EU Policies and Regulatory Surroundings

Abstract

European Union plays an active role in the fight against antimicrobial resistance both in human and veterinary medicine. Intensity of activities supported by the legal provisions, soft law, political declarations and expressed commitments, regulatory requirements, growing body of scientific evidence as well as business policies and models has been increasing. European Commission and its decentralised agencies: European Medicine Agency, European Food Safety Authority and European Centre for Disease Prevention and Control cooperate closely in sake of “One Health concept”. Active roles play not only these EU public bodies and public bodies in the Member States, but also academia and actors in various areas of the private sector. New regulation on Veterinary Medicinal Products, together with previously approved “Animal Health Law” and regulation on Medicated Feed will to the large extent determine how veterinary medicinal products will be authorised, prescribed, used and controlled in the EU. The newly adopted rules include a number of positive elements with the potential to contribute to containment of antimicrobial resistance in the EU, but also contain a number of pitfalls, which can significantly curtail the positive potential of the new legal settings. The final outcome will depend on a number of additional measures and policies implemented both in the EU and at the global scene. From the perspective of policy documents three documents of high importance have to be mentioned. First one, most political—Council conclusions on the next steps under a One Health approach to combat antimicrobial resistance has been adopted in the mid of 2016 and, followed up by another one from Council conclusions from June 2019. Following the evaluation of the European Action Plan 2011–2016, new European Action Plan has been released in June 2017. Third document, Prudent Use Guideline has been adopted in 2015 and creates the platform highlighting the role of different stakeholders, what seems key for any effective action. Reports targeted on issues related to antimicrobial resistance and use of antimicrobials were released (JIACRA II, RONAFA). It should be noted that a load of everyday practical work rests on the shoulders of veterinarians and farmers that will be driven by the national strategies respecting the local conditions.