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Brussels, 27 June 2006

Questions and Answers on organ donation and transplantation in the EU

What power does the European Commission have to take action on 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 (see IP/02/1919) and on tissues and cells (see IP/04/288). 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 with regard to organ 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 population in Spain to 6 per million population in Greece, and the exchange of organs between Member States is not common practice. When it comes to quality and safety requirements for organ donation and transplantation, there are large discrepancies between 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 between Member States when it comes to organ donation?

It is difficult to attribute the differences between Member States in organ donation and transplantation rates to one single factor, but several influencing factors 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 for organising and carrying out transplants, often based on history, 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 transplantation.

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 which surround 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 at EU level with regard to organ donation and transplantation?
A number of initiatives related to organ transplantation have already been undertaken by the European Commission in various policy areas.

  • Health and Consumer Protection Directorate General is currently working towards a new project to develop a European Training Program on Organ Donation.
  • The Information Society Directorate General is supporting the creation of a European online registry on organs, cells and tissues through the EUROCET project.
  • In the area of research, a number of projects are being carried out related to organ donation and transplantation. For example, there is a project to develop a list of national and regional research programmes on organ transplantation, in order to make the most of 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.
  • In the area of Justice, Freedom and Security, a project is underway which aims to compile information on national legislation on organ trafficking, and to identify the main problems and potential solutions.

What is the aim of the consultation on organ donation and transplantation policy options?

The consultation document firstly outlines some of the main problems in the EU in the area of organ donation and transplantation, and then invites stakeholders to provide further information on the current situation in this field. This information will enable a discussion between stakeholders and EU institutions on future measures that could be taken at EU level in order to address the identified problems. The consultation document outlines some possible future policy options (see below), asking stakeholders for feedback and further ideas. It also asks how the EU can maximise its role in ensuring the quality and safety of organs. On the basis of the feedback received through the consultation, the Commission will consider what future action to take in this field.

What could be the benefits of EU-level action with regard to organ donation and transplantation?

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 potential for further organ exchange. Among the areas highlighted by the Council of Europe as possibilities for a more coordinated approach were the authorisation of donation and procurement standards, establishments and programmes and the maintenance of donor records.

There are large differences between Member States when it comes to quality and safety requirements for organ donation and transplantation, as well as diverse organisational approaches which 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 encourage greater exchange of organs between Member States and would provide assurances to patients donating or receiving organs outside of their own Member State.

What options does the consultation document suggest in terms of EU action on organ donation and transplantation?
As a basis for discussion, the Commission consultation document puts forward 3 possible options for future EU action with regard to organ donation and transplantation. These are:

  1. No intervention or coordination at EU level in this area, but continuation of the basic projects already being carried out under different EU programmes (see above).
  2. Active coordination between Member States on organ quality, safety and availability. This would mean the development of a European structure to promote active coordination between Member States on organ donation and transplantation. Measures could include:
  • Establishing guidelines for quality and safety standards
  • Sharing experiences and best practice
  • Promoting European registers on transplantation
  • Promoting more training of EU professionals in this field
  • Identifying the main problems at EU-level when it comes to organ exchange
  • Working for further international cooperation on maximising organ donation
  • Reviewing the legal framework on organ trafficking
  1. Active coordination between Member States, as outlined in Option 2, and in addition, possible EU legislation on quality and safety standards. An EU Directive on organs could set quality and safety requirements for their donation, procurement, testing, preservation, transport and distribution. Furthermore, the Commission could look into proposing legislation against organ trafficking, which would define offences to be punishable in every Member State.

Could there be harmonised EU legislation on donation consent in the future?

This is very unlikely. Article 152 of the EU Treaty enables the Commission to propose initiatives which would ensure better quality and safety standards in organ donation, but it does not allow EU-level legislation when it comes to the organisation and delivery of health services and medical care. Consent for donation is a particularly sensitive issue, which needs to take into account local and cultural attitudes to donation and transplantation. Some Member States presume consent unless it is specifically refused by an individual in life or their family after death, while other Member States require a signed consent form or donor card before donation can proceed. National authorities are responsible for deciding the legal requirements and practices regarding donation consent in their own Member State, and for ensuring that their citizens are aware of their rights in this area.

What are the next steps after the consultation?

The consultation will run for 6 weeks, after which the Commission will compile and analyse the feedback received. On the basis of these results, the Commission will draw up a Communication on organ donation and transplantation at the end of 2006 or early 2007, proposing initiatives to be taken at EU level in this field.

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