Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what steps he is taking to help facilitate collaboration between (a) the Medicines and Healthcare products Regulatory Agency and (b) biotechnology companies developing (i) organ-on-a-chip technologies and (ii) human-specific methods for assessing the safety of new drugs.

The Medicines and Healthcare products Regulatory Agency (MHRA) is aware of organ-on-chip technologies to better identify potential toxicity 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 who have 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 for reasons of commercial sensitivity.

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.