Oireachtas Joint and Select Committees

Tuesday, 9 February 2021

Joint Oireachtas Committee on Agriculture, Food and the Marine

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

Mr. Colm Forde:

The Department's approach to policymaking, particularly now, is to facilitate extensive consultation with stakeholders in developing any policies. That is part and parcel of what we do. One of the consequences of that is that policymaking can take time because we need to take account of everyone's viewpoints. I appreciate that Senator Paul Daly asked Ray Doyle that question during the earlier session and the answer that came back to him may not have gotten across the breadth of consultation that we have had. I am sure Mr. Doyle will confirm this subsequently if asked but I have met with him countless times on these regulations, be it bilaterally with ICOS or though the different stakeholder groups we have.

The antiparasitic stakeholder group was set up in the middle of last year to address all of the various concerns that have been brought forward by stakeholders. As the Senator rightly pointed out, one of the key objectives of the group is to look at an efficient and competitive supply chain through effective regulation and innovation. The major concerns we have with this regulation are that there are certain entities which fear that they may suffer a loss in business as a result of the new prescribing regime. There are two different aspects involved. We want to make sure that the prescribing of these products is done prudently and effectively so that we can protect their efficacy. ICOS relayed that point well. It is so important that we protect the efficacy of these products to support the pasture-based farming model, which we are all so proud of. If these products fail to work, however, then we cannot help support that type of farming and that will ultimately impact on the ability of farms to cut costs.

I will go back to objective 6 which concerns facilitating an efficient and competitive supply chain. We would like to have a system whereby all suppliers in the market can continue to supply farmers and that, ultimately, farmers will have that choice on where they want to buy their medicines from. Farmers are savvy business people and if we allow them to have that choice it is up to them to decide where they buy their product.

There are five or six different actions within that strategic objective and maybe the most important one of those is the development of a secure electronic prescribing system. As outlined in our opening statement, our ambition is to have all prescriptions available online and that a farmer, in theory, could get a prescription sent to him or her by text message on his or her mobile phone. He or she would then be able to buy that wherever he or she may choose. We hope that would open up the market to a competitive level so that farmers can buy from their vet, pharmacist, or licensed merchant, whichever one they choose.

One of the issues we have been asked to consider, and I think ICOS is supportive of this, is to look at the decoupling of prescribing and sale of medicines. Some member states in Europe have gone down the route of not allowing vets to sell veterinary medicines. They only allow them to prescribe. We have committed to doing a piece of research on that and will present the pros and cons associated with that approach to the antiparasitic stakeholder group. It is important to say that there is no silver bullet answer to this. Obviously, if one stops vets from selling then that has other potential consequences.

We also outlined that we made representations to the Commission about the continued role of responsible persons. We received that response and it clearly indicated to us that we are not able to avail of the derogation in Article 105(4). As ICOS outlined, we separately sent a request for legal opinion on that to the Attorney General, which we are awaiting a response to. ICOS referred to the role we have given to the Veterinary Council. It is important to highlight that the Veterinary Council is an independent statutory body tasked with overseeing the practice of veterinary medicine in Ireland in the public interest. I think it was suggested that the Veterinary Council may be aligned with the views of particular stakeholders. It is important to outline that it is an independent regulatory body and is under the Department's remit.

One of the key articles in the regulation states that a veterinary prescription can only be issued following a clinical examination or any other proper assessment. The question from many of our stakeholders is, what exactly does that mean and what is a proper assessment? We tasked the Veterinary Council with meeting all stakeholders, including experts in the field, farming organisations, ICOS, Teagasc, and Animal Health Ireland, to benefit from the best practice that is out there and to determine what is a proper assessment. ICOS referred to the kind of data one should be aware of when determining the kind of prescription that should be used and for how long that prescription should last. If I get a prescription for some dosing products perhaps that could last for several months at a time, again this would give a farmer the choice as to where he or she could buy that product over a period of time. The council engaged extensively with stakeholders throughout the end of last year and early this year, and will be presenting its views on what constitutes a proper assessment to the antiparasitic stakeholder group in March. I hope I have given members an overview of where we are at with those consultations.

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