Directed and Conditional Deceased Donor Organ Donations: Laws and Misconceptions

The Human Tissue Act 2004 (hereafter the 2004 Act), which (inter alia) consolidated the law on organ donation and repealed earlier legislation, came into effect in England, Wales, and Northern Ireland on 1 September 2006.1 The Human Tissue Authority (HTA),2 the regulatory body established by the 2004 Act, and the NHS Blood and Transplant Organ Donation and Transplantation Directorate (NHSBT ODT), formerly known as UK Transplant (UKT),3 the national organ allocation body, continue to follow a long-established policy of accepting deceased donor organ donations only on an undirected, or ‘unconditional’ basis.4 The ‘central principle’ of organ allocation from deceased donors is that they must go to the person who is most in need and has the best match with the donor—a donor can neither direct the organ to a specific recipient nor impose conditions as to who shall be chosen; all such restrictions may be ignored as invalid.5 This policy did not come into being with the 2004 Act, but had already been generally adhered to in the case of deceased organ donations, since about the time of the Human Tissue Act 1961 (repealed by the 2004 Act). Although it does not appear to have been clearly expressed until relatively recently, it has been widely applied, with almost universal support of organ donation and transplant centres (at least as far as the exchange of organs between centres is concerned) and is usually regarded as legally binding.6 The ethical basis underpinning deceased organ donation allocation is one of impartial justice. It is in this context that issues of fairness and efficiency in allocation arise.7 Some have remarked that organs are public resources to be distributed by relevant agencies on behalf of the state.8 Consequentialists, who believe that an action should be judged in terms of the consequences that follow from it, and will support whatever action has the greatest benefit for the greatest number,9 may provide us with good and prudential reasons for supporting a system of organ donation in which organs from the deceased are considered public goods automatically available for transplantation, directly imported into an impartial equitable system of organ allocation.10 Any refusal to donate costs lives and it is undoubtedly the case that thousands of individuals have needlessly died an untimely death waiting for a transplant.11 But if we endorse the consequentialist position and consider that deceased donor organs are a public resource or community ‘property’ to be allocated according to agreed jurisdictional policies, then we must be able to provide an explanation as to from where such dispositional authority and property rights are derived. Moreover, the concept of human body parts as property requires a consideration of what this may imply for individual donor ownership, as well as for both directed and conditional donation.12 In marked contrast, the rationale underpinning living organ donation is donor autonomy and respect for an individual's wishes and informed decision. At their outset, living donor transplant programmes emphasised specifically directed donation. An individual was entitled to donate to another individual in whom he, or she, had a special interest, a brother say. Kluge, for instance, argued that donations by living persons ‘create and sustain intimate personal relationships’ and, in particular, family ties, and constitute exceptions to the general rules of impartial allocation.13 Non-directed donation was to some extent mistrusted as it did not involve the personal bond considered necessary to overcome the reluctance of doctors to inflict surgical injury on one person for the benefit of another. As late as 1986, the UK medical opinion regarded all living donation as justifiable only in exceptional circumstances.14 However, the increasingly good outcome of living donor transplantation, not only to close genetic relatives but also to unrelated recipients,15 combined with the ever-increasing demand for organs, made living donor organ transplantation an altogether more attractive model and enhanced its ethical acceptability. In the UK, it remains the case that most living donations are directed.16 They usually involve a healthy person donating an organ (often a kidney) or part organ (for example, the liver or lung lobe) to a specific recipient who is related to the donor either genetically or emotionally.17 Although now regulated by section 33 of the 2004 Act, directed donations between close family members, including spouses, are always lawful, provided that the HTA is satisfied that no element of reward or coercion exists—they currently account for over one-third of all annual kidney transplants.18 Thus, so it seems, two parallel have and are in with an impartial rationale deceased donation and a rationale underpinning living donation. This is in The is it is by in the UK the 2004 Act, to HTA the established such donations are not to be organs are allocated to the most waiting on the national transplant The of and into the of the deceased donor allocation requires that the of impartial and the the dispositional of individual and are also to HTA In this instance, donors and are in or and in a or donor organs are then allocated or between in such a as to the also In and the are not to be In in most not of or the transplant recipient is to the and living donor in the as a of the of donor organs for and of the of a living donor to donate a kidney to a recipient a to the of Non-directed and living donor in the UK by of section of the 2004 made it, this general of living donation does not where the HTA is satisfied that no reward has or is to and that conditions in the are of which or It has been that the 2004 Act the law to in in they have been the Human Organ Transplant Act (hereafter the Act), which living donation. was almost to that of the 2004 Act and