Select Committee on European Union Seventeenth Report

 
 

 
CHAPTER 3: SHORTAGE OF DONOR ORGANS ACROSS THE EU

Organ transplantation as a medical treatment

48.  The Chief Medical Officer for England, Sir Liam Donaldson, told us that organ transplantation had now become an important area of healthcare and medical practice. He added that it was likely to become increasingly important as the population ages and develops more chronic diseases which precipitate the failure of organs. Sir Liam noted, however, that "the disappointment is that it has not been able to fulfil its full potential because of the shortage of donors" (Q 44).

49.  Sir Liam referred to three areas of research into possible future means of creating replacement tissue or organs; the use of animal organs, modified genetically or otherwise; the development of mechanical organs; and the prospect of stem cells being produced which could yield tissue capable of being turned into the architecture of an organ (Q 44). He considered, however, as stated in his 2006 Annual Report[13], that the immediate priority was to increase the supply of donor organs suitable for transplant.

50.  When anticipating future demand in a UK context, the Organ Donation Taskforce reported[14] that waiting lists for organ transplants were rising by 8% per year, and that at least 50% more organs were needed than were currently available. Given the ageing of the population, a surge in diseases related to organ failure was anticipated, for example Type 2 diabetes. As a result, a further increase was to be expected in the demand for organs for transplantation.

51.  The gap between supply and demand of organs for transplantation is particularly large amongst specific groups within the UK, notably amongst patients of South Asian and African Caribbean origin. Within these groups relatively high levels of need, arising from a high incidence of such diseases as Type 2 diabetes, are coupled with low levels of donation. This issue is discussed in chapter 9.

52.  A shortage of organs for transplantation was also acknowledged to be a problem across the EU as a whole. The consequences of this shortage were clear. Dr Eduardo Fernandez-Zincke, Medical Officer at the European Commission, put the total EU figure for people on transplant waiting lists in 2006 at approximately 58,000 (Q 9).

Organ donation rates

53.  Table 1, published by the Commission in the Impact Assessment which accompanied their Communication[15], compares organ donation rates in 2004 across the 27 EU Member States, as well as in Iceland and Norway. The rates vary from 0.8 donors per million population in Bulgaria to 35.1 donors per million in Spain. In the UK, the donation rate was 12.8 per million. Dr Fernandez-Zincke pointed out that the EU average donation rate of 18.8 per million compared unfavourably with the USA, where the average donation rate was 25.5 per million (Q 8).

TABLE 1

Organ donor rates in EU Member States: 2004 (per million population)
Austria 24.8  Greece 8.1 Poland  14.5 
Bulgaria 0.8 Hungary  18 Portugal 19  
Belgium 23.8 Iceland  6.8 Romania 0.5  
Czech Republic 20.3 Ireland  17.6 Slovak Republic  12.1 
Cyprus 8.9 Italy  21 Slovenia 10.5  
Denmark 11.9 Latvia  20 Spain 35.1  
Estonia 26.9 Lithuania  10.2 Sweden 14.2  
Finland 16.2 Luxembourg  The Netherlands 14.6  
France 22.2 Malta  10 United Kingdom 12.8  
Germany 14.8 Norway  16.5   

Source: European Commission Communication on Organ Donation and Transplantation: Policy actions at EU level: Impact Assessment (page 23).

54.  Table 2, also shown in the Commission's Impact Assessment[16], puts the organ donation rates listed in Table 1 in context by showing the numbers of patients in each country who, in 2005, were waiting for a kidney transplant.

TABLE 2

Kidney transplant waiting lists in EU Member States: 2005
Austria 826  Greece 775 Poland  1105 
Bulgaria 36 Hungary  939 Portugal N/A  
Belgium 955 Iceland  N/A Romania 1512  
Czech. Republic 343 Ireland  N/A Slovak Republic 741  
Cyprus N/A Italy  8688 Slovenia 81  
Denmark 384 Latvia  354 Spain 4152  
Estonia 29 Lithuania  434 Sweden 503  
Finland 272 Luxembourg  11 The Netherlands 1088  
France 5932 Malta  N/A United Kingdom 7126  
Germany 8853 Norway  174 TOTAL 45313  

Source: European Commission Communication on Organ Donation and Transplantation: Policy actions at EU level: Impact Assessment (page 21)

55.  Despite the variation in donation rates across the EU, the Commission makes clear in its Communication that, even in Member States where there have been sustained increases in the number of donors, it is very difficult to reduce the numbers of patients waiting for transplants and the time they spend on waiting lists. It concludes, therefore, "The severe shortage of organ donors remains the main challenge that EU Member States face with regard to organ transplantation".

