Commission Delegated Regulation (EU) 2021/578 of 29 January 2021 supplementing Regulation (EU) 2019/6 of the European Parliament and of the Council with regard to requirements for the collection of data on the volume of sales and on the use of antimicrobial medicinal products in animals (Text with EEA relevance)
Commission Delegated Regulation (EU) 2021/578of 29 January 2021supplementing Regulation (EU) 2019/6 of the European Parliament and of the Council with regard to requirements for the collection of data on the volume of sales and on the use of antimicrobial medicinal products in animals(Text with EEA relevance)THE EUROPEAN COMMISSION,Having regard to the Treaty on the Functioning of the European Union,Having regard to Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/ECOJ L 4, 7.1.2019, p. 43., and in particular Article 57(3) thereof,Whereas:(1)In order to develop targeted measures to fight antimicrobial resistance, it is paramount to determine possible risk factors to public and animal health. The identification of relevant trends in the volume of sales and use of antimicrobials in animals at national and Union level should in turn allow to identify such risk factors following the use of antimicrobials in animals. This should set the basis for establishing appropriate risk management priorities, defining targeted measures to fight antimicrobial resistance and monitoring their effect. In line with the approach of the European One Health Action Plan against Antimicrobial ResistanceCOM(2017) 339, those priorities and measures should facilitate an integrated analysis of the relevant trends in the volume of sales and use of antimicrobials in animals with trends regarding the consumption of antimicrobials in humans and with relevant data on antimicrobial resistant organisms found in animals, food, humans and the environment, when available.(2)Since the establishment of the European Surveillance of Veterinary Antimicrobial Consumption (ESVAC) projecthttps://www.ema.europa.eu/en/veterinary-regulatory/overview/antimicrobial-resistance/european-surveillance-veterinary-antimicrobial-consumption-esvac in 2010 by the European Medicines Agency ("the Agency") at the request of the Commission, data on the volume of sales of veterinary antimicrobial agents for use in animals have been collected and reported following a harmonised approach at European level. All Member States, as well as Norway, Iceland and Switzerland participated in that project. Participating countries have reported on a voluntary basis the national sales figures of veterinary medicinal products classified as antibiotics and antiprotozoals with antibiotic effect. The data collected and the analyses carried out constituted a solid reference for the adoption of national action plans against antimicrobial resistance or other measures to promote prudent and responsible use of antimicrobials.(3)Although existing systems for the collection of data on the volume of sales have already made an important contribution to the significant decrease of sales of antimicrobials for animal use across Europe from 2011 to 2018, as shown by the ESVAC project, additional data are necessary to better target risk management measures and to further increase their efficiency. Therefore, it is relevant to broaden the types of antimicrobial medicinal products for which data on the volume of sales are collected, develop data collection on the use of antimicrobial medicinal products per animal species and categories as well as set up appropriate national data collection systems on use.(4)The prioritisation of the types of antimicrobial medicinal products for which data on the volume of sales and on use is to be collected by Member States should be carried out taking into account the best available scientific evidence. Furthermore, in order to allow integrated analysis of data on antimicrobial use and resistance across public health and animal health sectors, another criterion to be taken into account is the availability of resistance data in animals and humans.(5)The criteria referred to in recital 4 should determine whether data on the volume of sales and on the use of antimicrobials should be collected on a mandatory or a voluntary basis. For example, as regards those antimicrobials used in major food-producing animal species at Union level, the data collection should be mandatory. On the other hand, as regards those antimicrobials for which no resistance data are available at Union level, data may be collected on a voluntary basis. Member States may therefore collect data on types of antimicrobials other than those designated for mandatory data collection in this Regulation. In such cases, only the data originating from antimicrobials designated in this Regulation as relevant for a voluntary data collection may be submitted to the Agency for analysis.(6)A valid and recognised classification system should be used to identify antimicrobials for which data should or may be collected. Such a system should allow for a general comparison of the use of medicines between the public health and animal health sectors. The World Health Organisation (WHO) Anatomical Therapeutic Chemical (ATC)WHO Collaborating Centre for Drug Statistics Methodology, Guidelines for ATC classification and DDD assignment 2020. Oslo, Norway, 2019; ISSN 1726-4898, ISBN 978-82-8406-046-0. and the Anatomical Therapeutic Chemical veterinary (ATCvet)WHO Collaborating Centre for Drug Statistics Methodology, Guidelines for ATCvet classification 2020. Oslo, 2020; ISSN 1020-9891, ISBN 978-82-8406-047-7. classification systems fulfil this objective. The codes of those WHO classification systems should be used with a view to identifying the antimicrobial medicinal products for data collection, regardless of the therapeutic indications associated to the codes.(7)In accordance with Article 57(3) of Regulation (EU) 2019/6, Member States and the Agency should put in place quality assurance measures to ensure the quality and comparability of the data collected and reported. In order to ensure that the appropriate data quality requirements are fulfilled at all stages of the data management workflow, Member States should set out a data quality management plan describing the main procedures for data quality management along the different steps of the workflow. The Agency should also develop a protocol and a template for data reporting, as well as develop a web interface that facilitates the timely electronic reporting by Member States of collated data on the volume of sales and on the use of the antimicrobials referred to in this Regulation. Where necessary, the Agency should provide assistance on data quality management to the Member States.(8)Since data sources and data providers for the collection of data on sales and on use per species may vary considerably between Member States, they should select sources and providers for that data, as appropriate, to ensure that they obtain full coverage data in the process. Furthermore, Member States should introduce necessary control measures to avoid double reporting.(9)Requirements for the collection of data on the volume of sales should take account of the fact that many veterinary antimicrobial medicinal products marketed are authorised for use in two or more animal species. Therefore, it is not possible to identify the amounts sold for each animal species for such antimicrobial medicinal products. In such cases, data on overall sales of veterinary antimicrobial medicinal products should represent sales for the corresponding animal population in the reporting Member State.(10)When reporting to the Agency on the data they have collected, Member States should also provide a brief description of their national policy framework to fight antimicrobial resistance, as well as an indication of initiatives led within the Member State and relevant specific factors which may explain the results observed at national level, including possible pattern changes and trends. This would support an adequate interpretation and comparison of data, by allowing a better understanding of the national context in which those data have been produced.(11)Member States should develop suitable national data collection systems to ensure full coverage and high quality data on use per animal species. Such systems should consist in semi- or fully-automated continuous data collection systems, which enable direct evaluation of use and which allow to review the consistency of the data and to ensure the validity of the data per animal species.(12)In order to ensure an appropriate understanding and interpretation of the data on the volume of sales and on use collected by the Member States, it is essential that the analyses of the data by the Agency consider the relevant animal populations per Member State.(13)Article 8(4) of Regulation (EU) 2019/6 provides for a derogation for marketing authorisations of veterinary medicinal products intended for equine animals declared as not being intended for slaughter for human consumption. However, available statistics on the living horse animal population cover all horses, whether being intended or not for slaughter for human consumption. Use of antimicrobial medicinal products authorised for horses declared as not being intended for slaughter for human consumption should therefore also be included in the collection of data on the use of antimicrobial medicinal products in horses.(14)This Regulation should apply from 28 January 2022 in accordance with Article 153(3) of Regulation (EU) 2019/6,HAS ADOPTED THIS REGULATION: