{"id":150766,"date":"2024-09-19T07:15:00","date_gmt":"2024-09-19T05:15:00","guid":{"rendered":"https:\/\/renewable-carbon.eu\/news\/?p=150766"},"modified":"2024-09-19T10:31:24","modified_gmt":"2024-09-19T08:31:24","slug":"guide-the-eu-biotech-act-to-success-says-top-belgian-research-institute","status":"publish","type":"post","link":"https:\/\/renewable-carbon.eu\/news\/guide-the-eu-biotech-act-to-success-says-top-belgian-research-institute\/","title":{"rendered":"Guide the EU Biotech Act to success, says top Belgian research institute"},"content":{"rendered":"\n\n\n

Commission President Ursula von der Leyen has committed to a 2025 Biotech Act. Now, Belgium\u2019s Flanders Institute of Biotechnology is calling for a biotech coalition of member states to steer the Act to success.<\/strong><\/p>\n\n\n

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\"J\u00e9r\u00f4me
J\u00e9r\u00f4me Van Biervliet, Co-Managing Director of VIB – Flanders Institute of Biotechnology \u00a9 Euractiv<\/figcaption><\/figure><\/div>\n\n\n
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\u201cThe urgency for action cannot be overstated,\u201d said J\u00e9r\u00f4me Van Biervliet, co-managing director of VIB (Flanders Institute of Biotechnology)<\/strong>, in a conversation with Euractiv.<\/p>\n<\/blockquote>\n\n\n\n

Increasingly influential in health-tech policy advisory forums, VIB has played a key role in shaping Belgium\u2019s strategy for a Health & Biotech Valley<\/a> and guiding European policymakers on biotech initiatives.<\/p>\n\n\n\n

Europe\u2019s scientific renaissance<\/h3>\n\n\n\n
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Europe has recently challenged the United States\u2019 dominance in scientific research and innovation. \u201cThe EU\u2019s scientific output is at least equal to, if not surpassing, that of the US today,\u201d Van Biervliet<\/strong> told Euractiv.<\/p>\n<\/blockquote>\n\n\n\n

VIB has transformed fundamental scientific research into successful start-ups and business ventures. Yet, it operates within a European region that despite paralleling the US in academic excellence, lacks sufficient support systems to foster the growth of these emerging start-ups.<\/p>\n\n\n\n

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\u201cWe trail the US by a factor of two to three and a half in venture capital deals, which translates to fewer European start-ups,\u201d Van Biervliet<\/strong> says.<\/p>\n<\/blockquote>\n\n\n\n

The funding gap<\/h3>\n\n\n\n

As these companies expand, the need for development capital becomes critical, particularly for costly clinical trials essential for testing new treatments on hundreds of patients.<\/p>\n\n\n\n

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\u201cFinding such financing in Europe has become increasingly challenging,\u201d Van Biervliet<\/strong> notes with concern, adding that \u201cEurope faces a funding shortfall fivefold that of the US.\u201d<\/p>\n<\/blockquote>\n\n\n\n

While Europe has the capital, it lacks the investment momentum seen in the US market.<\/p>\n\n\n\n

Looking ahead to the commercialisation phase, biotech firms often resort to public markets to secure the needed capital. Yet, a troubling trend has emerged: over the past six years, 66 out of 67 biotech companies have chosen American IPOs, frequently opting for dual listings.<\/p>\n\n\n\n

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This tendency towards \u2018Americanisation\u2019 effectively shifts the economic benefits, which were intended for Europe, across the Atlantic. \u201cSuch a shift represents lost opportunities, as it directly impacts the locus of benefits derived from European innovation,\u201d Van Biervliet<\/strong> remarked.<\/p>\n\n\n\n

Capital markets union<\/strong><\/h2>\n<\/blockquote>\n\n\n\n

Mairead McGuiness, European Commissioner for Financial Stability, Financial Services and Capital Markets has shown concern for these issues.<\/p>\n\n\n\n

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In a March opinion paper<\/a>, McGuiness<\/strong> emphasised: \u201cFor a competitive European economy, for our start-ups to scale up within our borders, and to foster investments in green tech, clean tech, and biotech, the capital markets union is not just an added bonus \u2013 it\u2019s a fundamental necessity.\u201d<\/p>\n<\/blockquote>\n\n\n\n

Van Biervliet has contributed to this discourse through an input paper for the Letta report<\/a>, exploring the next frontiers for the single capital markets union, highlighting the urgent need for a cohesive financial ecosystem to support Europe\u2019s biotech ambitions.<\/p>\n\n\n\n

Regulatory roadblocks<\/h3>\n\n\n\n

Furthermore, the path to commercialisation is hindered by Europe\u2019s sluggish regulatory approval process.<\/p>\n\n\n\n

\u201cA study by Europabio points out that compared to the FDA\u2019s 200-day average, the EMA takes an additional 136 days, compounded by individual member state analyses,\u201d Van Biervliet points out. This delay not only hampers innovation but also affects the timely delivery of new therapies to the patient.<\/p>\n\n\n\n

