Researching, developing and manufacturing animal medicines
The role of animals
We know that animal health and welfare is a priority for society.
No matter how well they are cared for, any animal can get sick, injured or experience various health issues. Veterinary medicines serve to support the health and welfare of companion animals, food-producing animals and fish, as well as other animals.
Wherever possible, AnimalhealthEurope member companies strive to reduce the need to use animals in studies. Our members are committed to the 3Rs approach and actively work to Replace, Reduce, and Refine the use of animals in medicines development and production.
Nevertheless, the development and licencing of veterinary medicines offers long-term benefits for all animals, and animal-based research currently remains unavoidable for the discovery and innovation of medicines as well as the development and authorisation processes.
Why are animal studies necessary?
To ensure safety and efficacy for the animal in need of the medicine, studies on that species of animal for the medicine in question are a mandatory regulatory process required by law and a scientific necessity. This process helps ensure that, once authorised, medicines are indeed safe for the animal and its carer to use. It also means the medicines will have been proven to be effective at treating or preventing disease or other health issues, fulfilling the ultimate aim of keeping animals healthy and protecting their welfare.
Some manufacturing tests to ensure quality still require the use of animals where in vitro alternative methods are not yet available. This is one of the key research areas where we are committed to finding alternatives and further reduce the need to use animals.
Our 3Rs commitment - Replacing Reducing, and Refining animal studies
Wherever possible, researchers replace animal studies with non-animal methods such as computer simulations or tests on cell cultures. Researchers also exchange regularly with the health authorities and academics to share data on the latest developments that can help reduce the need for animals in research and refine protocols for better conditions for animals.
AnimalhealthEurope is a partner in the European Partnership for Alternative Approaches to Animal Testing (EPAA) and our members are actively involved in projects to develop alternatives to animal testing.
Our transparency commitment
Animal facilities of AnimalhealthEurope members are open to unannounced inspections by national authorities at any time and are generally inspected at least once per year. Facility and staff audits are also regularly conducted to ensure compliance with both company-specific codes of conduct and the regulations in force. Any breaches of practices set out in a code of conduct are addressed immediately by the company. Companies publicly share information related to animal research via national or European projects and are invited to speak on the topic at public conferences.
AnimalhealthEurope is also a member of the European Animal Research Association (EARA) which strives to promote an open and balanced dialogue about animal research.
Companies sign transparency agreements launched nationally that engage them to explain why animals are used for scientific purposes, what the regulatory requirements and constraints are, provide accessible communication to the public and media and to report annually on their progress. The list of existing transparency agreements in the EU is accessible on the EARA website.
Success stories
- C.septicum BSP130 project under EDQM led to revision of Pharmacopeia. This changed EU rules to offer the possibility for in-vitro tests for Clostridial vaccines.
- Deletion of Target Animal Batch Safety Test from European Pharmacopeia
- Moving to in-vitro technique (ELISA) for release of Rabies and Leptospira vaccines. This is now the preferred method setting precedent for further non-animal approaches.
- Supporting medicines regulators to push alternative methods where possible via the EMA Regulatory Science Strategy to 2025.
- EMA offers free scientific advice from regulators to shift to non-animal methods.
- Further progress to favour non-animal methods is enshrined in the new EU Regulation on veterinary medicines
- Continued progress leveraging Non-Animal Methods from other sectors in user safety:
- Reducing the use of animals in skin sensitisation potency assessment. Report from EPAA Partners Forum 2019.
- Establishing synergies for 3Rs so that there is no need to generate new research data. Toxicokinetics and read-across report from EPAA Partners Forum.
Projects in progress
- IMI2 VAC-2-VAC project on vaccine quality testing for in-vitro replacement tests for vaccines for various diseases.
- EPAA project on harmonisation of requirements for batch testing of vaccines at a global level.
- Following deletion of Target Animal Batch Safety Test from European Pharmacopeia, ongoing global effort to phase out requirement, starting with waiver in VICH Guidelines.
On a global level
Through participation in organisations working at global level such as VICH (International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products) which works with authorities to establish and implement harmonised technical requirements for the registration of veterinary medicinal products in the VICH regions, which meet high quality, safety, and efficacy standards, and minimise the use of test animals and costs of product development. Harmonisation of requirements across regions will undoubtedly lead to a reduction in the number of animal studies required. With this in mind, VICH guidelines are written and regularly updated with the 3Rs considerations as a basis. Support is needed from the EU regulatory authorities to build confidence with global regulators and strengthen understanding of advanced scientific practice. Regulatory convergence at a global level is essential to avoid having to repeat or duplicate tests that have already been conducted elsewhere.
Animal health companies also engage with projects initiated by civil society interest groups such as the AFSA project on animal free safety assessment.
