{"id":129599,"date":"2024-04-12T07:30:53","date_gmt":"2024-04-12T04:30:53","guid":{"rendered":"https:\/\/tietopankki.crnet.fi\/fi\/news\/parliament-adopts-its-position-on-eu-pharmaceutical-reform\/"},"modified":"2024-04-12T07:30:53","modified_gmt":"2024-04-12T04:30:53","slug":"parliament-adopts-its-position-on-eu-pharmaceutical-reform","status":"publish","type":"post","link":"https:\/\/tietopankki.crnet.fi\/fi\/news\/parliament-adopts-its-position-on-eu-pharmaceutical-reform\/","title":{"rendered":"Parliament adopts its position on EU pharmaceutical reform"},"content":{"rendered":"<div class=\"mp_wrapper\">\n  <div class=\"mepr-unauthorized-message\">\n    <p>You are unauthorized to view this page.<\/p>\n  <\/div>\n  <div class=\"mepr-login-form-wrap\">\n            \n<div class=\"mp_wrapper mp_login_form\">\n                  <!-- mp-login-form-start -->     <form name=\"mepr_loginform\" id=\"mepr_loginform\" class=\"mepr-form\" action=\"https:\/\/tietopankki.crnet.fi\/fi\/login-2\/\" method=\"post\">\n            <div class=\"mp-form-row mepr_username\">\n        <div class=\"mp-form-label\">\n                              <label for=\"user_login\">Username<\/label>\n        <\/div>\n        <input type=\"text\" name=\"log\" id=\"user_login\" value=\"\" \/>\n      <\/div>\n      <div class=\"mp-form-row mepr_password\">\n        <div class=\"mp-form-label\">\n          <label for=\"user_pass\">Password<\/label>\n          <div class=\"mp-hide-pw\">\n            <input type=\"password\" name=\"pwd\" id=\"user_pass\" value=\"\" \/>\n            <button type=\"button\" class=\"button mp-hide-pw hide-if-no-js\" data-toggle=\"0\" aria-label=\"Show password\">\n              <span class=\"dashicons dashicons-visibility\" aria-hidden=\"true\"><\/span>\n            <\/button>\n          <\/div>\n        <\/div>\n      <\/div>\n            <div>\n        <label><input name=\"rememberme\" type=\"checkbox\" id=\"rememberme\" value=\"forever\" \/> Remember Me<\/label>\n      <\/div>\n      <div class=\"mp-spacer\">&nbsp;<\/div>\n      <div class=\"submit\">\n        <input type=\"submit\" name=\"wp-submit\" id=\"wp-submit\" class=\"button-primary mepr-share-button \" value=\"Log In\" \/>\n        <input type=\"hidden\" name=\"redirect_to\" value=\"\/fi\/wp-json\/wp\/v2\/posts\/129599\" \/>\n        <input type=\"hidden\" name=\"mepr_process_login_form\" value=\"true\" \/>\n        <input type=\"hidden\" name=\"mepr_is_login_page\" value=\"false\" \/>\n      <\/div>\n    <\/form>\n    <div class=\"mp-spacer\">&nbsp;<\/div>\n    <div class=\"mepr-login-actions\">\n        <a\n          href=\"https:\/\/tietopankki.crnet.fi\/fi\/login-2\/?action=forgot_password\"\n          title=\"Click here to reset your password\"\n        >\n          Forgot Password        <\/a>\n    <\/div>\n\n      \n    <!-- mp-login-form-end --> \n  <\/div>\n      <\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<div class=\"smart_content_wrapper\">\nMEPs adopted their proposals to revamp EU pharmaceutical legislation, to foster innovation and enhance the security of supply, accessibility and affordability of medicines. The legislative package, covering medicinal products for human use, consists of a new directive (adopted with 495 votes in favour, 57 against and 45 abstentions) and regulation (adopted with 488 votes in favour, 67 against and 34 abstentions).<\/p>\n<p>MEPs want to introduce a minimum regulatory data protection period (during which other companies cannot access product data) of seven and a half years, in addition to two years of market protection (during which generic, hybrid or biosimilar products cannot be sold), following a marketing authorisation.<\/p>\n<p>Pharmaceutical companies would be eligible for additional periods of data protection if their particular product addresses an unmet medical need (+12 months), if comparative clinical trials are being conducted on the product (+6 months), and if a significant share of the product\u2019s research and development takes place in the EU and at least partly in collaboration with EU research entities (+6 months). MEPs also want a cap on the combined data protection period of eight and half years.<\/p>\n<p>A one-time extension (+12 months) of the two-year market protection period could be granted if the company obtains marketing authorisation for an additional therapeutic indication which provides significant clinical benefits in comparison with existing therapies. Orphan drugs (medicines developed to treat rare diseases) would benefit from up to 11 years of market exclusivity if they address a \u201chigh unmet medical need\u201d.<\/p>\n<p>To boost research and the development of novel antimicrobials, MEPs want to introduce market entry rewards and milestone payment reward schemes (e.g. early-stage financial support when certain R&amp;D objectives are achieved prior to market approval). These would be complemented by a subscription model scheme through voluntary joint procurement agreements, to encourage investment in antimicrobials.<\/p>\n<p>They support the introduction of a \u201ctransferable data exclusivity voucher\u201d for priority antimicrobials, providing for a maximum of 12 additional months of data protection for an authorised product. The voucher could not be used for a product that has already benefited from maximum regulatory data protection and would be transferable only once to another marketing authorisation holder.<\/p>\n<p>Source: <a rel=\"noopener\" href=\"https:\/\/www.europarl.europa.eu\/news\/en\/press-room\/20240408IPR20308\/parliament-adopts-its-position-on-eu-pharmaceutical-reform\">European Parliament<\/a><\/p>\n<\/div>\n<p>The post <a rel=\"noopener\" href=\"https:\/\/vastuullisuusuutiset.fi\/fi\/csr-news-en\/parliament-adopts-its-position-on-eu-pharmaceutical-reform\/\">Parliament adopts its position on EU pharmaceutical reform<\/a> appeared first on <a rel=\"noopener\" href=\"https:\/\/vastuullisuusuutiset.fi\/fi\">Vastuullisuusuutiset.fi<\/a>.<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_jetpack_memberships_contains_paid_content":false,"footnotes":""},"categories":[22],"tags":[555,10211,274,14129],"class_list":["post-129599","post","type-post","status-publish","format-standard","hentry","category-news","tag-csr-news-en","tag-ep","tag-eu","tag-pharmaceutical-reform"],"jetpack_featured_media_url":"","jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/tietopankki.crnet.fi\/fi\/wp-json\/wp\/v2\/posts\/129599","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/tietopankki.crnet.fi\/fi\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/tietopankki.crnet.fi\/fi\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/tietopankki.crnet.fi\/fi\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/tietopankki.crnet.fi\/fi\/wp-json\/wp\/v2\/comments?post=129599"}],"version-history":[{"count":0,"href":"https:\/\/tietopankki.crnet.fi\/fi\/wp-json\/wp\/v2\/posts\/129599\/revisions"}],"wp:attachment":[{"href":"https:\/\/tietopankki.crnet.fi\/fi\/wp-json\/wp\/v2\/media?parent=129599"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/tietopankki.crnet.fi\/fi\/wp-json\/wp\/v2\/categories?post=129599"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/tietopankki.crnet.fi\/fi\/wp-json\/wp\/v2\/tags?post=129599"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}