Answer given by Mr Andriukaitis on behalf of the Commission
10.1.2016
The Commission is aware of the events mentioned by the Honourable Member. The Commission would like to underline the fact that there is no Community competence for the pricing and discounting of veterinary medicines.
Current EU rules on veterinary medicines[1] prohibit advertising to the general public of veterinary medicinal products that are available on veterinary prescription only. While these rules do not deal with antimicrobial resistance (AMR), the Commission adopted in 2014 a proposal for a revision of the legislation on veterinary medicines[2] with a comprehensive set of provisions to address the threat of AMR, in line with its AMR Action plan[3]. These include, among others, the requirement of a prescription for all antimicrobials and stricter rules as regards the advertising of prescription medicines, including antimicrobials. They also set out special restrictions for the retail of antimicrobials by veterinarians, to be allowed only for animals under their care and only in the amount required for the treatment concerned. The proposal is currently being discussed in the ordinary legislative procedure.
Moreover, the recently published Guidelines for the prudent use of antimicrobials in veterinary medicine[4] provide that ‘The pharmaceutical industry and wholesalers should limit their advertising to veterinarians to objective information, which is in line with approved Summary of Products Characteristics. The information provided should also highlight the risk of AMR and the need for prudent use. Promotional campaigns involving economic or material benefits for prescribers or suppliers of veterinary medicines should be avoided’.
- [1] http://ec.europa.eu/health/files/eudralex/vol-5/dir_2001_82/dir_2001_82_en.pdf
- [2] http://ec.europa.eu/transparency/regdoc/rep/1/2014/EN/1-2014-558-EN-F1-1-ANNEX-1.pdf
- [3] http://ec.europa.eu/dgs/health_food-safety/docs/communication_amr_2011_748_en.pdf
- [4] http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.C_.2015.299.01.0007.01.ENG