EuropaBio

Biotechnology and bioeconomy are key cross sectoral circularity enablers that rely on renewable raw materials, enhancing resource efficiency while adding value in the process. The Circular Economy Act must foster a holistic, coherent and supportive policy framework for biotechnologies.

EuropaBio welcomes the European Commission commitment to initiate the Industrial Decarbonisation Accelerator (IDA) Act as part of the Clean Industrial Deal. Biotechnology and biomanufacturing are of high strategic importance to achieve the EUs net-zero ambitions and should be included in the IDA Act as essential for EU competitiveness. This would also boost industrial confidence.

EuropaBio, the industry association for biotechnology in Europe, welcomes the opportunity to contribute to the evaluation of the public procurement Directive 2014/24/EU. Please see our full response in the attached file. Biotechnologies play an essential and significant role for the delivery of EU goals for competitive, healthy, resilient and sustainable economies and societies.

EuropaBio, the industry association for biotechnology in Europe, welcomes the opportunity to contribute to the evaluation of the Regulation (EU) 2017/745 on Medical Devices (MDR) and the Regulation (EU) 2017/746 on In-Vitro Diagnostic Medical Devices (IVDR).

EuropaBio, the industry association for biotechnology in Europe, welcomes the opportunity to contribute to the evaluation of Regulation (EU) 2017/745 on Medical Devices (MDR) and Regulation (EU) 2017/746 on In-Vitro Diagnostic Medical Devices (IVDR).

The EU Inc. proposal is a major step forward for the internal market, notably through digital formation, harmonised company law, and potentially the EUESO with taxation deferred to disposal. However, several targeted adjustments are needed to ensure it works for biotech and deeptech scaleups, spin-outs and founder-led companies.

Please find attached EuropaBio's input. (For complementary feedback and recommendations, please also refer to our consultation response to the European Innovation Act.) Biotechnology is one of the most critical technologies to Europe's autonomy, prosperity and ability to compete globally.

EuropaBio welcomes the revision of the EU Taxonomy Delegated Acts as a key opportunity to strengthen the bioeconomy's role in achieving EU environmental objectives. EuropaBio supports completing an inclusive approach to feedstocks eligible for sustainable finance that ensures predictable access to sustainably sourced biomass across the entire bioeconomy, while appropriately recognising the specificities of biotech…

EuropaBio welcomes the revision of the EU Taxonomy Delegated Acts as a key opportunity to strengthen the bioeconomys role in achieving EU environmental objectives. To maximise impact, the review should: 1) Adopt a more inclusive approach to feedstocks eligible for sustainable financing mechanisms 2) Distinguish biotechnology from conventional processes, as highlighted in the EU Bioeconomy Strategy More details…

In the last 20 years, biotech transformed the pharmaceutical industry and enabled the development of breakthrough therapies that are live-saving or significantly improving quality of life of patients and their families. The development of biotech in Europe also continues to positively contribute to the regions economic well-being.

The evaluation and revision of the general pharmaceutical legislation is the opportunity to create a future-proof, patient-oriented and leading life sciences and biotechnology sector in the EU. New biotechnology-derived vaccines and treatments have helped to tackle numerous life-threatening illnesses. Targeted cell and gene therapies and new mRNA platforms are paving the way for future treatments.

EuropaBio represents the European biotechnology industry, including small and medium-sized enterprises, startups, scale-ups, established companies and European national and regional biotech associations. EuropaBio supports the objectives of the European Biotech Act and sets out chapter-by-chapter recommendations in the attached paper. Some of the main positions are as follows.

EuropaBio welcomes the introduction of targeted improvements in the Directive. It supports the objective of ensuring a high level of safety for human health and the environment while stimulating and advancing innovation, competitiveness and legal certainty.

Biotechnologies play an essential role for the delivery of EU objectives for competitive, healthy, resilient and sustainable economies and societies. Future-proofing fundamental frameworks across all biotech applications including healthcare, agri-food supply chains, manufacturing processes, chemicals and consumer goods, is critical.

The Biotech Act II shall complete the stated ambition from the European Commission and Member States for a far-reaching and multi-sector legislation. It should recognise EU advance through Biotech Act I in key aspects of biotechnology and extend these to the full delivery of biomanufacturing as central to Europes economic, supply chain and sustainable future.

The European Commissions proposal for plants produced by certain new genomic techniques (NGT legislation) is a sign of its commitment to timely and relevant policymaking to ensure food security and tackle environmental challenges such as climate change and biodiversity loss.

EuropaBio welcomes the opportunity to provide feedback on the implementation of Regulation (EU) 2026/1388. Its implementing framework should be science- and product-based, proportionate, predictable and workable, enabling innovation and competitiveness while maintaining a high level of protection for human health and the environment.

Europe is at a critical point in shaping its innovation agenda. Despite world-class science and a strong research base, too many promising ideas fail to reach the market. Innovative companies, especially in biotechnology, face structural barriers to finance, talent and cross-border growth.

EuropaBio welcomes the EC's plan to begin a discussion with stakeholders to develop the EHDS. Science is evolving fast and digital tools are accelerating our ability to conduct research. For the biotechnology industry, it is imperative quality data sets are collected and analysed, while protecting privacy and maintaining trust in how the data are used.

EuropaBio feedback following European Commission proposal on establishing a framework of measures for strengthening Europe’s net-zero technology products manufacturing ecosystem (Net-Zero Industry Act) EuropaBio welcomes the Net-Zero Industry Act (NZIA). This initiative is an extremely important step to preserve Europe’s competitiveness.

Opening of the attached position paper · the full paper is on the Commission’s record (source link above)

EuropaBio welcomes the adoption of the proposal for a Regulation on SoHO revising the EU’s Blood, Tissues, and Cells (BTC) legislation. The EU needs a predictable, future-proof, and robust SoHO framework to ensure the uptake of transformative advanced therapies which hold great potential for both the health and wellbeing of patients and the sustainability of healthcare systems.

EuropaBio considers the Advanced Materials Act a timely and strategic initiative to reinforce biotechnologys role in building Europes clean, competitive and resilient industrial base. To maximise impact, the Act should: 1) Fully integrate biotechnology as a design, production and scaleup pathway for advanced materials; 2) Enable industrial deployment through expanded biomanufacturing capacity, predictable regulatory…

Developing medicines for children and rare diseases is a lengthy and complex undertaking. Much less is known about these illnesses when compared to more common conditions, meaning extensive research is required before scientists and researchers can seek to transform their ideas into potential treatments.

The COVID-19 pandemic has shown the importance for Europe to have the right tools to respond to major health crises. The EU has already adopted several laws to improve its ability to respond to health emergencies and the coordination between the Member States.