Dr. Paul Corkery:

I thank the Chairman, Deputies and Senators for inviting the Department today. I am joined today by our director, Mr. Doyle, and Mr. Collins, assistant principal officer, both of whom are engaged in the policy and proposed implementation of the veterinary medicinal products regulation 2019/6. We welcome the opportunity to appear before the Joint Committee on Agriculture, Food and the Marine to provide updates and contribute to its discussions on the new regulation, which will come into force in January 2022.

The Department is conscious that the legislation is complex, and that regulation of veterinary medicinal products is itself complex. It is important to recall that the main objectives of these new regulations are to free up availability of veterinary medicinal products across the EU, while also introducing some additional controls to address the clear evidence of the sustained escalating resistance to certain veterinary medicinal products. Highlighting the additional controls which Ireland is implementing to address this global concern only helps to provide greater international market confidence in Ireland’s ability to produce the safest, highest-quality exports from its agriculture sector. As members will know, Ireland exported some €14.2 billion worth of agrifood in 2020 - with dairy produce at €5.1 billion and beef at €2.3 billion. The Irish agrifood sector makes a significant contribution to employment, accounting for 7.1% of total employment, especially in rural and coastal areas. This equates to 163,600 jobs. Meeting the higher level of controls in the EU veterinary medicines regulations will be pivotal to Ireland's ability in maintain these agribusiness employment and food export figures.

In ensuring that all concerns associated with the various elements and processes required or introduced under the new regulations have the opportunity to be considered, the Department has undertaken extensive stakeholder engagements since 2019. These are ongoing. We have met regularly with the multiple representative bodies in the sector, representing farmers, licensed merchants, pharmacists, veterinarians, co-ops, dairies, wholesalers, feed mills, educational groups and software companies. We have listened to their concerns, researched suggestions they have made as to possible options and included their suggestions in our planning for the implementation of these new regulations wherever possible. However, some suggestions were not legally feasible. We have also established regular contact and information-sharing links between Department officials on both sides of the Border. The Department is working on enabling the continuation of all retail outlets, and associated jobs, available to farmers, thus supporting competition in the marketplace and jobs in rural areas. We are ensuring farmers have control over where they purchase antiparasitics, as they did heretofore, notwithstanding that some of them will be prescription only. We have worked with stakeholders on a range of activities to reduce and reverse, wherever possible, the increased resistance patterns in both antibiotics and antiparasitics for the benefit of farmers and society. We are working with the Health Product Regulatory Authority, HPRA, to maximise the availability of veterinary medicinal products on the Irish market. We are working with the Veterinary Council of Ireland, VCI, to ensure alignment between our respective regulatory functions in the context of these new regulations.

Department officials have been before this committee on this matter on two previous occasions. In that context, I do not wish to repeat much of what members have already considered. However, the Department welcomes the committee’s recent comprehensive report on the matter and we appreciate the opportunity today to discuss the recommendations, observations and findings of the report, along with the chance to provide updates outlining the progress made in the intervening period on related matters pertaining to veterinary medicine regulation in Ireland. The committee’s report highlighted the importance of the role licensed merchants and veterinary pharmacists play in rural Ireland in particular and recommended this continue. The Department wholeheartedly supports this view and wishes to assure members that all existing retailers of veterinary medicines, including licensed merchants and veterinary pharmacists, will continue to be legally permitted to sell anti-parasitic medicines, as well as a whole range of other veterinary medicinal products they currently sell, as they have done heretofore. It is the Department’s view that responsible persons employed in licensed merchants, veterinary pharmacists and veterinary practitioners will all continue to play an important advisory role in supplying veterinary medicines to farmers thereby safeguarding animal health and welfare, public health, and supporting jobs in the agriculture sector.

When Department officials last appeared before the committee in February, legal advices were awaited from the Office of the Attorney General on the issue of the availability of the derogation in article 105(4) of the EU regulation. Those comprehensive advices were subsequently received within the Department on 12 April and the outcome was subsequently shared with this committee and the anti-parasitic resistance stakeholder group. This confirmed that the derogation provided for in Article 105(4) is not available to Ireland. This means that only registered veterinary practitioners may issue a veterinary prescription in Ireland. Veterinary practitioners have a key role to play in seeking to mitigate the problem of resistance to both antibiotics and antiparasitics. In that context, the VCI is the independent statutory body that regulates the practice of veterinary medicine and veterinary nursing in Ireland. The VCI is reviewing its professional codes of conduct. These are the rules that veterinary practitioners and nurses must comply with in order to practice veterinary medicine and veterinary nursing in the State.

The objective of the code is to ensure a consistent ethical and professional provision of veterinary service in the public interest.

