MEMO/07/212

Brussels, 30 May 2007

Q&A on organ donation and transplantation in the EU

What power does the European Commission have to take action in the field of human organs?

Since 1999, the EU has had the mandate, under Article 152 of the Treaty, to legislate on quality and safety standards for human tissues and cells, human organs, and blood used in medical treatment. EU Directives have already been adopted on blood (IP/02/1919 -http://ec.europa.eu/health/ph_threats/human_substance/legal_blood_en.htm)
and on tissues and cells (IP/04/288 - http://ec.europa.eu/health/ph_threats/human_substance/legal_tissues_cells_en.htm) A similar Directive on the quality and safety of organs could be envisaged in the future, depending on the outcome of the consultations and assessments currently being carried out by the Commission.

What is the current situation regarding donation and transplantation in the EU?

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. However, there are also many problems in this sector. The level of organ donation does not come close to meeting the demand, and nearly 10 people die every day in Europe while waiting for an organ. There are wide variations between Member States in organ donation rates, ranging from 34.6 donations per million people in Spain to 0.5 per million in Romania. The exchange of organs between Member States is not common practice with the exception of those areas covered by international agreements (Eurotransplant), where the interchange of organs accounts for up to 20% of total organ transplants. When it comes to quality and safety requirements for organ donation and transplantation, there are large differences among Member States, while the organisational approach to transplantation varies from country to country, leading to uneven standards across the EU.

Why are there such disparities?

It is difficult to attribute the differences between Member States in organ donation and transplantation rates to one single factor, but several reasons have been identified.

Organisation: Firstly, organ donation and transplantation is an extremely complex procedure that requires a well-developed organizational structure. Each Member State has its own particular methods of organising and carrying out transplants, often based on type of health systems and available resources.

Training opportunities and the number of qualified doctors to carry out the transplantations also varies from one country to another. Some of the newer Member States face greater health problems than the rest of the EU, but have fewer resources to address them, particularly when it comes to highly complicated operations such as transplantations.

Approach: Some Member States have dedicated more resources than others to proactively seeking potential donors (both live and dead).

Attitude: Different societies have different attitudes towards organ donation, often based on cultural and social factors. Family refusals to donation also vary widely within Europe, ranging from 6% in Portugal to 42% in the UK. The level of public awareness of organ donation and the ethical issues surrounding it, variations in the legal procedures for donor consent, and different practices on organ registration and allocation, can influence public perceptions of donation and transplantation and the willingness to donate organs.

What is already being done by the EU?

The European Commission has already undertaken a number of initiatives in various policy areas.

• The Health and Consumer Protection Directorate General is currently working towards two new projects to develop a European Training Program on Organ Donation and to contribute to create a consensus on European common standards regarding legal, ethical, protection and registration practices in relation to organ living donors in order to guarantee these donors health and safety.
• The Information Society Directorate General is supporting the creation of a European registry on organs, cells and tissues through the EUROCET project.

https://www.eurodonor.org/eurocet/

• In the area of research, a number of projects are being carried out. For example, there is a project to develop a list of national and regional research programmes on organ transplantation in order to maximise the research already being carried out and avoid duplication. A separate European research project is focusing on ways to increase the potential of organ donation, such as promoting cooperation and sharing information and best practices among certain European countries. Another project is focussed on reprogramming the immune system to tolerate transplanted organs.

What could the benefits of EU-level action be?

In 2004, the Council of Europe issued a recommendation for minimum common standards on organ donation across the EU, given the rise in patient mobility and the potential for further organ exchange. The authorisation of donation and procurement standards, establishments and programmes and the maintenance of donor records were among the areas singled out for a more coordinated approach. There are large differences among Member States when it comes to quality and safety requirements for organ donation and transplantation, as well as diverse organisational approaches that yield varying results. More cooperation in this field, including the exchange of good practice, could help to raise the overall standard of donation and transplantation across the EU. Collaboration on organ donation and transplantation could be of particular benefit to some of the newer Member States whose health systems have fewer resources and are, therefore, under more pressure when it comes to transplantation.

In addition, harmonised quality and safety standards could help to encourage greater exchange of organs between Member States and would provide assurances to patients donating or receiving organs outside of their own Member State.

Where should EU action focus on?

Four fields have been identified as the main areas of action in organ donation and transplantation:

• Improving quality and safety: The Commission will define a precise and balanced scope of the EU legal framework on quality and safety for human organs. This framework needs to be backed up by cooperation between Member States leading to the compilation of sufficient information that will assist in determining the acceptable levels of risk in the use of expanded donors and by the promotion of good medical practices and evaluation of post-transplant results (“organovigilance”)
• Increasing organ availability: The Commission will promote cooperation between Member States in order to share experience and best practices with a view to establishing efficient systems for organ donor detection and procurement. Other areas where cooperation is important include the promotion of training of professionals based on best experience, exploring the promotion of donations from living donors and evaluating the use of expanded donors, taking into account the quality and safety aspects. It will also be important to pool efforts and expertise in order to increase public awareness. In this context the creation of a European organ donor card or its incorporation into the existing European insurance health card is to be considered.
• Making transplantation systems more efficient and accessible: Like other healthcare access issues, this question has to be seen in relation to other initiatives at Community level in this area. Initiatives will be focused on identifying the most efficient systems, sharing experience and promoting best practices in accordance with local characteristics. Those Member States whose transplant systems are not yet sufficiently developed can be supported and guided in their efforts to improve patient care. Other actions will be geared to identifying needs at EU level for the interchange of organs. Guidelines for systems for offering surplus organs to other countries can be evaluated, with special reference to the exchange of organs for urgent patients and difficult-to treat patients. The increasing mobility of people within the EU makes it necessary to identify the main problems regarding patient mobility. It will also be important to secure EU-wide agreement on all issues concerning transplant medicine for extra-Community patients (“non-residents”).
• Fighting organ trafficking: The Commission will closely monitor any developments in the organ trafficking field.

What are the next steps after the Communication?

As next steps the Commission proposes the following:

• Action plan on strengthened cooperation between Member States. 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.
• An action plan for closer cooperation between Member States, specifically tailored to this concrete field, will provide the necessary policy mix to achieve a gradual approach to the development of an EU policy. This approach should be based on the identification and development of common objectives for which it is agreed that a Community response is necessary, agreed quantitative and qualitative indicators and benchmarks, regular reporting, and identification and sharing of best practices.
• EU Directive on quality and safety of organ donation and transplantation. The Community has already adopted Parliament and Council Directives on quality and safety standards for blood and for tissues and cells. A European Directive setting standards of quality and safety for organs will address similar topics; however, the risk-benefit ratio is a fundamental approach to organ transplantation. Because of organ shortage and life threatening diseases that can be treated with organ transplants, the benefits of an organ transplantation are high and more risks can be accepted than with blood or most tissues and cells treatments. In this context the clinical doctor has an important role in the decision on the acceptance of organs for transplantation. The Commission proposal will take into account these specificities of organ donation and transplantation.

The future legal instrument will include the principles needed to establish a basic quality and safety framework, such as:

• establishment of an oversight authority
• A common set of quality and safety standards for the authorization of establishments and programs of organ donation and procurement, and also for effective preservation and transportation of organs
• Ensure traceability and reporting of serious adverse events and reactions
• Establishment of inspection structures and control measures
• Ensure a complete characterisation of the organ, in order that the transplant team could undertake the appropriate risk assessment.

Taking into account the opinion of the European Parliament and of the Council on the Communication, the Commission will draw up an action plan and a Directive on quality and safety at the end of 2008 or early 2009.