Oireachtas Joint and Select Committees

Wednesday, 6 October 2021

Joint Oireachtas Committee on Agriculture, Food and the Marine

EU Regulation on Veterinary Medicinal Products (Resumed): Department of Agriculture, Food and the Marine

Dr. Paul Corkery:

No, it did not because of what was in existence at that stage in relation to non-prescription products, specifically those derogated products. Article 34 of the regulation helps here. It basically says every veterinary medicinal product needs a prescription. Then it says there are criteria under which you can derogate a product to not require a prescription. It was similar in the previous directive of 2001, regarding the criteria.

Our understanding was antiparasitic products would stay non-prescription. That is part of the HPRA's remit. It performs what is know as pharmacovigilance. It gives feedback on the effectiveness and adverse reactions to products. For example, if a vet went out to a farm and injected cattle and there was an adverse reaction, perhaps a skin condition, he or she would report it back to the HPRA. The authority accumulates all the information and it was finding there was pharmacovigilance that said certain antiparasitic products were not working. This had nothing to do with the new veterinary regulations. Even if we did not have the new veterinary regulations, the HPRA report under the previous directive would have meant we had enough regulation of these products. It happened previously back in 2003 to 2007 in relation to lactating and dry cow intramammary tubes. It was an up-regulation. Scientific evidence comes into play. The HPRA has to do this. It must check to see if these products are still meeting the conditions of the derogation from prescription, and it did that. Even if we did not have these new veterinary regulations, we would still have the issue of antiparasitics. Nobody back in 2018 could have foreseen this was going to happen because the evidence did not emerge back them. The evidence emerged in sheep and if you-----