Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, whether it is his Department's policy to authorise novel pharmaceutical products, therapies or medical devices for first-time human clinical trials by the MHRA on a case-by-case basis without relying on a standardised complement of pre-clinical animal toxicity or efficacy data; and what steps he is taking to promote the use of non-animal pre-clinical data.

There is no United Kingdom legislation that mandates animal testing. We do, however, work to a series of International Council of Harmonisation and Committee for Medicinal Products for Human Use guidelines that describe ways to evaluate different non-clinical aspects of medicines, many of which use animals. These aspects include safety pharmacology, repeat dose toxicity, genotoxicity, carcinogenicity, reproductive toxicity, phototoxicity, and immunotoxicity.

The non-clinical assessors have always taken the approach that data from a suitably validated model that has been demonstrated to be predictive could be submitted in lieu of animal data. On a case-by-case basis, a non-clinical assessor will also accept appropriate justifications for not conducting animal tests, for example, no pharmacologically relevant species.

In terms of promoting use of non-animal methods, we do not consider this to be within the remit of non-clinical assessors. Rather, it is for those using these methods to tell the Medicines and Healthcare products Regulatory Agency (MHRA) how they have validated them, or at least why they rely on the results and an assessor will then judge whether the data is appropriate to support the trial. The MHRA supports the developers of products by its offer of scientific advice services, the Innovation Office and the Innovative Licensing and Access Pathway.

The MHRA fully supports the National Centre for the 3Rs (Replacement, Reduction and Refinement), and agency staff play an active role in projects to support adoption and adherence to the 3Rs principles in medicines regulation worldwide.