Explanatory Memorandum to COM(2008)818 - Standards of quality and safety of human organs intended for transplantation - Main contents
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This page contains a limited version of this dossier in the EU Monitor.
| dossier | COM(2008)818 - Standards of quality and safety of human organs intended for transplantation. |
|---|---|
| source | COM(2008)818  |
| date | 08-12-2008 |
1. Organ transplantation is the therapeutic use of human organs involving the substitution of a non-functional organ by an organ from a donor. Organ transplantation is now the most cost-effective treatment for end-stage renal failure, and for end-stage failure of organs such the liver, lung and heart, it is the only available treatment.
2. The use of organs in therapy poses a risk of transmission of diseases to the recipient; infectious or cancerous diseases could be transmitted. While most Member States have adopted legislation on the ethical aspects of organ transplantation, many have yet to agree on rules covering quality and safety. In 2003, the Commission carried out a survey of legal requirements relating to organ transplantation in the EU which showed discrepancies in quality and safety requirements between Member States i.
3. The exchange of organs between Member States in an effort to achieve better quality in the allocation process is already common practice. There are, however, large differences between the number of organs exchanged across borders between Member States that have set up bodies and laid down rules for the international exchange of organs such as Eurotransplant and Scandiatransplant and the other Member States.
4. The shortage of organs is a major factor affecting transplantation programmes. Nearly 56.000 patients are now on waiting lists i. Mortality rates while waiting for a heart, liver or lung transplant usually range from 15 to 30%. Donation rates and availability of organs varies considerably across Europe with achievable good practice delivering far greater benefits in some Member States than in others.
5. One of the potential consequences of the scarcity of organs is the trafficking of human organs by organised criminal groups. Trafficking in human organs can be linked with trafficking in human beings for the purpose of the removal of organs which constitutes a serious violation of fundamental rights and, in particular, of human dignity and physical integrity. It is recognised that the best way of fighting organ trafficking is increasing the number of available organs and securing their quality and safety. This Directive, although having as its first objective the safety and quality of organs, will indirectly contribute to combating organ trafficking through the establishment of competent authorities, the authorisation of transplantation centres, the establishment of conditions of procurement and systems of traceability.
6. Since 1999, Article 152 of the EC Treaty, as introduced by the Treaty of Amsterdam, has enabled the European Parliament and the Council to adopt health measures setting high standards of quality and safety of organs and substances of human origin, blood and blood derivatives. The Community has already adopted directives, on quality and safety standards for blood in 2003 and for Tissues and Cells in 2004.
7. There are important differences between organ transplantation and the use of other human substances such as blood, tissues and cells. Given the current shortage of organs, two factors have to be balanced: the need for organs' transplantation that is usually a matter of life and death with the need to ensure high standards of quality and safety.
8. The Venice Conference on Safety and Quality in Organ Donation and Transplantation in the European Union was held on 17-18 September 2003 under the Italian presidency. The conclusions of the expert conference organised by the Italian government during its Presidency of the EU Council listed the shortage of organs as the main priority in this area and stressed the importance of addressing the quality and safety aspects given the current situation regarding the supply and demand for organs.
9. When adopting the Tissues and cells Directive on 31 March 2004, the Commission committed itself to conducting a thorough scientific review of the situation regarding organ transplantation. On 31 May 2007, the Commission adopted a Communication on organ donation and transplantation i based on that analysis. This Communication proposes what activities the EU should undertake in the field of organ transplantation. The Communication concludes that a flexible European legal framework establishing quality and safety standards would be the right Community response to meeting the mandate provided in Article 152 i (a) of the Treaty.
10. On 6 December 2007, the Council adopted conclusions on organ donation and transplantation. The Council recognises the importance of having high standards with respect to the quality and safety of organs for transplantation, so as to ensure a high level of protection for patients throughout Europe and called on the Commission to consult the Member States, and continue its examination of the need for an EU framework on quality and safety for human organs.
11. The European Parliament resolution adopted on 22 April 2008 recognised that it is vitally important to improve the quality and safety of organ donation and transplantation to reduce transplant risks. Hence, the resolution looks forward to the Commission’s proposal for a directive stipulating requirements to ensure the quality and safety of organ donation across the EU.
Contents
12. This proposal for a Directive covers human organs, that are used for transplantation, during all the phases of the process – donation, procurement, testing, preservation, transport and use – and aims to ensure their quality and safety and hence a high level of health protection.
13. The proposal excludes blood and blood components, human tissues and cells and organs or tissues and cells of animal origin. Blood and blood products are currently covered by Directives 2002/98/EC, 2004/33/EC, 2005/61/EC and 2005/62/EC, whereas Human Tissues and Cells are regulated by Directive 2004/23/EC, 2006/17/EC and 2006/86/EC.
14. This Directive does not intend to cover research using human organs, for purposes other than transplantation. However, organs that are transplanted into the human body in clinical trials should comply with the quality and safety standards laid down in this Directive.
15. This proposal aims to ensure that human organs used for transplantation in the EU comply with the same quality and safety requirements. In this way, the Directive will facilitate their exchange between Member States.
Ensuring quality and safety for patients at EU level
16. There are significant risks to using organs in therapy, but these can be effectively offset through the application of quality and safety procedures. A well-regulated donation and transplantation system is essential if organs are to be delivered on time, with accurate information and without any unnecessary risk of transmitting disease to the recipient.
