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Parliamentary questions
4 May 2017
Answer given by Mr Andriukaitis on behalf of the Commission

In the light of the growing challenge of antimicrobial resistance (AMR), the Commission is actively encouraging the development of alternatives to antibiotics.

The Commission is aware of the potential merits of bacteriophage therapy. However, studies in livestock have not always been positive. Lately, the EU funded project Camcon(1) did not show consistent reduction of Campylobacter in broiler chicken. The Commission is currently funding the PHAGOBURN project that aims to evaluate the efficacy and safety of phage therapy to treat bacterial infections of burn wounds in a clinical trial. The clinical trial is now running, and results will be available within the coming months. For all latest results, the project website can be consulted(2).

It should be emphasised that a veterinary medicine cannot be authorised before its safety and efficacy have been appropriately demonstrated. This is not currently the case for bacteriophage therapies, for which very few randomised controlled clinical trials have been conducted to date. Therefore, more robust evidence on bacteriophage treatments and further discussion of the scientific aspects are needed.

In its Proposal for a regulation on veterinary medicinal products(3), as adopted in 2014, the Commission has not included any specific provisions for the authorisation or use of bacteriophages as veterinary medicines.

Nonetheless, the Commission could, based on an actual application dossier, analyse if a specific product would fall under the scope of Regulation (EC) No 1831/2003 on additives for use in animal nutrition(4).

(3)COM(2014) 558 final.
(4)Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition, OJ L 268, 18.10.2003, p. 29‐43.

Last updated: 16 May 2017Legal notice