Opt In or Opt Out

Background

The current “opt-in” system of organ donation – where individuals are asked to register their willingness to be a donor after their death – has been the subject of debate for many years.

Due to the serious shortage of organ donors and consequent waiting lists for transplant operations in the UK, it is often suggested that the altruistic approach to organ donation is in need of review.

The British Medical Association (BMA), many transplant surgeons, and some patients’ groups and politicians are keen to see Britain adopt a system of “presumed consent”, where it is assumed that an individual wishes to be a donor unless he or she has “opted out” by registering their objection to donation after their death.

In recognition of the complex issues and widely differing viewpoints surrounding systems of consent to organ donation, the UK Secretary of State for Health, Alan Johnson, asked the Organ Donation Taskforce to assess the possible impact of a change to presumed consent and the acceptability of such a change for the UK.

The Taskforce examined the complex moral and medical issues around presumed consent, including giving the family of the deceased a final say on the donation of any organs.

Its work centred on examining the views of the public, health organisations and various other stakeholders on the clinical, ethical, legal and societal issues. The Taskforce established a series of expert working groups to help gather evidence and advise on all these areas.

The resulting report The potential impact of an opt out system for organ donation in the UK was delivered in November 2008. It recommended that the current system of opt-in be retained and the recommendations of the Taskforce’s earlier report Organs for Transplants, produced in January 2008, be implemented. The first report examined the barriers to donation and made recommendations for improvements within existing legal frameworks.

In July 2007, the Chief Medical Officer in his 2006 Annual Report on the State of Public Health, supported the idea of an opt-out system with proper safeguards and good public information. Prime Minister Gordon Brown has also called for a public debate on the issue of presumed consent.

Current legislation

In the UK, the law regarding removal of organs from people after their death is set out in the Human Tissue Act 2004, covering England, Wales and Northern Ireland, and the Human Tissue ( Scotland) Act 2006.

These laws repealed the 1961 Human Tissue Act, which was introduced when transplantation was in its infancy. The new legislation, which was announced in the Queen’s speech in 2003, takes a modern approach to the issues and was widely consulted on. The Department of Health consultation document entitled Human bodies, human choices was published in July 2002 followed by a summary of responses to the consultation in April 2003.

UK Transplant provided a formal response to this document following a meeting of UK Transplant Advisory Group, which met specifically to review the document. The group included representatives from the Royal Colleges of Medicine, Pathology, Paediatrics, Anaesthetics, Surgery, the Intensive Care Society, NHS management, UK Transplant’s solid organ advisory groups, UK Transplant Co-ordinators’ Association and the British Transplantation Society.

Both Human Tissue Acts state that if a person has, while alive and competent, given consent for some or all of their organs or tissue to be donated following his or her death (by joining the NHS Organ Donor Register or by other means, such as discussing their wishes with those closest to them), then that consent is sufficient for the donation to go ahead. Once consent is established, relatives or other relevant people should be advised of the fact and encouraged to respect the deceased’s wishes. They will be treated with the utmost sensitively but advised that they have no legal right to veto or overrule them. In some cases, however, there still may be circumstances where donation may not be appropriate.

If there is no record of the deceased’s wishes, the medical staff will approach the relatives or other relevant people to establish any known wishes of the deceased. If these are not known, and the deceased has nominated a person to deal with the use of their body after death, then consent can be given by that person.

If neither of the above apply, consent to donate can be given by someone in a “qualifying relationship” immediately before the death of the deceased person. Those in qualifying relationships differ slightly for Scotland but both lists, which are set out in a strict order of priority, include family members and close friends.

Alternative consent systems

As well as the opt out system which is in current practice in a number of countries around the world, another system known as “required request” is also used.

Opting out / presumed consent

Under a system of “opting out” or “presumed consent”, every person living in that country is deemed to have given their consent to organ donation unless they have specifically “opted out” by recording in writing their unwillingness to give organs.

Supporters of such a system’s introduction in the UK believe that establishing an automatic right to take organs when the donor has not expressed wishes to the contrary would lead to a significant increase in the number of potential donors. They also conclude that the relatives or those close to a person who has not expressed a wish to donate would be relieved of the burden of making that decision at such a traumatic time.

One fear with presumed consent is that people won’t get round to registering an objection and the subsequent expectation that organ donation should take place could lead to unnecessary distress to their relatives and widespread adverse publicity.

