Science-Backed Legislative Proposals

🧪🔬My (probably) last legislative update this year! On 16 December 2025, the European Commission published its Proposal for the Biotech Act 🧬At a conceptual level, the Biotech Act introduces a broad definition of “biotechnology”, understood as the application of science and technology to living organisms, as well as parts, products and models thereof, to alter living or non-living materials for the production of knowledge, products and services. 🧫The Proposal responds to a structural problem repeatedly identified by the Commission: despite a strong scientific base, the EU struggles to translate early-stage research into large-scale development, manufacturing and commercialisation. In practice, companies often move late-stage development, manufacturing or market placement outside the EU. The Biotech Act seeks to address this by improving access to funding etc. 🧑🔬A core pillar of the Biotech Act is the simplification and acceleration of clinical trials. Authorisation timelines for multinational trials are significantly shortened, additional assessment periods for ATMPs are removed, and procedures for substantial modifications are streamlined. The Proposal also introduces combined clinical trials, reduced GMO requirements for certain low-risk ATMPs, accelerated procedures during public health emergencies and a new category of minimal-intervention trials. 📍From a data protection perspective, the Biotech Act proposes a significant recalibration of the Clinical Trials Regulation. A new Article 93 explicitly requires sponsors and investigators to process personal data, including genetic and health data, for clearly defined regulatory purposes and qualifies both as controllers under the #GDPR. The legal basis for processing is harmonised at the EU level as compliance with a legal obligation, combined with public interest in public health, and Member States are prevented from introducing additional national conditions under Article 9(4) #GDPR. The Proposal also explicitly allows secondary use of clinical trial data for further clinical research and scientific purposes without requiring a new GDPR consent, while strengthening safeguards such as confidentiality, ethical review, pseudonymisation and security measures. 📍Beyond clinical trials, the Act places strong emphasis on artificial intelligence, with forthcoming EMA guidance on AI use across the entire medicinal product lifecycle and the creation of trusted AI testing environments. It also introduces strategic health biotechnology projects, enhanced access to EU-level funding, and new biodefence and biosecurity measures, including mechanisms to prevent misuse of biotechnology and mandatory screening for sequences of concern. #privacy

Science at the Heart of Climate Ambition Today, the European Commission proposed a 90% net GHG emissions reduction target by 2040—a major milestone on the path to climate neutrality by 2050. What’s especially noteworthy? This proposal is grounded firmly in science. The target is based on detailed analysis from the Intergovernmental Panel on Climate Change (IPCC) and the European Scientific Advisory Board on Climate Change. It reflects a pragmatic yet ambitious pathway to achieving the EU’s long-term climate goals. The Commission also proposes more flexibility: for the first time, carbon credits from outside the EU could count toward up to 3% of the total reduction target—a contentious but strategic move to maintain industrial competitiveness while progressing climate action. With 85% of Europeans concerned about climate change, science-based targets like this one are vital. Policymakers must continue to prioritize evidence, transparency, and justice—especially as heatwaves and extreme weather reshape public urgency. What are your thoughts on using international carbon credits within EU targets? Can flexibility coexist with environmental integrity?

Today I’m addressing global science communicators in Aberdeen on an Innovative Irish Model for Evidence-Informed Policy Science communication too often remains siloed within academia, detached from its practical implications. But Ireland’s Arranmore Island hearings turned that model on its head—bringing research directly into Parliament through the voices of those affected. Instead of relying solely on academic experts, islanders engaged in research presented firsthand evidence, making complex policy challenges more tangible and urgent. The result? ✅ 29 policy recommendations that informed government departments. ✅ Real-world legislative impact on rural healthcare and financial support for carers. ✅ A replicable framework for translating academic research into actionable policies. This participatory model proves that when science meets policy in the right format, it can drive meaningful change. It’s time to rethink how we bridge the usability gap between research and governance. Read the full paper here: https://lnkd.in/eWP4hW3E Let’s start a conversation—how can we improve science communication for policymakers? 💡