This updated Veterinary Council of Ireland code, which takes into account various elements and objectives of these new regulations, is currently open for public consultation. In the draft code, it is set out that in order for a veterinary practitioner to prescribe veterinary medicines, including antiparasitics, they must have established a relationship with a client or farmer. This is defined as an agreement between an animal owner or a keeper of animals and the veterinary practitioner or practitioners within a veterinary practice to provide veterinary services that demonstrate real and ongoing clinical veterinary practitioner or animal contact at the owner’s farm premises. This is designed to ensure that the best prescription choices are made in respect of the animals to be treated for the benefit of the animal, its owner and indeed wider society, mitigating the risk of the continued development of resistance to antibiotics and antiparasitics. The draft code recognises that farmers may choose to have, and often do have, such working relationships with more than one veterinary practitioner.

As highlighted by the committee, greater access and choice of veterinary medicinal products for farmers, along with maintaining fair competition of products, is hugely important to ensuring retention of competitive veterinary medicine supply channels such as licensed merchants and pharmacies. The Department’s objective is to place the farmer at the centre of decision-making as to where he or she purchases antiparasitic medicines and any other relevant veterinary medicinal products through the introduction of a national veterinary prescription system, NVPS, which is currently being developed. Without going into the technical details, essentially veterinary practitioners will electronically issue a prescription for animals under their care to a centralised Department system. Prescription details will then be made available to farmers by email or text. The farmer can then produce the prescription ID details contained in the email or text to the dispenser of their choice, be that a licensed merchant, a pharmacist or co-op, or indeed from the prescribing vet if they so choose. This will allow greater access and management of prescriptions as required. The introduction of the system provides the farmer with greater control over where they choose to purchase their medicines from.

All dispensers registered for the NVPS will have equal access to dispensing antiparasitics. As per recommendations of this committee, the system is currently being developed to allow for alternative or generic products, based on the active substances detailed on the prescription, to be dispensed as an alternative to a named product, as necessary. This is a welcome suggestion by the committee and one we are happy to be able to deliver on for the benefit of Irish farmers and retail suppliers alike. This will likely reduce costs to farmers and provide more choice and opportunities to retailers in the area.

While acknowledging the increased global risk of resistance to antimicrobial and antiparasitic veterinary medicinal products, the Department is acutely aware of the economic burden of parasites on Irish agriculture in general. A recent scientific paper suggested that this burden could be in the region of up to €237 million per annum. In order to support the farmers and agribusinesses potentially impacted by these factors, the Department has in the past and continues now to provide and develop support schemes such as the sheep welfare scheme and the beef environmental efficiency programme, BEEP, which include faecal egg counting for some of those parasites. The Department is currently working to develop a further antiparasitic measure to be introduced under the targeted advisory service on animal health scheme to assist farmers.

In growing the awareness of the issues surrounding resistances, the work of Ireland’s national action plan, INAP, on antimicrobial resistance stakeholder group and the antiparasitic resistance stakeholder group are both informed by extensive work plans. Each plan consists of a range of measures which aim to educate all actors in the production chain on addressing both antimicrobial resistance and antiparasitic resistance. Appropriate strategies will be implemented to deal with each kind of resistance. The INAP group only recently met while the antiparasitic resistance group will meet again in the near future. Between meetings, work continues in following through on the extensive action lists.

In addressing the recommendation in the committee report on the issue that is known as decoupling, which is breaking the link between the prescriber and dispenser, the Department sought legal advice on the issue. The advice received was that for such decoupling to be permissible, a sound evidential basis in veterinary medicine is required to justify any partial or full prohibition on veterinarians selling the veterinary medicines that they prescribe. Such decoupling could not be solely for the purpose of economically assisting one sector of an industry over another. This would be seen as providing state aid to one sector over another and is not allowed. The Department’s view is that there is an absence of such sound veterinary medicine evidential basis and, therefore, decoupling is not an option legally available to us. This aspect was also considered by the European Parliament during negotiations on the regulations in 2014 and it concluded, similar to the Department, that there is no substantive evidence which shows a correlation between decoupling and improved animal or human health, or a reduction in resistance development. The Department shared the outcome of these advices with members of the antiparasitic resistance stakeholder group in advance of its meeting on 15 April.

The Department noted that the committee also raised concerns about access to veterinary practitioners. We also note more recent commentary on this matter. While this concern is not directly linked to the introduction of the new veterinary medicinal product regulations, EU Regulation 2019/6, the matter was addressed as an action arising under the national farmed animal health strategy. The Department carried out research and analysis into the distribution and accessibility to farmers of large-animal veterinary services in rural Ireland. The outcome of this analysis was relatively positive, in that it identified that large animal veterinary services are available within 20 km to more than 95% of Irish livestock farms. While the provision of veterinary services to members of the public in Ireland is a private sector activity, nonetheless the Department will, from a public policy perspective, continue to monitor this position closely, recognising that it is critical that Irish farmers are adequately supported with the provision of veterinary services in the best interests of animal health and welfare.

I thank the Chair and the committee for the invitation to speak today and we are happy to address any questions the committee may have on the topic.