House of Lords - European Union - Seventeenth Report

Select Committee on European Union Seventeenth Report

CHAPTER 5: PROPOSED EU ACTION PLAN FOR COOPERATION ON ORGAN DONATION

126. While, as described in chapter 4, there were mixed views about the need for an EU directive on quality and safety, and significant concerns about its exact content, there was a greater degree of consensus about the potential benefits of an EU action plan for cooperation on organ donation across the Community.

Greater cooperation between EU Member States

BEST PRACTICE

127. UK Transplant took the view that there would clearly be advantages in greater cooperation across the EU in the sharing of experience and the more general introduction of best practice. While the scientific and clinical communities internationally already share knowledge and expertise regularly and constructively, there would be clear benefits to extending this collaboration (pp 26-30).

128. Professor Margot Brazier, Centre for Ethics and Social Policy, University of Manchester, stated, "In terms of an action plan for addressing these issues, the Commission will promote greater cooperation between Member States through the use of the Open Method of Coordination which will include the reporting and exchange of information on best practices, as well as the setting of benchmarks based on qualitative and quantitative indicators" (pp 161-164).

129. She went on to observe, "It is clear from the Commission's research (as set out in the Impact Assessment accompanying the Communication) that there is significant variability amongst Member States across a range of issues involved in the organ transplantation process. It is also clear that some Member States have systems in place that result in significantly higher rates of organ donation (e.g. Spain). So we welcome any structured process through which best practice in the organ transplantation process can be developed and disseminated on a uniform basis throughout the EU" (pp 161-164).

POTENTIAL DONORS

130. UK Transplant drew specific attention to the benefit of sharing good information, in a standardised format, on the identification and referral of potential donors and the consent rate for donation stating, "this is one of the many areas where accurate and comparable data are essential". They felt, "There would be considerable merit in a more structured approach to ensure that appropriate information is always available to make an informed judgement about the risk-benefit analysis inherent in organ exchange between EU states and to harmonise the documentation, transport and traceability requirements" (pp 26-30).

DIAGNOSIS OF DEATH

131. UK Transplant thought that consideration should be given to standardisation of the diagnosis of death by neurological and cardiovascular criteria across the EU stating, "This would prevent national differences in diagnosis impeding cross EU cooperation in organ donation." UK Transplant also suggested that it would also be of value to ensure a more standardised training programme for donor transplant co-ordinators, with training being recognised and transferable between EU Member States (pp 26-30).

TRANSPLANT OUTCOMES

132. Dr Magi Sque, University of Southampton, shared Mr Rudge's view about the benefits of information sharing, stating, "I think it could also be helpful in collating data about transplant outcomes for recipients and particularly for living donors because we do need to continue collecting information in that area. We could more quickly accrue data about unusual cases and this of course would help to provide better evidence for the United Kingdom transplant programmes. It could also be instrumental in coordinating and quickly and effectively disseminating best practice across Europe and this could also benefit our donation and transplant programmes" (Q 208).

MANAGEMENT INFORMATION

133. Mr Peter Lemmey, HTA, commented on the need for the sharing of management information relating to organ donation services. He said, "I think the Human Tissue Authority would particularly pick out the importance of sharing information about the organisation and management of organ transplant systems in other countries. I think all Member States would have something to learn from each other there. I think also there are questions about access to transplant services which it would be helpful to exchange information about. I think those are two of the areas in which we would see benefits from greater European action" (Q 377).

ACTION PLAN OVERALL

134. A dissenting view was put forward by Dr Nathanson of the BMA who stated, "The truth is that we see very little benefit from having a European centre of bureaucracy around this" (Q 391). Dr Jackie Long, of the Royal College of Physicians and Surgeons of Glasgow, shared this view when she wrote, "At a medical level we already exchange expertise through our professional organisations and I don't see that the EU would improve that" (pp 242-246).

135. In contrast, the DH Minister, Mrs Ann Keen MP, saw the action plan as an opportunity for the UK to both educate and learn from other Member States. In response to our question about whether an action plan would add value for the UK, or whether the UK would just pass information to others, she replied: "I think it is both. I think we would learn, but we could also benefit other countries with how we manage ourselves as well—because we do have a very high quality, a very high standard, of which we are very proud. But there is always scope, I am sure, in particular for the training of professionals, and how other cultures might look at it is something we should be open to" (Q 472).

