The famous Royal Decree 666/2023 which regulates the distribution, prescription and dispensing and use of veterinary medicines has kept the sector agitated since its implementation. The discontent is such that the Government, as Demócrata advanced, has taken the first steps to rectify it due to pressure from practitioners. With this scenario as a backdrop, Esquerra Republicana de Catalunya (ERC) agreed with the PSOE to create a subcommittee for a comprehensive review. The appearances have already started and have done so with a controversy that pits the pharmaceutical industry against the veterinary profession.
On March 25, the president of the General Council of Pharmaceutical Colleges, Jesús Aguilar Santamaría, appeared before the subcommission relative to the study of the situation of the veterinary sector in Spain, who accused veterinarians of prescribing mainly three antibiotics of category D due to alleged economic interests.
Aguilar Santamaría stated that “70% of antibiotic prescriptions used in companion animals are concentrated in only three active ingredients out of the 33 available: amoxicillin, metronidazole, and doxycycline”. “Are we aware of the risk of generating antimicrobial resistance and the serious impact on global health and the health of our companion animals?”, he questioned.
“When such a limited number of antimicrobials is used massively due to possibly economic and not clinical criteria, not only is the current legal framework violated, but public health is compromised and the emergence of resistances is favored,” asserted.
What is true?
Their harsh accusations did not fall on deaf ears. From VetWarriors (Cross-cutting and state veterinarians' association), one of the organizations that has most pressured the Executive to reform RD 666, they regretted the accusations and argue that they are merely adhering to the strict compliance with current regulations.
In the association's opinion, the president of the General Council of Pharmaceutical Associations "presented himself with a set of arguments full of serious accusations against veterinarians that had no basis." In statements to Demócrata, VetWarriors assures that "it left those familiar with the subject and the situation perplexed and speechless."
"He accused us of preferentially using three specific types of antibiotics, alleging our economic gain, when in reality they are the three that the law obliges us to choose as a first option and which, precisely, are very economical and accessible," they explain, "all within the framework of RD 666 and the Guarantees Law of 2015. Consequently, "he demonstrated a supreme ignorance in the field of veterinary medicine."
After what happened, VetWarriors has requested the Collegiate Veterinary Organization to demand explanations and a public rectification from the General Council of Pharmaceutical Colleges. As of today, the College of Veterinarians of Barcelona has been the only one of its kind that has requested it.
A reform underway
By the end of January, the Minister of Agriculture, Fisheries and Food put out for Public Hearing a draft Royal Decree that modifies the controversial RD 666. The initiative proposes relevant changes in some of the most conflictive points and that practitioners urged to change with the purpose of maintaining the balance between a prudent use of veterinary medicines within the framework of the fight against antimicrobial resistance and preserving their clinical judgment.
The draft proposes a new wording for the transfer of medicines, clarifies the prescription and use of antibiotics, and reduces the administrative burdens derived from the database Central Computer System for the Control of Veterinary Antibiotic Prescriptions (PRESVET).
It expressly clarifies that medication may be delivered to the owner or person responsible for the animal non-profit when necessary to guarantee the continuity of treatment and there are difficulties in access. In the case of companion animals, the transfer is also enabled to complete already initiated treatments, always within the limits set by the norm and excluding those medications whose administration is exclusively veterinary. This modification responds to one of the main claims of the sector, which warned of situations in which the regulations prevented solving immediate clinical problems.
If approved, it would allow the veterinarian to adapt the treatment when unforeseen clinical circumstances arise, based on their professional judgment and animal welfare. At the same time, the obligation to report cases of therapeutic ineffectiveness to the pharmacovigilance system within a maximum period of fifteen days is reinforced, incorporating this communication as a structural part of health control.
In the case of chronic treatments, a single prescription can cover up to six months; and authorizes, with conditions, the use of leftover medicines on the same livestock farm, except in the case of medicated feed for production animals.
Similarly, the proposal simplifies the communication of prescriptions and establishes a minimum monthly periodicity for the sending of information, both in ordinary and exceptional prescriptions. This adjustment seeks to alleviate one of the most recurrent criticisms from the sector, which denounced an excessively rigid reporting system and poorly adapted to daily practice.