17. This Directive sets out the basic quality and safety requirements needed in every transplant system. A sound infrastructure and responsible institutions for organ procurement and transplantation have been identified as the main features of a successful transplantation system. The proposed Directive provides for the creation or designation of a competent national authority in each Member State. These Competent authorities will ensure compliance with the requirements of the Directive. The Directive also establishes a system for the authorisation of programmes of organ procurement and transplantation based on common quality and safety criteria i. This system would provide a complete list of authorised centres throughout the European Union, accessible to the public and professionals alike.
18. Procurement, evaluation and selection of the donor are the first and decisive steps in the transplantation chain. The proposed Directive will establish common quality and safety standards for the processes of evaluating donors and human organs, thus ensuring the health of recipients.
19. Of equal importance is to ensure the quality of the processes performed by the various organisations in the field. To improve these processes, the Directive proposes the introduction of national quality programmes to ensure continuous monitoring of performance and improvement and learning. Specific standards for the procurement and transport of human organs and training of professionals will be part of the national quality programmes.
20. Establishment of a system to ensure that all organs can be traced from donation to reception and vice versa is a key factor to ensure safety but also in order to prevent remuneration, trade and trafficking in organs. The proposed Directive will ensure that Member States put in place organ traceability systems. The Commission will adopt procedures for guaranteeing full traceability of organs exchanged between Member States. Traceability does not mean that the organ receiver will learn the names and further details of the donor, or vice versa. Traceability therefore aims at safeguarding the health of donors and recipients and serves no other purpose than guaranteeing the quality and safety of the organs. The anonymity of both the donor and the recipient remains a cornerstone for their protection. But the relevant competent authorities should keep the necessary documentation and records, e.g. where the organ originated from, who supplied it and under which circumstances.
21. As organ donors are often also tissue and cell donors, it is additionally important that information about adverse events and infections can be quickly traced to a donation and immediately relayed to the tissue vigilance system provided for by the Tissue and Cell Directive 2004/23/EC. Currently such a system does not exist.
22. In addition, the proposal includes measures to capture serious adverse events related to the procurement, testing and transport of organs, as well as any serious adverse reactions observed during or after transplantation which may be connected to the procurement, testing and transport of the organ in the European Union. The Commission will adopt procedures for ensuring interoperability between the reporting systems on adverse events and reactions.
23. The use of human organs should be under conditions protecting the rights and health of donors. As a matter of principle, organ transplantation programmes should be based on the principle of voluntary and unpaid donation, altruism of the donor and solidarity between donor and recipient while ensuring anonymity of the deceased donor, the living donor (when relevant) and the recipient(s) and the protection of personal data. They should comply with the Charter of Fundamental Rights of the European Union, and take the principles of the Convention of Human Rights and Biomedicine of the Council of Europe fully into account.
24. Consent for procurement is as a general rule regulated by Member States in very different ways; ranging from presumed consent systems to systems where the consent of relatives is required. The Commission believes that this is a very sensitive field and that it raises a number of ethical concerns that falls within the competence of the Member States and should not be dealt with in this Directive.
25. The use of living donors is an increasing alternative given the failure to meet the growing need for organs with cadaver donation. The increase in living organ donation can be attributed to multiple factors, including pressure created by the shortage of deceased donors, surgical advances, and strong evidence of favourable transplant outcome and low donor risk.
26. The proposed Directive contains a number of measures to protect living donors. These include correct evaluation of the health of the donor and comprehensive information about the risks prior to donation, the introduction of registers for living donors to follow up their health and measures to ensure the altruistic and voluntary donation of organs by living donors.
27. The current proposal seeks to ensure a high level of quality and safety throughout the ‘organ transplantation chain’ in all Member States, bearing in mind the freedom of movement of citizens and the need to enhance the cross-border exchange of organs within the European Union. The establishment of quality and safety standards will help to reassure the public that human organs derived from donation in another Member State carry nonetheless the same guarantees as those in their own country.
28. The cross-border exchange of organs has clear benefits. Given that donor and recipient have to be matched, a large donor pool is important to cover the needs of all the patients on the waiting lists. If there is no exchange of organs between Member States, recipients in need of a rare match will have very low prospects of finding an organ, while at the same time donors will not be considered because there are no compatible recipients on the waiting lists. This holds particularly true for difficult to treat patients (paediatric, urgent or hypersensitised patients that require very specific matching) and small Member States.
29. The Directive will put in place the quality and safety conditions needed to facilitate cross-border exchanges. It will standardise the collection of the relevant information on the characteristics of the organ needed to make a proper risk assessment. It will also establish a mechanism for transmission of the information. 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. This will minimise the risks to the recipient and optimise the allocation of the organs across the EU level.
30. In addition the Directive will provide for the necessary mechanisms to be put in place for cross-border exchanges of organs to ensure traceability of the organ and pre-empt serious adverse reporting.
31. The establishment of competent authorities in all Member States and the organisation of regular meetings between them will help to promote European cooperation in this field as shown in the cases of blood and tissues and cells. Coordination between these authorities would make for a more efficient allocation of organs (especially helpful for smaller Member States and for urgent and difficult–to-treat patients). As more people move across borders information will need to move with them to optimise donation and transplantation while maintaining citizens’ confidence in the system in the country they are visiting.