Organ Directive 2010/53/EU
EU Directive 2012/53/EU was transposed into Irish law by the European Union (Quality and Safety of Human Organs Intended for Transplantation) Regulations, S.I. No. 325 of 2012, and came into effect on 27 August 2012. The Irish Medicines Board is the competent authority under the Regulations and it must authorise donation and transplantation in accordance with the requirements of the Regulations.
The Regulations apply to donation, procurement, testing, characterisation, transport and transplantation of organs. They set out a clear legal framework for the application of quality and safety standards for human organs intended for transplantation.
The Department is working with the HSE and the IMB to ensure that hospitals meet the requirements in the Regulations. The HSE's National Organ Donation and Transplantation Office is overseeing the development of guidance documents, which will set out the appropriate processes and procedures to comply with quality and safety standards for all aspects of donation and transplantation. It is also assisting hospitals through its National Transplant Advisory Group, to comply with the Regulations.
Presentations from workshop on implementing EU Directive 2010/53/EU on standards of quality and safety of human organs intended for transplantation 24 April 2012, Coach House, Dublin Castle
1. Introduction: Ms Mary Jackson: Cancer and Blood Policy Unit, Department of Health.
2. Regulatory Requirements under the EU Directive: Dr Patrick Costello, Blood and Tissue Manager, Irish Medicines Board.
3. Work of the National Organ Donation and Transplantation Office / Organ Procurement: Prof Jim Egan, National Organ Donation and Transplantation Office, HSE.
4. Role of Voluntary Organisations: Mr Philip Watt, Chairperson, Irish Donor Network.
5. Role of Voluntary Organisations: Mr Mark Murphy, Irish Kidney Association.
Publications
Summary of the above document (on the EU website).
Legislation on Tissues and Cells
SI No 158 of 2006: European Communities (Quality and Safety of Human Tissues and Cells) Regulations 2006
SI No 598 of 2007: European Communities (Human Tissues and Cells Traceability Requirements, Notification of Serious Adverse Reactions and Events and Certain Technical Requirements) Regulations 2007
Useful Websites
European Commission - Public Health
European Framework for the Evaluation of Organ Transplants
European Directorate for the Quality of Medicines & HealthCare
