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Code of practice 2

Donation of solid organs for transplantation

Licensing requirements and organ donation and transplantation

134. Since this Code of Practice originally came into force on 15 September 2009, The Quality and Safety of Organs Intended for Transplantation Regulations 2012 (the Q & S Organs Regulations) (Statutory Instrument (SI) 2012 No. 1501) have transposed into UK law the European Union Directive 2010/53/EU on the standards of quality and safety of human organs intended for transplantation (the Organ Donation Directive). The Human Tissue Authority (HTA) is the Competent Authority for the implementation of the Directive across the United Kingdom. 

135. The licensing requirement, under the Q & S Organs Regulations came into force on Monday 27 August 2012; from that date establishments must have a licence if they undertake any of the procurement or transplantation activities described in the Regulations. 

136. This Code will not be fully updated to reflect the new regulatory framework until the next full review of all the HTA Codes of Practice. However, the HTA has issued a number of key documents which provide practical advice to those operating within the new regulatory framework. 

137. The Quality and Safety of Human Organs Intended for Transplantation – a documentary framework

[http://www.hta.gov.uk/_db/_documents/Organs_Intended_for_Transplantation_-_documentary_framework_July_2012.pdf]

138. This document is designed to support corporate bodies or individual people who are licensed, or intending to be licensed, under the Regulations. It forms part of the regulatory framework, which builds on many of the existing processes in the donation and transplantation sector, to specify how the requirements for the quality and safety of organs intended for transplantation shall be ensured to secure compliance with the Directive.

139. Serious Adverse Event and Reaction Reporting for Organs Intended for Transplantation – guidance for licence holders [http://www.hta.gov.uk/_db/_documents/Guidance_-_SAEARs.pdf]

140. This document provides guidance on serious adverse event (SAE) and serious adverse reaction (SAR) reporting under the Q & S Organs Regulations.

Directions 003/2012

141. Directions given under Regulations 6 and 11 of the Quality and Safety of Organs Intended for Transplantation Regulations 2012 (SI 2012 no.1501) bringing into effect HTA’s Organs Intended for Transplantation – a documentary framework.

Licence exceptions under the HT Act

142. The storage of an organ or part organ (from the body of a living or deceased person) for the purpose of transplantation, which is to be used for the same purpose as the entire organ in the human body, is excepted from licensing requirements under the HT Act.

143. The storage of other tissue and cells for the purpose of transplantation is also excepted from licensing if the material is stored for less than 48 hours.

144. Blood and its derivatives used for the purpose of transplantation (including transfusion) are not considered relevant material [www.hta.gov.uk/guidance/licensing_guidance/definition_of_relevant_material.cfm],  for the purposes of section 16 of the HT Act and are therefore excepted from the HTA licensing requirements under that section. Additionally, under the Q&S Regulations [www.opsi.gov.uk/si/si2007/uksi_20071523_en_1] the procurement, processing, preservation, testing, storage, distribution, import or export of blood and blood components for human application are not licensable. However, the procurement, processing, preservation, testing, storage, distribution, import or export of lymphocytes intended for haematopoietic stem cell transplantation are licensable under those Regulations. 

Licence requirements – HLA tissue typing

145. If samples of relevant material from a deceased donor, such as blood, lymph nodes or spleen, are being stored for tissue typing to determine the suitability of an organ for a recipient, this is storage for the purpose of transplantation and subject to the licensing exceptions outlined above. If those samples of relevant material are subsequently stored as part of the diagnostic archive of the recipient, a licence is not required, however if such samples are subsequently stored for research, a licence may be required under the HT Act

(see paragraphs 142–145).

Licence requirements – procurement of vessels at the time of organ retrieval

146. Additional tissues and cells, such as vessels, may be removed at the same time as retrieval of organs for transplantation.  Consideration must be given to ensuring that any tissues and cells removed from an organ donor are dealt with appropriately.  Further information on the applicable licensing and regulatory requirements are outlined in paragraphs 52 – 56 of the HTA publication 'The Quality and Safety of Organs Intended for Transplantation – a documentary framework'.

http://www.hta.gov.uk/_db/_documents/Organs_Intended_for_Transplantation_-_documentary_framework_July_2012.pdf ]

Licence requirements – Research

147. A licence is required under the HT Act for the removal of relevant material from a deceased person for the purpose of research 'in connection with disorders, or the functioning, of the human body'. The removal must take place on licensed premises. 

148. The licence application form for post mortem and related activities allows the option of requesting a licence for removal of relevant material from the body of a deceased person for use for a scheduled purpose other than transplantation. That means that most establishments that have a post mortem licence will also have a licence covering removal for research.

149. Establishments may also apply for a specific removal licence under the HT Act, which covers premises for the removal of tissue for the deceased for scheduled purposes such as research.  Further information can be found on the HTA’s website. [www.hta.gov.uk/licensingandinspections/sectorspecificinformation/removallicence.cfm]

150. The storage of relevant material for the purpose of research also requires a licence, unless it is for a specific research project which is approved by a recognised research ethics committee (or where such approval is pending).

151. If relevant material removed for the purpose of transplantation is subsequently used for research, rather than transplantation, the storage of this material must be on licensed premises unless the research has ethical approval as indicated above.

152. Relevant material removed for the purpose of transplantation can be used for research with the valid consent of the donor or a person in a qualifying relationship to the donor (see paragraphs 109–114).

153. In cases where it is unknown whether donated tissue or organs will be used for transplantation or research, valid consent should be obtained at the outset for both transplantation and research. For further guidance on valid consent, refer to the code of practice on Consent.

154. Further guidance on both consent and licensing requirements for research can be found in the code of practice on Research. The above guidance is applicable to cases involving research using tissue and organs from a deceased donor; the code of practice on Research also provides guidance on research using tissue from the living.

Further guidance on licensing

155. Further guidance on the licensing requirements of the HT Act is available from the HTA’s website [www.hta.gov.uk/guidance/licensing_guidance.cfm].

156. For further detailed guidance on tissue for human application refer to Directions issued by the HTA summarising the requirements of the EUTCD and the Q&S Regulations [www.hta.gov.uk/about_hta/eutcd_information.cfm].

157. For detailed guidance on the licensing requirements for organ donation and transplantation refer to the HTA publication 'The Quality and Safety of Organs Intended for Transplantation – a documentary framework'. [http://www.hta.gov.uk/_db/_documents/Organs_Intended_for_Transplantation_-_documentary_framework_July_2012.pdf]