Question to the Department of Health and Social Care:

To ask the Secretary of State for Health, if he will make an assessment of the potential merits of using artificial human organs in medical testing.

The Medicines and Healthcare products Regulatory Agency (MHRA) is the competent authority responsible for authorising Clinical Trial Applications in the United Kingdom and for the issuing of Marketing Authorisations (licences) for medicinal products.

One of the joint MHRA and National Centre for 3 Rs (NC3Rs) projects involved surveying the global safety assessment community to better understand the current use of human tissue and what barriers exist to prevent wider uptake. For the purpose of the survey, human tissue was defined broadly as any material derived from human sources, including organs, tissues, (stem) cells, biofluids, etc.

The development and use of human tissue-based assays provides an obvious alternative to current approaches used to predict human pharmacological responses. Despite this however, very little drug development is conducted using human tissues.

The NC3Rs and MHRA are working together to increase the uptake of human tissue-based approaches to replace the use of animals and provide more predictive tools to determine the safety of drugs entering clinical studies. An expert working group was convened to generate an evidence base to support this project. The initial work has highlighted that human tissue use for safety assessment is currently limited, but there is increasing interest in adopting this approach.

A number of barriers to further developing work with human tissues have been identified, but these could potentially be overcome by sharing data, experiences and information.

The project identified that the development of human-based non-animal technologies is a rapidly evolving field, with advances being made in the development of tissue engineering, microfluidics and organ on chip technologies for many of the organ systems relevant to the safety assessment of new drugs.

The project is now looking for ways to ensure that the safety assessment community does more to connect with these technology developers to help shape the research and development of new technologies to meet their needs.

The initial work on this project has been summarised in a number of papers that are scheduled to be published in scientific journals during 2015. The results are also being discussed at a number of international scientific meetings to further publicise the project and encourage more involvement from the international safety assessment community to engage in the project and to share data, experiences and information.