John McGuinness (Carlow-Kilkenny, Fianna Fail)
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261. To ask the Minister for Agriculture, Food and the Marine his views on whether the EU clause contained in EU Directive 2019/6 allowing a professional person or responsible persons to issue a veterinary prescription for all medicines currently classified as LM in view of the fact it helps to achieve the best outcomes for farmers, licensed merchants, co-ops and pharmacists while safeguarding these essential medicines; his views on the submission by an association (details supplied) to his Department; if legal opinion has been sought on the matter; if a risk analysis has been conducted by his Department; his further views on the issues relative to the directive; and if he will make a statement on the matter. [29024/20]

Charlie McConalogue (Donegal, Fianna Fail)
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EU Regulation 2019/6 on veterinary medicinal products comes into effect in January 2022. This Regulation is binding in full and has direct effect on all Member States.

Two issues have now arisen

1. The new requirement under EU Law for a veterinary prescription to be issued before antiparasitic products can be dispensed and

2. The question as to whether Ireland can avail of a derogation in the Regulation which permits professionals other than veterinarians to issue veterinary prescriptions

In relation to the first issue, since 2004 European legislation established a requirement that all veterinary medicinal products that are intended for use in food-producing animals should be subject to a veterinary prescription. However, a 2006 EU Directive allowed for the maintenance of non-prescription status for certain veterinary medicinal products which did not present a risk to human or animal health or to the environment. Ireland availed of the exemption in Directive 2006/130/EC at the time and antiparasitics were allowed to continue to be available without prescription.

There is a similar exemption available under the new EU Regulation 2019/6. However, since that time, our knowledge regarding the impact of extensive use of antiparasitics has changed. In 2019, the Health Product Regulatory Authority’s (HPRA) Advisory Committee for Veterinary Medicines (ACVM) established a Task Force to review the method of supply of antiparasitic veterinary medicinal products that are intended for food-producing animals against the criteria set out in Regulation 2019/6. A copy of the Report is available on the HPRA’s website www.hpra.ie.

The Report states that the available scientific evidence shows that antiparasitic veterinary medicines that are intended for use in food-producing species do not comply with the criteria for derogation from veterinary prescription specified in EU Regulation 2019/6. Therefore, antiparasitic veterinary medicines must require a veterinary prescription before they can be dispensed from January 2022. Ireland has no national discretion on this issue.

On the second issue, there is a separate derogation in the Regulation, which allows professionals other than veterinarians to issue veterinary prescriptions, in limited circumstances, but only if this was provided for in a Member State's national legislation prior to Regulation 2019/6 coming into force in January 2019.

Ireland's national legislation has never permitted anyone other than a veterinarian to issue a veterinary prescription. Therefore, Ireland has no national discretion to now provide for a regime which would permit Responsible Persons in Licensed Merchants or pharmacists to dispense antiparasitic veterinary medicines without a veterinary prescription issued by a veterinarian.

My Department has sought legal opinion and clarification from the EU Commission on the issue. Both responses reaffirmed my Department’s understanding of the Regulation as outlined above.

I recognise these legislative changes will result in challenges for all impacted stakeholders. In recognition of this, my Department has established an Antiparasitic Resistance Stakeholder Group which is chaired by the Chief Veterinary Officer. Licensed Merchants and Co-Op organisations are both represented on this Group. Two meetings have been held to date and a programme of work containing over 30 antiparasitic related projects is currently underway. Risk analyses of various elements of the issues are addressed within this work programme. This group will examine all the issues related to the changed route of supply with two principal objectives

- Protecting the efficacy of antiparasitics which are critical to the Irish pasture-based production model.

- Establishing a regulatory system that is pragmatic, retains a substantive role for existing stakeholders and delivers value for money for farmers

A 5-week Public Consultation process on the Regulations, hosted by my Department, closed in late July with in excess of 100 submissions received, including from the organisation referred to by the Deputy. All submissions are being analysed by my officials and considered in the context of the implementation of the Regulation.

My Department is fully committed to working with all stakeholders in considering how best to implement the new EU Regulations on veterinary medicinal products. There is a dedicated email address allowing communications on the new Regulation: vetmedregs@agricuIture.gov.ie.