Legal & Scientific
UK Government & Animal Use
For the official Home Office guidance on what the law requires you can download the Guidance on the operation of the Animals (Scientific Procedures) Act 1986.
EU Law & Animal Testing
The legal requirements for toxicological and pharmacological testing are covered by Part 3, "II Performance of Tests" of Directive 2001/83/EC of the European Parliament.
The full text of Part 3 of this directive is in contained in the downloadable PDF file (65 KB) EU Law & Animal Testing.
The following extracts contain specifications of requirements of animal use.
1. Single dose toxicity
The acute toxicity test must be carried out in two or more mammalian species of known strain unless a single species can be justified. At least two different routes of administration shall normally be used, one being identical with or similar to that proposed for use in human beings and the other ensuring systemic exposure to the substance.
This study will cover the signs observed, including local reactions. The period during which the test animals are observed shall be fixed by the investigator as being adequate to reveal tissue or organ damage or recovery, usually for a period of 14 days but not less than 7 days, but without exposing the animals to prolonged suffering. Animals dying during the observation period should be subject to autopsy as also should all animals surviving to the end of the observation period. Histopathological examinations should be considered on any organ showing macroscopic changes at autopsy. The maximum amount of information should be obtained from the animals used in the study.
The single dose toxicity tests should be conducted in such a way that signs of acute toxicity are revealed and the mode of death assessed as far as reasonably possible. In suitable species, a quantitative evaluation of the approximate lethal dose and information on the dose effect relationship should be obtained, but a high level of precision is not required.
These studies may give some indication of the likely effects of acute overdosage in man and may be useful for the design of toxicity studies requiring repeated dosing on the suitable animal species.
2. Repeated dose toxicity (sub-acute or chronic toxicity)
Repeated dose toxicity tests shall be carried out on two species of mammals one of which must be a non-rodent. The choice of route(s) of administration employed shall depend on the intended therapeutic use and the possibilities of systemic absorption. The method and frequency of dosage shall be clearly stated.
The maximum dose should be chosen so as to bring harmful effects to light. The lower doses will then enable the animal's tolerance of the product to be determined. Wherever possible, and always in experiments on small rodents, the design of the experiment and the control procedures must be suited to the scale of the problem being tackled and enable fiducial limits to be determined.
The evaluation of the toxic effects shall be based on observation of behaviour, growth, haematological and biochemical tests, especially those relating to the excretory mechanism, and also on autopsy reports and accompanying histological data. The choice and range of each group of tests will depend on the species of animal used and the state of scientific knowledge at the time.
C. Embryo/foetal and perinatal toxicity
Embryo/foetal toxicity studies shall normally be conducted on two mammalian species, one of which should be other than a rodent. Peri- and postnatal studies shall be conducted in at least one species. Where metabolism of a medicinal product in a particular species is known to be similar to that in man, it is desirable to include this species. Also, it is desirable that one of the species is the same as in the repeated dose toxicity studies.
Legal Implications of Brexit
The effect of Brexit on the use of animals in research, and on research generally, in the UK will depend on the UK’s final deal with the EU on leaving. It will also depend on the nature of the UK’s trade deals with non-EU countries after Brexit. A major part of trade deals is agreement on standards and regulations. This not only has implications for animal welfare and the use of animals in research, but will also affect intellectual property rights, risking greater restrictions on the ability to access and share the content of research papers. This is further complicated by trade negotiations taking place in secret, enabling corporations to have a controlling influence on trade terms away from public scrutiny.
Following the referendum the Association of Lawyers for Animal Welfare (ALAW) has produced a guide to the legal implications of leaving the EU. See ALAW Animal Law Guide to the Legal Implications of Brexit.
On 15 November 2017 a vote took place in the House of Commons on a proposed amendment to the EU (Withdrawal) Bill (the Withdrawal Bill). The amendment (referred to as “New Clause 30”, or “NC30”) sought to incorporate into UK law Article 13 of the Treaty on the Functioning of the European Union (TFEU). Article 13 states that the EU and its member States “shall, since animals are sentient beings, pay full regard to the welfare requirements of animals” when formulating and implementing the EU’s policies. NC30 was defeated by 313 to 295 votes. The UK Government whipped its MPs to vote against NC30.
ALAW produced the legal briefing note Brexit, Article 13, and the debate on recognising “animal sentience” in law (PDF 566 KB).
ALAW have also produced recommendations for enhancing animal welfare, British industries, and consumer confidence and choice in post-Brexit Britain. See Brexit, getting the best deal for animals (PDF 1147 KB).