NOAH has written an open letter to the Competition & Markets Authority as part of its ongoing inquiry on veterinary services for household pets advocating for the veterinary prescribing cascade, a vital regulatory tool which balances access, safety and responsible medicine use.
In its letter, NOAH said: “We welcome the CMA’s inquiry into the companion animal veterinary sector and its focus on transparency and affordability for consumers. We feel compelled to respond to the recent open letter to the inquiry which includes a number of inaccuracies and draws conclusions that are based on a misrepresentation of the veterinary medicines sector.
“In evaluating the costs associated with veterinary medicines, it is critical to protect the integrity of the prescribing cascade, which underpins safe and effective animal healthcare in the UK. The prescribing cascade is not a barrier to affordability; it is a clinically essential framework that allows veterinary professionals to use their expert judgement when no licensed veterinary medicine is available. It ensures that animal welfare remains the primary consideration while maintaining a robust balance between access, safety, and responsible medicine use.”
The letter continued: “Proposals that suggest a wider or default use of human medicines, or unauthorised extemporaneous preparations, on cost grounds overlook serious clinical and regulatory concerns:
- Human medicines are not tested for animal use. They are not tested for absorption, metabolism, efficacy or safety in animals which raises significant risks: they may not work at all, or worse, have adverse effects. This undermines the principle of evidence-based care and risks harm to animals.
- There is no pharmacovigilance system in place for human medicines when used in animals. That means adverse events, following the use of human medicines in animals, are not reported or monitored, leaving both practitioners and regulators blind to potential harm.
- The cascade already provides flexibility. It allows the use of unlicensed products, including human medicines, when clinically justified where authorised veterinary medicinal products are not available or suitable, but within a system that maintains accountability and oversight.
- Long-term innovation in animal health. Maintaining a strong framework for licensed veterinary medicines is essential for long-term innovation in animal health. If the market moves towards a model that allows cost-driven substitution with human medicines, it will reduce the incentive for companies to invest in developing treatments tailored to animals, ultimately harming both competition and welfare. If animal health companies are to be encouraged to develop licensed veterinary medicines, there needs to be assurance that such products will be used ahead of unauthorised products like human medicines and extemporaneous preparations. The article referenced in the open letter to your inquiry, published byVetSurgeon.org, notes that over the past three years the EMA has approved veterinary products containing ‘only’ 14 new active ingredients. Given that the veterinary pharmaceutical industry is only around 3% of the size of its human equivalent, it’s important to note that over the same time period, the EMA approved products containing 126 new active ingredients for human use, meaning that the veterinary medicines industry’s approved new actives were 11% of its human equivalent, showing that it is in fact innovating in an outsize way. It also must be stated that veterinary medicines are also authorised through national competent authorities, meaning authorisation via the EMA centralised procedure, is not the only way in which companies obtain authorisations.
- International context matters. While the article referenced in the submission to the inquiry notes that there is no formal prescribing cascade in the United States, it is important to clarify that the US Food and Drug Administration only permits the extra-label use of human medicines in animals when there is a clinical advantage, i.e. where there is no approved new animal drug that is labelled for such use and that contains the same active ingredient in the dosage form and concentration that is required. The regulatory standard is consistent: clinical necessity must drive decision-making.
- The human medicine industry does not, and will not, provide technical support on correct use of products, provide educational and CPD events relating to their products’ use in animals, and will not participate in an active role in engaging with and supporting the veterinary community in the UK. In contrast, the animal health industry has a long, proven track record in engaging with the veterinary community and supporting their efforts for the betterment of animal health and welfare.
NOAH concluded: “We fully support efforts to improve price transparency, client communication, and access to care. But this must not come at the cost of weakening the clinical frameworks that protect patients and preserve public trust in the veterinary profession. The cascade is a vital part of the solution.”
