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Authored by Malte Lohan, CEO, AmCham EU

Europe’s life sciences sector sits at the heart of the EU’s competitiveness agenda. It supports advanced manufacturing and helps bring new treatments and technologies to patients. Yet companies deciding where to invest need a regulatory environment that is predictable and open to global cooperation. 

The European Commission’s work on the Biotech Act and the targeted revision of the Medical Devices and In Vitro Diagnostics Regulations (MDR/IVDR) offers an opportunity to improve that environment. Both files can help make Europe a stronger location for life sciences investment. 

The EU should use this moment to build a framework that keeps pace with scientific progress. That means faster and clearer procedures. It also means better use of data and intellectual property rules that recognise the realities of global supply chains. 

The EU’s agri-food regulatory framework is fragmented and lacks predictability. The Food and Feed Safety Omnibus is a chance to address these shortcomings by reducing delays, improving consistency and easing compliance burdens that limit market access. 

Uncertainty discourages investment and slows the uptake of new solutions. A more proportionate approach can improve legal certainty and support more consistent implementation across Member States. At the same time, maintaining a science-based, risk-based approach to trade measures is necessary to safeguard food security and avoid supply disruptions.