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Draft Human Tissue (Permitted Material: Exceptions) (England) Regulations: Government Response

Volume 672: debated on Tuesday 25 February 2020

The Organ Donation (Deemed Consent) Act 2019 heralds a new system of consent for organ and tissue donation in England. Subject to Parliament’s approval of the secondary legislation and code of practice for healthcare professionals, the new system is intended to start in England from 20 May 2020.

Under the new system, known as “opt out” or “deemed consent”, people over 18 in England will be considered to have agreed to donate their organs and tissue after death, except where:

they made a decision to not donate their organs and or tissue, i.e. they have opted out;

they have nominated a representative to make a decision on their behalf after death about whether to donate; or

they are in one of the excluded groups: under the age of 18; ordinarily resident in England for less than 12 months before their death; lacked mental capacity to understand the new system for a significant period before their death.

The Government held a 12-week public consultation from 29 April to 22 July 2019 to seek views on a proposed list of organs, tissues and cells to exclude from deemed consent and which should therefore continue to require express consent before they can be removed, stored or used for transplantation. The list of organs, tissues and cells to exclude from deemed consent was set out in the draft Human Tissue (Permitted Material): Exceptions (England) Regulations. The Government received over 3,200 responses across different demographics which provided rich data on the questions asked.

The Government response to the consultation on the regulations has been laid before Parliament today (CP 224), alongside the revised draft Human Tissue (Permitted Material): Exceptions (England) Regulations 2020 and the Human Tissue Authority’s codes of practice for healthcare professionals setting out practical guidance about deemed consent. Copies of the Government response, the regulations and the codes of practice are available to hon. Members from the Vote Office and to noble Lords from the Printed Paper Office, along with the Government response being published on at the following link:

To address the issues raised in the consultation, the Government have:

updated the list of what is excluded from deemed consent to clarify further that tissue from sexual and reproductive organs (including skin) will not be transplanted without express consent;

expanded the list featuring the parts of the male and the female reproductive system;

reviewed the list to clarify further that specific tissues (for example bone, skin and muscle) will be transplanted under deemed consent if the tissue is to be used for a routine transplant. As now, if the tissue is needed for a rare transplant this will require express consent; and

expanded the list of proposed advanced therapy medicinal products (ATMPs) to exclude from deemed consent. Although the Government recognise the benefits of ATMPs, use of ATMPs from deceased donors is novel and it is appropriate that express consent is in place when cells are donated.

To make the public aware of the new system of consent, NHS Blood and Transplant (NHSBT) launched a communication campaign on behalf of the Government in April 2019. A number of platforms have been used since then to raise public awareness of the new system, more recently through TV and radio adverts, along with public advertising with specific targeting of people with different backgrounds, faith and beliefs. NHSBT will continue their awareness campaign, also working with GP practices, schools and BAME communities to address barriers to organ donation.