Protection of animals used in testing facilities is rightly highly licensed to ensure that the animals have their care and welfare needs met and that harm-benefit analysis identifies the use of animals as the only option to determine adverse outcome data. The regulations all state that non-animal solutions must be used wherever possible.
Is There Still a Need for Animal Testing?
There are, however, circumstances where the predictive value of animals is often the only means to test the safety of new treatments and medicines. Animal testing is sometimes the only way to protect human health. Animals have many similarities in their genetics, physiology and anatomy, which scientists cannot replicate by other testing means. Due to safety concerns, many drugs never reach the market, stop at the preclinical stage, and never reach human-stage testing. Targeted animal testing allows scientists to identify the adverse outcome and the mechanics of the drug in use and determine the future viability of a project at the earliest opportunities, reducing the cost and time involved in drug development and bringing a new drug to market.
UK laws surrounding animal experimentation are widely recognised as the most stringent, constantly reviewed and refined set of legislation for the use of animals in scientific procedures, so much so that the European directive in place was based heavily on the UK laws at the time. The revised core legislation in the UK is the Animals (Scientific Procedures) Act 1986. In 2012, the act was updated to conform to the European Directive 2010/63/EU.
Animal research licencing in the UK
As we have mentioned, the legislation surrounding animal testing in the UK is stringent. It explicitly states that animals must not be used when reliable equivalent data can be achieved with non-animal alternatives. If animals are the way forward, each company or research institution will require three separately granted licences before undertaking any animal research.
For the Secretary of State to approve licensing for an institution or business, each establishment must supply facility details and apply for the Establishment licence. Each facility must meet a stringent Code of Practice. A premises schedule identifying the rooms or areas where animals are to be used must be submitted, along with names of individuals responsible for overseeing the care and welfare of the animals. Contract research organisations, such as Vivonics, offer the highest care and welfare provision for animals involved in animal testing, believing that happy, well-cared-for animals are essential to the quality of the collected data.
Only licensed individuals can carry out regulated animal testing activities. Specific individuals must hold a Personal Licence, which, before being granted, must have attended an accredited modular training course, with additional training required for individuals to perform surgical techniques. A project licence holder must ensure that an individual is suitably competent before issuing them with a personal licence to perform licenced procedures. Each new licence holder will then undergo further supervision and training to check their competency for their procedures.
The third licence is project-driven, with each research programme involving regulated animal testing procedures requiring a Project Licence. To be granted a project licence, the establishment must provide details of the specific procedures forming the testing and a programme of intended work required to complete the study. The project licence application must contain scientific reasoning as to why the study requires animal use and the reason that the study is necessary. The application is reviewed by an Animal Welfare and Ethical Review Body before submission to ensure that the guiding principles of the Three Rs policy, to Replace, Reduce and Refine animal testing, have been applied within the proposed project and any ethical concerns addressed. Only when the application has been reviewed, and ethical concerns dealt with will the application request Home Office approval.
Project Licences will only be granted by the Home Office, where it is clear that animal welfare, legal and ethical requirements will be upheld..