{"id":324898,"date":"2025-08-07T10:08:13","date_gmt":"2025-08-07T10:08:13","guid":{"rendered":"https:\/\/www.europesays.com\/uk\/324898\/"},"modified":"2025-08-07T10:08:13","modified_gmt":"2025-08-07T10:08:13","slug":"eu-biotech-act-public-consultation-opens-for-input","status":"publish","type":"post","link":"https:\/\/www.europesays.com\/uk\/324898\/","title":{"rendered":"EU Biotech Act public consultation opens for input"},"content":{"rendered":"<p>The European Commission hopes its planned legislation will enable biotechnology companies to bring products from laboratory to market more quickly.<\/p>\n<p><img data-lazyloaded=\"1\" width=\"600\" height=\"316\" src=\"https:\/\/www.europesays.com\/uk\/wp-content\/uploads\/2025\/08\/shutterstock_1916217376.jpg\" class=\"attachment-large-rectangle size-large-rectangle wp-post-image\" alt=\"EU biotech act\" decoding=\"async\" fetchpriority=\"high\"  data-\/><\/p>\n<p>The European Commission is seeking help from the public to fine tune its plans to accelerate biotechnology products from lab to factory to market.<\/p>\n<p>The EU Biotech Act, which forms part of the Commission\u2019s broader <a href=\"https:\/\/www.europeanpharmaceuticalreview.com\/news\/231529\/securing-europes-competitiveness-in-life-sciences\/\" target=\"_blank\" rel=\"noopener\">Strategy for Life Sciences<\/a>, aims to improve the competitiveness of European biotech companies and ease their regulatory challenges.<\/p>\n<p>A <a href=\"https:\/\/ec.europa.eu\/info\/law\/better-regulation\/have-your-say\/initiatives\/14627-Biotech-Act\/public-consultation_en\" target=\"_blank\" rel=\"noopener\">public consultation<\/a> on the proposed Act will run until 10 November 2025, after which its responses will feed into the EC\u2019s impact assessment of the legislative designs.<\/p>\n<p>As the EC moves to improve the size and competitiveness of the EU\u2019s biotech sector it will assess the biotech plans in terms of:<\/p>\n<p><strong>Speed and streamlining<\/strong>: improving \u2018time-to-market\u2019, particularly for biotech start-ups, with a view to simplifying the regulatory environment. This also feeds into the Commission\u2019s existing work in areas such as the reform of <a href=\"https:\/\/www.europeanpharmaceuticalreview.com\/core_topic\/regs-legs\/\" target=\"_blank\" rel=\"noopener\">pharmaceutical legislation<\/a>.<\/p>\n<p><strong>Financing<\/strong>: targeting access to new capital for companies at seed phase, as well as looking at how existing activities, incentives and funding schemes could be improved.<\/p>\n<p>Biotechnology is going to be a key pillar to bring forward a completely new set of therapies, much more quickly available for the patients, but also a completely new way of innovation\u201d<\/p>\n<p><strong>Scale<\/strong>: helping the sector tap into the EU\u2019s existing infrastructure so that more development and production work can be carried out in the region. As part of this there could be support for new biotech clusters or centres of excellence, and biomanufacturing will be a particular focus.<\/p>\n<p><strong>Skills<\/strong>: Upskilling academic developers with entrepreneurial skills will be one area for this strand, alongside a potential programme to attract R&amp;D, manufacturing and entrepreneurial global talent.<\/p>\n<p><strong>Data and AI<\/strong>: As the role of <a href=\"https:\/\/www.europeanpharmaceuticalreview.com\/article\/251105\/pharma-horizons-artificial-intelligence-2\/\" target=\"_blank\" rel=\"noopener\">artificial intelligence (AI)<\/a> in biotech increases, the Commission sees AI testing facilities \u2013 or \u2018AI Factories\u2019 \u2013 as essential to enabling biotech companies and organisations to use data effectively. A role is also seen for AI to complement initiatives such as the European Health Data Space and its access to anonymised real world health data.<\/p>\n<p>The exact timelines for the EU Biotech Act have yet to be confirmed, but the legislation\u2019s adoption is currently planned for the third quarter of 2026 as the EC looks to further boost the sector.<\/p>\n<p>Outlining Europe\u2019s biotech vision at last month\u2019s BIO International Convention in Boston, Health and Animal Welfare Commissioner Oliv\u00e9r V\u00e1rhelyi said: \u201cBiotechnology is going to be a key pillar to bring forward a completely new set of therapies, much more quickly available for the patients, but also a completely new way of innovation.<\/p>\n<p>\u201cIn that, we want to build on our strength, which is the availability of high-quality healthcare data, a substantive innovation capacity in Europe and still a huge manufacturing capacity in Europe. But for this to happen, we need to do things differently.\u201d<\/p>\n","protected":false},"excerpt":{"rendered":"The European Commission hopes its planned legislation will enable biotechnology companies to bring products from laboratory to market&hellip;\n","protected":false},"author":2,"featured_media":324899,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[5174],"tags":[2000,299,5187,1699],"class_list":{"0":"post-324898","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-eu","8":"tag-eu","9":"tag-europe","10":"tag-european","11":"tag-european-union"},"share_on_mastodon":{"url":"https:\/\/pubeurope.com\/@uk\/114986936177925475","error":""},"_links":{"self":[{"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/posts\/324898","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/comments?post=324898"}],"version-history":[{"count":0,"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/posts\/324898\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/media\/324899"}],"wp:attachment":[{"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/media?parent=324898"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/categories?post=324898"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/tags?post=324898"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}