European Platform for the Responsible use of medicines in animals
EPRUMA
EPRUMA facilitates and promotes a co-ordinated and integrated approach on the Responsible Use of Medicines in Animals.
ID: 174907742729-48
Lobbying Activity
Response to Critical Medicines Act
27 Feb 2025
EPRUMA is a multi-stakeholder platform operating since 2005, linking best practice with animal health, public health and environmental health. The platform has European organisations as members and national organisations as associate members, representing supply chains from animal breeding, to feed and animal health, farming, as well as pets. EPRUMA promotes prevention and responsible use of medicines in animal health by encouraging innovative and proactive efforts and implementation of best practices that support optimum animal health and welfare. The platform uses evidence-based information to promote disease prevention as well as responsible use of medicines, and has an ongoing focus on addressing antimicrobial resistance (AMR). EPRUMA works to promote recognition of the interdependence of human, animal and environmental health, fully embracing a One Health strategy. We would like to take the opportunity of this consultation on a Critical Medicines Act to recall the European Commissions support for the One Health approach. In this context , the challenges with medicines shortages should be considered simultaneously both for human and animal healthcare to fully support this One Health approach. As the manufacturing processes for both human and the animal medicines, and indeed the final products often use inputs in common (e.g. active pharmaceutical ingredients, raw materials, and intermediates), it is of extreme importance to prevent any inadvertent negative impacts on animal health and welfare stemming from the Critical Medicines Act. Access to a broad range of veterinary medicines is an essential element of disease prevention, ensuring responsible use of medicines, and maintaining our good stewardship efforts to contribute to the fight against antimicrobial resistance. Furthermore, shortages of critical veterinary medicines can in turn also negatively impact public health, a secure and sustainable food supply, and disrupt healthcare systems, consequently reducing trust in healthcare professionals across EU Member States.
Read full responseResponse to EU strategic Framework for Global Health
19 Sept 2022
The increasing world population means a growing demand for food. The growing population also means that the world is increasingly crowded and people inevitably are in closer contact with both domestic animals and wildlife. Other factors, including large-scale migration, international trade, and climate change, have meant that new diseases are occurring more often in parts of the world where they were previously unknown and likely unprepared. The ability to prevent such diseases spreading is increasingly important and should be a focal part of a global health strategy that follows a One Health approach.
EPRUMA – a multistakeholder platform comprising veterinarians, farmers and agri-cooperatives; manufacturers of animal medicines and diagnostics, feed manufacturers,
professionals working in animal health, sanitary security and sustainable agriculture – welcomes the opportunity to contribute to this call for evidence as it is widely recognised that around 60% of all human infectious diseases are zoonotic, meaning they can be transferred between animals and people either directly or through food products. And during the last three decades around three-quarters of emerging human infectious diseases – including SARS, Ebola, Zika and COVID-19 – have been zoonotic, mostly stemming from wildlife.
Our mission as EPRUMA is to promote Responsible Use of medicines in order to better manage animal diseases and support animal health and welfare, while contributing to food safety, safeguarding public health, and encouraging sustainable food production. We therefore welcome the commitment of the EU to bring forward a strategy based on human rights and health equity as well as highlighting the importance of the interconnection between people, animals, plants, and their shared environment.
We believe that greater One Health cooperation is needed to control emerging infectious diseases that can cross the human-animal boundary. We would therefore encourage the EU to support collaboration between all disciplines and to encourage society to look at the three areas of public, animal and environmental health together so that their complexities and inter-relationships are taken into account.
A One Health approach is fundamental for proper crisis preparedness and response to different public health threats, such as infectious and non-infectious diseases, foodborne diseases, etc. We believe including the One Health approach in the global health strategy should also go beyond challenges such as disease control and addressing antimicrobial resistance, and into a greater recognition of the role healthy animals play in terms of a safe and secure food supply, more sustainable farming practices, and even companionship and assistance for health needs.
Implementation of One Health and cross-sectoral collaboration will require proper education at all levels. Education and training for both medical doctors and veterinarians must go hand-in-hand with capacity building to prevent, control and manage disease outbreaks in animal reservoirs in conjunction with environmental professionals. Professionals in all three domains will also require the necessary tools and training to work collectively at the human-animal-environmental interface.
Above all the EU should ensure that the 'One Health' approach is applied comprehensively, as this approach will impact the level of success for any other action to be taken. Additionally, we believe the EU should engage with interdisciplinary representation in all international forums and initiatives and strive to be a leading advocate of One Health while ensuring transparency, and open-minded decision-making on fit-for-purpose health solutions.
Read full responseResponse to List of antimicrobials reserved for treatment of certain infections in humans
16 May 2022
EPRUMA welcomes the opportunity to provide feedback on the draft Implementing Act for reserved antimicrobial treatments for infections in humans.
As a multi-stakeholder platform of European veterinarians, farmers and agri-cooperative, manufacturers of animal medicines and diagnostics, feed manufacturers, and professionals working in animal health, sanitary security and sustainable agriculture, we believe that the health of animals plays an important role in the One Health triad.
Just like people, animals can get sick and require medicines. Specific important antimicrobials are needed for animal health in order to treat certain diseases, not only to restore animal health and welfare, but equally important to prevent spread of disease further to animals and people. Veterinarians are highly educated to evaluate the health condition of animals under their care, to diagnose and to prescribe the necessary treatment in the same way that doctors do for people. They are additionally well-aware of the mechanisms leading to the development of antibiotic resistance and the risks for animals and people in the same way that doctors are for people.
