Question to the Department of Health and Social Care:

To ask His Majesty's Government what assessment they have made of the potential of human-specific technologies, such as liver-on-a-chip, to improve the accuracy of tests to ascertain the safety of new drugs in humans.

The Medicines and Healthcare products Regulatory Agency (MHRA) is aware of human-specific technologies, including organ-on-chip technologies, to better identify potential toxicity and safety of novel medicines and has engaged with other organisations active in this space such as the National Centre for the Replacement, Refinement & Reduction of Animals in Research which has hosted meetings on this theme. The MHRA has also provided scientific advice to at least one biotechnology company on the use of this technology to support proof of concept for a new medicine. The MHRA does not identify those with whom it may have had discussions who are active commercially in this space.

In relation to human specific methods, some medicines have been developed which only have activity in humans, such as eculizumab (Soliris), tebentafusp (Kimmtrak) or CAR T cell products (for instance, Kymriah, Yescarta and Tecartus). These medicines were developed using human specific methods; however, versions of these medicines that were active in animals were, in some cases, also used. The MHRA supports the developers of these products by its offer of scientific advice services, the Innovation Office and the Innovative Licensing and Access Pathway.