Question 1

The government wants to look at different ways for people to register their decision under the new system. This could happen through government processes such as driving licence applications, and health settings such as dental surgeries and opticians.

Do you think people should have more ways to record a decision about organ and tissue donation?

Please select: ‘Yes – there should be more ways to record a decision, including when people are doing other things, such as registering with a GP’.

Question 2

There are advantages and disadvantages to including additional information when a person registers their decision on organ donation. On the one hand, potential donors may feel reassured about including information, on the other hand, the process of registering the decision needs to be as simple and straightforward as possible.

What do you think are the advantages or disadvantages of including personal information on someone’s organ donation decision?

Please state, in your own words, the reasons for why some extra information would be advantageous. Good reasons you can cite are:

  • For those who have particular philosophical or religious beliefs, their approach to when the individual dies, or towards the importance of family at their death, may inform the extent to which organ donation can take place, and the manner in which it can take place. This seems obvious additional information to be required.
  • More generally, a specific question as to whether the person has any specific objection to the removal of organs before circulatory death might be helpful to those with qualms about that practice.

Question 3

If the new rules come into force we need to make sure that everyone understands how the system has changed.

We would like to know what you think are the best ways of telling people what the changes are, so they can decide what they want to do.

How can we make people more aware of the new rules on organ donation?

Please state, in your own words, what you think about furthering awareness about new rules. It would be helpful to cite that:

  • A recent Welsh Government Survey on Public Attitudes Towards Organ Donation  shows that awareness of their presumed consent law is around 80% (it was 84% when the law came in), whereas support for the law is around 69% (down from 75%). That leaves 20% of people (1 in 5), even after the continued advertising and information ‘campaigns’ by the Welsh Government, unaware of the law and for whom consent cannot be ‘presumed’ (source: Welsh Government Social Research Survey: Public Attitudes to Organ Donation, 30th November 2017: http://gov.wales/statistics-and-research/public-attitudes-organ-donation/?lang=en).
  • This shows that even strong public information and advertising campaigns can be insufficient, and utterly undermines the claim that such actions guarantee that people are truly ‘consenting’ by not ‘opting-out’.

Question 4

If the law changes, would this affect your decision about organ donation?

No – It would make no difference.

Yes – It would make me want to become an organ donor after my death.

Yes – It would make me want to opt-out of being an organ donor after my death.

Here, please be honest about how what difference a change in the law would make as to your personal decision about organ donation.

For some, their predisposition to donate their organs is unaffected by state presumption of their consent. For others, the idea of the state presuming their consent to organ transplantation is abhorrent, and leads to their withdrawal. After presumed consent was introduced in Wales, 180,462 people opted out of the organ donor register who beforehand would have been potential donors.

Question 5

A person’s faith or background can play an important part in deciding whether to be an organ donor.

If the law changes, people would be considered willing to be an organ donor unless they have opted out. Do you think this change could have a negative impact on people from some religious groups or ethnic backgrounds?

Please select: ‘Yes’.

Please explain why you think this and what could be done about these concerns

Please state, in your own words, the reasons for why presumed consent would have a negative effect on people from some religious groups or ethnic backgrounds. Good grounds you can cite are:

    • Many religious believers, such as orthodox Judaists and Christians (especially Catholics and Evangelicals), take circulatory death to be the time at which death has occurred, based on their philosophical and religious beliefs concerning the soul. These same groups also object to the taking of organs without explicit consent.
    • Many people are not aware that harvesting of certain organs, such as the heart, means doing so on a ‘beating heart’ donor who is, by these definitions, still ‘alive’. Presuming consent on anyone who has these beliefs but who is not aware that this is what organ donation involves, would be deeply offensive to religious minorities.

 

  • There is a strong concern for many religions about the role of the family, and that no organs should be taken against their wishes. Particularly, many religious people will be concerned over the State trespassing onto territory that is, in their understanding of God’s providence, the responsibility of the family.
  • These issues raise concerns regarding presumed consent in the cases of those who are adherents to specific minority religions when family members may not be able to be present, or when informed consent has not sufficiently taken place such that when agreeing to donation the individual was not aware of the nature of harvesting certain organs.

Question 6

If someone is going to die and it is possible for them to donate their organs, medical staff always talk to their family or a long-standing friend to find out if they wanted to be a donor.

In many cases, families find it easier to support organ donation if they know that was what their loved one wanted.

If the law changes, and someone has died and they have not opted out of organ donation, should their family be able to make the final decision?

Please select: ‘Always – If someone had not ‘opted out’ their family should always be asked to make the final decision’.

