Consultation outcome

Organs and tissues to be excluded from the opt-out organ donation system: government response (quick read)

Updated 25 February 2020

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This publication is available at https://www.gov.uk/government/consultations/opt-out-organ-donation-organs-and-tissues-excluded-from-the-new-system/outcome/quick-read-organs-and-tissues-to-be-excluded-from-the-opt-out-organ-donation-system-government-response

1. Introduction

At the time of writing, over 5,200 people in England are on a waiting list for a transplant. By the time a suitable organ is found, some people have become too ill to receive one. Last year alone, 777 patients were removed from the transplant list and a further 400 died while on the active list waiting for a transplant.

The new consent arrangements that the government aims to introduce from spring 2020, known as ‘opt-out’ or ‘deemed consent’, mean that if someone has died and they have not made a decision about organ and tissue donation before their death, the default position will be that consent to donate will be considered to be in place (unless they have nominated someone else to make a decision for them after death or are in one of the excluded groups).

The excluded groups are:

  • people who lacked mental capacity to understand deemed consent for a significant period before their death
  • children under 18
  • people ordinarily resident in England for less than 12 months immediately before their death

It is intended that the new system will come into force on 20 May 2020.

Only 1 in 100 people die in circumstances that would allow donation. There are more people on the UK waiting list for a transplant than there are organs. The intention of the change in law is to address the shortage of organs, tissues and cells considered to be ‘routine’ transplants, such as those listed on the NHS Organ Donor Register (for example, heart, lung, kidney and liver).

On 29 April 2019, the government launched a 12-week public consultation to seek views on a list of organs, tissues and cells to exclude from deemed consent.

Those less common transplants are treated differently because they are novel or rare, for example face or limb transplants, and people might not expect that such organs, tissues and cells are subject to deemed consent.

In addition, there is not the same shortage of such organs, tissues and cells compared to routine transplants. The government therefore proposed that these organs, tissues and cells should continue to require the explicit permission (also known as ‘express consent’) of the potential donor before their death, or their nominated representative or their family after death, for donation to go ahead.

3. The proposed list following consultation

The government has considered the results of the consultation very carefully. Following the responses, it has revised the list of organs, tissues and cells that will continue to require express consent under deemed consent.

To address the issues raised in the consultation, the government has:

  • updated the list to clarify further that tissue from sexual and reproductive organs (including skin) will not be transplanted without express consent for any type of transplant, novel or routine

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

  • clarified 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 – if the tissue is needed for a rare transplant, this will require express consent

  • expanded the list to ensure that medicinal therapies from tissues, genes or cells from deceased donors known as Advanced Therapy Medicinal Products (ATMPs) will be excluded from deemed consent – this is because cells from deceased donors is considered a novel form of transplant and it is appropriate that express consent is in place for donating such cells

  • revised the list to mean that the trachea continues to be transplanted under deemed consent as part of a heart-lung transplantation, which is a routine transplant – transplantation of the trachea will still require express consent in all other circumstances.

The relevant regulations, Human Tissue (Permitted Material: Exceptions) (England) Regulations 2020, are subject to approval from Parliament. Further detail is available in the complete government response, laid in Parliament and available on GOV.UK

The list of what is excluded from deemed consent is in Annex A. The list of what is included is in Annex B.

4. Next steps

The next stage is for the proposed list of organs and tissues to be excluded from deemed consent to be debated in Parliament for approval. It is intended that the new system will come into force on 20 May 2020.

The list of organs and tissues below will continue to require express consent under the new system. This will mean that the potential donor (before their death), or their nominated representative or their family (after death), must explicitly give permission for the organs or tissues to be donated.

  • brain
  • spinal cord
  • face
  • nose
  • mouth
  • trachea (windpipe) - unless removed with the heart and lungs as part of a heart-lung transplantation, which is a routine transplant
  • arm
  • upper arm
  • forearm
  • hand
  • finger
  • leg
  • thigh
  • lower leg
  • foot
  • toe
  • ovary
  • uterus
  • penis
  • testicle
  • foetus
  • placenta
  • umbilical cord
  • vagina
  • labia
  • vulva
  • clitoris
  • cervix
  • fallopian tube(s)
  • prostate
  • perineum
  • embryo (inside the body)
  • limbal stem cells, renal epithelial cells, liver cells, and pancreatic cells – if they are used for an ATMP. These are medicinal therapies made from tissues, genes or cells manipulated in a laboratory
  • nervous tissue, artery, bone, muscle, tendon and skin – consent will be sought only if used as part of a rare transplant (above), but not a routine transplant in Annex B, unless they are part of a reproductive organ

This means that the new law allowing deemed consent for organ and tissue donation will not apply to these organs and tissues.

These are common and well-established transplants that are offered on the NHS.

If someone has died and they have not made a decision about organ and tissue donation before their death (unless they have nominated someone else to make a decision for them after death or are in one of the excluded groups), the default position will be that consent to donate will be considered to be in place.

  • heart, transplanted either as a whole organ or for heart valves
  • lung(s)
  • liver, transplanted either as an organ or for liver cells – unless the liver cells are for use for an Advanced Therapy Medicinal Product (ATMP)
  • kidneys
  • pancreas, transplanted either as a whole organ or pancreatic cells – unless the pancreatic cells are for use for an ATMP
  • intestinal organs (small bowel, stomach, abdominal wall, colon, spleen)
  • cornea
  • nervous tissue
  • arteries/veins/blood vessels
  • bone
  • muscle
  • tendon
  • skin
  • rectus fascia (tissue that encases abdominal muscles)

If someone has made a decision not to donate some or all of their organs and/or tissues before spring 2020, this decision will still apply after deemed consent comes into force.

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