Acquiring organs for transplant

56.  Organs for transplantation can be acquired via three routes—live donation, post mortem donation after brainstem death (DBD) and donation after cardiac death (DCD—also referred to as non-heart beating donation). Table 3, published by UK Transplant, shows the numbers of transplants in the UK from each category of donor during 2006. The Table also shows the total numbers of patients on the active national transplant list who were waiting for transplants.

TABLE 3

Numbers of patients on waiting lists for transplants; numbers of transplants from deceased donors (shown separately for heartbeating and non-heartbeating) and from living donors: UK, 2005 and 2006
Organ 
United Kingdom
 
 
Rep of Ireland
 
 
2005
 
2006
 
% change
 
 
2005
 
2006
 
% change
 
Patients on waiting lists for transplants
 
Kidney 
5660
 
6190
 
8
 
 
-
 
-
 
-
 
Kidney & Pancreas 
76
 
141
 
86
 
 
-
 
-
 
-
 
Pancreas 
53
 
53
 
0
 
 
-
 
-
 
-
 
Total Renal* 
5789
 
6384
 
10
 
 
-
 
-
 
-
 
Heart 
96
 
83
 
-14
 
 
-
 
-
 
-
 
Heart & Lung 
41
 
37
 
-10
 
 
-
 
-
 
-
 
Lung(s) 
257
 
272
 
6
 
 
-
 
-
 
-
 
Total Thoracic* 
394
 
392
 
-1
 
 
-
 
-
 
-
 
Liver 
360
 
326
 
-9
 
 
24
 
29
 
21
 
Total List 
6543
 
7102
 
9
 
 
24
 
29
 
21
 
Transplants from Deceased Donors
 
Kidney 
1197
 
1240
 
4
 
 
121
 
137
 
13
 
Kidney & Pancreas 
102
 
138
 
35
 
 
5
 
4
 
-
 
Pancreas 
15
 
25
 
67
 
 
0
 
0
 
-
 
Total Renal 
1314
 
1403
 
7
 
 
126
 
141
 
12
 
Heart 
147
 
156
 
6
 
 
11
 
14
 
27
 
Heart & Lung 
8
 
3
 
-
 
 
0
 
0
 
-
 
Lung(s) 
129
 
119
 
-8
 
 
3
 
9
 
-
 
Total Thoracic 
284
 
278
 
-2
 
 
14
 
23
 
64
 
Liver/Liver Lobe 
584
 
616
 
5
 
 
55
 
64
 
16
 
Other Multi-organ 
15
 
22
 
47
 
 
1
 
1
 
-
 
Total Solid Org. T/plants 
2197
 
2319
 
6
 
 
196
 
229
 
17
 
Cornea 
2443
 
2479
 
1
 
    
 
2005
 
2006
 
% change
 
 
2005
 
2006
 
% change
 
Transplants from Living Donors
 
Kidney 
543
 
671
 
24
 
 
2
 
4
 
-
 
Heart (domino) 
0
 
0
 
-
 
 
0
 
0
 
-
 
Liver/Liver Lobe 
8
 
9
 
-
 
 
0
 
0
 
-
 
Lung Segment 
0
 
0
 
-
 
 
0
 
0
 
-
 
Total Transplants 
551
 
680
 
23
 
 
2
 
4
 
-
 
Deceased Donors
 
Heartbeating 
630
 
633
 
0
 
 
71
 
85
 
20
 
Non-heartbeating 
122
 
146
 
20
 
 
0
 
0
 
-
 
Total Donors 
752
 
779
 
4
 
 
71
 
85
 
20
 
Cornea only 
1683
 
1927
 
14
 
    

Note: Cardiothoracic and renal transplant lists for the Republic of Ireland are not routinely reported to UKT. The statistics are those recorded on the National Transplant Database as at 30 May 2007 and might be subject to slight modification.

