NKF LettersHealth, Science and Bioethics Division
Department of Health
6th Floor South
Wellington House
133 - 155 Waterloo Road
London SE1 8UG
tel: 020 7972 4323
Ext: 24323
25 October 2011
Subject: Consultation by the Department of Health on proposed implementation approach for the Organ Directive
Your comments are invited as part of a consultation by the Department of Health that will run from 26 October 2011 to 21 December 2011 on draft Quality and Safety of Organs for Transplantation Regulations that transpose Directive 2010/53/EU on the standards of quality and safety of human organs intended for transplantation (the ‘Organ Directive’). The UK is required to be compliant with the Organ Directive from 27 August 2012. The Department of Health is undertaking the consultation on behalf of all UK health administrations.
One of the key requirements is that procurement organisations and transplantation centres must be licensed by the Human Tissue Authority. Copies of the draft Regulations, Directive, Impact Assessment including the Equality Impact Assessment and consultation document are below and will be put on the DH website on 26 October 2011
(See attached file: Consultation Regulations - PDF.pdf)(See attached file: Consultation Document 24 October final PDF.pdf)(See attached file: Consultation Impact Assessment - including EQIA.pdf)(See attached file: Organ Directive.pdf)
http://www.dh.gov.uk/en/Consultations/Liveconsultations/DH_130713. (please note this weblink, which contains all of the above documents, will not go live until Wednesday 26 October)
We have asked some specific questions in the consultation document but please provide comments on any aspect of the consultation package and email them to laurence.evans@dh.gsi.gov.uk or send them to the Organ Directive Consultation, c/o Organ Donation and Transplantation Team, Department of Health, 621 Wellington House, 133-155 Waterloo Road, London SE1 8UG using the template at Appendix A at the back of the consultation document.
The Human Tissue Authority are simultaneously consulting on their Framework Document which can be found at http://www.hta.gov.uk.
Please alert anyone else who may have an interest. Many thanks for your help.
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The National Kidney Federation cannot accept responsibility for the views expressed by others in these letters pages.