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Regulatory Impact Assessments

Dáil Éireann Debate, Wednesday - 24 March 2021

Wednesday, 24 March 2021

Questions (2034, 2035, 2036)

Catherine Connolly

Question:

2034. Deputy Catherine Connolly asked the Minister for Agriculture, Food and the Marine further to Parliamentary Question No. 1025 of 17 February 2021, the timeline for the completion of the regulatory impact assessment of the EU Regulation on Veterinary Medicinal Products EU 2019/6; and if he will make a statement on the matter. [15712/21]

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Catherine Connolly

Question:

2035. Deputy Catherine Connolly asked the Minister for Agriculture, Food and the Marine the analysis carried out or commissioned by his Department into the question of Ireland qualifying for the derogation in Article 105(4) of the EU Regulation on Veterinary Medicinal Products EU 2019/6; and if he will make a statement on the matter. [15713/21]

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Catherine Connolly

Question:

2036. Deputy Catherine Connolly asked the Minister for Agriculture, Food and the Marine if he has raised concerns at a national or EU level regarding the potential impact of the coming into force of the EU Regulation on Veterinary Medicinal Products EU 2019/6 in January 2022 on the livelihoods of responsible persons that will no longer be permitted to prescribe antiparasitic medicines; and if he will make a statement on the matter. [15714/21]

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Written answers

I propose to take Questions Nos. 2034 to 2036, inclusive, together.

My Department has committed to conducting a Regulatory Impact Assessment (RIA) on the EU Regulation, which is underway.  The RIA will focus on areas where Ireland has national discretion with regards transposing the Regulation and specifically where intended policy decisions may impact stakeholders. The RIA cannot be finalised until the relevant policy options have been examined which will be informed by stakeholder consultations and discussions at the Antiparasitic Stakeholder Group.

The Department’s interpretation of Article 105(4) is that Ireland is not in a position to avail of this derogation to allow people other than registered veterinary practitioners to issue veterinary prescriptions. This view has been informed through consideration by policy officials, consultation with the EU Commission and legal advisors.

However, given the range of views on Article 105(4), the Department has sought further legal advice from the Attorney General’s Office.  It is the intention of the Department to make a statement on the matter to all stakeholders when that advice is received.

All stakeholders, including Licensed Merchants, who are currently permitted to sell veterinary medicines under national legislation, such as cattle dosing medicines, will continue to be able to sell such medicines following the new veterinary medicines Regulation coming into effect in January 2022. However, from that date, antiparasitic veterinary medicines will require a veterinary prescription before they can be sold.

The Responsible Person in a Licensed Merchants can sell antiparasitic veterinary medicines but they do not prescribe them.  In Ireland, the legal definition of a veterinary prescription outlines that it can only be issued by a registered veterinary practitioner. A veterinary prescription is also defined in the incoming Veterinary Medicines Regulation as a document issued by a veterinarian for a veterinary medicine.

Several stakeholders, including Licensed Merchants, have raised concerns about the potential impact of this change in regulation. To address this, my Department has established an Antiparasitic Resistance Stakeholder Group which is chaired by the Chief Veterinary Officer. This group has an extensive work programme and its considerations are being guided by 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

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