What is the historical position on the derogation from requiring a veterinary prescription for antiparasitics?

In 2004, European veterinary legislation established a requirement that all veterinary medicinal products (VMPs) 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 VMPs which did not or were not known to 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 this exemption in Directive 2006/130/EC at the time and antiparasitics were allowed to continue to be available without prescription.

A similar exemption is available under the new EU VMP Regulation 2019/6. So, in effect, European legislation in respect of the supply and use of dosing products has not changed as a result of EU Regulation 2019/6. However, what has changed since that time is our knowledge regarding the impact of extensive use of antiparasitics:

  • Antiparasitic resistance has been widely reported in parasites of livestock species in Ireland.
  • Globally, resistance is developing year-on-year and is now a significant animal health issue.
  • What has led to the position that supply of antiparasitics must require a veterinary prescription from January 2022?

    In 2019, the Health Product Regulatory Authority (HPRA) established a taskforce to review the method of supply of antiparasitic VMPs that are intended for food-producing animals against the criteria set out in Article 34 of Regulation 2019/6.

    A copy of the report is available on www.hpra.ie.

    The report states that the current available scientific evidence shows that antiparasitic VMPs that are intended for use in food-producing species do not comply with the criteria for derogation from veterinary prescription specified under Article 34. Therefore, these products can only be supplied under veterinary prescription.

    Who will be permitted to dispense antiparasitics from January 2022?

    All current stakeholders who are already permitted to supply antiparasitics will be entitled to continue to supply them in the future (but from January 2022 onwards a veterinary prescription will be needed to dispense them).

    What about the derogation in Regulation 2019/6 which permits ‘Suitably Qualified Persons’ in Northern Ireland prescribe antiparasitics?

    Article 105(4) of EU Regulation 2019/6 states that “a member state may allow a veterinary prescription to be issued by a professional, other than a veterinarian, who is qualified to do so in accordance with applicable national law at the time of entry into force of this regulation”.

    This regulation entered into force in January 2019 and, at that time, Ireland’s national legislation did not allow for a veterinary prescription to be issued by anyone, other than a veterinarian.

    A “suitably qualified person” in Northern Ireland will not be permitted to prescribe and supply antiparasitics for use outside of Northern Ireland.

    Has the Department engaged with the European Commission or sought legal advice in an effort to recognise responsible persons and pharmacists in Ireland as professionals who can issue veterinary prescriptions?

    The Department’s chief veterinary officer (CVO) wrote to the Commission on 18 June, highlighting the important role played by responsible persons in licensed merchants (LMs) and pharmacists in supplying antiparasitics.

    The letter outlined the expertise available in LMs and pharmacies throughout rural Ireland and sought a view from the Commission as to whether these professions could be considered in the context of Article 105(4) of the regulation.

    DAFM received a response from the Commission on 7 September reiterating the position from Regulation 2019/6 that “a member state may allow a veterinary prescription to be issued by a professional, other than a veterinarian, who is qualified to do so in accordance with applicable national law at the time of entry into force of this regulation”.

    In Ireland, only veterinary practitioners have ever been permitted to issue veterinary prescriptions and therefore LMs and pharmacies will require the receipt of a veterinary prescription before they can dispense antiparasitics from January 2022.

    Implementation

    How will Irish authorities implement this legislation, taking account of a different regulatory environment in NI?

    Under Article 105(4) of Regulation 2019/6, suitably qualified persons in Northern Ireland are not permitted to supply prescriptions to anyone from outside Northern Ireland: “Such prescriptions shall be valid only in that member state and shall exclude prescriptions of antimicrobial medicinal products and any other veterinary medicinal products where a diagnosis by a veterinarian is necessary.” In Ireland it is only legal to buy and use VMPs obtained from suppliers who are licensed in accordance with national legislation.

    Challenges

    What is the Department doing to address the challenges posed by the mandatory change in route of supply of antiparasitics from January 2022?

    The Department of Agriculture has established an antiparasitic resistance stakeholder group, chaired by the Department’s CVO and made up of members from across the sector including those from farming, creamery, licensed merchant, co-op, pharmacy and advisory bodies. Its first meeting was held in mid-June and its second on 9 September. This group will examine all the issues related to the changed route of supply.

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