EFPIA对即将出台的《循环经济法案》的建议

Author:ECEGDate:29/10/25Version:Final Executive summary The European Federation of Pharmaceutical Industries and Associations (EFPIA) and its members support theEU’s ambition to advance a circular economy and share the objective of fostering sustainability whilesafeguarding public health and the resilience ofglobal supply chains. We are committed to innovation, To build an effective and forward-looking framework that meets the unique needs of the pharmaceuticalsector, we encourage authorities to promote a circular approach grounded in collaboration. By engaging earlywith industry, regulators, and other stakeholders, the circular economy framework can uphold patient safetyand support sustainability goals. Given the complexity of the healthcare sector—where thousands of highly We recommend the following key principles guide the Circular Economy Act from a healthcare lens:•Safety must be ensured: Certain materials cannot be easily substituted without creating a safety, efficacy or quality risk. Regulatory flexibility, from both environmental as well as pharmaceuticalperspective, is key to ensure circular economy principlescan be expanded within the pharmaceuticalsector without compromising on safety.•Plan for reality: Product and design changes take years. Transition periods must be appropriate tosafeguard the safety of our products for patients.•Coherence first: Avoid conflicting requirements across EU legislations. Align circularity rules withexisting pharmaceutical, MedTech and adjacent frameworks impacting the healthcare sector (e.g.packaging & packaging waste regulation, waste of electricaland electronic equipment directive).•One harmonised EU, not 27 versions: We need harmonised labelling, digital reporting and EPR depend on a regulatory system which adequately considers and accommodates the specificity of our sector.A well-structured Circular Economy Act can help us get there—supporting innovation, patient access andsustainability. Part 1: General Recommendations towards the upcoming Circular Economy Introduction We welcome the EU’s actions and policy plans to date in driving a fit-for-purpose regulatoryenvironment in support of the circular economy ambition. A range of regulatory frameworks require The pharmaceutical sector is proactively driving forward circularity and innovation during thedevelopment, manufacturing and supply of our pharmaceutical products. However, environmentalregulatory requirements often fail to consider the highly regulatednature and the complexities of We therefore urge the upcoming Circular Economy (CE) Act to ensure regulatory coherence, avoidduplication, and incentivize ongoing sustainability efforts and accommodate a range of varied sectors,including healthcare. Europe’s framework must foster an environment encouraging innovation and An effective CE Act must address overlapping frameworks, further incentivize the development ofsustainable products, and recognize the pharmaceutical sector’s actual and potential contributions tothe objectives of the circular economy. We encourage authorities across the themes of environment Key Opportunities and Concerns with Current Frameworks Driving Circular Economy in EuropeOpportunities •Setting the scene: The EU is pioneering the integration of circular economy principles intoindustrial trade policies, fostering sustainable practices. Through global partnerships, Europeis setting the scene towards international standards for sustainability and circularresource •Climate Action advancement: Minimization, increased re-use and recovery of materialsthrough recycling reduces the EU’s dependency on virgin resources, and directly contributingto Europe’s climate and emissions reduction goals. A strong secondary raw materials sector •Innovation and Economic Competitiveness: Horizontal legislation (Packaging & Packaging Waste Regulation2, Directive on Waste of Electrical and Electronic Equipment3, etc., and nowalso including the Circular Economy Act) can drive sustainable innovation in healthcare and actively support the reduction of waste across sectors, especially if they (i) accommodatesector-specific issues like adaptation timeline for regulated sector, (ii) engage industry acrossthe value chain to develop appropriate implementation guidelines and share best practices, •Digitalization toolshave the potential to enable transparent and efficient circular value chainsand foster economic modernization as well as support a coherent regulatory ecosystem. Welook forward to further collaboration in defining tools such as the Digital Product Passportapplication in the pharmaceutical sector. Challenges•Fragmentation and Complexity across the environment framework: From burdensome, non- harmonized/standardized reporting requirements to numerous PROs across or even withinMember States, conflicting definitions, and divergent national implementations create thereby hindering innovative strategies, often impacting international market a