Published on 24 May 2021

The HTA publishes its revised Code of Practice F to reflect the introduction of deemed consent for organ and tissue donation in England

  • Organ donation and transplantation

From 18 May 2020, the Organ Donation (Deemed Consent) Act 2019 introduces a system of deemed consent for organ and tissue donation in England.  

Under the new system (also known as an ‘opt-out system’) all adults can be considered as a possible organ and tissue donor when they die, unless they have recorded a decision not to donate or are in an excluded group.

To coincide with the new law being introduced, the HTA has today published a revised Code of Practice F: Donation of solid organs and tissue for transplantation. Our Code of Practice F provides advice and guidance to transplant professionals in England on how the new deemed consent system will affect their practice.

The new Code of Practice has been divided into two parts:

  • Part one: living organ donation
    The system for living organ donation is not affected by the introduction of deemed consent in England.
  • Part two: deceased organ and tissue donation
    This has been revised and updated to reflect the introduction of deemed consent in England.
    We consulted on a draft version of our Code of Practice F last summer, which helped shape the final version of the Code that is released today. We have also published our consultation response document, which provides a summary of all the responses we received last year, and how we engaged with our stakeholders to seek their views.

The HTA has also today published an updated Public Guide to Code of Practice F. The Public Guide explains to members of the public how the deemed consent system works, and what it means for them.


“Now that the new deemed consent law for organ and tissue donation has today come into effect in England, it is crucial that those working in this area have clear and straightforward guidance on how the system will affect their day-to-day work and that the public has confidence that the new system will work to safeguard their interests.

I warmly welcome the publication of our new Code of Practice F and would like to take the opportunity to thank those that shared their feedback with us last year to help shape the final version.

I also welcome the publication of our new Public Guide to Code of Practice F which the HTA hopes can help support important organ and tissue donation conversations and encourage individuals to make the decision that is right for them.”

Allan Marriott-Smith
Chief Executive of the HTA



  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 and 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. Our Codes of Practice can be found here.

  6. The Organ Donation (Deemed Consent) Act 2019 came into force in England on 20 May 2020. For more information, please visit NHS Blood and Transplant’s website.

  7. 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.

  8. The HTA’s role is to ensure that current law in this area is adhered to.