Changes from report parliamentary committee draft to plenary report

Biotechnology is a transformative discipline that has rapidly evolved, particularly following the sequencing of DNA structure and the development of new technologies. Its application spans various sectors, most notably healthcare and pharmaceuticals, where it enables the development of innovative products and therapeutic approaches. As a result, political attention is increasingly shifting towards this sector, not only in Europe but also in third countries such as the United States and China. In the context of the EU Competitiveness Compass, the forthcoming Strategy for European Life Sciences (2025) and the EU Biotech Act (2026) represent key opportunities to bolster Europe’s competitiveness, regulatory clarity, and investment capacity in this field.

The rapid evolution of biotechnological applications has not been matched by an equally adaptive regulatory framework. Despite the investments the EU has already made in these fields, the EU faces challenges in translating research into market-ready solutions. Structural obstacles—including fragmented support systems, lack of traceability, insufficient early-stage investment, and complex intellectual property and licensing regimes—continue to hamper effective technology transfer and commercialisation. This has led to a notable decline in its global share of pharmaceutical R&D. The complexity and fragmentation of the current EU regulatory framework, exacerbates this gap and lacks the agility to respond to emerging technologies. This regulatory uncertainty creates barriers for industry actors and delays the delivery of innovative treatments to patients. This disproportionately affects small and medium-sized enterprises (SMEs), which constitute the majority of biotech actors in the EU and are responsible for much of the sector’s innovation. They often lack access to appropriate financing and face high regulatory and operational costs.

In light of the upcoming Biotech Act, it is essential to establish a coherent, streamlined, and flexible framework that facilitates innovation, while maintaining high standards of safety and ethical compliance. Such a framework must be future-oriented, adaptable to scientific developments, and designed to reduce administrative burdens, while ensuring legal clarity. A more integrated and supportive ecosystem is needed to strengthen IP protection, improve coordination between academia and industry, and provide tailored support across the entire innovation lifecycle, from research and development to market entry. Complementary measures, including tax incentives, simplified authorisation procedures, and improved access to infrastructure, will enhance the sector’s competitiveness.

At the same time, biotechnology raises important ethical, safety, and security concerns that must be carefully addressed, in line with the principles of the Universal Declaration on the Human Genome adopted by UNESCO. Given the profound societal and human implications of these technologies, their development must be firmly anchored in the respect for human dignity, the right to life, and fundamental rights. Consequently, all forms of discrimination based on genetic characteristics must be strictly prohibited. Human embryo manipulation and germline modifications are also banned due to their unpredictable impact on individuals and future generations. The regulatory framework should adopt a precautionary approach regarding the balance risk-benefit. Cooperation among independent and transparent national ethics committees should be facilitated, ensuring the involvement of affected communities and in full compliance with the subsidiarity principle and the competence of Member States.

Looking ahead, the EU Biotech Act should strike a balance between fostering innovation and upholding public health and ethical principles. A flexible, technology-neutral framework—based on a robust impact assessment and comprehensive stakeholder consultation—is crucial to ensure that scientific excellence is translated into tangible health benefits for European citizens.