Oireachtas Joint and Select Committees

Tuesday, 11 October 2022

Joint Oireachtas Committee on Agriculture, Food and the Marine

General Scheme of the Veterinary Medicinal Products, Medicated Feed and Fertilisers Regulation Bill 2022: Discussion (Resumed)

Dr. Paul Corkery:

I will deal with objective No. 5. Objective No. 5 is about the availability of product. Previously, each member state would have had its own authorising agency, such as the Health Products Regulatory Authority, and its own number of products that each market would have. This new regulation has brought in access to products in other markets in certain circumstances. The first thing it has done is to make sure the prescription issued by a vet is valid throughout the community. This is one way in which the availability has been increased. That prescription can be used throughout the community but one must use the products that are, in the main, authorised in the member states. There are circumstances where those products are not available and there are some that are specifically for exotic animals and equines.

Ireland is such a small market within the veterinary medicinal products sphere that we need products from other member states. Prior to this regulation it was much more difficult to access them. The provision in Article 110 of the veterinary medicinal products regulation relates to what we know as the "cascade". For example, one can go to Lithuania for a product if the product is not available here or if that product is not available with those ingredients. This is where the market has been greatly improved in the context of objective No. 5. It is very important we are able to utilise this system of accessing medicines in other EU member states, and for the European Medicines Agency, EMA, to facilitate that. The EMA has designed a new database, the union product database, UPD. The agency has made that database available to all of the member states. We now have a big repository of all the drugs available throughout the community that we can access if we are in short supply or if we do not have them in this market. It would not be fair to say this regulation is not being implemented here. My division in the Department, along with Mr. O'Mahony's section, are communicating the benefits around the accessibility and availability of products, of which there are very many for vets and for animals. At the end of the day this is to ensure there is enhanced animal welfare so that, for example, the gerbil or other pet animals that might need a particular treatment will have access to product and so we have access to certain products for horses, along with vaccines. It is all to ensure there is more preventative medicine and less use of antimicrobials, which is another of the objectives. This is where the availability comes in. We are utilising all of those flexibilities this new regulation extends to us.