Minister McConalogue acknowledges new veterinary medicines and medicated feed regulations

The Minister for Agriculture, Food and the Marine, Charlie McConalogue TD, has acknowledged that EU Regulations 2019/6 on Veterinary Medicinal Products and 2019/4 on Medicated Feed are now in effect since 28^th January 2022. These regulations are a legal requirement in all European Union (EU) countries. The regulations provide for a range of measures aimed at increasing the availability of veterinary medicinal products and also tackling antimicrobial resistance (AMR).

The Minister said ‘’these regulations, which have been implemented by supporting national legislation, set out the rules for the manufacture, import, export, sale, supply, distribution, advertisement, and use of veterinary medicinal products and medicated feed in all animal species. These new EU regulations seeks to address the challenges around medicine availability and growing fears around antimicrobial resistance.’’

The Minister continued by saying ‘’These regulations provide an important framework underpinning the use of antimicrobials in the agricultural sector, contributing to the overall societal ‘One Health’ challenge of AMR – to protect human health, animal health and welfare and the health of our shared environment. The new requirements regarding prescribing and use of antimicrobials serve to promote optimal animal health and food security, in line with objectives in Food Vision 2030. This legislation will also support delivery of strategic objectives in our second national One Health antimicrobial resistance action plan, iNAP2.’

In addition, the Minister welcomed the introduction of a newly developed National Veterinary Prescription System (NVPS) which his Department  has released, on a phased basis from 31^st January. This new system initially focuses on the issue of prescriptions and the dispensing of veterinary medicines for food producing animals. The system will ensure that farmers retain full control over where, and facilitate greater choice for farmers when, they get prescriptions dispensed.

The Minister concluded by saying that: “My Department will continue to engage collaboratively on our collective journey to comply with these new regulations. I want this change to be as seamless as possible which will benefit farmers as well as everyone else in the sector. I have worked with all stakeholders in this process to ensure that these new regulations have minimal impact on our farmers.

Notes for Editors

More information with regard to the new regulations can be found at www.gov.ie/VeterinaryMedicines

What is AMR?

Antimicrobial resistance (AMR) is resistance of a microorganism to a drug that was originally effective for treatment of infections caused by that microorganism. Resistant microorganisms (including bacteria, fungi, viruses and parasites) are able to withstand attack by antimicrobial drugs, such as antibacterial drugs (e.g., antibiotics), antifungals, antivirals, and antimalarials, so that standard treatments become ineffective and infections persist, increasing the risk of spread to others.

The evolution of resistant strains is a natural phenomenon that occurs when microorganisms replicate themselves erroneously or when resistant traits are exchanged between them. The use and misuse of antimicrobial drugs accelerates the emergence of drug-resistant strains. Poor infection control practices, inadequate sanitary conditions and inappropriate food handling encourage the further spread of AMR.

What is the effect of AMR?

A European Centre for Disease Control/European Medicines Agency (ECDC/EMEA) 2009 Report estimated that in 2007 drug-resistant bacteria were responsible for about 25,000 human deaths per annum in the EU alone, with associated healthcare costs and productivity losses of €1.5bn. The Report also stated that approx. 4 million patients are estimated to acquire a healthcare associated infection in the EU every year.  (ECDC JOINT TECHNICAL REPORT ‘The Bacterial Challenge: time to react’ (2009)).

What does ‘One Health’ mean?

The ‘One Health’ concept is a worldwide strategy for expanding interdisciplinary collaborations and communications in all aspects of health care for humans, animals and the environment.  Recognising that human health, animal health and ecosystem health are inextricably linked, ‘One Health’ seeks to promote, improve and defend the health and well-being of all species by enhancing cooperation and collaboration between physicians, veterinarians, other scientific health and environmental professionals and by promoting strengths in leadership and management to achieve these goals.

National Veterinary Prescription System 

The National Veterinary Prescription System will assist Ireland in meeting its annual EU regulatory requirement to report on antimicrobial usage, which is a critical aspect in the fight against anti-microbial resistance.  It also provides for the continuance of the competitive market for the supply of veterinary medical products and will provide greater choice to the farming community on where they can purchase and access veterinary medicines.  The development and introduction of the system is coherent with Ireland’s ambition to continue improving customer online digital services in line with the Government’s National Digital Strategy, and will provide greater assurance to our national and international trading partners and customers through greater regulatory oversight in Ireland’s agri-food production sector.

The system is a free online prescription and dispensing application and portal supported by a centralised database which will in the initial phase support veterinary prescribing and dispensing of veterinary medicines for food producing animal species.

The NVPS will be made available for use on Monday Jan 31^st 2022 to a cohort of veterinary practitioners, with a phased implementation plan to ensure optimal functionality before full functionality is made available to all in Phase III, expected to be April 2022.

More information with regard to the NVPS can be found at: gov.ie – National Veterinary Prescription System (www.gov.ie)