Select Committee on European Union Seventeenth Report


CHAPTER 8: ALTERNATIVE FORMS FOR DONOR CONSENT

Consent to organ donation and the EU

264.  Dr Fernandez-Zincke, of the European Commission, made clear that the issue of consent to organ donation was not one on which the Commission intended to legislate or lay down guidelines. He stated, "It is not the intention of the Commission to say how consent should be organised in the different Member States but, as we have done with the Tissue and Cells Directive, it is important to stress the need for consent, however the Member States organise this consent" (Q 24).

265.  Dr Fernandez-Zincke emphasised, "I think Member States should choose the preferable options that they consider are more appropriate for their own societies, let us say. It is not something that will be coming from the European Union" (Q 26).

266.  Nevertheless, the issue of consent is inextricably linked with the issue of the cooperation among Member States on an action plan to help raise the level of organ donation rates across the EU, which forms a key element of the Commission's proposals (see chapter 5). It is only by sharing experiences between Member States that it is possible to assess how different forms of consent, in combination with different forms of organisation of donation services, may affect donation rates.

267.  In order to understand properly the arguments put forward by witnesses about the value of cooperation across the EU on matters related to organ donation, we therefore needed to take evidence about donor consent in the UK.

Consent to organ donation in the UK

268.  The present system for consent in the UK is often referred to as "explicit consent". This term describes an "opting-in" system for consenting to donate organs, under which a person expresses a clear wish to donate organs after death, often by joining an organ donation register or by carrying a signed donor card.

269.  There has been some discussion about a future switch in the UK to a different system for consent known as "presumed consent". This term describes an "opting-out" model for consent, under which all citizens are presumed to be willing to donate organs after death unless they actively register a wish not to do so.

270.  In England and Wales and Northern Ireland, consent to organ donation is governed by the Human Tissue Act 2004[41], which covers both living and post mortem donation. In Scotland the Human Tissue (Scotland) Act 2006 is the relevant legislation which, as Mr Peter Lemmey of the Human Tissue Authority (HTA) pointed out, contains one or two differences including the replacement of "consent" with "authorisation" (Q 366). Mr Lemmey stressed, however, that "consistency of approach across the UK has been the watchword" (Q 366).

271.  In regulating organ donation, Mr Lemmey believed that the HTA was guided by three important factors (Q 368):

  • The ethical principles which underlie the 2004 Act, i.e. ideas of the degree of individual autonomy, the primacy of consent in the process, the importance of consent being properly informed, no trafficking and no coercion;
  • The key principles promulgated by the Better Regulation Commission i.e. accountability, proportionality, being targeted and transparent; and,
  • The need to support the Secretary of State for Health's objective to maximise transplantation rates, without compromising on the HTA's remit to regulate the process according to the 2004 Act.

272.  Many witnesses were clear that consent should be explicit, with Patient Concern, for example, rejecting presumed consent as "no consent at all" (pp 46-48). Professor David Price, a medical lawyer, argued that explicit consent—obtained either by the person adding his or her name to the relevant organ donor register or by signing an organ donor card—could provide the best unambiguous evidence that a person wanted and had decided to donate (pp 234-236).

273.  However, Professor Price went on to say that explicit consent could only be effective if the wishes of the now deceased person had been reliably and directly recorded or, at a minimum, had been conveyed to the relatives who would have decision-making power at the time of death. Where this was not the case, he suggested that the family would usually have to rely on guesswork about the deceased's wishes, which would weaken the system (pp 234-236).

UK donor cards and the Organ Donor Register

274.  UK citizens can register their willingness to donate an organ after their death by joining the Organ Donation Register (ODR), by carrying a donor card or by making any other form of advance statement that would be recognised under the terms of the Mental Capacity Act 2005. Mr Chris Rudge, Managing Director of UK Transplant, reported that there is "seemingly, a very high degree of public support for donation—90% of the population we are told support the principle—but in practice only 25% of the population are on the Organ Donor Register" (Q 101). He expressed his regret that there was only a limited budget available to UK Transplant for promoting the register (Q 107).

