Primate testing in Europe

The Investigation

This study of the use of primates in regulatory testing includes an insight into the functioning of a typical European commercial testing laboratory. An ADI/NAVS investigator worked as an animal technician in the primate toxicology units at Huntingdon Life Sciences (HLS), Cambridgeshire, UK for a year, until the summer of 2008. Duties included cleaning and feeding the animals, as well as observing and assisting researchers and senior technicians with procedures; training included a UK Home Office animal technician training course.

HLS is a commercial toxicological testing facility. The nature of the experiments it conducts on behalf of its clients is to look for adverse effects or symptoms of test compounds. Its clients are manufacturers of drugs, chemicals and other products. They include GlaxoSmithKline, the Ministry of Defence, AstraZeneca among others.
HLS has two establishments in the UK at Huntingdon Cambridgeshire and Eye, Suffolk, with its headquarters in the USA and the company employs in the region of 1,700 people. All of the experiments discussed here took place in the primate units in the HLS Huntingdon laboratories, which employs in the region of 900 people.
During the period of our study, the company held 25 Home Office licences carrying a ‘mild’ suffering protocol, 148 with a moderate suffering protocol, 36 substantial suffering and 3 unclassified[20].

This is therefore a major contract testing operation providing testing facilities to wealthy multi-national manufacturers of a range of products. HLS offers its clients: dogs, monkeys, mini-pigs, rodents, guinea pigs and rabbits; it also has capacity for larger animals, such as horses. The beagle block holds up to 2,500 dogs at any one time[21].

There were many studies (animal tests) under way during the time that the investigator worked in the primate units. The units had capacity for 550 monkeys at any one time, and the numbers of monkeys used in the tests observed during this investigation ranged from 4 to 72. Just five studies accounted for the lives of 217 monkeys.

The number of primates killed each day depended upon the status of the individual study and the capacity of the necropsy teams to cut up and analyse each animal – each necropsy team could not handle more than 8 animals per day[21]. The investigator commented: “on the day of the necropsies, the monkeys are silent”[21].
Commercial and regulatory tests such as these are not generally published in scientific journals, making critical review of the procedures, the justification and discussion of alternatives difficult. This investigation provides a unique insight into the world of commercial animal experimentation.

Secrecy, accountability

Progress on the development and adoption of non-animal replacement techiques has been slow; regulators are used to the data they receive from animal tests, and the law does not have a mechanism to enable a wider critical review of toxicology tests on animals and input from experts on non-animal methodology.

Any new legislation on animal experiments needs to include a framework and a mechanism to ensure that animal tests are replaced by non-animal alternatives. There needs to be a wider scientific and public scrutiny, before a licence to use animals is granted.

An important bar to wider input in the UK is that the government has retained the secrecy clause (Section 24) of the ASPA, and made an exemption from the full provisions of the Freedom of Information Act 2000. A House of Lords Select Committee and the government’s own advisory body had agreed with us that there needed to be more openness and accountability on this issue, and that the freedom of information rules should apply. However, although the government accepted this point, it decided to retain the blanket of secrecy that gives rise so much public concern[22].

It will be important for European legislation to ensure that assessments of the need for animal use are made with the widest possible scientific and ethical input, before authorisation to use animals is given.

A huge gap in transparency and public accountability exists at the heart of the UK’s ASPA (EU Directive 86/609/EEC). This was highlighted in 2005 when the Home Office was questioned about regulatory animal testing at Inveresk laboratories in Scotland. NAVS and ADI submitted freedom of information requests on a number of studies (including primates), only to be informed that the information was not kept.

The reason given was that authorisations for groups of drugs or chemicals (i.e., covering many animal tests for individual products within a group of chemicals or pharmaceuticals) – no individual assessment of studies takes place and records of outcomes are not kept. The individual study reports are the property of the client, and the Home Office does not hold copies[23].

In effect, commercial testing laboratories are policing themselves.