欧盟新数据经济下制药企业如何制胜

How Pharma Wins in theEU’s New Data Economy Redesigning business models, partnerships and platformsfor the coming regulatory shift 01Executive summary How pharma companies can thrive under the EDA The EU Data Act (EDA) isn’t just anotherregulation. It’s a structural reset in the waypharma companies create, share andmonetize value. For early movers, the opportunity is clear: → Access to real-time, patient-generated datato power evidence-based pricing, adaptivereimbursement and scalable real-world evidence(RWE) By September 2025, every pharma organizationoperating in Europe will be accountable to afundamentally different data regime. → Enhanced ecosystem positioning by designingEDA-compliant services that deliver value beyondthe product Control over patient-generated data willbecome central to commercial leadership,not just compliance. → Reduced platform dependency and risk throughinteroperable, trust-first infrastructure The EDA reshapes the rules of data ownershipand access. It breaks down closed systems infavor of ecosystem-enabled value creation,where pharma doesn’t just hold data, butparticipates, orchestrates and earns trustthrough transparency and performance. The stakes are commercial Revenue growth This is structural economic transformation,not marginal policy. EDA enables high-velocity RWE and dynamicpricing strategies directly linked to patientoutcomes, unlocking share, improving marginsand strengthening access negotiations. Competitive edge First movers will define how pharma operatesin emerging data ecosystems. They’ll shape therules, influence partnerships and lead throughparticipation. Our indicators estimate thatthe data economy’scontribution to EU GDP willsurpass €630 billion in 2025and expand to €815 billionby 2030 under the Baselinescenario, representing 4.7 %and 5.6 % of GDP, respectively. Risk reduction Companies that align their platform, consentand contracting models with EDA provisions willminimize compliance friction and avoid costlytechnical debt. European Data Market Study 2024-2026, European Commission This paper provides a commercially focused roadmapfor turning compliance into advantage. Inside, you’ll find: A strategic interpretation Five high-impact transformationzones How the EDA fits into Europe’s digital healthagenda, including intersections with EHDS,DARWIN EU and the AI Act What pharma leaders can act on today to unlockvalue and reduce exposure Real-world scenerios A self assessment framework How the EDA will drive new engagement, pricingand ecosystem models across therapeutic areas Which capability gaps could becomecommercial liabilities Why now? Europe is building a common digital infrastructurefor healthcare, from MyHealth@EU to federatedresearch networks like DARWIN EU. The directionis set. The enablers are real. The window isnarrowing. and being outpaced by data-native competitors.This is no longer about being compliant. It’sabout being relevant in a system where access,transparency and orchestration are strategicdifferentiators. This is your EDA moment. Let’s define whatcomes next. The risk to pharma companies that delay?Exclusion from key ecosystems, loss of payer trust The next wave of leadership in pharma won’tbe built on owning more data. It will be built onusing data differently, faster, more fairly andmore collaboratively. 02Leadership imperatives 10 critical EDA questions every pharma companymust answer laying the legal and technical foundation forshared value creation at scale. The EDA marks a strategic inflection point, notjust for how pharma handles data, but for howit competes. For pharma, the leadership opportunity lies in howquickly and decisively companies can pivot, fromcompliance awareness to commercial activation. The old model, with closed systems, proprietarycontrol and bilateral deals, is ending. Whatreplaces it is a new operating landscape, shapedby ecosystem participation, real-time access andregulatory alignment by design. The following 10 questions are not abstractstrategy prompts. They’re the starting pointfor commercial leaders to define where they’reexposed, where they can lead and where time isalready running out. This isn’t theory. It’s being implemented acrossEurope right now. The EDA, together withMyHealth@EU, the EHDS and DARWIN EU, is The companies that can answer thesequestions clearly and act on them quicklywill help define how the next decade ofpharma gets built. 6. What role do we want to own in theemerging healthcare data economy? 1. How will the EDA shift our control overpatient-generated data? First move:Decide now whether you’re a passivedata source, a compliance follower or a platformorchestrator. Then, build toward it. First move:Reframe your strategy from ownershipto participation. Map where value can be co-created and who controls the interface. 7. Is our EDA strategy cross-functionalor stuck in a siloed operating model? 2. Where is our fastest path to commercialvalue? Fi