HC Deb 27 April 2004 vol 420 cc930-2W
Mrs. Curtis-Thomas

To ask the Secretary of State for the Home Department what cost/benefit analysis has been conducted regarding animal experimentation. [165891]

Caroline Flint

The Home Office has not itself conducted a general cost/benefit analysis regarding animal experimentation. Various competent bodies have considered whether animal experimentation is valid and justified, including the Animal Procedures Committee and the House of Lords Select Committee on Animals in Scientific Procedures. They have concluded, in line with the consensus within the scientific community, that there is a continuing need for animal research and testing.

A form of cost benefit assessment of individual programmes of work has to be undertaken before the Home Office grants licences under the Animals (Scientific Procedures) Act 1986 to authorise the use of animals. Such licences can accordingly only be granted where, among other considerations, the likely benefits of the work are expected to outweigh the welfare costs to the animals involved. No animal procedures are therefore lawfully carried out which have not been fully justified.

More information about the statutory cost benefit assessment used in particular cases can be found at Appendix I of Guidance on the Operation of the Animals (Scientific Procedures) Act 1986 (HC321).

Mrs. Curtis-Thomas

To ask the Secretary of State for the Home Department what research has been conducted into the effects on animals of heterotopic transplants. [165892]

Caroline Flint

Heterotopic transplants of organs are those in which the transplanted organ is not located at the same anatomical position as the animal's own organ, for example, where a third kidney is implanted into the abdomen. We are not aware of any research carried out in the United Kingdom, or elsewhere, exclusively to study the effects of such transplants on the welfare of the animals concerned.

Such transplants have been carried out under the Animals (Scientific Procedures) Act 1986 to investigate aspects of the performance of the transplanted organs, and causes of transplant rejection and methods of overcoming this problem. Significant scientific findings have been published in peer-reviewed scientific journals. The effects on the welfare of the animals would be reported in records maintained by the researchers.

Mrs. Curtis-Thomas

To ask the Secretary of State for the Home Department if he will make a statement on the openness of the(a) regulation and (b) licensing procedures in relation to animal experimentation. [165893]

Caroline Flint

For some time now the Government has taken the view that greater openness and transparency regarding the regulation and use of animals in scientific procedures is desirable, providing it does not jeopardise the safety of individual scientists and their establishments, or their legitimate commercial and intellectual interests.

We have undertaken to review all statutory bars to the disclosure of information as part of our commitment to freedom of information, including section 24 of the Animals (Scientific Procedures) Act 1986, the so-called confidentiality clause'. Section 24 makes the unauthorised disclosure of confidential information relating to the use of animals in scientific procedures by Home Office Ministers and officials, members of the Animal Procedures Committee, and others appointed for specific purposes under the Act, a criminal offence. I hope to announce the outcome of the review of section 24 shortly.

Separately, in our response to the report of the House of Lords Select Committee on Animals in Scientific Procedures, published in January 2003 (Cm 5729), we announced plans to publish summary information relating to project licences issued under the 1986 Act as part of the Home Office publication scheme under the Freedom of Information Act 2000. Home Office officials are working out the practical arrangements with licensees now and we plan to publish the first summaries in the autumn 2004.

At the same time, we have concluded that there would be value in the Animals (Scientific Procedures) Inspectorate publishing an annual report on its work. The Inspectorate's first annual report will also be published in the autumn of 2004. In addition, the Inspectorate has an active outreach and education programme to inform stakeholders about the regulatory system and the Home Office web-site includes a range of material relating to the implementation of the 1986 Act.

Mrs. Curtis-Thomas

To ask the Secretary of State for the Home Department how the classification of animal experiments is decided. [165894]

Caroline Flint

The Home Office issues project licences under the Animals (Scientific Procedures) Act 1986 for the use of protected animals for experimental and other scientific purposes.

Project licences are assigned severity bands reflecting the average overall level of suffering likely to be experienced by the animals used on authorised programmes of work. Each protocol within a programme of work is assigned a severity limit which sets the maximum permissible level of suffering which could be experienced by any single animal used on that protocol.

There are four severity bands and four severity limits: unclassified, mild, moderate and substantial. Definitions of these categories are provided in paragraph 5.42 of the published Home Office Guidance on the Operation of the Animals (Scientific Procedures) Act1986(HC321).

Mrs. Calton

To ask the Secretary of State for the Home Department what official Home Office classification was approved for experiments on primates by Imutran Ltd. [166357]

Caroline Flint

The Imutran Limited research licensed by the Home Office under the Animals (Scientific Procedures) Act 1986 involving pig to non-human primate xenotransplantation studies was carried out between 1994 and 2000 under three project licences all of which were allocated an overall severity band of `moderate'. In addition, of the 28 separate protocols of regulated procedures authorised under these licences, two were allocated substantial severity limits, 16 were classified as moderate, seven were classified as mild, and three were unclassified.

The administrative system under the Animals (Scientific Procedure) Act 1986 distinguishes between the 'severity limit' of a protocol and the 'severity band' of a project. The severity limit of a protocol is determined by the upper limit of the expected adverse effects that may be encountered by the animal involved, taking into account the measures specified in the licence for avoiding and controlling adverse effects. It represents the worse potential outcome for any animal subjected to the series of regulated procedures in the protocol, even if it may only be experienced by a small number of the animals to be used. Severity limits are categorised as unclassified, mild, moderate and substantial. Definitions of these categories are provided in paragraph 5.42 of the published Guidance on the Operation of the Animals (Scientific Procedures) Act 1986 (HC321).

The allocation of severity band to a project reflects the number of animals used on each protocol and the actual suffering likely to be caused as a result. It is based on the overall level of cumulative suffering to be experienced by each animal, not just the worst possible case. It takes into account the proportion of animals expected to reach the severity limit of the protocol and the duration of the exposure to that severity limit, the nature and intensity of the adverse effects, and the actions to be taken to relieve the suffering.