The research-based pharmaceutical companies obtain the vast majority of the animals they need for experiments from certified breeding facilities in the international marketplace, primarily Europe. The animals used in an experiment must possess specific features to suit the purpose of the research. To reduce the variance in the results, and thus also the number of animals, experiments are standardised. Standardisation comprises a combination of the conditions in which the animals are kept (exogenous factors) and properties of the animals themselves (endogenous factors such as age, sex, genotype, physical condition and physiology). A decision is also taken on whether a particular genetic mutation is required. Working with preferred partners ensures that animals of a certain quality are available and that there is compliance with specifics. Standardisation of animal health status is also key, since animals bred for experiments have to be free of germs and pathogens that could make other animals ill or impact the results of the experiment. All this requires breeding facilities and research-based pharmaceutical companies with experience and expertise.
2. Strict requirements for companies and breeders
Research institutions and companies in Switzerland and throughout Europe may only order, keep or breed animals for research if they comply with specific conditions. Holding a permit to keep the animals is essential. Breeding facilities count as animal keeping facilities and must therefore fulfil similar conditions to research-based pharmaceutical companies or other research institutions. These include strict legal requirements governing infrastructure and technical installations such as ventilation, temperature, drinking water supply, bedding, feed and hygiene, but also cage size, material and resilience, and staff training. A large number of pharmaceutical companies also require breeders to comply with additional requirements beyond those prescribed by law. These include, for example, environmental enrichment – providing toys, things to climb on, raised platforms or other things that are beneficial to the animals’ well-being.
3. Regular inspections and audits
The authorities in European countries conduct inspections in accordance with the applicable European and national legislation governing animal keeping and breeding facilities. In addition, many pharmaceutical and biotechnology companies, universities, hospitals and other research institutes around the world have been accredited by the Association for the Assessment and Accreditation of Laboratory Animals Care and Use (AAALAC), a private international non-profit organization that offers voluntary assessment and accreditation programmes that promote the humane treatment of animals. This means that they have been certified and are regularly audited by AAALAC. AAALAC accreditation guarantees an international standard on which research-based companies can rely. Furthermore, the research-based pharmaceutical companies that are members of Interpharma regularly conduct their own audits of the breeders they work with using comprehensive checklists (shared audits; see Animal Welfare Charter p. 20 and Audit process p. 33).
4. Transport as short and stress-free as possible
In view of the strict requirements that apply throughout Europe, there is an ongoing process of consolidation under which breeding facilities are becoming bigger. Since there are no longer any such facilities in Switzerland, the animals used in the country come primarily from France, Germany, Denmark and, to a lesser extent, Italy. More rarely, laboratory animals are imported from the USA and Asia. However, the shorter distances the animals have to travel and the associated smaller risk of delays and other incidents make Europe preferable. To avoid the animals becoming stressed and exhausted, it is important to ensure that they are exposed to as little stress and have to travel as short a distance as possible. In most cases, the animals are therefore transported by road in climate controlled vehicles. This is more tolerable for the animals than flying. When animals do have to travel between continents(from overseas), they always do so by air, by direct flight with no stopovers wherever possible.
5. Meticulous planning with experienced partners
In evolutionary terms, animals and humans are related. They share common ancestors and thus also biological similarities, even if these are not always equally pronounced. As evolution has progressed, nature has retained a large number of processes. Hence research with animals can deliver valuable pointers on the cause of diseases and the effect of medicines. It provides information on desirable effects and brings around 70 percent of undesirable effects to light.
6. Strict rules and emergency plans
Switzerland’s Animal Welfare Ordinance lays down strict criteria for transporting animals. It specifies the responsibilities of the sender, transport company and recipient. The people who transport the animals must be proficient and trained in the conditions associated with transporting experimental animals. Customs brokers who work hand-in-hand with the transport companies are used to ensure there are no holdups at customs. In complex cases, border veterinary inspectors may be notified in advance so they can be involved. Transport companies must have a disaster plan for incidents such as road congestion, accidents, extreme weather, fire or earthquake and situations associated with pandemics. This plan must describe the actions to be taken in each scenario.
7. Animals are settled in at their destination
The rules for the animals when they arrive at their destination vary depending on species, origin and hygiene standard. Each animal is examined to assess its health status. In certain cases– depending on species, hygiene status, health status and company requirements – animals may have to be quarantined; otherwise they are taken straight to the housing facility. If there are any anomalies or concerns, the animals are examined for infectious pathogens. All animals have a mandatory one-week acclimatisation period.
Laws such as the overarching EU Directive 2010/63 of the European Parliament and of the Council on the protection of animals used for scientific purposes sets minimum standards for the whole of the EU and EEA. Individual countries have used this Directive as the basis for their own national legislation, which may include further-reaching requirements than the Directive.
In Switzerland, the Animal Welfare Act and the Animal Welfare Ordinance provide the legal basis for research involving animals. Swiss legislation is among the strictest in the world and promotes ethically responsible research.
The Animal Welfare Ordinance also governs the transport of laboratory animals. In addition, the International Air Transport Association (IATA) issues annually updated regulations for animal transport. These include clear specifications on how individual species have to be prepared for carriage (carrier size, etc.).
8. A complex process demands exact planning
The process of specifying the laboratory animals needed for a particular research goal, ordering the animals from the breeding facility, transporting them to their destination and settling them in there is demanding. It requires experts, clear responsibilities and effective collaboration between the point of contact at the pharmaceutical company, the researchers and the breeders. Thanks to foresighted and exact planning of the cohorts that will be needed for a particular experiment and the timeframes in which they will be required, the quality of biomedical research involving animals can be constantly improved and the number of animals required can be reduced. This is an active contribution to the 3Rs: refinement in terms of the species that are needed and when, and reduction in terms of optimising breeding schedules. All member companies of Interpharma are working on alternatives to animal experiments. For the time being, however, in vivo research is still needed to develop new treatments for severe diseases. It is therefore important to ensure that this research remains possible, subject to strict conditions, in Switzerland and throughout Europe.