Q: MEP Silvia Sardone  (ID, IT)- Treatment of illnesses in pets – new provision in Italy (2021-02-11)

With Law No 178 of 30 December 2020, Italy has become the only EU country to have introduced a provision (Article 10-a, Legislative Decree 193/2006) permitting medicines for human use to be administered to animals, instead of veterinary ones, on the basis of the criterion of lowest cost.

The reference legislation (Directive 2001/82/EC, Directive 2004/28/EC) provides that animals may only be treated with veterinary medicines, the sole exception being where no suitable veterinary medicine exists, in which case medicines authorised for human use may be administered to animals.

The reason for the sole use provision is that veterinary medicines are species-specific, hence produced for the individual animal species for which they are intended. The dosage forms are manufactured specifically for each individual species/body size, in accordance with stringent obligations and prohibitions, and tested for efficacy and safety, as well as their environmental impact.

In light of the above, and with a view also to the forthcoming entry into force of Regulation (EU) 2019/6, what action will the Commission take to avert risks to the well‑being and health of animals, and to ensure that this new provision in Italy’s legislation does not render the medicinal-products track and trace system, the pharmacovigilance system and the collection of data on antibiotics used in the veterinary field any less efficient, or cause any serious harm to work on tackling antibiotic resistance?

A: Ms Kyriakides on behalf of the European Commission

Article 10(1)(b)(i) of Directive 2001/82/EC on the Community Code relating to veterinary medicinal products[1] provides, by way of exception, that a medicinal product authorised for human use may be used to treat a non-food-producing animal, if there is no authorised veterinary medicinal product available to treat the condition. From 28 January 2022, Regulation (EU) 2019/6 on veterinary medicinal products[2] will enter into application and replace Directive 2001/82/EC. Article 112(1)(b) of Regulation (EU) 2019/6 contains a similar provision to the Directive. It states that where there is no authorised veterinary medicinal product available for an indication concerning a non-food-producing animal, the veterinarian may exceptionally treat the animal concerned with a medicinal product authorised for human use.

In both of the above cases, the only justification that allows a veterinarian prescribing a medicinal product authorised for human use is the lack of availability of a suitable veterinary medicinal product. Therefore, the cost of a veterinary medicinal product would not be an acceptable justification.

The Commission was not aware of Law No. 178 of 30 December 2020 referred to by the Honourable Member and intends to clarify the matter further with the Italian competent authorities.

[1] OJ L 311, 28.11.2001, p. 1.

[2] OJ L 4, 7.1.2019, p. 43.