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AnimalhealthEurope

AnimalhealthEurope represents manufacturers of veterinary medicines, vaccines and animal health products across Europe.

Lobbying Activity

Meeting with Maria Walsh (Member of the European Parliament)

5 Dec 2025 · Agricultural Policy

Meeting with Elsi Katainen (Member of the European Parliament)

27 Nov 2025 · Animal welfare

Meeting with Jessika Van Leeuwen (Member of the European Parliament)

26 Nov 2025 · Competitiveness, Preparednes, Eu vaccination strategy

Meeting with Ana Vasconcelos (Member of the European Parliament)

26 Nov 2025 · Animal Health

Meeting with Cristina Maestre (Member of the European Parliament)

26 Nov 2025 · EU Vaccination Strategy and Preparedness, and Health Resilience and Security for Animals

Meeting with Catherine Geslain-Laneelle (Director Agriculture and Rural Development) and Federation of Veterinarians of Europe

24 Nov 2025 · Representation in advisory groups, notably the Livestock workstream

AnimalhealthEurope urges simplified organic rules to improve animal welfare

18 Nov 2025
Topic — This consultation updates EU organic production rules to address trade and simplification.
Message — The organization requests exempting vaccines from mandatory 48-hour waiting periods. They also want easier access to pain relief and support for vaccination alternatives to castration.12
Why — This would increase the commercial viability and use of veterinary products in organic farming.3
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AnimalhealthEurope seeks dedicated funding for veterinary sector resilience

12 Nov 2025
Topic — The consultation explores EU funding priorities for competitiveness in the next long-term budget.
Message — The association requests dedicated funding for animal vaccination, vaccine development, and digital health tools. They urge the inclusion of the veterinary sector in biotech-related programs and the EU4Health initiative. Additionally, they call for investment in the Union Product Database to streamline regulatory requirements.12
Why — This would lower compliance costs for manufacturers and strengthen their global market position.34
Impact — Public health preparedness and food security are compromised if animal health funding is neglected.5
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Animal Health Industry Urges EU to Fund Disease Preparedness

6 Nov 2025
Topic — EU budget for civil protection and health emergency preparedness post-2027.
Message — The organization requests that the regulation include flexible funding for animal health preparedness and response to disease outbreaks. They emphasize that 60% of human infectious diseases originate from animals, making animal health protection essential for overall health security.123
Why — This would provide funding for their members' vaccines and medical products for animals.45
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AnimalhealthEurope Urges One Health Integration in EU Crisis Plan

29 Oct 2025
Topic — The EU is establishing a coordinated response plan for cross-border health security threats.
Message — They request including animal health as a strategic pillar in the response plan. The group also calls for faster regulatory assessments and expanded veterinary vaccine banks.12
Why — Public procurement and vaccine banks would reduce financial risks for veterinary medicine manufacturers.3
Impact — Environmental regulators lose the power to restrict chemicals when medical preparedness takes priority.4
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Meeting with Eva Maria Zamora Escribano (Head of Unit Health and Food Safety) and Access VetMed

29 Oct 2025 · First of regular meetings with stakeholders. - Supporting innovation - Optimising the application of Regulation (EU) 2019/6 - Fighting antimicrobial resistance

Veterinary vaccine manufacturers call for better EU bluetongue monitoring and vaccination strategy

21 Oct 2025
Topic — Reclassification of bluetongue virus from Category C to Category D+E disease.
Message — The organization accepts the reclassification but calls for better EU-wide bluetongue monitoring systems, harmonized vaccination strategies, simplified vaccine regulations, and regular dialogue between industry and authorities. They emphasize the need for predictive systems and serotype-specific surveillance.1234
Why — This would help manufacturers better allocate manufacturing capacity and R&D efforts.5
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AnimalhealthEurope pushes for reduced administrative burden in animal health

14 Oct 2025
Topic — The European Commission is seeking ways to reduce administrative burdens in food safety.
Message — The group wants veterinary medicines included in simplification efforts to reduce double reporting. They propose replacing paper leaflets with digital versions to increase efficiency.12
Why — The sector would save millions in compliance costs and reduce packaging waste.34
Impact — National regulators would lose direct oversight through their own market monitoring platforms.56
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Response to Integrated farm statistics for the period 2030-2039

9 Sept 2025

We welcome the recognition that EU action is therefore necessary to obtain comparable information about EU agriculture. This is particularly important for animal health data, which remains underrepresented despite its central role in sustainable farming, food safety, and animal welfare. The need for harmonised, granular, and actionable data is just as critical in the animal health domain as it is for crop production and environmental indicators. Connected health Connected health is not only about technologies, but also about connecting people and information within a system the animal healthcare system. Technology is vital and exciting but it is just one part of the picture that includes healthcare pathways, business and revenue models, data analytics and more. Connected health consolidates information from many different spheres of one animals world (biological, medical, identification, management, behavioural, etc) to give a more complete picture of their health. Medical intelligence can, this way, benefit not only sick animals but healthy ones as well. At farm level, data reports that reveal trends within animal groups enable farmers to make timely decisions. The 1st age of data-driven farming was reporting on what happened, the 2nd age is real-time analytics on what is happening. The 3rd age will be predictive analytics on what is likely to happen. This can be particularly relevant in the context of the Animal Health Visits previewed in the Animal Health Law. Preparedness, prevention and control can be strong allies to minimise the animal welfare and economic impacts of disease. How is it going for statistics on animal health? The number of European Commissions farm-related data initiatives which are apparently not connected are quite significant. Examples of a siloed approach are the AgriDataspace, the Farm Sustainability Data Network (FSDN), the EU Food System Monitoring Dashboard, Eurostat, the Animal Disease Information System (ADIS), the European Partnership on Animal Health and Welfare (EUPAH&W) Knowledge Platform and the Digi4Live project. To those, we can add data initiatives at Member State level, like the Classyfarm Database or the support for Animal Welfare reported through the Agri-food data portal on CAP. This siloed approach and the low coverage of statistics on animal health limits our ability to assess animal health investments and progress. We lack clarity on: -Which solutions were supported (e.g. vaccines, digital tools, health plans) -How much funding was allocated to each -The uptake of innovative animal health solutions Unleashing the power of data and AI AI can play a significant role in avoiding duplications and reducing administrative burden, but to truly unlock the potential of AI the European Commission needs to: Guarantee access to data which can be used for machine learning Ensure the data used respects Q-FAIR principles (Quality, Findable, Accessible, Interoperable, Reusable) Harmonise data collection, providing guidance on terminology and data formats for example Avoid duplication of reporting obligations Consider compensation mechanisms for data providers Our recommendations to prepare the EU integrated farm statistics (2030-2039) Legislative Proposal To ensure the EU Integrated Farm Statistics (20302039) support meaningful animal health insights, we recommend: 1) Map all the EU data initiatives that farmers, veterinarians and any other relevant professionals or stakeholder groups are inputting to 2) Map other existing sources of data that would allow to measure progress in improving animal health outcomes 3) Identify the duplications and corresponding opportunities of simplification and/or harmonisation 4) Identify relevant data, which is currently not being collected, but could support the development of relevant, proportionate and realistic animal health indicators 5) Invest in stakeholder engagement as much as possible
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AnimalhealthEurope Urges CAP Support for Preventive Animal Vaccination

25 Jul 2025
Topic — The consultation concerns simplifying the implementation of the Common Agricultural Policy strategic plans.
Message — The association requests earmarked funding for disease outbreaks and financial incentives for preventive vaccinations. They also advocate for simplification benefits to be extended across all farm categories.123
Why — Directing public funds toward vaccinations would increase market demand for veterinary medicine manufacturers.45
Impact — Organic farms may lose their preferential regulatory status if larger conventional farms receive similar benefits.6
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Meeting with Maria Walsh (Member of the European Parliament)

23 Jul 2025 · Animal Health

AnimalhealthEurope urges EU to link animal welfare with health

16 Jul 2025
Topic — The European Commission is modernising legislation for on-farm animal welfare.
Message — The group argues that good animal health is the essential foundation for any welfare standards. They request that the legislation supports the use of vaccines, medicines, and digital tools to monitor animal condition.12
Why — Promoting veterinary medicines as welfare tools would secure long-term demand for their products.3
Impact — Global animal welfare could suffer if EU trade rules limit access to necessary medicines.4
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Response to Critical Medicines Act

4 Jul 2025

AnimalhealthEurope represents manufacturers of animal medicines, vaccines, and other animal health products across Europe. Our membership includes corporate and national animal health associations, innovators, generics, and companies of all sizes, covering 90% of the European market for animal health products. We welcome the opportunity of providing feedback on the commission proposal for a Critical Medicines Act. Our answer aims to: 1) highlight aspects that could potentially lead to inadvertent consequences for Veterinary Medicinal Products (VMPs) and how to avoid them 2) provide clear explanations and examples to illustrate the need to follow a One Health approach. Our feedback, which includes schemes and lists, can be found in annex.
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AnimalhealthEurope seeks more computing power for veterinary innovation

3 Jul 2025
Topic — A plan to triple EU data processing capacity and green AI infrastructure.
Message — The federation calls for coordinated investment in infrastructure and better access to scalable computing resources. They emphasize the need for regulatory alignment and sectoral guidance to advance AI in animal health.12
Why — Greater computing power would accelerate veterinary research and improve pharmaceutical safety monitoring.3
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Meeting with Benoit Cassart (Member of the European Parliament, Shadow rapporteur)

3 Jul 2025 · INI livestock

AnimalhealthEurope Urges EU Support for Animal Health Biotechnologies

18 Jun 2025
Topic — The initiative aims to create solutions for a circular and climate neutral European economy.
Message — The association requests financial support for farmers using vaccines and a coordinated EU vaccination strategy. They also advocate for digitizing product information and simplifying reporting through the Union Product Database.123
Why — Streamlining reporting and adopting electronic leaflets would reduce compliance costs and environmental footprints.45
Impact — Global trade partners face pressure to accept imports from vaccinated animals despite their own restrictions.6
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AnimalhealthEurope urges streamlined approvals for veterinary biotech products

11 Jun 2025
Topic — The EU Biotech Act aims to accelerate the transition of biotechnologies from laboratories to markets.
Message — The association requests simplified reporting and a one-stop shop for regulatory data. They also seek exemptions from GMO rules and more flexible clinical trials.123
Why — Streamlining regulations would lower administrative costs and accelerate the delivery of innovative treatments.4
Impact — Environmental groups may lose oversight if risk assessments for gene therapies are eliminated.5
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Response to Communication on the EU Stockpiling Strategy

