Ms Clare Fitzell:

I thank the committee for the kind invitation to contribute to this discussion. We look forward to highlighting the concerns of our members. The IPU is the representative and professional organisation for more than 1,900 community pharmacies and more than 2,300 individual pharmacists. Our vision is to be the authoritative voice of community pharmacy and a driving force in the evolution of accessible, equitable primary healthcare. The sector employs 31,000 people directly and indirectly. Of our members, in excess of 300 pharmacies operate dedicated professional services to animal owners through the supply of veterinary medicinal products, advice on their correct use and associated recording keeping and legislative requirements.

Pharmacists are trained healthcare professionals and are fully committed to the Government's one health strategy. We are acutely aware of the serious global public health challenge presented by antimicrobial resistance, AMR, that we are facing not only from the perspective of medicines used in human health, animal health and welfare but also from our shared environment. We are actively supporting initiatives such as the Pharmacy Antimicrobial Stewardship Network, which promotes the responsible and rational use of antimicrobials, including antiparasitics from the animal welfare perspective.

The committee will be well aware of the current situation and, therefore, I will focus on our concerns and potential solutions. Implementation of the regulation in its proposed format will have a myriad of unintended consequences. The impact on antiparasitic veterinary medicinal products, VMPs, will be quite the opposite of that intended as stated in objective 5 of EU Regulation 2019/6, which states: "This Regulation aims to reduce the administrative burden, enhance the internal market, and increase the availability of veterinary medicinal products, whilst guaranteeing the highest level of public and animal health and environmental protection." With regard to antiparasitic VMPs, we anticipate an increased administrative burden for all stakeholders, reduced competition in the sector, reduced availability of products, increased costs for animal owners, adverse impact on animal welfare, increased cross-Border trade due to different regulatory stances, reduced accountability of use, diminished food quality assurance, loss of services and jobs, reduced viability of essential small rural pharmacies that have a sizeable veterinary business and reduced compliance with the one health approach.

The experience since the implementation of Regulation EU 2019/6 came into effect on 28 January 2019 regarding VMPs other than antiparasitic medicines, which took effect in Ireland on 28 January 2022, has resulted in what can only be described as a seismic downturn in the dispensing of some prescription-only VMPs by pharmacists. Intramammary antibiotic tubes have seen a downturn of between 80% and 90%, which is similar to that reported by ICOS last week. Some prescription-only veterinary vaccines, dispensing and supplies from pharmacies have decreased by 50% to 60% over the same period. We understand that veterinary pharmaceutical manufacturers and suppliers have not reported any differential in the Irish market. It is our assumption that pharmacists, licensed merchants and co-operatives have all experienced a significant downturn in their business and this business has migrated elsewhere. The critical factor is the absence of veterinary prescriptions for the aforementioned products.

The IPU along with other stakeholders was assured that the NVPS would achieve the objectives of reduced administrative burden, enhanced market and increased availability of VMP prescriptions and VMP choices for animal owners. Despite the best intentions and efforts, the NVPS has been beset by challenges, one of the most significant hurdles to date being the lack of engagement by veterinarians. Other challenges that we have encountered with the current NVPS solution are an initial lack of engagement with pharmacists and other end users to gather essential user requirements before design; no integration with prescribing or dispensing systems in pharmacies; the need for double administrative activities when dispensing to comply with legal requirements; no facility to amend a record, which is essential before this solution comes into place; no facility for generic substitution; no engagement by veterinarians; slow response time to queries raised regarding the solution; no facility to print a pharmacy information label to attach to the VMP to meet pharmacy legal requirements; the fact that no pharmacies have been registered to use this system despite submitting registration forms for access; and the fact that the system is set to pharmacist level, not pharmacy level, which is highly problematic when it comes to our record-keeping requirements.

Regarding our recommended solutions, resolution of the impasse regarding prescribing antiparasitic VMPs can be achieved by retrospectively amending SI 786/2007 European Communities (Animal Remedies) (No. 2) Regulations 2007. Precedent exists throughout the Statute Book of such retrospective amendments. Article 105(4) of EU Regulation 2019/6 provides a derogation designed for precisely this purpose. It is intended to facilitate professionals other than veterinarians to issue veterinary prescriptions, where such individuals will qualify to do so at the time the regulation entered into force. The availability and potential application of the derogation were confirmed in September 2020 by Ms Stella Kyriakides on behalf of the EU Commission in response to letters from Chris McManus, MEP and Martin Blake, Chief Veterinary Officer. In summary, this means that Ireland can confirm by means of submission that the terms of the derogation have been met by virtue of the retrospective amendment of SI 786/2007.

The IPU call on the committee to delay further implementation of the regulation and the associated Bill until the NVPS is fit for purpose; ensure the completion or sharing of the HPRA task force recommended impact assessment as we are not sure whether it has been completed; design and implement an education programme for the animal owners to address this serious issue, as highlighted by at last week's meeting of this committee and as proven by UK studies, this measure was the most successful; consult pharmacists on a multi-actor stakeholder approach to be taken to elaborate national guidelines for sustainable parasite control, including the development of consistent scientifically-based advice on targeted selective treatments; and ensure that involve all stakeholders involved in the prescribing and dispensing of antiparasitic VMPs are provided with access to training-continuous professional development on sustainable parasite control as recommended by the HPRA task force.

Removing pharmacists and responsible persons from their prescribing roles in the supply of antiparasitics will result in the loss of the holistic approach previously favoured by the Department of Agriculture, Food and the Marine and required as part of the one health strategy. Collaboration is the key to ensuring that the focus on compliance and patient-animal safety is maintained as part of the safe and responsible use of antiparasitics. To this end, the status quoin the supply route should be maintained and we respectfully suggest that the committee plays a significant role in ensuring this equity. I thank members for your time. We are happy to answer any questions from committee members.