Document type : Written answer from the European Commission
Authors: Question: Eleonora Evi (Greens/EFA). Answer: Ms Kyriakides on behalf of the European Commission
Question:
The decree of the Italian Minister for Health of 14 April 2021, published in the Official Gazette of the Italian Republic No 120 of 21 May 2021, defines the cases in which a veterinarian may prescribe an equivalent human-use medicine for the treatment of an animal, provided that it has the same active ingredient.
Regulation (EU) 2019/6 was adopted to ensure a high level of protection of animal health and welfare; indeed, it states that "the regulatory framework for veterinary medicinal products should be adapted (...) while continuing to ensure a high level of protection of animal health and welfare and the environment" .
Article 106(3) of that Regulation gives Member States discretionary power as to the implementation of these procedures, taking into account social and economic variables.
As the wording of the regulation indicates, the exercise of the derogation power can only be done "in the interest of animal health or animal welfare". This limit becomes the basis for permitting the use of equivalent medicines to treat an animal that would otherwise suffer or die unnecessarily for reasons that may also be economic and social.
In the light of the above, will the Commission propose supplementing EU legislation in order to extend the positive effects of this Italian decree with a view to protecting animal health and welfare?
Answer: Articles 112 to 114 of Regulation (EU) 2019/6 regulate the use of veterinary medicinal products outside the terms of a marketing authorisation in non-food producing, as well as in food-producing terrestrial and aquatic animal species. To note that medicinal products for human use become an option only where there are no suitable veterinary medicinal products to treat the condition authorised in the relevant Member State or in another Member State.
Article 106(3) allows Member States to lay down procedures they deem necessary for the implementation of the above provisions on the use outside the terms of a marketing authorisation. However, this provision should not be interpreted as allowing for any derogations to the substantive rules in Articles 112 to 114, nor for changing the order of the options available.
The Commission does not intend to take further action to propose any amendment to Regulation (EU) 2019/6 as it considers that its provisions cover the protection of animal health and welfare in an adequate manner.
