EFPIA对《欧洲生物技术法》公众问卷的回应

Fields marked with * are mandatory. Introduction The European Biotech Act Biotechnology and biomanufacturing hold great promise for advancing competitiveness and innovation withinthe European Union (EU). As previously acknowledged in the Communication on Biotechnology and(March 2024) and the reports by(April 2024) and(SeptemberBiomanufacturingEnrico LettaMario Draghi2024), it is necessary to address the challenges faced by European companies, users and consumers, and allstakeholders involved to boost the technological advancement, competitiveness and economic growth of theEU. To this end, the Commission has announced in thea new European Biotech2024-2029 political guidelinesAct, aimed at creating an enabling environment to make it easier to bring biotech products from the laboratoryto the factory and then onto the market, while maintaining the highest safety standards for the protection of thepopulation and the environment. EU policy initiatives relevant for this sector are for example the Strategy for European Life Sciences, theCompetitiveness Compass, new, the AI in science Strategy, the Vision forEU Bioeconomy StrategyAgriculture and Food, the, the, theEuropean Innovation ActEU Start-Up and Scale-up StrategyUnion of Skillsand the. Some of these are currently still under development and the EuropeanSavings and Investment UnionBiotech Act will be defined in synergies with them. The public consultation The European Commission is launching aon the European Biotech Act in the form of anpublic consultationonline questionnaire. The aim is to gather evidence and views from stakeholders across all relevant sectors ofbiotechnology and biomanufacturing, including the medical and pharmaceutical, agricultural, food and feed,industrial, environmental and marine sectors. Your feedback is crucial for identifying the most importantchallenges and barriers that could be addressed by the Act and for shaping targeted policy actions. Instructions The first section of the questionnaire contains questions about you or the organisation you represent, which isthen followed by questions on the regulatory and non-regulatory environment in the EU to inform the policy- making process of the European Biotech Act. Whenever possible, please substantiate your replies with data and sources of information or practicalexamples. This questionnaire is available in all EU official languages and you can reply in any EU official language. Youcan pause at any time and continue later. You can download your contribution once you have submitted youranswers. About you Language of my contribution* BulgarianCroatianCzechDanishDutchEnglishEstonianFinnishFrenchGermanGreekHungarianIrishItalianLatvianLithuanianMaltesePolishPortugueseRomanianSlovakSlovenian SpanishSwedish I am giving my contribution as* Academic/research institutionBusiness associationCompany/businessConsumer organisationEU citizenEnvironmental organisationNon-EU citizenNon-governmental organisation (NGO)Public authorityTrade unionOther You have identified yourself as a business association or a company/business.Please indicate whether you belong to one of the following areas: Company conducting research and/or development in biotechnology and/orbiomanufacturingCompany supplying materials or equipment to the biotechnology manufacturingsector (e.g. strains, bioreactors)Biotechnology manufacturerBiotechnology distributor or retailerOther Do you identify yourself as a private investor (e.g. venture capitalist, business angel)? YesNoI don't know/I'd rather not say Are you or the organisation you represent part of aor of aclustercluster?organisation 'are groups of firms, related economic actors, and institutions located nearClusterseach other and with sufficient scale to develop specialised expertise, services,resources, suppliers and skills.' []link to definition of clusters 'are the legal entities that support the strengthening ofCluster organisationscollaboration, networking and learning in innovation clusters and act as innovationsupport providers by providing or channelling specialised and customised businesssupport services to stimulate innovation activities, especially in SMEs. They areusually the actors that facilitate strategic partnering across clusters.' [link to ]definition of cluster organisations YesNoI don't know/Not applicable This questionnaire coversPlease indicate theall areas of biotechnologies.sectorthat are relevant to you or the organisation you represent, or which you have mostsknowledge on.* You can select multiple sectors. Please note that your answers to the questionnaire will be analysed inrelation to the sector(s) you have selected. Medical/pharmaceuticalAgriculturalFood/feedIndustrialEnvironmentalMarineBioinformaticsBiotechnology for defence and security Other areas of biotechnology Not applicable If a different sector of biotechnology is relevant to you or the organisation yourepresent, please specify. First name* Surname* Tyszk