either in the or in its to only and coercion specifically the of the Act, the Authority the for of This was but not In we consider that and to its authority in this and as a on a relatively for individual in In the ethical which in are by the regulatory authority to both deceased and living donor transplantation, and and or living donor transplant we can that is in the so it seems, the is as Although we are to for or not we to be organ donors in the that we we to to or a if this is a person with whom we have a personal or donation into the of public resource and impartial is the donation can on the we are we we may then direct donation to a person with whom we a of some or another. In provided living donation in the context of a we can have donation directed on behalf to a and in we will the benefit of the person with whom we have a a living donation is not in the context of a of some or we direct the donation to a but must an of living donations are directed or living donor is not to donation but the of an individual who wishes to a deceased must the of the regulatory body we consider that are two allocation in parallel the can be so and conditional donations the model of deceased donor organ allocation on and impartial in a and that for such restrictions will the that organs from deceased donors should be distributed according to a system of impartial and with an with the greatest medical in specific But if we continue to to a model of or both in the 2004 Act and the Human Tissue Act as the basis which deceased donor organs available for transplantation, then we must provide good as to such does not for the of individual deceased donors restrictions or conditions such their In particular, if the context of a such and, as appear to be the to the of should deceased donations, to family not also be unrelated and related living donors have some of their as all living donations now by a body to the of reward or This was about the and of organ being in the UK since In the case of deceased the 2004 Act now requires that must be established in all of organ for the of which to earlier In both living and deceased donation now always the of a The of regulatory is that they donation the and to some extent The is that if they have the to donations, either by law or in if in the the law by their ethical the which the law In this we that the of the ‘central principle’ of deceased donor organ donation as legally or close to legally as an is such a and to not only that directed and conditional deceased donor organ donations are not but also that to an individual's to a a may in law with the of considered by to be the and of the 2004 Moreover, we that organs as they may a of for transplant and the HTA Although the HTA is to an policy for the of organs this body has no over deceased organ Thus, so it seems, both directed and conditional deceased donor organ donations may be its provided that they with the 2004 Act and are not for The between individual and public benefit was to the in the of which a for an of the between ethical regulatory and the law of organ donation. In of an directed deceased donor organ donation between close to The a had to donate one of to who had and was that time on However, the time of had not the of a the to the HTA an its was The of and organs from the it that they are allocated to the person on the waiting who is most in need and who is the best with the This is of or In with this a person to whom their organ can be they nor can their However, the HTA that may be exceptional where this be but the of the that such exceptional need to be considered with the greatest part of the rules to be In the case the to direct donation of one of the to was not and the organs distributed according to the Although may have the of with the of the donor in the it if have been This about the of deceased donations the 2004 In as a policy on of a was most is to and the two of and equitable for all on to the the in which a for specific allocation may be the death of an living donor and exceptional in which an organ from a deceased donor benefit a close family or of the policy is to which is as to may be or on the of The need for with the the of the UK, and by of the of organ donation is specifically An with available for all is also Although the policy does some of for in such as that of the law and policy and its of all deceased donations must be restrictions to donations may be and the donations as all deceased donations in the UK must be allocated UK now the national allocation body, in with the of the The both and is the law as as the HTA In a of the of organ donation law on all its It will be that the 2004 Act does not conditional or directed deceased donations, but to for in its of will that the of an organ to the terms of a is an section of the 2004 will that the HTA has no to the of the authority is to will that is no law that requires organs to be distributed only In with or conditions or they may be the of the 2004 Act, provided that they are The HTA has no to such of donation is lawful, but only to an It is entitled to conditional donations, but not to or the 2004 The has been that the human body be a At it is well established that can be no property in a This that a body or body parts generally be This has come in as a of and and In the of that body parts that instance, the of property for the of section of the Act if had been on to law does not It may be that on some the the will that human body parts are of being property for the of section the of if they have a or their This may be so for example, they are for in an organ transplant This the that the of a donor organ in be as it may be that only the of to the has that from being already by the In the of body parts as was to be a of to as It is to the not be to organs for have been to to for not only surgical and with and but also the of recipient by of and of in to the considered by the in to property in body