275.  Views on the effectiveness and significance of carrying a donor card or registering with the ODR differed. Patient Concern thought they were little known to the general public. They cited the Bishop of Southwark who "speaking on Thought for the Day on BBC Radio 4 related his difficulties in replacing a lost donor card, when he was told by various agencies that they 'hadn't seen one for years'". Patient Concern added, "That is our experience too" (pp 63-66).

276.  However, Dr Paul Murphy, an experienced intensive care doctor who dealt regularly with the families of donors, felt that the donor card was an important and direct means for the family and clinician to share an understanding of a potential donor's consent. He thought, moreover, that "serious consideration should be given to extending the electronic opportunities to register, particularly given the increasing access of the population to on-line services such as Amazon, eBay, YouTube etc." (pp 111-113).

277.  There was further support among patient groups for working to enhance the donor card system. The Patient Liaison Group of the Royal College of Surgeons, for example, said that "Information held must be accurate and easily accessed—time is of the essence. The national register seems a good idea for the public and clinicians when in urgent need of a donor" (pp 48-52).

278.  The Royal College of Physicians was keen that other options than the use of a donor card should be explored. They took the view that "The success in increasing donor card registrations from the Boots Advantage Card scheme[42] suggested that similar approaches through banks or other commercial bodies might also be considered." (pp 239-242).

279.  Dr Tracy Long, Southampton University, took the view that there was something to be learnt from how other EU Member States managed donor registration. She explained that, in the Netherlands, where they have 40% of the population on the donor register, the register provided for three options: agreement to donate organs; disagreement; or decision to be left to a relative. She said that it was thought that the possibility of choosing from these three options encouraged individuals to register, because they knew that their wishes would be clear (Q 206).

The role of the family

280.  Under the 2004 Act, "appropriate consent" to donate organs is considered to have come from a deceased person if the person had given explicit consent, by registering as an organ donor or by carrying a signed donor card. If no prior consent had been given, the consent of a representative nominated before death by the deceased person is acceptable. If no such nomination had been made, people who had a "qualifying relationship" with the deceased would be eligible under the Act to consent on behalf of the deceased.[43]

281.  The HTA Code of Practice relating to consent under the Act ranks such eligible relatives in order of the closeness of their relationship for the purpose of authorising donation ranging from a spouse or partner (including civil or same sex partner); parent or child; brother or sister and other relatives to a friend of long standing (see Box 3). This enables specialist healthcare professionals seeking permission for donation to know whom they should approach and in what order.

BOX 3

Qualifying relationships for giving consent to organ donation
If the deceased person has not indicated their consent (or refusal) to post mortem removal, storage or use of their body or tissue for scheduled purposes, nor appointed a nominated representative (or the nomination has been disregarded in accordance with paragraph 52), then the appropriate consent can be given by someone in a 'qualifying relationship' to the deceased immediately before their death. Those in a qualifying relationship to the deceased person are (highest first):

(a)  spouse or partner (including civil or same sex partner)

(b)  parent or child (in this context a 'child' can be any age)

(c)  brother or sister

(d)  grandparent or grandchild

(e)  niece or nephew

(f)  stepfather or stepmother

(g)  half-brother or half-sister

(h)  friend of long standing.

Source: Human Tissue Authority: Code of Practice—Consent, para 53. 1 July 2006

282.  In cases where no explicit statement regarding a willingness to donate was available, the UK Transplant's Potential Donor Audit[44] recorded that the family refusal rate within the UK was 40% in relation to donations from brain-stem dead potential donors across the general population. Within specific population sub-groups, the refusal rate was as high as 75%[45].

283.  Despite the fact that families would often object to donation, even in cases where their relative had carried a card or signed the organ donation register, there was little support for excluding the family completely from the consent process. The Cystic Fibrosis Trust said that they would "have grave reservations about taking organs from a brain dead patient if their family is vehemently opposed to this process. We feel it would be counter-productive and would cause considerable ill will, which is likely to harm the transplant programme more than it will help it" (pp 212-213).