9 May 2025

AnimalhealthEurope, the association representing the manufacturers of Veterinary Medicinal Products (VMPs), vaccines and other animal health products, is grateful to the DG for European Civil Protection and Humanitarian Aid Operations (DG ECHO) for the opportunity to provide feedback for this call for evidence. In the EU there is a limited budget to support antigen, vaccine and reagent banks for listed diseases, which are guided by Regulation (EU) 2016/429 of the European Parliament and of the Council of 9 March 2016 on transmissible animal diseases and amending and repealing certain acts in the area of animal health (Animal Health Law). In some cases, Member States have their own national solutions. Considering the recent DG SANTEs clarifications regarding the Critical Medicines Act, we interpret that Contingency Stocks represent an obligation imposed on supply chain actors to establish buffer stocks of certain medicines to mitigate the risk of supply disruption, while Stockpiling represents an obligation imposed on a (public) health institution in order to anticipate and manage a specific crisis. Keeping that in mind: 1) We would like to raise attention to the need to consider commonalities between supply chains for (Human) Medicinal Products and Veterinary Medicinal Products (VMPs), in order to avoid unintended consequences for animal health and, ultimately to public health. 2) We would like to emphasise that Veterinary Medicinal Products are strategic in the context of EU Preparedness and Health Security: To address zoonotic threats: VMPs help mitigate risks from and to animals, such as COVID-19, Avian Flu, and Q-fever. These zoonotic diseases can have significant impacts on both animal and human health, making preparedness essential to prevent outbreaks and manage crises effectively. Supporting food supplies: VMPs are essential for livestock medicines, ensuring the stability of food supplies. In times of crisis, maintaining a stable food supply is critical for societal resilience and preventing food insecurity. Supporting companion animal health: VMPs contribute to the emotional well-being of society, which can be critical in crisis situations. Companion animals play a significant role in providing emotional support, and their health directly impacts human mental health and societal stability. Critical resources in disaster management and war situation: VMPs are vital in crises such as natural or man-made disasters. Ensuring the availability of these medicines largely contributes for disease prevention, preparedness and control. There are several challenges with stockpiling in the context of vaccine banks but also with stockpiling of any other VMPs. Considering how essential is availability and access to animal medicines, the animal health medicines industry is open to, together with the EU authorities, addressing key points for consideration in our sector, namely: Procurement and/or other commercial drivers and guarantees to contributors Emergency situations (different threats need different approaches; demand size measure) Range of products covered (expansion of antigen, vaccine and reagent banks) Waste generation and destruction Complexity of regulatory compliance Traceability Warehouse space Limited production capacity Labels and leaflets in 24 official languages Double reporting and additional administrative burden Transition times Costs (our small and fragmented market; who pays the social responsibility bill?) Market distortions (Price inflation; Inequitable distribution) Furthermore, we call the Commission to evaluate existing and under development proposals to ensure coherence within the frameworks (specially between the EU Strategy to support MCM, the EU Stockpiling Strategy and the Critical Medicines Act).
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Response to EU Strategy on medical countermeasures

9 May 2025

AnimalhealthEurope, the association representing the manufacturers of Veterinary Medicinal Products (VMPs), vaccines and other animal health products, emphasizes the importance of animal health in the context of public health threats. Breaking the disease cycle before it reaches humans is crucial. We advocate for timely information, rapid and early decisions, accelerated regulatory assessments, EU coordination, and the involvement of private sector actors to strengthen the development and access to Medical Countermeasures (MCMs). We believe that this Strategy needs to properly adopt a One Health approach, starting by: Recognising that Veterinary Medicinal Products (VMPs) are strategic in the context of EU preparedness and health security: VMPs are essential for addressing zoonotic threats, supporting food supplies, and maintaining companion animal health. Considering the commonalities between supply chains for Medicinal Products and VMPs to avoid unintended consequences for animal health and public health. Furthermore, we believe that establishing a formal platform for collaboration between industry and authorities is essential for effective disease prevention, preparedness and control. Finally, we call the Commission to evaluate existing and under development proposals to ensure coherence within the frameworks (specially between the EU Strategy to support MCM, the EU Stockpiling Strategy and the Critical Medicines Act). You can find our detailed answer attached.
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Meeting with Alisa Tiganj (Cabinet of Commissioner Christophe Hansen) and European farmers and

30 Apr 2025 · • ELV five recommendations for the Vision for the Future of EU Agriculture and for the mandate • Presentation of ELV (European Livestock Voice) • Exchange of views: Vision for the future of Livestock • EU Trade policy review: State of play

Meeting with Vilija Sysaite (Cabinet of Executive Vice-President Stéphane Séjourné)

29 Apr 2025 · Reach, simplification

Meeting with Alisa Tiganj (Cabinet of Commissioner Christophe Hansen), Antonella Rossetti (Cabinet of Commissioner Christophe Hansen) and

29 Apr 2025 · Role of animal health sector in contributing to a sustainable livestock sector in the EU; Trade and animal health and agricultural policies; Upcoming livestock strategy: content and timeline; Digitalisation in support of farmers

AnimalhealthEurope urges EU vaccination strategy and regulatory simplification

16 Apr 2025
Topic — The EU consultation focuses on boosting life sciences competitiveness and reducing innovation dependencies.
Message — They urge a coordinated EU response through a specific strategy on vaccination. They advocate for simplifying reporting requirements and improving digital product databases.12
Why — Reducing administrative complexity would help the industry focus on its core business.34
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Meeting with Maria Walsh (Member of the European Parliament)

4 Apr 2025 · Agricultural Policy

Meeting with Olivér Várhelyi (Commissioner) and

31 Mar 2025 · Meeting with representatives of AnimalhealthEurope

AnimalhealthEurope urges One Health approach for critical medicine supplies

27 Feb 2025
Topic — The initiative aims to secure supply chains for medicines essential to European public health.
Message — The organization calls for the inclusion of veterinary medicine supply chains in the Critical Medicines Act. They advocate for a One Health approach that recognizes the shared raw materials between human and animal drugs.12
Why — This would protect the animal health sector from supply shortages caused by human-centric regulations.3
Impact — Public health is at risk if neglected animal health leads to zoonotic disease outbreaks.4
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Meeting with Eva Maria Zamora Escribano (Head of Unit Health and Food Safety)

27 Feb 2025 · Public feedback on the draft Implementing Regulations on good manufacturing practice for veterinary medicinal products and for active substances used as starting materials for veterinary medicinal products – Regulation (EU) 2019/6, Article 93(2)

Response to Uniform rules on good manufacturing practice for veterinary medicinal products and active substances

19 Feb 2025

AnimalhealthEurope is happy to provide a few comments on the draft IA on GMPs of Veterinary Medicinal Products in the attached document.
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Response to Rules on good manufacturing practice for active substances used as starting materials in veterinary medicinal products

19 Feb 2025

AnimalhealthEurope is happy to provide the European Commission with a few comments on the draft Implementing act on Good Manufacturing Practice for active substances used as starting materials in veterinary medicinal products. These comments can be found in the attached document.
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Meeting with Eva Maria Zamora Escribano (Head of Unit Health and Food Safety) and Access VetMed

31 Jan 2025 · Informative session on the development of the draft Implementing Regulations on good manufacturing practice for veterinary medicinal products and for active substances used as starting materials for veterinary medicinal products

Meeting with Hildegard Bentele (Member of the European Parliament, Shadow rapporteur)

21 Jan 2025 · Surface water and groundwater pollutants

Meeting with Ana Vasconcelos (Member of the European Parliament)

9 Dec 2024 · Protection of animals during transport and related operations

Meeting with Maria Noichl (Member of the European Parliament, Shadow rapporteur)

12 Nov 2024 · Animal health

Meeting with Marta Temido (Member of the European Parliament)

24 Oct 2024 · A One Health Strategy for a healthier and more sustainable Europe

Meeting with César Luena (Member of the European Parliament)

24 Oct 2024 · PFAS, One health approach

Meeting with Veronika Vrecionová (Member of the European Parliament, Rapporteur) and Merck Sharp Dohme Europe Belgium SRL

23 Oct 2024 · Animal health and welfare in legislative term

Meeting with Benoit Cassart (Member of the European Parliament)

23 Oct 2024 · Situation sanitaire dans l'agriculture

Meeting with Stefan Köhler (Member of the European Parliament) and BASF SE and Bayer AG

23 Oct 2024 · Politischer Austausch

Response to Commission Roadmap to phase out animal testing

14 Oct 2024

AnimalhealthEurope is the association representing manufacturers of animal medicines, both veterinary pharmaceuticals and vaccines, and suppliers of other animal health products in Europe. These products require regulatory safety testing for the animal patient, the consumer (of animal produce), the user and the environment. Consequently, we are highly motivated to contribute to the Commission roadmap by sharing our expertise and specificities of our sector in the areas where we use animal testing for safety assessment of chemicals outside of the target species. AnimalhealthEurope welcomes the opportunity to provide feedback to the Call for evidence on the European Commissions roadmap to phase out animal testing in chemical safety assessments. AnimalhealthEurope firmly supports the principles of the European Commissions initiative to develop this Roadmap and to phase out animal testing wherever possible and would like to provide more details in the attached feedback, including on our sectorial roadmap.
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Response to Interim Evaluation of Digital Europe

20 Sept 2024

AnimalhealthEurope welcomes the opportunity to provide feedback on the interim evaluation of the Digital Europe Program. As the association representing developers and manufacturers of animal medicines, vaccines, and suppliers of other health products in Europe, innovation and digitalisation are top priorities for our members. To help the animal health sector better adapt to the digital ageespecially in agriculture and companion animal caremore support is crucial. Of the six key capacity areas in the Digital Europe Program, we are particularly focused on two: - Adoption and best use of key digital technologies There is a clear need to reinforce the adoption of new technologies across the animal health sector. Our members are already contributing digital solutions, particularly in disease prediction and monitoring. However, current socio-economic challenges in the EU are hindering wider adoption, making it difficult to achieve optimal rates of implementation. - Advanced digital skills We also recognize the increasing demand for advanced digital skills. The animal health sector needs to attract more engineers and developers to drive innovation and meet the growing digital needs. As demonstrated through our Connected Health platform, our members are making the difference in the farming sector, positioning digitalisation as a solution to animal health complex challenges: - Sensors used to detect the chewing activity (rumination) of cows can detect disease as much as 5 days before clinical signs of a disease are detected. - Calving prediction technologies give alerts from 6 to 12 hours in advance of calving, reducing calf mortality and improving fertility in dairy cattle. - Use of data captured via live video camera footage can be fed into an algorithm to warn free-range poultry farmers when birds should be kept indoors to minimise the risk of introducing avian influenza. - New sound monitoring technology for indoor pig farms help pig farmers to detect and respond to respiratory disease up to five days earlier than conventional methods, reducing the need for antibiotic treatment. - Smart collars with monitoring technologies linked to a phone app help farmers to accurately identify the various stages of dairy cow fertility, filtering out any false heats, and accurately detecting up to 95% of real heats, improving farm efficiency and reducing milk production losses. Furthermore, we welcome the possibility to develop and market products making use of e-leaflets as provided for in the Regulation 2019/6 on VMPs. It will not only enhance product availability but also bring significant environmental benefits by reducing waste, aligning with sustainable practices, and demonstrating a strong commitment to environmental stewardship. This is a new area for veterinary medicines which will open new perspectives in terms of contents that are not always possible on paper versions (such as e.g. use of non-commercial videos with instructions for use...), but for which rules and skills are necessary to help in its implementation. These are just examples of how our sector can, with your help, boost productivity with digital tech diffusion, contribute to a Preparedness Union and strengthen EU's Competitiveness, as aspired by Ursula von der Leyen in her Political Guidelines and the Members States in their Strategic Agenda. We believe that ensuring a wide development and use of digital technologies across the animal health sector, largely contributes to our 3 strategic focus areas: - One Health - Innovation - Sustainability In conclusion, to maximise the impact of EU investment, we defend that investing in digital solutions for animal health should be among the funding priorities. Not only to raise our standards of care and welfare in the EU, but also to better protect public health.
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Response to Export and import of hazardous chemicals - review of the list of chemicals subject to international trade rules

