The purpose of our inquiry

1.  The first successful kidney transplant, between identical twins, was carried out in the USA in 1954, but much more widely remembered is the first successful transplant of a human heart performed by Dr Christian Barnard, in South Africa, in 1967. In the years which have passed since then, the medical techniques required for successful organ transplantation have advanced considerably and this is now a widely used form of treatment. In fact, kidney transplantation has now become the most cost-effective form of treatment for cases of renal failure and is almost always preferable to kidney dialysis.

2.  Unfortunately, many of the patients who potentially could benefit from receiving an organ transplant cannot be treated in that way as a result of the severe shortage of available donor organs both in the United Kingdom (UK) and, more widely, across the whole of the European Union (EU).

3.  In his Annual Report for 2006[1], the Chief Medical Officer (CMO) for England quoted figures produced by UK Transplant showing that, while the number of patients waiting for an organ transplant in the UK had risen from around 7,200 in 2002/03 to around 8,400 in 2005/06, the proportion of these for whom a transplant operation had been performed had fallen, during the same period, from 39% to 34%. In 2005/06, directly as a result of the shortage of organs, the number of transplant operations carried out had been limited to 2,794.

4.  The CMO estimated that 1,000 patients on the transplant waiting list were dying every year for lack of a transplant; and that others who were not put on transplant waiting lists "because doctors know there is no hope of them getting treatment" were "dying silently" (Q 44).

5.  In May 2007, the European Commission issued a Communication[2] which made a number of suggestions for actions at Community and Member State levels designed to help increase the supply of donor organs across the EU. The Commission commented that, across the EU as a whole, over 40,000 patients were on waiting lists for a kidney transplant. It concluded that, "the severe shortage of organ donors remains the main challenge that EU Member States face with regard to organ donation".

6.  Our inquiry had the principal aim of taking evidence in order to assess the merit of the suggestions for action at EU level which were put forward in the Commission's Communication. In order to address these issues in a fully informed way and to put them in context, we found it necessary to take evidence also about matters relating to organ donation and transplantation in the UK which went beyond the scope of any potential EU involvement. We report also on this additional information.

What the Commission's Communication says

7.  The Communication proposes three main areas of action at EU level in relation to organ donation and transplantation:

• The introduction of an EU directive on the quality and safety of organ donation and transplantation;
• The introduction of an Action Plan for strengthened cooperation between Member States; and,
• Continued vigilance to combat trafficking in human organs.

8.  The Communication proposes that an EU directive, setting standards of quality and safety for organ donation and transplantation, could serve a similar purpose to that served, in a related field, by the existing Directive on quality and safety standards for blood, tissues and cells[3]. The Commission argues that, based on further cooperation with the Member States, an appropriate and flexible European legal framework for this would be provided by Article 152(4)(a) of the Treaty of Rome[4].

9.  The Commission also proposes to develop an action plan for the sharing of expertise among EU Member States designed to help maximise organ donation rates and to promote greater access to transplantation. This approach should be based on: the identification and development of common objectives for which it is agreed that a Community response is necessary; agreed quantitative and qualitative indicators and benchmarks: regular reporting; and identification and sharing of best practices.

10.  In relation to organ trafficking, the Communication refers to existing international legal instruments and envisages that it will closely monitor any developments in the organ trafficking field both inside the EU and worldwide.

11.  Further details of the Commission's proposals are set out in chapters 2, 4 and 5 of this Report.

Relevant developments during our inquiry

12.  An important development which occurred during our inquiry was the publication of a report[5] by the Department of Health's (DH) Organ Donation Taskforce which made recommendations about how to re-organise the health infrastructure in the UK in order to increase organ donation rates. The issues addressed by the Taskforce report were also central to the subject matter of our inquiry and we heard a great deal of evidence from our witnesses which related to the recommendations it made. Our evidence and conclusions on this issue are reported in chapter 6.

13.  We were delighted to hear from Elisabeth Buggins, Chair of the Organ Donation Taskforce that the Government had allocated, in full, the funding needed for implementation of the recommendations of the Taskforce report (Q 489).

14.  We were pleased also to hear from Ann Keen MP, Parliamentary Under-Secretary of State for Health Services that a new National Clinical Director for Transplant had been appointed in April 2008 with the responsibility of taking forward delivery of the Taskforce recommendations (Q 490).

15.  The timing of our inquiry also coincided with a great deal of publicity, arising from the proposal set out in the CMO's report[6], that current legislation in England should be changed in order to create a "presumed consent" or "opt-out" system for organ donation in place of the existing "opt-in" system. The EU has no competence in this area, and the Commission has shown no intention of suggesting what model for consent Member States should adopt. Nevertheless, the potential advantages and disadvantages of presumed consent are so central to the assessment of how the supply of donor organs might be increased, that our inquiry needed to take account of the arguments both for and against the CMO's suggestion. Our evidence and conclusions on this issue are reported in chapter 8.

16.  In September 2007, the Organ Donation Taskforce was requested by the Secretary of State for Health to explore the issue of presumed consent. We understand that the Taskforce report will be published in summer 2008 so there has been no opportunity to take account of its findings in our inquiry. We hope, however, that our Report will provide a useful input to the work of Taskforce on this issue and we have sent it to the Taskforce Chair drawing her attention to the relevant sections.

How we conducted the inquiry

17.  The Members of our Social Policy and Consumer Affairs Sub-Committee (Sub-Committee G) who conducted the Inquiry, showing their declared interests, are listed in Appendix 1.

18.  We are most grateful for the evidence that we received for our inquiry; the witnesses who provided it are listed in Appendix 2. In particular, we thank those witnesses who gave us evidence in person. The Calls for Evidence we issued are shown in Appendices 3 and 4, and the evidence we received in response is printed in a companion volume to this Report.

19.  We acknowledge with considerable thanks the expertise and hard work of our Specialist Adviser for the inquiry—Professor Bobbie Farsides of the Brighton and Sussex Medical School—who played a key role in helping us to prepare the Report.

20.  We make this Report to the House for debate.

2   European Commission Communication, Organ donation and transplantation: policy actions at EU level, May 2007. http://ec.europa.eu/health/ph_threats/human_substance/documents/organs_com_en.pdf Back

3   Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells, OJ L102, 7.4.2004, p. 48-58 Back

4   Treaty establishing the European Community: Article 152(4)a. "The Council, acting in accordance with the procedure referred to in Article 251 and after consulting the Economic and Social Committee and the Committee of the Regions, shall contribute to the achievement of the objectives referred to in this Article through adopting: (a) measures setting high standards of quality and safety of organs and substances of human origin, blood and blood derivatives; these measures shall not prevent any Member State from maintaining or introducing more stringent protective measures." Back

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

6   op. cit. Back