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Brussels, 8th December 2008
What mandate 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). The Treaty therefore provides a clear opportunity and obligation to adopt quality and safety standards for human organs.
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, the level of organ donation does not come close to meeting the demand, and nearly 12 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 and Scandiatransplant), 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.
What preceded the EU organ Directive and action plan?
The Commission adopted a Communication on organ donation and transplantation in May 2007. Three priority areas of action were identified: 1) improving quality and safety of organs, 2) increasing organ availability and 3) making transplantation systems more efficient and accessible. In order to respond to these objectives the Communication suggested two different mechanisms of action: an Action plan for strengthened coordination between Members States on organ donation and transplantation and an EU legal framework (Directive) on quality and safety of human organs.
On 6 December 2007, the Health Council adopted conclusions in line with the Commission's Communication and invited the Commission to continue its examination of the need for an EU framework on quality and safety and to coordinate, promote and strengthen the cooperation between the Member States.
Following the Commission Communication, on 22 April 2008 the European Parliament adopted a Resolution on organ donation and transplantation. The resolution was adopted by huge majority. It welcomed the approach taken in the Commission's Communication, and clearly acknowledged the need for action at European level.
What is the Commission proposing today?
A Directive and Action Plan
The Action Plan on Organ Donation and Transplantation for the period 2009 to 2015 sets out a collaborative approach with 10 European and Member State priority actions. This approach is based on the identification and development of common objectives, agreed quantitative and qualitative indicators and benchmarks, regular reporting and identification of best practices.
The Commission, having gathered the information, knowledge and expertise generated in the field of organ donation and transplantation identifying a detailed list of 10 priority actions. The action plan will promote a number of initiatives aimed at increasing organ donation through organisations changes that have proved effective in some Member States. The action plan will also assist Member States to evaluate the performance of their transplant systems and exchange best practices to improve them.
The regulatory approach of this proposed directive based on a framework model, ensuring that national legislation is put in place to deal with key aspects of organ donation and transplantation but without prescribing detailed policy measures. The Directive will ensure that the quality and safety structures are in place. These will facilitate the conditions for organ exchanges and ensure a basic level of quality and safety for all patients in Europe.
The Directive will complement the action plan. The Directive, given its binding nature, will support and trigger the implementation of key priority actions of the Action Plan. The proposed framework approach in the Directive will deal with the key aspects of organ donation: establishing of competent authorities, authorisation of the conditions of procurements and basic standards for procurement, traceability of the organ, reporting of serious adverse events and reactions, basic protection of the donor and organ characterisation (collection of the relevant information on the characteristics of the organ and the donor needed to undertake an adequate risk assessment in order to minimise the risks for the recipient and to optimise the allocation of the organ.)
This proposed package will leave enough flexibility to Member States to adapt the existing systems where in place and reducing to the maximum red tape and administrative burden.
What is the added value of further EU action in this field?
The Treaty (Article 152.4 a) expressly provides the possibility for the EC to adopt harmonising measures to ensure safety and quality of organs. A national approach could not ensure the same minimum standard of quality and safety for organs as every year a number of organs are exchanged between EU Member States. The establishment of common binding standards of quality and safety will be the only mechanism to ensure a high level of health protection throughout the EU.
Organ shortage is a common dilemma in all European countries. Sharing of best practices, best models and expertise across the EU has already proved useful in increasing organ donor rates in some countries. Experience shows how some organisational models in Europe are performing better than others. (Across Europe, there are big disparities in the number of organ donors, ranging from 34.6 donors per million people in Spain to 13.8 in the UK, 6 in Greece and 0.5 in Romania).
Identifying those elements in the different systems that could be promoted at Community level and will bring a clear European added value, in particular for those Member States with less developed systems.
In addition there are patients that can not be adequately treated in small Member States with limited donor pool, and can clearly benefit from an EU initiative.
[ Figures and graphics available in PDF and WORD PROCESSED ]