16 Aug 2024

AnimalhealthEurope welcomes the opportunity to provide feedback to the draft Delegated Regulation amending Regulation (EU) No 649/2012 of the European Parliament and of the Council as regards the listing of pesticides and industrial chemicals (PIC Regulation). AnimalhealthEurope is the association representing manufacturers of animal medicines, vaccines and suppliers of other animal health products in Europe. By preventing and managing the spread of animal diseases, the animal health industry is actively participating to environmental protection. The One Health approach, acknowledging that human, animal and plant health are interdependent and bound to the health of the ecosystems in which they exist is among AnimalhealthEuropes driving principles. AnimalhealthEurope believes that the restrictions on the renewal of substances used in the Europe should be applied in a fair, proportionate and equitable way and that it why we would like to present the attached information.
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Meeting with Alexander Bernhuber (Member of the European Parliament)

18 Jul 2024 · Future of animal farming

Meeting with Benoit Cassart (Member of the European Parliament)

17 Jul 2024 · Livestock

AnimalhealthEurope seeks clinical trial protections in welfare overhaul

10 Apr 2024
Topic — The European Commission is revising legislation on animal welfare during transport and commercial trade.
Message — The group wants to ensure that new welfare rules do not accidentally impede mandatory veterinary clinical trials. They also recommend lowering thresholds for exemptions to prevent small breeders from avoiding health standards. Finally, they suggest allowing trained staff to supervise loading due to veterinarian shortages.1234
Why — This would protect the pharmaceutical industry's drug approval processes from legal uncertainty and delays.5
Impact — Small breeders and pet shops would face higher costs by losing their regulatory exemptions.6
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AnimalhealthEurope urges removing GMOs from chemical data platform

4 Apr 2024
Topic — This consultation proposes a common platform for sharing and reusing chemical safety data.
Message — The group requests removing genetically modified organisms and medicated feed from the scope. They argue the regulation should only share existing data without creating new reporting burdens. Finally, they insist on protecting confidentiality rules currently managed by the medicines agency.12
Why — This would lower compliance costs and prevent confusion between chemical and biological rules.3
Impact — Regulatory agencies face heavy workloads that could compromise their ability to perform core duties.4
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AnimalhealthEurope Calls for More Vaccine Investment and Harmonised Rules

2 Apr 2024
Topic — An evaluation of the EU framework for managing transmissible animal diseases.
Message — The federation calls for a frequent update of tracked diseases and more funding for vaccine banks. They want the EU to foster an environment that encourages research and investment in new veterinary tools. Finally, they urge for harmonised veterinary visits to ensure consistent monitoring across Europe.123
Why — Standardised rules and more funding would increase demand for their veterinary products.45
Impact — Member States would lose flexibility to set independent rules on animal medicines.67
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Response to Welfare of dogs and cats and their traceability

14 Mar 2024

AnimalhealthEurope welcomes the opportunity to provide feedback to the public consultations on the Welfare and traceability of dogs and cats and on Animal welfare protection of animals during transport. AnimalhealthEurope is the association representing manufacturers of animal medicines, vaccines and suppliers of other animal health products in Europe. The health and the welfare of animals are intrinsically linked and for this reason animal welfare is a priority for AnimalhealthEuropes members. We would therefore like to further develop our feedback in the attachment.
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Response to Evaluation of the Regulation on serious cross-border threats to health

12 Feb 2024

We welcome the opportunity to provide feedback. AnimalhealthEurope represents manufacturers of animal medicines, vaccines and suppliers of other animal health products in Europe. According to WOAH, approximately 75% of emerging human infectious diseases have been zoonotic. We consider that animal health has an essential role to play in controlling serious cross border threats. It is therefore essential to prevent and limit the development of animal diseases. For example, just as vaccines do for humans, vaccines for animals help prevent many serious and sometimes fatal diseases in all species (including humans). Vaccines for pets can help protect humans from infections such as Rabies and Leptospirosis; assurance of geographical law compliance; vaccination is a cost-effective option compared to treatment of any infectious diseases. Many animal vaccinations also serve a public health function by forming a barrier against zoonotic diseases affecting animals and humans. Animal vaccines have been helping Europe to protect its citizens successfully for many years now, preventing zoonotic diseases and managing many food-borne illnesses. Although still present in Europe, food-borne illnesses posed serious threats to food safety and public health some years ago, but f.e. the early 2000s saw a 50% reduction in salmonella cases in people thanks to vaccine use in chickens. Protecting animals through vaccination and other prevention methods halts transmission and slows further spread. Working together, industry and authorities can respond rapidly to halt or slow transmission of existing and newly emerging diseases, such as Lumpy Skin Disease in cattle which was halted in south-east Europe just a few years ago, largely thanks to a regional vaccination programme. The lumpy skin disease virus was believed not to be zoonotic in nature. However, a recent human infection in Cairo, Egypt, proved that LSD is communicable to humans. Since LSD has emerged as a zoonosis, proper care must be observed by the staff working with livestock, especially cattle, to check the spread of infection. Where preventive methods for certain diseases are not yet available, the manufacturers of animal health products continue to invest in research and development that will ultimately lead to the production of safe and effective vaccines. To accomplish that, our position is: 1. The producers of animal health products need to be informed in due time about the need for vaccination and the required quantity, leaving time for development and manufacturing of vaccines. 2. Beyond providing adapted requirements for application in exceptional circumstances (Reg. (EU) 2019/6 on veterinary medicinal products), every step of the regulatory assessment must also be accelerated in order to ensure timely availability of products. In the meantime, our members are investing in products that can help monitor and control the spread of animal diseases such as rapid diagnostics and biosecurity tools. Looking towards the future: 1.there is an urgent need for European coordination to ensure any vaccine produced will be used 2.vaccination is a key, important long-term solution within the context of pandemic preparedness 3.it's important to involve the private sector actors at an early stage. Any future systems should build on the private sectors R&D, manufacturing, and distribution capacity. 4.more flexible regulatory systems that facilitate rapid responses, including better regulatory cooperation between countries for faster approvals are needed. Easier, more rapid access to pathogens and genetic sequence data should be facilitated. We also suggest the creation of a truly operative public-private sector platform that serves as early warning and planning mechanism to enable timely government decisions and commitments, which in turn will enable timely and risk-based industry efforts to pre-empt emergency situations and successfully prevent full materialisation of pandemic risk.
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Response to Rules on appropriate measures to ensure effective and safe use of veterinary medicinal products for oral administration

10 Jan 2024

AnimalhealthEurope welcomes the opportunity to provide comments to this draft delegated act. We have concerns on some aspects of the delegated act which are detailed in the attached submission
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Response to Uniform rules on the size of small immediate packaging units for veterinary medicinal products

15 Dec 2023

AnimalhealthEurope welcomes the opportunity to provide feedback to this draft implementing regulation on the rules of labelling on small immediate packaging to used on the labeling and packaging of veterinary medicinal products, article 17 (3) of Reg. 2019/6. Our comments are enclosed in a separate pdf file attached. Should something be unclear, please contact us. Many thanks.
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Response to List of abbreviations and pictograms to be used on the labelling of veterinary medicinal products

15 Dec 2023

AnimalhealthEurope welcomes the opportunity to provide feedback to this draft implementing regulation on the list of abbreviations and pictograms to be used on the labeling and packaging of veterinary medicinal products, article 17 (2) of Reg. 2019/6. Our comments are enclosed in a separate pdf file attached. Should something be unclear, please contact us. Many thanks.
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Meeting with Joanna Stawowy (Cabinet of Commissioner Janusz Wojciechowski)

12 Dec 2023 · Digitalisation of agriculture; Livestock farming advancements; Overview of the NSP (National Strategic Plans) that have taken up digitalisation and animal health

AnimalhealthEurope Urges Streamlining of Veterinary Medicine Reporting Rules

28 Nov 2023
Topic — The European Commission initiative aims to reduce business reporting requirements by 25 percent.
Message — The association proposes removing redundant pharmacovigilance statements and extending the timeline for reporting minor product variations. They also request exempting the animal health sector from new packaging waste regulations for an interim period.123
Why — These changes would reduce operational costs and prevent a double burden of compliance.45
Impact — National regulators might have less frequent data, and environmental goals face implementation delays.67
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Response to Waste Framework review to reduce waste and the environmental impact of waste management

21 Nov 2023

We welcome the possibility to provide feedback to this consultation. At the European Parliament level, we noticed some push from different political groups to include primary production. This said, and if option 3 will be chosen, Animal Health can be one of the most important allies to achieve the legally binding target of 10% for the primary production. According to WOAH, approximately 20% of animal production losses are attributable to animal diseases. The prevention and treatment of diseases not only safeguard animal health but also mitigate animal mortality, thus reducing food loss. Healthy animals are efficient resource users, requiring fewer inputs such as feed, water, energy, and land to produce a secure supply of fish, meat, milk, and eggs. Livestock, for instance, efficiently utilize crop by-products, with 86% of their feed composed of materials inedible by humans, making them excellent up-cyclers. AnimalhealthEurope members are committed to reduce food loss, not only through treatment solutions, but also through prevention: ->Vaccination ensures higher welfare, less illness and deaths, making more efficient resource use -A single dose vaccine for avian influenza for 1-day old chicks, show an immunity duration of at least 20 weeks, preventing the development of disease, reducing the need for culling and the ensuing food losses -A single dose vaccine against calf scour - a common disease in dairy herds - administered to the cow prior to calving helps provide immunity to calves through the maternal colostrum -Fish vaccination enables more resource-friendly aquafarming ->Data-driven management decisions with Precision Livestock Farming techniques support farmers in sustainable food production, avoiding food losses and waste at farm level -A new diagnostic technology used for diagnosis of Q Fever is making diagnosis easier, leading to better management of the disease in herds -Use of data captured via live video camera footage can be fed into an algorithm to warn free-range poultry farmers when birds should be kept indoors to minimise the risk of introducing avian influenza -New sound monitoring technology for indoor pig farms help pig farmers to detect and respond to respiratory disease up to five days earlier than conventional methods -Smart collars with monitoring technologies linked to a phone app help farmers to accurately identify the various stages of dairy cow fertility, filtering out any false heats, and accurately detecting up to 95% of real heats, improving farm efficiency and reducing milk production losses -Calving prediction technologies give alerts from 6 to 12 hours in advance of calving, reducing calf mortality and improving fertility in dairy cattle Controlling food loss due to animal disease contributes to all the 3 dimensions of sustainability: -Economic: PRRSv cost in the US was estimated at $664 million annually and, in Europe, if the farm was severely affected in all stages annual losses ranged from a median of 650.090. Bluetongue virus, Sheep and Goat Pox and HPAI can also be taken as examples of disease impact -Social: 800 million people dont get enough protein. Animal medicines help improve food yields, contributing to the supply of affordable protein. Livestock provides 18% of global calories and 39% of global protein. Vaccination and preventive animal health care creates more reliable food supplies. Also, animal health is one of the pre-requisites for achieving animal welfare -Environmental: Healthy animals are not only well-cared for, but they also have a smaller environmental footprint. In FAO's report The role of animal health in national climate commitments, six regional mitigation case studies with animal health included as a mitigation measure estimated significant emission reduction potentials from 10% to 41% Furthermore, we would like to emphasize the importance of aligning with the definitions of "of food loss and food waste, according with what is published on FAO website.
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Meeting with Seán Kelly (Member of the European Parliament)

