信息图：环境、食品和动物立法对制药行业的累积立法影响：呼吁一致性

EFPIA members are committed to sustainability: However overlapping regulations... We support the EU’s climate and environmental goalsWe lead initiatives to minimise the impact of medicinesand operations on the environment, including throughthe Innovative Health Initiative (IHI)1,2,3 Delay patient access to medicinesSlow down innovationUndermine long-term sustainabilityHarm Europe’s competitiveness We must act now to ensure that environmental ambition and healthcare resiliencego together hand in hand–not head-to-head. The Legislative Labyrinth TheClean Industrial Deal, launched in February2025, reflects a broader EU ambition to enhancecompetitiveness while decarbonising the economy. TheEU Green Deal, chemical strategy,and circular economy initiatives have triggereda wave of overlapping legislation impacting pharma. Environmental &Data Compliance Innovation &Competitiveness RegulatoryComplexity Patient Access Shortages, productwithdrawals, and higherprices due toreformulationsandExtended ProducerResponsibility (EPR) fees.Over600 essentialmedicinesthreatenedby PFAS restrictions.60-70% of oralmedications at riskiftitanium dioxide is banned. Regulatory instability andtight timelines are redirectingR&Daway from Europe.Stringent EU Taxonomy rulesmaymisrepresent pharma’ssustainability progress,deterring green investment.Putting the cost of treatingurban wastewater solely onthe pharmaceutical andcosmetics industries willfailto incentivise other sectorsto reduce micropollutantsin the water. Newreporting obligationsrisk exposing commerciallysensitive data.Unclear rules onIP, clinicaltrials, and reformulateddrugsadd further businessuncertainty.Complex regulations meanthat new sustainableinnovative manufacturingis veryhard to implement. Conflicting rulesbetween EU agenciesand with global standards.Legal uncertainty andmisalignment across newchemical, water, andpackaging legislation.Legislative requirementsmust align with theanimaltestingphaseout roadmapto avoid contradictoryobligations that couldundermine progress ofnon-animal methods. Let’s ensure policy coherence across legislations to secure resilient development,manufacturing and supply chains of innovative medicines in Europe. Our recommendations– Building a legislative framework that worksfor the patients, the planet and the industry 1 3 Align &Coordinate:Create Flexible ContinuousImpact Assessment: Better Regulation:Ensurelegislation respectscompetitiveness,health security, andavoids duplication. an EU Office for LifeSciences to monitorand drive coherenceacross green,chemical, and pharmapolicy. Timelines:Adjustimplementationschedules as scientificevidence andfeasibility evolve. Evaluate cumulative effects of new lawsand ensure broadstakeholderengagement beforefinalising. 7 EarlyEngagement: Protect Clear Science- Based Green DealTransition:Develop a Patient Access:Allowtargeted exemptionsfor medicinal productsin non-pharmalegislation followingan evidence andrisk-based approach. Guidance:Issuetimely and transparentimplementationdocuments–developedwith industry input. Consult EMA early resilient supply chainplan that balancesenvironmental goalswith innovationcapacity and industrialcompetitiveness. in legislation thatimpacts medicinesand supportregulatory sandboxes. 10 Enable &IncentiviseInnovation:Recognise the unique EngageBroadly:Work with industry, patients,academia, andsuppliers to findalternative sustainablesolutions and managerisks. needs of advancedtherapies and secureEurope’s leadership inbiomedical innovation. https://efpia.eu/about-medicines/development-of-medicines/regulations-safety-supply/environment-health-safety-sustainability/circular-economy/https://efpia.eu/about-medicines/development-of-medicines/regulations-safety-supply/environment-health-safety-sustainability/climate-changehttps://efpia.eu/about-medicines/development-of-medicines/regulations-safety-supply/environment-health-safety-sustainability/water-pharmaceuticals-in-the-environment/123 Read thefull impactreport ›