Question 7

Do you think someone’s family should be able to decide if their organs are donated, if it is different to the decision they made when they were alive?

Please select: ‘Sometimes – there are some circumstances where someone’s family should be able to make a different decision’.

Can you explain more about why you think this?

Please state, in your own words, your further reasons about circumstances in which someone’s family should be able to make a different decision. A good reasoning is that:

Normally, the wishes of the person who wants to donate should not be overridden, as their wishes in life about their own body should be of paramount concern and not overridden simply by alternative wishes of relative on whim. This issue is not all black or all white however, and the law and regulation should be flexible so as to cater to individual circumstances. For example:

  • The decision to donate may not have, in fact, been a fully informed choice, especially in relation to the diagnosis of death. Many people are unaware that organs may be harvested from a person whose heart is still beating, and that the harvesting itself will stop a beating heart. This means that they will also be unaware, at the time of consenting to their organs being taken, that this will mean that their relatives will be expected to say goodbye to them in the intensive care unit while the heart is still beating, and whilst they ‘look alive’, maintained on a ventilator.
  • Information campaigns about becoming an organ donor by signing the organ donor registry or completing a donor form do not, certainly with any prominence, explain that organ harvesting of certain organs happens whilst the heart is still beating, and that not being with someone in that quietness that occurs after circulatory death can result in a greater sense of loss. This can lead to shock and dismay of relatives as they only get to say goodbye in the intensive care unit rather than when they expect.
  • A potential donor relatives may be concerned about the practice of organ transplantation of which the donor was unaware at the time of donation, such as doubts about the diagnosis of death. Jewish and Catholic believers take circulatory death to the time at which death has occurred, and so again, harvesting on a ‘beating heart’ donor could be deeply problematic.
  • Given this, and given the perhaps unexpectedly grave grief of their relatives, after or near death a potential donor is no longer in a position to adjust her view to accommodate the needs of those nearest to her.

Question 8

The government thinks there are some people who should not be included in the new rules. This is either because they are too young, they’re not able to make a decision about organ donation, or they don’t usually live in England. It means they would still need to ‘opt-in’ to be an organ donor when they were alive.

Which of the following should not be included in the proposed new rules about organ donation?

(please tick all those that apply)

Please select all options:

Children under 18 years old.

People who lack capacity, which means they are not able to make the decision.

Visitors to England.

People living in England for less than 12 months (for example students or people in the armed forces).

Are there any other groups you think should not be included? Please say why.

Please state, in your own words, which groups should not be included. Please cite the following examples:

 

  • Any deceased person whose identity is unknown.
  • Residents in England who have not opted out but whose families are unavailable for consultation.
  • Residents in England who have not opted out, whose family is unavailable for consultation, and who belong to ethnic or religious groups known to be averse to forms of organ donation (e.g. Japanese people with Confucian beliefs).

Question 9

Please tell us about any opinions or evidence you have about opting out of organ donation.

Please state, in your own words, the reasons for your opposition to presuming the consent to organ retrieval. Good grounds you can cite are:

=> There is no Probative Evidence that Moving to a Presumed Consent System Will Increase the Number of Organ Transplants:

  • The Welsh Assembly voted to move from autonomous donation to presumed consent in 2013. Since this came into effect, the Welsh Government’s own two-year evaluation of the system so far has shown that instead of increasing donation rates as hoped, the resident Welsh donor rate fell from an average of 14.6 donors per quarter under autonomous donation to 13.4 donors per quarter for the first 21 months under presumed consent (source: Evaluation of the Human Transplantation (Wales) Act, Welsh Government, 30th November 2017, pg. 53 –

http://gov.wales/docs/caecd/research/2017/171130-evaluation-human-transplantation-wales-act-impact-en.pdf).

  • There is no probative evidence for any country in the world that moving to ‘opt out’ presumed consent system of organ donation has actually led to an increase in donation rates.

=> This is Because Presumed Consent Doesn’t Increase The Organ Donor Base:

  • Under the current system of autonomous donation, which operates according to informed consent, the organs of any deceased person can already be retrieved for transplantation, so long as the deceased has not already explicitly stated that they do not wish this to happen, and as long as family consent to the procedure is secured.
  • In the 5 years prior before presumed consent was introduced in Wales, 167 donation decisions were made by families in the absence of direction from the deceased compared to 131 by those who ‘opted in’ by signing the donation register (source: Answer to Welsh Assembly Written Question WAQ75281, 07th December 2017

http://record.assembly.wales/WrittenQuestion/75281).

