Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, with reference to the debate of 4 July on Human-specific medical research techniques, Official Report columns 293WH to 304WH, what assessment he has made of the capability of the UK’s regulatory system to support the (a) development and (b) use of human-specific technologies in medical research.

As the regulator of medicines, medical devices and blood components for transfusion in the United Kingdom, the Medicines and Healthcare products Regulatory Agency (MHRA) keeps abreast of advances in human-specific technologies in medical research that are relevant to the development of medicines and medical devices. The MHRA is aware of human-specific techniques, such as organ-on-chip technologies used 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 on the use of this technology to support proof of concept for a new medicine. That said, 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 technologies, 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.