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Image header Agence Europe
Europe Daily Bulletin No. 9609
Contents Publication in full By article 26 / 33
GENERAL NEWS / (eu) eu/health

Commission prepares transplant action plan and directive of quality and safety of transplants

Brussels, 25/02/2008 (Agence Europe) -European Commission Health and Consumer Protection Directorate General (SANCO) is currently working on two texts following on directly from the May 2007 communication on organ donation and transplantation. An action plan, largely using the open method of communication, will help develop best practice and enhance cooperation between member states. This text will be accompanied by a draft directive on the quality and safety of organ donation and transplantation.

The action plan will set out a number of objectives and priority actions to encourage increased organ donation and improve the organisation of transplant systems. Nearly ten patients die in Europe every day while awaiting an organ transplant. Waiting lists are growing faster than organ donor rates. The first priority will be to improve the availability of organs for transplant, through the implementation of the Council of European recommendation. Member states will have to identify all potential donors, so as to be able to reach the full potential of deceased donations. The working paper highlights the role that could be played by a donations coordinator in every hospital. The Commission, the working paper says, should put in place a number of indicators (number of donors per million inhabitants, multi-organ donations, the number of hospitals which have a quality assurance programme, transplant rate, donation refusals, waiting lists, etc) to be able to gauge the performance of each member state. Every hospital should put in place quality improvement programmes. These programmes should cover intensive care services and, in particular, ensure the highest level of quality at each stage of the organ removal.

Encouraging organ donation remains useful and, along with discussion and explanation of organ donation with the family of deceased potential donors, is a priority of the future action plan. There could be action targeted at minorities, particularly religious, which are reluctant to give organs. According to a 2006 Eurobarometer report, eight Europeans out of ten support the idea of an organ donation card. But there is a wide gap between the idea and the actual use of such cards: only 12% of European citizens carry one, and in the new member states, this figure falls to 1%. Some member states require express consent, while others assume consent. The various donor cards have, then, a limited impact, particularly since medical staff usually have to obtain the consent of the family. In view of the increasing cross-border mobility within Europe, the Commission is considering a European organ donor card to raise public awareness and increase donation rates.

The legislation on giving donations varies widely from one member state to another, particularly because of the potential risks run by the donor, but the Commission wants to improve the sharing of best practice between member states on this matter.

Relatively few organs are exchanged between member states. This is in part due to the conditions of the specific transplant. But the lack of a network linking the various national authorities is also a factor. Interchange of organs is higher in the Eurotransplant and Scanditransplant areas. The working paper suggests developing network cooperation and adopting guidelines for patients who are difficult and/or whose situation is critical.

The Commission is also considering a Europe-wide agreement on conditions for registration of patients on the waiting lists of a number of member states, reimbursement conditions and after-care services following the transplant. The creation of a European transplant research network is another possibility.

Following on from directives already adopted on the quality and safety of blood and blood derivatives (2003), and tissues and cells (2004), the Commission is likely to propose setting quality and safety standards for the donation, removal, analysis, transport, preservation and transplant of organs. As with other substances of human origin, the text will ensure the donation is free and the donor's identity remains anonymous. It will also guarantee organ traceability and notification of any adverse events or reactions. Apart from the adoption of national quality programmes, member states will have to put in place a system of accreditation of transplant establishments and to ensure that staff have received training specific to transplant-related activities. (O.J.)

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