{"id":65901,"date":"2026-04-22T07:36:10","date_gmt":"2026-04-22T07:36:10","guid":{"rendered":"https:\/\/www.europesays.com\/dk\/65901\/"},"modified":"2026-04-22T07:36:10","modified_gmt":"2026-04-22T07:36:10","slug":"brussels-biotech-offensive-an-overdue-signal-with-flaws","status":"publish","type":"post","link":"https:\/\/www.europesays.com\/dk\/65901\/","title":{"rendered":"Brussels’ biotech offensive: an overdue signal with flaws"},"content":{"rendered":"

\"Dr<\/a>Dr Manja Epping, Heuking, Dr Stefanie Greifeneder, Heuking, Martin Krauss, FGK<\/p>\n

Bildnachweis: Dr Manja Epping, Heuking, Dr Stefanie Greifeneder, Heuking, Martin Krauss, FGK<\/a>.<\/p>\n

Together with leading chinical research and legal experts, we analyse: is Brussels\u2018 75-day fast-track enough to stop the innovation drain, or does the lack of capital remain the true bottleneck?<\/p>\n

The EU Biotech Act, presented in December 2025 and currently facing intense scrutiny in the European Parliament, promises a long-awaited acceleration for the healthcare sector. Yet, while EU Commissioner V\u00e1rhelyi speaks of playing catch-up, experts warn: regulation is good, capital is better. Placed on the table at the end of last year as a strategic move to boost the European life sciences community, the proposal fulfils Commission President Ursula von der Leyen\u2019s promise to make the \u201abiotechnological revolution\u2018 a top priority. V\u00e1rhelyi left no doubt about the urgency, stating the declared goal is \u201ato bring breakthroughs from the lab to the market faster\u2018.<\/p>\n

Operational bottlenecks versus regulatory speed<\/p>\n

Do trials truly fail due to the legal situation or operational bottlenecks like staffing and patient recruitment? Martin Krauss, Managing Director of the Munich-based contract research organization (CRO) FGK Clinical Research GmbH<\/a>, which manages trials across Europe, emphasises it is not an either-or scenario: \u201aOperational challenges like recruiting patients and finding qualified study staff are very real bottlenecks. But the regulatory framework absolutely matters \u2013 especially in global portfolio decisions.\u2018 He explains that when sponsors compare the EU with the US, speed, predictability, and simplicity are decisive. If approval timelines are shorter and procedures more harmonised across Member States, Europe becomes more competitive for multinational trials, he adds. While patient recruitment is often a national issue \u2013 with improvements expected in Germany through the Medical Research Act \u2013 Krauss concludes: Both regulatory reform at EU level and operational optimisation at national level must go hand in hand. The pressure to act is backed by hard data: while China\u2019s R&D investments recently jumped 88% over five years, the European share of global pharmaceutical investments has slipped to just 29% \u2013 the USA now dominates with 55%. Is Europe losing the strategic battle? Dr Stefanie Greifeneder, Lawyer and Partner at Heuking<\/a>, a leading German commercial law firm advising the healthcare and life sciences sector, confirms this issue is significant. Approval times for multinational trials in the EU remain substantially longer than in competing jurisdictions, creating strong incentives to conduct trials outside Europe. It is therefore
encouraging that the EU recognises the need for regulatory reform,\u2019 she warns. \u2018The Biotech Act aims to streamline procedures, mobilise capital, and support coordinated implementation across Member States. Whether it succeeds will depend largely on swift execution and sustained political commitment.\u2019<\/p>\n

