The regulations, which came into force on 27 August 2012, introduce a licensing regime to regulate those entities carrying out procurement and transplantation activity in this field. The Human Tissue Authority (HTA) will license appropriate entities and carry out audits of licence holders. Procurement activity includes retrieval of and making transportation arrangements for organs, donor and organ characterisation and preservation of organs. Transplantation activities are the same, excluding organ retrieval, and with the addition of implantation of organs.

Carrying out these activities without a licence will be an offence under the regulations and those found guilty of such an offence could face a fine and/or a prison sentence of up to two years.

The HTA will also set up and maintain a framework for quality and safety of organs for transplantation, covering all stages of the chain from donation to transplantation or disposal. In addition, the HTA will establish a traceability system.

One key requirement of a licence holder is the rapid reporting of serious adverse events or reactions and licence holders will also need to comply with other licensing conditions as set out in Schedule 1 to the regulations.

The regulations transpose into UK law European Directive 2010/53/EU, which aims to set standards in relation to the various aspects of organ transplantation