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Essay: Will presumed consent for organ donation violate the rights of the deceased?

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  • Will presumed consent for organ donation violate the rights of the deceased?
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Unless it is devised as soft opt-out system that allows the next of kin to make the final decision, presumed consent for organ donation will violate the rights of the deceased leading to fear and a reduction in available organs.

Introduction

The British Prime Minister, Theresa May proposed to remove the need for donor cards in order to save thousands of lives at the Conservative Party Conference in 2017. She believed that introduction to a new opt-out legislation will increase the number of organ donation across the UK. The proposed legislation will make everyone donor, unless a person expressly register the objection. The bill claimed that by enacting the new legislation, it is possible to save 500 lives each year. Though, no evidence was submitted in support of the claim. There are contrasting views in relation to ‘opt-out’ laws among the medical professionals. Some professionals believe that introducing an ‘opt-out’ will increase the number of organ donation and thus, will save many lives. However, there are contradictory views as well. According to Nuffield Council on Bioethics (NCB) enacting the ‘opt-out’ law will undermine the public trust and this will make people reluctant to donate.

Different system for organ donation around the world

There are wide ranges of systems available for organ donation around the world. In Austria, a hard opt-out system is in place. So, doctors can take out any organ which they consider appropriate after a person dies unless that person registered to opt-out. If the deceased failed to register for opt-out during life, this rule applies regardless of the relatives’ knowledge that the deceased would object to donate organ. In Belgium, a soft opt-out system is currently in place. Doctors can take out any organ which they consider appropriate after a person dies unless that person registered to opt-out or the relatives inform the doctors that the doctors should not remove doctors. However, it is the responsibility of the relatives to inform the doctors. There is a different soft opt-out system is in place in Spain. According to this system, doctors can take out any organ which they consider appropriate after a person dies unless that person registered to opt-out. However, the doctors take the relatives’ opinion with regard to organ donation at the time of death. In the UK, the current system for organ donation is called the ‘soft’ opt-in system. According to this system, doctors can take out any organ which they consider appropriate after a person dies if that person registered to opt-in during his/her life. Therefore, it is for the individual to register for opt-in if that person wants to donate his/her organ. However, doctors may not remove organ if they face challenge from the relatives of deceased even if the deceased had registered to opt-in. In a hard opt-in system, the doctors can remove organ from the deceased body if the deceased registered to opt-in during life. Here, the objection from the relatives will not be taken into account.
Organ donation: UK perspective
Deceased donors play important role for organ transplantation by agreeing to donate their organs after their death. However, there are lacks of required organs supply for transplantation than the current demand. There have been significant developments in the field of medical science and major changes occurred in medical ethical attitudes. Moreover, the Parliament adopted new legislation in order to facilitate the organ donation. The organ donations were discouraged by the large portion of the society. However, now organ donations are encouraged widely.
As discussed above there are several systems around the world regulating organ donation. Where opt-out systems are in place, the organ donation rate is high there. This is sometimes known as presumed consent. In many countries in Western Europe, the presumed consent with regard to the organ donation of the deceased has been adopted successfully. On the other hand, in most of the English speaking countries, this system has not been adopted. Under the presumed consent principle, it is presumed that all adults those are mentally capable to consent to donate their organs after their death save contrary evidence is presented. However, depending on which opt-out law is in place (hard opt-out law or soft opt-out law), the views of the relatives of the deceased can be important. It is difficult to assess the success of the opt-out laws with regard to organ donation because there are several other factors which should be taken into consideration before measuring the effect of opt-out laws. These factors include: cultural environment, economic condition, the standard of intensive care units, the government’s policy and strategy on organ transplantation, number of trained doctors and nurses etc. However, generally it can be asserted by analyzing evidence that “opt-out systems have higher donation, and lower refusal, rates than express consent (opt-in) systems” .