Phase One: Is prioritising health enough?<\/p>\n

The draft reveals that Brussels opted for a two-speed strategy. Referred to internally as Biotech Act I, it focuses almost exclusively on healthcare. At its heart lies a drastic reduction in red tape, tightening approval timelines from over 100 days to around 75 days. For seamless procedures, it envisages a \u2018fast-track\u2019 option of 47 days, while substantial modifications are to be approved in 33 days instead of 96. This ambitious goal is flanked by regulatory sandboxes where companies can test therapies under flexible conditions. However, a glance across the Atlantic is sobering: the US FDA already operates with a 30-day window for IND applications. Regarding authorities handling this 75-day limit, Krauss states: \u2018The 75 days will only be credible if processes truly change \u2013 but the proposal does more than just shorten deadlines.\u2019 Strengthening the reporting Member State should significantly improve coordination and avoid duplicative assessments. Since authorities are legally bound to meet timelines, they adapt internal processes accordingly. \u2018In the longer term, this could be the starting point for further simplification\u2014perhaps moving towards a system where not every authority reassesses everything, but responsibilities are more clearly streamlined.\u2019<\/p>\n

Data, AI, and GDPR<\/p>\n

In a digitised world, innovation collides with European data protection. Addressing concerns that GDPR and AI Act regulations might hinder patient data use, Krauss clarifies: \u2018It\u2019s a legitimate concern \u2013 but the intention is not to trip ourselves up. The Biotech Act is designed as a strategic pillar to actively promote data use and AI in life sciences, particularly through implementation of the European Health Data Space (EHDS).\u2019 The idea is to make these frameworks work coherently. \u2018The goal is clear: enable responsible use of patient data for research and drug development. However, translating multiple complex regulations into a truly functioning, practical system will remain a major implementation challenge.\u2019 While EuropaBio<\/a>\u2019s Director General Dr Claire Skentelbery praised the Act as a \u2018global signal,\u2019 the acceleration push faces a contradiction regarding the planned reduction in regulatory data protection (RDP). Dr Manja Epping, Lawyer and Partner at Heuking, notes this tension is undeniable. \u2018The agreement on the Pharma Package reached in December 2025 has mitigated the most significant concerns,\u2019 preserving the eight-year RDP baseline and abandoning the proposed reduction to six years, she explains. \u2018Nevertheless, the underlying contradiction remains. The new RDP framework will be more restrictive than the existing regime and will require companies to meet a set of demanding conditions.\u2019 These include conducting comparative trials and submitting the EU marketing authorisation within 90 days of the first non-EU application.<\/p>\n

Capital and risk<\/p>\n

Dr Skentelbery urgently called for the integration of fragmented European capital markets. Without venture capital for late clinical phases, fast approvals are of little use. The bioeconomy faces an annual investment gap of EUR 121.8 billion, with US biotechs raising three times as much latestage capital. Does approval duration or reimbursement uncertainty deter investors? Dr Epping clarifies: \u2018The length of regulatory approval is a major obstacle. Yet reimbursement uncertainty is equally deterrent for venture capital.\u2019 Fragmented pricing systems and differing HTA procedures create difficult-to-model structural risks. Ideally, regulatory simplifications would be complemented by cross-border reimbursement coordination \u2013 though Dr Epping notes this remains politically unlikely. \u2018A first step has at least been taken with the start of Joint Clinical Assessments at EU level in January 2025,\u2019 she notes.<\/p>\n

M&A, or: The sell-out of innovation<\/p>\n

The capital gap has fatal consequences: 80% of new active substances are approved in the USA first, and European patients receive therapies six months later. Regarding the gloomy scenario of a \u2018sell-out\u2019 to US pharma giants, Dr Greifeneder explains: \u2018This concern is well-founded, as the Biotech Act only partially addresses it.\u2019 While the Commission highlights the Capital Markets Union\u2019s relevance, these initiatives lie outside the Biotech Act\u2019s scope. \u2018Meaningful progress on capital-markets integration will therefore be required in parallel to mitigate the risk of sell\u2010outs. As it stands, the Biotech Act contains no incentives to retain intellectual property or long-term value creation in Europe.\u2019 Operationally, companies battle bureaucratic fragmentation. Krauss notes: \u2018Overall, harmonisation in the EU is clearly advancing. The common framework for clinical trials has already reduced fragmentation. That said, national peculiarities have not disappeared.\u2019 Differences in administrative culture or contractual requirements create additional effort. \u2018The direction of travel is right: the objective must be to further minimise national deviations and make the European framework not just legally harmonised, but operationally consistent,\u2019 he asserts. If individual Member States increase price pressure, Brussels\u2019 impulses are thwarted. Regarding the tension between EU innovation and national reimbursement realities like the German AMNOG, Dr Epping explains: \u2018This is one of the core structural tensions. However,
the contradiction is not a policy oversight, but a consequence of the EU treaties.\u2019 Neither the Biotech Act nor the Pharma Package can resolve payer-level barriers, as they fall outside EU competence. Regarding the criticism that the Act might fall short here, she
notes: \u2018The Act was simply never intended to address these issues.\u2019 Joint Clinical Assessments provide shared evaluations, but Member States retain full autonomy in pricing decisions.<\/p>\n