Source: UK Transplant Active national transplant list: Yearly up-date to end 2006 https://www.uktransplant.org.uk/ukt/statistics/calendar_year_statistics/pdf/yearly_statistics_2006.pdf

Living donation

57.  The Communication recommends that "exploring the promotion of altruistic donations from volunteer living donors, on the basis of appropriate safeguards for the donors and the prevention of trafficking, could be important in expanding the organ pool."

58.  Dr Chris Rudge, of UK Transplant, informed us that living donor kidney transplantation has been established in the UK for many years, as is the case in most EU Member States. The number of such transplants had more than doubled in the UK in the past 5-6 years, to approximately 700 per year (pp 26-30). Dr Anthony Warrens, British Transplantation Society, added, "the outcome following living donation is better than the outcome following cadaveric donation, even if the living donor is not particularly well matched" (Q 243).

59.  The Human Tissue Authority (HTA) explained their role in managing living donation in the UK. Under the Human Tissue Act 2004[17], all donors and recipients had to be individually assessed by a local independent assessor, who was trained and accredited by the HTA to act on behalf of the donor. The independent assessor ensured that the donor and recipient had an appropriate relationship; that the donor fully understood the risks which donation involves; that the donor was not under any pressure to donate; and that consent had been given freely and voluntarily (Q 359, pp 145-148).

60.  The British Transplantation Society (BTS), the National Kidney Federation and the Royal College of Physicians all stressed the importance of developing live donation as a response to the shortage of certain organs, kidneys in particular (pp 94-97, pp 227-228, pp 239-242). The BTS thought that support should be given to altruistic, unrelated donation including "paired" donation, "pooled" donation and "non-directed" donation (pp 94-97). These terms were explained as follows.

61.  "Paired" donation, according to the HTA, occurred when a donor and recipient, who are connected to each other, but whose blood groups or tissue types were mismatched or incompatible, were paired with another donor and recipient in the same situation. (pp 145-148).

62.  "Pooled" donation, according to Mr Rigg of the BTS, occurred when more than one pair of donors was involved (Q 220). He said that at least 30 to 50 pairs of donors were needed in a "pool" in order to generate a reasonable chance of finding successful organ matches for transplantation (Q 245).

63.  "Non-directed altruistic" donation, according to the HTA, involved a donation by a person who did not have a relationship with the recipient. In such cases a psychiatric assessment of the donor was required (pp 145-148).

64.  UK Transplant commented on paired donation and drew attention to the potential benefit of EU cooperation in relation to this approach in the case of kidney transplants. Such cooperation could generate more pairs of donors in a pool which would increase the chances of finding a suitable exchange (pp 26-30).

65.  Mr Peter Lemmey, Director of Policy at the HTA, pointed out that, while different forms of living donation were a means of increasing the supply of donor organs, such donations were never likely to be numerous. He added, however, that the "enthusiasm on the part of the transplant community, and the wide national publicity that accompanied the first paired donation, suggests that the number of paired donations is likely to increase substantially, perhaps to as many as 50 per year" (pp 145-148).

Donation after brain stem death

66.  The mainstay of donation in the UK has been donation after the diagnosis of brain stem death (DBD). However, the January 2008 report of the Organ Donation Taskforce[18] stated that, between 2000 and 2006, the annual number of such donations in the UK fell from 739 to 633.

67.  The medical criteria for identifying brain stem death are well established, and Sir Liam Donaldson, Chief Medical Officer for England, supplied us with a document, prepared on behalf of the Intensive Care Society (p 40), which set out guidelines for the certification of death by brain stem testing[19]. This document stated that, in addition to their wide acceptance by the medical profession across the world, "the criteria for the diagnosis of brain stem death have also been adopted by the courts in England and Northern Ireland for the certification of death".

68.  Despite this background, there are still a limited number of groups and individuals who disagree with this way of defining and confirming death as a replacement for the traditional process of establishing that there is no heartbeat and that breathing has stopped. Dr David Hill, a retired consultant anaesthetist, put it like this, "death can only be assured by complete cardio-pulmonary failure over a period of time and at normal temperature" (pp 223-225). Dr David Evans, a consultant cardiologist, also took this view, asserting that "so-called 'brain stem dead' patients who are designated as organ donors are self-evidently alive" (pp 213-216). The views of faith groups on this issue are reported in chapter 10.

