Law - Animal welfare

Controls on Animal Research - The Law, Compassion and Respect

• Striking a difficult balance
• Britain has strong legislation
• What the law says
• Other provisions
• Overseeing the Act
• Animal Procedures Committee
• Leading the world
• Does this mean things are perfect?

There are many areas in which society, and those who govern on its behalf, have to strike a difficult balance between allowing progress and respecting individual needs and freedoms while setting boundaries on what is permissible.

Medical research raises some particularly challenging issues. For many people the use of animals in medical research is one of them.

As a society we want to protect the safety of people likely to benefit from a new treatment and we want to see continued medical progress. We also expect research to be conducted in an ethical manner. Hence, regulations require the comprehensive testing of new medicines (including testing in animals). And there is also legislation to control the use of animals and ensure that the principles and practice of good animal welfare are closely observed.

Legal controls on the use of animals in experiments have existed in Britain since 1876. Britain was the first country to have such a law. It was a significant piece of legislation, which required that high standards be met and it put in place a unique system of inspection. These controls were significantly extended with the introduction of the Animals (Scientific Procedures) Act 1986, which is overseen by the Home Office. The Act's provisions are designed to balance the legitimate needs of research with the welfare of laboratory animals.

Alongside these statutory controls, researchers and the organisations they work for are expected, and strive, to promote high standards of animal welfare by ensuring that the research is conducted within a 'culture of care'. People working with animals are expected to observe both the letter and the spirit of the law.

The Act requires that before a researcher can use an animal, three special authorisations must be obtained. These are granted only if:

• the research laboratory has the necessary facilities and staff to house and care for the animals properly,
• the individual researcher is considered to have the necessary skills and training, and
• the object of the research cannot be achieved in other ways and the likely benefits of the research justify any likely distress to the animals.

A Certificate of Designation is only given to a laboratory or research institute that has all the facilities needed to look after research animals properly. The Certificate Holder, a senior representative of the organisation, is responsible for seeing that strict Home Office criteria in matters such as staffing, veterinary care, properly trained animal technicians and the quality of housing, lighting, ventilation and temperature control are met. The Certificate must specify a 'Named Veterinary Surgeon' and a 'Named Animal Care and Welfare Officer', both of whose prime concern must be the health and welfare of the animals within the establishment

To obtain a Personal Licence, researchers must first go on an independently approved training course to familiarise themselves with the law and ethics of animal research, the basics of caring for animals and handling them, and ways of recognising symptoms of illness or distress. A person is then allowed to use only those techniques specifically listed in his or her individual licence. The species of animals covered are also clearly stated. If circumstances change, the researcher must apply for a change to the licence.

The third, and most complicated of the three is the Project Licence, which covers the specific research project. The application is extremely detailed and may run into scores of pages. It must contain a complete description of the research programme explaining:

• the likely benefits of the research to man, animals (veterinary research) or the environment,
• why and how many animals are needed and of what species,
• every procedure that will be included,
• the potential ill-effects on the animals,
• how any pain or distress will be minimised,
• what steps the researcher has taken to look for alternative methods using fewer (or no) animals and why other methods cannot provide the required information.

Only the smallest number of animals necessary to meet the objectives of the research may be used. If in the course of a study, new questions develop, the Project Licence holder must explain the circumstances and formally ask the Home Office for the licence to be amended.

Distress must be kept to the minimum possible given the nature of the research. As part of the Project Licence, the severity of the procedures - the potential pain or distress to animals - must be explained and, if the licence is granted, that limit cannot be exceeded. Any likely adverse effects on the animals are weighed against the likely benefits of the proposed work before the Home Office will grant a licence.

Most of the animals used are rodents. Dogs, cats, primates and equidae (eg horses) can only be used if less advanced animals could not provide the information. Except in rare circumstances (requiring special permission), animals used in UK research must be specially bred.

Anaesthetics or painkillers must be used wherever appropriate, although the majority of procedures are too minor to require this - giving anaesthesia would be more troubling to the animals than the procedure itself.

Animals must be examined every day, and a vet must be on call at all times. Any animal judged to be in severe pain that cannot be relieved must be immediately and painlessly put down, regardless of whether or not the purpose of the research has been achieved.

To oversee the Act, the Home Office employs a team of inspectors who have to be qualified vets or doctors. These inspectors advise on the granting of licences and regularly visit laboratories, often unannounced, to check that the conditions of the licences are being observed. Inspectors carry out about 2,500 visits a year. They have to be given complete access to all the facilities.

The inspectors are held in high regard by scientists, who respect their knowledge and know that, if breaches of the law are found, their licences could be suspended or revoked, and whole research projects delayed. Most breaches are of a technical nature that have no impact on animal welfare, because licences are so specific and detailed, but any breach must be taken seriously so that welfare problems do not arise in the longer term. In cases involving a serious breach, criminal proceedings can be brought against researchers.

Even if a serious breach did not result in criminal charges the person's job, and possibly their whole career in science, would be in jeopardy.

In complex licence applications, for instance in a new area of research, the Home Office can refer to experts in a particular field, or to the Animal Procedures Committee (APC). The APC is an independent, and very active, body set up to advise the Home Secretary about matters to do with the Act. The APC will look in depth at particular areas of its own choosing and advise on ethical issues. The membership of the APC includes doctors, vets, biologists, animal welfarists, lawyers, and philosophers.

Other countries do not have the equivalent of our triple licensing system or Home Office Inspectorate. Most use variations of what is known as an 'ethical review process'.

In the UK, Project Licence applications now have to go through two separate approval systems. As from April 1999, the Home Office requires projects to be formally vetted and approved through local ethical review, taking a wide range of scientific and welfare considerations into account, before the Home Office will assess the application. The nature of the local review must, itself, be approved by the Home Office.

Does this mean that nothing can ever go wrong? No law, in any area of human endeavour, can provide such a guarantee. But what can be done, and what is continually being done, is to ensure that everyone involved is clear about their moral and legal responsibilities and that, if something does go wrong, lessons will be learned and appropriate steps taken to see that the problem does not recur.

Research organisations fully expect all those who work for them to obey the law at all times and to conduct their research with compassion and respect for the animals in their care. We can be proud that Britain is a world leader in the discovery and development of new medicines. We can also be proud that Britain is a world leader in the care and welfare of animals in research.

NB The Animals (Scientific Procedures) Act 1986 uses the term 'procedure' rather than 'experiment' so that laboratory animals used in ways which are not experimental, such as producing antibodies used in otherwise non-animal systems to screen new medicines, are also covered. 

 

It would be wrong (and in any event would not be permitted) to leave out the animal tests, as that could cause lasting harm and endanger people’s lives.