Summary of the proposal for a new directive
Scope
The directive will apply where animals are used or intended to be used in procedures or where they are bred specifically so that their organs or tissues may be used for scientific purposes.
The directive will cover the use of:
vertebrates
cyclostomes (hagfish and lampreys)
cephalopods (octopuses and squid)
decapod crustaceans (crabs, lobsters and prawns)
including:
a) independently feeding larval forms
b) embryonic or foetal forms for the last third of their development
The following are excluded from the directive:
i) non-experimental, agricultural or vererinary practices
ii) animal husbandry practices
iii) marking an animal
iv) non-invasive practices
It is assumed that point iv) refers to purely observational studies, but there is no recital to explain this.
Permitted purposes
Animals can be used in procedures for the following purposes:
a) basic research for the advancement of knowledge in the biological or behavioural sciences
b) translational or applied research aimed at:
i. the avoidance, prevention diagnosis or treatment of illness
ii. the assessment detection, regulation of modification of physiological conditions
c) the development, manufacture or testing of drugs, foodstuff or other products with the aims in b) above
d) protection of the environment in the interests of human welfare
e) research aimed at the preservation of the species
f) higher education or training
g) forensic inquiries
Non-human Primates etc
Primates must be purpose-bred for research and may only be used in procedures that are “undertaken with a view to the avoidance, diagnosis, prevention or treatment of life-threatening or debilitating clinical conditions in human beings.” It is made clear in the recitals that this can include fundamental research. Research aimed at the preservation of the species is also permitted.
From the following dates primates used in research must be "the offspring of non-human primates which have been bred in captivity.”
Marmosets – as soon as Member States apply the directive.
Cynomolgus and Rhesus macaques – 7 years after Member States apply the directive
All other primates – 10 years after Member States apply the directive
When acquiring primates for research use, you must show proof that the breeding establishment has a strategy in place to increase their breeding of F2 animals.
The use of great apes is banned, although there is a ‘safeguard’ procedure to allow Member States, with the European Commission’s agreement, to authorise their use for research that is considered essential for the preservation of the species or in relation to an unexpected outbreak of a life-threatening disease.
Endangered species (CITES Annexe A) can only be used for translational/applied research and testing, but not for basic research.
Stray and feral domestic animals cannot be used.
Animals taken from the wild cannot be used, although an exemption to this can be granted by a Member State on the basis of scientific justification.
The usual species (mice, rats, guinea pig, hamsters, gerbils, rabbits, frogs, dogs. cats and primates) must be purpose-bred, although an exemption to this can be granted by a Member State on the basis of scientific justification.
Severity of procedures
These are four classes of severity: up to mild, moderate, severe and non-recovery (ie killed while still under anaesthesia)
The Commission will establish criteria for the classification of procedures to be adopted by a regulatory committee.
Re-use
Definition: Using an animal that has already used in a procedure, when a different animal on which no procedure has previously been carried out could also be used.
To apply this definition, for any experiment apply the test 'at this point, could one substitute a different animal to which nothing at all had been done'. This wording thus allows continuing use (eg surgical preparation and then an experiment) as part of the same procedure.
Restrictions
a) the first procedure must be classified as ‘mild’, although an exemption to this can be granted by a Member State on the basis of scientific justification.
b) the animals general state of health and well-being has been fully restored
c) the further procedure must be classified as ‘mild’ or ‘non-recovery’
d) If an animal has been used first in a severe procedure, it can only be re-used once in a further procedure.
a) the first procedure must be classified as ‘mild’, although an exemption to this can be granted by a Member State on the basis of scientific justification.
b) the animals general state of health and well-being has been fully restored
c) the further procedure must be classified as ‘mild’ or ‘non-recovery’
d) If an animal has been used first in a severe procedure, it can only be re-used once in a further procedure.
Authorisation
Individuals require authorisations to carry out:
a) procedures
b) humane killing
c) Supervision of projects or procedures
d) Supervision of animal care staff
Authorisations for a maximum of 5 years.
Institutions require authorisation:
a) for breeding, supplying or using animals in procedures
b) the person responsible for the institution must be named
c) the institution must have staff to ensure that projects are carried out in accordance with their authorisations and to deal with undue suffering or non-compliance, including:
i. animal care and welfare staff
ii. designated veterinarian (for advisory duties)
d) the institution must have a permanent ethical review body
Permanent ethical review body
Its functions are to:
a) Provide advice to staff on ethics, animal husbandry and the three Rs
b) Establish internal procedures for monitoring animal welfare
c) Review all projects annually, to check compliance with authorisations
d) Keep records of all advice given to staff and licence-holders
a) Provide advice to staff on ethics, animal husbandry and the three Rs
b) Establish internal procedures for monitoring animal welfare
c) Review all projects annually, to check compliance with authorisations
d) Keep records of all advice given to staff and licence-holders
Project authorisations
National authority can give authorisations for projects for up to 4 years based on an ethical evaluation of the project including:
a) Scientific or legal justification of the project
b) Application of the 3 Rs in project design
c) The severity of the procedures involved
d) Harm-benefit analysis (is the animal use and suffering justified by the expected advancement of science that ultimately benefits human beings, animals or the environment.)
b) Application of the 3 Rs in project design
c) The severity of the procedures involved
d) Harm-benefit analysis (is the animal use and suffering justified by the expected advancement of science that ultimately benefits human beings, animals or the environment.)
The ethical evaluation shall be performed in a transparent manner, by integrating the opinion of independent parties.
The ethical evaluation will determine whether the project should also be assessed retrospectively. All NHP projects must be retrospectively assessed.
Decisions on authorisations must be communicated to the applicant within 30 days of submission. Failure to communicate such a decision shall, for any non-primate projects which only include up to mild procedures, will result in automatic approval of the project. In exceptional circumstances, for complex project, this limit can be extended to 60 days.
Non-technical project summaries
Subject to safeguarding confidential information, non-technical summaries will cover the objectives of the project, numbers and types of animals to be used and potential suffering, application of the 3 Rs, whether retrospective assessment is required and outcome of the retrospective assessment. These summaries will be published for all authorised projects.
These summaries must be included in all project applications, except that Members States can decide to use a reduced project application system (which does include such summaries) for any non-primate projects which only include up to mild procedures.
Care and accommodation
The ETS123 guidelines will be mandatory requirements.
Inspections
a) All Member States must have an appropriate infrastructure with sufficient numbers of trained inspectors
b) Each establishment will have at least 2 inspections a year by the national authority
c) At least one of these must be unannounced
d) Larger establishments to have more frequent inspections
e) The Commission may undertake controls of the infrastructure and operation of inspections
Alternatives
Each Member State must designate a national reference laboratory for the validation of alternative methods.
The Commission will set the work priorities for these national reference laboratories.