Select Committee on European Scrutiny Twenty-Seventh Report


6 Organ donation and transplantation

(28686)

9834/07

ADDs 1-2

COM(07) 275

Commission Communication: Organ donation and transplantation: policy actions at EU level

Legal base
Document originated30 May 2007
Deposited in Parliament11 June 2007
DepartmentHealth
Basis of considerationEM of 20 June 2007
Previous Committee ReportNone
To be discussed in CouncilNo date set
Committee's assessmentPolitically important
Committee's decisionCleared

The European Community's responsibilities for public health

6.1 Article 152 of the EC Treaty requires the Community to encourage cooperation between Member States to improve public health and prevent human illness and disease. It also requires Member States, in liaison with the Commission, to coordinate their public health policies and authorises the Commission to "take any useful initiative to promote such coordination". Moreover, it expressly requires the Council to adopt measures setting high standards for the safety and quality of human organs. However, Article 152(5) requires Community action to respect fully the responsibility of Member States for the organisation and delivery of health services and medical care; in particular, it provides that Community measures on organs must "not affect national provisions on the donation or medical use of organs".

6.2 In 2003, the Council adopted a Directive on standards of quality and safety for human blood; and, in 2004, it adopted a Directive on the safety and quality of tissues and cells.

The Commission's Communication

6.3 The Communication sets out the action the Commission intends to take to ensure the quality and safety of organs donated for transplantation; to increase donations; and to deter trafficking in human organs.

6.4 The Commission believes that action by the Community is needed because:

  • donated organs can transmit disease or illness to their recipients;
  • there is a shortage of organs throughout the Community — every day, ten people die while waiting for a transplant and there are 40,000 people on waiting lists for a transplant;
  • donation and transplantation rates are much higher in some Member States than in others;
  • there is some legal transfer of donated organs between Member States and some people are travelling from their home Member States to others to get transplants; and
  • the shortage of organs is an incentive to organised criminal groups to traffick in human organs.

6.5 The Communication is based on views the Commission invited from Member States, health organisations, scientific institutions and associations representing patients and donors. It also takes account of meetings the Commission arranged with a wide range of experts and of the findings of research funded from the EC's R&D programme.

6.6 The Commission proposes to prepare an Action Plan for strengthening cooperation between Member States. It will also draft EC legislation on quality and safety standards for organ donation and transplantation.

6.7 The Commission notes that:

    "Analysis of the organ transplantation situation in the EU has revealed large differences in the deceased and living organ donor rate within the EU and also considerable differences in transplantation activity. These differences cannot be easily explained and it is clear that some models are performing better than others. There is scope for sharing expertise among EU Member States and for cooperation between countries to help maximise organ donation and equalise access to transplantation. The Community will identify the best of the best models and support its application throughout the EU while respecting cultural and organisational diversity."[22]

6.8 The Commission says that the Action Plan should apply the "open method of coordination"[23] to organ donation and transplantation in order to help Member States agree common objectives and performance indicators, monitor outcomes and share best practice. The Action Plan could cover such matters as:

  • ways to increase donation rates through, for example, donor cards, public education and awareness raising campaigns;
  • training for doctors and other staff who deal with potential donors and their families;
  • guidelines on offering any surplus organs to other countries;
  • arrangements for assessing, allocating and transporting organs; and
  • systems to record and trace transplanted organs.

6.9 The Communication stresses the importance of the international agreements which ban trafficking in human organs. For example, it refers to the UN Treaty against international organised crime which requires the parties to the Treaty to criminalise trafficking and penalise traffickers. The Commission says that "it will closely monitor any developments in the organ trafficking field both inside the EU and worldwide".[24]

6.10 The Commission also plans to propose EC legislation on organ donation and transplantation. The legislation might include :

  • quality and safety standards for the authorisation of organ donation and for the preservation and transport of donated organs;
  • requirements for the establishment and maintenance of donor records and systems for tracing organs and reporting adverse reactions; and
  • provision on inspection and control of donations and transplants.

6.11 The Commission staff working document (ADD 1) enlarges on the proposals in the Communication, provides supporting information and discusses the impact of the Commission's preferred course of action and alternatives to it.

The Government's view

6.12 The Minister of State for Health Services at the Department of Health (Ms Rosie Winterton) tells us that the Commission's proposals "are broadly in line with policy across the UK to increase the number of high quality and safe organs available for transplantation". She adds, however, that:

    "We will need to ensure that the principle of subsidiarity continues to be respected — in a couple of places the document talks about the best models for organising services to increase donation. Although we support the sharing of good practice, final decisions on the organisation of health services must rest with Member States."

6.13 The Minister also tells us that officials from her Department and from NHS Blood and Transplants (which is responsible for the matching and allocation of organs for transplantation) will be meeting the Commission and experts from other Member States to discuss such matters as common objectives, indicators and how to identify best practice. They will also discuss what provision might be included in a new Directive on organ donation and transplantation.

Conclusion

6.14 We are satisfied that Article 152 of the EC Treaty provides an appropriate legal base for Community action on organ donation and transplantation. We also recognise the potential benefits of cooperation between Member States to disseminate best practice and agree common minimum standards for the safety and quality of donated organs. But we endorse the Minister's cautionary words about the need for vigilance to ensure that Community action is consistent with the principle of subsidiarity. It will also be necessary to ensure that the proposed Directive is compatible with the requirement of Article 152(5) that the measure should not "affect national provisions on the donation or medical use of organs".

6.15 We regard the Communication as a useful contribution on an important aspect of public health. Accordingly, we draw the document to the attention of the House. We shall reserve further comment until the Commission presents its proposals for the Action Plan and a new Directive. Meanwhile, we clear the Communication from scrutiny.


22   Commission Communication, page 10, first paragraph. Back

23   In March 2000, the European Council defined the open method of coordination. Its purpose is to help Member States develop their own policies by agreeing European guidelines and timetables for short, medium and long-term goals, quantitative and qualitative indicators and benchmarks. Member States then translate the guidelines into national and regional policies. Outcomes are subjected to periodic monitoring, evaluation and peer review. Back

24   Ibid, page 8, last paragraph. Back


 
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Prepared 6 July 2007