As with all other aspects of medicine, legal considerations impact on the clinical practice of solid organ transplantation. In most countries, there are laws relating to specific areas of transplantation, examples include the regulation of living donation, outlawing of paid donation and of transplant tourism, even though there remains an ethical debate on these issues. Such laws must be seen within the context of the international declarations drawn up by the World Health Organization Guiding Principles and the World Health Assembly Resolutions (1) to which many countries are signatories.
Given that the great majority of transplants are life-saving procedures and there is a shortage of organs, it is essential that policies on selection (that is who gets on to the transplant list) and allocation (who gets a donated organ) are developed and published. In developing such policies, many jurisdictions have accepted that organs donated from deceased donors should be considered a national resource and not “owned” by the local or retrieval team so these rules must be applied nationally.
Transplant teams work to common standards to minimize the risks of geographical inequity. In this context, geographic is used to imply a political administrative boundary rather than one constrained by geophysical limits. There may lead to some arbitrary variation. The United Kingdom consists of four nations (England, Scotland, Wales, and Northern Ireland), and thus, an organ donated by a deceased donor in England may be allocated to a recipient in one of the other four nations of the United Kingdom but would not be offered preferentially to a recipient from the same region of England as the donor. Similarly, an organ would not be offered to a recipient in continental Europe unless there was no suitable recipient in United Kingdom, even though the need of the recipient in continental Europe may be greater and the transport time (as a reflection of cold ischemic time) shorter. The recent European Union (EU) Directive on Transplantation (2) will facilitate transport of organs between member states and ensure that minimum standards of quality are met. However, the issue of nonresidency continues to trouble the allocation process, whereas transplant tourism is not acceptable (3), the right of potential recipients to move within jurisdictions remains controversial and variation exists within the EU (4). Different administrations have different rules allowing access to transplantation for nonresidents and nonnationals. We are aware of potential legal challenges to some of the current rulings but whether appeals under Human Rights legislation would be successful remains to be tested.
Virtually all Transplant Units make decisions on listing at multidisciplinary team meetings but membership and formats vary. Although healthcare clinicians may assume the role of the patient's advocate at these meetings, there is not always an advocate for the other potential recipients competing for that organ. Furthermore, in the courts at least, the advocate does not make the decision—that is left to other independent parties. The obligation and responsibility of the surgeon to act in the best interest of the patient is, rightly in our view, a key component of the selection and allocation process. Yet, because of the limited availability of life-saving grafts, the surgeon may well have more than one suitable recipient with similar need and, whereas there are more than one suitable recipients under the care of other surgeons, the rules of selection and allocation must be applied to all potential recipients and so limit the surgeon's autonomy.
As patients become more aware of their rights, legal challenges to selection and allocation policies are likely to become more common, although this is still relatively infrequent. On this basis, NHS Blood and Transplant, the UK body charged with supervising the selection and allocation of organs and tissues from deceased donors, sought a legal review of our policies. The review raised a number of issues: clinicians and others have reacted with mixed emotions but clinicians do have to follow the law even though they may feel that this is counter to their ethical and professional view.
Compliance with legal requirements has been unexpectedly problematic and legal requirements may clash with both current clinical practice and public opinion. For example, most allocation systems (both in United Kingdom and elsewhere) prioritize children over adults (5–7). This approach accords with public opinion (8,9,10). There may be excellent clinical reasons for such a course of action but age discrimination legislation does not allow giving priority or disadvantage to be given to a potential candidate solely because of age. To introduce age as a criterion in policy making it must be a proportionate means of achieving a legitimate aim and capable of objective justification. Of course, there are several clinical reasons why children may receive priority, such as the beneficial impact of transplantation on growth or psychological; development or lack of vascular access. In the case of growth, criteria should prioritize not children per se, but those with growth retardation. Thus, Eurotransplant (6) recommend a radiological examination of the hand to confirm growth is continuing if the child is older than 16 years. Similarly, if there is a justification to prioritize because of size, this does not necessarily mean only children. Any preferential treatment based on size might also apply equally to small adults.
At the other end of life, there is evidence that older recipients have a lower survival; thus, it may be legally acceptable to exclude older candidates, not because of their age but because of a clinically demonstrable lower survival benefit. However, this may not necessarily justify a specific age cutoff but point to the need for further factors to be taken into account when considering transplantation for patients over a specific age.
In reviewing any criterion for selection and allocation, it is important to consider the potential impact strict compliance may have. For example, any cutoff, such as weight, can lead to apparently arbitrary decisions, in that a small change in weight, whereas clinically meaningless, could lead to dramatic change in the chance of getting a graft or dying. However, such apparent irrational consequences are not uncommon in law, one day may make the difference whether an individual can legally buy alcoholic beverages, vote, or drive a car. To avoid anarchy, we need such rules in society but the law is increasingly asking questions about the fairness of applying such strict rules to the allocation of limited resources.
