In October 2012, the European Commission adopted a implementing Directive to facilitate EU cross-border exchange of information about organs and their donors (in 2011, 30,000 organs were transplanted across the EU, many of which were shipped across borders).
The legislation aims to foster cross-border transmission of valuable information about:
- organs and donors (eg. types of organ – donor's age, gender, health history)
- the traceability of organs once exchanged, in compliance with confidentiality and data security measures
- reporting of serious adverse events and reactions to specific organs, allowing doctors to take appropriate measures if needed.
The Directive makes it mandatory for national authorities to exchange and store information on cross-border organ exchanges and to provide a 24/7 service in case of serious adverse reactions or events, allowing medical teams to take appropriate and timely action and to ensure safety of patients.
You can access the implementing Directive on the European Commission's website.
The implementing Directive follows the adoption of the general Directive on organ donations and transplantation in July 2010, which provides a framework of minimum standards that will apply throughout the EU, covering all stages of the process from donation to transplantation. Each EU country is required to create or designate a national authority which will be responsible for ensuring compliance with EU quality and safety standards, including requirements relating to information and data collection, traceability and reporting of adverse events, as well as deciding which healthcare organisations can procure and transplant organs.
Rapid alert system
Launched in February 2013, a secure alert platform seeks to improve the safety of patients undergoing transplantation and medical procedures involving human tissues and cells. The web-based Rapid Alert system for Tissues and Cells (RATC) allows national health authorities to raise alerts relating to human tissues or cells transferred across borders, ensuring that cross-border adverse incidents are prevented or contained and immediate measures are taken to ensure the safety of patients.
The RATC functions in parallel with existing national vigilance systems, which collect and manage alerts on tissues and cells donated and used within a Member State.
In addition to quality and safety defects of tissues and cells, the RATC can also be used to raise the alarm on illegal and fraudulent activities in this field.