Oireachtas Joint and Select Committees

Tuesday, 27 April 2021

Joint Oireachtas Committee on Agriculture, Food and the Marine

Regulation of Veterinary Medicines: Discussion (Resumed)

Dr. J.G. Beechinor:

The HPRA monitors medicines. We do that for human and veterinary medicines. As the Senator is aware, in the context of Covid, we are monitoring adverse reactions to medicines, and so on. We have been doing such work on the veterinary side for years.

There are spontaneous reports of a lack of effectiveness. The odd report does not mean that much until it is scientifically investigated. Our role as regulator is to ensure that we do not just have a little cluster of reports here and there on an annual basis, but that we are able to stand back and see the bigger picture. The bigger picture for us is filled not just with what happens on the ground in Ireland, but throughout the EU and indeed the wider world.

To answer the Senator's question, there is research. The research is not done by the HPRA. It is done by organisations such as Teagasc or published in peer-reviewed journals, demonstrating that the research is scientifically valid. Teagasc started producing reports from around 2006. It first produced reports on sheep, including many thousands of them. Therefore, I am not talking about a few sheep; it is thousands of sheep. Data on cattle followed. The first report containing data on cattle was produced by a Department of Agriculture inspector in 2014. It was a confirmed case in which he effectively managed it, treated the animals, took faecal egg counts and so on, confirmed it and wrote it up. In 2018, Teagasc came in on the back of that and did a study on 16 farms throughout Ireland. It found that there is resistance in every farm. Not only did it find that there is resistance in every farm, but multiple resistance.

That is the evidence from Ireland. I acknowledge that some farmers may not even know that they have a problem. Indeed, some farmers may not have a problem. However, the majority of farmers do. Resistance is ubiquitous; it is everywhere. It is a natural process. We have seen, in the context of Covid in places such as India, how resistant strains emerge. It is genetic. As soon as parasites multiply, they exchange genetics and throw up resistant genes. That is what then leads to resistance on the farm. As products are used, resistance emerges.

The Senator mentioned Scandinavia. Notwithstanding that products are prescription-only medicines, they still get resistance. The Senator is absolutely right that making products prescription-only medicines is not the silver bullet that is going to cure things. What it is, is a step in the right direction. It is our job to ensure that the products comply with the legislation. If we do not do that, the European Commission, which is aware of this report, will find out. The European Commission audits our national residue plan every four, five or six years. It is a risk-based approach. If it comes knocking on our door to ask how we are implementing the requirements for the authorisation of medicines and the residue controls and so on, it will know that the products do not comply. The regulation is crystal-clear - if resistance occurs, the products cannot be regulated other than by prescription.

The Senator also asked about the specially qualified person, SQP. The SQP term is a UK one. As I understand it, in the UK the SQPs have been given rights to prescribe. However, we do not have that system in Ireland. That system is unique to the UK, as far as I know. Everywhere else in Europe, and indeed in the UK, these products are prescription-only medicines. Basically, we must bring Ireland into compliance because we are not, currently.

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