Another issue relates to behavior or illness that might affect the outcome of transplantation. If all parts of the Equality Act in the United Kingdom are implemented this will mean that most public bodies must work to reduce inequalities of outcome which is reinforced by the current Health and Social Care Bill. Thus, it may be legitimate to exclude a potential candidate from listing if their lifestyle means they will not comply with treatment and follow-up to the extent that there is a high risk that the graft will be lost but only if this will happen despite full support and the team making such a decision can demonstrate that there is robust evidence to support their conclusions. Similar considerations apply to those with mental illness, exclusion may be acceptable only if the illness would significantly affect graft survival despite full treatment.
Some allocation systems adopt a payback scheme, whereby a center (or sometimes a country) which provides an organ to another center or country for a “high priority” recipient will be paid back when another organ becomes available. Where this is center based, the rationale is to ensure that there is no “gaming” or manipulation of the system to the advantage of one individual but also to ensure that activities of smaller centers are retained. Where payback is between countries, this is, at least in part, to ensure that public confidence in the donation process is maintained. Center-based payback is open to legal scrutiny as the interests of the center should not take precedence over those of the patients, particularly when modern information systems enable a national register and system to be operated.
Transparency is essential so that clinicians can justify their actions, where there is a national allocation scheme, clinicians, or national bodies must record the reason for refusal, where there is a center-based allocation scheme, the national body needs to have validated criteria for allocation and the local center needs to have a clear audit trail to justify not only why one patient was selected but also why others were not. National bodies, responsible for developing, implementing and policing selection and allocation policies, must comply with the legal requirements and may be challenged in the courts and, if the policies have not been developed with due process or are contrary to the law, will be required to change them. These policies are drawn up over time and after consultation with all interested parties. In contrast, the clinician may have to make decisions in a short period of time and perhaps without knowing all the relevant data, nonetheless, the clinician remains accountable both to the Courts and to their professional bodies and, if the clinician has behaved inappropriately, may be penalized. There is no reason to believe that, as in other instances, common sense will not allow sensible interpretation of the legal obligations in light of the clinical scenario.
Another concern, as yet untested in the United Kingdom, is whether donated organs are considered as products, thus placing a liability on transplant authorities for the safety of the organ. This could be disastrous because all organs carry a risk to the donor, screening will minimize the risks but not abolish it. Product liability could put an unacceptable financial and administrative burden on transplant agencies and local transplant centers and clinicians. Based on this review, we suggest that selection and allocation policies should meet the minimal criteria:
- The aims and principles of both selection and allocation should be clearly documented. There are many different approaches to developing selection and allocation policies. Patients could be listed because they would benefit from a transplant, in which case the list would be much greater than if selection criteria were restricted to ensure that those who were listed had a realistic chance of being offered a transplant. The principles of allocation may place different emphasis on equity, utility, benefit and justice or be focused on reducing mortality on the list. Many of these terms are not easily defined, for example, equity may imply that a 95-year old with advanced cardiovascular disease has the same chance of being offered a graft as a 21-year old or that a person in the north of the country will be given the chance of being listed and grafted as someone in the south, that everyone on the list has the same chance of getting a graft or dying on the list or that those with similar risks will be treated the same. The principles will be likely to vary between organs and between countries, depending on current opinion, the availability and characteristics of donated organs and the requirements of allocation system.
- Evidence based: although it is ideal that all policies should be evidence-based and that evidence provided, it is clear that in many areas, there is not always such evidence base. Where policies rely on current expert opinion, this should be stated and kept under review.
- Transparency of implementation: it should be clear how policies are implemented and there should be a clear audit trail. This is particularly important where there is local allocation.
- Clarity: although the selection and allocation policies are designed primarily for practical use by healthcare professional, they should be written in a form that is readily understandable by patients and their families, donors and their families, and the public in general.
- Compliance with legal requirements: although different administrations will have their own legal framework, most European countries have legislation aimed at eliminating discrimination, this will cover age, gender, ethnicity, physical and psychological disability, sexual orientation, and religion.
Other recommended criteria are listed in the Table 1. In summary, those drawing up and implementing guidelines for selection and allocation must be mindful of legal requirements. Although compliance with legal obligations must take priority over clinical judgment, it is usually possible to develop procedures that are legally robust but clinically relevant. The law and medicine must work together and should be capable of working together in the best interests of all patients.
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2. European Union, Directive 2010/53/EU.
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