{"id":26842,"date":"2021-06-07T11:10:10","date_gmt":"2021-06-07T10:10:10","guid":{"rendered":"https:\/\/faus-moliner.com\/regulacion-de-los-psps-para-cuando\/"},"modified":"2021-06-07T11:11:06","modified_gmt":"2021-06-07T10:11:06","slug":"regulacion-de-los-psps-para-cuando","status":"publish","type":"post","link":"https:\/\/faus-moliner.com\/ca\/regulacion-de-los-psps-para-cuando\/","title":{"rendered":"Regulaci\u00f3n de los PSPs \u00bfpara cu\u00e1ndo?"},"content":{"rendered":"\n<p>Las compa\u00f1\u00edas que operan en el mercado (y especialmente aquellas que lo hacen en sectores profusamente regulados como el sector&nbsp;<em>life&nbsp;<\/em>sciences) deber\u00edan poder hacerlo en un entorno normativo claro, sin cargas excesivas, estable, y con un grado de previsibilidad razonable. De ello se ocupa la&nbsp;<em>better regulation,&nbsp;<\/em>principio b\u00e1sico de la pol\u00edtica europea desde los a\u00f1os noventa y positivizado tambi\u00e9n en nuestro ordenamiento en normas como la Ley 39\/2015.<\/p>\n\n\n\n<p>En el \u00e1mbito de los estudios observacionales con medicamentos de uso humano, se ha aprobado recientemente el Real Decreto 957\/2020 que deroga la Orden SAS\/3470\/2009 vigente hasta la fecha. Sobre esta nueva norma tuve ocasi\u00f3n de expresar mi opini\u00f3n como ponente en el curso de derecho farmac\u00e9utico de CEFI celebrado esta semana. Al respecto, y vinculado con el principio b\u00e1sico de&nbsp;<em>better regulation<\/em>&nbsp;al que hac\u00eda referencia, me gustar\u00eda compartir dos reflexiones.<\/p>\n\n\n\n<p>Los objetivos del Real Decreto 957\/2020 tiene buen anclaje en los principios de la&nbsp;<em>better regulation<\/em>. Tanto la simplificaci\u00f3n y reducci\u00f3n de cargas burocr\u00e1ticas como la orientaci\u00f3n de la intervenci\u00f3n administrativa hac\u00eda los estudios prospectivos (que se considera son los que pueden tener un mayor impacto en las decisiones de prescripci\u00f3n y en el uso de medicamentos en el SNS) son prop\u00f3sitos loables y oportunos. El complejo y burocr\u00e1tico sistema contemplado en la Orden SAS\/3470\/2009 se ha sustituido por un sistema m\u00e1s sencillo y r\u00e1pido que favorecer\u00e1 la realizaci\u00f3n de estudios observacionales. Esto es, en mi opini\u00f3n, una buena noticia en un contexto en el que la evidencia obtenida en pr\u00e1ctica cl\u00ednica habitual (<em>Real World Evidence)<\/em>&nbsp;adquiere cada vez mayor relevancia.<\/p>\n\n\n\n<p>Ahora bien, considero tambi\u00e9n que el Real Decreto 957\/2020 incorpora una nota negativa, que es la importante incertidumbre que ha generado en torno a los programas de soporte a pacientes (PSPs). Es sabido que el auge de los PSPs durante los \u00faltimos a\u00f1os no ha ido acompa\u00f1ado de un esfuerzo del legislador para dotarlos de un marco jur\u00eddico cierto y sin confusiones normativas. El Real Decreto 957\/2020 era una buena oportunidad para revertir esta situaci\u00f3n y, en mi opini\u00f3n, no ha cumplido con las expectativas. En lugar de clarificar el marco aplicable a este tipo de programas y dotar a los operadores de seguridad jur\u00eddica; ha generado justo lo contrario, m\u00e1s inseguridad e incertidumbre. El ambiguo y confuso redactado del art. 3.2&nbsp;<em>in fine<\/em>&nbsp;y la interpretaci\u00f3n expansiva del mismo hecha por la AEMPS no ofrecen el grado de claridad y previsibilidad que la&nbsp;<em>better regulation&nbsp;<\/em>hace tantos a\u00f1os que exige. En definitiva, una oportunidad perdida.