In recent meetings with Irish MEPs, IFA animal health chairman, Bert Stewart, further outlined the concerns that farmers have with EU proposals for the regulation of veterinary medicinal products.
According to Bert, these regulations have the potential to impact negatively on Irish farmers and their ability to ensure the health and welfare of their animals in a practical and cost-efficient way. “They will place unnecessary obstacles to the supply and availability of products, such as vaccines and doses. IFA has consistently identified key areas that must be addressed to allow farmers access to competitively priced veterinary medicines,” he said.
The following key areas were identified: availability of veterinary medicines; cross-border trade of veterinary medicines; definition of ‘antimicrobial’ for the purpose of regulation; valid period of antimicrobial-product prescription; prescriptions for veterinary medicinal products; the licensing, categorisation and supply routes of veterinary medicines; and the lack of new product development.
Regarding the availability of veterinary medicines, the current proposals fall short of establishing a single centralised-licensing system for all veterinary medicine products in the EU. Once licensed in the EU, veterinary medicines should be available in all Member States to maximise availability of products for farmers and provide a transparent price-comparison system throughout the community. The current individual Member State licensing system adds unnecessary costs for farmers and reduces the availability of product. Referencing the cross-border trade of veterinary medicines, farmers must be facilitated in sourcing veterinary medicines from other Member States to maximise competition in the supply of veterinary medicines.
While it is broadly understood that 'antimicrobial' refers to antibiotics and the developing of antibiotic resistance, the use of the broader definition in the regulation may have unintended consequences for the supply and availability of some products.
Clearly the intention of the regulation in relation to antimicrobial products, is to address the growing concerns for antibiotic resistance in both humans and animals. In this regard, and to facilitate appropriate controls on the prescribing and supply of antibiotics and avoid the potential implications for a wider group of veterinary medicines, the definition for the purpose of the regulation should refer only to antibiotic products and products containing antibiotics.
The proposal for a five-a-day validity period for a prescription for antimicrobial products, particularly based on the broader definition applied in the regulation, warrants further serious consideration, both in terms of the practicality and impact on product sourcing and additional costs that may arise.
The regulation must provide Member States with the flexibility to allow prescriptions to be provided by suitable persons other than veterinarians for products that do not contain antibiotics.
It is not necessary, practical or cost-efficient to categorise all veterinary-medicinal products as prescription-only medicines (POM). This effectively removes vital competition from the supply of products and adds further cost for farmers. In order to be consistent with the stated objectives of ‘prevention is better than cure’ and reduced antibiotic usage in farm animals, these regulations must ensure treatment and preventative medicines not containing antibiotics are readily and cost-efficiently available to farmers. This must be achieved by providing Member States with maximum flexibility in determining the categories and supply routes for veterinary medicines that do not contain antibiotics.
The lack of development of new veterinary medicinal products is a major concern for the sector. Categorising new veterinary medicinal products as POM for a period after licensing, will limit the availability of these products and increase their cost. New products not containing antibiotics should be available on licensing to farmers under the licensed merchant (LM) category where appropriate.
Bert said it is incumbent on the Minister for Agriculture Food and the Marine, Michael Creed, and our MEPs, to recognise the professionalism of farmers and their role in protecting the health and welfare of their animals. They cannot be hindered by increased costs and bureaucracy. He said the current proposals for veterinary medicinal products fail to adequately distinguish between antibiotics and all other products, which are key health and welfare products on farms.
In the context of appropriately addressing the antimicrobial resistance (AMR) concerns, Bert said the emphasis must be on competitive prices for key animal medicines, such as vaccines and doses. Limiting access to these types of products is counterproductive to reducing the use of antibiotics.
Bert said veterinary medicinal products are an expensive and vital annual input for farmers in protecting and maintaining the health and welfare of their animals. He said it is of critical importance that access remains in a competitive market with minimal bureaucracy.