My colleagues from FinBio.org and I recently responded to EFRAG's call for input on the reform of EU corporate sustainability reporting. We emphasized that simplification should be based on Science to ensure that reporting is useful and effective. By making corporate environmental impacts clearly and credibly visible ESRS allows investors, regulators, and others to track progress and identify risks. We have two key concerns: (i) the excessive volume and complexity of E1-5, and (ii) the subjectivity introduced as companies self-identify financially material environmental impacts, which risks inconsistency and weak comparability. We recommend a science-based, sector-specific baseline for identification of material sector-specific material topics to guide disclosures and ensure data quality. For more on our comments to EFRAG see: https://lnkd.in/dMet9Pju finbio.org/wp-content/u... And for more on our views on how to reform sustainability reporting in EU see our policy brief Staying Green: Retaining the integrity of environmental disclosures under European corporate sustainability reporting https://lnkd.in/d24ED5hw That policy brief recommends reform should: • Leverage the best available scientific evidence to identify and mandate location-specific information on a limited set of scientifically validated and prioritized environmental impacts (pressures). This will enhance regulatory efficiency while ensuring the disclosures are reliable and decision-useful. • Ground double materiality assessments in scientific evidence of key environmental topics. This will significantly improve the transparency, reliability, and comparability of environmental disclosures. • Ensure expert-guided streamlining of corporate sustainability legislation and regulation. Engaging experts from environmental and sustainability sciences, law, accounting, and other directly relevant disciplines can help reduce compliance burdens without compromising on disclosure integrity and legislative intent. We emphasize that failing to prioritize and mandate scientifically validated disclosures in streamlining efforts heightens the dangers of significant information gaps and unreported material environmental impacts and risks. This undermines the reliability and usefulness of ESRS for effective decision-making. Also see from December of last year, our OPEN LETTER TO THE EUROPEAN COMMISSION Grounding EU Sustainability Reporting in Science: A Call for Action https://lnkd.in/dchw7rFQ

Access to safe, clean drinking water is one of the most basic responsibilities of government. That’s why I introduced House Bill 815. Ohio currently lacks a consistent, proactive framework to address emerging contaminants in drinking water. Too often, standards are developed after exposure has already occurred. HB 815 is designed to change that by requiring the Ohio EPA to establish clear, science-based rules and strengthen water quality protections statewide. This legislation is focused on three core principles: • Protecting public health • Holding polluters accountable • Ensuring science drives decision-making I’m grateful to Rep. Allison Russo for her leadership on this issue! Communities across Ohio, whether in Lakewood, Lima, or Logan, deserve confidence in their drinking water. This bill is about restoring that trust and building a stronger, more responsive system moving forward. Safe water is not optional. It’s foundational. #CleanWater #PublicPolicy #Ohio #EnvironmentalPolicy #PublicHealth

📜 Legislative Update Big week for biotech on the Hill. Two different packages — one on agriculture, and one in the intelligence space — are moving forward, both rooted in recommendations from the National Security Commission on Emerging Biotechnology (NSCEB). 🌱 Agriculture Package Six bills, led by #NSCEB Chair Todd Young and Alex Padilla, that take direct aim at the bottlenecks holding U.S. ag biotech back. Here’s the quick run-down: - National Biotechnology Safety Act (S.2697) – Funds NSF research to give regulators the science they need to streamline approvals. - Foundation for Enabling Biotechnology Innovation Act (S.2696) – Creates a new non-profit hub to bring government, industry, and academia together to solve regulatory challenges. - Agriculture and National Security Act (S.2694) – Elevates “food security as national security” by creating a new Assistant Secretary for National Security at USDA. - Ag Biotechnology Coordination Act (S.2692) – Establishes a USDA Office of Biotechnology Policy to coordinate across agencies and with innovators. - Biobased Market Expansion Act (S.2693) – Expands federal procurement of U.S. biobased products to boost demand, jobs, and strategic resilience. - Synthetic Biology Advancement Act (S.2695) – Creates a National Synthetic Biology Center at USDA to accelerate disruptive innovation in food and ag. Bottom line: this package cuts red tape, builds capacity, and makes sure U.S. agriculture is ready for the next wave of biotech. 🧬 Intelligence Authorization Act (IAA) At the same time, the House Intelligence Committee just advanced three biotech provisions in the FY26 IAA — making sure the IC has the people, data, and strategy it needs as biotech reshapes global competition. - Designates senior biotech officials across agencies (CIA, NSA, DIA, FBI, DOE, DHS, State, ODNI). - Requires a National Intelligence Estimate on Chinese biotech advancements within a year. - Launches planning for a “web of biological data” to give the IC the tools it needs to make sense of the biotech revolution. As I’ve said before — biotech is redefining global power dynamics. Our intelligence agencies need to be ready, and these provisions are a big step. ✅ Taken together, these packages show real bipartisan momentum to move biotech from recommendations to reality. The work continues!