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Las compa\u00f1\u00edas que operan en el mercado (y especialmente aquellas que lo hacen en sectores profusamente regulados como el sector&nbsp;life&nbsp;sciences) deber\u00edan poder hacerlo en un entorno normativo claro, sin cargas excesivas, estable, y con un grado de previsibilidad razonable. De ello se ocupa la&nbsp;better regulation,&nbsp;principio b\u00e1sico de la pol\u00edtica europea desde los a\u00f1os noventa y&#8230; <\/p>\n<div class=\"clear\"><\/div>\n<p><a href=\"https:\/\/faus-moliner.com\/ca\/regulacion-de-los-psps-para-cuando\/\" class=\"excerpt-read-more\">M\u00e9s informaci\u00f3<\/a><\/p>\n","protected":false},"author":19,"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":[],"class_list":["post-26842","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>Regulaci\u00f3n de los PSPs \u00bfpara cu\u00e1ndo? - 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\/regulacion-de-los-psps-para-cuando\/\" \/>\n<meta property=\"og:locale\" content=\"ca_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Regulaci\u00f3n de los PSPs \u00bfpara cu\u00e1ndo? - Faus Moliner\" \/>\n<meta property=\"og:description\" content=\"Las compa\u00f1\u00edas que operan en el mercado (y especialmente aquellas que lo hacen en sectores profusamente regulados como el sector&nbsp;life&nbsp;sciences) deber\u00edan poder hacerlo en un entorno normativo claro, sin cargas excesivas, estable, y con un grado de previsibilidad razonable. De ello se ocupa la&nbsp;better regulation,&nbsp;principio b\u00e1sico de la pol\u00edtica europea desde los a\u00f1os noventa y... M\u00e9s informaci\u00f3\" \/>\n<meta property=\"og:url\" content=\"https:\/\/faus-moliner.com\/ca\/regulacion-de-los-psps-para-cuando\/\" \/>\n<meta property=\"og:site_name\" content=\"Faus Moliner\" \/>\n<meta property=\"article:published_time\" content=\"2021-06-07T10:10:10+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2021-06-07T10:11:06+00:00\" \/>\n<meta name=\"author\" content=\"Llu\u00eds Alcover\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Escrit per\" \/>\n\t<meta name=\"twitter:data1\" content=\"Llu\u00eds Alcover\" \/>\n\t<meta name=\"twitter:label2\" content=\"Temps estimat de lectura\" \/>\n\t<meta name=\"twitter:data2\" content=\"2 minuts\" \/>\n\t<meta name=\"twitter:label3\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data3\" content=\"Llu\u00eds Alcover\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\/\/faus-moliner.com\/ca\/regulacion-de-los-psps-para-cuando\/#article\",\"isPartOf\":{\"@id\":\"https:\/\/faus-moliner.com\/ca\/regulacion-de-los-psps-para-cuando\/\"},\"author\":{\"name\":\"Llu\u00eds Alcover\",\"@id\":\"https:\/\/faus-moliner.com\/en\/#\/schema\/person\/9c887db396e6c9997a6208a40c3e4670\"},\"headline\":\"Regulaci\u00f3n de los PSPs \u00bfpara cu\u00e1ndo?\",\"datePublished\":\"2021-06-07T10:10:10+00:00\",\"dateModified\":\"2021-06-07T10:11:06+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\/\/faus-moliner.com\/ca\/regulacion-de-los-psps-para-cuando\/\"},\"wordCount\":470,\"publisher\":{\"@id\":\"https:\/\/faus-moliner.com\/en\/#organization\"},\"articleSection\":[\"El Global\",\"Publicacions\"],\"inLanguage\":\"ca\"},{\"@type\":\"WebPage\",\"@id\":\"https:\/\/faus-moliner.com\/ca\/regulacion-de-los-psps-para-cuando\/\",\"url\":\"https:\/\/faus-moliner.com\/ca\/regulacion-de-los-psps-para-cuando\/\",\"name\":\"Regulaci\u00f3n de los PSPs \u00bfpara cu\u00e1ndo? - Faus Moliner\",\"isPartOf\":{\"@id\":\"https:\/\/faus-moliner.com\/en\/#website\"},\"datePublished\":\"2021-06-07T10:10:10+00:00\",\"dateModified\":\"2021-06-07T10:11:06+00:00\",\"breadcrumb\":{\"@id\":\"https:\/\/faus-moliner.com\/ca\/regulacion-de-los-psps-para-cuando\/#breadcrumb\"},\"inLanguage\":\"ca\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\/\/faus-moliner.com\/ca\/regulacion-de-los-psps-para-cuando\/\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\/\/faus-moliner.com\/ca\/regulacion-de-los-psps-para-cuando\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Portada\",\"item\":\"https:\/\/faus-moliner.com\/ca\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Regulaci\u00f3n de los PSPs \u00bfpara cu\u00e1ndo?