Availability of veterinary medicines in Ireland
Ireland is renowned for producing high-quality food and excelling in horse breeding. However, the veterinary medicines market in Ireland is minor compared to neighbour countries like the UK and France and lags significantly behind Germany and the Netherlands.
Marketing a veterinary medicine in Ireland hinges on two crucial factors:
- The size of the Irish market,
- The profit potential.
Even if a suitable product has been authorised in another EU country, it might not be available here, regardless of the country’s need for it.
Availability issues in veterinary medicines arise from a range of factors, each requiring customised solutions to address the specific problems. The veterinary medicine market differs notably from that of human medicines in several ways:
- Globally, the veterinary market is only 2-3% of that for human medicines. Unlike human medicines, which often receive financial support from the public purse, commercial interests solely drive the veterinary medicines market. Consequently, companies invest in developing new medicines only where there is a viable commercial return.
- Veterinary medicines cater to a wide variety of animal species with unique physiological traits and diseases, necessitating the development of customised drugs for effective treatment.
- Animal diseases tend to cluster in certain regions, leading to uneven demand for veterinary medicines. For example, fish medicines are relevant only to countries with coastlines, lakes, and rivers.
- Veterinary medicines must undergo an evaluation to ensure that drug residues do not pose risks for consumer safety, in addition to meeting the strict regulatory standards for medicinal products. Such studies are expensive to conduct.
- The market itself is highly fragmented, requiring diverse product formulations to accommodate different animal species, sizes, and specific needs.
To address availability challenges, EU legislation permits veterinarians, under certain conditions and on an exceptional basis, to use veterinary or human medicines off-label, or to import veterinary medicines from other countries, or to prepare medicines extemporaneously. The Department of Agriculture, Food, and the Marine (DAFM) regulates this process, known as ‘cascade use.’ DAFM had a protocol to import and use veterinary medicines. Additionally, DAFM has established a protocol to manage potential shortages of veterinary medicines. Furthermore, DAFM has designated a specific email address (email@example.com) to handle queries related to shortages.
At European level, the HPRA collaborates with the Heads of Medicines Agencies (HMA) to improve availability of veterinary medicines. The HPRA has also developed national initiatives to assist companies in obtaining marketing authorisation for veterinary medicines already marketed in other EU member states. However, Brexit presents an additional challenge to the availability of veterinary medicines in Ireland, as over 50% of the products on the Irish market share labelling with the UK, and maintaining this labelling arrangement remains demanding.
Shortages can contribute to availability challenges and may arise due to several reasons, including manufacturing issues, changes in regulatory requirements, unpredictable demand, economics, and specific national labelling requirements.
While the HPRA’s initiatives aim to safeguard medicine availability for the benefit of animal health and the public, the HPRA maintains objectivity, impartiality, and a robust evaluation process as State regulator. The HPRA adheres to EU standards and manages any real or perceived conflicts of interest transparently and in accordance with good governance practice during the evaluation and monitoring of veterinary medicines.