Organ donation laws in the UK

The Human Tissue Act 1961 was the first act which dealt with the legality of the organ donation of deceased in the UK. The act stated that where the deceased expressly gave the consent to the organ donation, it will be lawful. However, the law permits the doctors to remove organ from the dead body in absence of express consent from the deceased provided that there is no reasonable ground to believe that the deceased had objected the procedure, surviving spouse or any surviving relative would object the procedure. The 1961 Act does not require express consent; therefore, this act could be viewed as soft opt-out law. In most of the cases, the designated authority is required to contact with the relatives of the deceased in order to obtain their views on organ donation. It is worth remembering that “the distinction between ‘absence of objection’ and ‘consent’ was often blurred and hard to discern” .

The Human Tissue Act 1961 failed to mention any penalty if anyone could not comply with the requirement prescribed by the act. This was the principal drawback of the act. However, there are some other defects. The 1961 Act was repealed subsequently. Kennedy and Redfren conducted a research focusing the sources of organ and tissue retention in hospital pathology departments. The reports found shocking findings with regard to the preservation of the tissue after post-mortem and utilize the tissue for the purpose of scientific research. In effect, sometimes this caused the burial or cremation of dead bodies, where the family members or relatives of the deceased were unable to understand that the tissue was removed from the dead body. The 2004 Act deals with the human tissues and clearly stated that express consent is mandatory for carrying out such activities. It is worth mentioning that the 2004 Act combined the two issues (tissue retention and organ donation). The issue related to organ donation was not affected by the Bristol and Alder Hey scandals. So, the 2004 Act has been criticized by the academics and professionals for this reason.
Taskforce and recommendations
More than 14 million people were on the NHS Organ Donation Register in 2006-07. The doctors performed 3,000 transplants; however, the doctors could not save 1,000 people as they were on the waiting list for the transplants. The governed showed its concern regarding this matter and authorized the UK Organ Donation Task Force to carry out an investigation in this regard. The Task Force, in its report proposed to increase the number of organ donation by 50 percent at the end of 2013. However, this goal was not achieved by the stipulated time. The Task Force made 14 recommendations which include: setting up a UK-wide organ donation organization ; resolving outstanding legal, ethical and professional issues ; dedicated organ retrieval team should be established ; developing the formal guidelines for organ donation . It is worth mentioning that the recommendations did not mention anything with regard to the change in opt-in system. The Task Force published a report on the possible impact of introducing an opt-out system for organ donation in the UK in 2010. In the report it was stated that the need to change in the opt-in system for organ donation is a finely balanced question and the current system is unable to do enough against the need of public. The report revealed that almost 60% people will support the opt-out system provided that the system would protect the rights of the vulnerable people. According to the report published by the Task Force in 2010, the change in the opt-in system would be able to bring certain benefits; however, it fears that there could be a detrimental effect on the health system, it emphasized on “the potential to damage the vital relationship of trust between clinicians caring for people at the end of life, their patients and their families.”
The Human Transplantation (Wales) Act 2013
Before implementing the 2013 (Wales) Act, there had been extensive research with regard to the impact of opt-out laws. The efficiency of the opt-out laws was considered around the world. Particular emphasized on the Europe was given. Moreover, opinion from the public was assed and this is an important consideration before adopting the new legislation. The Welsh government came out with the conclusion that adopting a soft opt-out system will increase the organ donation 25% to 30%. Moreover, adopting soft opt-out legislation was supported by more than 60% of the Welsh public. It is not possible to state that presumed consent was the only reason for the increase in organ donation in many parts of the world. There are also many other factors those play important role along with presumed consent in order to increase the donation rates. The Welsh government found that introduction of an opt-out system is able to promote organ donation. The Human Transplantation (Wales) Act 2013 cannot be viewed as a complete law regarding transplant. Therefore, the 2004 Act is still in force in Wales.
By virtue of section 2 of the 2013 Act, Welsh ministers are required to carry out some specific duties. The ministers are required to encourage transplantation and take steps to increase the awareness on organ transplantation. They must make it clear to the public that what is deemed consent and where this will be applicable. It is an important aspect of the new legislation. The public in general should have a clear idea about ‘deemed consent’.
Deemed consent under the Human Transplantation (Wales) Act 2013
Some sections of the Human Transplantation (Wales) Act 2013 have the analogous construction that of the Human Tissue Act 2004. Section 3 of the HTWA 2003 states the express consent and deemed consent. In addition, the section clarifies the situations where consent is required for transplantation activities.
Section 4 of the HTWA 2013 states express consent. This section illustrates the validity of refusal to donate before a person dies. This section also explains the power of a deceased person’s appointed representative. Though, the 2013 Act has some similarities with the 2004 Act in many aspects, however, there are some differences as well. It is possible for a child to appoint a representative under the 2013 Act, but it is not possible under the 2004 Act. It is worth mentioning that where a person nominates a representative under the 2004 Act or Scottish Acts, the HTWA recognizes that appointment.
By virtue of the 2013 Act, all the persons dying in Wales, other than those who or their relatives expressly object the organ donation; will be deemed to consent to organ donation. There are some other exceptions to this rule which will be discussed later. The 2013 Act uses the term ‘deemed consent’ rather than using the term ‘presumed consent’. However, it actually does not make any difference in the meaning. Both the terms have identical meaning and can be used interchangeably. In the explanatory literature, the Welsh government used both the terms. So, it can be stated that “in an Act of Parliament, therefore, both terms can be used to create statutory presumptions — ie legal fictions which must be interpreted according to their natural meaning” .
The legislators of Wales did not provide any explanation for using the term ‘deemed consent’. It is worth mentioning that Wales is the first English-speaking country and as well as, the first Common Law country to implement the opt-out law for organ donation. Therefore, it is possible for Wales to set-out a precedent. Academics and professionals tried to find out the differences between two terms. The word ‘deemed’ has an element of adjudgement. Whereas, the word ‘presumed’ contains an element of supposition. Therefore, by using the term ‘deemed consent’ the Parliament wishes to highlight the unique nature of the 2013 Act which is enacted to promote organ donation across the Wales.
It could be argued that stating the term ‘deemed consent’ suggests that the people in general was completely aware of the fact that what does it mean by consent and how to object in this regard. It also implies that people in that society know the procedure to object if they want to set aside the deemed consent. So the word ‘deemed’ can be viewed “as having less cause to complain of a loss of autonomy than one whose consent has been presumed, or supposed, without any such explicit briefing” . The explanatory literature published by the Welsh Government supports this view. According to the explanatory literature, where a person has the opportunity to opt-out of donation, but he/she decides not to opt-out despite having the chance, that person “will be treated as though they had no objection to being a donor (or in other words their consent will be deemed)” . However, this explanation will be workable in practice if the people have the clear idea about the organ donation and the related formalities associated with that process.

