Human Tissue Authority

The regulator for human tissue and organs

The HTA is consulting on new guidance for organ and tissue donation professionals in England

Issue date: 
04 July 2019

The Human Tissue Authority is now consulting on a revised Code of Practice for organ and tissue donation and transplant professionals on the new Organ Donation (Deemed Consent) Act 2019.

A consultation on proposed changes to the HTA Code of Practice for organ and tissues donation and transplant professionals in England has been launched today by the HTA.

Our current ‘Code of Practice F: Donation of solid organs and tissue for transplantation’ has been revised to reflect amendments to the Human Tissue Act 2004, as a result of the Organ Donation (Deemed Consent) Act 2019. This law will come into force from spring 2020.

The consultation, which is open until 5pm on Thursday 26 September 2019, provides an opportunity for all those working in the field of organ and tissue donation and transplantation to inform the development of the revised Code. The updated version will be published, subject to approval by Parliament, in early 2020.

The Code offers practical advice on the introduction of a system of ‘deemed consent’ for deceased organ and tissue donation in England. It also provides guidance in situations where someone’s consent to donate their organs is not clear, or when clinical decisions are complex.


Allan Marriott-Smith, Chief Executive of the HTA, said:


The proposed changes to our Code of Practice are to help guide professionals in the day-to day application of the new law.


It is crucial that those working in this area have confidence that they are acting within the law, and that the public has confidence that the new system will work as it is intended.


In many cases, a deceased person will have made a clear decision about their willingness to donate their organs. However, in cases where there is uncertainty about the decision, or in more complex cases, our Code of Practice will provide guidance.


Our consultation is primarily aimed at professionals working in the organ and tissue donation and transplant sector; we want to hear from as many of them as possible to ensure the Code of Practice is both clear and accessible, and meets the needs of those who use it.


How to respond

The consultation on the draft code of practice runs from midday Thursday 4 July 2019 until 5pm Thursday 26 September 2019. It can be completed online, or submitted via email or by post.

More information on the consultation and instructions on how to respond.



  1. The Human Tissue Authority (HTA) is an executive non-departmental public body sponsored by the Department of Health and Social Care
  2. The HTA was established by the Human Tissue Act 2004.
  3. The HTA is the regulator for human tissues, cells and organs (excluding gametes and zygotes, which are regulated by the Human Fertilisation Embryology Authority).
  4. The HTA is also the Competent Authority for ensuring the quality and safety of organs intended for Transplantation, and tissues and cells for patient treatment.
  5. The HTA has a statutory duty to produce Codes of Practice for professionals across the sectors we regulate, to give them advice and guidance on how to meet our standards under the Human Tissue Act 2004. The Codes also provide guidance on the regulatory requirements for organ and bone marrow donations from living people. Browse our Codes of Practice.
  6. The Organ Donation (Deemed Consent) Bill 2017-2019 received Royal Assent on 15 March 2019. The Organ Donation (Deemed Consent) Act 2019 (the Deemed Consent Act) will come into force in spring 2020. For more information on the new legislation, please visit NHS Blood and Transplant’s website.
  7. Please note, this consultation will not be accepting feedback on the merits of the law change itself, or how this change is implemented operationally.
  8. It is the Department of Health and Social Care who are responsible for working with Ministers to consider and implement a change to law, and NHS Blood and Transplant who are the operational body that run the national organ and tissue retrieval and transplantation service.
  9. The HTA’s role is to ensure that current law in this area is adhered to.
Last updated on: 12 Nov 2019