284.  The British Medical Association (BMA) agreed that donation against the strongly expressed views of the relatives could be disadvantageous. They explained that the changes introduced in the Human Tissue Act 2004 and the Human Tissue (Scotland) Act 2006 clarified that, when an individual had given prior consent to donation, there was no legal right of veto by the relatives. However, quite rightly in the BTA's view, the legislation was permissive and did not require donation to proceed. As a result, there could be exceptional cases, if relatives had strong and sustained objections, when donation would not proceed, despite consent having been obtained from the potential donor (pp 165-169).

285.  The Scottish Council on Human Bioethics (SCHB) considered it crucial that organs or tissue should only be removed from a deceased person if this person had given his or her prior informed consent to the procedure. Their view was that for the next of kin to authorise the retrieval of organs, when an individual had left no wishes, should not be possible in an "opting in" i.e. informed consent system (pp 246-250).

"Ownership" of a deceased body

286.  In discussing the issue of posthumous donation, the Committee sought evidence to answer the question of who, if anyone, owned a body after death.

287.  Mr Peter Lemmey reported that the 2004 Human Tissue Act had been set up to operate without needing to establish ownership of the body. He went on to state the view that this omission was consistent with the position in common law. "Our view (I imagine widely shared) is that, as there is no statute, the position is as established in common law. Halsbury's Laws of England [which is a definitive encyclopedic treatise on the laws of England] states that, 'It is said that the law recognises no property in a dead body ...'" (pp 160-161).

Living donation

288.  For living donations, Mr Lemmey explained that the 2004 Act required that "the consent be properly informed, that it is clear and that the risks have been explained to both the donor of the organ—the donor of a kidney perhaps—and the recipient, and that it is clear as far as we can be that there has been no coercion of the donor and that there has been no payment" (Q 359). Mr Lemmey went on to say that in 2006-07 the authority had approved 690 recommendations for live donation (Q 361).

Presumed consent

289.  In September 2007, the Organ Donation Taskforce was requested by the Secretary of State for Health to explore the issue of presumed consent. The Department of Health Press Release[46] which announced the study, stated, "The proposal, known as presumed consent, would view everybody as a potential donor unless they had registered an objection or 'opted out' before death. The Taskforce will examine 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". We understand that the Taskforce report will be published in summer 2008, so there was no opportunity to take account of its findings in our inquiry.

290.  The Chief Medical Officer for England, Sir Liam Donaldson, argued in his 2006 Annual Report[47] that a significant increase in the size of the pool of potentially available organs and tissues would occur if all citizens were to be registered on the NHS Organ Donor Register, i.e. if a system of presumed consent were to be introduced. He acknowledged that such an approach might be viewed by some as totalitarian, but argued that, as long as the option to opt out from the system was both available and easily accessible, and strict measures were applied to protect vulnerable groups, the experience of other countries showed that such a system could command public confidence.

291.  Referring to the acceptability of a switch to a presumed consent system, Sir Liam stated, "I think quite a lot of people in the transplant field—although not all—are in favour. I think the majority of public opinion—but not the wholesale majority of public opinion—is in favour" (Q 53). He thought that it would be possible to enhance the acceptability of the system through public education and other measures. "I think there are things that could be done to increase the acceptability. That would largely be about educating and informing the public and making absolutely sure that every opportunity was taken to make people aware of their right to opt out" (Q 58).

292.  The British Humanist Association agreed that the current "opt-in" system had contributed to the present shortage of organs and was therefore the cause of many preventable deaths every year. They therefore fully supported the replacement of the present system with one of presumed consent (pp 207-209).

293.  The BMA also supported Sir Liam's point of view and told us that they had campaigned for many years to move the UK to a system of presumed consent. Dr Tony Calland, Chair of the BMA Ethics Committee, made their position clear. "In simple terms we are supportive of what might be called 'soft presumed consent', but before we would support that we would need there to be a very clear publicity campaign so that … what is meant by presumed consent is much better understood by the general public" (Q 398).

294.  The BMA described the term "soft presumed consent" to mean a presumed consent system under which the relatives of a deceased potential donor would be consulted, and donation would not take place if "it became evident that to do so would cause severe distress to those close to the deceased patient" (pp 165-169).