5 Oct 2023 · Animal Welfare

Meeting with Pascal Arimont (Member of the European Parliament)

5 Oct 2023 · Animal Welfare

AnimalhealthEurope seeks uniform EU sustainability reporting rules

7 Jul 2023
Topic — This consultation seeks feedback on standards for companies to report environmental, social, and governance data.
Message — The association recommends that reporting obligations are implemented in a uniform, consistent manner. They propose to delay the effective date until all Member States have adopted the legislation.12
Why — Harmonized reporting would reduce compliance burdens for firms that operate across many member states.3
Impact — Stakeholders may receive confusing or misleading information due to inconsistent reporting at local levels.4
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AnimalhealthEurope seeks permanent exemptions for veterinary medicine packaging rules

21 Apr 2023
Topic — The European Commission is revising packaging rules to reduce waste and improve circularity.
Message — The group requests a permanent exemption from recyclability requirements for all primary veterinary medicine packaging. They also advocate for replacing paper leaflets with digital versions to decrease waste.12
Why — This prevents massive regulatory costs and delays from re-validating medicine packaging materials.3
Impact — Recyclers lose because medical packaging components remain difficult to process or contaminate streams.4
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AnimalhealthEurope warns chemical labelling rules risk veterinary medicine supplies

28 Mar 2023
Topic — Revision of EU rules for classifying, labelling and packaging hazardous chemical substances.
Message — The federation requests a one-year transition for label updates and flexible font sizes for small bottles. They also insist that new hazard classifications must follow international global standards.123
Why — This approach would reduce administrative burdens and prevent unnecessary costs for pharmaceutical manufacturers.4
Impact — Farmers and pet owners could lose access to essential medicines due to supply disruptions.5
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Meeting with Salvatore De Meo (Member of the European Parliament, Rapporteur) and European Environmental Bureau and

20 Mar 2023 · PPWR

Meeting with Luisa Regimenti (Member of the European Parliament, Shadow rapporteur) and Amazon Europe Core SARL and

9 Mar 2023 · PPWR

Response to Revision of EMA fees

7 Feb 2023

AnimalhealthEurope supports the appropriate funding of regulatory agencies essential to the efficient regulatory control of veterinary medicinal products (VMPs). However, the proposed cost-based system for EMA fees will be too expensive for the VMP sector. The EMA is being asked to expand its role, but this cannot and should not be funded by the VMP sector. The proposal represents in the region of a 50% (range 44% to 67%) increase in overall fees paid by a company in the VMP sector. This is not realistic for a small sector that represents just 3 to 5% of the human medicines market. The priority for the VMP sector is not simplification of the fee structure, but affordability. Veterinary medicines are a public good, for food security and public health, and the EU contribution to the EMA budget (13% in 2022) needs to continue. In the USA the FDA-CVM budget is 81% state funded. There should be no fee review in the VMP sector until Regulation 2019/6 has been fully implemented and its objectives of reduced administrative burden and increased efficiencies delivered for the benefit of both regulators and the regulated industry. Moving to a cost-based fee system for VMPs must first be preceded with reducing the cost of regulatory agencies in the veterinary sector to ensure costs are economically realistic and related to the market size. The use of veterinary medicines represents an entirely different risk and safety profile to human medicines, and the regulatory procedures for veterinary medicines must be significantly streamlined to reflect this. The proposed fee increases will increase costs leading to a further rationalisation of company product portfolios, with an impact on medicines availability, particularly small product lines and products in smaller countries. The diversion of a higher portion of R&D budgets to fees will lead to a slow down in research and a slow down in new products reaching the marketplace. Both these factors will have consequences for public health, and animal health and welfare. Despite the fee reductions for vaccines, vaccines will be particularly affected, at a time when strategies aimed at reducing the risk of development of antimicrobial resistance include the need to encourage the development and use of veterinary vaccines to control disease.
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AnimalhealthEurope urges scientific basis for antimicrobial import restrictions

1 Jan 2023
Topic — A consultation on prohibiting certain antimicrobials in animals and products imported into the Union.
Message — The group seeks precise definitions for antimicrobials and medicated feed within the regulation. They insist that standards must be consensus-led and account for local geographic and socio-economic specificities.12
Why — Scientific alignment protects the industry from retaliatory trade restrictions and ensures regulatory predictability.3
Impact — Compliant producers in third countries lose market access due to administrative registration requirements.4
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Response to Fitness check of how the Polluter Pays Principle is applied to the environment

9 Dec 2022

AnimalhealthEurope welcomes the opportunity to provide feedback to the fitness check of the application of the Polluter Pays Principle (PPP) to the environment. AnimalhealthEurope is the association representing manufacturers of animal medicines, vaccines and suppliers of other animal health products in Europe. By preventing and managing the spread of animal diseases, the animal health industry is actively participating to environmental protection. The One Health approach, acknowledging that human, animal and plant health are interdependent and bound to the health of the ecosystems in which they exist is among AnimalhealthEuropes driving principles. AnimalhealthEurope believes that the PPP should be applied in a fair, proportionate and equitable way and that it why we would like to present the specificity of our industry and provide the attached feedback on the application of the Polluter Pays Principle to the environment.
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Meeting with Emma Wiesner (Member of the European Parliament)

26 Oct 2022 · Möte om antibiotikaresistens inom jordbruket

AnimalhealthEurope urges protection of veterinary medicine agency's role

10 Oct 2022
Topic — Updating the governance and financing framework for the European Chemicals Agency.
Message — The group insists ECHA’s new powers must not overlap with existing medicine assessments. They demand that funding changes do not drain resources from medicines regulatory networks.12
Why — Preventing dual regulation ensures specialized oversight and reduces the risk of supply disruptions.3
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Response to Amending Annex II to Regulation (EU) 2019/6 to adapt it to technical and scientific progress

5 Oct 2022

AnimalhealthEurope is grateful for this important amendment to Annex II and has no specific comments to the wording of the draft amendment.
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Response to EU strategic Framework for Global Health

19 Sept 2022

Animal health, human health and our shared environment are part of a deeply interconnected system. With this in mind, AnimalhealthEurope - representing the manufacturers of animal health products and services across Europe - welcomes this opportunity to provide feedback on the EU strategic framework for global health. As the population increases and demand for food grows, and with people and animals living closer together, the interdependence of human and animal health, and our shared environment has never been clearer than it is today. Yet the role that healthy animals play for our future health is sometimes overlooked. AnimalhealthEurope promotes and supports collaboration between all disciplines: encouraging society to look at the three areas of people, animals and environment together, to develop practices that take their complexities and inter-relationships into account. This goes beyond challenges such as zoonoses 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. Nevertheless, a rapidly growing global population means that the world is increasingly crowded, and that people inevitably live closer to the animals they rely upon. Other factors, including large-scale migration, international trade, and global warming, have created an opportunity for new diseases to occur in regions where they were previously unknown and potentially unprepared. The ability to prevent such diseases spreading is increasingly important and should be a focal part of any health strategy. It is recognised that around 60% of all human infectious diseases are zoonotic, meaning they can be transferred between animal and man. Perhaps more worryingly, around three-quarters of emerging human infectious diseases – including SARS, Ebola, Zika and COVID-19 – during the last three decades have been zoonotic, mostly stemming from wildlife. Greater One Health cooperation is needed to control emerging infectious diseases. This requires a strategic framework for global health that support actions such as: • Building effective collaboration between animal, human and environmental health sectors • Improving surveillance for early detection of disease threats in both animals and people • Strengthening laboratory diagnostic capacities for novel pathogens • Improving disease case management and infection control in disease hotspots • Developing epidemic preparedness and response capacities for emerging zoonoses Capacity building to prevent, control and manage disease outbreaks in animal reservoirs will be essential for our future collective health. This includes not just education and training but also equipping professionals and paraprofessionals with the necessary tools and equipment to work collectively at the human-animal-environmental interface. The role of animal medicines is globally recognised as a key contributor to the One Health triad, and we hope to see greater recognition of the role for animal health within the strategic framework for global health.
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Meeting with Joanna Stawowy (Cabinet of Commissioner Janusz Wojciechowski), Jorge Pinto Antunes (Cabinet of Commissioner Janusz Wojciechowski)

16 Sept 2022 · To introduce newly elected a President Rob Kelly and a Vice-President Claire Fowler. AnimalHealthEUrope has adopted a new strategy for 2023-2027 and also want to present their priority topics

AnimalhealthEurope urges protection of commercial secrets in data sharing

16 Aug 2022
Topic — The initiative aims to streamline chemical data sharing for safety assessments across EU authorities.
Message — The organization argues that data sharing should be limited to public authorities to prevent competitors from benefiting for free. They request that the Commission protect intellectual property and ensure data owners are compensated if third parties use their files.123
Why — These protections would preserve the market value of their research and prevent rival firms from copying products.4
Impact — Smaller commercial competitors lose the chance to use existing safety data to lower their entry costs.5
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AnimalhealthEurope backs EU list of human-only antimicrobials

16 May 2022
Topic — This initiative designates specific antimicrobials to be reserved exclusively for treating human infections.
Message — The organization supports the list because it follows thorough scientific assessment and expert advice. They maintain that animals must still have access to necessary medicines to ensure welfare.12
Why — The industry preserves the market for veterinary antibiotics not listed for human-only use.3
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Response to Single Market Emergency Instrument (SMEI)