In the of an organ being from for the of organ it that the be of in the as the in the case if an organ allocation body a organ from the of a it to be to some transplantation into a the be for not only the 2004 Act, but also the The of in NHS a case which had been made by a law of property rights in by that a more from the In the of its on the concept for the of for the rights over the of that case living persons and the to imply that if the of human has whatever the position as for transplant also be of being considered as that one that such in from the to in the 2004 This be section of the 2004 Act transplantation for section also which is the of property of an of human But this and property with can and which one may not it does not from the of that is in nor that it can be to all the context of organ donation and However, the and and this a and as to the of human which can only be by The concept of a body part as property has been directly considered in the of organ donation. In this it as far as the law is that of an organ is not a but a to the of organ and Although it is not to of a donation or no of law the transplantation of organs into if this is with the of the to of the the personal the transplantation of a body part or to or has to to in the earlier of transplantation more and had to the that the of human to a body part be able to some of property The of the Human Tissue Act 1961 (hereafter the 1961 was to the of organ donation with the or of from the donor their It has been that it did not conditional However, section that the death part as the case may the be to be in with the This does not conditions or In section in this section shall be as or with part the body of a deceased person which is from this Thus, if conditional and directed donations not they not the 1961 or not the 1961 Act for the of conditions and it no specific for and so to the general of ‘unconditional’ donation a of and ethical which it was that a deceased donor have been of person who be as a the of close and, of allocation made it to to the or national and and to an already and the concept of organ donation as a to was in with the of the It had public In a case of conditional deceased organ donation public and to The which of allocation to the organ allocation being as to its policy of donation. the then of for made an to the effect that conditional donation was by a with the of the Transplantation that must not be if conditions about the recipient are The of a into Organ in Although most of its the it did on of the to The of the of conditional donations of the that the policy of donation should now be it that to all conditions and not of a and that the should be to what the law requires in this The Human Tissue Act 1961 not conditional the donor to a part of or body being for donation or they is no on a donor to the of their organs or the reasons for to if by the must be and the organ for the most of since may be a of the Act But an organ has been with a the that that the be into effect does not the to donate for the of the 1961 The organ can be The the that all deceased conditional donations must be some of the that is no to donate organs to the NHS UK In particular, as in the 1961 Act conditional donations and the to conditions was not an effect of that Act, but a of its of In the to account of the that the UK was then remains or a of to their deceased organ donation policies, provided that the general law was the 1961 Act, as this was not In the the 2004 Act, it was for conditional or directed kidney donations to be if and policy it, as the national to one kidney for their specific conditions or be the general law has been in the case be a donation for to such a and can be The in the case to a as to the However, the position may be more the organ allocation body was to the donation as its the Act did in to by public by the Act In section of the Act shall persons of a to or to the special of persons of that in to their or allocation policy currently to with and The is that to a donation such combined with a of to deceased donor transplantation is This of is by section of the it may be either by section or by the that it is justifiable of However, if this is lawful, it is a donation in of or should not also be the position to the 2004 Act, the of the organ allocation body, by the of individual to by its policies, the of conditions the the of the 1961 Act, by for the of the and allocation authority for conditional donations, and the of in the combined to the of the of the into Donation of they They the policy of the allocation body, but no support from either law or The policy the conditional and directed donations and such donations be allocated as if the restrictions did not In the allocation body, the Transplant a Authority in was by an to organ in policy or law but a in the of all donations was about to The 2004 Act, which and earlier the Organ donation now The relevant rules are as conditional or directed deceased are policy is remains to conditional or directed is no for organs to be allocated according to provided that they not the terms of the 2004 The most from the of the of to the policy of conditions and in of The 2004 Act for to be The 2004 Act general one of which is are only if with are now regulatory body, the has been to and the of the of for as the and extent of It is to the of since may be for section of the 2004 is made between for the of and that for organ donation. in is the 2004 we will only the position of a deceased donor who had been to or in the of in the person died if a of to to the or a of not to to it, was in can if to the of for it need not be to a a person their a can only be for into a general and a general to specific It may be argued that in section of the 2004 Act must be in the of in with the of the HTA and ODT), must have been to that restrictions on deceased donations should be and this does not The of is that the of to be from the which