To ask the Secretary of State for the Home Department what recent representations she has received on the necessity of acute toxicity studies in animals to ensure the safety of medicines prior to first clinical trials on humans; what plans she has to amend the conditions under which licences under the Animals (Scientific Procedures) Act 1986 are issued; and if she will make a statement.
We have received representation from the Dr. Hadwen Trust, and have taken note of the conclusions of the European pharmaceutical company initiative challenging the regulatory requirement for acute toxicity studies in pharmaceutical drug development reported in Regulatory Toxicology and Pharmacology 50 (2008) 345-352.
A recent review of the use of single dose acute toxicity studies in the UK confirms that single dose acute toxicity studies prior to first clinical use in humans is no longer routinely conducted. However, in some specific instances, it may be possible to justify such studies on a case-by-case basis; for example, prior to microdose studies in humans.
In view of this, and the fact that the conclusions of the European pharmaceutical company report largely reflects current UK practice, I see no need and have no plans to amend the conditions under which project licences for the purpose of conducting regulatory toxicology and safety evaluation studies have been granted under the Animals (Scientific Procedures) Act 1986.