01-07-2025
Belgian biotech stakeholders urge EU to fast-track innovation and financing reforms
As the European Commission prepares its Biotech Act, Belgium's biotech sector has submitted detailed responses to the Commission's call for evidence, advocating for a bold and comprehensive legislative package.
If the EU wants to lead in global biotechnology, the Biotech Act must deliver radical simplification, stronger financial instruments, and smarter regulation, they say.
Sharing priorities and concerns, a wide range of Belgian stakeholders, including industry associations, regulators, academic institutions, and patient groups, paint a picture of a country eager to see Europe reclaim its leadership in biotechnology. A turning point for EU biotech
Belgium punches above its weight in biotech, home to thriving clusters in Flanders and Wallonia, as well as over 450 innovation-driven biotech entities. But recent trends have raised alarm. Clinical trial authorisations in Belgium dropped by 10% between 2022 and 2023, part of a broader EU decline.
'Over the past five years, 60,000 EU patients missed out on clinical trials,' warned
The message from Belgium is clear: without fast, pragmatic reforms, Europe risks falling behind the US and China.
'Regulatory delays, fragmented markets, and lack of capital are costing Europe its biotech edge,' said Biovia, the Flemish health innovation cluster. 'The Biotech Act must turn scientific excellence into global competitiveness.' Streamlining regulation
All Belgian contributors emphasise the need to streamline regulatory frameworks, particularly in clinical trials, market access and data governance.
called for a reform of the EU Clinical Trial Regulation (CTR) to reduce national divergences, shorten approval timelines, and minimise administrative burdens for modifications during trials.
Amgen echoed these concerns, advocating for a centralised EU procedure under EMA oversight, especially for combination products involving medical devices or diagnostics.
The Flemish government similarly pushed for harmonised, lean approval procedures aligned across sectors, calling for 'regulatory sandboxes' to support high-risk innovation.
The Belgian Federal Agency for Medicines and Health Products (FAMHP) warned of duplicative procedures, inconsistent interpretations between Member States, and a lack of clarity on the regulatory status of advanced therapies.
It flagged the need for harmonisation in the handling of genetically modified organisms (GMOs) in clinical trials and import regulations for short-life advanced therapy medicinal products (ATMPs), noting that the current customs procedures are unfit for these innovative medicines. Investing in innovation, not just frameworks
Beyond regulation, financing innovation emerged as a central demand. Biovia and VIB both highlighted Europe's chronic funding gap, particularly in growth-stage biotech.
'The EU lags the US by a factor of six to ten in available biotech capital,' Biovia noted, calling for more non-dilutive EU funding, a unified biotech stock exchange, and better incentives for pension funds and long-term investors.
VIB proposed a 'EuroTech Stock Exchange' modelled after NASDAQ and urged the Commission to mandate more venture-friendly policies at the European Investment Fund (EIF). 'EIF-backed funds should prioritise excellence, not geographical quotas that distort investments,' it argued.
The Flemish government, in turn, advocated for prioritising biotech in the forthcoming European Competitiveness Fund and creating pan-European access to pilot plants and infrastructures, including for SMEs. Digital, data, and AI
Belgian stakeholders were aligned in calling for greater digital integration.
MSD, and Sanofi stressed the importance of secure, high-quality datasets, interoperable systems, and responsible AI integration. Leveraging the European Health Data Space (EHDS), aligning with the AI Act, and enabling real-world evidence (RWE) use in clinical trials were flagged as top priorities.
The FAMHP also called for broadening the focus from AI to include a wider range of digital tools such as modelling, simulation, and 'white-box' computational methods. Meanwhile, Amgen called for a Regulatory Innovation Fund to support digital regulatory sandboxes and keep EMA guidance on biotech manufacturing up to date. Environmental balance
A notable concern raised by was the EU's environmental legislation, in particular the Urban Waste Water Treatment Directive (UWWTD).
The group urged the Commission to pause its implementation and redesign the directive in line with the 'polluter pays' principle.
Currently, only the pharmaceutical and cosmetic industries are expected to foot the bill for micropollutant removal, while industrial chemicals, pesticides, and household products are excluded. 'This undermines both competitiveness and the valorisation of green innovation,' warned. Paediatric oncology
In a poignant submission, patient group KickCancer stressed that paediatric cancer research illustrates the untapped promise and systemic failings of the current biotech landscape.
The group called for a true single market to support early, multinational paediatric trials, wider access to CAR-T and other ATMPs, and a financing model that combines public and private capital to keep therapies affordable. 'We must build a European model for low-cost, high-impact paediatric cancer treatments,' the group stated. Coordinated ecosystem
Belgium's submissions also underscore that biotech policy must move beyond healthcare. The Flemish government and Biovia argued for a full-spectrum approach that includes food, agriculture, industrial biotech, and recycling. Biovia's recent merger of and MEDVIA reflects this shift, positioning itself as a cluster for both human and planetary health.
Belgian actors support integrating New Genomic Techniques (NGTs) into climate adaptation policies and promoting sustainable biotech use in agriculture and food. They also called for simplifying Regulation (EC) No 1107/2009 to better accommodate biocontrol products and microbial biostimulants, noting that many promising innovations remain excluded under current EU rules.
Belgium's biotech ecosystem speaks with unity on the future of European biotechnology, converging on three pillars: streamline regulation, secure strategic financing, and empower innovation with digital infrastructure.
[Edited by Vasiliki Angouridi, Brian Maguire]
