The Directive 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 will be 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.
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. The new Directive's framework approach means that EU countries have some flexibility in how they implement the new rules and the UK will be able to do this through existing systems and organisations, such as NHS Blood and Transplant. The Directive does, however, impose some new requirements, such as the need to individually authorise procurement organisations and transplant centres. EU Countries will have 2 years to implement the Directive rules.