corresponde a coste y efectividades positivas. El 67% de las simulaciones se sitúa por debajo del umbral de los 30.000€/AVAC. Conclusión: La utilización de los modelos de Markov de tipo probabilístico requiere la integración de conceptos provenientes de la economía, la epidemiología, la estadística y la clínica. Algunas etapas del proceso, como la construcción y el procesamiento del modelo, la gestión de los riesgos absolutos y relativos, y el manejo de las distribuciones estadísticas, suelen plantear mayores dificultades, pero son necesarias para que el modelo reproduzca la enfermedad de forma válida.Objective: Markov models are the standard method used in cost-effectiveness studies to represent the natural history of disease. The objective of this study was to show the key elements in building probabilistic Markov models. Methods: We used the example of a new treatment for a generic disease. A probabilistic Markov model was constructed using statistical distributions. Monte Carlo simulations were carried out to obtain the probabilistic sensitivity analysis. The results were analyzed in terms of the cost-effectiveness plane and acceptability curve. Results: The incremental cost-effectiveness rate for the average patient was €22,855/quality adjusted life years (QALY). In the probabilistic sensitivity analysis, the results from all simulations were located in the northeast quadrant, corresponding to positive cost and effectiveness. However, 67% of the simulations were below the threshold of €30,000/QALY. Conclusion: The use of probabilistic Markov models requires the integration of concepts from economics, epidemiology, statistics, and the clinical setting. Some stages of the process, such as the construction and processing of these models, the management of absolute and relative risks and of statistical distributions, often pose major difficulties but are key steps required to reproduce the disease with validity.

La evaluación económica de tecnologías sanitarias se ha convertido en los últimos años en Europa en una herramienta de primer orden para los gestores sanitarios en sus estrategias de asignación de recursos sanitarios y de adopción de nuevas tecnologías. España fue uno de los países pioneros en realizar propuestas de estandarización metodológica aplicable a estudios de evaluación económica. No obstante, la falta de decisión política y de apoyo de los gestores sanitarios a este tipo de herramientas hizo que las propuestas cayeran en desuso. Sin embargo, lo esperable es que a medio plazo sea cada vez más habitual que las nuevas tecnologías sanitarias financiadas por el Sistema Nacional de Salud deban aportar una adecuada evidencia de su valor terapéutico y social en comparación con su coste. Llegado ese momento, los actores del sistema requerirán una serie de reglas claras y consensuadas por parte de los agentes del sistema sobre las cuestiones técnicas o metodológicas que deben respetar los estudios de evaluación de tecnologías sanitarias. Por este motivo, las presentes recomendaciones orientan sobre cómo realizar y analizar los estudios de evaluación económica de calidad. Las recomendaciones aparecen bajo 17 encabezamientos o dominios, y bajo cada recomendación hay además un comentario, en el cual se justifican y discuten las propuestas en relación con otras opciones posibles.Over the last few years, economic evaluation of health technologies has become a major tool used by European health policy decision-makers to create strategies for prioritizing the allocation of health resources and the approval of new technologies. Spain was a pioneer in proposing the standardization of methodology applicable to economic evaluation studies. However, because health policy decision-makers refused to support the initiative, the methodology was never put into practice. In the medium term, evidence of the economic value of new health technologies financed by the national health system will probably be increasingly required. At that time, stakeholders and decision-makers will have to agree upon a clear and concise set of rules on the technical and methodological issues that must be followed by economic evaluations of health technologies. Consequently, we have provided guidelines and recommendations for producing first-rate economic evaluations. The recommendations appear under seventeen headings or sections. In each case, the recommended requirements to be satisfied by an economic evaluation of health technologies are provided and each recommendation is followed by a commentary, providing a justification and comparing and contrasting the proposal with other available alternatives.

La utilización conjunta de árboles de decisión y modelos epidemiológicos basados en ecuaciones diferenciales es un método apropiado para la evaluación económica de medidas profilácticas ante enfermedades infecciosas. Estos modelos permiten combinar el comportamiento dinámico de la enfermedad con el consumo de recursos sanitarios. Para ilustrar este tipo de modelos se ajusta un sistema dinámico de ecuaciones diferenciales al comportamiento epidémico de la gripe en España, con el fin de proyectar el impacto epidemiológico de la vacunación antigripal. Los resultados del modelo dinámico se implementan en un diagrama con estructura de árbol para medir el consumo de recursos sanitarios y su repercusión en términos monetarios.The joint utilization of both decision trees and epidemiological models based on differential equations is an appropriate method for the economic evaluation of preventative interventions applied to infectious diseases. These models can combine the dynamic pattern of the disease together with health resource consumption. To illustrate this type of model, we adjusted a dynamic system of differential equations to the epidemic behavior of influenza in Spain, with a view to projecting the epidemiologic impact of influenza vaccination. The results of the epidemic model are implemented in a diagram with the structure of a decision tree so that health resource consumption and the economic implications can be calculated.