69.  A view, more in line with the mainstream of opinion, was expressed by the Patient Liaison Group of the Royal College of Surgeons (England), who identified the need for more public education about the concept of brain stem death in order for organ donation from such patients to be more widely accepted. They took the view that "the heart beating donors issue is a difficult one and the public will need reassurance on the ethics of it as well as greater clarification about how it is defined. Issues related to the diagnosis of brain stem death must be transparent, with clear guidelines and nothing left to clinical judgement. Public education on understanding of brain stem death as opposed to cardiac death is important" (pp 48-52).

70.  Mr Keith Rigg, British Transplantation Society, told us that the Academy of Medical Royal Colleges (AMRC) was working on an up-dated Code of Practice for the diagnosis of death (Q 241). We subsequently heard from Dr Martin Smith, a consultant in neuroscience critical care at University College London Hospitals who was involved with this work, that the AMRC code had been agreed some time ago but was awaiting the endorsement of the Department for Health before it could be published (pp 250-251).

71.  Dr Smith explained that the code agreed by the AMRC consisted of two parts: the first dealing with the diagnosis of death; and the second with related issues affecting organ donation. While the code did not alter any essentials of the existing guidance for the diagnosis of brain stem death, it did provide additional clarification in some areas which had been a cause for concern. Dr Smith added that the code also included, for the first time, guidance on the diagnosis of death by cardiovascular criteria.

Donation after cardiac death

72.  Donation after cardiac death, or non-heart beating donation, takes place from donors who have suffered a cardio-respiratory arrest sometimes, but not always, subsequent to the withdrawal of treatment. The Organ Donation Taskforce reported[20] that, after specific support from UK Transplant, between 2000 and 2006 there was an increase in the annual number of such donations from 38 to 146.

73.  Dr Paul Murphy, Leeds General Infirmary, told us that post cardiac death organ donation (NHBOD) most commonly occurred after the planned withdrawal of life-sustaining therapies for patients in intensive care units, for whom there was no prospect of recovery. In order for a donation to occur, a surgical team had to be assembled (usually from another hospital), and only when they were ready could treatment be withdrawn. This inevitably meant that the patient might have to be maintained on therapies, which would otherwise have been withdrawn because there was no hope of preserving life, purely to maintain the organs in a suitable state for transplantation (pp 122-132).

74.  Against this background, Dr Murphy emphasised to us, "The committee should recognise that many ICUs are resistant to the introduction of NHBOD—certainly in the absence of a binding and authoritative statement on the ethico-legal probity of the process".

75.  Once again, the situation across the EU differs widely with regard to donation after cardiac death, with the UK having one of the most permissive regimes in this regard. According to the Impact Assessment which accompanied the Commission's Communication[21], Croatia, Germany, Hungary and Poland legally prohibit the practice. Moreover, while it is legally permitted in other Member States, some countries have not developed any programme to implement such donations, notably, Italy, Portugal, and France.

Cross border donation

76.  Dr Chris Rudge, UK Transplant, supplied us with the statistics shown in Table 4 which show the extent to which organs were exchanged between the UK and other countries during a recent 12 month period.

TABLE 4

Solid organs exchanged between the UK and other countries:
April 2006 to March 2007
 Ireland Other countries  Total 
(a) Overseas to UK      
Organs offered to the UK by other countries  
95
 
118
 
213
 
Organs transplanted which were offered to the UK  
34
 
13
 
47
 
(b) UK to Overseas     
Organs offered by the UK to other countries  
219
 
14
 
233
 
Organs transplanted which were offered by the UK  
12
 
6
 
18
 

Source: Based on tables supplied by UK Transplant from the National Transplant Database

77.  Responding to the Commission's view, which we report in chapter 2, that the exchange of organs across internal EU borders was a good way to increase the size of the donor pool, Mr Keith Rigg, British Transplant Society, identified the problem of transporting such shared organs. He told us that "one of the concerns, if you start to share between more countries, is the actual time that is involved … There is only a finite storage time for organs and, therefore, if you increase the transport times, that then means that the organs can become unusable" (Q 220).

78.  Dr Adamos Adamou MEP, rapporteur to the European Parliament Committee commenting on the Commission's proposals, took a similar view, but suggested that there was scope for neighbouring countries to cooperate. He explained, "There is a time limit. It does not make any sense to transport one organ from Cyprus to London or to Sweden. What we are looking for is for neighbouring countries to cooperate. We know this very well because we have examples like Eurotransplant or Scandiatransplant where countries have built up an alliance among them" (Q 443).

