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Europe, medicines and AMR

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FOR the next three months, attention in the UK is likely to remain fixed on the in or out referendum but, despite this, the day-to-day legislative business of the EU cannot be ignored. This is certainly true of new EU legislation on veterinary medicines. No one seems to have given much thought to what might happen to all the UK legislation based on European rules if, as a result of the referendum, the country decides to leave the EU. However, given the length of the legislative process, and with politicians likely to be preoccupied with much weightier matters if the UK opts to leave, European rules on veterinary medicines, as on much else, are likely to remain relevant to the UK well into the future, whatever the referendum's outcome.

The process of overhauling the legislation on medicines has been grinding on for several years now, and, in 2014, the European Commission adopted proposals on both veterinary medicines and medicated feed (VR, September 20, 2014, vol 175, p 262). According to the Commission, the aim is to make more medicines available to treat and prevent diseases in animals, tackle antimicrobial resistance and foster innovation. It would be hard to disagree with those aims. However, as always, much will depend on the detail of the legislation, and this has still to be finalised and agreed. In the latest development, the Environment and Public Health Committee of the European Parliament has adopted a number of amendments, which will be put to the European Parliament in the next month or so. As reported on pp 201-202 of this issue, some of the proposed amendments pay particular attention to the issue of antimicrobial resistance.

The committee argues that the Commission should be more ambitious in its proposals on resistance and has suggested a number of amendments to that effect. For example, it advocates banning collective and preventive antibiotic treatment of animals and makes clear that antibiotics should not be used to improve performance and compensate for poor husbandry in any circumstances. Calling for clearer definitions of therapeutic, prophylactic and metaphylactic treatment, it says that prophylactic use should be limited to single animals and only when fully justified by a veterinarian, and that metaphylactic use should be restricted to clinically ill animals and to single animals that are identified as being at high risk of contamination.

Similarly, the committee backs European Commission plans to draw up a list of critical antibiotics that would be reserved for use in human medicine but notes that this needs to be based on solid scientific criteria. At the same time, it suggests that this should be a list of ‘antimicrobial substances or groups of substances’, rather than of ‘antimicrobial medicinal products’ as originally proposed by the Commission.

The proposals regarding metaphylactic treatment could prove problematic in practice, not least because, from an animal health point of view, there are circumstances in which prevention is better than cure. They might also prove counterproductive because, as David Burch argues in a letter on p 218 of this issue, there are situations where treating animals later rather than sooner could result in more antimicrobials being used, to less effect. Meanwhile, regarding the proposed reserved list, the Federation of Veterinarians of Europe (FVE) has expressed concern about the consequences of certain antimicrobials being banned from veterinary use. While the FVE agrees with the committee's wish to introduce conditions on the use of some important antibiotics, it fears a complete ban could lead to serious animal health and welfare issues. It will be some time yet before the text of the legislation is finally agreed but, when it is, it will be important to ensure that animal health and welfare is not put at risk as a result.

It could be argued that all this might not matter if the UK decides to leave the EU, but regulation is likely in some shape or form, whether it stays in or not. Antimicrobial resistance is not just of concern in Europe; it is very much a global issue, as recognised, for example, by a global action plan agreed by the World Health Organization last May (VR, May 30, 2015, vol 176, p 556). In the UK itself, an antimicrobial resistance strategy produced jointly by the Department and Health and Defra has been in place since 2013, emphasising the importance of a One Health approach (VR, January 17, 2015, vol 176, p 56). The relative contribution to resistance of the use of antibiotics in people and animals continues to be debated but, in November last year, a report produced by the O'Neill Commission in the UK took a tough line on the use of antimicrobials in animals (VR, December 12, 2015, vol 177, p 580). Against this backdrop, and as momentum continues to grow around resistance, regulation in the UK can be expected to mirror that being developed by the EU, even if it decides to go independent. The danger is that, amid all the palaver about the referendum, the new legislation may not get the attention it deserves from the UK at a critical stage of its development.

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