\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\/\/faus-moliner.com\/en\/#website\",\"url\":\"https:\/\/faus-moliner.com\/en\/\",\"name\":\"faus-moliner.com\",\"description\":\"Otro sitio realizado con WordPress\",\"publisher\":{\"@id\":\"https:\/\/faus-moliner.com\/en\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\/\/faus-moliner.com\/en\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"ca\"},{\"@type\":\"Organization\",\"@id\":\"https:\/\/faus-moliner.com\/en\/#organization\",\"name\":\"Faus Moliner\",\"url\":\"https:\/\/faus-moliner.com\/en\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"ca\",\"@id\":\"https:\/\/faus-moliner.com\/en\/#\/schema\/logo\/image\/\",\"url\":\"https:\/\/faus-moliner.com\/wp-content\/uploads\/2023\/03\/Logo-FM-web.jpg\",\"contentUrl\":\"https:\/\/faus-moliner.com\/wp-content\/uploads\/2023\/03\/Logo-FM-web.jpg\",\"width\":400,\"height\":283,\"caption\":\"Faus Moliner\"},\"image\":{\"@id\":\"https:\/\/faus-moliner.com\/en\/#\/schema\/logo\/image\/\"},\"sameAs\":[\"https:\/\/www.linkedin.com\/company\/2372042\/admin\/\"]},{\"@type\":\"Person\",\"@id\":\"https:\/\/faus-moliner.com\/en\/#\/schema\/person\/9c887db396e6c9997a6208a40c3e4670\",\"name\":\"Llu\u00eds Alcover\",\"image\":{\"@type\":\"ImageObject\",\"inLanguage\":\"ca\",\"@id\":\"https:\/\/faus-moliner.com\/en\/#\/schema\/person\/image\/7c013ebf5b5f97c6203cfd8a6b59d506\",\"url\":\"https:\/\/secure.gravatar.com\/avatar\/dbf0132b5844b926fc2d4f49851ed7a8141b4197ba6d8378277521f451ff89c7?s=96&d=mm&r=g\",\"contentUrl\":\"https:\/\/secure.gravatar.com\/avatar\/dbf0132b5844b926fc2d4f49851ed7a8141b4197ba6d8378277521f451ff89c7?s=96&d=mm&r=g\",\"caption\":\"Llu\u00eds Alcover\"},\"url\":\"https:\/\/faus-moliner.com\/ca\/author\/lluis-alcover\/\"}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"Regulaci\u00f3n de los PSPs \u00bfpara cu\u00e1ndo? - Faus Moliner","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/faus-moliner.com\/ca\/regulacion-de-los-psps-para-cuando\/","og_locale":"ca_ES","og_type":"article","og_title":"Regulaci\u00f3n de los PSPs \u00bfpara cu\u00e1ndo? - Faus Moliner","og_description":"Las compa\u00f1\u00edas que operan en el mercado (y especialmente aquellas que lo hacen en sectores profusamente regulados como el sector&nbsp;life&nbsp;sciences) deber\u00edan poder hacerlo en un entorno normativo claro, sin cargas excesivas, estable, y con un grado de previsibilidad razonable. De ello se ocupa la&nbsp;better regulation,&nbsp;principio b\u00e1sico de la pol\u00edtica europea desde los a\u00f1os noventa y... M\u00e9s informaci\u00f3","og_url":"https:\/\/faus-moliner.com\/ca\/regulacion-de-los-psps-para-cuando\/","og_site_name":"Faus Moliner","article_published_time":"2021-06-07T10:10:10+00:00","article_modified_time":"2021-06-07T10:11:06+00:00","author":"Llu\u00eds Alcover","twitter_card":"summary_large_image","twitter_misc":{"Escrit per":"Llu\u00eds Alcover","Temps estimat de lectura":"2 minuts","Written by":"Llu\u00eds Alcover"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/faus-moliner.com\/ca\/regulacion-de-los-psps-para-cuando\/#article","isPartOf":{"@id":"https:\/\/faus-moliner.com\/ca\/regulacion-de-los-psps-para-cuando\/"},"author":{"name":"Llu\u00eds Alcover","@id":"https:\/\/faus-moliner.com\/en\/#\/schema\/person\/9c887db396e6c9997a6208a40c3e4670"},"headline":"Regulaci\u00f3n de los PSPs \u00bfpara cu\u00e1ndo?","datePublished":"2021-06-07T10:10:10+00:00","dateModified":"2021-06-07T10:11:06+00:00","mainEntityOfPage":{"@id":"https:\/\/faus-moliner.com\/ca\/regulacion-de-los-psps-para-cuando\/"},"wordCount":470,"publisher":{"@id":"https:\/\/faus-moliner.com\/en\/#organization"},"articleSection":["El