The European Union\u2019s approach to regulatory approval for biotech therapies is a labyrinthine process, with each member state conducting its own analysis. This redundancy adds an average of 500 days to the approval timeline, ranging from 128 to 800 days.<\/p>\n\n\n\n

For successful biotech companies like ArgenX, despite their European origins, this means entering markets in the US, Canada and Japan years before navigating the fragmented European landscape.<\/p>\n\n\n\n

The dawn of Europe\u2019s Biotech Union<\/h3>\n\n\n\n
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Time is of the essence. \u201cEchoing the pioneering spirit that led to the creation of the European Coal and Steel Community, Europe is now at the threshold of establishing a Biotech Union,\u201c shares Van Biervliet<\/strong>.<\/p>\n<\/blockquote>\n\n\n\n

Belgium\u2019s commitment to biotechnology over the past thirty years has fostered a vibrant ecosystem, significantly bolstering the economy and setting a benchmark for the proposed Biotech Union.<\/p>\n\n\n\n

Coalition of the willing member states<\/h3>\n\n\n\n

Van Biervliet envisions a \u201cCoalition of the Willing Member States\u201d to streamline the path forward for biotechs and researchers. This prospective think tank could address regulatory approval challenges, enhance the fiscal environment, refine the Health Technology Assessment (HTA), increase venture capital availability, and ignite innovation.<\/p>\n\n\n\n

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\u201cUniting willing member states under a shared mission will allow us to harmonise our processes, simplify procedures, and integrate our capital markets. This could be the start of more,\u201d he<\/strong> explained. The proposed coalition could include innovation powerhouses like the Netherlands, France, Denmark, and Sweden\u2014each home to a strong biotech sector.<\/p>\n\n\n\n

\u201cHarnessing collective expertise and forming a think tank of seasoned professionals could lead to the creation of e.g. a cadre where equity markets in Europe are tailored to the unique needs of biotech equities across a truly integrated European Stock Exchange that could rival the US NASDAQ in terms of its performance,\u201d proposes Van Biervliet<\/strong>, underscoring the transformative potential of efficient financial frameworks to empower the biotech sector.<\/p>\n<\/blockquote>\n\n\n\n

Following the EU\u2019s recent elections, the lack of such a coalition prompts questions about the European Commission\u2019s forthcoming agenda. Van Biervliet hopes for the deep involvement of sector specialists in crafting the 2025 EU Biotech Act, and it remains available to serve this important cause.<\/p>\n\n\n\n

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\u201cAs sector experts, we must guide the Act to success. The current numbers clearly indicate a need for change,\u201d he<\/strong> said.<\/p>\n<\/blockquote>\n","protected":false},"excerpt":{"rendered":"

Commission President Ursula von der Leyen has committed to a 2025 Biotech Act. Now, Belgium\u2019s Flanders Institute of Biotechnology is calling for a biotech coalition of member states to steer the Act to success. \u201cThe urgency for action cannot be overstated,\u201d said J\u00e9r\u00f4me Van Biervliet, co-managing director of VIB (Flanders Institute of Biotechnology), in a […]<\/p>\n","protected":false},"author":114,"featured_media":150768,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_seopress_robots_primary_cat":"none","nova_meta_subtitle":"Europe has recently challenged the United States\u2019 dominance in scientific research and innovation","footnotes":""},"categories":[5572],"tags":[5838,5796,10416,5817],"supplier":[24827,2317,5585,4396],"class_list":["post-150766","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-bio-based","tag-bioeconomy","tag-biotechnology","tag-circulareconomy","tag-research","supplier-argenx","supplier-european-commission","supplier-european-union","supplier-vlaams-instituut-voor-biotechnologie-vib"],"_links":{"self":[{"href":"https:\/\/renewable-carbon.eu\/news\/wp-json\/wp\/v2\/posts\/150766","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/renewable-carbon.eu\/news\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/renewable-carbon.eu\/news\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/renewable-carbon.eu\/news\/wp-json\/wp\/v2\/users\/114"}],"replies":[{"embeddable":true,"href":"https:\/\/renewable-carbon.eu\/news\/wp-json\/wp\/v2\/comments?post=150766"}],"version-history":[{"count":0,"href":"https:\/\/renewable-carbon.eu\/news\/wp-json\/wp\/v2\/posts\/150766\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/renewable-carbon.eu\/news\/wp-json\/wp\/v2\/media\/150768"}],"wp:attachment":[{"href":"https:\/\/renewable-carbon.eu\/news\/wp-json\/wp\/v2\/media?parent=150766"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/renewable-carbon.eu\/news\/wp-json\/wp\/v2\/categories?post=150766"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/renewable-carbon.eu\/news\/wp-json\/wp\/v2\/tags?post=150766"},{"taxonomy":"supplier","embeddable":true,"href":"https:\/\/renewable-carbon.eu\/news\/wp-json\/wp\/v2\/supplier?post=150766"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}