Publication: Evolución de la oferta de medicamentos en España en el período 2001-2012
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2017-03-02
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Universidad Complutense de Madrid
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Abstract
El repertorio de medicamentos que están accesibles para su prescripción y uso viene determinado por múltiples factores sanitarios, sociales, económicos, científicos e industriales. A ellos se suman los resultados de una regulación muy desarrollada que pretende modular, en defensa de la salud pública, los intereses contrapuestos de los distintos sectores implicados. Al tratar de describir la oferta de medicamentos en nuestro país y su comparación con el entorno, uno se encuentra con la sorpresa de encontrar poca o nula información objetiva y actualizada, sobre todo en lo que se refiere a su acceso bajo financiación por el SNS. Por todo ello, se considera oportuno realizar una descripción objetiva de la oferta de medicamentos en España y su evolución a lo largo de una década completa, la comprendida entre los años 2000 y 2010. Se trata de una década crucial en la que, entre otros hechos, se consolida el sistema europeo de registro y se desarrolla una presencia creciente de la EMA, están en vigor distintos incentivos al desarrollo de medicamentos con menor interés comercial e irrumpen con fuerza los genéricos de medicamentos de alto consumo OBJETIVOS Describir las características del mercado de medicamentos en España y sus cambios a lo largo del período 2001-2010 MATERIAL Y METODOS La fuente de datos ha sido la aplicación RAEFAR de la Agencia Española de Medicamentos y Productos Sanitarios. RAEFAR es la herramienta de gestión de las autorizaciones de medicamentos por parte de la AEMPS y por lo tanto es la fuente de información primaria y de mayor fiabilidad sobre medicamentos autorizados en España. La información se ha completado con el resultado de otras búsquedas para los datos sobre financiación en le SNS y para su evaluación se han tenido en cuenta los resultados de búsquedas complementarias tales como bases de datos de medicamentos de otros países o los informes de evaluación de la utilidad terapéutica de nuevos medicamentos por administraciones públicas españolas...
The repertory of medicinal products that are accessible for their prescription and use is determined by multiple health, social, economic, scientific and industrial factors. In addition to the above are the results of a highly developed regulation which aims to modulate the conflicting interests of the different sectors involved for the protection of public health. In attempting to describe the offer of medicinal products in our country and its comparison with neighbouring countries, one is surprised to find little or no objective and up-to-date information, particularly with respect to their access under financing by the NHS. It is therefore considered appropriate to provide an objective description of the offer of medicinal products in Spain and their evolution over an entire decade, from 2000 to 2010. This is a crucial period in which, inter alia, the European registration system has been consolidated and a growing presence of the EMA developed, different incentives for the development of medicinal products of less commercial interest have been put in place and high consumption generic medicines have emerged with force. OBJECTIVES: To describe the characteristics of the medicinal product market in Spain and the changes which have taken place over the period from 2001 to 2010. MATERIAL AND METHODS: The data source has been the RAEFAR application of the Spanish Agency of Medicines and Medical Devices (AEMPS in its Spanish acronym). RAEFAR is the management tool for authorisations of medicines by the AEMPS and is therefore the primary and most reliable information source for medicines authorised in Spain. Information has been completed with the results of other investigations to cover data about reimbursement in the NHS. For its evaluation, the results of supplementary searches such as the medicinal products databases of other countries or the assessment reports on therapeutic usefulness of new medicines by the Spanish Public Administration have been taken into account...
The repertory of medicinal products that are accessible for their prescription and use is determined by multiple health, social, economic, scientific and industrial factors. In addition to the above are the results of a highly developed regulation which aims to modulate the conflicting interests of the different sectors involved for the protection of public health. In attempting to describe the offer of medicinal products in our country and its comparison with neighbouring countries, one is surprised to find little or no objective and up-to-date information, particularly with respect to their access under financing by the NHS. It is therefore considered appropriate to provide an objective description of the offer of medicinal products in Spain and their evolution over an entire decade, from 2000 to 2010. This is a crucial period in which, inter alia, the European registration system has been consolidated and a growing presence of the EMA developed, different incentives for the development of medicinal products of less commercial interest have been put in place and high consumption generic medicines have emerged with force. OBJECTIVES: To describe the characteristics of the medicinal product market in Spain and the changes which have taken place over the period from 2001 to 2010. MATERIAL AND METHODS: The data source has been the RAEFAR application of the Spanish Agency of Medicines and Medical Devices (AEMPS in its Spanish acronym). RAEFAR is the management tool for authorisations of medicines by the AEMPS and is therefore the primary and most reliable information source for medicines authorised in Spain. Information has been completed with the results of other investigations to cover data about reimbursement in the NHS. For its evaluation, the results of supplementary searches such as the medicinal products databases of other countries or the assessment reports on therapeutic usefulness of new medicines by the Spanish Public Administration have been taken into account...
Description
Tesis inédita de la Universidad Complutense de Madrid, Facultad de Medicina, Departamento de Farmacología, leída el 23-09-2015