HL Deb 15 December 2003 vol 655 cc115-6WA
Lord Soulsby of Swaffham Prior

asked Her Majesty's Government:

What steps they are taking to encourage the development, validation and use of replacement alternatives for the in vivo potency testing in the United Kingdom of batches of botulism toxin for use in clinical and cosmetic purposes. [HL276]

The Parliamentary Under-Secretary of State, Department of Health (Lord Warner)

The Medicines and Healthcare products Regulatory Agency (MHRA) evaluates data submitted in support of applications for clinical trials and marketing authorisation applications. The MHRA works to agreed Home Office principles on animal welfare in the assessment of safety.

Regulatory guidelines allow the use of alternatives to animal tests where appropriate, and when the alternative technique has been adequately validated. An in vitro assay for botulinum toxin is being developed as an alternative to the currently used in vivo test.

The use of animals in testing cosmetics is banned by law in the United Kingdom.