Directive 2010/53 - Standards of quality and safety of human organs intended for transplantation - Main contents
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official title
Directive 2010/45/EU of the European Parliament and of the Council of 7 July 2010 on standards of quality and safety of human organs intended for transplantation| Legal instrument | Directive |
|---|---|
| Number legal act | Directive 2010/53 |
| Original proposal | COM(2008)818  |
| CELEX number i | 32010L0053 |
| Document | 07-07-2010 |
|---|---|
| Publication in Official Journal | 06-08-2010; OJ L 207, 6.8.2010,Special edition in Croatian: Chapter 13 Volume 062 |
| Effect | 26-08-2010; Entry into force Date pub. +20 See Art 32 |
| End of validity | 31-12-9999 |
| Transposition | 27-08-2012; At the latest See Art 31 |
6.8.2010 |
EN |
Official Journal of the European Union |
L 207/14 |
DIRECTIVE 2010/45/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 7 July 2010
on standards of quality and safety of human organs intended for transplantation
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty on the Functioning of the European Union, and in particular Article 168(4) thereof,
Having regard to the proposal from the European Commission,
Having regard to the opinion of the European Economic and Social Committee (1),
After consulting the Committee of the Regions,
Having regard to the opinion of the European Data Protection Supervisor (2),
Acting in accordance with the ordinary legislative procedure (3),
Whereas:
(1) |
Over the past 50 years organ transplantation has become an established worldwide practice, bringing immense benefits to hundreds of thousands of patients. The use of human organs (hereinafter ‘organs’) for transplantation has steadily increased during the last two decades. Organ transplantation is now the most cost-effective treatment for end-stage renal failure, while for end-stage failure of organs such as the liver, lung and heart it is the only available treatment. |
(2) |
Risks are, however, associated with the use of organs in transplantation. The extensive therapeutic use of organs for transplantation demands that their quality and safety should be such as to minimise any risks associated with the transmission of diseases. Well organised national and international transplantation systems and use of the best available expertise, technology and innovative medical treatment can significantly reduce the associated risks of transplanted organs for recipients. |
(3) |
In addition the availability of organs used for therapeutic purposes is dependent on citizens of the Union being prepared to donate them. In order to safeguard public health and to prevent the transmission of diseases by these organs, precautionary measures should be taken during their procurement, transport and use. |
(4) |
Every year organs are exchanged between Member States. The exchange of organs is an important way of increasing the number of organs available and ensuring a better match between donor and recipient and therefore improving the quality of the transplantation. This is particularly important for the optimum treatment of specific patients such as patients requiring urgent treatment, hypersensitised patients or paediatric patients. Available organs should be able to cross borders without unnecessary problems and delays. |
(5) |
However, transplantation is carried out by hospitals or professionals falling under different jurisdictions and there are significant differences in quality and safety requirements between Member States. |
(6) |
There is therefore a need for common quality and safety standards for the procurement, transport and use of organs at Union level. Such standards would facilitate exchanges of organs to the benefit of thousands of European patients in need of this type of therapy each year. Union legislation should ensure that organs comply with recognised standards of quality and safety. Such standards would help to reassure the public that organs procured in another Member State carry the same basic quality and safety guarantees as those obtained in their own country. |
(7) |
Unacceptable practices in organ donation and transplantation include trafficking in organs, sometimes linked to trafficking in persons 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. This Directive, although having as its first objective the safety and quality of organs, contributes indirectly to combating organ trafficking... |
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