Select Committee on European Union Seventeenth Report


CHAPTER 2: THE EUROPEAN COMMISSION'S PROPOSALS

21.  The European Commission's Communication[7] on organ donation and transplantation was published in May 2007. A substantial amount of work has been done since then by the Commission, in consultation with Member States, to develop their proposals in relation to: 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.

22.  Dr Eduardo Fernandez-Zincke, Medical Officer in the European Commission's Directorate of Public Health and Risk Assessment, told us that the Commission was planning to publish its firm proposals by the end of 2008 (Q 2).

23.  The Commission's proposals in the field of health are subject to a co-decision procedure under which both the Council of Ministers and the European Parliament need to agree them. In April 2008, the European Parliament adopted a resolution[8] on organ donation and transplantation which put forward a number of views about the Commission's Communication.

EU Directive on the quality and safety of organ donation and transplantation

24.  Dr Fernandez-Zincke pointed out that cooperation between EU Member states to exchange organs across national boundaries was a valuable way of increasing the size of the donor pool. This was especially helpful for smaller Member States for which available, suitable organs may not readily be found when needed for transplant (Q 20). The evidence we received relating to cross-border exchanges of organs within the EU is set out in chapter 3.

25.  At present the five Member States that comprise the Eurotransplant area (Austria, Belgium, Luxembourg, the Netherlands and Slovenia) have entered into collaborative agreements relating to organ exchange. While the Commission has not suggested that this area should be extended to include any further Member States, it does argue that a Community framework would be desirable for setting quality and safety criteria with respect to the procurement, transport and use of organs across the Community. In the Commission's view, such standards would help to facilitate exchanges of organs across internal EU boundaries.

26.  Dr Fernandez-Zincke confirmed that the Commission would wish to introduce a legal framework—a directive—in order to put in place such standards across the EU saying, "I think that probably you could find in the Communication the key principles that we would like to introduce and include into the legal framework" (Q 21).

27.  Box 1 in chapter 4 shows the content of the Communication which sets out the key principles to which Dr Fernandez-Zincke referred.

28.  The European Parliament's resolution[9] on this matter recognises that it is "vitally important to ensure the quality and safety of organ donation and transplantation" and acknowledges that "actions on quality and safety could have an effect on organ availability". The resolution calls on the Commission to "help Member States develop their capacity to create and develop national regulations and a regulatory framework to enhance quality and safety, without this having a negative impact on the availability of transplant organs".

29.  It seems likely also that a consensus will be reached among Member States in the Council of Ministers that a directive will be acceptable as a way of ensuring high quality standards in relation to organ donation across the EU. Ann Keen MP, the responsible DH Minister, lent weight to this view when she told us, "I would suspect that all Member States would agree that there is a need for a common high quality standard in organ donation. More safe, high-quality donor organs available for transplant across Europe will benefit all Member States" (Q 467).

30.  We heard little evidence opposing entirely the introduction of an EU directive relating to organ quality and safety. However, we did hear a wide range of views about the potential problems that such a directive could cause if care were not taken to ensure that it did not inhibit in any way existing beneficial medical practice, and did not cause an unacceptable administrative burden.

31.  A more detailed account of the evidence we received relating to the Commission's ideas about a directive on the quality and safety of organ donation and transplantation is given in chapter 4.

Action Plan for strengthened cooperation between Member States

32.  The motivation for the Commission's suggested action plan for strengthened cooperation between Member States is its perception that this would be a positive way of improving the supply of available donor organs across the EU. The Commission observes in its Communication[10] that organ donation rates vary widely between different EU Member States for reasons which cannot easily be explained.

33.  The Commission concludes from this that some of the national models used to organise organ donation and transplantation services perform better than others in generating a supply of donor organs. It suggests, therefore, that sharing expertise between Member States would help the Community as a whole to "identify the best of the models and support its application throughout the EU, while respecting cultural and organisational diversity."

34.  The Commission envisages that this cooperation between Member States would be based on the identification and development of common objectives, agreed quantitative and qualitative indicators and benchmarks, regular reporting, and the identification and sharing of best practices.

