New regulations concerning organ-preserving treatment and other provisions

Organ donation saves lives, but the need for organs continues to be greater than the supply. To enable the healthcare services to perform more organ donations, new provisions in the Transplant Act (1995:831) will come into force on 1 July 2022.

In brief, the new regulations entail:

• Clearer rules concerning how continued intensive care may be provided to make more donations possible.
• The relatives’ veto has been removed. Instead, it is the individual’s position on donation that will be decisive. The relatives remain an important source of information.
• Incapacitated adults are exempted as they have not been able to make their own decisions concerning the issue of donation.

In order to be an organ donor, the individual must die during the provision of intensive care treatment. In Sweden, several hundred people die every year under circumstances in which organ donation could be relevant.

When the patient’s life cannot be saved

Healthcare providers always do everything they can to save the patient’s life. If it becomes apparent that it is not possible to save the patient’s life, a so-called ‘turning-point decision’ is made. This means that the decision is made to not continue with the life-support treatment. The turning-point decision is made in consultation between two licensed physicians and is entered into the patient records. The relatives are informed of the decision in a so-called ‘turning-point discussion’.

Once the physicians have made the decision to cease life-support treatment, the healthcare staff will begin to investigate the patient’s position on organ and tissue donation. They will then search in the donation register and talk to the patient’s relatives. These routines are not changed in the new proposed legislation.

The legislative changes mean that intensive care to make donation possible is regulated

The new provisions entail clearer rules concerning the provision of continued intensive care following the turning-point decision.

The continued intensive care is called organ-preserving treatment and is aimed at preserving organ function in preparation for a potential donation. Essentially, the organ-preserving treatment involves the same care interventions that the patient has already received in the form of intensive care, but additional pharmaceuticals or treatment on ventilator may be relevant.

The organ-preserving treatment takes place concurrently with the end-of-life care that is provided for the patient’s own sake. Without continued intensive care at this stage, the patient could die without the healthcare staff having had time to investigate the possibility of donation. Providing intensive care aimed at preserving organ function is a prerequisite for a donation to be possible.

If it emerges during the investigation of willingness to donate that the patient does not want to donate organs, the intensive care interventions will be stopped. If the patient does want to donate organs, the organ-preserving treatment may continue for up to 72 hours. If there is a willingness to donate, investigations are also conducted to determine if the patient is medically suitable for a donation.

It is only intensive care interventions that cannot wait until after death that may be given, and these may not cause more than negligible pain or negligible injury. And care for the patient’s own sake always comes before the organ-preserving treatment. Against this, the doctor in charge decides what interventions are to be taken.

Organ and tissue donation always takes place after death

Any organ or tissue donation is always done after the physician has confirmed that the patient is dead. Under Swedish law, a person is dead when all brain functions have completely and irreversibly ceased in a so-called total cerebral infarction. Death must be ascertained according to specific criteria that are also regulated in laws and regulations. These conditions are not changed by the new legislative changes.

Donation after death can take place after:

• a primary brain injury has occurred, for example due to a major brain haemorrhage or skull injury that leads to total cerebral infarction (so-called DBD, Donation after Brain Death)
• the patient has suffered a circulatory arrest that leads to total cerebral infarction (so-called DCD, Donation after Circulatory Death).

Death is ascertained by licensed physicians

Common to both donation processes is that a dying patient is receiving care in an intensive care ward and that the question of donation may become relevant after a decision has been made that life-support treatment is no longer meaningful for the patient. Death may only be ascertained by a licensed physician, which is governed by law. This is not changed by the new legislative changes.

The legislative changes reinforce that the patient’s position on donation must be respected.

In Sweden, everyone has the right to decide for themselves whether or not they would like to donate their organs and tissue after death. The individual’s wishes must be respected. Individuals can make their wishes known by registering in the national donor register and by talking to their relatives about their position.

If the patient’s position on organ donation is unknown, their relatives no longer have the right to decide. Previously, it was the patient’s relatives who were able to decide on donation, but this is now being removed from the law. The healthcare services will contact the relatives to investigate the patient’s willingness to donate, but if it emerges from this investigation that donation does not go against the patient’s wishes, a donation may be possible.

The legislative changes mean that incapacitated adults are exempted from donation

Interventions may not be carried out if a person had a disability of such a nature and degree that he or she has obviously never had the capacity to understand the meaning of and be able to take a position on donation. This means that adults who are incapacitated with intellectual disabilities, such as learning disabilities and other disabilities, will be exempted as concerns donations from deceased persons.

This restriction does not cover an adult who is temporarily incapacitated, or who later in life suffers, for example, from a dementia disease which means that the person is no longer able to understand the meaning of donation.

Children up to 18 years of age who have a severe disability are also not covered by this restriction because they are represented by their guardians.

The organs go to the person who needs them most

All people who are covered by the healthcare system in Sweden, regardless of origin, creed, lifestyle, etc. have the right to equal and good care. The distribution of organs and tissue and who is to receive transplants is determined by physicians, based on a waiting list but also on a medical assessment of who has the greatest need and is best suited to undergo the transplant. This is not changed by the new legislative changes.