  • 21 donations were prevented in Wales in 2017 because the family opposed the donation, even though the consent of the deceased was deemed to have been given because they had not signed the opt-out register. This prevented 65 transplants (source: Pleas for organ donors to talk to families about choice, BBC News, 01st November 2018:

http://www.bbc.co.uk/news/uk-wales-41824670).

  • Clearly, knowing or presuming consent is not the key to retrieving organs for transplant: securing family consent is.

=> Presumed Consent Could Actually Reduce The Donor Base:

  • It is not merely that presumed consent fails to increase the organ donor base. Critically, it is counter-productive, as it actually reduces the total pool of individuals whose families can agree to donate organs. As we have seen the family of the person who about to die have to agree in order for presumed consent to have any practical effect. The evidence shows however, that when presumed consent is introduced, a proportion of the public withdraw from donation and sign the opt-out register. This can be because they dislike the idea of the state presuming their consent, or for other reasons.
  • In Wales 180,462 people withdrew from donation in response to presumed consent being introduced (source: Organ Donation and Transplantation Activity Data: Wales, NHS, January 2018:

https://nhsbtdbe.blob.core.windows.net/umbraco-assets/1518/wales.pdf). Those 180,462 people would have been potential donors before presumed consent in the event that they died in an intensive care unit and their families agreed to donation.

  • Under presumed consent families cannot be asked about donation when the person concerned has opted out. All their organs are lost to the possibility of donation.
  • The Impact Assessment published alongside this presumed consent consultation suggests that 3,000,000 people will opt out if the rate is the same as in Wales (source: Impact Assessment, Consultation on an opt-out system of organ and tissue donation, Department of Health, 06th November 2017, pp. 6-7:

https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/666518/Organ_Donation_Opt-Out_Consultation_Impact_Assessment.pdf).

  • It is worth noting that the 3,000,000 figure was based on past numbers of 165,000 people opting out in Wales. That number has since increased, as noted above, to 180,462, so it follows that the number of people opting out in England is likely to be even more. That would mean that over 3,000,000 people lost to the possibility of organ donation.

=> Presumed Consent Would Disregard the Feelings of Grieving Relatives:

  • At a time when they are experiencing profound grief, especially at the untimely death of a child, spouse, sibling, or other close relative or friend, for a family to be confronted with the presumption that their loved one consented to organ harvesting and be made to feel that they must work to try to stop it, rather than approached sensitively whilst they concentrate on their grief, is wrong and inhumane.
  • In those unusual circumstances where harvesting might go ahead despite their objection (most doctors will not want to grieve a family further), the the relatives will be expected to say goodbye to their loved one in the intensive care unit while the heart is still beating, and whilst they ‘look alive’, maintained on a ventilator. This could easily result in a greater sense of loss, and lead to shock and dismay of relatives as they only get to say goodbye in the intensive care unit rather than quietly at the time of circulatory death.
  • Such a practice would also frequently place clinicians in a very difficult position, requiring them to try to harvest organs from a soon-to-be deceased person, risking the offence of that person’s family.

=> Approaching Families Through Specialist Nurses in Organ Donation (SN-ODs) is a Positive, Evidence-Based Alternative to Presumed Consent that Actually has Increased Organ Donation Rates:

  • As we have seen, it is simplistic to think that simply presuming consent will lead to an increase in transplantations. This is because families will, quite rightly, have the right to block such transplantations.
  • Given the central role of the family – both when the deceased has left no donation instructions and when he or she has – the truth is that the key to increasing donation rates lies with convincing families to consent to their loved one’s organs being transplanted. This is the central principle that informs the approach to organ donation in Spain, a country that has had the highest organ donor rate in the world over many years.
  • Whilst Spain has an ‘opt-out’ organ donation law, this was never implemented. Instead, the Spanish focus their energies instead on working with families to encourage them to donate in the absence of instructions from the deceased, or to honour the donation instructions of the deceased. (sources: Rafael Matesanz, Beatriz Domínguez-Gil, Elisabeth Coll, Beatriz Mahíllo, and Rosario Marazuela, How Spain reached 40 deceased organ donors per million population, American Journal of Transplantation; January 09th, 2017: http://doi.wiley.com/10.1111/ajt.14104; Rafael Matesanz and Beatriz Domingues-Gil, Strategies to optimise deceased organ donation, Transplantation Reviews 21, 2007, pp. 177 – 188: https://www.sciencedirect.com/science/article/pii/S0955470X07000614; Prof John Fabre, Paul Murphy and Rafael Matesanz, Presumed consent: a distraction in the quest for increasing rates of organ donation, BMJ 2010; 341: c4973: http://www.bmj.com/content/341/bmj.c4973.)
  • Whilst we have no evidence to suggest that presumed consent works, there is powerful evidence from Spain of the positive effect made by investment in the provision of Specialist Nurses in Organ Donation (SN-ODs) to talk to the families of potential donors. Table 13.1 of the National Potential Donor Audit (2016-2017) has shown that UK rates of family consent or authorisation were 68.6% when a SN-OD approached the family, but just 27.5% when the approach was made by other staff without the specialised training (source: National Potential Donor Audit, Transplant Activity Report 2016-2017, Table 13.1:

