International initiatives to improve availability of veterinary medicines
Availability of veterinary medicines is not only a national issue, but also an international one. This is a long-standing challenge, which is being tackled in the new legislative proposals for veterinary medicines in the EU as well as global initiatives on the harmonisation of technical requirements for veterinary medicines.
The relatively small size of the market for veterinary medicinal products in Ireland compared to a number of other European countries poses a particular challenge to the animal health industry. This is the case for all veterinary species but is a particularly so in respect of the so-called minor species (e.g. horses, game, laboratory animals, exotic animals, bees and many fish species). This is a long-standing challenge which has been the subject of various European initiatives over recent decades, including:
In response to the needs of the animal health sector, the European Commission launched a proposal for a new legal framework for veterinary medicinal products in September 2014. The proposal aims to:
• Increase the availability of veterinary medicinal products;
• Reduce administrative burden;
• Stimulate competitiveness and innovation;
• Improve the functioning of the internal market; and
• Address the public health risk of antimicrobial resistance.
The elaboration of the legislation is being conducted under a co-decision process, involving the European Council and the European Parliament. In April 2015, the network of European Union Heads of Medicines Agencies (HMA) issued a consensual statement on the review, to highlight key concerns in the hope that amendments can be made to the proposal during the process of adoption. It is expected that the co-decision process will completed during 2016 and that any new legislation will come two years thereafter.
At an international level, a trilateral (EU-Japan-USA) programme aimed at harmonising technical requirements for applications for the authorisation of veterinary medicines in these regions is in operation since 1996. This is known as the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). The HPRA links to the VICH through our involvement in the European Medicines Agency and the HMA network.