Sector & service specialists

Healthcare is one of the EU’s most regulated and most intensely lobbied sectors. The industry consumes over 10% of GDP in most developed nations. Europe’s pharmaceutical sector employs 750,000 people directly, generating three to four times more employment indirectly. Medical technology employs over 650,000 people in a market estimated at around €110 billion. EFPIA’s 40 leading pharmaceutical members and MedTech Europe’s device manufacturers collectively represent the sector’s largest Brussels spenders. 

The long-awaited Pharma Package was agreed in trilogue on 11 December 2025 and the final texts published by the Council on 6 March 2026. It represents the most significant overhaul of EU pharmaceutical legislation in over two decades. The traditional ‘8+2(+1)’ data protection model has been replaced by a more complex ‘8+1(+1+1)’ framework. Baseline protection is 8 years of data protection plus 1 year of market protection, with extensions available for new indications with significant clinical benefit, timely EU marketing authorisation, and comparative clinical trials. Orphan medicines receive 9 or 11 years of market exclusivity depending on whether they meet breakthrough criteria. Final formal adoption is expected in autumn 2026, with the new regime applying from approximately mid-2028. 

The Biotech Act, proposed in December 2025, establishes a framework to address EU competitiveness gaps in biotechnology – including regulatory sandboxes, a 12-month SPC extension for biotech medicines, and support for scaling. A Biotech Act II is announced for Q3 2026. MDR and IVDR reform proposals, published December 2025, aim to simplify medical device regulation and importantly propose exempting AI-enabled medical devices from the AI Act’s high-risk system requirements, treating them under sector-specific regulation instead. 

Implementation of the European Health Data Space – the EU’s framework for sharing and secondary use of health data for research, innovation, and policy – is creating major new debates around patient data governance, interoperability, and AI-enabled clinical research. It represents a significant new advocacy arena for pharmaceutical, medtech, and digital health companies simultaneously. The Trump drug pricing executive order has created a new transatlantic dimension: the administration is pressing EU governments to pay more for prescription drugs, and pharmaceutical CEOs issued a stark warning to President von der Leyen in April 2026 that unless Europe delivers rapid policy change, R&D and manufacturing investment will increasingly be directed to the US. This is now an active and politically sensitive dossier with implications for the entire life sciences sector’s Brussels strategy.