295.  The Royal College of Physicians had considerable doubts about the "soft presumed consent" system advocated by the BMA. They stated, "Our understanding is that many practitioners approaching a bereaved family already introduce discussion of organ retrieval by inquiring if the family members are aware of objection, rather than of positive wishes to donate. The BMA proposal has little to offer beyond that and the public debate needed to achieve it could easily backfire with reduced donations" (pp 239-242).

296.  The Scottish Council on Human Bioethics (SCHB) believed that the Human Tissue (Scotland) Act 2006 created an unsatisfactory hybrid system somewhere between "opt in" and "soft opt out". People could opt-in by registering their wish to donate a number of organs before death on the NHS Organ Donor Registry or by carrying an organ donor card. But, when no prior wishes of the deceased person were known, the Act stated[48] that relatives could accept the presumed consent of a deceased person to the removal of organs when they had no "actual knowledge that the adult was unwilling for any part of the adult's body … to be used for transplantation." The SHCB went on to state the view that, "The absence of fail-safe mechanisms to allow people to record their wishes, be they positive or negative, in the Act is a cause of concern" (pp 246-250).

297.  Several patient groups supported a change to presumed consent in the belief that this would increase the supply of organs. Mr Roy Thomas, Executive Chair of the Kidney Wales Foundation, supported it unreservedly and said they had been lobbying for it for some years (Q 166). Their view was that "Even with improved conventional donation rates the case for presumed consent remains a strong one to vastly increase the availability of organs to meet growing demand" (pp 43-46). They quoted a paper[49] by Abadie and Gay of Harvard and Chicago Universities which, on the basis of a study of 22 countries which introduced presumed consent systems over a 10 year period, claimed that presumed consent had a positive and sizeable effect on organ donation rates.

298.  The Welsh Kidney Patients Association (pp 251-254) and the British Kidney Patient Association (pp 209-211) also supported a change to a presumed consent system. The National Kidney Federation also favoured presumed consent, but qualified this view as follows, "unless substantial changes are made to the NHS infrastructure to cope with any resulting increase in organs—it will all be wasted" (pp 227-228).

299.  Ms Lesley Bentley, Lay Chair of the Patient Liaison Group of the Royal College of Surgeons, however, thought that a great deal of public education about donation issues would be needed before presumed consent could be acceptable. She felt that "it would be premature to suggest a system of presumed consent before ways had been found of improving the effectiveness of the current system" (Q 161).

300.  Ms Elizabeth Gibb, Trustee of the Jeanette Crizzle Trust, opposed a switch to presumed consent. Based on her experiences with ethnic minorities and "hard-to-reach" groups she stated, "they do not like presumed consent, and if you go down the presumed consent road, my feeling is—and it is a personal feeling—that you could lose a lot more ethnic minorities" (QQ 173,174).

301.  Ms Joyce Robins, writing on behalf of Patient Concern, strongly opposed the idea of presumed consent, stating, "Presumed consent would turn us from volunteers into conscripts—unless we register as conscientious objectors ... Such a system would make the term 'donation' redundant. A donation is something freely gifted, not taken by default" (pp 63-66).

Presumed consent and the organisation of donation services

302.  While Sir Liam Donaldson took the view that the introduction of a presumed consent system should be accompanied by changes in the organisation of donation services, he was confident that the introduction of presumed consent alone would significantly increase the supply of donor organs (QQ 59, 60).

303.  The BMA, however, took a different view on this issue. Dr Calland said, "I do not personally believe that it would dramatically improve the rates, and there is no point improving the rates through presumed consent if you do not have an infrastructure in place to support the numbers if they suddenly came rushing through" (Q 399). Dr Nathanson, also from the BMA, went on to say that the way to introduce a switch to presumed consent should be "Number one, spend the money on getting the infrastructure right so that you can benefit from more donors. Once you have got your infrastructure in place then you move to presumed consent" (Q 408).

