Brussels, 8 December 2008
Today, the Commission adopted important safety and quality measures for organ donation and a 10 point action plan to work with Member States on strengthening organ donation and transplantation systems in Europe. For many patients, organ transplantation represents the only life saving treatment available. There are currently 56,000 patients waiting for a suitable organ donor in the EU. It is estimated that every day 12 people die while waiting for transplantation. The Directive and Action Plan address three key challenges: improving the quality and safety of organs across Europe, increasing organ availability and making transplant systems more efficient and accessible.
Health Commissioner Androulla Vassiliou said: "These measures are all about saving lives. We want to reassure citizens and patients across Europe that the EU and Member States are working together to maximise efforts to provide high quality and safe transplantation systems."
Organ Quality and Safety measures – the Directive
The Directive provides a clear legal framework for organ donation and transplantation in the European Union. Concretely this means that in every Member State a national competent authority will be created or designated to ensure compliance with EU quality and safety standards. These standards include establishing a traceability system of human organs and a reporting system of serious adverse events and reactions. To facilitate exchange of human organs, data collection on specific organ characteristics will be standardised. Finally, national quality programmes will ensure continuous monitoring of performance and result in improved processes and learning. The goal of this Directive is to minimise the risk for the organ transplant recipient, to improve and optimise the allocation of organs across the European Union and to provide the transplant surgeon with the necessary information to make the best choice.
10 point Action Plan
The Action Plan (2009-2015) is a 6 year plan with 10 priority actions addressing the 3 key challenges in organ donation and transplantation in Europe. These are: improving the quality and safety of organs across Europe, increasing organ availability and making transplant systems more efficient and accessible. The Action Plan aims to stimulate joint actions and facilitate coordination with Member States. This will be achieved through different mechanism such as exchanging good practice or creating EU wide agreements on specific topics. For example, one priority area is improving the knowledge and communication skills of health professionals and patient support groups on organ donation. A second key area is the exchange of experiences on the use of Transplant Donor Coordinators to increase the number of available organs.
On 31 May 2007, the Commission adopted a Communication on organ donation and transplantation. This Communication and the accompanying Impact Assessment made a number of suggestions for actions at Community and Member State level. The actions are designed to help increase the supply of organ donors across the EU and ensure the quality and safety of these procedures.
The Communication proposed a dual mechanism for action: an Action Plan enhancing active coordination and cooperation between Member States complemented by a legal instrument containing the common quality and safety requirements.
On this basis, the Commission developed the draft directive and action plan it has adopted today.
The Directive on quality and safety of organ donation and transplantation and The Action Plan for closer cooperation between MS on organ donation and transplantation can be found at: