{"id":12911,"date":"2023-10-09T11:40:50","date_gmt":"2023-10-09T09:40:50","guid":{"rendered":"https:\/\/pharmavalue.it\/?p=12911"},"modified":"2023-10-09T15:34:31","modified_gmt":"2023-10-09T13:34:31","slug":"new-aifa-regulation","status":"publish","type":"post","link":"https:\/\/pharmavalue.it\/en\/new-aifa-regulation\/","title":{"rendered":"New AIFA Regulation"},"content":{"rendered":"<p>On <strong>December 14th, 2022<\/strong>, a <strong>draft of the interministerial decree for the new AIFA regulation<\/strong> was shared by 'Quotidiano Sanit\u00e0,' <strong>and on September 29th, what appears to be the final version was released.<\/strong><\/p>\n<p><strong>THE CHANGES IN THE DECREE <\/strong><\/p>\n<ul>\n<li>A more hierarchical and politicised structure: all powers will be in the hands of the <strong>President<\/strong>, who will be <strong>directly appointed by the Minister of Health, in consultation with the Minister of Economy and Finance<\/strong> and with the Permanent Conference for Relations between the State, Regions, and Autonomous Provinces, which <strong>will have the legal representation<\/strong>.<\/li>\n<li>The role of the General Director is abolished.<\/li>\n<li><strong>New roles<\/strong> of Technical-Scientific Director and Administrative Director are established, appointed by the Minister of Health, in consultation with the Minister of Economy and Finance.<\/li>\n<li>The two commissions, CTS and CPR, merge to create the new Scientific and Economic Commission on Medicines (CSE), consisting of <strong>10 members<\/strong>which will assume all the functions currently attributed to the two commissions.<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p><strong>THE MAIN DIFFERENCES FROM THE PREVIOUS DRAFT<\/strong><\/p>\n<ol>\n<li>In the <strong>appointment of the President,<\/strong> Administrative Director, and Technical-Scientific Director, as well as in the decision to potentially dissolve the administrative bodies of the Agency for reasons related to the economic and financial balance in the pharmaceutical sector, <strong>the Minister of Economy and Finance is also involved<\/strong>.<\/li>\n<li>The Minister of Health may decide in the decree appointing the President to remove the exclusivity clause for his office.<\/li>\n<li><strong>The Minister of Public Administration will also be involved<\/strong> <strong>in defining the functioning and organisation of AIFA personnel<\/strong> and in reshaping the distribution of staff positions.<\/li>\n<li><strong>The Council of Ministers, upon the request of the Minister of Health, can dissolve the administrative bodies<\/strong>. We believe that all administrative bodies that have objectives related to the appointment defined in the contract are subjected to a 'spoil system'.<\/li>\n<li><strong>There is an increase in managerial offices at the non-general managerial level to 43<\/strong> (instead of 38 as specified in the previous draft).<\/li>\n<li>There is no deadline by which the Minister of Health must approve the resolution made by the Board of Directors of operation and the Agency's staff's organisation.<\/li>\n<li><strong>Changes in the transitional provisions<\/strong>: the new administrative bodies come into effect the day after the publication of this decree, but <strong>the previous administrative bodies cease at the time of the new appointments<\/strong>. CTS and CPR also cease with the appointment of CSE.<\/li>\n<\/ol>\n<p>&nbsp;<\/p>\n<p><img fetchpriority=\"high\" decoding=\"async\" class=\"alignnone size-large wp-image-12919\" src=\"https:\/\/pharmavalue.it\/wp-content\/uploads\/2023\/10\/DEF_New-AIFA-Regulation-Predicted-Timeline-1024x576.jpg\" alt=\"New AIFA Regulation\" width=\"800\" height=\"450\" srcset=\"https:\/\/pharmavalue.it\/wp-content\/uploads\/2023\/10\/DEF_New-AIFA-Regulation-Predicted-Timeline-1024x576.jpg 1024w, https:\/\/pharmavalue.it\/wp-content\/uploads\/2023\/10\/DEF_New-AIFA-Regulation-Predicted-Timeline-300x169.jpg 300w, https:\/\/pharmavalue.it\/wp-content\/uploads\/2023\/10\/DEF_New-AIFA-Regulation-Predicted-Timeline-768x432.jpg 768w, https:\/\/pharmavalue.it\/wp-content\/uploads\/2023\/10\/DEF_New-AIFA-Regulation-Predicted-Timeline-1536x864.jpg 1536w, https:\/\/pharmavalue.it\/wp-content\/uploads\/2023\/10\/DEF_New-AIFA-Regulation-Predicted-Timeline.jpg 1920w\" sizes=\"(max-width: 800px) 100vw, 800px\" \/><\/p>\n<p>&nbsp;<\/p>\n<p><strong>NEXT STEPS AND POSSIBLE TIMELINES FOR THE AIFA REFORM<\/strong> (see our attached infographic)<\/p>\n<p>The text will be examined in one of the upcoming State-Regions' Conference sessions.<\/p>\n<p>While waiting for the publication of the New AIFA Regulation, <strong><a href=\"https:\/\/pharmavalue.it\/en\/new-postponement-of-aifa-commission-renewal\/\">six extensions of the AIFA Commissions<\/a> (CTS and CPR)<\/strong> have already been issued. <strong>The latest<\/strong> was approved on September 27th, 2023, <strong>in the legislative decree extending regulatory deadlines and tax payments<\/strong>, which <strong>extended the deadline to December 1st, 2023.<\/strong><\/p>","protected":false},"excerpt":{"rendered":"<p>On December 14th, 2022, a draft of the interministerial decree for the new AIFA regulation was shared by &#8220;Quotidiano Sanit\u00e0,&#8221; and on September 29th, what appears to be the final version was released. THE CHANGES IN THE DECREE A more hierarchical and politicized structure: all powers will be in the hands of the President, who [&hellip;]<\/p>\n","protected":false},"author":314,"featured_media":12915,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_seopress_robots_primary_cat":"none","_seopress_titles_title":"","_seopress_titles_desc":"","_seopress_robots_index":"","footnotes":""},"categories":[67],"tags":[],"class_list":["post-12911","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-drug-policy"],"_links":{"self":[{"href":"https:\/\/pharmavalue.it\/en\/wp-json\/wp\/v2\/posts\/12911","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/pharmavalue.it\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/pharmavalue.it\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/pharmavalue.it\/en\/wp-json\/wp\/v2\/users\/314"}],"replies":[{"embeddable":true,"href":"https:\/\/pharmavalue.it\/en\/wp-json\/wp\/v2\/comments?post=12911"}],"version-history":[{"count":0,"href":"https:\/\/pharmavalue.it\/en\/wp-json\/wp\/v2\/posts\/12911\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/pharmavalue.it\/en\/wp-json\/wp\/v2\/media\/12915"}],"wp:attachment":[{"href":"https:\/\/pharmavalue.it\/en\/wp-json\/wp\/v2\/media?parent=12911"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/pharmavalue.it\/en\/wp-json\/wp\/v2\/categories?post=12911"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/pharmavalue.it\/en\/wp-json\/wp\/v2\/tags?post=12911"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}