PUBLIC AWARENESS

136. We found significant support for increasing public awareness of organ donation both to encourage donation across the EU and to inform potential donors and their families of what was entailed in donation. There were differences of opinion as to how this could best be achieved, and it was recognised that there might be a tension between these two goals.

137. Drs Sque and Long, University of Southampton, argued, "Information regarding the possibility of organ donation should be fundamental to all areas of EU health care systems and not left until individuals are at the death bed. The function of public education therefore should be to enhance awareness of organ donation to the extent that when the question of organ donation is raised the idea is neither foreign nor intimidating to the grieving family but simply reminds them that other lives hang in the balance of their response" (pp 75-79).

138. The Cystic Fibrosis Trust's view was that "It is extremely important to raise public awareness of organ donation. It may be sensible to remind people that they are far more likely to need an organ than to be in a position to donate one" (pp 212-213).

139. UK Transplant also strongly advocated the need for raising public awareness, stating, "Much more work is required to identify the most effective way to promote public awareness, and even more importantly public acceptance of organ donation. This in turn needs to be supported by adequate funding of a high-profile, national campaign. This might go some way towards addressing the discrepancy between the large numbers of individuals who claim to be supportive of organ donation and the actual number who register as donors" (pp 26-30).

140. The BMA agreed that "There is an important role for public campaigns and the BMA has supported and initiated many campaigns to improve awareness of organ donation generally and specifically to encourage people to make their wishes about donation known. We have co-ordinated public campaigns and run campaigns within our own membership" (pp 165-169).

141. In considering their own role in increasing public awareness, the Christian Medical Fellowship concluded that, in order to raise the numbers of Christians on the donor register, "more teaching should be given within the Christian church to support the principles of organ donation and transplantation" (pp 261-263).

142. Dr Paul Murphy, Leeds General Infirmary, while he felt that the evidence for the sustained effectiveness of publicity campaigns in the UK was not convincing, thought that efforts to increase public understanding of donation and transplantation were to be encouraged, particularly when incorporated into educational programmes such as the National Curriculum (pp 111-113). The need to focus on education in schools about organ donation was also a key element of the evidence from the Jeannette Crizzle Trust (p 43).

143. Based on his experience in Spain, Dr Rafael Matesanz believed that while he did not oppose publicity campaigns, they were expensive and his view was that any available funding in relation to organ donation would be better invested in the hospital system and in skills and training (QQ 332, 334).

144. Despite these reservations, we took the view that previous Government publicity campaigns relating to health issues, for example those addressing AIDS and cigarette smoking, had made a significant impact. We recognised, however, that a publicity campaign relating to organ donation could only be effective if the organisational infrastructure were in place to take advantage of any impact that a campaign might have in increasing donation rates.

145. Against this background, we pursued the issue of whether a campaign relating to organ donation would be funded by the Government. Ann Keen MP, the DH Health Minister, felt that this was a very important issue and Elisabeth Buggins, Chair of the Organ Donation Taskforce, confirmed that a budget of £4.5 million over two years had been allocated for raising public awareness as part of the funding for implementation of the recommendations[25] of the Organ Donation Taskforce for the re-organisation of services in the UK (QQ 503, 504).

Organ trafficking

146. Dr Sque and Dr Long drew attention to the Council of Europe's[26] report[27] on organ trafficking[28]in relation to collaborative European action in this area. That report stated that Council of Europe Member States had a common responsibility to deal openly with the problem of organ trafficking nationally, but also through multilateral cooperation at the European level. Drs Sque and Long suggested that EU level intervention to develop a "rigorous and orchestrated" response to organ trafficking would be welcome (pp 75-79).

147. Dr Sque went further in giving her opinion on how organ trafficking might be tackled, stating, "I think that certainly both within the UK and at European level there would need to be very strong legislation against it. At the moment the criminality is not clear. Are we going to say that we would bring a case against a doctor, for instance, that had supplied a patient with information that they could take abroad in order to get a kidney? I think that needs to be looked at in legislative terms both within Member States and across Europe" (Q 210).

148. The British Transplantation Society (BTS) shared the concern of the Commission about organ trafficking. It took the view that the best response to this problem, and the related problem of transplant tourism,[29] was to improve the supply of organs within the high quality, regulated health care systems of the EU so that the incentive for people to travel abroad for organs was greatly reduced (pp 94-97).

