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On 21 October 2025, the European Commission published its 2026 Work Programme outlining an ambitious legislative and policy agenda with major implications for the Life Sciences sector, in particular the pharmaceutical, medical technology, biotechnology, food and feed industries. Emphasising competitiveness, simplification, and strategic autonomy, the Work Programme will, within the broader framework of the new European Life Sciences Strategy, shape the regulatory environment in 2026 and beyond. Below, we have curated some of the most significant developments.
With one of the centrepieces of its innovation agenda, the European Biotech Act II, the Commission aims to modernise the regulatory framework for biotechnology by streamlining authorisation procedures and improving access to big data and AI. The hope is that these changes will help boost R&D and attract investment in key areas such as clinical development and new production technologies.
One key point to look out for in the upcoming proposal is the scope of the proposed act. Member States and stakeholders have expressed concern that the Biotech Act might be limited primarily to healthcare, potentially overlooking the biotech industry’s significant broader potential in critical sectors including defence, energy, food & agriculture, and climate change mitigation.
The Commission pledges to cut administrative burdens by 25% overall — and 35% for SMEs — with a specific focus on sectors such as medical devices, food and feed safety. The Commission intends to apply the proportionality principle more rigorously as part of its Better Regulation framework for assessing whether to undertake EU initiatives and will announce the specifics of this change in rulemaking practices in the first half of 2026.
Further, additional simplification and omnibus packages will revise and consolidate existing rules, reduce reporting obligations, and streamline authorisation procedures to align regulations with prevailing market conditions. However, given the divergent enforcement regimes in the Member States, particularly within food and feed law, the extent to which these changes will translate into actual compliance relief for all companies remains to be seen.
The Work Programme builds on the 2023 pharmaceutical package, with continued emphasis on ensuring availability and security of supply of critical medicinal products. Importantly, the Commission has maintained its proposal for a Critical Medicines Act safeguarding the security and supply of critical medicinal products and the availability and accessibility of medicinal products of common interest.
The Commission will advance a non-legislative Livestock Strategy accompanied by an update of rules on unfair trading practices in the food chain. An updated evaluation of the European Food Safety Authority (EFSA) is also scheduled for 2026, assessing its governance, scientific integrity, and capacity to support innovation in food and feed legislation.
Key evaluations will be conducted in 2026 that could influence upcoming legislative revisions:
Stakeholders in chemical, biotech, and consumer health industries should anticipate potential follow-up measures or streamlined amendments in 2027.
Finally, the European Innovation Act and Circular Economy Act will underpin a horizontal regulatory shift toward innovation-driven compliance and sustainable industrial policy. The stated aim of the Commission is to make doing business and accessing finance in Europe easier for all companies, particularly innovative companies, startups and SMEs, while also fostering the future of “clean tech” in Europe by creating additional demand and supply for circular products. While the Commission intends for its focus on “lighter, clearer and easier-to-implement” lawmaking to extend across product safety, medical device certification, and biotech sectors, it is unclear how the tensions between sustainable industrial policy and business-friendly compliance regimes will be resolved.
With the ambitious agenda set out in the Work Programme, 2026 may be a pivotal year for companies in the Life Sciences industry. Stakeholders should:
Gorrissen Federspiel is monitoring the European Commission’s implementation of its policy and legislative agenda for the Life Sciences-industry closely.