John Gormley (Dublin South East, Green Party)
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Question 171: To ask the Tánaiste and Minister for Health and Children if the mouse LD50 test is still used by pharmaceutical companies which produce and test botulinum toxin here; if so, the reason this test has not been replaced by the non-animal method described in the European Pharmacopoeia; the number of animals of each species which are used in regulatory toxicology here each year; and the institutions at which they are used. [23840/05]

Mary Harney (Dublin Mid West, Progressive Democrats)
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While three botulinum toxin medicinal products are authorised for marketing in Ireland, only one, botox, is produced and tested in Ireland. I am advised by the Irish Medicines Board that the only potency test currently available for defining the strength of botulinum toxin products is the LD50 test in mice; therefore, this test continues to be used. In regard to possible alternative tests, it is important to note that the development of any such test must, according to the European Pharmacopoeia, include validation, that is, experimental proof that any new test is equivalent to the LD50 test in terms of analytical performance. I am advised by the Irish Medicines Board that manufacturers are conducting development studies of this nature but the outcome of these studies, which by their nature take a considerable length of time to complete, cannot be predicted.

The use of live animals in scientific research and other experimental activity is strictly controlled in accordance with the Cruelty to Animals Act 1876 as amended by the European Communities (Amendment of Cruelty to Animals Act, 1876) Regulations 2002. The Act, as amended, gives full effect to European Council Directive 86/609/EEC on the protection of experimental animals and ensures that Ireland is fully in line with European standards for the welfare of experimental animals. One of the objectives of the directive is to reduce the numbers of animals used for experiments by encouraging the development and the validation of alternative methods to replace animal methods. The Act provides, inter alia, that an experiment shall not be performed if another scientifically satisfactory method of obtaining the result sought, not entailing the use of an animal, is reasonably and practicably available.

As part of the licence application process, applicants must indicate that the use of alternatives has been fully considered prior to applying for a licence. The experimental procedure for which a licence is being sought must be certified as being essential and that there is no alternative method reasonably and practicably available. This certification must be performed by two qualified persons of professorial standing, from a relevant scientific, medical or veterinary discipline.

I have arranged to make the 1999 and 2002 statistics on the use of animals for experimental and other scientific purposes available to the Deputy. These include data on the use of the LD50 test. The 2002 statistics are also available on the Department's website www.dohc.ie. These statistics are compiled in accordance with the requirements of the European Commission. Information on individual licence applications relating to experimental animals held at specific registered premises is provided in confidence and is treated as such by my Department.