Scope
Article 1 states that the Directive 2010/63 applies when animals are “used or intended to be used in procedures, or bred specifically so that their organs or tissues may be used for scientific purposes.” The Directive primarily covers live non-human vertebrate animals. However, it also covers certain other developmental stages in vertebrates as well as some non-vertebrate species deemed likely to experience pain. These include independently feeding larvae, mammalian fetuses in the last trimester of development, live cephalopods, and animals at earlier stages of development if they will be allowed to live beyond that stage and are expected to experience pain or lasting harm from the procedure. The Directive does not cover non-invasive research; non-experimental agricultural or clinical veterinary practices; veterinary clinical trials; military experiments; behavioral studies of zoo animals; recognized animal husbandry practices; or procedures undertaken for the primary purpose of identifying an animal.
Article 2 says that European Union member nations may implement more stringent animal welfare rules, but they are not allowed to impede research in another member nation or to block the marketing of products tested in animals elsewhere so long as the research complied with the Directive.
Article 3 defines terminology used in the Directive, while Article 4 codifies the “principle of replacement, reduction, and refinement.” Replacement is defined as ensuring that “wherever possible, a scientifically satisfactory method or testing strategy, not entailing the use of live animals shall be used instead of a procedure” that involves animals. Reduction is defined as reducing animal numbers to as few as possible “without compromising the objectives of the project.” Refinement is defined as minimizing or eliminating “possible pain, suffering, distress or lasting harm to the animals.” (The latter phrase—pain, suffering, distress, or harm—is used frequently in the Directive to describe the potential negative effects of experimental procedures.)
Article 5 lists the acceptable purposes for which animal procedures may be carried out. These include basic and translational research; development, safety testing, and quality assurance of drugs, foods, agricultural feedstuffs, and other products; environmental protection; species preservation; education and training to develop, maintain, or improve vocational skills, and forensic inquiries.
Article 6 discusses humane methods of killing. It emphasizes that animals should be killed with a minimum of pain, suffering, and distress.
Restrictions
Articles 7–11 list restrictions on what animals may be used. These articles contain a number of prohibitions, which are then qualified with certain exemptions that may be sought from the “competent national authority,” namely, the agency in the EU member country that is responsible for implementing the Directive. This approach reflects the efforts that were made to ensure that the provisions of the Directive would accommodate current research needs and those that might arise in the future.
Articles 7–9 prohibit research on endangered species, non-human primates including great apes, or animals taken from the wild. Other than the ban on great ape research—which is no longer conducted within the EU—each of these prohibitions is coupled with a list of conditions that could warrant exceptions. Typically exceptions may be granted where there is no scientifically viable alternative to address health threats to humans, animals, or plants.
Article 10 states that only non-human primates bred in captivity may be utilized. However, Annex II of the Directive provides timetables of up to five years for the implementation of this provision with respect to various species. Even the ultimate goal of utilizing only second-generation captive bred non-human primates from self-sustaining colonies is subject to confirmation based upon a feasibility study, and exemptions could still be granted on the basis of scientific justification.
Article 11 begins with the statement, “Stray and feral animals of domestic species shall not be used in procedures.” It then goes on to say that exemptions may be granted by the competent national authority for studies concerning the health and welfare of these animals or if the research can only be accomplished using stray or feral animals.
Procedures, authorizations, and inspections
Articles 12–19 contain various requirements about where procedures may be conducted; what methods are permissible; that anesthesia and analgesia must be used to minimize pain unless it is inappropriate to do so; that procedures must be classified according to severity; that animals which have recovered from an earlier procedure can be re-used so long as the severity of both procedures is no more than mild to moderate; that consideration should be given to whether animals should be killed or allowed to recover at the end of a procedure; what conditions must be met if animals are to be either adopted out or returned to a suitable habitat at the conclusion of a procedure; and establishing mechanisms to promote organ and tissue sharing.
Articles 20–33 detail what animal breeders, suppliers, and users are required to do. Each member nation must establish or designate an agency to verify that these entities are in compliance with the Directive and to issue sanctions, suspensions or withdrawal of permission if entities are out of compliance. These articles address facilities and equipment; qualification and training requirements for personnel; protocols for adopting animals out where it is appropriate to do so; record keeping; and “care and accommodation.”
Each breeder, supplier, and user is also required to establish an “animal welfare body” whose role is essentially to foster a climate of care. Animal welfare bodies are supposed to advise the staff on animal welfare; implement the Three Rs; establish and review facility operations and processes; monitor the development and outcome of projects; and provide advice on plans to adopt animals out at the conclusion of research projects.
Articles 34–35 requires that the competent authority carry out regular inspections of breeders, suppliers, and users to verify compliance with the Directive. The frequency of inspections is to be determined through risk analysis. However, at least one third of users should be inspected each year, and all breeders, suppliers, and users of non-human primates are to be inspected annually.
Project requirements
Articles 36–45 deal with project-specific requirements. Member nations are required to ensure that no project involving animals is performed without prior authorization by the competent authority. Projects are to be evaluated based upon whether they are “justified from a scientific or educational point of view or required by law;” whether the “purposes of the project justify the use of animals;” and whether the project has been designed so that procedures involving animals can be “carried out in the most humane and environmentally sensitive manner possible.” The evaluation will also consider the “predicted scientific benefits or educational value” of the proposal; its compliance with the “requirement of replacement, reduction, and refinement”; study design; appropriateness of veterinary care and husbandry; how severe the project’s impact would be on the animals in terms of pain and distress; a harm-benefit analysis; and a determination whether the actual impact on the animals should be assessed retrospectively. Retrospective analysis is required for all projects involving NHP and for any procedure whose impact is classified as severe.
The project evaluation process is also supposed to be transparent: “Subject to safeguarding intellectual property and confidential information, the project evaluation shall be performed in an impartial manner and may integrate the opinion of independent parties.” In addition, the Directive specifies that authorization decisions will be made promptly and communicated back to the applicant within 40 days of when the completed application is received, although that period may be extended for another 15 working days for complex or multi-disciplinary projects.
In some cases, a simplified administrative procedure for approvals can be used. This can be applied to projects with procedures with lower pain classifications (e.g., non-recovery, mild, or moderate) when the procedure is needed to satisfy regulatory requirements or when animals are used for production of diagnostic purposes with established methods. However, projects involving nonhuman primates are not eligible for simplified administrative approval.
Member states are required to publish nontechnical summaries of all research projects. The summary is to describe the objectives of the project, its predicted harm and benefits; the number and types of animals to be used; and evidence of compliance with the requirement of replacement, reduction, and refinement. Summaries are not to include the names or addresses of those involved in the project, nor are intellectual property or confidential information to be disclosed.
Other provisions
Articles 46–66 deal with a variety of topics ranging from efforts to develop and validate alternatives to animal procedures to administrative matters related to the implementation of the Directive and the annexes, which contain technical information.