Dáil Éireann Debate, Tuesday - 6 October 2020
786. Deputy Marian Harkin asked the Minister for Agriculture, Food and the Marine his plans in place to ensure conformity of regulations between Ireland and Northern Ireland in view of proposed new EU regulations governing the purchase of veterinary medicines in respect of the availability and authorised dispensing of such products; and if he will make a statement on the matter. [28152/20]
Amharc ar fhreagra787. Deputy Marian Harkin asked the Minister for Agriculture, Food and the Marine if he will ensure the continuation of the existing right of suitably qualified persons to sell veterinary medicines to farmers and not restrict such authorisation to qualified veterinarians; and if he will make a statement on the matter. [28153/20]
Amharc ar fhreagraI propose to take Questions Nos. 786 and 787 together.
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.
Prior to January 2019, UK national legislation did provide for persons other than veterinarians (known as Suitably Qualified Persons) to issue veterinary prescriptions. Therefore Suitably Qualified Persons (SQPs) in Northern Ireland will be permitted under EU law to continue issuing veterinary prescriptions for antiparasitic veterinary medicinal products after January 2022. SQPs in Northern Ireland are not permitted to issue prescriptions to anyone from outside Northern Ireland.
In Ireland it is only legal to buy and use veterinary medicinal products obtained from suppliers who are licensed in accordance with national legislation. To do otherwise and to use unauthorised medicines in Ireland is a contravention to EU and Irish legislation and offending parties are subject to prosecution.
Across every economic activity, there are different laws and regulations that apply in Northern Ireland and Ireland. Authorities on both side of the border work in a cooperative manner to ensure national laws are respected.
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 chaired by the Chief Veterinary Officer. Two meetings have been held to date and a programme of work containing over 30 antiparasitic related projects is currently underway. 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
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.
