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Animal research in the European Union (EU) is regulated under Directive 2010/63/EU on the protection of animals used for scientific purposes.
The final aim of the Directive is to replace all animal research with non-animal methods of research, such as organoids or through computer simulations.
EU regulations on animal research
The Directive harmonises animal research legislation throughout the EU, to ensure high standards of animal welfare and scientific research. It was implemented into national laws in each EU Member State in 2013. Member States who had stricter measures to protect research animals before the Directive was introduced can maintain them as long as they do not hinder EU-wide scientific cooperation and trade.
Animals can only be used in research in the EU when there is a convincing scientific justification, when the expected benefits of the research outweigh the potential risks in terms of animal suffering and when the scientific objectives cannot be achieved using non-animal alternative methods. Only projects that fulfil these requirements are authorised.
The Directive sets out legal requirements to implement the 3Rs principles of replacement, reduction and refinement: replace animals with non-animal methods where possible; reduce the number of animals used to a minimum while still obtaining scientifically valid results; and refine practices to reduce any possible pain, suffering, distress or lasting harm to the animals.
Directive 2010/63/EU harmonises animal research legislation throughout the EU to ensure high standards of animal welfare and scientific research. Image: Understanding Animal Research (UAR)
In the EU, animals are used for a limited number of research purposes including basic research, applied research into human and animal diseases and cures, the protection of species and the environment, and education and training. The EU-wide ban on animal testing for cosmetic purposes has been complete since 2013.
The selection of species depends on the type, aim and method of the research. Scientists must use the species least able to experience pain and suffering, with which they can obtain relevant results. The origin of animals also matters: species including mice, rats, zebrafish, frogs, rabbits, cats, dogs and non-human primates need to be specifically bred for research purposes.
Authorities can grant an exemption for the use of stray animals and animals taken from the wild if the research objective is only achievable in these animals. Some animals can only be used if the research cannot be done in any other species or in exceptional circumstances: non-human primates may only be used for basic or specific medical research, or research aimed at preservation of the species.
Non-human primates can only be used for a limited number of research purposes and if the research cannot be done in any other species. Image: UAR
The use of an animal in research, either invasive or non-invasive, is called a ‘procedure’ when it leads to a level of pain, suffering, distress or lasting harm that is equivalent to or higher than an injection with a needle. Procedures can only be carried out in an authorised establishment and as part of an authorised research project.
A ‘procedure’ is any use of an animal in research that leads to a level of suffering that is equivalent to or higher than an injection with a needle. Image: UAR
The severity of procedures is divided up into four categories: ‘non-recovery’, ‘mild’, ‘moderate’, or ‘severe’. Suffering should always be minimised, which is why animals are given local or general anaesthesia and analgesia (numbing all feeling, and numbing pain only, respectively) where appropriate. For example, the animal might not be anaesthetised if the injection causes more harm than the procedure itself, or if the painkiller interferes with the goal of the research.
Such exceptions are never allowed in the case of severe procedures. In non-recovery procedures, the animal is put under full-anaesthesia and stays unconscious throughout the entire procedure, so it does not experience any suffering.
A procedure ends when animals are no longer studied. Animals are then put back into their housing where they continue to be cared for. If their welfare is compromised because the level of suffering is expected to stay moderate or severe, animals need to be humanely killed. Killing is carried out by a qualified person using a humane method appropriate for the species. If the health and wellbeing of an animal has fully restored after use in mild or moderate procedures, it can be reused.
When animals are no longer required for study, they can be rehomed if they are healthy and it would not endanger public health or the environment. Before animals are rehomed, they are first socialised to get used to their new lives. The same is true for any wild animals that are returned to their habitat.
Animal husbandry and care
Animals used in research are kept in purpose-built animal-facilities (‘establishments’) of breeders, suppliers, and ‘users’ such as universities, pharmaceutical companies and research organisations. All animals in establishments are provided with species-specific housing, environmental enrichment, food, water and care to suit their needs, health requirements and overall wellbeing. These conditions are checked daily, and any restrictions to animals’ needs must be kept to a minimum.
Animals are kept in species-specific housing with environmental enrichment, food, water and care to suit their needs. Image: UAR
Staff must be adequately trained before they are allowed to care for the animals, carry out or design procedures, or kill animals. Staff works under supervision until they have demonstrated their practical competence, and receive continuous training. Installations and equipment must be suited to the species housed and to the particular procedures carried out in the establishment. The standard of equipment must ensure that procedures are performed efficiently, causing the least amount of harm and obtaining reliable results through the minimum number of animals.
Every breeder, supplier and user has a designated veterinarian or animal welfare expert and an animal-welfare body (AWB). The veterinarian or animal welfare expert advises on animal wellbeing and treatment, while the AWB is a senior committee that advises staff on welfare matters related to the acquisition, care, housing and use of the animals. The AWB also keeps track of how research projects affect the animals, and gives advice on the application and developments in the replacement, reduction and refinement of the use of animals in research.
Regular inspections are carried out of breeders, suppliers, users and their establishments. Image: Cmdragon
Authorities appointed in each EU Member State carry out regular inspections of breeders, suppliers, users and their establishments. Some inspections are carried out without warning, and inspections take place more or less frequently depending on the number and types of animals and projects, but covering at least one third of the users each year. These ‘competent authorities’ also grant authorisation for animal research projects to take place within their Member State.
Authorisation is required for all establishments. Separate authorisation is required for breeders, suppliers and users of research animals, which lasts for a limited time. Authorisation is only granted or renewed when establishments fulfil the requirements of the Directive. Establishments have to adhere to a wide range of general and species-specific requirements set out in a dedicated annex of the Directive.
Every research project that makes use of animals must be authorised before it can start. Applications for project authorisation have to contain a project proposal with the scheduled procedures, a non-technical (lay) summary, and include a scientific explanation of why animal research is needed in the project. They must show that the 3Rs have been considered and outline the number of animals that will be used and the level of suffering they are expected to experience. A project proposal is evaluated through a harm-benefit analysis by the ‘competent authority’ in each EU Member State, which then decides whether to grant the license.
Every country in the EU has a national committee for the protection of animals used for scientific purposes. This committee advises the competent authority and animal-welfare bodies in the country on matters relating to research animals, including their acquisition, breeding, accommodation, care and use. All national committees share information on EU level about best practices and the functioning of animal-welfare bodies.
The European Commission and EU Member States support research into non-animal methods and 3Rs initiatives.
Image: Novartis AG
The European Commission and EU Member States support research into developing and confirming the effectivity of new non-animal methods and 3Rs initiatives. These methods have to produce at least the same amount of information as the animal method, while using fewer or no animals and/or causing the animals less harm. The European Commission’s Joint Research Centre focuses on developing and validating non-animal methods, as well as helping make sure new non-animal methods are internationally recognised and accepted for regulatory purposes.
The Directive has to be reviewed by 10 November 2017. The Commission’s review of the Directive is currently underway; the main focus is to find out if there are any scientific developments in non-animal alternatives, especially to the use of non-human primates, that need to be taken into account.