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Summaries of EU Legislation

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Quality and safety of organs intended for transplantation

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Quality and safety of organs intended for transplantation

SUMMARY OF:

Directive 2010/53/EU on standards of quality and safety of human organs intended for transplantation

SUMMARY

WHAT DOES THE DIRECTIVE DO?

  • It lays down rules to ensure quality and safety standards for organ transplantation.
  • It seeks to ensure donors and recipients are guaranteed the same quality, safety and legal standards no matter where they live.
  • It covers organ donation, testing, characterisation, procurement, preservation, transport and transplantation.

KEY POINTS

EU countries must ensure:

  • A quality and safety framework is in place to cover the entire organ chain from donation to transplantation or disposal. This must include the donor's identity and the person's or family's consent, as well as other conditions set out in the legislation.
  • Donor selection and evaluation are carried out by recognised doctors and organisations, with suitably qualified healthcare personnel.
  • Minimum data about the donor are available, such as age, weight and past or present medical history.
  • Transport of organs meets certain requirements such as correct labelling and identification.
  • The procurement and transplant of organs can only take place in centres authorised for the purpose in line with the EU legislation.
  • All organs can be traced from the donor to the recipient, and vice versa, for a minimum of 30 years.
  • They put in place a system to report, investigate, register and transmit relevant information about any serious adverse event or reaction. Information must also be exchanged when organs are exchanged between EU countries.
  • Donations of all organs from deceased and living donors are voluntary and unpaid and they should be accompanied by the necessary consent.
  • Living donors are carefully selected and screened. They have to be guaranteed the highest possible levels of protection.
  • All personal data are ‘fully and effectively protected’.
  • Their competent authorities regularly exchange information in a network set up by the European Commission.

WHEN DOES THIS DIRECTIVE APPLY?

It entered into force on 26 August 2010. EU countries had to incorporate it into national legislation by 27 August 2012.

BACKGROUND

Organ transplant operations now literally mean the difference between life and death for hundreds of thousands of people worldwide. They improve the quality of life of patients, are often the most cost-effective treatment, and sometimes only way to treat liver, lung and heart failure.

  • For more information, see the section Organs on the European Commission's website.

ACT

Directive 2010/53/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 (OJ L 207, 6.8.2010, pp. 14–29)

Corrigendum to 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 (OJ L 243, 16.9.2010, p. 68)

RELATED ACTS

Commission Implementing Directive 2012/25/EU of 9 October 2012 laying down information procedures for the exchange, between Member States, of human organs intended for transplantation (OJ L 275, 10.10.2012, pp. 27–32)

Commission Staff Working Document on the mid-term review of the ‘Action Plan on Organ Donation and Transplantation (2009-2015): Strengthened Cooperation between Member States’ (SWD(2014) 147 final of 25.4.2014)

Report from the Commission to the European Parliament and the Council on the exercise of the power to adopt delegated acts conferred on the Commission pursuant to Directive 2010/53/EU of the European Parliament and of the Council of 7 July 2010 on the standards of quality and safety of human organs intended for transplantation (COM(2015) 123 final of 10.3.2015)

last update 12.01.2016

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