The use and storage of human tissue and cells has been subject to a licensing regime in the UK since 2004. In the UK, the Human Tissue Authority (HTA) oversees not only the use of tissues and cells for human application, but also the handling and storage in pathology, educational and research contexts, and the import and export of cells and tissues.

UK human tissue legislation sits alongside a growing body of other laws and requirements which also impact upon the use of tissues and cells. These related frameworks are not always harmonised, and it can sometimes be challenging to navigate the regulatory pathway to take a new cell therapy to market.

At Denoon Legal we have worked with a large number of companies and researchers in relation to the regulation of tissue and cell therapies. Some examples of our work in this sector include:

• drafting and negotiating agreements regarding the procurement, processing, transfer, export and use of blood, cells, tissues and organs;
• advising in relation to HTA licence applications and inspections;
• advising and representing HTA licence holders and designated individuals;
• acting for a public body in relation to a public inquiry into human tissue retention;
• advising in relation to non-consensual DNA analysis; 
• advising in relation to the establishment and maintenance of biobanks; and
• advising in relation to the data protection and management aspects of tissue and cell banking.

See also:
Clinical trials
Regulation
Cell-Based Therapies and ATMPs