11 May 2022

AnimalhealthEurope welcomes this opportunity to provide feedback to the call for evidence for an impact assessment on the Single Market Emergency Instrument initiative. As an industry we appreciate the multitude of benefits brought by the single market. Whereas we recognise that free movement is not an absolute right, the benefits of the availability and access to goods and services are a testament to Europe’s economic and social successes. Clear guidance for crisis preparedness and response: As outlined in the call for evidence, the COVID-19 pandemic and Russia’s invasion of Ukraine have shed light on various structural shortcomings in the organisation of the Single Market in case of unforeseen crises and a lack of awareness on the correct channels to use to ensure free movement during a crisis. As such we would support clear guidance for both crisis preparedness and crisis response in the future. This should include: • Coordination and communication channels dedicated to Single Market crisis management between the EU institutions, Member States and businesses. • Clarification on EU rules to ensure the free movement of products and services remains operational during a crisis or in the context of emergency situations. Animal health products and services are a recognised public health input: During the above-mentioned crises the animal health industry proved to be well placed to ensure resilience and reduce vulnerabilities in the supply of animal health products and services. Evidence speaks to the fact that our products are a recognised public health input. Examples of this evidence include: 1) During the pandemic • Our industry did not experience any major shortages or blocking of supplies to continue production of medicines, vaccines and other products • Our products and services were granted access to the EU Green Lanes for priority goods • Our companies responded to calls to produce and deliver protective gear, disinfectants, antiseptics, anaesthetics and in some cases vaccines for the public health response across Europe • Our laboratories also responded to calls to support testing efforts to detect cases of the virus 2) During the ongoing war in Ukraine • Our personnel in affected areas have been safely evacuated • Our companies have donated financial support to aid bodies • Our companies have responded to calls from the Ukrainian government to supply specific animal health products for the care of animals remaining in the country Continued free movement of animal health products and services: We fully support that the implementation of EU policies on checks of persons and goods should be governed by a principle of solidarity between the Member States, with clear guidance on deference of specific rules or application of emergency measures in times of crisis. We would like to highlight 3 issues of relevance to the animal health sector: 1. Animal health products should be a fixed item on essential goods lists We would welcome clarification from the Commission that, as with human medicines, animal health products and services should have priority within the transport system and be considered as “essential goods” just like food supplies. 2. Member States should take measures based on science and avoid supply disruption We would welcome a Commission recommendation to Member States to avoid restrictions on animal health products coming from restricted areas unless notified by scientific bodies. We ask the Commission to ensure that the principle of solidarity between the Member States remains valid and ask that restrictions are not applied to risk countries where necessary medicines, vaccines and other animal health products are being produced/shipped around Europe. 3. Member States should notify the Commission of transport-related restrictions We would welcome a Commission recommendation for Member States to notify planned transport-related restrictions, and follow EU mandates on goods transportation during crises.
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Response to Streamlining EU scientific and technical work on chemicals through the EU agencies

12 Apr 2022

AnimalhealthEurope represents the manufacturers of animal health products and services across Europe. The call for evidence refers to the “Fitness Check of all Chemicals Legislation” (COM(2019)264 final). We understand that the REACH Regulation, the pharmaceutical, veterinary and food additives legislations were excluded from the scope of this Fitness Check. AnimalhealthEurope fully supports that veterinary medicine is not concerned by this call for evidence, for the seven reasons put forward in the attached submission.
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Response to Recommendation for strengthened actions against antimicrobial resistance

24 Mar 2022

AnimalhealthEurope represents the manufacturers of animal health products and services across Europe. As an industry we recognise the importance of tackling antimicrobial resistance in a One Health manner and ensuring the continued efficacy of antimicrobials. As a key contributor to One Health, we acknowledge the relevant role the animal health sector has to play in that effort. In tackling antimicrobial resistance One Health must play a central role, we encourage the EU institutions to tackle AMR from a holistic perspective by fostering partnership building between the human health, veterinary medicine and environmental sectors. This is the meaning of a One Health approach and essential to ensure all actors work together to address the major human and animal health challenges in an effective manner. Additional input can be found in the attached document.
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Response to Application of EU health and environmental standards to imported agricultural and agri-food products

8 Mar 2022

With the EU’s recognised high standards in the areas of sustainable food production, animal welfare and food safety, we understand the desire to apply EU health and environmental standards on imports of agricultural and food products. However, this raises several complex legal, political and societal questions. Any policy incorporating the global application of EU standards would need to be based on consensus-led, scientific criteria that would serve to consider local specificities and capacities. EU import standards on agri-food products should remain fair and consider differences in climatic and epidemiological conditions, as well as agricultural practices, access to natural resources, and socio-economic development of the trading country. While we fully understand the desires to ensure fair competition between European and non-European agri-food production, improve the overall coherence of EU policy, avoid ‘environmental leakage’ to third countries, and ensure a sustainable food system worldwide, it is essential that such policy would not have negative repercussions on ongoing efforts to secure a safe and sustainable food supply in other regions, nor undermine the effectiveness of EU development policies. At this time there is a stark lack of clarity as to how the so-called ‘mirror clauses’ can be applied to imports in accordance with existing trade law. Applying EU health and environmental standards to imports remain a largely philosophical concept with little specificity or granularity as to: how they would work; to which importing countries they would apply; and which products/production systems would be in scope. We believe it is important to wait for the DG Trade report which should indicate a clear rationale and legal feasibility of applying environmental, health and animal welfare standards to imported agri-food products. Legal considerations: Under current World Trade Organisation rules, member countries are legally allowed to block the entry of agri-food products that do not meet with the importing country’s sanitary and phytosanitary standards on the basis that it poses a public health risk to the importing country’s consumers. It is not currently permitted for a country to block imports of products for reasons linked to differing production standards. It is important therefore that a clear, legal, and science-based assessment is established to identify if there is a threat or not. If there are threats, measures can be taken, but if risks are mitigated locally, no restrictions on imports should apply. Political considerations: Another consideration is the potential for legal and trade repercussions. The EU is the largest global exporter of agri-food products with a value of €184 billion in exports reported in 2020. Non-scientifically justified application of EU standards to imports could lead to counter reactions and retaliations from third country governments including possible restrictions applied on EU exports. Societal considerations: Without close consideration of the potential impacts, there is a risk that unjustified application of EU standards on imports may undermine the work of global standard-setting bodies. It is in the interest of the EU, but also of the animal health sector, that such global standard setting bodies and the standards they set, are respected. Such action may have the indirect effect of weakening existing multilateral agreements and standards to the detriment of social, financial, and environmental sustainability in non-EU regions. Challenges such as climate change, biodiversity loss, and antibiotic resistance should be addressed in a global fashion. The question remains as to whether unilateral trade policy is an appropriate route, or whether further efforts to encourage the raising of standards in external markets could be achieved through other existing means - such as political discussion, private standards between producers, and standard setting in global bodies.
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Response to Sustainable food system – setting up an EU framework

26 Oct 2021

It is very important that any legislative initiative that arises from the objectives set in the European Green Deal and its related strategies and initiatives, in particular the Farm to Fork Strategy, is accompanied by a comprehensive and cumulative impact assessment based on the latest scientific data. Any policy measures put in place should be backed by robust data on economic, social, and environmental impacts. The likelihood of achieving the EU’s environmental goals in coherence with other policies while maintaining a strong and sustainable food chain must also be considered. The animal health industry welcomes the move to a more integrated and One Health approach to the EU’s food systems. And we fully support the move towards climate-resilient agri-food systems, which take into account the relationships between human, animal and environmental health, and the need to protect all three dimensions. While practices may vary between EU Member States, we reiterate that European agri-food is recognised globally as carrying a standard for food that is safe, plentiful, nutritious, affordable, of high quality, and with high standards for animal welfare. We acknowledge nevertheless that further efficiencies and improvements in terms of sustainable food production can be gained. We believe that Voluntary Approaches are the best way forward. This would also be in line with the recently adopted EU Code of Conduct on Responsible Food Business and Marketing Practices under the Farm to Fork Strategy. However, any measurement or labelling requirements must be based on a comprehensive scientific assessment that takes into account the social, economic and environmental impacts and returns of the production methods. Furthermore, the Commission should ensure measures to ensure a level-playing field between EU products and third country products. It is important that the Commission develops a comprehensive and unified concept of sustainability, that takes into consideration both the One Health concept (animal, human and environmental health) and all three pillars of sustainability (social, economic, environment). It is essential also that there is coherence between a Sustainable Food System Framework and existing food-related and trade policies, and that there is coordination within the DGs involved in ensuring the sustainability of the agri-food chain. Sustainability is a broad and complex horizontal topic. The European agri-food sector as a whole has already made considerable efforts to become more sustainable, and any future policy should be science-based. A Sustainable Food System Framework must consider potential implications on food trade. Recognition of science-based standards developed outside the EU should also be considered. Early involvement of trade partners and science-based measurement of achieved sustainability indicators are essential to allow the EU to take a leading role globally. This will also be essential to gain understanding for adequate compensation for food chain partners who exceed environmental and animal welfare standards and contribute to global food supply. The animal health industry will continue to play its role in supporting agri-food chain partners through the development of innovative tools to contribute to more sustainable food production while ensuring good animal health and welfare.
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Response to Animal welfare labelling for food

13 Aug 2021

Please find our full submission attached. AnimalhealthEurope welcomes this opportunity to provide feedback to the initial plans laid out by the European Commission for the revision of EU animal welfare legislation. Animals, just like people can get sick and require medicines. If left untreated, the animal suffers and its welfare is compromised. The animal health industry is driving advances in animal health and well-being that make it possible to sustainably raise healthy livestock and maintain the health and welfare of our companion animals. Animal health and welfare also constitute a key component for the two interdependent elements: sustainable livestock farming and sustainable food production. Animal health is a prerequisite for maintaining good animal welfare. Moreover, we contribute to animal health and animal wellbeing by providing practical advice, educational material or platforms to exchange innovative ideas on how to ensure the health of our animals. Three important reservations to proposed approach First, together with a number of other stakeholders, we note with some concern that this inception impact assessment comes at a time when the outcomes of the fitness check of the current rules remain unknown. On the one hand, the roadmap for the inception impact assessment confirms that the fitness check for the animal welfare legislation is still ongoing and only due to be completed in 2022. On the other hand, it highlights that available information already points to weaknesses in the design, implementation, compliance with and enforcement of the EU legislation. While we welcome the publication of the roadmap, having not had the opportunity to review key findings, we reserve more detailed considerations on individual pieces of legislation to be revised until after the outcome of the full fitness check of the EU animal welfare acquis is made available. Second, we note now in several of DG SANTE’s communications the call for a reduction in the use/need of veterinary medicines. While this may appear as a natural aspiration to breed only healthy animals, in rare need of treatment with veterinary medicines, it cannot be a goal in itself to reduce the use of veterinary medicines. Animals which are sick require treatment, to prevent suffering and to prevent their well-being being negatively affected. The continued access to and availability of different animal health tools should be guaranteed in all circumstances, and the responsible use of these medicines advocated to all users, to ensure the health and welfare of our animals as well as the continued efficacy of veterinary medicines. Third, while we fully support the EU’s ambitions to maintain the position as a global leader in animal welfare, we must – together with our fellow stakeholders in livestock production – emphasise that the application of the future animal welfare legislation must be feasible. This requires that any such measures ensure the protection of animal health, while also being feasible in economic terms, and ensuring farmers are supported to attain higher welfare standards. Aligning with current scientific knowledge We welcome the revision of this legislation and in particular the bringing it into line with current scientific information on the welfare of animals, and in particular to ensure the rules consistently and coherently interact with the recently revised regulations on transmissible animal diseases, official controls, veterinary medicinal products and medicated feed. This will be particularly important when exploring the option to introduce common and comprehensive animal welfare principles as requirements, which require as essential elements good health of the animals, a good environment and good nutrition. In addition, we welcome the planned integration of the One Health approach, acknowledging the interconnectedness of animal and public health, our environment and animal welfare. ....continues (find our full submission attached)
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Response to Good distribution practice for active substances for veterinary medicines