it has and are to be according to their and An of which restrictions is in such a The is that the 2004 Act is on conditional and directed deceased and be so as to appear to provide for this the is not to law rights by or necessary At a the that or conditions will be to as it is in not in and so may be to have been The of the need for to be informed if it is to be The from this of is but a has been to specific it that allocation of organs to such that and to with the organs Although it that organ remains to such donations as to its allocation is not to the donation the The of the into Donation in can no be with the on the directed donation so be an section of the It has been argued already that conditional and directed donations have been as they are not by if a to be the it does not follow that it then be for the of to donation. the it to the the of as a In the and organs a of persons and to section of the 2004 The directly in the donation and transplantation are However, is always a the terms of section which requires a a This that a person will not be if that does the with Although all persons are to be of the the that the in good on the of both the donations by and the policy of the HTA to in is the not directly section is by section which person an if to a person whom or is or an that is to the of the or that the is not one to which the and that the is or does not believe it to be The is the HTA It is a and both the of the general that it should be and the of and for in organ donation and of if a is its of it as for the of section it, on its but of the law in that as a In opinion it the and are by their on its which they as the HTA has no such and of the law more Although we have no to it we that the in its policy if into effect in a case of directed deceased the the regulatory authority It may be argued that in the the HTA did in the should be as to to with a more general to donation if that should However, such an need to have been and not be in the of what In the its to continue such conditions for the time it of in a was by in with respect to the donation of that a between conditions to a which part of it and not be from it, and conditions being as an to a which was already should be Although this to be a to an that does not with the rules of The policy of a requires in it is that family should can be considered in donation must be conditional on the allocation This an on the to the donation a by not to the of an appear to be But as more in of of the the family in the only it that it has no its be by this and as a to the of the ‘unconditional’ policy if not in directed and conditional donations in if it is an the 2004 Act to is no to effect to and, in to its will not As a donations will not This have a if with allocation an or to as in the where the Organ Transplant Act to with the of the Organ and Transplant may to from the and as well as to But in the UK, as already deceased donations to appear to no they the of the it be for transplant to in and effect to an directed or conditional donation on its a and for the This not the of for the of donations by their is It only be to in in which the ‘unconditional’ policy of and the HTA with an on the part of the It is to that in the with is its of are combined with to allocation The of that in this section shall the allocation of an organ to a recipient by to the In the Organ from to which provide the authority for deceased organ also donations to be made to specific The is that if the donation to be the organ is to be allocated according to Thus, the law an for personal autonomy an of impartial justice. The appear to provide for a of to that which the in its on the to consider for only it not by the that it is not so and already that is also to that public opinion in the UK not be to its in The of the 2004 Act have As it does not conditional or directed donations, and are not it be for donors to national allocation policy by their organs to be only in their or NHS Although to a the system of close it well public for instance, organ donor and to conditions or have to be by both and transplant or on of the legally but and the that the organs be the donor death had agreed that should have be a of the concept of property in organs, as already the national allocation of an organ by the authority in of a for or allocation the of its being for The by of the of conditional and directed donations has come about as is no that such a can that are a of In of the of all it remains that the HTA should be so about the and of its authority that it the of its its the best explanation is that the of of in this of NHS in in the between law and In the authority of the NHS may as a to if But have also about one the ethical for or conditions and to deceased donations, be As as the of and as the basis which deceased donor organs available for transplantation, they must be account of in the of Moreover, they are not is no they should not be into in if This to with some public opinion and does not to be to the in a the is for it that the of into the of organ donation and transplantation has been by a of and that who the transplant not their It has not been the 2004 In particular, the of the law that or had been on the of donation and the of It was not for example, that since conditional or directed was not it must be The of the Human Tissue Act 1961 and its of for to a policy of donation which was but to the in the of law donation to individual to follow donation The by the the donation consideration of donations in some be The and of such donations that was to The of the into Donation had the to the but it in of the NHS policy as if it established The to the of in both organ donation and had the of support for the concept that for deceased organ donation need not be The of to the of the NHS and its has of their which to be are not satisfied with their This legally of both in the of to its authority the Act and in the of the HTA the