The human and economic cost of organ scarcity

79.  Several witnesses provided powerful accounts of the human cost of the current shortage, as well as inspiring stories of lives saved and enhanced by donation. The National Kidney Federation, for example, pointed out that "a dialysis patient leads a poor quality of life, unable to work and a non-contributor to society. A transplanted patient usually leads a near normal life and is part of the community. A transplanted patient is a contributor—not a taker" (pp 227-228).

80.  Mr Gordon Nicholas, who described himself as "a patient of some 30 years, on dialysis and then transplanted, for 12 years now back on dialysis", wrote to tell us of the way his life had been transformed by transplantation, saying, "when I had my transplant my life was transformed leading as normal life as others, my time on dialysis was/is not a pleasant experience. Transplantation gave me back my life; dialysis gives me eight years to live" (p 233).

81.  The Organ Donation Taskforce's report[22] of January 2008 included an assessment of the economic case for increasing donation rates. They reported that in the UK the average annual cost for treating kidney failure by dialysis is £23,177 per year. This compared with an initial cost of £42,025 for a kidney transplant followed by annual costs for care of £6,500.

Conclusions

82.  The shortage of organs available for transplant both in the UK and across the EU is a serious public health problem which has significant human and economic costs. (paras 48-52; 79-81)

83.  In the UK, the organ donation rate lags substantially behind not only the best achieved in the EU, but also the overall EU average rate. (paras 53-55)

84.  All forms of donation—living donation, donation after brain-stem death and donation after cardiac death—have the potential for increases in volume, although brain-stem death donation is the principal source. There are ethical and legal uncertainties relating to donation after cardiac death which limit its acceptability among medical practitioners. (paras 56-75)

85.  While the criteria for the definition of brain stem death are widely accepted across the medical profession, there are some aspects on which clarification would be valuable. The work of the Academy of Medical Royal Colleges (AMRC) to develop an up-dated Code of Practice for the diagnosis of death is therefore most timely, although its publication appears to be awaiting endorsement from the Department of Health. (paras 69-71)

86.  There are practical limitations, largely arising from the deterioration in the quality of a donated organ during its travel from donor to recipient, to the practical extent of cross-border donation within the EU. Nevertheless, there is a potential for expanding the numbers of such donations between neighbouring Member States. (paras 76-78)

Recommendations

87.  We recommend that the Government should support the work of the European Commission in seeking to raise the profile of organ donation issues across the EU and in seeking ways to reduce the shortage of organs for transplantation.

88.  We recommend also that the Government should act urgently to address the shortage of organs for transplantation in the UK by taking measures which will significantly increase organ donation rates over the next five years.

89.  We recommend that the Government should address the ethical and legal issues which currently limit the extent to which donation after cardiac death is accepted across the medical profession.

90.  We recommend that the Commission should pursue their ideas for increasing the supply of suitable organs for transplantation by encouraging Member States to improve the arrangements for donation across internal EU borders. These arrangements should take account of the impracticality of successful donation in cases for which the time to transport the organ between donor and recipient would be too long.

91.  We welcome the completion of the work by the Academy of Medical Royal Colleges (AMRC) to produce an up-dated Code of Practice for the diagnosis of death. We urge the Government to expedite the publication of this badly needed new guidance and to draw it to the attention of the European Commission.


13   op. cit Back

14   op. cit Back

15   op. cit Impact Assessment (ps. 22,23) Back

16   op. cit Impact Assessment (p. 21) Back

17   See http://www.opsi.gov.uk/acts/acts2004/ukpga_20040030_en_1 Back

18   op. cit Back

19   According to the Intensive Care Society document, brain stem death is diagnosed in three stages:
1. It must be established that the patient has suffered an event of known cause resulting in irreversible brain damage with apnoeic coma, i.e. the patient is deeply unconscious, mechanically ventilated with no spontaneous respiratory movement.
2. Reversible causes of coma must be excluded.
3. A set of bedside clinical tests of brain stem function are undertaken to confirm the diagnosis of brain stem death. 
Back

20   op. cit Back

21   op. cit (see the table on p. 34 of the Impact Assessment) Back

22   op. cit Back


 

 
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