Many transplant recipients add that a donated organ is more easily accepted because they know it has been positively given by the deceased whereas presuming consent would turn donation into an action by default.

Other concerns surround the potential medical risks involved in removing organs without full discussion with relatives. Families are a valuable source of information about their loved one’s previous health and relatives are questioned as part of the screening process.

If an individual does not register an objection, it is possible that their silence may indicate a lack of understanding rather than agreement with the policy. It is because of these concerns that in the majority of countries operating an opt-out system, health care professionals still consult the family to establish consent.

Required request

A policy of “required request” or “required referral” is operated in the United States of America. Required referral is defined “that it shall be illegal, as well as irresponsible and immoral to disconnect a ventilator from an individual who is declared dead following brain stem testing without first making proper enquiry as to the possibility of that individual’s tissues and organs being used for the purposes of transplantation”.

The policy means opportunities for donation are less likely to be overlooked. Many individuals may be having their right to donate removed if their relatives are not approached. The next of kin also has a moral and legal right to know they can donate organs and tissue if they or the family so wish. Many families report that such a donation was helpful rather than harmful.

Although the introduction of this scheme saw an initial increase in the availability of organs, over time the numbers have declined.

Experience in other countries

Large disparities in organ donation rates exist throughout the world, despite the laws governing organ donation.

Some European countries with opt-out systems have higher donation rates than the UK. However there is no clear evidence that opt-out is the sole factor. The fact that Sweden has an opt-out law does not seem to influence the donation rate per million of population, which is lower than that of the UK, which does not. Within almost all countries, large local variations exist in donation rates, despite a common legislative background.

Opt-out systems can be “hard”, as in Austria, where the views of close relatives are not taken into account, or “soft”, as in Spain, where relatives’ views are sought.

Different cultural attitudes to the disposal of bodies, greater provision of intensive care beds, more pro-active donation programmes and the numbers of road deaths, each play their part. However, the single most important factor so far identified is ensuring that the relatives of potential organ donors are always approached, and approached by someone specifically trained for the purpose, as happens in Spain.

In fact, while Spain is recognised as having a higher number of donors than the UK, it is acknowledged by the director of national transplant organisation in Spain himself that the increase in organ donation during the 1990s could not be attributed to a change in legislation which had remained the same since 1979. The improvements in donor rates in Spain followed the implementation of a comprehensive national procurement system.

NHSBT’s position

We welcome any debate that raises the value and importance of transplantation and increases the general public’s knowledge of the importance of organ and tissue donation.

Transplant services in the UK are renowned for the honest, open and transparent manner in which they operate. This is due, in part, to the fact that consent has always been an integral part of the process of donating organs for transplant. In turn, society, recipients and their families acknowledge the wonderful gift of life that donors contribute. During 2006-07 the generosity of donors led to a 10% increase in the number of solid organ transplants to an all-time high of 3,087. Since 2002, around a million people have joined the NHS Organ Donor Register (ODR) every year, pledging to pass on the gift of life.

Our current experience in the UK shows that up to 90% of people support organ donation with more than 15 million people, or 25%, having joined the ODR. An ongoing potential donor audit of deaths in intensive care units shows that six out of ten families approached about organ donation will give their agreement or authorisation for donation. It makes it easier for them if they know the donor has registered their wish to donate on the ODR.

The Human Tissue Acts introduced in 2006 reinforce the importance of giving consent for donation. Many people have found it difficult to accept that relatives could overturn any wish they may have registered or expressed during their lifetime but the new law makes it explicit that it is the wishes of the deceased individual that should prevail. .

The important issue is that people discuss their desire to donate organs so that close family members and friends are aware of their wishes. As much as possible should be done to persuade people to join the NHS Organ Donor Register by calling 0300 123 23 23 or via www.organdonation.nhs.uk

NHSBT is neither against nor in favour of a change to presumed consent legislation. Now that the Organ Donation Taskforce review has been delivered, we will continue to promote the need for more voluntary registrations on the Organ Donor Register. We will work within whatever legislative framework is introduced in any of the four health administrations in the United Kingdom. In the meantime, we work in earnest towards supporting the implementation of the 14 recommendations contained in the Taskforce’s first report which are seen as critical prerequisites for improving organ donation in the UK.

Updated November 2008