The draft proposals would provide a framework of minimum standards that would apply throughout the EU. If adopted, each EU country would need to create or designate a national authority which would 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.
The proposals are currently being examined at EU level and the European Parliament's Environment and Public Health Committee has adopted a draft report on the proposals. This will be put to a vote of the whole Parliament (provisionally scheduled for mid-May). The final text will need to be agreed by the health ministers of the EU countries and the European Parliament before it can become law.
Alongside the draft directive, the European Commission has adopted a 10-point action plan, covering the period 2009-2015, which aims to increase the number of organs available for transplantation and make transplantation systems more efficient and accessible, whilst maintaining high standards of quality and safety.
Potential impact on the NHS
In the UK, high standards of quality and safety already apply to organ transplants. In view of this, the NHS European Office is working with NHS organisations and NHS Blood and Transplant to ensure that, insofar as possible, the EU framework compliments existing UK arrangements and does not impose new, burdensome requirements on NHS organisations.
For further information, please contact: helena.bowden@nhsconfed.org