149. The BTS went on to advise that "All Member States should develop appropriate protocols to eliminate the possibility of undue inducement or coercion and ensure informed donor consent" (pp 94-97).

150. The National Kidney Federation, however, expressed the view that people involved as patients in illegal trafficking should not be made criminals "as they do it to save their own lives—or at least try to" (pp 227-228).

151. Chris Rudge, UK Transplant, drew a clear distinction between organ trafficking and organ tourism and the legitimate and proper situation in which some patients now resident in this country travel to their country of origin for a transplant from a family member as a donor (Q 127). In the case of illegal trafficking, however, he agreed that the EU had a role to play in spreading good and correct practice, both in legal terms and in structural terms (Q 126).

152. Dr Fernandez-Zincke, EU Commission, did not see organ trafficking in the European Union as a major problem. He considered that the first priority of the Commission in this area was to collaborate with the competent authorities in the Member States. He went on to say that the Commission recognised the problem of organ tourism by EU citizens. It was working together with the World Health Organisation and with the Council of Europe in order to monitor the extent of this. He concluded, "Probably where we can play a role is to try to agree with Member States common national positions regarding this problem" (Q 22).

153. Dr Adamos Adamou MEP took the view that "a mechanism of traceability should be put in place so as to prevent trafficked organs from entering the European Union" (Q 456). The Impact Assessment which accompanied the Commission's Communication addressed this issue stating, "It is important to ensure that all transplanted material can be traced forward to recipients and back to the donor. It is mandatory to inform the relevant contacts of donors or other recipients about potential problems coming to light after transplantation, when relevant to their health. Twenty-five of the countries surveyed have a national register containing data on the origin and destination of the organs; in 18 of these countries this register is legally binding".[30] A mechanism for ensuring a comprehensive system for ensuring the traceability of organs from donor to recipient across all Member States forms part of the proposed framework for a Community directive on organ quality and safety.[31]

European Donor Card

154. The Welsh Kidney Patients' Association and the Kidney Wales Foundation supported the Commission's proposal for a European Donor Card[32] believing that this could lead to an increase in the number of donated organs (pp 43-46, pp 251-254,). The Welsh Kidney Patients' Association felt, however, that this "should be in addition to, and not instead of, individual Member States' organ donor cards" (pp 251-254).

155. Dr Adamos Adamou MEP reported that the European Parliament had given support to the idea of a European donor card in its resolution[33] on the Commission's Communication as something which should be complementary to the existing systems of Member States (Q 446). Dr Adamou's colleague Ms Pavlou stated, however, that "From the evidence we have gathered, we think it would be more suited in smaller countries and in smaller regions than on a pan-European level" (Q 447).

156. A rather less positive view of the benefits of an EU donor card was taken by Mr Chris Rudge, UK Transplant. In relation to the UK's NHS Organ Donor Register and its predecessor the donor card, his view was that "both have proved to be very useful vehicles for the promotion of organ donation to the public. However, there is little direct evidence that donor cards or registers have an effect on actual donation. There are those who question whether any card or register can provide enough information to people who want to register their wishes to ensure that their consent to donation is informed and valid (in the general rather than the legal sense)" (pp 26-30).

157. Mr Rudge went on to question how an EU donor card could sit easily alongside national systems, particularly in those Member States with presumed consent legislation. His view was that such a card might be most effective as a simple record of the wishes of the individual. If it were intended as proof of legally valid consent, however, he thought, "it could raise major anxieties about its use, not least amongst the public, with the possibility of negative impact on the level of willingness to sign up for donation" (pp 26-30).

158. Other witnesses also had little enthusiasm for the idea. Dr Paul Murphy, of the Leeds General Infirmary, for example, who was an advocate for the retention of the donor card at a national level, doubted that this would meet with public approval in the UK (pp 111-113).

159. The BMA was less firm in its opposition saying, "We have concerns about the idea of a European organ donor card, but we do not feel that sufficient information has been provided to make an informed judgement on this issue. We would need to see good evidence of benefit arising from such an initiative before we could support it" (pp 165-169).

160. The BMA went on to say that they felt it was not clear whether the intention of a European organ donor card would be that organs would be routinely shared throughout Europe, rather than throughout the UK as at present. Their view was that routine sharing across Europe might make people less, rather than more, inclined to sign up for donation. They felt also that such a system, requiring the transmission of "full donor records" across the EU, would raise issues about confidentiality (pp 165-169).

