Veterinary centres in Andalusia may have a stock of medicinal products for human use

Background

This judgment derives from a previous judgment set down by the High Court of Justice of Andalusia (TSJA) on 29 September 2014, resulting from an appeal filed by the Association for Animal Health against a range of provisions in Decree 79/2011, which established rules on the distribution, prescription, dispensation and use of medicinal products for veterinary use and created the register of Veterinary Medicinal Product Establishments of Andalusia.

The TSJA judgment annulled, amongst others, the provisions of the decree that made it possible for veterinary clinics and pet animal establishments to request authorisation to have a special stock of medicinal products for human use for use on animals in their veterinary medical supplies. The Andalusian court ruled that said provisions infringed the state regulations, which establish that pharmacy services and outlets are responsible for the custody and dispensation of medicinal products for human use. In turn, the Regional Government of Andalusia, which considered that said judgment was in violation of the law, appealed before the Supreme Court.

Conclusions of the Supreme Court

The Supreme Court started its analysis with a reminder that the Spanish legal system allows veterinarians to purchase the medicinal products required to perform their professional activities, which will be supplied by pharmacies and retail establishments. On the other hand, said healthcare professionals are also allowed to employ “the prescribing cascade”, in other words, the one-off prescription of medicinal products for human use to certain animals when no appropriate veterinary medicinal product is available.

The Andalusian Decree, in turn, regulates the so-called “veterinary medical supplies”, as part of which veterinarians store medicinal products supplied by pharmacies and retail establishments for their administration to animals they attend in their veterinary establishments. The Court asserted that the legality of the stocks in question must be analysed according to the logic of veterinary medical supplies and the capacity of veterinary professionals to prescribe medicinal products for human use on an exceptional basis. As a result, the Supreme Court concluded that the regulation on special stocks of medicinal products for human use in veterinary establishments wholly complies with the basic State regulations, as it provides for the use of these medicines as part of veterinary practice pursuant to the aforementioned state regulations and does not address their commercial dispensation, which remains reserved to pharmacy outlets, services and retail establishments. The Supreme Court therefore annulled the TSJA judgment on this matter and ruled that the provisions of Decree 79/2011 regulating these special deposits were legal.