Dáil Éireann Debate, Wednesday - 16 September 2020
153. Deputy Carol Nolan asked the Minister for Agriculture, Food and the Marine if the concerns of agricultural merchants who fear that their ability to prescribe and dispense veterinary medicines will be adversely impacted by the introduction of EU regulations in this area will be addressed; if he will consider seeking a derogation on the matter from the EU regulatory authorities; and if he will make a statement on the matter. [24211/20]
Amharc ar fhreagraEU 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. There is limited national discretion available to Member States in relation to a number of the Regulation's articles.
In 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, and which met the specified criteria for exemption from veterinary prescription. 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. For example, antiparasitic resistance has been widely reported in parasites of livestock species in Ireland and globally, resistance is developing year-on-year and is now a significant animal health issue.
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. It also states that a consequence of this determination is that any such products that are supplied without veterinary prescription will need to be upregulated to supply under veterinary prescription. Therefore, Ireland and all other Member States must now comply with this regulation from January 2022.
In accordance with existing national legislation, from January 2022 antiparasitic veterinary medicinal products for use in food-producing species that are supplied under prescription may be dispensed by veterinary practitioners, pharmacists and Licenced Merchant's. This means that all current stakeholders that are already permitted to supply such products will be entitled to continue to supply them in the future, however, from January 2022 onwards, a veterinary prescription will be needed to dispense them.
Livestock based agriculture is critically dependent on the availability of effective veterinary medicines. Increasing resistance to veterinary medicinal products threatens their availability in the future. It is imperative to protect the drugs we have available currently as it is not envisaged that any new drugs are imminent.
In recognition of the challenges posed to numerous stakeholders by the new rules my Department has established an Antiparasitic Resistance Stakeholder Group chaired by the CVO. Licenced Merchant and Co-Op representative bodies are members of this group. Two meetings have been held to date and a programme of work involving over 30 antiparasitic related projects is currently being developed. This group will examine all the issues 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 the Department, closed in late July with in excess of 100 submissions received.
My Department is considering these submissions, and 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.
