Law - Approval of medicines

Government departments of health around the world demand evidence from animal tests before they will give permission for medicines to be tested and used in people.

In the UK, research organisations developing new medicines must meet the requirements of the Medicines Act 1968. The Act came into being following the Thalidomide tragedy in which babies were born with major deformities because a drug had been inadequately tested. Until the fifties when thalidomide was being developed, there were no legally established research protocols as to how to investigate safety.

The Medicines Act requires that a medicine must demonstrate it is safe (given the seriousness of the condition it is meant to treat), effective and of uniform high quality. The rules covering the licensing of medicines are now harmonised throughout the European Union. All member states must abide by them. The UK’s Medicines Act therefore, incorporates the EU Directive and its guidelines.

Little deviation from the protocols laid down in the guidelines is permitted and any deviation must be scientifically justified and agreed on by the medicines licensing authority - either by the UK’s Medicines Control Agency (MCA) or the European Medicines Evaluation Agency (EMEA). Some small amount of flexibility might be allowed if, for instance, the way a particular medicine will be used makes a specific test unnecessary or a new testing method may have been validated. But all new prescription medicines must be studied in animals before they are tested in people.

In other countries, medicines are licensed through their equivalent regulatory authority e.g. in the US, the Food and Drug Administration (FDA) and in Japan, The Ministry of Health Labour and Welfare.

NB EU member states implement Directives and their guidelines by incorporating them into national law. In the case of the licensing of medicines, the relevant provisions form the Rules governing medicinal products in the European Union covering Council Directive 2001/83/EC.

For further information about the legal requirements see the Department of Health Memorandum for House of Lords Committee on Animals in Scientific Procedures.