EU Organ Donation Directive


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

The European Union Organ Donation Directive (EUODD) sets minimum standards that must be met across all Member States in the EU, ensuring the quality and safety of human organs for transplantation. Achieving equivalent minimum standards will promote effective movement and end use of donated organs across all Member States. Members of the public in each Member State will have increased confidence in the quality and safety of donated organs.

The Human Tissue Authority (HTA) is the Competent Authority for the implementation of the Directive across the United Kingdom.

HTA: The Quality and Safety of Organs Intended for Transplantation: a documentary framework

The EUODD has been written into UK law through the Quality and Safety of Organs Intended for Transplantation Regulations 2012. These regulations apply in England, Scotland, Wales and Northern Ireland. Each transplant unit and NHSBT as an organisation who facilitates the organ donation process are required to have a licence to perform any of the activities regulated under the Regulations 2012.

Licensing under the Regulations

For the purposes of licensing by the HTA, there are two separate groups of activity detailed in the Regulations – procurement and transplantation.

Each includes a number of individual activities, described as follows.

  1. a. Procurement activities may include one or more of the following:
    1. donor characterisation;
    2. organ characterisation;
    3. preservation of an organ;
    4. making arrangements to transport an organ; and
    5. retrieval of an organ.
  2. b. Transplantation activities may include one or more of the following:
    1. organ characterisation;
    2. preservation of an organ;
    3. making arrangements to transport an organ; and
    4. implantation of an organ.
Each organisation must apply for a licence and state on the licence application form which activity or activities they wish to undertake. Multiple activities, both procurement and transplantation, can be carried out under a single licence.

http://www.legislation.gov.uk/uksi/2012/1501/pdfs/uksi_20121501_en.pdf

The framework for the quality and safety of human organs intended for transplantation

The document is designed to support organisations that are licensed under the Regulations. It forms part of the regulatory framework, which builds on many of the existing processes in the donation and transplantation community, to specify how the requirements for the quality and safety of organs intended for transplantation shall be ensured to secure compliance with the Directive.

HTA: The Quality and Safety of Organs Intended for Transplantation: a documentary framework

Under the Regulations there is a requirement that any licensed organisation report any serious adverse events or adverse incidents which affect the quality and safety of organs for transplantation in the chain or donation to transplantation.

Reporting of serious adverse events and adverse reactions under the Regulations.

It is a statutory condition of a licence for procurement or a transplantation activity to rapidly report to NHSBT (acting on behalf of the HTA):
  1. Relevant and necessary information concerning serious adverse events that may influence the quality and safety of organs and that may be attributed to the testing, characterisation, procurement, preservation and transport of organs, as well as any serious adverse reaction observed during or after transplantation, which may be connected to those activities;
  2. The management measures taken with regard to such a serious adverse event or reaction.
NHSBT assisted functions under the Quality and Safety of Organs Intended for Transplantation Regulations 2012.

In its role as the Competent Authority, the HTA has put in place an agreement with NHSBT to assist it with the following functions as permitted by regulation 21 of the Regulations. One of the assisted functions is the management of a reporting system for serious adverse events and serious adverse reactions (SAEARs).

This will require NHSBT to:
  1. Manage a system to report, investigate, register and transmit information about SAEARs associated with organ donation and transplantation; and
  2. fy the HTA of any SAEAR associated with organ donation and transplantation, the steps being taken to manage the SAEAR and confirmation that all actions associated with the SAEAR have been concluded.
NHSBT therefore have a system in place where incidents are reported, investigated and managed. NHSBT are required to report these serious adverse events or adverse incidents to the HTA. Further information can be found on the link below.

Guidance SAEARs

Next section: EU Tissue and Cells Directive

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