9 Jun 2021

Please see attached file. AnimalhealthEurope thank the European Commission for their work and for the opportunity to comment.
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Response to Good distribution practices for VMPs

9 Jun 2021

Please see attached file. We thank the European Commission for their work and for the opportunity to comment.
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Response to Revision of EU legislation on registration, evaluation, authorisation and restriction of chemicals

1 Jun 2021

While medicines are exempted from REACH, bans and restrictions on substances used in manufacturing can be prohibitive for the production of certain medicines or diagnostics as often no suitable alternatives are available. Furthermore, the whole manufacturing process is regulated in the medicines legislation, and substitutions can be impossible, or have an important impact on quality, safety and/or efficacy of a medicine. The REACH restriction process must therefore exempt substances used in human and veterinary medicines as these substances are already evaluated for quality, safety and/or efficacy. This causes duplicate regulation resulting in conflicts of risk management—leading to increased confusion by users with no greater protection of risks. Additionally, duplicate regulation could lead to non-compliance under at least one regulation due to conflicts in the regulatory schemes. The Veterinary Medicines Regulation 2019/6 (VMR) ensure the safety of veterinary medicines to users, consumers and the environment and therefore, veterinary medicines should not be covered in these chemical legislations. The scope of REACH and CLP should make it clear that veterinary medicines are out of scope (as it is the case at the moment). Double regulation must be avoided as it would only cause more administrative burden and confusion, including regarding enforcement responsibilities, with no benefit to society.
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Response to Revision of EU legislation on hazard classification, labelling and packaging of chemicals

1 Jun 2021

While medicines are exempted from REACH, bans and restrictions on substances used in manufacturing can be prohibitive for the production of certain medicines or diagnostics as often no suitable alternatives are available. Furthermore, the whole manufacturing process is regulated in the medicines legislation, and substitutions can be impossible, or have an important impact on quality, safety and/or efficacy of a medicine. The REACH restriction process must therefore exempt substances used in human and veterinary medicines as these substances are already evaluated for quality, safety and/or efficacy. This causes duplicate regulation resulting in conflicts of risk management—leading to increased confusion by users with no greater protection of risks. Additionally, duplicate regulation could lead to non-compliance under at least one regulation due to conflicts in the regulatory schemes. The Veterinary Medicines Regulation 2019/6 (VMR) ensure the safety of veterinary medicines to users, consumers and the environment and therefore, veterinary medicines should not be covered in these chemical legislations. The scope of REACH and CLP should make it clear that veterinary medicines are out of scope (as it is the case at the moment). Double regulation must be avoided as it would only cause more administrative burden and confusion, including regarding enforcement responsibilities, with no benefit to society. Through the recent revision of the VMR the requirements for labels and leaflets of veterinary medicines have been revised in order to ensure the appropriate and sufficient information is available on the label but without over-crowding the label so as to enable more multi-lingual packs, which in turn will help to address the availability of veterinary medicines across EU. The proposal to add additional hazard information would be contrary to the aims of the Commission when they embarked on the revision of the legislation for veterinary medicines.
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Meeting with Frans Timmermans (Executive Vice-President) and European farmers and

31 May 2021 · Exchange on Farm to Fork Strategy with European Livestock Voice

Response to Establishment of Criteria for the designation of antimicrobials reserved for human use

23 Apr 2021

AnimalhealthEurope welcomes the opportunity to provide comments to the draft delegated act. We are happy to see that the draft delegated act and its annex reflect the principles of the scientific advice provided by the EMA. We also note and support that the act underlines in Recital 5 that banning the use of an antimicrobial in animals is one of the most severe risk management measures that can be taken, thus such measures should be taken cautiously. And whenever possible other risk management measures should be favoured. The introduction of an option in Criterion C (Paragraph 1 c) for an antimicrobial to be restricted for human use even if no alternatives for veterinary use are available is of concern as this by its presence severely weakens the ability of Criterion C, as intended in the EMA Scientific Advice, to protect animal health and welfare. Any reservation where that will leave an unmet need in animals must only occur in the most exceptional cases where human need significantly outweighs the damage to animal health and welfare and as stated in Recital 9 when not using that antimicrobial would only result in limited morbidity or limited mortality. This would need to be supported by robust scientific evidence. The language used in the draft delegated act and its criteria is high level and the exact meaning of certain phrases is open to interpretation, for instance “significant”. Therefore, to ensure clarity and transparency in the use of the criteria to assess antimicrobials for inclusion on the reserved list more detailed guidance by the EMA may be necessary, for instance on the types and levels of scientific data required. This guidance should also cover the regulatory process of assessing an antimicrobial for potential inclusion on the reserved list against the criteria. The implementation of the criteria must be science-based and transparent and to this end we strongly believe that a new article should be included in the Delegated Act which specifies that the assessment which leads to the inclusion of a substance on the reserved list shall be published.
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Response to European Health Emergency Response Authority

24 Feb 2021

Please find full submission attached. Thank you for the opportunity to comment on this legislative initiative. AnimalhealthEurope is contributing to this consultation as a key stakeholder in the animal health sector, and in the context of the close inter-relation between human health and animal health - the One Health concept. Although not mentioned in the Roadmap (Inception Impact Assessment), earlier documents from the European Commission on this initiative (references 1 and 2) made reference to “recognising the interaction between human and animal health and the environment” and a “One-Health approach”, and also “arrangements aimed at ensuring interoperability between the health sector and other sectors including the veterinary sector”. The precise references are summarised in the annex. Consequently, AnimalhealthEurope regards it as critical that a future agency targeted with ensuring EU health emergency preparedness will have systems in place to engage with animal health stakeholders, with those that monitor disease threats of a zoonotic origin and recognises the importance of funding research into the origins of zoonotic disease and medical solutions as well as animal disease threats that can impact food security. The initiative will focus on emerging biological threats - of which a significant proportion will be of zoonotic origin - and will respond to all cross-border threats to health. Animal diseases certainly class as “cross-border threats and emergencies”. This underlines the importance of interoperability and the animal health sector being seen to be part the emergency preparedness network. For joined-up thinking on shared health issues, we need joined up networks involving all stakeholders, both human health and animal health orientated. AnimalhealthEurope is not calling for direct inclusion in the remit of the proposed new agency. However, AnimalhealthEurope will continue to engage in public consultations connected to this initiative, in particular to promote the importance of: • zoonotic disease towards public health • the link between animal health and food security • funding for basic research into zoonotic animal diseases and new product development • interoperability between the health sector and other sectors, particularly the veterinary sector • the need to improve the ability of EU centralised systems to rapidly authorise or approve the use of unauthorised medicines, particularly vaccines, in emergency situations. The importance of zoonotic disease: The incidence of emerging infectious disease (EID) is increasing, and the proportion of these that are of zoonotic origin is increasing. The majority (60%) of EIDs are caused by zoonotic pathogens (reference 3). The world is shrinking, both in terms of rapidity of travel and trade in goods. Human encroachment into wild-life habitats is increasing, making human-animal contact more frequent. Climate change is changing the geographical spread of vector-borne disease (29% of EIDs), including zoonotic diseases. The importance of One Health approach: A collaborative and multi-disciplinary approach, cutting across boundaries of animal, human, and environmental health, is needed to understand the ecology of each emerging zoonotic disease and animal diseases that can impact food supply in order to undertake a risk assessment, and to develop plans for response and control. The One Health concept focusses on consequences, responses, and actions at the animal–human–ecosystems interfaces, and especially on emerging and endemic zoonoses, which are responsible for a large part of the burden of disease; but it also focusses on the impacts on food safety and food security and the impacts of antimicrobial resistance, which can arise in humans or animals. Veterinary medicines play a major role for animal and public health especially against zoonoses but also diseases... (continues) (please see full submission attached)
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Response to Feed additives - revision of EU rules

25 Jan 2021

AnimalhealthEurope welcomes the opportunity to comment on this combined roadmap and inception impact assessment. In general we are in agreement with the document, particularly the intention to tackle the Non-authorised Feed Additives issue and the creation of new functional groups. However there does seem to be a dichotomy between the elements on innovation, confidentiality and administrative burden and the new transparency regulation (EU) 2019/1381. As the latter will have the effect of stifling innovation and increasing administrative burden.
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Response to Method for the Collection of data on antimicrobial medicinal products used in animals

18 Dec 2020

AnimalhealthEurope welcomes the opportunity to comment on this draft delegated act. We are supportive of the legal basis given to the ESVAC project in the new regulation. Marketing authorisation holders (MAH) are named as one source of data. This should be changed. With the Union Product Database and the future requirement for information to be entered by MAHs on sales volumes, this should be used as the source rather than requiring specific and additional information returns from MAHs. This would result in duplication of effort and an increase in administrative burden Article 11 (2) Comment: Further to our comment above we appreciate the reference to the use of the Union product database as a source of data. However, we believe the wording should be strengthened to make this the primary source of data whenever possible in order to reduce administrative burden. Proposed Change: Member States shall use the data on the volume of sales provided by marketing authorisation holders to the Union product database as the possible data source for the volume of sales of the veterinary antimicrobial medicinal products whenever possible,
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Response to Details for the application dossier for the authorisation of a veterinary medicine

