§ Mr. EtheringtonTo ask the Secretary of State for the Home Department how many laboratory animals were used in potency testing of batches of botulinium toxin for human use in each year since 2000, indicating the end points used in the tests conducted; and if he will make a statement on the steps the Government are taking(a) to reduce the number of animals used in each batch test and (b) to ensure the most humane end points are used. [136515]
§ Caroline FlintInformation on the number of animals used for potency testing of botulinium toxin for human use is not recorded separately in the Statistics of Scientific Procedures on Living Animals which is published annually by the Home Office (copies of the latest publication, for the year 2002, are in the House Library—Command 5886). Figures for pharmaceutical safety/efficacy testing are included in Table 10 of the Statistics, which also includes data from testing other pharmaceutical and safety products. It is not possible from the format of the data to identify the number of animals used in testing a particular substance or product.
Procedures are ended in each case as soon as the scientific objective is achieved, which is usually when the onset of relevant clinical signs are observed. Animals are humanely killed to avoid any undue suffering.
Under the Animals (Scientific Procedures) Act 1986 the Home Office can only license the use of animals when the scientific purpose cannot be achieved satisfactorily by any other reasonably practicable method not involving the use of animals. The Home Office has to be satisfied that the proposed procedure uses the minimum numbers of animals, of the lowest degree of neurophysiological sensitivity, and causes the least amount of pain, suffering, distress, or lasting harm and is the most likely to produce satisfactory results. 232W This reflects the principles of the 3Rs—the refinement of scientific procedures, reduction in the number of animals used and their replacement wherever possible.
Special conditions are tailored to each project licence in order to control or minimise pain or suffering. Animals in scientific procedures are carefully monitored by licensees, named animal care and welfare officers and animal care staff to ensure that agreed humane endpoints are implemented. In addition a named veterinary surgeon must always be available for advice.
Schedule 1 of the Guidance on the Operation of the Animals (Scientific Procedures) Act 1986 sets out the appropriate methods of humane killing of animals used in scientific procedures.
The potency testing of botulinium toxin licensed under the 1986 Act is solely for pharmaceutical purposes, in relation to use of the substance as a prescription only medicine.
§ Dr. IddonTo ask the Secretary of State for the Home Department what steps the Government is taking to encourage the(a) development, (b) validation and (c) use of replacement alternatives for the in vivo potency testing in the United Kingdom of batches of botulinium toxin for use for (i) clinical and (ii) cosmetic purposes. [135480]
§ Caroline FlintThe animal testing of botulinium toxin, licensed under the Animals (Scientific Procedures) Act 1986, is required and conducted solely in relation to its use for clinical purposes as a prescription only medicine. The Home Office does not license animal testing of this substance for use in cosmetic treatments.
Under the 1986 Act the Home Office can only license the use of animals for scientific purposes where there is no non-animal alternative, and then only when both the number of animals and their suffering is minimised. This reflects the principles of the 3Rs—the refinement of scientific procedures, reduction in the number of animals used and their replacement wherever possible.
No alternative to using animals has regrettably yet been developed to test the safety and efficacy of botulinium toxin for therapeutic medical purposes. Refinement of the test has, however, been the subject of useful research undertaken some years ago under a Home Office grant administered by the Animal Procedures Committee (as recorded in that Committee's published report for 1992—Command 2301).
The Government fully supports and encourages the general development and promotion of the 3Rs in a number of ways. It is involved in the validation of alternatives at the ED level, and seeks to take forward related matters through the Inter-Departmental Group on the 3Rs. It is estimated that the total spent by the UK Government and its funding agencies, on research into and development of alternatives, is between £2 and £10 million each year.
However, most work on the search for and development of alternatives to using animals in scientific procedures is neither done by Government nor with Government money—it is conducted and funded by the research community itself, which spends many millions of pounds on it each year. We must continue to 233W look mainly to the scientist community itself to come up with viable alternatives in specific areas such as the type of regulatory toxin testing subject of this Question.
§ Dr. IddonTo ask the Secretary of State for the Home Department what regulatory requirements govern the use of botulinium toxin for cosmetic purposes; and if he will make a statement. [135481]
§ Caroline FlintUnder the Animals (Scientific Procedures) Act 1986 the Home Office regulates the testing on live animals of botulinium toxin for clinical purposes as a prescription-only medicine. The Home Office does not license the use of animals for the testing of cosmetic treatments or products.
The use of botulinium toxin for cosmetic treatments, for which it is not licensed or tested, is not a matter over which the Home Office has any control. Regulation of the different uses made of botulinium toxin is a matter for the Medicines and Healthcare products Regulatory Agency (MHRA), which is an Executive Agency of the Department of Health, to whom further inquiries on this aspect should be addressed.