Veterinary Medicines Discontinuation in Northern Ireland Threatens Health
The discontinuation of insulin will prevent the effective management of diabetes, leading to cataracts, blindness, kidney failure and even death in some cases.
As a result of the Northern Ireland Protocol, 51% of veterinary medicines are expected to be discontinued in Northern Ireland at the end of 2025, posing considerable risks to animal and human health and welfare.
Unless a permanent solution is found, the Veterinary Medicines Directorate (VMD) estimates that around 1700 veterinary medicines will be discontinued. Of particular concern is the loss of preventative veterinary medicines such as vaccines, which will have a detrimental impact on animal health and welfare, and increase the usage of antibiotics, at a time when the veterinary profession is making good progress to reduce antibiotic usage in production animals.
Some of the most concerning discontinuations include: in cattle, the only licenced salmonella vaccine and both leptospirosis vaccines, which will have major animal and human health implications, and one BVD vaccine, which will negatively impact the BVD control strategy in Northern Ireland; in sheep, the toxoplasma vaccine and an enzootic abortion vaccine, which will have severe implications for flock health and farm profitability; in horses, the flu and tetanus vaccine, which will lead to an increased number of horses contracting tetanus, an invariably fatal disease; Insulin will also be discontinued, preventing the management of diabetes, which if not controlled can lead to cataracts, blindness, urinary tract infections, kidney failure, ketoacidosis and even death.
The British Veterinary Association has been involved in discussions with the UK Government, the EU, the Federation of Veterinarians of Europe (FVE), the pharmaceutical industry and a range of other stakeholders, to try and find a resolution to this important issue. As such, we welcomed the three-year extension to the grace period which was announced in December 2022. However, while this extension has been helpful, it is essential that a permanent solution is now found.
Given the importance and urgency of this situation, we urge the UK Government and European Commission to put this high up the priority working list
At the end of the grace period, EU rules on the supply of veterinary medicines will apply in Northern Ireland, meaning that medicines supplied to Northern Ireland from Great Britain, including those originating from the EU, would need to be re-batch tested and re-released by a qualified person in NI or the EU, even if originally batch tested in the EU. There will also be a requirement for Marketing Authorisation Holders (MAH) and Pharmacovigilance Qualified Persons to be based in the EU or NI (and not GB). Finally, certain vaccines imported from outside the EU and used in exceptional circumstances by veterinary surgeons would no longer be available under the VMD’s Special Import Scheme.
Due to the relatively small veterinary market in Northern Ireland, the pharmaceutical industry has stated that the required investment to implement these changes will not be economically viable, inevitably leading to the discontinuation of these vital veterinary medicines. While it would be possible to write Special Import Certificates to import veterinary medicines from other EU countries, this would put additional bureaucratic pressure on a veterinary workforce that is already under pressure and stretched.
Northern Ireland vets cannot continue to work to a high standard for animal welfare and to protect human health if over half of all veterinary medicines are discontinued. Losing access to these veterinary medicines will also have serious implications for the Northern Ireland economy, which is heavily dependent on agriculture. However, this pressing issue could be resolved with a solution such as the introduction of a ‘grandfather rule’, allowing for the continued supply of veterinary medicines that were aligned with EU regulations pre-Brexit, with only newly licensed products required to adhere fully with EU rules.
Given the importance and urgency of this situation, we urge the UK Government and European Commission to put this high up the priority working list and work together to find a sustainable long-term solution which safeguards the future supply of veterinary medicines in Northern Ireland.
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