{"id":45683,"date":"2023-05-23T09:10:00","date_gmt":"2023-05-23T09:10:00","guid":{"rendered":"https:\/\/setterwalls.se\/?post_type=articles&#038;p=45683"},"modified":"2023-05-23T10:58:25","modified_gmt":"2023-05-23T10:58:25","slug":"commission-proposes-eu-pharmaceutical-reform","status":"publish","type":"articles","link":"https:\/\/setterwalls.se\/en\/article\/commission-proposes-eu-pharmaceutical-reform\/","title":{"rendered":"Commission proposes EU pharmaceutical reform"},"content":{"rendered":"    <section class=\"block text \">\n        <div class=\"container container-sm\">\n            <div class=\"row\">\n                <div class=\"col-12\">\n                    <div class=\"editor-content\">\n                                                <p>After several delays, the European Commission finally published its proposal for the reform of EU pharmaceutical legislation on 26 April 2023.<\/p>\n<p>The long-awaited proposal sets out a comprehensive reform of pharmaceutical legislation through the introduction of both a <a href=\"https:\/\/health.ec.europa.eu\/publications\/proposal-regulation-laying-down-union-procedures-authorisation-and-supervision-medicinal-products_en\">new directive<\/a> and a <a href=\"https:\/\/health.ec.europa.eu\/publications\/proposal-directive-union-code-relating-medicinal-products-human-use_en\">new regulation<\/a>. A key element of the Commission\u2019s proposal is the introduction of a scheme for data protection and market exclusivity, which makes the length of the exclusivity period conditional on the fulfilment of certain criteria, while reducing the previous standard period.<\/p>\n<p>The official proposal has been met with criticism from some pharmaceutical market operators, with the <a href=\"https:\/\/www.efpia.eu\/news-events\/the-efpia-view\/statements-press-releases\/eu-pharma-legislation-risks-sabotaging-europe-s-life-science-industry-putting-european-patients-further-away-from-the-cutting-edge-of-healthcare\/\">EFPIA<\/a> stating that the \u201c<em>proposal manages to undermine research and development in Europe while failing to address access to medicines for patients.\u201d<\/em> On the other hand, some operators have welcomed the proposal as a positive precedent for further reform on access to medicines.<\/p>\n<p>Setterwalls looks forward to seeing how this develops and is continuing to monitor the process.<\/p>\n                    <\/div>\n                <\/div>\n            <\/div>\n        <\/div>\n    <\/section>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":4,"featured_media":29534,"template":"","meta":{"_acf_changed":false,"_seopress_robots_primary_cat":"","_seopress_titles_title":"","_seopress_titles_desc":"","_seopress_robots_index":""},"article_category":[1058],"class_list":["post-45683","articles","type-articles","status-publish","has-post-thumbnail","hentry","article_category-life-sciences-en"],"acf":[],"_links":{"self":[{"href":"https:\/\/setterwalls.se\/en\/wp-json\/wp\/v2\/articles\/45683","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/setterwalls.se\/en\/wp-json\/wp\/v2\/articles"}],"about":[{"href":"https:\/\/setterwalls.se\/en\/wp-json\/wp\/v2\/types\/articles"}],"author":[{"embeddable":true,"href":"https:\/\/setterwalls.se\/en\/wp-json\/wp\/v2\/users\/4"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/setterwalls.se\/en\/wp-json\/wp\/v2\/media\/29534"}],"wp:attachment":[{"href":"https:\/\/setterwalls.se\/en\/wp-json\/wp\/v2\/media?parent=45683"}],"wp:term":[{"taxonomy":"article_category","embeddable":true,"href":"https:\/\/setterwalls.se\/en\/wp-json\/wp\/v2\/article_category?post=45683"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}