Latest news with #BiotechAct
Euractiv
01-07-2025
- Business
- Euractiv
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]
Euronews
05-03-2025
- Business
- Euronews
Commission playing catch up with US, China in life science sector
Plans for a forthcoming life science strategy include the launch of a non-legislative initiative connecting other upcoming proposals for biotech, AI and research, according to minutes of a recent meeting seen by Euronews, in which the EU executive acknowledged that the bloc is lagging behind the US and China in the sector. Commission President Ursula von der Leyen flagged expectations that the Life science strategy is expected to boost the EU's competitiveness in the sector in her political manifesto last summer. Although still in its early stages, EU representatives provided an update in a closed-door meeting last week, outlining key areas of focus. According to meeting minutes reviewed by Euronews, the strategy is expected to be a non-legislative initiative designed to connect with existing and upcoming EU policies - including the upcoming Biotech Act, the Startup and Scaleup Strategy, the Research & Technology Infrastructure Strategy, the AI in Science Strategy, and the European Innovation Act. The Commission acknowledges that life sciences are crucial to the EU economy but also recognises that the bloc lags behind the US, China, and other global players in market delivery. A recent study by the European Patent Office highlighted this decline, showing that while Europe hosts many oncology startups, it is losing its competitive edge in key research areas. With increasing global competition, the EU hopes this strategy will help close the gap and re-establish Europe as a leader in life sciences. One of the core priorities will be advanced therapy medicinal products (ATMPs), a term that encompasses cell and gene therapies. These treatments, identified in the Draghi report as critical for addressing genetic diseases, aim to replace faulty genes, silence harmful ones, or introduce new genes to fight disease. The Commission is also looking at ways to de-risk medicinal product development and improve the conditions for multi-country clinical trials. Additionally, AI and data-driven modelling will play a crucial role in predicting and monitoring personalised health approaches, as well as expanding research in microbiome-related data sharing. In addition to healthcare, the strategy will also focus on improving food systems to ensure their competitiveness and sustainability by 2050, strengthening the bioeconomy, and advancing safer, greener innovations in the chemicals sector. Another key element will be investment strategies to support early-stage biotech firms, particularly in the area of blue biotechnology. The first step toward the strategy's development will be a call for evidence, expected in March 2025, although the timeline is not yet confirmed. The final strategy seems set for release in the second half of the year, with Denmark, which will hold the EU Council presidency from July 2025, potentially hosting a major life sciences conference to present it.
Euronews
20-02-2025
- Politics
- Euronews
Pesticide cuts are off the table, says EU Agriculture Commissioner
The goal of halving pesticide use in the EU by 2030 was once a cornerstone of the European Green Deal. But now, that target has been shelved indefinitely. In an interview with Euronews, Agriculture Commissioner Christophe Hansen confirmed that reviving the plan is no longer on the EU executive's agenda. "It didn't work out, and now we have no progress at all. Is that facility off the table? That is off the table," Hansen said. The now-defunct sustainable use of pesticide regulation (SUR) aimed not only to cut pesticide use but also to ban these products in sensitive areas - such as urban green spaces and Natura 2000 sites - while promoting safer alternatives. Initially proposed in June 2022, the reform was withdrawn a year later due to mounting opposition from right-wing parties and widespread farmer protests. At the time, EU Commission President Ursula von der Leyen insisted that pesticide regulation would remain a priority and could be reintroduced with a "much more mature" proposal. However, as the European Parliament elections were approaching, any fresh draft was pushed back to the current Commission that took office last December. "Of course, the topic stays, and to move forward, more dialogue and a different approach is needed," von der Leyen told MEPs in February 2024. But Hansen made it clear that any future initiatives will focus on trade aspects such as reciprocity - for instance forcing food imports to meet EU's pesticide standards - and innovation rather than mandatory pesticide reduction targets. He pointed to the upcoming Biotech Act, which aims to accelerate the development of safer alternatives to conventional pesticides. "We have to ramp up our efforts to get those alternatives that are not toxic to the environment and human health," he said. As part of its broader regulatory simplification package, the Commission will later this year propose measures to fast-track the approval of biopesticides. This revision - one of the few elements of the withdrawn pesticide framework that saw broad political support - aims to fill legal gaps related to aerial pesticide application and biocontrol. This shift reflects the Commission's newly unveiled Vision for Agriculture and Food, which prioritises making farming a more attractive profession - especially for younger generations - over tightening environmental regulations.