Global","Publicacions"],"inLanguage":"ca"},{"@type":"WebPage","@id":"https:\/\/faus-moliner.com\/ca\/regulacion-de-los-psps-para-cuando\/","url":"https:\/\/faus-moliner.com\/ca\/regulacion-de-los-psps-para-cuando\/","name":"Regulaci\u00f3n de los PSPs \u00bfpara cu\u00e1ndo? - Faus Moliner","isPartOf":{"@id":"https:\/\/faus-moliner.com\/en\/#website"},"datePublished":"2021-06-07T10:10:10+00:00","dateModified":"2021-06-07T10:11:06+00:00","breadcrumb":{"@id":"https:\/\/faus-moliner.com\/ca\/regulacion-de-los-psps-para-cuando\/#breadcrumb"},"inLanguage":"ca","potentialAction":[{"@type":"ReadAction","target":["https:\/\/faus-moliner.com\/ca\/regulacion-de-los-psps-para-cuando\/"]}]},{"@type":"BreadcrumbList","@id":"https:\/\/faus-moliner.com\/ca\/regulacion-de-los-psps-para-cuando\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Portada","item":"https:\/\/faus-moliner.com\/ca\/"},{"@type":"ListItem","position":2,"name":"Regulaci\u00f3n de los PSPs \u00bfpara cu\u00e1ndo?"}]},{"@type":"WebSite","@id":"https:\/\/faus-moliner.com\/en\/#website","url":"https:\/\/faus-moliner.com\/en\/","name":"faus-moliner.com","description":"Otro sitio realizado con WordPress","publisher":{"@id":"https:\/\/faus-moliner.com\/en\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/faus-moliner.com\/en\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"ca"},{"@type":"Organization","@id":"https:\/\/faus-moliner.com\/en\/#organization","name":"Faus Moliner","url":"https:\/\/faus-moliner.com\/en\/","logo":{"@type":"ImageObject","inLanguage":"ca","@id":"https:\/\/faus-moliner.com\/en\/#\/schema\/logo\/image\/","url":"https:\/\/faus-moliner.com\/wp-content\/uploads\/2023\/03\/Logo-FM-web.jpg","contentUrl":"https:\/\/faus-moliner.com\/wp-content\/uploads\/2023\/03\/Logo-FM-web.jpg","width":400,"height":283,"caption":"Faus Moliner"},"image":{"@id":"https:\/\/faus-moliner.com\/en\/#\/schema\/logo\/image\/"},"sameAs":["https:\/\/www.linkedin.com\/company\/2372042\/admin\/"]},{"@type":"Person","@id":"https:\/\/faus-moliner.com\/en\/#\/schema\/person\/9c887db396e6c9997a6208a40c3e4670","name":"Llu\u00eds Alcover","image":{"@type":"ImageObject","inLanguage":"ca","@id":"https:\/\/faus-moliner.com\/en\/#\/schema\/person\/image\/7c013ebf5b5f97c6203cfd8a6b59d506","url":"https:\/\/secure.gravatar.com\/avatar\/dbf0132b5844b926fc2d4f49851ed7a8141b4197ba6d8378277521f451ff89c7?s=96&d=mm&r=g","contentUrl":"https:\/\/secure.gravatar.com\/avatar\/dbf0132b5844b926fc2d4f49851ed7a8141b4197ba6d8378277521f451ff89c7?s=96&d=mm&r=g","caption":"Llu\u00eds Alcover"},"url":"https:\/\/faus-moliner.com\/ca\/author\/lluis-alcover\/"}]}},"_links":{"self":[{"href":"https:\/\/faus-moliner.com\/ca\/wp-json\/wp\/v2\/posts\/26842","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/faus-moliner.com\/ca\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/faus-moliner.com\/ca\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/faus-moliner.com\/ca\/wp-json\/wp\/v2\/users\/19"}],"replies":[{"embeddable":true,"href":"https:\/\/faus-moliner.com\/ca\/wp-json\/wp\/v2\/comments?post=26842"}],"version-history":[{"count":1,"href":"https:\/\/faus-moliner.com\/ca\/wp-json\/wp\/v2\/posts\/26842\/revisions"}],"predecessor-version":[{"id":26844,"href":"https:\/\/faus-moliner.com\/ca\/wp-json\/wp\/v2\/posts\/26842\/revisions\/26844"}],"wp:attachment":[{"href":"https:\/\/faus-moliner.com\/ca\/wp-json\/wp\/v2\/media?parent=26842"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/faus-moliner.com\/ca\/wp-json\/wp\/v2\/categories?post=26842"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/faus-moliner.com\/ca\/wp-json\/wp\/v2\/tags?post=26842"},{"taxonomy":"author","embeddable":true,"href":"https:\/\/faus-moliner.com\/ca\/wp-json\/wp\/v2\/coauthors?post=26842"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}