Veronica English

In an opt-out system for organ donation, dead donors’ consent is presumed (or “deemed”) unless there is evidence that they did not want to donate. Opt-in systems, as in England currently, require donors to give explicit consent while alive or require the family to consent. In both systems, families are still consulted.

How would presumed consent work? Presumed consent is often portrayed in its extreme form where, if an individual has not opted out, the organs will automatically be available for donation. However, the system proposed for the UK would continue to involve the family.5 Before a change to presumed consent there would be extensive publicity advising people how to opt out. Mechanisms must be in place to ensure all sections of the public are informed and can register an objection easily. With the new system in place, when a person is identified as a potential donor doctors must check the opt-out register. If the person has not opted out, the relatives are informed of this and, as an added safeguard, are asked if they are aware if the person has any unregistered objection. If the answer is no, the relatives are informed of the intention to proceed with donation. However, the organs would not be used if it would cause severe distress to the relatives. In this way, relatives are still involved but the approach is easier for all concerned. Of course, the key question is does it work? It is notoriously difficult to prove a causal relation between particular determinants and donation rates and to extrapolate from the experiences of one country to another. Nevertheless, careful analyses seem to indicate that presumed consent improves donation rates. Analysis of 28 countries found that those countries that consistently implemented a policy of presumed consent had higher donation rates than those that did not.6 Abadie and Gay did a detailed regression analysis comparing 22 countries over 10 years taking account of determinants that might affect donation rates: gross domestic product per capita, health expenditure, religious beliefs, legislative system, and number of deaths from traffic crashes and cerebrovascular diseases.7 They concluded that “When other determinants of donation rates are accounted for, presumed consent countries have roughly 25-30% higher donation rates than informed consent countries.” One explanation is that, even if the family has the final say, countries with presumed consent legislation have fewer refusals. Spain has the highest recorded donor rate in the world, at 35.1 donors per million population (compared with 12.8 in the UK).8 So what can we learn from there? Spain has a presumed consent system (although in practice relatives are consulted) and has invested heavily in transplantation9: over a decade the number of transplant coordinator teams increased from 25 to 139.10 This combination of a system of presumed consent, which portrays a positive attitude towards donation, major financial investment, and good organisation, seems to be the way forward.

Parliament will soon be asked to decide about the future regulation of IVF in the United Kingdom. Given that IVF is now considered to be a routine clinical procedure and the fact that we live in an age of unprecedented emphasis on autonomy and patient rights, the justification for continuing to regulate this form of treatment will undoubtedly be challenged. This article considers the four key reasons why the Human Fertilisation and Embryology Authority (HFEA) was originally established—to protect patients and their children, to allay public concerns, to protect scientific freedom and to protect IVF practitioners from claims of unethical behaviour—and asks to what extent these reasons are still valid today. Acknowledging that there are difficulties and frustrations with the HFEA, the article warns that all parties—patients, researchers, IVF practitioners and society—have a lot to lose by limiting the scope of regulation. It concludes that before moving too quickly to get rid of the HFEA as we know it, we need to think carefully about whether the burdens and restrictions imposed by regulation are sufficiently onerous to justify this loss.

In the wake of scandals about the unauthorised retention of organs following postmortem examination, the issue of valid consent (or the lack of it) has returned to the forefront. Emphasis is put on obtaining explicit authorisation from the patient or family prior to any medical intervention, including those involving the dead. Although the controversies in the UK arose from the retention of human material for education or research rather than therapy, concern has been expressed that public mistrust could also adversely affect organ donation for transplantation. At the same time, however, the British Medical Association (BMA) continues to call for a shift to a system of presumed consent for organ transplantation. This apparent inconsistency can be justified because valid distinctions exist between the reasons requiring explicit consent for retention and the acceptability of presumed consent for transplantation. This paper argues for introducing a system of presumed consent for organ donation, given the overwhelming expressions of public support for transplantation. Ongoing legislative review in the UK provides an ideal chance to alter the default position to one where potential donors can simply acquiesce or opt out of donation. Combined with consultation with their relatives, this could be a much better method of realising individuals’ wishes. It would also achieve a better balance between the duties owed to the deceased and those owed to people awaiting a transplant.