Primate testing in Europe
The Primate Environment and Animal Welfare at Huntingdon Life Sciences (HLS)
Huntingdon Life Sciences is a major European contract testing laboratory, conducting toxicological (safety) tests on behalf of a range of clients who include manufacturers of drugs, chemicals, and other products. As mentioned earlier, regulatory testing represents approximately 70% of the 10,000 primates used in European laboratories each year, it is therefore important to study this sector of the animal testing industry (see Investigation section).
Tests on non-human primates: legal requirements
The use of primates in laboratories can be placed into two broad categories: commercial and regulatory testing (toxicology, also called safety tests), ‘regulatory’ are standardised and required for permission to be given for a product to be sold on the market, and academic (or fundamental) research, which is varied in nature and includes a range of experiments in the fields of biology, neurology, biochemistry, physiology, psychology and more.
There are no specific legal requirements for the use of primates in regulatory testing. European Council Directive 2001/83/EC requires two mammalian species to be used in regulatory testing, one of which should be other than a rodent6. Like dogs, non-human primate species are therefore used at the end of the testing strategy.
The UK’s Animals (Scientific Procedures) Act 1986 (ASPA) is the legislation that brings Directive 86/609/EEC into effect in the UK. The UK Home Office issues a Code of Practice for the Housing and Care of Animals used in Scientific Procedures, under the authority of the Act. The UK requires that primates should only be used if no other species is suitable or practicable, and also that “any use of non-human primates must be specifically justified”. The Home Office emphasises that the criteria for selection of the second species include regulatory, scientific and ethical requirements7.
It is of concern that regulatory tests conducted by contract testing laboratories, on behalf of clients such as drug companies, are not scrutinised in advance by the Home Office on a case-by-case basis. Project licences for these companies are authorised for groups of chemicals or drugs – avoiding the need for project authorisation for each product. This means that the scrutiny of the proposal to use animals is not undertaken.
Not only does this mean less scrutiny, but it means that less information is reviewed and held by the national authority on those experiments. The reports of the studies of regulatory and commercial animal tests are the property of the customer and therefore the authority does not have access to full information. This can lead to cases of unexpected suffering or occurrences that are not fully reported to the authority (NAVS & UK Home Office discussions, Inveresk Laboratories, 2005).
Group authorisations have been proposed for the new Directive currently under discussion at the European Parliament, and should be opposed.
Primate use has been rising, since the introduction of the new generation of so-called ‘biological’ products: In their report on the use of non-human primates in the development of monoclonal antibodies, the UK National Centre for the 3Rs (NC3Rs), highlights the issues “Four main areas for investigation have been identified, including toxicology, pharmacokinetics (PK), drug dependency and biologicals. These.... reflect the differing drivers for primate use from regulatory requirements to emerging technologies and the opportunities for reducing this use. The use of primates in the development of biologicals was a timely area for review given the increasing number of biological products in the pharmaceutical pipeline, the specific challenges faced in providing preclinical data and the implications for primate use”8.
Academic experiments in universities (e.g. neurology, psychology, physiology, biochemistry) is another large area of primate use. There are no regulatory requirements for these academic experiments, so this is field where replacement could be very rapid.
Due to the varied nature of the experiments, a different approach would be needed for different fields of research, but this could be achieved through expert consultation and a focussed, technical review, managed by the Commission, under the new Directive.
These studies cause extreme suffering for example, brain research can include implanting electrodes and other equipment into the animals’ heads, and the restraint involved to make recordings, as we shall show later, causes immense stress in primates. Often this so-called ‘fundamental’ research does not describe any potential application for human benefit.
Such experiments can be replaced by advances in modern scanning techniques such as fMRI and MEG, which are enabling non-invasive neuroimaging of the human brain, providing unprecedented understanding of mental illness, neurodegenerative diseases, vision, hearing, speech, pain and more. This provides data of direct relevance to patients, who can be asked to describe how they feel.
In 2008, a meeting at the European Parliament was presented with a comparison of data from scanning studies of human patients and electrodes implanted in the heads of monkeys. The same level of data was obtained – yet importantly one set of data was of direct relevance to people.
- Political and Public Support for Replacement of Primate Tests
- Drug development and safety testing using animals
- Advanced Techniques to Replace use of Primates
- The Investigation
- Suppliers and Travel
- The Primate Environment and Animal Welfare at Huntingdon Life Sciences (HLS)
- (HLS) Husbandry-related welfare issues
- (HLS) Health and sickness
- (HLS) Procedures, handling and restraint
- (HLS) Welfare and suffering related to specific studies
- (HLS) Critique of studies observed at HLS
- Replacing primates