Objection from relative or friend
Section 4(3) of the Human Transplantation (Wales) Act 2013 points out situations where it is possible to object the ‘deemed’ consent of organ donation. However, only the relatives of the deceased or friend of long standing may do so. They can do so on the ground that they knew the deceased’s objection to organ donation. As a result of this availability to object, the 2013 Act is classified as a ‘soft’ opt-out law. It is important to note that the relatives or friends of long standing of the deceased are not allowed to object on the basis of their personal opinion. It is not permitted by the 2013 Act. They are only allowed to object on the basis of the deceased’s state of mind with regard to organ donation before death. The explanatory notes made it clear that a person must comply with certain requirements in order to justify an objection. The information provided by the person objecting the organ donation has to be assessed from the point of view of a reasonable person. In essence, the reasonable person would form the view that the person objecting knew ‘the most recent view of the deceased’ . The legal restriction in this regard is viewed as ‘soft’ opt-out law. The soft-opt out law is in operation in Spain. The views of the relatives are always important in Spain. However, the views of the relatives or friends are irrelevant in Austria because ‘hard’ opt-out law is in operation there. So, doctors are allowed to remove organ from the deceased’s body unless they know contrary view of the deceased. Currently, in the UK (except Wales) a soft opt-in law is in place for organ donation. In practice, the views of the family members are always important regardless of the type of law is in operation for organ donation.

