House of Lords written question – answered on 28th November 2013.
To ask Her Majesty’s Government whether they intend to ban the use of animals in the testing of potential new medicines.
The Government's position is clear on minimising the use of animal testing, and on encouraging the development of other in vitro methods in place of animal testing where this is possible. The Government has a coalition agreement to reduce the number of animals used in scientific research. The Medicines and Healthcare products Regulatory Agency is working closely with the National Centre for the Replacement, Refinement and Reduction of Animals in Research on a number of projects committed to reducing or replacement of animals in safety testing. It is very important to recognise that at present there are no laboratory methods available to totally replace animal testing of medicinal products.
Pharmaceutical legislation requires that before a new medicine is granted a licence, a battery of in vitro and in vivo tests are conducted to establish the toxicity profiles for the medicine. Before humans are exposed to a new medicine for the first time, it is required to go through appropriate tests in animal studies to ensure that the toxicity profile is adequately characterised. As a result of adverse findings from animal studies, a large number of drug candidates do not progress to being tested in humans. Animal tests are also crucial for understanding the absorption, distribution and disposition of the medicine by the body and its therapeutic effect on the body and for detecting unforeseen toxic effects. Only on the basis of a full evaluation of all the available data can it be decided whether it is safe to proceed to clinical trials in humans. It would be unacceptable to expose humans to potentially dangerous medicinal products without knowledge of their toxicity profiles.
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