Objetivo: Describir el estado de salud autopercibido y la calidad de vida relacionada con la salud (CVRS) de individuos sanos en edad laboral, medir el cambio experimentado con el padecimiento de la gripe y valorarlo en términos monetarios. Método: Estudio observacional descriptivo mediante cuestionarios administrados a 50 individuos, en edad laboral, infectados por el virus de la gripe durante el año epidemiológico 2004-2005 y residentes en domicilios particulares de la ciudad de Logroño (España). Los pacientes completaron los cuestionarios en dos ocasiones: con gripe y una vez restablecidos. Se efectuó un análisis de las variables sociodemográficas, las dimensiones y los indicadores de CVRS del cuestionario European Quality of Life-5 Dimensions (EQ-5D). Los índices de utilidad de la CVRS se emplearon para el cálculo de los años de vida ajustados por calidad (AVAC) perdidos. Resultados: Por término medio, la reducción del índice de la CVRS debida al padecimiento de la gripe varió entre 0,37 y 0,65, en una escala que va del 0 (muerte) al 1 (salud perfecta). Una epidemia de gripe, sobre un grupo de 100.000 individuos, puede suponer una pérdida de 137 AVAC, que valorados en términos monetarios ascenderían a 2.722.609 euros. Conclusiones: "Actividades cotidianas" es la dimensión EQ-5D que más empeoró, mientras que «ansiedad/depresión» fue la menos afectada. La gripe ocasiona importantes pérdidas de CVRS en la población en edad laboral. Los resultados monetarios del análisis de sensibilidad estuvieron comprendidos en intervalos cuya amplitud fue de más de 5 veces el valor medio.Objective: To describe self-perceived health status and health-related quality of life (HRQoL) in healthy individuals of working age, to measure changes due to influenza infection, and to evaluate the effect of influenza infection on HRQoL in monetary terms. Method: We performed a descriptive observational study through questionnaires administered to 50 patients of working age infected with the influenza virus during the epidemiologic year 2004-2005 and living in private homes of the city of Logroño (Spain). The patients completed the questionnaires twi with and without influenza. The dimensions and HRQoL indicators of the European Quality of Life-5 Dimensions (EQ-5D) questionnaire were evaluated. HRQoL utility indices were used to calculate lost quality-adjusted life years (QALYs). Results: On average, the reduction in the HRQoL utility index caused by influenza infection was between 0.37 and 0.65, on a scale from 0 (death) to 1 (perfect health). An influenza epidemic in 100,000 individuals could imply a loss of 137 QALYs, which in monetary terms could represent 2,722,609€. Conclusions: The EQ-5D dimension most negatively affected by influenza was «daily activities" while the least affected dimension was "anxiety/depression». Influenza causes substantial losses in HRQoL among the population of working age. The results of the sensitivity analysis of the monetary effects of influenza infection yielded intervals showing a range of more than 5 times the mean value.

Objetivos: Caracterizar la naturaleza económica singular del mercado de medicamentos en la Unión Europea, estudiar las posibles agrupaciones de países en función de ciertas variables farmacéuticas, analizar algunas normas reguladoras recientes dirigidas a la creación del mercado único y presentar algunas reflexiones sobre la toma de decisiones en materia de salud pública desde la perspectiva de la situación actual de los presupuestos públicos sanitarios. Método: análisis económico de macromagnitudes sanitarias y farmacéuticas, análisis de agrupamiento de datos («cluster»), revisión de la legislación farmacéutica e industrial comunitaria, así como de las formas de presupuestación farmacéutica de los estados miembros. Resultados: Se ha caracterizado el mercado de medicamentos en la Unión Europea y se han clasificado los países a partir de 5 variables en torno a 2 grupos principales. Las medidas legislativas comunitarias tienden a fomentar la I+D y la producción de fármacos, de modo que se consolide el sector industrial. Las regulaciones nacionales son diferentes en materias de reembolso y establecimiento de precios. Conclusiones: La creación del mercado único del medicamento en la Unión Europea debe contemplar esta diversidad reguladora y buscar un equilibrio entre los aspectos económicos y de salud pública. El mercado único farmacéutico puede ser una estrategia peligrosa si se convierte en dogma general y más si se determinan plazos fijos y breves.Objectives: To characterize the peculiar economic nature of the pharmaceutical market in the EU, to study potential groupings of countries based on several pharmaceutical variables, to analyze some recent regulations designed to create the single market, and to present some thoughts on the decision making process in public health from the perspective of current public health budgets. Method: We performed an economic analysis of health and pharmaceutical macrovariables, cluster analysis, review of EU pharmaceutical and industrial regulations and review of pharmaceutical budgeting legislation in the member states. Results: The pharmaceutical market of the EU was characterized and EU countries were classified into two principal groups according to 5 selected variables. EU regulations tend to promote R + D and drug production and thus the EU industrial sector is backed up. National regulations differ in terms of pricing and drugs reimbursement. Conclusions: The creation of a single market for drugs in theEU should take this regulatory diversity into account and seek equilibrium between economic factors and public health. This single market may be a dangerous strategy if it becomes a general dogma and even more so if deadlines are fixed andshort.