The critique and timeline<\/p>\n

The industrial bioeconomy\u2019s view is sobering. The Commission offloaded sustainable fuels into a Biotech Act II, announced for Q3\/2026. For BIO Deutschland, this is a strategic error. Chairman Roland Sackers found clear words: \u2018Biotechnology is a platform technology.\u2019 Sackers demanded the industrial part must \u2018follow swiftly.\u2019 The industry\u2019s concern: a bioeconomy that is not conceived holistically loses impact in global competition. There is a dangerous possibility that the industrial branch will lose momentum in the political minutiae of late 2026. The dossier is currently being debated in the European Parliament and the Council. While conservative forces may push for even more radical deregulation, resistance regarding ethical standards and pricing is expected from the left. Realists in Brussels do not expect adoption before the end of 2026, becoming law in 2027. Regarding investment security until 2027, Dr Greifeneder advises: \u2018Although the period until 2027 creates a degree of uncertainty, companies in the life sciences sector should not suspend long-term European location decisions solely because the EU Biotech Act remains in draft form.\u2019 Europe offers broad fundamentals like talent and infrastructure. \u2018However, a finalised and ambitious EU Biotech Act would provide greater predictability, reduce perceived fragmentation, and send a strong political signal,\u2019 she notes. The Biotech Act addresses the right pain points with shortened timelines. Yet by unbundling the package and leaving financing open, the Commission takes a risk. Europe has the chance to turn the tide \u2013 but the window of opportunity is closing.<\/p>\n","protected":false},"excerpt":{"rendered":"Dr Manja Epping, Heuking, Dr Stefanie Greifeneder, Heuking, Martin Krauss, FGK Bildnachweis: Dr Manja Epping, Heuking, Dr Stefanie…\n","protected":false},"author":2,"featured_media":65902,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[104],"tags":[211,15043,210,36232,36233,36234,36235,36236,2016,36237,3868,36238,36239],"class_list":{"0":"post-65901","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-brussels","8":"tag-belgium","9":"tag-biotech","10":"tag-brussels","11":"tag-dr-claire-skentelbery","12":"tag-dr-manja-epping","13":"tag-dr-stefanie-greifeneder","14":"tag-europabio","15":"tag-fgk-clinical-research-gmbh","16":"tag-healthcare","17":"tag-heuking","18":"tag-life-sciences","19":"tag-market-insights","20":"tag-martin-krauss"},"share_on_mastodon":{"url":"https:\/\/pubeurope.com\/@dk\/116447215472272386","error":""},"_links":{"self":[{"href":"https:\/\/www.europesays.com\/dk\/wp-json\/wp\/v2\/posts\/65901","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.europesays.com\/dk\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.europesays.com\/dk\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/dk\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/dk\/wp-json\/wp\/v2\/comments?post=65901"}],"version-history":[{"count":0,"href":"https:\/\/www.europesays.com\/dk\/wp-json\/wp\/v2\/posts\/65901\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/dk\/wp-json\/wp\/v2\/media\/65902"}],"wp:attachment":[{"href":"https:\/\/www.europesays.com\/dk\/wp-json\/wp\/v2\/media?parent=65901"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.europesays.com\/dk\/wp-json\/wp\/v2\/categories?post=65901"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.europesays.com\/dk\/wp-json\/wp\/v2\/tags?post=65901"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}