8 Dec 2020

AnimalhealthEurope welcomes the opportunity to comment on this draft delegated act. We are pleased to see improvements in the text from the EMA Scientific Advice including the inclusion of bacteria in the scope of the multistrain dossier, the approach to field efficacy trials for vaccines, the opportunity to lift GLP requirements for specific studies for vaccine strain and the adaptation of requirements for sterility of non-parenteral vaccines. Some general comments on proposals for further improvement of this new annex are outlined below: • The Annex still contains references to specific guidelines, particularly the VICH guidelines. Currently the inclusion of the guidelines makes the text read more as a NtA. As this text will form part of a Regulation if a guideline is stated in the law, it receives characteristics of law. This would give undue weight to guidance documents. Therefore, we suggest the removal of all references to specific guidelines, or make a clear statement that a reference to a specific guideline is for illustrative purposes only. • The General principles and requirements are partly redundant with the text under each specific chapter. Notably for Immunologicals a lot of terminology was taken over from Pharmaceuticals (e.g. pre-clinical and clinical, the use of GLP studies) which may lead to some initial confusion and later increase need for justifications to provide reasoning for deviating. • For Limited Markets we believe there is a need to look at the quality part in addition to safety and efficacy. Even though the regulation states “only a limited assessment of safety or efficacy has been conducted due to the lack of comprehensive safety or efficacy data”, there is scope for a reduction in requirements whilst providing a sufficient guarantee of quality as noted in the existing CVMP guideline EMA/CVMP/IWP/123243/2006-Rev.3. The quality part has proved a significant hurdle in developing products for limited markets and not allowing this flexibility may hamper future solutions. • The possibility to introduce the use of a diluent master file and/or an adjuvant master file is still regarded as potential regulatory innovation giving flexibility comparable to other master file concepts, aiming at reducing unnecessary Regulatory burden for both Competent Authorities and Industry. Enlarging the current scope of this annex is therefore recommended. • There remains extensive reference to European Pharmacopeia. Often the wording of the references is not in the spirit of the Ph.Eur., especially for vaccines. The Technical guide for the elaboration and use of monographs for vaccines and immunological veterinary medicinal products often notes tests as advisory (e.g. safety): “Advisory. The description of the test is given as an example of suitable method. If the test is carried out as described, it will be acceptable to Competent Authorities in Ph. Eur. Member States.” In contrast to that the annex turns this positive statement into an absolute requirement. • Innovation may be hampered in some areas: e.g. novel excipients to be fully described, negative statements about DNA- or nano- technology. Further specific comments may be found in the attached file.
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Response to Pharmaceutical Strategy - Timely patient access to affordable medicines

6 Jul 2020

>> Attention: Please see our full submission annexed to this form. << Addressing a common challenge Pharmaceuticals are essential to safeguard both animal and public health. It is from this perspective that we respond to this Roadmap. Whilst we take note that the new EU Pharmaceutical Strategy will focus primarily on public health and human healthcare, AnimalhealthEurope wishes to contribute by offering an additional dimension to the Commission’s deliberations on health and access to medicines which may bring useful insights. The broader pharmaceutical industry consists of companies who produce human medicinal products or veterinary medicinal products, as well as companies who produce both. All share a common goal to protect both human and animal health, as well as our environment. We both advocate the One Health Approach. The human and veterinary “pharmaceutical industry” have some challenges in common, from availability and access to medicines, providing affordable solutions, remaining innovative solution providers, to combating antimicrobial resistance. Both human and animal health actors have a role to play. In these times when we are facing a pandemic caused by zoonosis, the importance of safeguarding animal health to protect human health comes to the fore. The animal health industry asks that we learn from this moment of crisis to ensure better preparedness for identifying and controlling animal diseases in the future. Some of these diseases may impact public health and thus we require strong support for preventing animal diseases where possible. AnimalhealthEurope members are committed to act. Prevention is key Disease prevention is greatly enhanced through the provision of high quality, safe and effective vaccines. When farmers take preventive measures such as vaccination and biosecurity, this makes for efficient farm management from an animal welfare perspective, an economic perspective and an environmental perspective. Protecting animals from disease also prevents transmission and slows further spread. Working together, industry and authorities can respond rapidly to halt or slow transmission of existing and newly emerging diseases through (amongst others) the establishment of vaccine banks and/or fast-tracking approvals of vaccines in the case of disease outbreaks. Prioritising investment at national and European level in innovative early research through funding programmes such as Horizon Europe can also support much-needed R&D to develop new generations of vaccines and other therapies for both animal and human health. New Regulation on Veterinary Medicines The EU rules that govern the marketing and uses of veterinary medicinal products (Regulation 2019/6) were only recently revised and will become applicable from early 2022. This new Regulation has as one of its core objectives to increase the availability of veterinary medicines in Europe. It also seeks to stimulate innovation in the sector and puts in place an even firmer set of rules on the use of antimicrobials in animals, with a view to combatting antibiotic resistance. AnimalhealthEurope members are preparing for the full implementation of this new Regulation and look forward to a more harmonised manner for placing veterinary medicines on the market to increase access across Europe. Differences between human and veterinary pharmaceuticals While animal medicines share many of the same characteristics and challenges as human medicines, there are also several ways in which the animal health sector is very different, and therefore requires different approaches to regulation. The veterinary medicines market is a fraction of the human medicines market (approximately 3%). (... continues): see pdf attached. >> Please see our full submission annexed to this form.
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Meeting with Stella Kyriakides (Commissioner)

6 Jul 2020 · Farm to Fork Strategy, animal health law and the implementation of the veterinary medicinal products regulation.

Meeting with Marius Vascega (Cabinet of Commissioner Virginijus Sinkevičius)

6 Jul 2020 · Animal Health, Farm to Fork Strategy and Biodiversity Strategy

Response to Chemicals strategy for sustainability

19 Jun 2020

As noted in the Commission’s Roadmap, chemicals are crucial for many manufacturing industries - including pharmaceuticals. Whilst veterinary medicinal products themselves are outside the scope of REACH, the chemicals used in the manufacture of those products are not. These pharmaceuticals are essential to safeguard animal and public health. It is from this perspective that we respond to this Roadmap. Veterinary medicines are regulated by means of dedicated EU rules, and shortly by the new Regulation 2019/6 which introduces even stricter requirements for authorising the placing on the market of a veterinary medicine, particularly in the field of environmental safety. The EU regulatory process for animal medicines licencing is designed to assess environmental safety prior to medicine approval. Our members comply with all relevant independent regulatory processes for licencing medicines, which include animal, user, consumer and environmental safety assessments. We strongly believe that medicines, including veterinary medicines, should remain outside of the scope of the EU’s renewed chemicals legislation, specifically due to the importance of the product-based benefit/risk assessment. This enables the benefits of the medicine to animal health, and by extension to human health, to be weighed against any potential risks to the animals, humans and the environment, taking into account the way and frequency the medicine will be used in an overarching benefit-risk assessment. An independent and robust evaluation and authorisation process for animal medicines means that, before reaching the market, their quality, safety, and efficacy is assessed as part of this benefit-risk evaluation. Moreover, every medicine we make goes through a rigorous Environmental Risk Assessment by the appropriate regulatory agencies in the EU that examine any potential risks associated with the medicine, including its environmental impact. If the overall benefit-risk assessment for the product is negative, authorisation of a veterinary medicinal product can be denied based on environmental concerns. AnimalhealthEurope members are fully committed to ensuring the environmental safety of animal medicines. We consider it our responsibility to minimise levels of medicines and their by-products in the environment. We want to do more than just ensure the health of our animals – we want to make sure we do it without harming our environment. We know our world is changing fast. And we recognise the importance of protecting our planet now more than ever. That’s why we’re are committed to reducing levels of pharmaceuticals in the environment as much as possible. During the development of medicines, companies look for safe and sustainable products. In veterinary product development, 1000’s or even 10,000’s of compounds are tested to find just one that is both efficacious and safe for use in the patient and environment. Veterinary medicines also must possess a certain inherent chemical/metabolic stability so that they can be stored until needed and/or do not break down in the body until they have completed their intended therapeutic task. Once these criteria have been satisfied, and if there is then a choice of candidate compounds that meet the necessary criteria, companies will choose the compound with the lower potential environmental impact. We look forward to working with the EU using our industry’s expert knowledge concerning the risk posed by endocrine disruptors, hazardous chemicals including imports, combination effects of different chemicals and very persistent chemicals. AnimalhealthEurope is encouraged by DG ENV’s planned efforts to provide greater transparency on its decision-making and prioritising action when dealing with chemicals. AnimalhealthEurope looks forward to joining other stakeholders in working with the Commission. The animal health industry ... (full formatted submission included in annex)
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Meeting with Lukas Visek (Cabinet of Executive Vice-President Frans Timmermans)

3 Jun 2020 · Sustainable food systems

Response to Farm to Fork Strategy

10 Mar 2020

AnimalhealthEurope is the association representing manufacturers of animal medicines and other animal health products in Europe. This document summarises how we can contribute and some requests made in our discussion paper. In this annex you will also find illustrations of the contributions made by several animal health solutions. We take this opportunity to share with you our key demands for consideration pertaining to animal health in your preparations for a new Farm to Fork strategy. The animal health industry would like to share with you a range of solutions and directions that can help meet the objectives of such transformation. We also believe that innovation in animal health must be supported in order to provide farmers and vets with the necessary tools to respond rapidly to disease outbreaks. 1. Animal health and welfare As 20% of farm animals are lost to animal disease and as a consequence cannot enter our food chain, we look to the new Farm to Fork policy to future-proof our new approach to agricultural production. This can start with support measures, e.g. demonstration projects illustrating the benefits thereof, and research projects for new or upcoming technologies and tools that can prevent animal diseases and improve animal welfare. 2. Disease prevention Working together, industry and authorities can respond rapidly to halt or slow transmission of existing and newly emerging diseases through the establishment of vaccine banks and/or fast-tracking approvals of vaccines in the case of disease outbreaks. Prioritising investment at national and European level in innovative early research through funding programmes such as Horizon Europe can also support much-needed R&D to develop new generations of vaccines and other therapies for both animal and human health. 3. Disease preparedness It is essential that new technologies are widely accepted, and that sufficient means are dedicated to ensuring that farmers are equipped with the tools that facilitate their work while supporting animal well-being, and that farmers are given adequate training on their use. The new policy should therefore promote those tools and also support farmers to make the transition, allowing them to make full use of this wide range of capabilities. 4. Responsible use of antibiotics The new Regulation on Veterinary Medicines provides measures to reduce the need for antibiotic use to a minimum. It is essential that the success of this new Regulation be evaluated prior to any further legislative measure being added beyond the outstanding implementing measures. These measures should also consider the impact on animal health and wellbeing, as well as the impact of such restrictions on public health. With national One Health action plans under implementation, a continued and steady decrease in the use of antibiotics in agriculture recorded across the Union, and the upcoming implementation of the new Regulation, we strongly oppose the imposition of absolute reduction targets which would place at risk animals in need of antibiotic treatment. Particular care should be taken even with the setting of aspirational goals for reducing sales of antibiotics as bacterial diseases must be treated efficiently in order to ensure good health and welfare. 5. One Health - As mentioned by the WHO, food safety is an area of work in which the One Health approach is particularly relevant. We take this opportunity to reiterate our long-standing call for the creation of a One Health platform for stakeholders, running in parallel to the EU One Health Platform for Member States, to further our progress in this joint approach. 6. Dietary preferences -We encourage the European Commission to gather evidence-based and fact-checked information. It is essential that the consumer has access to such information so that the consumer can make an informed decision on his/her food preferences. We ask the Commission to stimulate the use of modern digital tools to inform consumers.
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Meeting with Jorge Pinto Antunes (Cabinet of Commissioner Janusz Wojciechowski)