https://nhsbtdbe.blob.core.windows.net/umbraco-assets-corp/4660/section_13_national_potential_audit_donors.pdf).

=> Presumed Consent Would Contradict an Important Principle of Medical Law – Explicit Consent Based on Bodily Autonomy:

  • Fundamental to medical practice and ethics is that explicit consent to a procedure has to be given by a patient, or someone to whom the patient has given power of attorney, before action can be taken. This applies just as much to those who have died or are about to die. Presumed consent gives the State the power to reverse that principle, by presuming the consent of a patient unless they have explicitly refused donation.
  • By presuming consent rather than secure it explicitly, the State and medical system fail to respect patient autonomy, effectively conscripting organs unless they go through the process of ‘opting out’ of having their organs harvested after death.

=> Presumed Consent Would Undermine the Concept of Donation Itself:

  • ‘Donation’ comes from ‘Donum’, meaning ‘Gift’. The very idea of organ donation it that it is a free gift from one person to another. By presuming consent, donation stops being a gift, and instead becomes the state appropriation of bodily remains.

Impact Assessment

The Department of Health would welcome any further quantitive evidence you have on the following areas:

  • for people who have received a transplant:
  • any evidence on the financial costs of this to the health system and wider society.
  • the quality of life of the individual and those around them.
  • for people who would benefit from a transplant but have not had a transplant:
  • any evidence on the financial costs to the health system and wider society.
  • the quality of life of the individual and those around them.
  • any other factors that have not been considered in the consultation analysis, which could impact on the desired outcome to increase the number of organs for transplant in England, or which could have other considerable costs / benefits.

Finally, please re-state, in your own words, the positive evidence-based alternative to presumed consent, that actually has increased organ donation rates:

  • As we have seen, it is simplistic to think that simply presuming consent will lead to an increase in transplantations. This is because families will, quite rightly, have the right to block such transplantations.
  • Given the central role of the family – both when the deceased has left no donation instructions and when he or she has – the truth is that the key to increasing donation rates lies with convincing families to consent to their loved one’s organs being transplanted. This is the central principle that informs the approach to organ donation in Spain, a country that has had the highest organ donor rate in the world over many years.
  • Whilst Spain has an ‘opt-out’ organ donation law, this was never implemented. Instead, the Spanish focus their energies instead on working with families to encourage them to donate in the absence of instructions from the deceased, or to honour the donation instructions of the deceased. (sources: Rafael Matesanz, Beatriz Domínguez-Gil, Elisabeth Coll, Beatriz Mahíllo, and Rosario Marazuela, How Spain reached 40 deceased organ donors per million population, American Journal of Transplantation; January 09th, 2017: http://doi.wiley.com/10.1111/ajt.14104; Rafael Matesanz and Beatriz Domingues-Gil, Strategies to optimise deceased organ donation, Transplantation Reviews 21, 2007, pp. 177 – 188: https://www.sciencedirect.com/science/article/pii/S0955470X07000614; Prof John Fabre, Paul Murphy and Rafael Matesanz, Presumed consent: a distraction in the quest for increasing rates of organ donation, BMJ 2010; 341: c4973: http://www.bmj.com/content/341/bmj.c4973.)
  • Whilst we have no evidence to suggest that presumed consent works, there is powerful evidence from Spain of the positive effect made by investment in the provision of Specialist Nurses in Organ Donation (SN-ODs) to talk to the families of potential donors. Table 13.1 of the National Potential Donor Audit (2016-2017) has shown that UK rates of family consent or authorisation were 68.6% when a SN-OD approached the family, but just 27.5% when the approach was made by other staff without the specialised training (source: National Potential Donor Audit, Transplant Activity Report 2016-2017, Table 13.1: https://nhsbtdbe.blob.core.windows.net/umbraco-assets-corp/4660/section_13_national_potential_audit_donors.pdf).