35.  The Communication highlights three areas in which such action could be beneficial: increasing the availability of donor organs; raising public awareness of organ donation and transplantation issues; and improving the effectiveness of organ donation and transplantation services.

36.  In relation to the availability of donor organs, the Commission points out that, in some Member States, many potential donors are lost because taking organs for transplantation is never seriously considered by the medical staff responsible for the patient. As a result, the option of donation is never presented to the patient's relatives, and no evaluation is made of the suitability of the patient's organs for donation. Sharing information about how to raise the profile of organ donation in the medical context would address the problem.

37.  The Communication suggests that public awareness should be raised by improving the knowledge of both health professionals and the media of transplantation issues. People should be encouraged to talk about organ donation within their families and to ensure that their relatives are aware of their wishes about organ donation. According to the Commission, the evidence shows that the members of families who have discussed these issues among themselves tend to be more likely to be willing to donate organs.

38.  The Communication goes on to suggest that the creation of a European organ donor card, indicating the willingness of the holder to donate organs, would be a positive factor in raising public awareness and in raising organ donation rates.

39.  Health service systems differ widely between Member States, the Commission comments, as a result of their different origins and history. However, even among those countries which have well-developed systems, there are wide differences in the ways they organise organ donation and transplantation services. The organisational models adopted in some Member States seem to stand out for their success in achieving high rates of organ donation and successful transplantation.

40.  The Communication comments that the most effective organisational approach appears to be to combine a decentralised network, formed by local organisations which have the roles of promoting organ donation and of procuring donor organs, with a centralised organisation which focuses on ensuring cooperation between local areas in sharing organs and on other matters. Again the sharing of information, about how such models achieve relative success, would be beneficial across the EU.

41.  We heard evidence indicating that the Commission's ideas for an action plan for information sharing were widely accepted. The European Parliament's resolution[11] on organ donation and transplantation looks forward to the Commission's action plan, stating that the Parliament "strongly believes that there is significant potential for sharing expertise between Member States in order to increase donor rates and equalise access to transplantation across the EU".

42.  Support for the concept of an action plan from the Council of Ministers also seems likely. Ann Keen MP, the responsible UK Minister, told us, "I believe that we can learn from each other" and added, "looking at best practice and promoting that is also something that I believe we are very keen to follow and to do" (Q 471).

43.  A more detailed account of the evidence we received in relation to the Commission's proposals for an action plan on organ donation and transplantation is given in chapter 5.

Combating organ trafficking

44.  In relation to the issue of combating organ trafficking, the Commission refers to Article 3 of the EU Charter of Fundamental Rights[12] (which states that everyone has the right to respect for his or her physical integrity) and to a range of existing international legal instruments which ban trafficking in human organs and tissues. The Commission states that it bases its actions on these important international instruments and that it will closely monitor any developments in the organ trafficking field both within the EU and worldwide.

45.  Few of the witnesses for our inquiry saw the issue of organ trafficking as a serious problem within the EU. In fact, Dr. Eduardo Fernandez-Zincke, Medical Officer in the European Commission's Directorate of Public Health and Risk Assessment, told us that the cases of this which had been reported in the EU were rare (Q 22).

46.  Dr Adamos Adamou MEP, rapporteur to the European Parliament's Committee that produced the resolution on organ donation, however, did regard this as a problem that the EU should not underestimate. His view was that, in large part, trafficking arose as a result of poverty and deprivation in countries outside the EU, but that the demand for trafficked organs resulted from the shortage of donor organs in both EU countries and elsewhere.

47.  Further evidence that we received in relation to organ trafficking and the related phenomenon of "transplant tourism" is reported in chapter 5.


7   op. cit. Back

8   European Parliament resolution of 22 April 2008 on organ donation and transplantation: policy actions at EU level-see
http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+TA+20080422+SIT+DOC+WORD+V0//EN&language=EN 
Back

9   op. cit. Back

10   op. cit. Back

11   op. cit. Back

12   Charter of fundamental rights of the European Union (2000/c 364/01) Official Journal of the European Communities, 18.12.2000 Back


 
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