21 Feb 2020 · Animal welfare contribution and European Green Deal

Response to Evaluation of the EU Animal Welfare Strategy (2012-2015)

14 Jun 2019

On behalf of AnimalhealthEurope, we hereby submit the comments of the animal health industry with regard to the European Commission’s Roadmap on the Evaluation of the EU Strategy for the Protection and Welfare of Animals, for the period covering the Strategy (2012-2015) but extending to 2018 as per the scope determined in the Roadmap. Please find our comments to the roadmap in the pdf enclosed.
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Meeting with Anne Bucher (Director-General Health and Food Safety)

28 Nov 2018 · AnimalHealthEurope meeting the new DirGen

Response to Transparency and sustainability of the EU risk assessment model in the food chain

25 Jun 2018

AnimalhealthEurope welcomes the proposal to address concerns around public confidence in the risk assessment process under the General Food Law. In particular, we welcome the increased focus on risk communication. In our opinion science based risk communication is the most important factor in addressing public concerns. The introduction of pre-submission meetings is a welcome move, which will help to ensure the applicant is aware of and can adhere to the applicable requirements relating to the content of authorisation applications. Procedures for disclosure of information (Art.38) is an area of concern to our members. Whilst we support the need for improvements in transparency of the risk assessment process, as an industry we believe that publication of the contents of the dossier on receipt will not achieve the desired aims. Procedures should be put in place to ensure that information made available in the EU cannot be misused for regulatory or commercial purposes in other parts of the world and that such procedures are enforceable. The level of protection in the Commission proposal against such misuse is currently inadequate. We suggest for example a mandatory “Legal Notice” which requestors have to accept before they can submit their request for information. The Legal Notice should specify among others that the information requested is to be used for non-commercial purposes only. The standard undertaking needs to be backed up by accurately identifying the requesting party and availability of legal remedies and injunctive to seek recourse for misuse of information.
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Meeting with Arunas Ribokas (Cabinet of Commissioner Vytenis Andriukaitis)

28 Mar 2018 · Antimicrobial resistance

Response to Evaluation of the feed additives Regulation

20 Sept 2017

IFAH-Europe takes note of the European Commission’s initiative to commence its evaluation of the EU Feed Additives Regulation 1831/2003. The animal health industry welcomes the opportunity to provide feedback on the effectiveness, efficiency and added value of the Regulation more than 13 years after its entry into force. We, in particular, note the Executive’s plans to conduct bilateral meetings with pertinent stakeholders. We take this opportunity to highlight the role feed additives play in ensuring the health of our animals through their nutrition and the checks that are in place to ensure that any feed additives authorised in Europe are safe and efficacious, and therefore not harmful to the health of animals or people. With over a decade of experience with the registration and (re-)authorisation processes put in place by the Regulation, we believe important lessons can be drawn, and improvements made to these processes, primarily handled by the European Food Safety Authority. IFAH-Europe agrees with the Commission’s assessment that the evaluation process should investigate the current criteria to establish the efficacy of feed additives, the procedures for modifying existing authorisation and the rules of confidentiality applicable to the authorisation dossiers. Moreover, we would recommend that the evaluation process also reviews the additive categories, and in particular investigates the addition of a category supporting the health and welfare of healthy animals. IFAH-Europe looks forward to further opportunities to engage with the European Commission and its chosen contractor to share our views on the impact, anticipated and unexpected, of Regulation 1831/2003, including bilateral meetings and the forthcoming open consultation later this year.
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Response to Strategic approach to pharmaceuticals in the environment

26 May 2017

IFAH-Europe welcomes the opportunity to comment on the new EU Commission Roadmap on a Strategic Approach to Pharmaceuticals in the Environment and looks forward to participating in future consultation activities. We support the intent to protect the environment and at the same time safeguard access to effective and appropriate treatments for human patients and animals, considering inter alia the opportunities for innovation. The animal health industry has closely followed discussions relating to the wider issue of environmental pollution. As alluded to in the Roadmap document (ref: Ares (2017) 2210630), residues of veterinary medicines, with the exception of aquaculture, primarily enter the environment via the soil, not surface water. The Commission is aware of the robust environmental risk assessment procedures that both precede the authorisation of veterinary medicinal products, as well as follow the marketing of such products. For any new veterinary medicine seeking a marketing authorisation, environmental safety data in the dossier forms part of the benefit-risk assessment performed by the EU’s competent agencies and Member State authorities, and can be a grounds for refusal of the marketing authorisation. This requirement, in place for 25 years, constitutes a substantial challenge for any product which may present an environmental risk from its use. Inevitably, there are cases where a balance between adequate efficacy and full environmental safety is difficult to strike; causing companies to abandon the development of new innovative products in certain disease areas (including for MUMS) for the EU because of the insurmountable hurdles the standards require. This requirement has also resulted in referral procedures for some existing products, often restricting their use. We agree with the Roadmap that existing legislation already provides a comprehensive legislative framework to assess the risk of pharmaceuticals in the environment. We would also like to point out that the new proposed EU legislation on Veterinary Medicinal Products (currently under revision by the Council of the EU) will further strengthen the existing rules on the authorisation of veterinary medicines (scrutinising the marketing of medicines with certain hazardous properties), their use (streamlining the conditions of use), and disposal. New anticipated rules to improve the pharmacovigilance system will also continue to ensure that adverse events noted in the environment are monitored. All of this should be taken into account before proposing further policy options as part of a Strategic Approach to Pharmaceuticals in the Environment. IFAH-Europe members take very seriously our responsibility to the environment during the lifecycle of our products. We actively promote the responsible use and disposal of veterinary medicines. We also support efforts to increase the transparency of environmental information and advocate the publication of environmental endpoints in the (European) Public Assessment Reports for all products – a practice already adopted by the EMA and certain Agencies in the Member States. As a result of the robust environmental risk assessments already in place for veterinary medicines, we are confident that a broad environmental knowledge base already exists within appropriate governmental agencies. IFAH-Europe members recognise the importance of understanding and minimising any significant contribution from the presence of residues of antibacterial products in the environment to the human impact of disease-related resistant strains of bacteria. We agree that there is a need for further research to support a science-based approach for any proposed policy options associated with this topic. We support the Commission’s efforts to identify knowledge gaps and investigate how we may, jointly, address any challenges we might face as a society to protect our environment.
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Meeting with Vytenis Andriukaitis (Commissioner) and

30 Jan 2017 · Antimicrobial resistance, Veterinary medicines, Medicated feed, Animal Welfare Platform

Meeting with Vytenis Andriukaitis (Commissioner) and

17 Nov 2016 · Roundtable on the future of the General Food Law Regulation

Response to REACH Regulation - Annex XIV

12 Oct 2016

The decision to include Aprotic solvents, e.g. NN- Dimethyl Acetamide (DMAc), Dimethyl Formamide (DMF) or N-Methyl Pyrrolidone, in annex XIV (REACH) affects the veterinary medicines sector as these substances are used for the production of veterinary medicinal products (VMPs). In particular DMAc is used in different steps of the process: during the synthesis of API: as DMAc is used to produce several APIs, several VMPs are concerned; during manufacturing of the excipient entering the final VMP and as excipient itself: many VMPs contain DMAc used as excipient mainly in injectable and transcutaneous forms. There is no simple alternative to replace this solvent. As DMAc is used in the final formulation of the product, the ban of this substance would have a direct impact on the availability of the VMPs. DMAc is classified as a pharmacologically active substance for which no MRL is necessary to be established for all food producing species according to the Annex to Commission Regulation (EU) No 37/2010 of 22 December 2009 on pharmacologically active substances in their classification regarding maximum residue limits in foodstuffs of animal origin. DMAc is regarded as safe (no MRL is required) for its use as a component of a drug intended for use in food producing animals. This means that DMAc is allowed to enter into the composition (as excipient) of a finished veterinary medicine product that might be used for a food producing animal. Impact of REACH on pharmaceutical manufacturing: The possible ban of a solvent was not anticipated by the veterinary medicines sector as our understanding is that medicinal products are outside of the remit of REACH. However it does apply to chemicals used in the manufacturing of APIs. As many APIs or VMPs use DMAc during manufacturing process, the VMP sector is also impacted by this decision to include it in annex XIV. Substituting Aprotic solvents in a defined manufacturing process is extremely difficult. Substitution may require additional trials and animal testing to prove equivalent efficacy and safety. Assuming an alternative is found, amendments to Marketing Authorisations previously assessed/approved by the EMA and other National Authorities, would be required. This will represent additional costs that could inevitably push manufacturers to source their medicines outside EU and place severe pressure on supply chains of critical medicines. Impact on EU competitiveness: The authorisation of a molecule is only granted for a limited period of time after which it must be reviewed again by the Agency. The application process for an authorisation is a heavy and costly process. The assessment of the benefits/costs of these application procedures, if found to be economically unsustainable, could lead the companies to reconsider the sourcing programs and take other supplying/production decisions. The authorisation process is adding uncertainty, is costly and will discourage the competitiveness of the EU pharma sector and could have very negative impact on access to medicinal products. Furthermore, as these substances are not found in the final API and as REACH authorisation only applies to EU-based manufacturing, this would place companies with operations in Europe at a competitive disadvantage and would create incentives for companies to relocate operations outside of Europe or decide to not relocate manufacturing sites back to Europe. Conclusions: IFAH-Europe urges the Competent Authorities to reconsider their position to ban the aprotic solvents (in particular DMAc) as many companies use these solvents to manufacture VMPs in particular in the formulation phase where DMAc is used as an excipient. This decision would have major impact on the availability of several VMPs and animal health and welfare, with consequential risks to public health. REACH Authorisation process should also be reconsidered in view of the concerns for competitiveness of the EU as a destination for pharma manufacturing.
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Meeting with Vytenis Andriukaitis (Commissioner) and

16 Jun 2016 · AMR, COM proposals on veterinary medicines and medicated feed

Meeting with Arunas Ribokas (Cabinet of Commissioner Vytenis Andriukaitis), Arunas Vinciunas (Cabinet of Commissioner Vytenis Andriukaitis)

2 May 2016 · Preparation for the Annual Conference

Meeting with Cecile Billaux (Cabinet of Vice-President Cecilia Malmström)

16 Dec 2015 · animal health industry and TTIP

Meeting with Arunas Vinciunas (Cabinet of Commissioner Vytenis Andriukaitis)

29 May 2015 · Preparation for the conference speech on the 11th June 2015