304.  Dr Rafael Matesanz, Director of the Spanish Organ Donation Office, argued strongly that organisational changes were much more important for increasing donation rates than presumed consent. "Opting in, opting out in my opinion means nothing" (Q 324). He explained that, although the presumed consent system had been in place since 1979, organ donation rates in Spain had remained low until changes to the organisational structure had started to be made in 1989 (Q 300).

305.  Dr Tracy Long, Southampton University, was not in favour of presumed consent saying, "I would argue that it is unethical to presume someone's consent to such an emotive procedure". Moreover, she agreed with the view that the achievement of relatively high donation rates in Spain had been due to the organisational redesign as opposed to the legal changes permitting presumed consent (Q 204).

306.  Professor Margaret Brazier and Dr Muireann Quigley, Manchester University, took a similar view and argued that it was a fallacy to cite organ donation rates in Spain as a reason for the introduction of presumed consent elsewhere. "Proponents of presumed consent often cite Spain as incontrovertible evidence that it is presumed consent which results in better rates of organ donation … In Spain deceased donation rates did not start to rise for 10 years after the change in the law. It was the introduction of an organisation to coordinate all aspects of donation activity, the Organización Nacional de Trasplantes (ONT), which made the difference" (pp 148-151).

307.  The views of faith groups on the issue of presumed consent are covered in chapter 10.

Conclusions

308.  We welcome the Commission's view that the process by which consent to donation is managed is a matter to be determined by individual Member States, but recognise that cooperation across Member States to share experiences relating to the operation of different forms of consent will prove valuable for developing the systems that best suit each individual country. (paras 264-267)

309.  We understand that the present UK system for indicating explicit consent to be an organ donor has some strong advantages, but we regret that it is so little recognised and used by the public at large. We are persuaded also that it would be valuable to explore the feasibility of using innovative means for expanding the extent of donor registration (paras 268-279).

310.  We understand also the guidelines that are in place in the UK for involving the relatives of a donor, where there are any, in the decision to donate organs; and we consider that securing the support of these relatives forms a key part of the donation process (paras 280-288).

311.  We welcome the work by the Organ Donation Taskforce to study the case for introducing presumed consent in the UK. (para. 289)

312.  Pending the outcome of this study, and on the basis of the evidence we have heard during our inquiry, we do not believe that a convincing case has yet been made for an immediate move to a presumed consent system in the UK. (paras 290-301)

313.  We are persuaded, however, whether or not an eventual move is made to a presumed consent system, that it will be essential first to strengthen the organisation of organ donation services and to raise the level of public awareness and understanding of donation issues. (paras 302-306)

Recommendations

314.  We recommend that the Government's top priority, in seeking to raise UK organ donation rates, should be to implement the re-organisation of organ donation and transplantation services.

315.  We recommend that the Government should enhance the operation of the existing system of donor registration in the UK (which currently operates through a register and donor cards) by raising public awareness and understanding of organ donation issues generally and by targeted campaigns to encourage donor registration. We recommend also that the Government should explore the feasibility of using innovative means to expand the extent of donor registration.

316.  We recommend further that, before a decision is taken about presumed consent, the Government should implement national and local education programmes to improve public understanding of the issue. If, at a later stage, a decision is taken to switch to presumed consent, this should not be implemented until considerable progress has been made in strengthening organ donation services.


41   op. cit Back

42   The Boots advantage card is a form of store-specific loyalty card. If a customer wishes the card to double up as an organ donor card he or she can specify this when applying for one or at any time subsequently Back

43   Human Tissue Act 2004 Part 2 Section 27 (4) Back

44   op. cit Back

45   Department of Health, Organs for Transplants: A report from the Organ Donation Taskforce, January 2008 Back

46   DH Press Release, 20 September 2007, Government task force to explore presumed consent for organ donation Back

47   op. cit Back

48   Human Tissue (Scotland) Act 2006 - section 7 Back

49   Abadie A, Gay S, (2005) The impact of presumed consent legislation on cadaveric organ donation: a cross country study: http://ksghome.harvard.edu/~aabadie/pconsent.pdf Back


 
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