Roxane Feller, Secretary General of AnimalhealthEurope, informs us about the new EU regulations for veterinary medicines to support a more responsible use of antibiotics
The new EU rules on veterinary medicines, which will come into force in January 2022, are widely promoted by the European Commission as a key tool in addressing the antibiotic resistance (AMR) challenge.
In addition to reducing the administrative burden, this was one of the objectives pursued; Stimulating innovation; Improve the functioning of the internal market and improve the availability of veterinary medicines. These goals had the common goal of promoting the development of suitable medicines for all animal species and making a wider range of medicines available in all EU countries.
Optimization to improve availability and coverage
Changes to encourage innovation and increase the availability of animal health care options include streamlining a number of key processes to reduce the administrative burden on veterinary drug manufacturers. The most important of these changes is the abolition of the 5-year license renewal system, supported by changes in the pharmacovigilance system for reporting side effects of drug use. The new regulations put an end to the current periodic safety reports that marketing authorization holders had to submit regularly, even if there was nothing to report.
Side effects are now only reported via a signal management system when they occur and are stored centrally in the EU pharmacovigilance database, which also contains the relevant information on pharmacovigilance contact persons and marketing authorization holders. This is directly linked to the EU product database, in which companies report their annual product sales and will be accessible to the general public for complete transparency on the safety management of products.
The increase in the availability of pharmaceuticals and the facilitation of the internal market are also being driven by changed approval procedures. The centralized EU procedure, which provides EU-wide authorization to place a product on the market, is now open to all types of products, not just those that have been classified as novel products as before. All approval applications are also processed electronically via a central e-submission platform in order to simplify the process.
Deliver when addressing AMR
Aside from supporting innovation and improving availability, the new rules provide an improved capacity to combat antimicrobial resistance. And the European Commission has hailed them as a facilitator in helping farmers achieve the ambitious targets proposed in the EU’s Farm to Fork strategy to reduce antimicrobial use and sales by 50% by 2030.
With regard to the use of antibiotics, a number of changes come into force in the new rules, with a key element to establish a list of antibiotics for human health based on scientific advice from the European Medicines Agency. Member States also have the power to further ban the use of certain antibiotics in animals, but the measures must be proportionate and reasoned and the Commission must be informed when such measures are taken. For animal welfare, it is important that veterinarians retain the right to treat certain diseases in animals with the appropriate antibiotic if necessary.
As today, all antibiotics for animals are prescription-only across the EU. However, the new rules relate more clearly to regulations on the preventive use of antibiotics. Antibiotics cannot be used for prevention (prophylaxis), except in a single animal or a limited number of animals, when the risk of infection is very high and the consequences are likely to be severe. And antibiotics may only be used for group treatment (metaphylaxis) if the risk of spreading an infection or infectious disease already present in the animal group is high and no other suitable alternatives are available.
The prescription of antibiotics for metaphylaxis should only be limited in time to the period of risk of infection and limited to small groups of animals only after the veterinarian has diagnosed the infectious disease. Antibiotic prescriptions must also include all of the warnings necessary to use antibiotics responsibly and are only valid for 5 days from the date of issue.
As is currently the case, the routine use of antibiotics to compensate for poor industrial hygiene, poor husbandry, care or management is not permitted. The ban on the use of antibiotics to promote growth or increase yields, which has been in force since 2006, will also be retained. Another point of the new rules is that these restrictions on the use of antibiotics and the ban on the use of treatments classified as important for human health also apply to manufacturers in third countries who export animals or food of animal origin to the EU.
It will surely be interesting to see how these rules come into play in 2022 and beyond, and how they can affect animal health around the world!