11.3 billion dollar investment to address capital shortages

The European Commission is set to officially propose the 'EU Biotech Act I' in December 2025 to address the capital shortage issue faced by startups. From 2015 to June 2025, the total investment in European health and biotech VC reached 25 billion euros (approximately 28.4 billion dollars), which is significantly lower than the 219 billion euros (approximately 24.9 billion dollars) in the United States, nearly a nine-fold difference. As a result, companies like BioNTech SE (BNTX) in Germany chose to list on the Nasdaq to raise funds during the development of the Comirnaty COVID-19 vaccine, leading to a continued outflow of talent from the region. The European Union (EU) plans to mobilize 10 billion euros (approximately 11.36 billion dollars) in public funds in collaboration with the European Investment Bank (EIB) to support late-stage growth and maximize private capital attraction.

Streamlined clinical approval process to improve patient access

Over the past decade, Europe's share in global clinical trials has decreased significantly from 22% to 12%, while China has increased its share to 18%. The average clinical approval time in the United States and China is around 60 days, while in Europe, it takes more than 113 days, delaying the launch of new drugs. This bill aims to significantly shorten the initial clinical approval period from the current 75 days to 47 days, based on a mutual trust system among member states. This will help ensure that new drugs reach approximately 36 million patients with rare diseases in Europe quickly and will be a key factor in enhancing the competitiveness of clinical research at a global level.

Introduction of regulatory sandboxes to break down regulatory barriers and eliminate silos

Unlike the United States, which has a unified regulatory system for pharmaceuticals and medical devices, Europe has fragmented laws across different areas, which has caused delays in the approval of innovative new drugs. New therapies targeting FcRn, such as Vyvgart (active ingredient: efgartigimod alfa) developed by argenx SE (ARGX), have had to go through complex regulatory approval processes. To overcome these inefficiencies, the bill introduces a regulatory sandbox that maintains the European Medicines Agency (EMA)'s strict safety standards while eliminating redundant reviews among different agencies. This will simplify the approval process for next-generation combination drugs, significantly reducing regulatory uncertainty for developers.

Strengthening biomanufacturing capabilities for bio-security

Europe has strong basic research capabilities but lacks biomanufacturing facilities at the commercialization stage, leading to a vicious cycle where innovative technologies are dominated by overseas companies. If innovative therapies cannot be produced directly in Europe, it will eventually lead to reliance on supply chains in China or the United States, threatening the health security of European patients. The second phase of this bill focuses on expanding industrial biotech and bio-raw material production capabilities to increase the self-sufficiency rate of pharmaceuticals and build an independent supply chain. With local production infrastructure in place, investment in Europe can extend to the manufacturing stage, establishing a high-value-added industrial ecosystem.