{"id":32747,"date":"2023-05-29T09:42:27","date_gmt":"2023-05-29T08:42:27","guid":{"rendered":"https:\/\/faus-moliner.com\/la-triple-a-access-availability-and-affordability\/"},"modified":"2023-05-29T09:45:27","modified_gmt":"2023-05-29T08:45:27","slug":"la-triple-a-access-availability-and-affordability","status":"publish","type":"post","link":"https:\/\/faus-moliner.com\/ca\/la-triple-a-access-availability-and-affordability\/","title":{"rendered":"La triple A: access, availability and affordability"},"content":{"rendered":"\n<p>Hace unas semanas, nuestra compa\u00f1era Claudia Gonzalo, escrib\u00eda en esta misma tribuna sobre la propuesta de revisi\u00f3n de la legislaci\u00f3n farmac\u00e9utica presentada por la&nbsp;<strong>Comisi\u00f3n Europea<\/strong>. Esta propuesta, seg\u00fan la propia Comisi\u00f3n, tiene como objetivo crear una verdadera \u201cUni\u00f3n Europea de la Salud\u201d, y estimular lo que ya se conoce como la triple A:&nbsp;<strong>access, availability and affordability.<\/strong><\/p>\n\n\n\n<p>Esta semana, hemos participado en el&nbsp;<strong>EU Pharmaceutical Law Forum<\/strong>&nbsp;en Bruselas donde se han abordado las novedades m\u00e1s destacadas de esta propuesta. Entre las cuestiones que se trataron, destac\u00f3 la fragmentaci\u00f3n del periodo de regulatorio de protecci\u00f3n de datos para los medicamentos innovadores. La Comisi\u00f3n propone someter la consecuci\u00f3n del&nbsp;<strong>m\u00e1ximo periodo de protecci\u00f3n posible&nbsp;<\/strong>a que se cumplan ciertas condiciones, entre ellas que el producto est\u00e9 disponible en los 27 Estados miembro en un plazo m\u00e1ximo de 2 a\u00f1os desde que se conceda la&nbsp;<strong>autorizaci\u00f3n de comercializaci\u00f3n<\/strong>. Se trata, en palabras de Florian Schmidt (DG Sant\u00e9), de establecer medidas que fomenten el acceso universal, en la Uni\u00f3n Europea, a los f\u00e1rmacos aprobados, lograr el ansiado mercado \u00fanico, la Uni\u00f3n Europea de la Salud.<\/p>\n\n\n\n<p>El objetivo no puede ser m\u00e1s loable, pero la partitura tiene alg\u00fan problema. Alcanzar este hito, lograr que el producto est\u00e9 comercializado en los 27 Estados miembro en el plazo de 2 a\u00f1os&nbsp;<strong>no depende de la voluntad del titular del medicamento<\/strong>. Puede haber casos en los que un titular no tenga la capacidad, la estructura o inter\u00e9s en comercializar el producto en todos los Estados miembro. En esos casos, el incentivo de un mayor periodo de protecci\u00f3n puede ser atractivo.<\/p>\n\n\n\n<p>Pero \u00bfc\u00f3mo abordar la mayor\u00eda de los casos, en los que la puesta del producto en el mercado depende de que el sistema de salud nacional decida incluirlo en su&nbsp;<strong>cat\u00e1logo de prestaciones<\/strong>, y de que se llegue a un acuerdo sobre su financiaci\u00f3n p\u00fablica? Condicionar el incentivo de dos a\u00f1os de protecci\u00f3n regulatoria a que el procedimiento de precio y reembolso concluya con una decisi\u00f3n aceptada por ambas partes, y con la consiguiente comercializaci\u00f3n del producto, coloca a las compa\u00f1\u00edas en una situaci\u00f3n extremadamente complicada, especialmente a los efectos de tomar decisiones a largo plazo. EFPIA propone establecer, como \u00fanica condici\u00f3n para&nbsp;<strong>conseguir este periodo de 2 a\u00f1os<\/strong>, que la compa\u00f1\u00eda farmac\u00e9utica haya presentado la solicitud de precio y reembolso en los 27 Estados miembro durante los primeros dos a\u00f1os tras conseguir la AC; a lo que la Comisi\u00f3n responde que esta condici\u00f3n no servir\u00e1 para mejorar la accesibilidad a nuevos medicamentos en la Uni\u00f3n Europea.<\/p>\n\n\n\n<p>Hace m\u00e1s de 30 a\u00f1os, en Europa se consigui\u00f3 aprobar la directiva de transparencia, que impone a los Estados miembro ciertas obligaciones en relaci\u00f3n con los procedimientos de financiaci\u00f3n de los medicamentos. El debate de las propuestas actuales obliga a reconocer que ir m\u00e1s all\u00e1 de lo previsto en la&nbsp;<strong>Directiva 89\/105<\/strong>&nbsp;es muy dif\u00edcil, que la capacidad de influencia de la Uni\u00f3n Europea en este \u00e1mbito es limitada, pero quien sabe, en 2020 la compra de vacunas contra la Covid-19 se hizo en condiciones paritarias en toda la UE, logrando un abordaje unitario de la pandemia.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Hace unas semanas, nuestra compa\u00f1era Claudia Gonzalo, escrib\u00eda en esta misma tribuna sobre la propuesta de revisi\u00f3n de la legislaci\u00f3n farmac\u00e9utica presentada por la&nbsp;Comisi\u00f3n Europea. Esta propuesta, seg\u00fan la propia Comisi\u00f3n, tiene como objetivo crear una verdadera \u201cUni\u00f3n Europea de la Salud\u201d, y estimular lo que ya se conoce como la triple A:&nbsp;access, availability and&#8230; <\/p>\n<div class=\"clear\"><\/div>\n<p><a href=\"https:\/\/faus-moliner.com\/ca\/la-triple-a-access-availability-and-affordability\/\" class=\"excerpt-read-more\">M\u00e9s informaci\u00f3<\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"categories":[502,319],"tags":[],"coauthors":[105],"class_list":["post-32747","post","type-post","status-publish","format-standard","hentry","category-el-global-ca-2","category-publicacions"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.6 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>La triple A: access, availability and affordability - Faus Moliner<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/faus-moliner.com\/ca\/la-triple-a-access-availability-and-affordability\/\" \/>\n<meta property=\"og:locale\" content=\"ca_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"La triple A: access, availability and affordability - Faus Moliner\" \/>\n<meta property=\"og:description\" content=\"Hace unas semanas, nuestra compa\u00f1era Claudia Gonzalo, escrib\u00eda en esta misma tribuna sobre la propuesta de revisi\u00f3n de la legislaci\u00f3n farmac\u00e9utica presentada por la&nbsp;Comisi\u00f3n Europea. Esta propuesta, seg\u00fan la propia Comisi\u00f3n, tiene como objetivo crear una verdadera \u201cUni\u00f3n Europea de la Salud\u201d, y estimular lo que ya se conoce como la triple A:&nbsp;access, availability and... 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