Exceptions of deemed consent under the HTWA 2013

The concept of deemed consent under the 2013 Act does not apply to the people with mental incapacity. People with such difficulties may not be able to understand properly what is meant by deemed consent. However, short period of mental incapacity before death should not be relevant. This exception applies to person with long term mental incapacity. Opinions from the family members are crucial in this regard.
Section 6 of the HTWA 2013 deals with the organ donation arrangements of children. This section applies to children who die in Wales regardless of residence. In order to donate organ, an express consent from the child is required. If the child is unable to express such consent, then his/her parents can do so.
The impact of the ‘opt-out’ law
The HTWA 2013 primarily addresses the issue of consent for organ donation. Before enacting the 2013 Act, it was believed that after the enactment of the Act, the organ donation will increase to 20% – 30%. Research and studies show that countries with an opt-out system have high organ donation rate. On the other hand, having taken many measures in accordance with the recommendations suggested by the Task Force, the organ donation rate in the UK is relatively low. The 2013 Act was introduced in order to increase the number of organ donation, so that more lives can be saved. The government, health professionals and media should spread the rationale behind implementing the act to the public. This will encourage the public to donate organs. If it is evident that the organ donation has been increased, then it could be asserted that the opt-out law is successful in this regard. Though theoretically, the 2013 Act allows the relatives or friends in a limited extent to express their views. However, in practice they will have a bigger role with regard to deceased’s organ donation.

The current system of organ donation is not working as it is expected to work. Therefore, the government has initiated to introduce an opt-out system with a view to save thousands of lives. Most of the people are agreed that there should be a change in the system. However, there is an ongoing debate regarding what would be the best system for organ donation. The research conducted by the Task Force in 2010 and other evidence revealed that there is, in fact, a connection between the high donation rate and opt-out system. This means, in countries where there is opt-out law for organ donation, the organ donation rate is high in those countries. Having stated the statistics, it cannot be stated that opt-out system alone increased the organ donation. The system alone cannot explain the differences in organ donations between different countries. There are certain other factors responsible for donation rates.

Some countries like Spain and USA have higher organ donation rates compared with other countries. The success of these countries has not achieved by adopting a single measure in isolation. The successful countries address all the important factors associated with organ donation separately and with proper care. Considering the above mentioned points, it could be illustrated that adopting an opt-out system for organ donation can bring benefits. However, there are changes of damaging the current system by implementing the opt-out law.

Presumed consent: problems and possible solutions
Wales introduced the ‘opt-out’ law by enacting the Human Transplantation (Wales) Act 2013. Statistics from Wales show that the presumed consent did not work effectively. Organ transplantation decreased from 214 to 187 between 2015 – 16 and 2016 – 17. The Nuffield Council on Bioethics stated that introducing presumed consent may have adverse effect on organ donation. Therefore, it could be argued that there is little evidence that the ‘opt-out’ law has worked effectively. There are other elements which play important role in increasing the rate of organ donation. The government can introduce training programmes for nurses for discussing the organ donation with the family of bereaved. Moreover, making people aware of the donation may be an effective step. The government wishes to increase the number of organ donation. However, making legislative change in absence of proper evidence may not be a suitable step. According to Hugh Whittall, who is the director of NCB “we are concerned that making a legislative change based on poor evidence risks undermining public trust in the organ donation system, and could have serious consequences for rates of organ donation” .
In the UK, for the purpose of organ donation, the consent of the deceased’s family member is vital. This is important even where the deceased had completed the registration for organ donation. 1,200 families refuse to donate every year among the registered donors.

Health professional advanced some serious arguments with regard to the potential negative impact of presumed consent of organ donation. They pointed out that there is a chance that the ‘opt-out’ law would damage the important relationship between clinicians who take care for people at the end of life, the patients and the members of family. The relationship is based on trust. Some concerns were expressed by the staffs work in intensive care. They feared that change in organ donation law would make the critical care more difficult to manage. Some intensive care practitioners may undertake the task of organ donation programmes.

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