欧洲生物技术法案公众问卷的EFPIA附件

The following questions underSection 3-Access to capitaldidnot load,hence EFPIA responsescan be found below: From an SME perspective, growth is closely linked to the US, with the availability of largeinvestment and cross over funds, and NASDAQ liquidities and valuation more efficient thanEuronext. In addition, the SME definition in Europe does not fully reflectthe complexity oftoday’s Life Science ecosystem. Introducing a “small mid-cap" category with relevant incentivesas used in different EU funding instruments would reflect industry reality and ensure thatinnovative mid-cap companies remain and grow in Europe. Q7. Is the EU a priority region under your investment strategy?Neutral Q7a.If you would like to indicate why, you can do so here.In EFPIA report on “factors affecting the location of biopharmaceutical investments”, key drivers are: presence of world-class appropriately funded innovation hubs; Enhancement ofend-to-end capabilities and funding of disruptive pharma innovation; Appropriate policies alongthe supply chain to attract ATMP investment; Support of innovation by implementing earlyaccess mechanisms, including RWE; Boost EU digital transformation; Adoption of sustainableprocurement and pricing policies for innovation; Development of collaborative method toattract biopharmaceutical investments. These elements are weak or missing in Europe. List of abbreviations used in the EFPIA response to the questionnaire is pasted below (point5) Input specific to the EU BioTech Act •Proposals for a Competitive, Best-In-Class EU Intellectual PropertyEnvironment–full paper pasted below (1)•One vision on the regulatory ecosystem•Key recommendations from the comparative analysis of biopharmaceuticalstrategies in 10 countries–pasted below (2)•CIRS RD Briefing 101–New drug approvals by six major authorities 2015-2024•EFPIA THEMATIC ANALYSIS ON CUMULATIVE LEGISLATIVE IMPACTShttps://www.efpia.eu/media/i0ihfkys/efpia-cumulative-legislative-impacts.pdf•PaediatricRegulatory Simplification Proposals–full paper pasted below (4) Input specific to Strengthening the Manufacturing Base •EFPIA paper on location of manufacturing–pasted below(3)•Delivering treatments to patients: The medicines manufacturing journey Input specific to Clinical Trials in Europe •Improving EU Clinical Trials: Proposals to Overcome Current Challenges andStrengthen the Ecosystemhttps://www.efpia.eu/media/pl0nag0s/efpias-list-of-proposals-clinical-trials-15-apr-2025.pdf•Assessing the clinical trial ecosystem in Europehttps://efpia.eu/media/3edpooqp/assessing-the-clinical-trial-ecosystem-in-europe.pdf•EFPIA Vision for 2030+•EFPIA Press Release-60,000 fewer clinical trial places for Europeans, despiteglobal surge in research projects•Unlocking cross-border clinical trials for patients in Europe•Tracking Availability in China of Medicines Approved in Six Key GlobalMarkets Input specific to the needs of start-up and scale-up that are different from other sectors •An Agenda for Action: Expanding Funding Options for Small and Medium-Sized Pharma companies in Europe Input specific to data and digital (AI): •EFPIA position on the use of artificial intelligence in the medicinal productlifecycle•EFPIA position on the Regulation on the European Health Data Space (EHDS) Input specific to the industry’s economic footprint, research pipeline•Economic footprint of the pharmaceutical industry in Europe https://efpia.eu/media/3dqjpl3x/economic-footprint-of-the-pharmaceutical-industry-in-europe-report.pdf•2024 Pipeline Review–Innovation for Unmet Need Input specific to market conditions for innovation:•https://www.efpia.eu/news-events/the-efpia-view/statements-press- releases/guidance-needed-to-ensure-eu-joint-clinical-assessment-improves-patient-access-to-innovative-cancer-treatments/•https://www.efpia.eu/media/qrjah2ij/efpia-evidera-research-on-eunethta21-methods.pdf Input related to industry investment in greening and waste reductionEFPIA White Paper on Circular Economy •https://www.efpia.eu/media/554663/circular-economy.pdf•https://www.efpia.eu/more-than-medicine/responsible-innovation/•EFPIA White Paper on Climate Changehttps://www.efpia.eu/media/554662/white-paper-climate-change.pdf•EFPIA submission to the Environment omnibus Have your say:https://ec.europa.eu/info/law/better-regulation/info/law/better-regulation/have-your-say/initiatives/14794-Simplification-of-administrative-burdens-in-environmental-legislation-/F3693516_en•EFPIA submission to the Circular Economy Act Have your sayhttps://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/14812-Circular-Economy-Act/F33113219_en•https://pharmeco.eu/•https://imi-premier.eu/•https://enkoreecohealthcare.eu/•IHI PFAS open call Input related to FP10 •EFPIA preliminary response to the European Commission MultiannualFinancial Framework package•EFPIA recommendations for Framework Programme 10 1.Proposals for a Competitive, Best-In-Class EU Intellectual Property Environment The Sta