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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/organs-and-tissues-to-be-excluded-from-the-opt-out-organ-donation-system-quick-read
The government recently passed a law to change the rules for organ donation in England from 2020. The law introduced a system commonly called “opt-out” or “deemed consent”.
Everyone in England over the age of 18 will be considered to be in favour of donating their organs and tissues after death unless:
- they have said they don’t want to donate their organs (they have “opted out”)
- they have appointed a representative to decide for them after their death
- 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, or lack mental capacity for a significant period before their death
The family of the deceased will always be consulted first and they will still be able to provide information on their loved one’s wishes. If they have information that their loved one would not have wanted to donate their organs or tissues, organ donation will not go ahead.
When the law was passing through Parliament, the government agreed that the law would only apply to routine transplants, and not novel or rare transplants.
The government proposes that novel or rare transplants will still require express consent. This means you or someone representing you must explicitly give permission for your organs or tissues to be donated for novel or rare transplants. Such transplants also cover what is called Advanced Therapy Medicinal Products (ATMP). This is when tissues, cells and genes are manipulated in a laboratory for treatment of a disease or injury. Some of the tissues and cells come from deceased donors.
This consultation is to ask you if the government is excluding the right organs and tissues. We would like you to answer five questions about what you think should happen.
The government has decided to change the law because there is a shortage of available organs in England. There are currently 5,100 people waiting for an organ transplant in England. Three people die waiting for an organ each day.
Although 80% of people say they would be happy to donate their organs after their death, only 37% are registered as donors. To increase the number of donors, the government changed the law in line with what the majority of people want to do.
The law will come into force in 2020. This is so we can run a 12-month communication campaign from the end of April 2019, to make everyone aware ahead of the changes and allow time for them to make the decision that’s right for them before the new system starts.
2.1 What are routine transplants?
These are transplants that happen frequently and have been part of organ donation for a long time. They are:
- heart, transplanted either as a whole organ or for heart valves
- liver, transplanted either as an organ or for liver cells – unless the liver cells are for use for an ATMP
- 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)
- nervous tissue
- arteries/veins/blood vessels
- rectus fascia (tissue that encases abdominal muscles)
2.2 What are ‘novel’ or ‘rare’ transplants?
Advances in medical science may make new types of transplants possible. Recent examples include hand and face transplants.
However, such transplants will be experimental, and it may take some time before they are considered safe, effective, ethical, and can be offered on the NHS. Some transplants may also only be possible for a small number of people and will always be very rare.
People might not think about novel and/or rare transplants when considering whether to donate their organs, so the government thinks they should be excluded from deemed consent.
The government is planning to exclude the following parts of the body. This means you or someone representing you would need to give explicit permission for them to be donated:
- spinal cord
- trachea (windpipe)
- upper arm
- lower leg
- umbilical cord
- embryo (inside the body)
- limbal stem cells (eye cells that allow the cornea to regenerate) – if they are used for an ATMP
- liver cells – if they are used for an ATMP
- pancreatic cells – if they are used for an ATMP
The government also proposes that some tissues (eye, nervous tissue, artery, bone, muscle, tendon and skin) would require express consent if they are used for a novel and/or rare transplant.
2.3 What is the government proposing?
The government is proposing that the novel and rare transplants listed above will still require express consent. To do this, it will ask Parliament to pass regulations that exclude novel and/or rare organs and tissues from deemed consent and is seeking your views on what should be excluded.
This will mean that the current arrangements for consent for novel transplants won’t change.
2.4 Next steps
The government will consider the responses to this consultation and will publish a formal response, presented to Parliament alongside a written ministerial statement.
The revised regulations setting out the organs and tissues to be excluded will then be debated and approved by the House of Commons and the House of Lords before they become law.
3. Your views and evidence
In our consultation, we are asking for your views on:
- whether the regulations are clear
- whether we are excluding the right parts of the body from opt-out
You can respond to the consultation online. The consultation will close on 22 July 2019.