EFPIA welcomes the European Commission's initiative to develop the Biotech Act and strongly supports its objective of strengthening Europe's life sciences ecosystem. Europe has world-class scientific capabilities and a strong industrial base but continues to face challenges in translating research excellence into investment, clinical development, manufacturing and patient access.

The Biotech Act provides a unique opportunity to create a more innovation-friendly and globally competitive environment. A key priority for EFPIA is modernising the EU clinical trials framework. Measures to reduce authorisation timelines, strengthen coordination between Member States, improve predictability and streamline assessments have the potential to significantly enhance Europe's attractiveness as a location for clinical research. Faster approvals, coordinated assessments for combined studies, greater harmonisation of ethical reviews and simplified procedures would enable earlier patient access to innovative therapies and strengthen Europe's ability to attract global R&D investment.

While these proposals are a welcome step, the EU should pursue further reductions in approval timelines while maintaining high standards of patient safety, ethics and scientific quality, supported by adequate resources. Globally, clinical trial authorisation timelines continue to accelerate, with 30-day competent authority reviews followed by ethics review increasingly becoming the benchmark.

EFPIA welcomes the proposed Supplementary Protection Certificate (SPC) extension as a positive signal of Europes commitment to innovation. However, its effectiveness will depend on its scope, duration and eligibility criteria. To provide a meaningful incentive capable of influencing investment decisions, the SPC extension should be broadened to encompass all innovative medicines, remain technology-neutral and be supported by clear, predictable and attainable award criteria. Any conditions linked to manufacturing or operational activities in the EU should recognise the global nature of pharmaceutical R&D and supply chains and avoid creating legal uncertainty or unintended barriers to investment.

EFPIA supports measures to improve regulatory coherence and reduce fragmentation. Clarifying the processing and reuse of clinical trial data, harmonising GDPR requirements, introducing regulatory sandboxes and adopting a risk-proportionate GMO exemption can enable innovation while reducing unnecessary administrative burdens and maintaining appropriate safeguards.

Strategic Projects should accelerate innovation, strengthen industrial capacity and translate scientific breakthroughs into market-ready solutions. They should focus on excellence, critical mass, industry involvement and international openness.

The Biotech Act should also be more ambitious in improving access to funding throughout the lifecycle of innovative products. EU funding should support scale-up, attract investment and prevent companies from relocating outside Europe while reflecting the long development timelines characteristic of the pharmaceutical innovation.

EFPIA welcomes the recognition of artificial intelligence (AI) and data as key innovation enablers. Trusted AI testing environments, interoperable data infrastructures and coherent governance can support responsible innovation across the medicines lifecycle. Future governance should align with existing legislation, avoid duplication and provide a risk-based, proportionate framework that supports innovation while safeguarding patient trust, data protection and regulatory integrity.

While the Biotech Act is an important step forward, it will not be sufficient on its own. Robust R&D and predictable regulation must be complemented by market conditions that support timely patient access, adequate funding, and recognition of the value of innovation at national level.