With this in mind, EPRUMA welcomes the thorough scientific assessment undertaken by the European Medicines Agency to develop the recommendation for reserve antimicrobials. This opinion developed by experts in both human and veterinary medicine coming from the different Member States, experts from ECDC, EFSA and EMA itself, alongside international experts from the WHO and OIE. We also welcome that in the drafting of this Implementing Act the European Commission has followed the EMA scientific advice in full.
We believe that this draft Implementing Act is in line with the EU’s One Health approach to addressing the challenge of antimicrobial resistance, and that the annexed list of antimicrobials reserved for humans is in line with Regulation (EU) 2019/6 on veterinary medicines which further restricts antimicrobial use for veterinary purposes.
It should be noted that this list with reserved antimicrobials for human use is only one of the tools implemented by the new regulation on veterinary medicines. The new regulation presents a holistic strategy for enhancing responsible use and minimising disease. EPRUMA partners are committed to making the EU the best practice region in line with the EU Action Plan on AMR and continue their efforts to raise awareness on the responsible use of all medicines in animals. Programmes exist in many Member States to reduce the need to use important antimicrobials in veterinary care and further changes are being implemented in animal husbandry to prevent diseases that require treatment with important antimicrobials. Such proactive efforts have seen increased Responsible Use not only as regards the amounts of antibiotics used, but also as regards the classes of antibiotics used for veterinary purposes. For example, the latest ESVAC report records continued decreases in sales of antibiotics regarded as medically important for humans, e.g.: 32.8% for 3rd- and 4th-generation cephalosporins; 76.5% for polymyxins, 12.8% for fluoroquinolones and 85.4% for other quinolones between 2011-2020.
EPRUMA partners are strongly committed to the fight against AMR and underline that the ultimate goal is to reduce antimicrobial resistance, which can only be achieved through science-based solutions and enforcement of responsible use of antimicrobials in all sectors. EPRUMA calls on the European Commission to trust its scientists and continue to work together with all stakeholders on making the EU a best practice region.
Read full responseResponse to Recommendation for strengthened actions against antimicrobial resistance
24 Mar 2022
EPRUMA is a multi-stakeholder platform working at European level since 2005 formed of veterinarians, farmers and agri-cooperatives, manufacturers of animal medicines and diagnostics, feed manufacturers, and professionals working in animal health, sanitary security and sustainable agriculture.
Our proactive efforts to facilitate and promote a coordinated and integrated approach to raising awareness on the Responsible Use of veterinary medicines, including antimicrobials, have included the development of best practice frameworks for antimicrobial, anthelmintic and vaccine use in animals. We have widely promoted through national partners and members of partner associations the holistic care of animals to minimise disease through a set of actions, fostering the use of antibiotics as little as possible, and only when necessary. These measures include:
• biosecurity;
• good housing and ventilation;
• good hygiene;
• appropriate nutrition;
• regular monitoring of health and welfare;
• animal health planning;
• use of diagnostics;
• vaccination; and
• using and maintaining the pharmacovigilance system.
Adherence to these principles has led to measurable, successful outcomes across Europe. As recorded in the latest European Surveillance of Veterinary Antimicrobial Consumption (ESVAC) report, we see an overall decline of 43.2% in sales of veterinary antimicrobials. The latest report from 2021 also shows a noticeable decrease in sales identified for some of the highest-selling countries.
Moreover, our awareness-raising efforts have seen increased Responsible Use not only as regards the amounts of antibiotics used, but also as regards the classes of antibiotics used for veterinary purposes. The latest ESVAC report outlines continued decreases in sales of antibiotics regarded as medically important for humans, e.g.: 32.8% for 3rd- and 4th-generation cephalosporins; 76.5% for polymyxins, 12.8% for fluoroquinolones and 85.4% for other quinolones.
When it comes to recommendations for greater action, we believe that the new EU Regulation on Veterinary Medicines (2019/6) which came into force in January this year will serve to foster further action for Responsible Use in the animal sector. Additional measures in these new rules such as: strict rules on prophylaxis and metaphylaxis; the reservation of certain antimicrobials for use in human medicine; more detailed collection of antimicrobial use data; support for innovation in preventive medicines and measures such as vaccines and biosecurity will help in several ways.
• Improved data collection will support a better understanding of why antimicrobials are used, in what species they are used, and what infections they’re needed for.
• Increased options and support for preventive measures on farms will help to improve animal health and reduce the need to use antimicrobials.
Greater research into potential for transfer of resistance between animals and humans would also be recommended to better understand where efforts should be focused further. As stated by ECDC, 75% of the health burden of AMR in EU and EEA countries is due to health care associated infections. Further research into the occurrence of AMR development in both humans and animals will help to ensure we take the correct measures in all settings to ensure the continued efficacy of antimicrobials.
In conclusion, we believe that given the successes recorded so far in the animal sector, our best-practice frameworks and awareness-raising efforts can serve as an example for further encouraging better preventive measures and increased Responsible Use of antibiotics in all sectors, in a One Health approach. EPRUMA partners remain active within a number of projects at EU level to take further action (AVANT, DISARM, Roadmap, Healthy Livestock) and we reiterate our sustained commitment to continue playing our part in tackling the global challenge of AMR in a One Health manner.
Read full responseMeeting with Stella Kyriakides (Commissioner)
24 Jun 2021 · VTC Meeting on AMR and implementation of the new veterinary medicinal products regulation.