Brussels, 19 May 2010
Why do we need an EU Directive on Organ Donation and Transplantation?
The number of organ donations and transplantations has grown steadily across the EU and thousands of lives are saved every year through this medical procedure. Organ transplantation is now the most cost-effective treatment for end-stage renal failure. For end-stage failure of organs such as the liver, lung and heart it is the only available treatment.
Currently, there are wide variations in quality and safety requirements between Member States. A national approach could not ensure a minimum standard of quality and safety for the organs that are exchanged between EU countries each year. A Directive is needed to ensure a high level of health protection throughout the EU by establishing common standards of quality and safety of human organs intended for transplantation.
How will this Directive address these problems?
The Directive will ensure that the necessary quality and safety structures are put in place across the EU for the donation and transplantation of organs. This will also facilitate the exchange of organs and expand the pool of organs available, ensuring a better match between donor and recipient. It will do so via several means:
A competent authority will be appointed in each Member State, where one does not already exist, to make sure that the quality and safety standards of the Directive are complied with;
A system for the authorisation of organ procurement and transplantation will be established, based on common quality and safety criteria;
National quality programmes will be introduced to ensure continuous monitoring of performance, leading to learning and improvement;
Member States will put in place organ traceability systems and systems for the reporting of serious adverse events and reactions;
Transplant teams in all Member States will be reassured that they will receive the appropriate and complete information required regardless of the country of origin of the organ;
These standards will help to reassure the public that human organs procured all over the EU will carry the same basic quality and safety guarantees, regardless of the country. Moreover, measures introduced by the Directive such as the establishment of competent authorities and systems of traceability should help to fight "organ trafficking".
Are there already some good examples of cooperation in Europe?
There are already areas covered by international agreements where the interchange of organs between countries accounts for up to 20% of total organ transplants. This exchange of human organs is carried out within recognised quality and safety standards. Eurotransplant is the largest such organ exchange organisation and includes Austria, Belgium, Croatia, Germany, Luxembourg, the Netherlands and Slovenia as members. Eurotransplant also exchanges with other national and international organisations. Scandiatransplant is a Nordic organ exchange organisation and covers a population of 24,5 million inhabitants in five countries: Denmark, Finland, Iceland, Norway and Sweden.
Now that this Directive has received a positive vote in the European Parliament, what happens next?
After adoption by the Council and publication in the Official Journal in June 2010, the Member States now have 24 months to transpose the Directive into national law. The Directive leaves enough flexibility to Member States to accommodate the existing systems where in place, so red tape and administrative burdens should be minimal. Member States shall report to the Commission every 3 years on the implementation of the Directive.
What is the Action Plan on organ donation and transplantation and how does it tie in with the Directive?
The Directive and the Action Plan on organ donation and transplantation are mutually reinforcing. While the Directive lays down binding measures to be adopted by the Members States for the quality and safety of organs, the Action Plan, adopted in 2009, has a broader scope, covering also the availability of organs and efficiency of transplantation systems. The Action Plan runs for the period 2009 to 2015 and sets out 10 priority actions. Nearly 12 people die every day in Europe while waiting for an organ. The availability of organs varies widely between European countries and we are far from meeting the demand. The lowest deceased donation rate in Europe is 1 organ donated per million inhabitants. Spain has the highest rate, with 33.8 organs donated per million inhabitants. The Action Plan will help increase the number of organs for transplantation. The approach is collaborative between Member States and based on the identification and development of common objectives, agreed quantitative and qualitative indicators and benchmarks, regular reporting and identification of best practices. The Action Plan will promote a number of initiatives aimed at increasing organ donation through organisation changes that have proven effective in some Member States. It will also help Member States to evaluate the performance of their transplant systems and exchange best practices to improve them.