161. The British Transplantation Society's view was that a donor card might achieve maximum acceptability by aligning it with something with which the public most closely identified and that this might be more likely to be their own community than the EU or even the Member State. The idea would be to promote the idea of donation through the means of a donor card in a manner which dealt explicitly with some of the concerns of their own community, not to suggest that donors should donate organs only to members of the same community.

162. The BTS quoted the example, in the USA, of the Orthodox Jewish community's development of their own card which had adopted this approach (pp 94-97). When we followed up this reference, we found that it referred to an initiative by the Jewish Halachic Organ Donation Society. This organisation stated on its website[34] that it had the mission "to save lives by encouraging organ donation from Jews to the general population (including non-Jews) by educating them about the different halachic and medical issues concerning organ donation".

Information and research

163. A number of witnesses, including Dr Warrens (British Transplant Society), Professor Brazier (Manchester University), Professor Gurch Randhawa (University of Bedfordshire) and Kidney Research UK, were enthusiastic for an EU action plan to clarify the Commission's role in, and commitment to, encouraging and funding research in the area of organ donation.

164. Dr Warrens thought that the Commission could help in the field of social science research relating to organ donation, for example in understanding attitudes within the communities with which people identify. He wanted the Commission to recognise the need to increase knowledge in this area and to allocate funding to it (QQ 225, 226). He made the point that "an EU-wide approach to research across national boundaries would have value in determining common themes in attitudes to organ donation" (pp 94-97).

165. Professor Brazier made the point that there was a wealth of evidence across the EU about what worked and what did not. She thought that the best approach to obtain the information needed to prepare guidance on best practice would be to conduct EU-wide research (pp 161-164).

166. Professor Randhawa, University of Bedfordshire, thought that the EU could help by coordinating the collection of data across the Community in relation to the attitudes of different population sub-groups, including ethnic minority groups, towards organ donation issues. At a recent international conference he had formed the impression that there was no appetite among major EU countries to collect such data. He thought that an action plan could help to promote EU-wide understanding that there was a need for such data in order to develop EU-wide strategies for handling the issues which arise in different groups in relation to organ donation (Q 184).

167. Kidney Research UK agreed with this view, arguing that "Research needs to be undertaken across national boundaries to address the impact of ethnicity, country of origin, religion, level of education and socio-economic class on the decision to offer organs for donation". They identified a number of other areas which could benefit from cross-EU research and concluded that "investment in research that leads to an increase in successful transplantation will be cost effective for the EU and we would commend it to the Commission" (pp 225-227).

168. Ms Norman, Department of Health, agreed that it might be useful for the Commission to spend money on research that might enhance work that was going on across Europe in all countries on organ donation (Q 488).

Conclusions

169. We support the proposal for an EU action plan to promote cooperation between Member States on organ donation in the interests of increasing the supply of organs. Our view is that the exchange of information via this means would be valuable over a number of areas including: best practice; the identification of potential donors; the diagnosis of death; information about transplant outcomes; and management information. (paras 126-134)

170. We recognise the need for public awareness and understanding of organ donation and transplantation issues to be increased, and we welcome the Government's commitment to fund this in the UK over the next two years. Given the scepticism expressed by some key witnesses, we would, however, like to see work done to establish a basis for assessing the effectiveness of such awareness raising in increasing donation rates. (paras 135-144)

171. While we understand that organ trafficking and organ tourism are not currently major problems in the EU, we agree that there is a need for the Commission and Member States to be vigilant in monitoring and tackling any cases which may occur. While we note the view that it would be desirable to have in place a mechanism for tracing trafficked organs, we are not clear how such a mechanism could operate in practice. (paras 145-152)

172. The balance of views we have heard is that a European Organ Donor Card would not command public support and would not add value to national donor card systems already in place. We were concerned that it would be difficult for carriers of a standardised European Organ Donor Card to understand that their wishes regarding donation would be interpreted differently in Members States according to the arrangements for consent in place in each country. Nevertheless, we do see some merit in the idea of introducing a common format for the donation cards used by each Member State, providing that these are designed to be consistent with the donation consent process which is in force in the Member State of the holder's origin. (paras 153-159)